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Patient Safety APSQ & PANASbmjqs-2014-002987supp

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WHO PATIENT SAFETY CURRICULUM GUIDE FOR MEDICAL SCHOOLS

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WHO PATIENT SAFETY CURRICULUM GUIDE FOR MEDICAL SCHOOLS

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COVERPAGE

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FULL VERSION

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SUMMARY VERSION

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MALAYSIAN PATIENT SAFETY GOALBOOK

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Attitudes to patient safety amongst medicalstudents and tutors: Developing a reliableand valid measure

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Attitudes to patient safety amongst medicalstudents and tutors: Developing a reliableand valid measure

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Carruthers et al 2009

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Patient safety awareness among UndergraduateMedical Students in Pakistani Medical School

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Patient safety awareness among UndergraduateMedical Students in Pakistani Medical School

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Kamran et al 2018

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PAKISTAN PATIENT SAFETY MEDICAL STUDENTS

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Patient Safety score Postgrade Residents  & Nurses

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UNIVERSITY OF ABERDEEN

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PATIENT SAFETY AWARENESS COURSE FOR JUNIOR HEALTH CARE PROFESSIONAL

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PATIENT SAFETY AWARENESS COURSE FOR JUNIOR HEALTH CARE PROFESSIONAL

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PATIENT SAFETY CULTURE AMONG MEDICAL STUDNETS IN SINGAPORE & HONG KONG

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PATIENT SAFETY CULTURE AMONG MEDICAL STUDNETS IN SINGAPORE & HONG KONG

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Leung et al 2013

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Educating future leaders in patient safety

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Agnès Leotsakos, ¹ Antonella Ardolino, ² Ronny Cheung, ³ Hao Zheng, ¹ Bruce Barraclough, ⁴ Merrilyn Walton ⁵

1Patient Safety Programme, World Health Organization, Geneva, Switzerland; ²Wessex Deanery, Winchester, UK; ³Imperial Healthcare NHS, London, UK; ⁴The Australian E Health Research Centre, Royal Brisbane and Women's Hospital, Brisbane, Australia; ⁵Sydney School of Public Health, Faculty of Medicine, University of Sydney, Sydney, Australia

Abstract: Education of health care professionals has given little attention to patient safety, resulting in limited understanding of the nature of risk in health care and the importance of strengthening systems. The World Health Organization developed the Patient Safety Curriculum Guide: Multiprofessional Edition to accelerate the incorporation of patient safety teaching into higher educational curricula. The World Health Organization Curriculum Guide uses a health system-focused, team-dependent approach, which impacts all health care professionals and students learning in an integrated way about how to operate within a culture of safety. The guide is pertinent in the context of global educational reforms and growing recognition of the need to introduce patient safety into health care professionals' curricula. The guide helps to advance patient safety education worldwide in five ways. First, it addresses the variety of opportunities and contexts in which health care educators teach, and provides practical recommendations to learning. Second, it recommends shared learning by students of different professions, thus enhancing student capacity to work together effectively in multidisciplinary teams. Third, it provides guidance on a range of teaching methods and pedagogical activities to ensure that students understand that patient safety is a practical science teaching them to act in evidence-based ways to reduce patient risk. Fourth, it encourages supportive teaching and learning, emphasizing the need to establishing teaching environments in which students feel comfortable to learn and practice patient safety. Finally, it helps educators incorporate patient safety topics across all areas of clinical practice.

Keywords: patient safety education, WHO Patient Safety Curriculum Guide: Multiprofessional Edition

A Letter to the Editor has been received and published for this article.

Introduction

Patient safety is fundamental to safe patient care. Although the principles and concepts of patient safety are acknowledged as a critical part of health professional education and training, many health care providers and academics remain uncertain as to how to integrate patient safety into health care education and clinical care, and are yet to integrate patient safety knowledge into bedside practice.

The importance of education and training in patient safety has been acknowledged for over a decade, yet, in most countries, it remains underutilized and undervalued as a method of addressing the many challenges facing contemporary health care. The World Health Organization (WHO) Patient Safety Curriculum Guide: Multiprofessional edition is a comprehensive curriculum designed to achieve that improvement in health care. The curriculum, when implemented, has the capacity to provide health care professionals with the underpinning and applied knowledge to incorporate patient safety principles into their practice, in a range of health care contexts.

The WHO Patient Safety Curriculum Guide: Multiprofessional Edition was launched in October 2011. It was based on the 2009 Patient Safety Curriculum Guide for Medical Schools, which was a first step in the process of establishing a patient safety curriculum for all health care professionals.

Patient safety education worldwide

Over the last decade, national patient safety and quality agencies as well as regional and global bodies have initiated Patient Safety Programs and have galvanized the support of political and health leaders worldwide (see Table 1). Patient safety learning in the workplace, coupled with greater recognition of the need to prepare health professional students for safe practice during their education, have led to a gradual transformation in the way that patient safety is viewed. While we are yet to reach a tipping point, many clinicians and leaders know that adverse events will only be reduced and managed effectively by health professionals when they are aware of and integrate patient safety principles and concepts into their daily practice.

Despite a plethora of patient safety initiatives, patient safety education for health professionals in the higher education sector has not kept up with workforce requirements. In developed countries, medication errors and surgical mistakes are routinely documented using incident reporting systems, but we are yet to see curricula contain the knowledge and skills required by health professional students to address and reduce patient harm. Patient safety has been incorporated into the higher education curricula slowly and somewhat sporadically. For example, a media article recently cited a leader's view that "patient safety is not incorporated fast enough in medical schools". A 2007 multi-institutional assessment of patient safety knowledge among medical trainee clinicians confirmed the need for patient safety education, but found that patient safety knowledge across a broad range of training, types of qualification, and specialties were substantially limited and that trainees were unable to self-assess their knowledge deficits.

A UK study of the impact of teaching, learning, and practicing patient safety in academic, organizational, and practice contexts highlighted that patient safety education needs to be more explicitly and integrated in health care curricula. The Commission on Education of Healthcare Professionals for the 21st Century (although not focused specifically on patient safety) highlighted the weaknesses of health care professional training, including:

a mismatch of competencies to patient needs; curricular rigidities and static pedagogy, poor teamwork learning; narrow technical focus without broader contextual understanding; and weak leadership to improve health-system performance.

The Commission recommended a system-wide reform to encourage adaptation, improvement, and flexibility in health care education generally and to create a health care professional workforce prepared for collaboration and trans- and interprofessional teamwork who are able to adapt to local requirements and needs. More recently, the WHO presented the general requirements necessary for incorporating patient safety in education and the skills inherent in that, such as teamwork and communication, human factors and safety, engagement of patients in their care, and wider contextual awareness and system-wide understanding of health care.

Patient safety education in the developing world merits particular attention. Poor educational infrastructure, lack of resources and education materials, shortcomings of qualified educators because of low motivation or insufficient skills, and underfinancing of the higher education sector for health care professionals make patient safety education more challenging than in resource-rich countries. Integrating patient safety into undergraduate education in developing countries and in some transitional countries, which have advanced health care and education systems, is a significant challenge. A recent study in the People's Republic of China reported that, in addition to an already busy curriculum, leadership support, faculty engagement, course design, and teaching formats presented major challenges that deter the integration of patient safety education into existing curricula.

In higher education for health care professionals, professionalism generally, but patient safety specifically, has been overlooked by many academic institutions. Integrating new patient safety and patient-centered curricula is important if education is to contribute to improving patient safety. Patient safety is not another subject to add to an already over-packed curricula, but serious thought is required as to how health professional teachers can integrate patient safety competencies into their clinical teaching and learning. Each health care profession should tailor patient safety principles and concepts to their own needs, limitations, and culture for positive changes to occur.

The role of education and training in patient safety

Patient safety education of health care professionals has been given little attention, resulting in students' limited understanding of the risk in health care and the importance of strengthening systems. Furthermore, the professional ethos of extending a health care provider's responsibilities beyond the care of their individual patients to ensuring safe delivery of health care as a whole is not often conveyed or obvious to students. There is also little emphasis in much curricula or practice of multi-professional teamwork and communication about the causes of harm and how to protect patients. Some of the factors that contribute to this situation are:

Lack of recognition by health care educators that teaching and learning patient safety should be an essential part of the undergraduate curricula for health care students, and that patient safety skills can be taught.

Lack of familiarity of educators or trainers to teach patient safety as a new area of knowledge and learning.

Reluctance by academic institutions and educators to teach health care students knowledge that is outside the clinical discipline, often because of existing full curricula.

A historical emphasis on treatment of disease rather than prevention of illness creates a culture that finds it difficult to give merit to a "non-event" (ie, a preventable adverse event).

Educational silos when different disciplines are taught separately, which is contrary to the interdisciplinary team approach stressed by patient safety education.

Entrenched attitudes regarding the traditional teacher-student relationship - a relationship that may be hierarchical and competitive, and in which an "expert" disseminates information to the student.

Undergraduate education plays a major role in the promulgation of evidence-based competencies incorporating concepts, knowledge, and skills in patient safety. Teaching patient safety can have a positive impact by promoting the competencies needed for safe health care.

The WHO Patient Safety Curriculum Guide: Multiprofessional Edition

Patient safety is recognized as the responsibility of all health care professionals and not specific to one profession; therefore, all health professional learning should integrate patient safety competencies into clinical teaching and skills development.

The 2011 WHO Multi-professional Patient Safety Curriculum Guide was developed to satisfy the demand for a single coordinated, systems-based, team-dependent approach, to ensure patient safety learning is delivered in an integrated way. This encourages shared learning across professions, as well as building an organizational culture of safety in all health care systems - a need highlighted by the Commission on Education of Healthcare Professionals for the 21st Century.

The WHO Patient Safety Curriculum Guide: Multiprofessional Edition is an updated, evidence-based edition of the WHO Patient Safety Curriculum Guide for Medical Schools. It is divided into two parts. Part A provides practical support and guidance to educators on how to deliver the patient safety topics described in Part B and also offers background information to educators on how to select and teach each topic, makes suggestions on how to integrate patient safety teaching, and provides techniques for exploring how patient safety learning could fit into the institution's existing curricula. Clear examples are provided throughout Part A on how patient safety might be taught. Part B describes eleven patient safety topics (see Table 2) that cover a wide range of contexts in which patient safety learning can occur. The ready-to-teach topics can be used either as a whole or on a per-topic basis. They provide the foundation for undergraduate and graduate health care students to obtain the core knowledge and skills required to practice safely. Educators can choose topics to introduce into their curricula as guided by institutional requirements, resources, and their capacity. A number of different educational approaches are suggested for each topic.

The underpinning principles of the WHO Curriculum Guide are to support educators to teach patient safety. It is easily adaptable to local patient safety requirements and written in an easily understood language so that it applies to all countries, cultures, and contexts.

Evaluation of WHO Patient Safety Curriculum Guide: Multiprofessional Edition took place in 12 pilot sites, which included dental, nursing, midwifery, and pharmacy schools around the world, and ten complementary test sites. Outcomes of the evaluation study are available at the WHO website.

How to advance patient safety education

Taking into account the suggestions of The Commission on Education of Healthcare Professionals for the 21st Century, the WHO Curriculum Guide provides instructions, practical recommendations, and technical content to address educational weaknesses that include the mismatch of competencies to patient needs, the rigidity of curricula and static pedagogy, and poor teamwork learning.

In addition, the Curriculum Guide helps build capacity for patient safety education in all countries across the whole socioeconomic spectrum. It prioritizes and describes what to teach and how to teach, in terms of patient safety, in a single volume. The guide helps in five ways (described below) to advance patient safety education, taking advantage of global trends and opportunities for educational reforms, focusing particularly on the need to introduce patient safety into health care professionals' curricula.

International scope and context

The Commission on Education of Healthcare Professionals for the 21st Century states that, because of global interdependence in health and the fact that universities and educational institutions are broadening their traditional roles, "educational reforms are timely for health professional education to meet standards and needs of 21st century". The Curriculum Guide attempts to encourage both health care educators and students worldwide to share common understanding, knowledge, and skills in patient safety to assure coverage of high-quality and safe services, as members of locally responsive teams operating within a culture of safety and globally connected members advancing patient safety definitions, content, and solutions. The content of the Curriculum Guide takes into account the wide variety of contexts in which health care educators and students teach and learn. The WHO Expert Working Group, composed of more than 50 international experts, was involved in the development of the curriculum to ensure its cultural appropriateness and global reach. Teaching and assessment strategies are designed to take into account both the diversity in available resources and cultural differences that could affect the learning environment. As a resource that is freely available to all health care systems globally, the Curriculum Guide reinforces the ethos that safety is a right for all patients, and not a luxury confined to better-resourced health care systems.

Team-based approach to patient safety

The second aspect of the Curriculum Guide is about building student competencies in relation to patient needs. This is reflected in the multi-professional perspective of the Curriculum Guide, and the context of educating health care students, irrespective of their chosen profession, to understand and practice patient safety. It supports and promotes a collaborative, nonhierarchical way of delivering care. Multidisciplinary teamworking is increasingly part of the role of doctors, midwives, nurses, pharmacists, and even dentists, who have traditionally provided their services in isolation from other health care services. The multi-professional WHO Curriculum Guide is the first coordinated product of its kind to embrace a global outlook and a multi-professional perspective within a systems approach. It demonstrates how patient safety learning can be delivered in an integrated way. This approach encourages shared learning by students of different professions and a better understanding of the need for joint working, thus enhancing student capacity to work together effectively in future practice. This perspective pervades all of the guide's topic chapters. Knowledge and skill requirements are described for students to enable them to become effective team players, deliver accurate and timely cross-disciplinary communication, and act ethically with respect for colleagues. It also prepares them for working in a culture that does not identify all errors and mistakes as blameworthy but only those made in the context of working in a complex system. Within this context, each topic chapter provides examples of case studies drawn from different health care settings and professional groups and highlights a range of tools and resources reflecting the multi-professional viewpoint. Case studies are regarded as an effective learning tool in interdisciplinary education. In the Curriculum Guide, case studies have been described to highlight the risks to patients from a multi-professional perspective and to bring the Curriculum to life by giving real examples of what can go wrong and how effective teamwork can have an immediate and positive impact on patient safety.

Patient safety beyond the classroom

To address the challenge of rigid curricula and static pedagogy, the WHO Curriculum Guide recommends the use of many, different learning channels to provide balanced guidance for didactic teaching. Recommended teaching methods include active instruction of students through a range of pedagogical activities, including patient and health professional buddying, role-modeling, undertaking hospital-based improvement and team-based learning projects, independent studies, and participating in simulation training. The WHO Curriculum Guide provides lists of websites and links to resources and information on patient safety for both learners and teachers. The theme of educational collaboration runs across all the topic chapters as an instrument for enhancing the sharing of information, experiences, and synergies between institutions. The importance of extending educational activities beyond the use of static curricula and the university boundaries is highlighted, and educators are encouraged to use instruments such as networking and partnerships with other universities in the same country and internationally for academic exchange and practical learning.

The Curriculum Guide is designed to make use of multiple dissemination channels so that its teaching resources, tools, slides, case studies, and references are available worldwide through printed copies, websites (for example, http://www.who.int/patientsafety/education/curriculum/en/index.html, http://www.who.int/patientsafety/education/vincristine_download/en/index.html, http://www.who.int/patientsafety/research/online_course/en/index.html), CD-ROMs, instruction in WHO workshops, and WHO e-learning.

Grounded in sound educational theory and practice

Every country and institution has its own unique traditions and culture of educating health care professionals. Hierarchical teaching styles, stagnant pedagogy, and professional silos have a negative impact on student learning generally, but specifically for patient safety. The Curriculum Guide encourages supportive teaching and learning, emphasizing the importance of establishing an environment in which students feel comfortable to learn and practice patient safety. The chapters emphasize that educators are role models for students; their clinical knowledge and patient safety skills are explicit within training the next generation of health care providers. At the same time, WHO Curriculum Guide empowers students to recognize their educators as embodying an open safety culture and instilling the professional ethos of open reporting and safety consciousness in them.

Integration into existing curricula

The content and structure of the WHO Curriculum Guide is designed to support educators in incorporating priority patient safety topics into all areas of practice and all health care professions. The topic modules of the Curriculum Guide are not taught as a stand alone course, but can be incorporated into existing teaching of, for example, microbiology, obstetrics, physiology, etc. Addressing patient safety is integral to all health care professionals' clinical practice and is not a subject to be studied in isolation. The eleven priority topics are self-contained, ready-to-teach modules that can be used as a whole, modified, or taught on a per-topic basis.

Almost all health care curricula have limited space and time for the addition of new courses. Each patient safety topic from the Curriculum Guide is designed to be easily integrated into existing curricula, although integration of all topics is necessary for the development of safe clinicians.

Conclusion

The WHO Curriculum Guide is a freely available resource for implementing patient safety education. As a comprehensive guide, it contains information for all levels of faculty and students and lays the foundation for capacity-building in the essential patient safety principles and concepts. Part A of the Curriculum Guide is a rich resource for educators involved in the development of health care curricula.

Its global, multi-professional perspective reflects the need to address patient safety on a system-wide basis, involving all health care professionals and students learning in an integrated way how to operate within a culture of safety, openness, and reporting, which should be the cornerstones of future health care systems worldwide. It is through such an integrated approach including all future health care professionals that we can change, at pace and scale, the global health care environment to one in which health-related harm becomes a rare event.

Author contributions

Agnès Leotsakos (main author): writing of the paper; execution of the study. Antonella Ardolino: desk research and writing of the paper; Ronny Cheung: desk research and writing of the paper; Hao Zheng: writing of the paper, execution of the study; Bruce Barraclough: execution of the study, revised and approved final version of the paper; Merrilyn Walton: editing of the paper and execution of the study.

Acknowledgments

Enrique Acosta-Gio, National Autonomous University of Mexico, Mexico; Jean Barry, International Council of Nurses, Switzerland; Jiri Vlcek, Charles University, Czech Republic; Nermin Yamalik, Hacettepe University, Turkey, Eleni Azarias and Reema Harrison, Sydney University, Australia.

Disclosure

The authors report no conflicts of interest in this work.

References

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[Full text] Educating future leaders in patient safety | JMDH

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Educating future leaders in patient safety Agnès Leotsakos,1 Antonella Ardolino,2 Ronny Cheung,3 Hao Zheng,1 Bruce Barraclough,4 Merrilyn Walton5 1Patient Safety Programme, World Health Organization, Geneva, Switzerland; 2Wessex Deanery, Winchester, UK; 3Imperial Healthcare NHS, London, UK; 4The Australian E Health Research Centre, Royal Brisbane and Women's Hospital, Brisbane, Australia; 5Sydney School

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Role of medical students in preventing patient harm and enhancing patient safety

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Role of medical students in preventing patient harm and enhancing patient safety

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Abstract

Background: Substantial efforts are focused on the high prevalence of patient harm due to medical errors and the mechanisms to prevent them. The potential role of the medical student as a valuable member of the team in preventing patient harm has, however, often been overlooked.

Methods: Four cases are presented from two US academic health centers in which medical students prevented or were in a position to prevent patient harm from occurring. The authors directly participated in each case.

Results: The types of harm prevented included averting non-sterile conditions, missing medications, mitigating exposure to highly contagious patients, and respecting patients' "do not resuscitate" requests.

Conclusion: Medical students are often overlooked as valuable participants in ensuring patient safety. These cases show that medical students may be an untapped resource for medical error prevention. Medical students should be trained to recognize errors and to speak up when errors occur. Those supervising students should welcome and encourage students to actively communicate observed errors and near misses and should work to eliminate all intimidation by medical hierarchy that can prevent students from being safety advocates.

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Deaths attributed to medical error are estimated to be the third leading cause of death in the US, resulting in 48 000-98 000 deaths each year. The literature on preventing medical errors in general is rapidly evolving, but applicability toward trainees has not been sufficiently addressed. Some attention has been paid to the role of resident physicians in preventing errors and to the importance of teaching about patient safety in graduate medical education. However, there has been less attention to the perception of errors by medical students and to the role they could have in error prevention.

Medical students want to contribute to the healthcare team, but their lack of clinical knowledge and inexperience (and corresponding lack of confidence), the fact that they are not licensed providers, unwillingness or hesitancy to speak up (possibly routed in fear of negative evaluation or other consequences), and the medical hierarchy all discourage error identification and student communication of observed errors. As the cases in this paper illustrate, student contributions to patient safety therefore may be not initiated, ignored, or overlooked. However, because medical errors are often caused from miscommunication and poor accessibility of information, medical students may be as adept at preventing certain types of errors as other members of the healthcare team. Because students usually follow fewer patients than house staff, they can afford greater attention to details that may frequently lead to medical errors (for example, prescribed versus administered medications). Moreover, the inclusion of medical students in the care of the patient affords increased redundancy to catching medical errors and mitigating their consequences.

Medical students do witness medical errors, with one study reporting that 76% of medical students had observed a medical error. Yet only about half of these students (who had received formal training in patient safety) reported the errors to a resident or attending, and only 7% reported using an electronic error reporting system. These data, and the cases presented below, suggest that substantial cultural changes are needed to make students proactive when they see errors.

This paper illustrates the powerful role medical students can play in preventing patient harm and introduces students as an untapped resource for error prevention. We present four real case histories in which one of the authors (then medical students) prevented or could have prevented patient harm (table 1).

CASES

Case 1: Sterile technique in the operating room (OR)

Case history

A third year medical student on her surgery rotation was scrubbing on a wrist arthroscopy case. The student had seen two previous wrist arthroscopies performed by other surgeons. The resident and student positioned the patient's arm for sterile preparation. After the arm was in position the attending, resident, and student left the OR to scrub. As the patient's arm was being positioned into the traction apparatus the student noticed that skin on the arm of the Caucasian patient lacked the residual yellow hue of the iodine based prep and concluded that the arm must not have been prepped sterilely. The student assumed that the attending was aware of this. On previous surgeries the student had noticed that the surgeons would often double glove while prepping and setting up and then remove their outer gloves. At one point in draping, the patient's unprepped hand touched the attending's arm above his outer gloves. The student mentioned this to the attending but the attending did not respond.

The student felt that the maxim in surgery was "medical students should be seen and not heard" and therefore did not repeat the warning. The student also still thought sterile prep was forthcoming. After the patient's arm was positioned, the student inquired if they should take off their outer gloves (which had been holding the patient's unprepped arm). The resident and attending, confused by the question, responded that the student could. As the attending prepared to make the first incision on the unclean skin, the student quietly told the resident that the patient's arm had not been prepped. The resident replied that the arm had been prepped, but then noticed the patient's arm was still white. The patient's arm was re-draped, prepped, a sterile traction apparatus located, and the operation proceeded without incident.

Error analysis

This near miss raises many important issues. As in many medical errors, the etiology was one of poor communication and follow through. The OR team failed to communicate who was going to be responsible for prepping. The student's perception of surgical hierarchy and the OR culture made it difficult for the student to speak up when she first noticed the unprepped arm. The student also felt more comfortable disclosing the error to the resident instead of the attending (a behavior seen elsewhere).

In this case the student prevented the medical error. Some students might have spoken up sooner; some may not have said anything at all. In addition, some luck was involved in making this case a near miss (the hue of the iodine based prep on a light skinned patient).

Lessons learned

The Accreditation Council for Graduate Medical Education (ACGME) competencies for US resident education provide a useful framework for categorizing the lessons learned in the cases in this paper and illustrate how this construct can be applied to undergraduate medical education. Firstly, the competencies of patient centred care and professionalism suggest that students should prioritize the safety of the patient ahead of their own hesitancy to speak up. However, the student also needs sufficient medical knowledge to recognize that sterile preparation is always performed for invasive procedures. Increased use of interdisciplinary team training (with emphasis on talking to superiors) would enhance the practice-based learning and improvement opportunities, and aim to provide an increased comfort level for any team member to speak up when an error is recognized.

The cornerstone of earlier detection of the near miss in this case rests upon interpersonal and communication skills. Students, as well as the entire healthcare team, should be encouraged to speak up in times of uncertainty regarding procedures and patient safety. Unfortunately, the case above is not an isolated example of a failure to speak up. The pre-procedure "time out", which is now mandated by the Joint Commission on Accreditation of Healthcare Organizations (JCAHO) immediately prior to beginning invasive procedures, creates a valuable opportunity for communication between members of the operative team. If the team leader uses this "time out" not only for verification of the patient's name and anticipated procedure but also as a forum to remind all operative team members that they are expected to speak up if they see any safety concerns, even junior or novice team members such as medical students may be more likely to express concerns when they arise. Finally, systems based practice changes (such as standardization of the sterile prepping procedure) could provide another approach to prevent this kind of near miss from recurring.

Case 2: Drugs prescribed versus drugs administered

Case history

A student on her first third year clinical rotation was assigned to follow a 21 year old man with steroid treated ulcerative colitis admitted for a planned total abdominal colectomy. The patient was doing well for the first three postoperative days, but on day 4 the student found while pre-rounding that the patient had been vomiting since 3 am and appeared acutely ill. The team later questioned if the symptoms were secondary to the patient's recent change in diet from "nothing by mouth" to clear liquids. A plain abdominal radiograph was ordered and showed apparent free air under the diaphragm, indicating a possible postoperative perforation.

Upon review of the patient's chart the resident realized that the patient had not received the ordered postoperative famotidine (Pepcid) during the first four postoperative days. The service's practice was for selective histamine blockers such as famotidine to be prescribed after gastrointestinal surgery to protect the gastrointestinal mucosa, relaxed from anesthesia, from the potentially erosive effects of gastric acid. While famotidine was written in the postoperative orders, it had never been transcribed to the computer based medication administration record (MAR).

A subsequent gastrointestinal follow through study showed that the patient had not perforated but probably had a postoperative ileus with the observed free air possibly residual from the surgery. He received a nasogastric tube and was finally started on famotidine. The patient quickly improved and was discharged home approximately 4 days later.

Error analysis

This case is a relatively benign example of the common problem of medication errors-that is, the failure to administer ordered medications. This medical error could have been prevented in many ways. For example, enhanced systems based practice such as the use of computerized physician order entry systems with standard order sets and decision support may help prevent such errors (although they are not without flaws themselves).

Lesson learned

In this case only the resident noticed the missing medication once the patient became symptomatic. However, this error could have been prevented by the medical student if students performed a daily check of their patients' MAR to see that all medications ordered for their patients are being administered. One suggestion is for students to add a table (fig 1) to their daily work round sheet that includes check boxes for drugs ordered, or to otherwise make it their practice to check the MAR daily. From a competencies perspective, it is also helpful for students' medical knowledge to include common medication errors and drug interactions. Students could also easily be trained to perform the increasingly used safety practice of medication reconciliations, or to use error prone drugs as "trigger tools" to prompt heightened awareness for error. Communication skills and professionalism would come into play if the student detected an error.

Case 3: Respecting the do not resuscitate (DNR) order

A third year student on his medicine rotation was following a very sick elderly patient with end stage Alzheimer's disease and severely compromised activities of daily living who was admitted for percutaneous endoscopic gastrotomy tube insertion. The patient's code status was "do not resuscitate" (DNR). On the day of the procedure a cardiac arrest code was called in the post-anesthesia care unit (PACU). Upon arrival in the PACU the resuscitation had been started by the PACU staff, and the student's senior resident began to lead the code. The third year student whispered to a classmate that the patient was DNR but did not know what to do-the student did not know resuscitation efforts could be stopped once initiated. After several minutes the student realized that there was no harm in reminding the team of the DNR status of the patient. After discussion, during which the code continued, resuscitation efforts were terminated and the patient was pronounced dead.

Error analysis

In spite of the ethical, legal, and individual value of DNR orders, the medical community lacks consistent mechanisms for maintaining continuity of a patient's code status and they have been overlooked in the past. Wachter and Shojania reported the termination of resuscitation efforts because the wrong patient's chart was pulled and, similarly, a junior staff member was afraid to speak up (the patient's nurse, just out of nursing school, correctly thought that the patient was full code). This case illustrates the confusion and diffusion of authority that can take place in resuscitations.

Lesson learned

Like case 1, this case illustrates the troubling pattern of medical students being afraid to speak up, suggesting greater need for increased communication based competency training of all parties from student to faculty member. When medical students possess vital information it is essential that it is promptly communicated to the team. In addition, students' medical knowledge competency should include information on appropriate initiation and termination of resuscitation efforts. Finally, in terms of patient centred care, emphasis should be placed on appropriate display and communication of patients' individual resuscitation preferences.

Case 4: Infection precautions complicated by language barrier

A third year student on his medicine rotation was called to the Emergency Department (ED) to evaluate a Spanish speaking patient with a presumed pneumonia. As the student had only moderate Spanish skills, he decided to request a translator. The student found the patient's symptoms included hemoptysis, night sweats, and weight loss, and the patient had recently immigrated from Mexico where her mother had died of tuberculosis (TB). The student immediately obtained protective masks for the providers, the patient, and the patient's husband. The student asked the ED attending whether TB was on her differential diagnosis for this patient, to which the attending responded: "Yeah, I thought about it". The attending did not comment about the possible danger the patient posed to the other patients, the student, or the translator. Examination of the chest radiograph revealed markings consistent with TB. Several days later the patient's sputum tested positive for acid-fast bacilli (diagnostic for TB). The patient was placed on appropriate treatment and exposed staff were screened for PPD conversion.

Error analysis

The error in this case is one of delaying treatment and exposing other patients and staff to a potentially infectious disease. This error probably occurred because of insufficient triage evaluation of a patient with a cough and was complicated by the language barrier.

Lesson learned

Medical students are repeatedly told in their training that the patient's history is their most powerful diagnostic tool. An inability to communicate effectively, due to language barrier or otherwise, significantly diminishes the effectiveness of patient histories. Students, with their additional time, may more readily seek the help of translators. In this case we can see that this student's perseverance led to the correct diagnosis and correct treatment for the patient and also avoided further unnecessary exposure of hospital personnel. However, this case also illustrates the difficulty that students and other trainees may encounter when trying to convey information or management suggestions to an unreceptive superior, and the need for competency in communication and patient centred care. In this case the student pursued a diagnosis of TB that the attending had dismissed. In such situations, appropriate but sensitive confrontation with the goal of providing safe patient care is imperative. In addition, students should note that systems changes could also improve patient centred care and communication-for instance, by automatically paging a translator when a non-English speaking patient arrives in triage.

DISCUSSION AND RECOMMENDATIONS

In this paper we present several cases in which medical students appropriately characterized a problematic situation and, in some cases, prevented a medical error and patient harm. Medical students are members of the healthcare team with sufficient knowledge and awareness to recognize medical errors and add another layer to system defences. Moreover, because students follow fewer patients and can spend more time with each patient than residents, they can afford greater attention to detail. While students can and should participate to their fullest ability to enhance patient safety, it should be noted that students should never be seen as being the principal team member responsible for patient safety, as they may often be required to leave patient care activities for lectures, examinations, or to study. And there is always the possibility that a student's knowledge base will be deficient to prevent a particularly complex error from occurring.

This paper does not present examples in which students themselves may cause errors (procedural or otherwise), another important subject that has received only limited attention. Some recommendations-such as a patient safety curriculum for undergraduate medical education, the use of interdisciplinary team training, and the use of simulation-show promise as useful interventions to improve safety, but have been significantly discussed elsewhere. We offer below new recommendations categorized by the ACGME resident based competencies to increase student awareness of medical errors and to empower them as team members who can contribute to patient safety. These recommendations are derived from the experiences seen in the cases presented above. However, the small number of cases examined may mean that the cases are not generalizable to all medical student experiences.

Train students to practise patient centred care and to be familiar with patient information that is essential to safety.

Train students in elements of practice-based learning and improvement as well as systems-based practice.

Provide students with appropriate medical knowledge for common causes of medical error.

Recommendation 1: Improve students' interpersonal, communication, and professionalism skills

Providing health care always involves accessing pertinent information and data. The number of sources and the large volume of information that must be synthesized stack the odds that a clinician may at some point miss an important piece of data. Students should be trained and have practical experience in speaking up without hesitation when they possess information that is critical to safe patient care. The wrist arthroscopy and the DNR order cases indicate the need for students to be vocal when they possess overlooked information and how hierarchy and unfamiliarity with roles and responsibilities can hamper disclosure. Prefacing phrases such as "I'm probably mistaken, but..." or "this might be a ridiculous question, however..." can deflect the confrontational interaction that might otherwise discourage a student from questioning the action of his/her superior.

Similarly, the medical staff hierarchy must become receptive to students raising patient safety-related questions. Students rarely spend a period longer than a month in any one clinical setting, and thus may always have a tendency to feel like an outsider. Our experience and that of others shows that students may feel hesitant and delay communicating a known error because of their junior or outsider status and the intimidation they feel from the medical hierarchy. In aviation, a hesitancy to question the captain led to 583 fatalities in the 1977 collision at Tenerife, Canary Islands-the worst aviation accident in history. As a result of this accident, however, the training technique of crew resource management (CRM) was pioneered in an attempt to teach that concerns regarding safety can and must be conveyed by any team member. Moreover, high reliability organizations (such as aviation and nuclear power) teach us the importance of having respect for an individual's expertise, regardless of their rank. In addition, because patient safety is such a new topic in the realm of medical knowledge, all learners from medical student to attending faculty can be considered novices and should be equally receptive to questions and comments regarding safety.

Making the medical staff more receptive to students raising safety questions requires challenging cultural changes that will not occur without consistent high level leadership, ongoing training in communication and teamwork, and accountability for patient safety outcomes. In this way the medical staff might see students as assets in trying to help the team reach patient safety goals. Finally, students should recognize that appropriate competency in professionalism means the patient's needs for safe patient care supersede any self-interest that might cause hesitancy in bringing attention to a potential error.

Recommendation 2: Train students to practise patient centred care and to be familiar with patient information that is essential to safety

Students should be familiar with common and essential data about their patients such as medications (that they are ordered and administered), allergies, code status, and other information that might easily be overlooked. The second case above illustrates how an ordered drug may not actually be administered. Also, when patients have a procedure or surgery planned, students should assist the team in completing verification of site, side, correct patient, and correct procedure.

Recommendation 3: Train students in elements of practice-based learning and improvement as well as systems-based practice

Students should report errors and near miss events to available reporting systems to enhance understanding of errors. While students sometimes report errors to residents and faculty, event reporting tools are used much less frequently. Moreover, by reporting both errors and near miss events, students contribute to the knowledge base that can help prevent future errors and increase their own awareness of error prevention.

In addition, a demonstrated understanding and attention to quality and patient safety should be part of medical student competencies and corresponding evaluation. For medical students especially, assessment drives behavior. If students are expected to achieve competency in improving quality and safety and are given methods to achieve this competency, they will do so. For example, routine evaluations on clinical clerkships could include a question as to whether the student noticed, discussed, or otherwise contributed to areas of quality improvement or safety concerns.

Recommendation 4: Provide students with appropriate medical knowledge for common causes of medical error

In the case series presented here, medical knowledge was necessary in sterile technique (case 1); postoperative perforations after gastrointestinal surgery and medication prophylaxis (case 2); ethical termination of resuscitation efforts (case 3); and recognition of contagious diseases such as TB (case 4). This is merely an anecdotal list of ways in which medical knowledge can be important to safety. While the necessary knowledge for these cases might be imparted in any medical school curriculum (for example, in the surgery clerkship or ethics course), specific emphasis on how this is safety related content should also be provided. Comprehensive literature on the epidemiology and etiology of medical error should be matched to related content in medical school curricula so that specific safety related medical knowledge is developed.

Incorporation of these recommendations can bolster the safety in academic medical centers by using medical students as a previously untapped advocate for patient safety.

Acknowledgments

The authors thank Julie Johnson, Paul Barach, Robert Wachter, John Hickner, Steve Small, and David Stevens for review and suggestions regarding this manuscript.

View Abstract

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Role of medical students in preventing patient harm and enhancing patient safety

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Background: Substantial efforts are focused on the high prevalence of patient harm due to medical errors and the mechanisms to prevent them. The potential role of the medical student as a valuable member of the team in preventing patient harm has, however, often been overlooked.

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Patient safety education for undergraduate medical students: a systematic review

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Research article

Open Open Peer Review

Published:

Abstract

Background

To reduce harm caused by health care is a global priority. Medical students should be able to recognize unsafe conditions, systematically report errors and near misses, investigate and improve such systems with a thorough understanding of human fallibility, and disclose errors to patients. Incorporating the knowledge of how to do this into the medical student curriculum is an urgent necessity. This paper aims to systematically review the literature about patient safety education for undergraduate medical students in terms of its content, teaching strategies, faculty availability and resources provided so as to identify evidence on how to promote patient safety in the curriculum for medical schools. This paper includes a perspective from the faculty of a medical school, a major hospital and an Evidence Based Medicine Centre in Sichuan Province, China.

Methods

We searched MEDLINE, ERIC, Academic Source Premier(ASP), EMBASE and three Chinese Databases (Chinese Biomedical Literature Database, CBM; China National Knowledge Infrastructure, CNKI; Wangfang Data) from 1980 to Dec. 2009. The pre-specified form of inclusion and exclusion criteria were developed for literature screening. The quality of included studies was assessed using Darcy Reed and Gemma Flores-Mateo criteria. Two reviewers selected the studies, undertook quality assessment, and data extraction independently. Differing opinions were resolved by consensus or with help from the third person.

Results

This was a descriptive study of a total of seven studies that met the selection criteria. There were no relevant Chinese studies to be included. Only one study included patient safety education in the medical curriculum and the remaining studies integrated patient safety into clinical rotations or medical clerkships. Seven studies were of a pre and post study design, of which there was only one controlled study. There was considerable variation in relation to contents, teaching strategies, faculty knowledge and background in patient safety, other resources and outcome evaluation in these reports. The outcomes from including patient safety in the curriculum as measured by medical students' knowledge, skills, and attitudes varied between the studies.

Conclusions

There are only a few relevant published studies on the inclusion of patient safety education into the undergraduate curriculum in medical schools either as a selective course, a lecture program, or by being integrated into the existing curriculum even in developed countries with advanced health and education systems. The integration of patient safety education into the existing curriculum in medical schools internationally, provides significant challenges.

Background

Health care outcomes have significantly improved with the scientific discoveries of modern medicine. But we also know as a result of studies undertaken in many countries that alongside these benefits are significant risks to patient safety. An extensive literature has been published about the effect of adverse drug reactions and medication errors since the Harvard study in the USA in 1991 first described the extent of harm to patients. Other countries have found similar results, notwithstanding differences in cultures and health systems [ 1- 6]. In order to change the culture of healthcare organizations to one focused on patient safety, medical students should be able to recognize unsafe conditions, systematically report errors and near misses, investigate and improve such systems with a thorough understanding of human fallibility, and disclose errors to patients [ 7]. They should be taught about human error and the factors influencing adverse events early in their medical education [ 8]. Incorporating the knowledge of how to do this into the curriculum of medical schools is an urgent necessity [ 9].

To help medical schools introduce and promote patient safety education, the World Health Organization (WHO) published the "WHO Patient Safety Curriculum Guide for Medical Schools" in 2009 [ 9]. It focuses on eleven topics, derived from the evidence based, Australian Patient Safety Education Framework" and underwent formal evaluation of its impact during the first 12 months after publication [ 10, 11]. Traditionally, curricula for medical students have focused on 3 major competencies-medical knowledge, technical skills and judgment -clinical decision making. The non-technical and professional competencies such as situational awareness, teamwork and leadership, communication and collaboration, risk management and human factors are not usually explicitly taught or assessed [ 9]. This WHO guide will enable and encourage medical schools to include patient safety education in the curriculum.

To date, a number of countries have initiated or implemented some patient safety education or training and have undertaken pilot studies on the knowledge and attitudes of undergraduate medical students towards patient safety and medical error [ 7, 8, 12- 15]. The majority of these studies used, for evaluation, before and after survey processes that involved patient safety education for medical students [ 7, 8, 13- 16]. On the other hand, some studies on patient safety education focused primarily on health care providers especially, more senior hospital doctors and nurses rather than undergraduate medical students. With the growing recognition of that "medical errors were usually caused by failures of systems, not failures of individuals" [ 17], it needs to be understood that patient safety education and training as a system property, has a key role to play in achieving the goal of harm minimization. A more fundamental change is required within healthcare curricular, with clear acknowledgement of the importance of creating a patient safety culture at the very beginning of training [ 18]. As yet, there are relatively few countries and medical colleges that have followed the trend by implementing patient safety education [ 7, 8, 13- 16]. Although a number of pilot survey studies have been published on patient safety education, no systematic review has been done of the success of this intervention. This research aims to systematically review studies related to the introduction/implementation of a patient safety education curriculum for undergraduate medical students including the curriculum content, teaching strategies, faculty knowledge and background in patient safety, other resources and outcomes. This work aims to understand and promote this knowledge and recommend implementation strategies.

Methods

Inclusion criteria

Studies were included if they satisfied all of the following criteria:

Study design

Publications were included of either randomized controlled or non-randomized studies including pre/post or descriptive studies reporting the outcomes of patient safety curriculum/training on knowledge, skills, and attitudes of undergraduate medical students.

Study subjects

Studies involving undergraduate medical students were included.

Interventions

Delivery of concepts, skills, and knowledge and attitude to patient safety within existing curriculum/training.

Outcomes

Understanding of teaching strategies, faculty knowledge and background in patient safety, course design and duration. Evaluation was focused on the patient safety curriculum components, improvement of knowledge, skill and attitudes related to patient safety, reported or described in the included studies.

Exclusion criteria

Studies such as commentaries, personal viewpoints, theoretical and methodology analyses on patient safety were excluded.

Literature search

We conducted a comprehensive literature search that included MEDLINE, ERIC, Academic Source Premier (ASP), EMBASE and also three Chinese Databases (Chinese Biomedical Literature Database, CBM; China National Knowledge Infrastructure, CNKI; Wangfang Data). Publications from 1980 to 2009 and relevant reference lists of studies identified in the electronic searching were retrieved. The search terms were: ' medical errors',' patient safety', 'medical education', 'curriculum', 'teach', 'medical student', 'undergraduate'.

Study selection

Two reviewers independently selected studies initially based on title, key words and abstract of the retrieved record. Studies that did not meet the inclusion criteria were discarded during the initial review. When uncertainty existed we retrieved and assessed the full text studies if they were available. Differing opinions were resolved by discussion to reach consensus between the reviewers.

Quality assessment

Two reviewers independently assessed the quality of all included studies using the 13 item quality criteria of Gemma Flores-Mateo and Darcy Reed [ 19, 20]. We added one item, namely "is the course design assessed?" Items 1-6 of the quality criteria, were used to assess the completeness of study, items 7-12 for scientific quality, and items 13 and 14 for reliability and validity of evaluation instruments. We assessed each item as "Yes" (1 point) or "No" (0 point). Quality scores were calculated and classified as: poor quality (score < 6), moderate quality (score between 6 and 9), high quality (score between 10 and 14).

Data extraction

Two reviewers extracted data that met the inclusion criteria by independently using a pre-specified extraction form containing the following information: study design, study subjects, teaching strategies and content, outcome measures.

Data analysis

Meta-analysis of pooled results was performed or calculated if data synthesis was possible, otherwise descriptive analysis was conducted.

Results

Study searching and selection (Figure 1)

Flow Diagram for searching and selection processes.

We identified 1481 studies based on our initial searching. After applying the inclusion and exclusion criteria, a total of seven studies [ 7, 8, 12- 16] were studied.

Study characteristics (Table 1)

Table 1 presents some basic information including study design, year of implementation,, characteristics of learner and instructor, teaching content and strategy respectively. Most of the studies were from the USA, and most patient safety courses were implemented in year 3. The teaching faculty were a mixture of interdisciplinary professionals, including clinicians, ethicists and medical education experts. Course design tended to be either as a selective course or incorporated into a clinical rotation of internship training, rather than being integrated into the formal undergraduate medical education system. The duration of the course, course contents and teaching strategies varied across all studies. Most studies were pre and post survey studies of which only one by Anderson 2009 was a controlled study [ 14]. Three other studies reported the results of a questionnaire and conducted pre-tests [ 7, 8, 13].

Table 1 Characteristics of included studies

Quality assessment (Table 2)

The quality of included studies was assessed using Darcy Reed and Gemma Flores-Mateo criteria [ 19, 20]. The review found that the lowest score of study quality was 3, while the highest score was 10 (mean = 6.88). All studies met the first six items. But no study conducted power analysis to determine sample size or assessed the reliability of the evaluation questionnaire. Four studies conducted evaluation of course design [ 7, 8, 12, 14].

Table 2 Quality criteria for evaluating studies

Effects on medical students' knowledge, skills, and attitudes about patient safety (Table 3)

All seven studies reported the effects of the patient safety curriculum on students' knowledge, skills and attitudes, and the surveys were all performed by use of a self-made questionnaire [ 7, 8, 12- 16]. Results are shown in Table 3 and summaries were described as follows:

Table 3 Effects of the patient safety on medical students' knowledge, skills, and attitudes

Knowledge of patient safety included definition and understanding of medical error, rates and types of adverse events in healthcare, error classification, contributing factors to medical error and overview of mechanisms for learning from error. Six studies reported that patient safety knowledge was improved after the course was given [ 7, 8, 13- 16].

Patient safety skills training included recognition of error, dealing with error, reporting and learning from error, supporting others involved in error.

Students' attitudes to patient safety were explored, focusing on an understanding of a just culture, willingness to learn from mistakes, being prepared to acknowledge and deal with error, being prepared to reflect on practice, and aspects of trust and respect. Three studies evaluating attitudes towards patient safety all reported that attitudes were improved [ 7, 12, 16], One study demonstrated there was no change of attitudes after one year follow-up(8).

In addition, three studies evaluated long-term effects of the course [ 7, 8, 13]. Four studies surveyed students, the contents and teaching strategies, teaching resources and faculty knowledge and background in patient safety [ 7, 8, 13, 14]. Six studies obtained full ethical approval from an Institutional Review Board and/or other Ethics Committees [ 7, 8, 13- 16], two studies were funded by the National Patient Safety Agency [ 8, 14].

Discussion

The complexity of modern health care increases the risk of error and accidental harm and medical trainees knowledge about patient safety has been shown to be limited [ 7, 8, 12- 16]. Formal training related to the concepts and principles of patient safety would be expected to address these issues. Although medical schools have begun to incorporate content about patient safety and medical error into their curricula, little has been published so far about these efforts. Our recent initial literature search included MEDLINE, Educational Resources Information Center, Academic Source Premier and EMBASE and Chinese Biomedical Database and China National Knowledge Infrastructure yielded a total of 1481 relevant studies of this subject, with only a few studies meeting the criteria for inclusion. Most are case reports, and none of the studies were identified from China.

Patient safety in undergraduate education

This review indicates that the addition of patient safety education into the medical school curriculum is most commonly implemented in medical schools in developed countries such as the United States of America and the United Kingdom. Most of these courses are optional courses or are integrated into clinical internship or skill courses, and have not been formally included in the undergraduate medical education system. Also, this literature review shows that there are great difference in course design and contents, who is taught, the teaching resources and faculty development and outcome evaluation. For example, 1) course design and content time ranges from 4 to 30 hours [ 11, 16] and none of studies systematically cover all the accepted key areas of patient safety knowledge. 2) teaching formats: there are eight types of educational format for delivery of the curricula including interactive lectures/discussions, recommended texts, case-based discussions, seminars, small group discussions, role play, interdisciplinary team work and videotaped simulation with a standardized patient; 3) outcome evaluation: all of the included studies adopted a pre/post questionnaire evaluation strategy to measure whether there is an improvement in students' patient safety knowledge, skills and attitudes, but there was no uniform criteria to evaluate the effect of teaching. No study explicitly identified the framework on which the patient safety education curriculum for undergraduate students was based. 4) Student' characteristics also varied from Year 1 to 3 of the medical course.

The results have demonstrated, using pre and post survey methods, that students' knowledge, skills, and attitudes to patient safety improved in most studies [ 7, 11, 15, 16]. There was also improved implementation of patient safety education in two studies with funding support [ 8, 14] compared to those without funding.

Quality of included studies

The most commonly inlcuded studies on the teaching patient safety and medical error are descriptive studies, therefore, criteria by Gemma Flores-Mateo et al were used for quality assessement. Seven studies only met the first six items of these quality criteria, while other items were poorly met. As patient safety is a relatively new initiative for medical education, it is assumed that, in future, there will be a growing volume of research in this field with high quality of design.

From four of these studies focused on students knowledge, skills, and attitudes about patient safety [ 7, 8, 12, 16], the results indicate that the majority of Year 1 medical students reported that they had 'medium low' or 'average' levels of knowledge of error and patient safety issues, but that they hoped to learn more about patient safety knowledge, and skill. To achieve this improvment in knowledge, skills and attitudes, it is unlikely to be sufficient to just construct a system of medical quality assurance and continuous improvement and to build up a harmonious medical environment with a patient safety culture. Addressing the issues from the fundamentals, namely, in undergraduate medical education, is considered to be an important step.

If the implementation of patient safety eduation in medical schools is to achieve the desired outcomes, it should meet local needs in relation to curriculum change and teaching styles and methods and should be based on an evidence based framwork. The "WHO Patient Safety Curriculum Guide for Medical Schools" is an appropriate resource on which to base such activity [ 9, 10]. This curriculum guide aims to prepare students for safer practice in the workplace, inform university faculty about patient safety topics and increase their capacity as patient safety educators, increase the profile of patient safety and encourage international collaboration and research in this field. It also provides a comprehensive curriculum to assist with the teaching and integration of patient safety learning. The guide suggests that a range of teaching methods be used to introduce patient safety topics into the existing curriculum including; the addition of patient safety topics into Problem Based Learning scenarios, the use of high and low fidelity simulation based learning, interactive and didactic lectures, mentoring and coaching, student initiated learning through projects and prescribed activities in the workplace, small group and on line discussion, and the intergration of teaching into practice in the operating room, clinic and at the hospital bedside. It also recognises that there are barriers to be overcome in adding to an already busy curriculum and suggests that university and hospital decision makers and faculty be fully engaged by explaining; the need and rational, and that it can be integrated into the teaching of clinical medicine to enhance existing material; that it does not necessarily need new blocks of time but can be integrated when mapped to the existing curriculum. This process does require recognition of the need for leadership by champions and some developmental resources [ 9, 10].Using this guide and other resources, the Chinese Evidenced Based Medicine Centre, the West China School of Medicine and the West China Hospital, Sichuan University, Chengdu, China, have introduced patient safety education, delivered as selected or continuing education courses, or lectures. The Centre has planned to implemente patient safety education in a number of different educational formats, including, ward round-based teaching, small group learning, case-based discussions, independent study, patient tracking, role play, simulation, as well as incorporation into problem-based learning scenarios. Basic knowledge is integrated into the traditional medical curriculum including the use of a multimedia teaching to deliver real-case-based discussion to teach students about patient safety in the first two years. A greater emphasis is placed on skills training in the later years, such as interdisciplinary activities, professional mentoring and simulation by standardized patients, so that medical students have a full understanding of their healthcare service role in real medical settings [ 9, 10, 21- 23].

Finally, it is considered that the key to patient safety education lies in prevention, not remedy, so the ideal educational strategy with regard to patient safety is that it should be taught throughout the entire curriculum with all opportunities taken to teach students to prevent mistakes in clinical practice and improve safety and quality of care [ 13].

Conclusion

This literature review has shown that there are significant differences in how patient safety education is provided for medical students in relation to course design, and contents, the stage at which it is introduced to the curriculum, evaluation processes and outcomes. in the included studies. While knowledge about the most appropriate way to introduce and teach patient safety into current medical school curricula in order to achieve improvements in care, is still being gathered, the WHO Patient Safety Curriculum Guide for medical Schools is a current evidenced based resource to guide curriculum development and intoduction. In this early developmental stage and with the current knowledge base, patient safety continues to provide major challenges for integration into existing medical education curricula.

Acknowledgements

This project was supported by CMB of New York, nos. CMB-0082827601147, CMB-00-721 and by National Natural Science fundation. nos. 70973083.

Author information

Author notes

Affiliations

1. Chinese Evidence-Based Medicine Centre, West China Hospital Sichuan University, Chengdu, 610041, P.R. China

Yanli Nie

, Yurong Duan

& Mingming Zhang

2. West China School of Medicine, Sichuan University, Chengdu, 610041, P.R. China

3. Royal Australasian College of Surgeons, East Melbourne, VIC, 3002, Australia

4. Department of Evidence-Based Medicine and Clinical Epidemiology, West China Hospital, Sichuan University, Chengdu, 610041, P.R. China

Corresponding authors

Correspondence to Mingming Zhang or Jing Li.

Additional information

Competing interests

The authors report no conflicts of interest, but note that Mingming Zhang was a member of and Bruce Barraclough the expert clinical lead of the WHO working party for the development of the "WHO Patient Safety Curriculum Guide for Medical Schools". The authors alone are responsible for the content and writing of the article.

Authors' contributions

MMZ and JL conceptualized and designed the study. LL, YRD, YLN and PXC acquired and analyzed with the support of MMZ. JL provided methodology support. MMZ, LL, YRD and YLN drafted the manuscript. MMZ revised it critically for important intellectual content. Barraclough BH provided expert suggestions and revised the manuscript for English proof. All authors approved the final manuscript for publication.

Yanli Nie, Lin Li contributed equally to this work.

Authors' original submitted files for images

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About this article

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Patient safety education for undergraduate medical students: a systematic review

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To reduce harm caused by health care is a global priority. Medical students should be able to recognize unsafe conditions, systematically report errors and near misses, investigate and improve such systems with a thorough understanding of human fallibility, and disclose errors to patients.

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Assessing Medical Students’ Perceptions of Patient SafetyThe Medical Student Safety Attitudes and Professionalism Survey

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Assessing Medical Students’ Perceptions of Patient SafetyThe Medical Student Safety Attitudes and Professionalism Survey

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Liao, Joshua M., MD; Etchegaray, Jason M., PhD; Williams, S. Tyler; Berger, David H., MD, MHCM; Bell, Sigall K., MD; Thomas, Eric J., MD, MPH

doi: 10.1097/ACM.0000000000000124

To develop and test the psychometric properties of a survey to measure students' perceptions about patient safety as observed on clinical rotations.

Method In 2012, the authors surveyed 367 graduating fourth-year medical students at three U.S. MD-granting medical schools. They assessed the survey's reliability and construct and concurrent validity. They examined correlations between students' perceptions of organizational cultural factors, organizational patient safety measures, and students' intended safety behaviors. They also calculated percent positive scores for cultural factors.

Results Two hundred twenty-eight students (62%) responded. Analyses identified five cultural factors (teamwork culture, safety culture, error disclosure culture, experiences with professionalism, and comfort expressing professional concerns) that had construct validity, concurrent validity, and good reliability (Cronbach alphas > 0.70). Across schools, percent positive scores for safety culture ranged from 28% (95% confidence interval [CI], 13%-43%) to 64% (30%-98%), while those for teamwork culture ranged from 47% (32%-62%) to 74% (66%-81%). They were low for error disclosure culture (range: 10% [0%-20%] to 27% [20%-35%]), experiences with professionalism (range: 7% [0%-15%] to 23% [16%-30%]), and comfort expressing professional concerns (range: 17% [5%-29%] to 38% [8%-69%]). Each cultural factor correlated positively with perceptions of overall patient safety as observed in clinical rotations ( r = 0.37-0.69, P < .05) and at least one safety behavioral intent item.

This study provided initial evidence for the survey's reliability and validity and illustrated its applicability for determining whether students' clinical experiences exemplify positive patient safety environments.

Dr. Liao is a resident physician, Department of Internal Medicine, Brigham and Women's Hospital and Harvard Medical School, Boston, Massachusetts. At the time of writing, he was a fourth-year medical student, Baylor College of Medicine, Houston, Texas.

Dr. Etchegaray is assistant professor, Department of Internal Medicine, University of Texas Medical School at Houston and UT-Memorial Hermann Center for Healthcare Quality and Safety, Houston, Texas.

Mr. Williams is a fourth-year medical student, University of Texas Health Science Center at Houston, Houston, Texas.

Dr. Berger is professor and vice chair, Michael E. DeBakey Department of Surgery, Baylor College of Medicine, and vice president and chief medical officer, Baylor College of Medicine Medical Center, Houston, Texas.

Dr. Bell is assistant professor of medicine, division of general medicine and primary care, Harvard Medical School, Boston, Massachusetts.

Dr. Thomas is professor of medicine, associate dean for health care quality, and director, UT-Memorial Hermann Center for Healthcare Quality and Safety and at University of Texas Medical School at Houston, Houston, Texas.

Other disclosures: None reported.

Ethical approval: This study was approved by the institutional review board of the University of Texas Health Science Center at Houston.

Correspondence should be addressed to Dr. Etchegaray, 6410 Fannin, UPB 1100, Houston, TX 77030-3006; telephone: (713) 500-6782; e-mail: jason.etchegaray@uth.tmc.edu.

Since the Institute of Medicine reports To Err Is Human 1 and Crossing the Quality Chasm 2 demonstrated the prevalence and impact of medical errors, patient safety and quality improvement have become areas of focus in U.S. health care. Attention from policy makers, payers, and groups such as the Agency for Healthcare Research and Quality (AHRQ), National Patient Safety Agency, and World Health Organization has resulted in numerous safety initiatives at the national and institutional levels. Most of these initiatives have targeted physicians, administrators, and other health care professionals. Less attention has been paid to medical students, a population that plays a crucial role in carrying the patient safety agenda forward.

Despite calls to include longitudinal patient safety and quality improvement instruction in undergraduate medical education,3-5 not all medical schools teach these topics to students. Among those that do, curricula vary in format, content, rigor, and evaluation methods.6 Further, many formal educational efforts focus on the acquisition of safety knowledge. Few tools have been developed to help researchers and educators understand how students' actual clinical experiences may affect their attitudes about patient safety and their intentions regarding their future safety-related behavior.

There is growing awareness that learners are influenced not only by what is taught in the formal curriculum but also by unspoken, powerful messages and beliefs conveyed through interactions with superiors and educators during their clinical rotations. Work on this "hidden curriculum" has shown that there are frequently stark differences between what medical educators say and what they do (knowingly or unknowingly) when acting as role models for students and, in turn, between what students are explicitly taught and what they actually learn.7-9 The resulting culture in the clinical learning environment may deliver messages that oppose the content of the formal curriculum, professional values, and even practices for safe patient care.

Organizations' cultural factors-safety culture, teamwork culture, error disclosure culture, and professionalism-are distinct from safety knowledge and are important for understanding aspects of the health care workplace environment that have been linked with patient safety and quality of care. For example, staff members' perceptions of safety culture and teamwork culture are associated with their perceptions of how well their units are providing safe patient care.10,11 Physicians' perceptions of error disclosure culture are associated with their intent to disclose a hypothetical error to a patient.12 Students who experience unprofessional behavior may be willing to do things they believe are wrong in order to avoid poor evaluations and to fit in with their clinical teams.13 Taken together, these four cultural factors can predict important patient safety outcomes.

We sought to understand how these cultural factors affect medical students. To do this, we developed the Medical Student Safety Attitudes and Professionalism Survey (MSSAPS) to measure students' perceptions of these cultural factors in their clinical rotations. In this study, we examined the survey's reliability and its construct and concurrent validity. We also tested the following two hypotheses:

1. Medical students' perceptions of safety culture, teamwork culture, error disclosure culture, and professionalism will be positively correlated with their perceptions of patient safety on their clinical rotations.

2. Medical students' perceptions of these four cultural factors will be positively correlated with their intended behavior concerning patient safety issues.

Our overall goal was to demonstrate that medical students could provide valuable information about their experiences with respect to the cultural factors we identified, and that this information could have important educational and clinical implications.

Method

Developing the MSSAPS

We examined the literature to identify published survey items that we could use to measure medical students' perceptions of their clinical rotation experiences with respect to four cultural factors-safety culture, teamwork culture, error disclosure culture, and professionalism-and overall patient safety, as well as students' intended safety-related behaviors. For safety culture and teamwork culture, we adapted items from the Safety Attitudes Questionnaire (SAQ).11 For error disclosure culture, we adapted items from our recently published survey.12 For professionalism, we adapted items from the SAQ11 and a survey on medical student moral distress in clinical learning environments.14 For patient safety, we adapted the overall patient safety grade from the AHRQ's Hospital Survey on Patient Safety Culture15 and included five safety behavioral intent items-one adapted from a survey about student safety perceptions16 and four that we created.

In creating the safety behavioral intent items, members of our team-two medical students (J.L., S.W.), two patient safety experts (E.T., D.B.), and one psychometrician (J.E.)-chose commonly accepted safety behaviors, such as participation in quality improvement activities and reporting and encouraging others to report errors and patient safety issues.

We pilot tested the first draft of the survey by e-mailing a link to the survey, which was hosted by SurveyMonkey ( www.SurveyMonkey.com), to 38 medical students at two medical schools. We asked these students to (1) complete the draft survey and (2) indicate which items they found to be "unclear, confusing, or difficult to answer." We received feedback from 14 students and made substantive changes to the instructions and item wording based on their input.

In the MSAPPS as administered in this study, we asked students to think about "all of their rotations" when responding. Thirty-four cultural factor items and five safety behavioral intent items were rated using a five-point Likert scale (ranging from 1 = disagree strongly to 5 = agree strongly, with NA = not applicable). Overall patient safety was measured on a five-point scale (ranging from A = excellent to E = failing) in response to the following item: "What overall grade would you give all of your rotations on patient safety?" We also included items to collect demographic information (age, gender, and anticipated residency specialty) as well as eight additional items not relevant to this study. We reverse-coded negatively worded items during data analysis.

Participants and survey administration

Graduating fourth-year medical students at three U.S. MD-granting medical schools were eligible to participate in this study. All three schools were located in urban areas; one school was state funded and the other two were private. The number of faculty at the schools ranged from approximately 1,000 to more than 9,000. This study was approved by the institutional review board of the University of Texas Health Science Center at Houston.

In February to April 2012, we administered the MSSAPS to consenting students as part of their fourth-year capstone courses focusing on "transition to residency." The capstone course was mandatory at two sites and voluntary at the third. At each study site, students were introduced to the questionnaire during patient safety sessions included in the course. Students were invited via e-mail to participate in the Web-based survey. The survey took most respondents 10 to 15 minutes to complete, according to SurveyMonkey time stamps (when the survey was first accessed and last modified).

Statistical analysis

Our hypotheses allowed us to test concurrent validity-that is, whether a predictor is correlated with an outcome at the same point in time. Concurrent validity is important to establish because it shows that a link exists between a predictor (i.e., a cultural factor) and a criterion (i.e., overall patient safety grade or a future behavioral intent item). Additionally, we collected data to determine whether the MSSAPS also had evidence for reliability and construct validity. Because the survey items we adapted from other sources were developed predominantly for physicians and staff, we first conducted confirmatory factor analysis (CFA) to ensure that these items functioned in a similar psychometric manner for medical students. CFA provides evidence for construct validity by indicating whether survey items measured the intended factors (in this study, safety culture, teamwork culture, error disclosure culture, and professionalism). We chose the CFA approach rather than exploratory factor analysis because we had a priori beliefs, based on data with other populations,11,12 about how items would behave statistically (i.e., which items belonged with certain factors).

We determined the adequacy of CFA results on the basis of statistical and practical aspects of model fit.17 We examined the χ ²/ df ratio, Tucker-Lewis Index (TLI),18 comparative fit index (CFI),19 and root mean square error of approximation (RMSEA).20 The χ ²/ df ratio should be < 3, TLI and CFI values should be ≥ 0.90, and RMSEA values should be ≤ 0.05.21,22 We then computed an initial CFA model for each cultural factor. On the basis of parameter estimates and examination of survey item content, we modified the initial model into a revised model and then tested the revised model. We also assessed the reliability of each factor with Cronbach's alpha (should be > 0.70). By conducting these analyses, we were able to have confidence in which survey items would be needed to effectively measure the study's cultural factors.

We then tested our two hypotheses by examining the associations via Spearman correlations between the cultural factors and the patient safety measures, which were (1) safety behavioral intent (consisting of five separate items about the participant's intent regarding future behavior) and (2) overall patient safety grade (one item representing the participant's overall assessment of patient safety observed during clinical rotations).

We also examined percent positive scores for each cultural factor because this is a typical way to report culture scores.11,12 Percent positive scores allow medical educators to see variability within and among schools, allowing them to identify areas of concern. We computed percent positive by adding the numbers of participants who agreed slightly or strongly with the items comprising each factor and then dividing the sum by the total number of participants who answered the items for that factor.

Results

Of the 367 fourth-year students invited to participate in the survey, 228 (62%) responded. Response rates varied by school, as follows: 164/200 (82%) at School A; 49/145 (34%) at School B; and 15/19 (79%) at School C. Of the 188 students who responded to the demographic questions, 96 (51%) were male, and 92 (49%) were female. The majority (94%; n = 177) indicated their age was in the range of 25 to 34 years.

MSSAPS performance characteristics: Evidence of construct validity and reliability

Safety culture.

The initial CFA model for safety culture had an adequate CFI value but was lacking on the other indices. The regression weights for the last 2 of the factor's 10 items were lower than the other items, so we excluded items 9 and 10. We ran a revised model with items 1 through 8 only and obtained much better model fit (Δ χ ² was statistically significant at P < .001) and improved values for χ ²/ df ratio, RMSEA, CFI, and TLI ( Table 1; see Table 2 for items). Cronbach's alpha for the 8-item factor was 0.89.

Teamwork culture.

The initial CFA model for teamwork culture had poor values for the indices. The regression weights for the last 2 of the factor's 8 items were lower than for the other items, so we excluded items 7 and 8. The revised model, which included items 1 through 6, had a significantly improved fit: Δ χ ² was statistically significant at P < .001, and we obtained better values for the χ ²/ df ratio, RMSEA, CFI, and TLI ( Table 1; see Table 2 for items). Cronbach's alpha for the six-item factor was 0.81.

Error disclosure culture.

The initial CFA model results indicated poor values for the χ ²/ df ratio, RMSEA, CFI, and TLI. The regression weights for the last 2 of the factor's 6 items were lower than the other 4 items. The content for items 5 and 6-importance of disclosing errors-was also different from that of items 1 through 4, which focused on disclosure behavior. As a result, we tested a revised CFA model with just items 1 through 4. The revised model had a significantly better fit than the initial model, with a statistically significant Δ χ ² ( P < .001) as well as values for χ ²/ df ratio, RMSEA, CFI, and TLI that met expectations ( Table 1; see Table 2 for items). Cronbach's alpha for the 4-item factor was 0.75.

Professionalism.

We used a one-factor solution to test the initial CFA model for professionalism. The CFI value (0.90) was the only value to meet expectations, and the regression weights for the last 3 of the 10 professionalism items were lower than those for the other 7. Given this finding, and the determination that the last 3 items focused on participants' comfort expressing concerns whereas the first 7 focused on observed professional behaviors, we created a revised model that replaced the single professionalism factor with two factors: experiences with professionalism (the first 7 items), and comfort expressing professional concerns (the last 3 items; see Table 2). The df did not change between the initial and revised models, so we could not compute Δ χ ², but as shown in Table 1, the χ ² value for the revised model was reduced by more than half (from 131.5 to 64.7). Additionally, the χ ²/ df ratio and CFI and TLI values met expectations. Although the RMSEA was > 0.05, it improved from the initial model. Cronbach's alpha values for experiences with professionalism and comfort expressing professional concerns were 0.87 and 0.84, respectively.

CFA results overview.

In summary, CFA identified five cultural factors comprising 28 items: safety culture (8 items), teamwork culture (6 items), error disclosure culture (4 items), experiences with professionalism (7 items), and comfort expressing professional concerns (3 items). On the basis of the CFA results, we accepted the revised model as depicting each cultural factor (see Table 2).

Hypothesis testing: Medical students' perceptions of cultural factors and safety

We report the response frequencies for the cultural factor items in Table 2 and for the safety behavioral intent items in Table 3. As described above, we calculated Spearman correlations between the five cultural factors, the five safety behavioral intent items, and overall patient safety grade as observed during clinical rotations. We found that each of the cultural factors was correlated with overall patient safety grade ( r = 0.37-0.69, P < .05) and at least one of the safety behavioral intent items ( Table 4). Safety culture was the strongest predictor of the four patient-safety-related behavioral intent items.

Percent positive scores for cultural factors

There was substantial variation in percent positive scores across participating institutions, with statistically significant differences in safety and teamwork cultures ( Table 5). Safety culture positive perception scores ranged from 28% (95% confidence interval [CI], 13%-43%) to 64% (95% CI, 30%-98%), while teamwork culture percent positive scores ranged from 47% (95% CI, 32%-62%) to 74% (95% CI, 66%-81%). Error disclosure culture percent positive scores were low, ranging from 10% (95% CI, 0%-20%) to 27% (95% CI, 20%-35%). Percent positive scores were also low for experiences with professionalism, ranging from 7% (95% CI, 0%-15%) to 23% (95% CI, 16%-30%). Of note, individual items revealed that among responding students, 159/213 (75%) agreed that a team member had made disparaging remarks about a patient, and 140/213 (66%) agreed that a team member had been disrespectful to someone below himself/herself in the team hierarchy (see Table 2). Percent positive scores were low for comfort expressing professional concerns, with scores ranging from 17% (95% CI, 5%-29%) to 38% (95% CI, 8%-69%). Individual items revealed that at least one-quarter of responding students did not feel comfortable expressing concerns to superiors about patient safety (52/213; 25%) or their own mistreatment (91/213; 43%). Finally, percent positive for overall patient safety grade ranged from 38% (95% CI, 23%-53%) to 79% (95% CI, 54%-100%).

Discussion

Medical students' experiences during clinical rotations have an important influence on their attitudes toward patient safety and their future behaviors. Negative experiences with respect to safety culture, teamwork culture, error disclosure culture, and professionalism-including both experiences with professionalism and comfort expressing personal concerns-have the potential to contradict lessons learned during formal patient safety curricula. In this study, we have provided initial evidence for the reliability and validity of the MSSAPS in measuring medical students' perceptions of the above-mentioned cultural factors as experienced during clinical rotations. Our study demonstrates that medical students' clinical experiences are associated with their safety attitudes and intended behaviors. On the basis of our findings, we believe the MSSAPS can serve as an important tool for measuring these aspects of clinical experiences and targeting areas that need improvement in student/trainee education and in faculty development to provide trainees with effective role models.22

Our study shows that the MSSAPS is psychometrically sound and provides descriptive data that can be used to promote curricular and cultural change. For example, less than one-third of students from any of the three participating schools had positive perceptions of the error disclosure culture or professional behaviors they witnessed during their clinical rotations. Students reported they did not receive education about error disclosure or see errors routinely disclosed to patients and families; such experiences could lead them to internalize the message that disclosure is not an institutional priority. The low percentage of students with positive perceptions of experiences with professionalism suggests that students witnessed disrespectful behaviors among their team members (residents and attending physicians) and between their teams and their patients. The positive perception scores for comfort expressing professional concerns were also low, suggesting that many students had difficulty speaking up about unprofessional behaviors (e.g., mistreatment of themselves and others) or concerns about patient safety. In comparison, students viewed safety and teamwork cultures more positively, perhaps because of relatively long-standing efforts by hospitals to measure and make improvements in these areas.23-31 Importantly, each of the five cultural factors was correlated with students' perceptions of overall patient safety for their clinical rotations (overall patient safety grade), and all of the factors except error disclosure culture were correlated with at least three of the five safety behavioral intent items. Further, the school with the lowest overall patient safety grade also had the lowest positive perception scores on the five cultural factors. Overall, these findings provide initial evidence for the validity of the MSSAPS and indicate that perceptions of patient safety may be shaped not only by safety and teamwork cultures but also by experiences with professionalism.32

Our study is the first to simultaneously measure medical student attitudes about teamwork culture, safety culture, error disclosure culture, and professionalism. It builds on prior studies of student experiences with unprofessional behavior and the hidden curriculum's impact on patient safety33-35 by demonstrating quantitative correlations between students' lived experiences in the hidden curriculum (represented by the cultural factors), their perceptions of patient safety, and their intentions regarding their future safety-related behaviors. Students frequently report experiencing and assimilating into a culture of unprofessional behaviors36 that likely undermine the explicit teachings of medical school curricula. Despite national attention and focused efforts to tackle unprofessional behav ior, a recent study documented a sobering persistence of medical student mistreatment.37 Given the importance of patient safety improvements, our results linking measures of professionalism (i.e., experiences with professionalism and comfort expressing professional concerns) with patient safety measures may provide additional motivation to change medical culture in light of the emphasis that health care professionals, regulators, payers, and the public have placed on improving patient safety.

The MSSAPS can be used for internal benchmarking purposes. Given the concurrent validity evidence for the instrument, students' patient safety perceptions should improve as clinical rotation sites make improvements in the areas mentioned above. Educators could also administer the MSSAPS after individual rotations to identify problematic clinical experiences. Organizations could use percent positive scores to determine where to prioritize improvement efforts. For example, on the basis of the scores in this study, all three participating institutions could focus on improvements related to error disclosure culture and professionalism (both experiences with professionalism and comfort expressing concerns; see Table 5). School B could also target safety culture and teamwork culture as areas for improvement. Tracking percent positive scores longitudinally would allow schools to conduct year-to-year comparisons of changes in perceptions. In this way, the MSSAPS could be used at the institution level to identify aspects of clinical rotations and overall culture that may deviate from the mission of training safe, professional physicians.

Additionally, the MSSAPS could be useful for external benchmarking and to help medical schools and teaching hospitals answer the call to create cultures of respect that promote ethical, safe behavior.38 By targeting medical students-who are often sensitive to behavioral modeling-this survey could serve as a much-needed tool for measuring the effectiveness of institutional efforts to address disrespectful, unprofessional behavior.

This study has several limitations. First, it includes only the experiences of graduating fourth-year medical students from three institutions. Additional work across other medical schools and years of study is required to better understand the generalizability of our results. Second, further validity testing should be done, specifically to probe whether student responses (i.e., perceptions) relate to actual clinical behavior, because some students may not have had enough experience to distinguish between professional and unprofessional behaviors or between safe and unsafe acts. Third, the voluntary participation in School C's capstone course (and therefore in the MSSAPS) may introduce bias. Fourth, there has traditionally been a lack of student exposure and experience with topics like medical error disclosure, which may limit the validity of student responses to corresponding survey items. Finally, additional research is needed to determine to what degree incremental changes in clinical curricula based on MSSAPS results would be reflected in subsequent administrations of the survey.

In conclusion, this study provides initial evidence for the reliability and validity of the MSSAPS, a survey instrument that can be used to determine whether medical students are having clinical experiences in positive patient safety learning environments. Our data suggest that a large proportion of students are exposed during their clinical rotations to behaviors that do not exemplify best practices for safe and professional patient care. However, we believe that by building on our findings that unprofessional behaviors in clinical learning environments are linked to students' perceptions of patient safety, educators can help create a sense of urgency and encourage more leaders and clinical educators to address both explicit and hidden patient safety curricula-and the institutional cultures that affect them.

Acknowledgments: Dr. Bell's work in humanism was supported through an Arnold P. Gold Foundation Professorship. The authors acknowledge course directors Katharine K. Treadway, MD, and Margaret Uthman, MD, for facilitating access to their students.

References

16. Leung GK, Patil NG. Patient safety in the undergraduate curriculum: Medical students' perception. Hong Kong Med J. 2010;16:101-105

24. Vigorito MC, McNicoll L, Adams L, Sexton B. Improving safety culture results in Rhode Island ICUs: Lessons learned from the development of action-oriented plans. Jt Comm J Qual Patient Saf. 2011;37:509-514

© 2014 by the Association of American Medical Colleges

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# data[].attributes.attachment_link.title
Assessing Medical Students' Perceptions of Patient Safety:... : Academic Medicine

# data[].attributes.attachment_link.description
ed the survey's reliability and construct and concurrent validity. They examined correlations between students' perceptions of organizational cultural factors, organizational patient safety measures, and students' intended safety behaviors. They also calculated percent positive scores for cultural factors. Results Two hundred twenty-eight students (62%) responded.

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An Interactive Quality Improvement and Patient Safety Workshop for First-Year Medical Students

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An Interactive Quality Improvement and Patient Safety Workshop for First-Year Medical Students

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There is wide consensus that content related to quality improvement and patient safety (QI/PS) must be incorporated into medical education. While graduate medical education includes QI/PS in the ACGME competency domains, the AAMC and World Health Organization call for more formal training of these concepts in undergraduate medical education. 1,2 The NBME has echoed the importance of teaching this content, as USMLE Step 1 and Step 2 Clinical Knowledge licensing exams both now include items incorporating QI/PS content, including improvement science principles, specific models of QI, quality measurement, and specific types of errors. ³

Several systematic reviews addressed training in QI/PS with learners ranging from medical students to residents over the 2000-2015 time period. ⁴⁻⁸ Not surprisingly, the majority of literature regarding teaching of QI/PS in medical school targets third- and fourth-year medical students in their clinical years rather than preclerkship students, whose curricula now likely incorporate early clinical experiences.

While published research on QI/PS curricula for first- and second-year (preclerkship) medical students exists, there are many opportunities for improvement. Of the publications relating to preclerkship medical students, several included curricular descriptions but did not provide direct assessment data of student knowledge with pre- and postmeasures. ⁹⁻¹¹ This lack of direct assessment data makes it difficult to determine the effects of a curriculum on student knowledge and skills. Furthermore, student satisfaction with early QI/PS curricula has been historically low. For example, one study that included a mandatory curriculum for preclinical students ( n = 77) showed an increase in student knowledge, skills, and attitudes, but the level of learner satisfaction was poor. ¹² Also of note, in some cases, the QI/PS curriculum published was an elective component of the curriculum and not integrated or mandatory for all students. ¹³ The QI/PS curriculum reported by Madigosky, Headrick, Nelson, Cox, and Anderson ¹⁴ is perhaps most aligned to the workshop described here as it features lectures, panel discussions, demonstrations, and role-playing. This QI/PS curriculum included all medical students and was integrated into the core curriculum at the end of year 2. Results indicated growth in student knowledge and a high degree of student satisfaction, though results were not all sustained over time. Furthermore, some gains were reversed, a situation that was hypothesized to be a result of informal curriculum experiences in clinical clerkships.

A review of publications in MedEdPORTAL yielded similar results. Much the published material regarding QI/PS training has focused on resident learners, 15,16 while those resources targeting undergraduate medical students were primarily elective and not required of the entire class. ¹⁷ A QI/PS simulation by Worsham, Swamy, Gilad, and Abbott ¹⁸ has been used in undergraduate medical education, but student performance on a knowledge-based test was not found to significantly increase from pre- to posttest. Moreover, while the methods of the study indicated the simulation was used with undergraduate medical students, it was unclear if this was during their preclerkship or clinical years. As previously stated, there are studies focusing on undergraduate medical students in their clinical years ¹⁹; however, there remains a paucity of literature regarding QI/PS curricula focused on required curricular components for students in their early preclerkship years that have demonstrated significant growth on direct assessments of student knowledge pre- and posttest. In addition, evidence is lacking as to the optimal educational format, the amount of curricular time that should be devoted to these topics in light of ever-increasing curricular time constraints, and how early QI/PS training should begin. To address the need for a required QI/PS training for an entire class of undergraduate medical students, we created an innovative workshop. The workshop presented here features active learning components that provide students with opportunities to apply and practice skills based on the principles that they have learned in self-study Institute for Healthcare Improvement (IHI) modules.

Educational Theory
No single approach to teaching QI/PS is superior in improving learning outcomes. 7,8 Therefore, we relied upon adult learning theory principles, including problem-oriented, goal-focused, experiential, and collaborative active learning techniques. ²⁰ Madigosky and colleagues ¹⁴ suggested that application-focused learning and QI/PS case-based interactive sessions resulted in greater preclinical student satisfaction and more long-lasting impact on students' knowledge, skills, and attitudes. Similarly, discussions of real-life mistakes are preferred by medical students learning about PS. ²¹

To date, the literature on optimal teaching strategies for early undergraduate medical education learners is very limited. The QI/PS workshop described here is part of a longitudinal curriculum being developed at the Warren Alpert Medical School of Brown University. It is designed to address the need for introduction of QI/PS teaching into early undergraduate medical education (and thus targets preclerkship medical students) as well as the need to identify effective, evidence-based teaching practices in QI/PS. We sought to contribute to the existing literature by creating a required, interactive workshop focusing on building foundational QI/PS knowledge and providing opportunities for our first-year medical students to practice new skills. Each of the sessions included interactive components and small-group learning opportunities. Additionally, the case-study session approach was incorporated into one of the workshop sessions. To address the gap in the literature on assessment methods, this workshop was evaluated using a multimodal approach. We included direct assessment of student knowledge using a locally developed multiple-choice content section as well as a portion of a validated assessment tool, the revised Quality Improvement Knowledge Application Tool (QIKAT-R), ²² indirect assessment of students' perceived skills, and a curriculum evaluation. Together, these assessments used a mixed-methods, quantitative and qualitative approach. Note that although we targeted first-year learners in order to provide QI/PS foundational knowledge early in training, we see no reason that medical students in subsequent years could not also benefit from the workshop.

# data[].attributes.attachment_link.title
An Interactive Quality Improvement and Patient Safety Workshop for First-Year Medical Students

# data[].attributes.attachment_link.description
There is wide consensus that content related to quality improvement and patient safety (QI/PS) must be incorporated into medical education. While graduate medical education includes QI/PS in the ACGME competency domains, the AAMC and World Health Organization call for more formal training of these concepts in undergraduate medical education.

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Perceptions of patient safety culture among medical students: a cross-sectional investigation in Heilongjiang Province, China

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Perceptions of patient safety culture among medical students: a cross-sectional investigation in Heilongjiang Province, China

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This is an open access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited, appropriate credit is given, any changes made indicated, and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/.

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Strengths and limitations of this study

This is the first study to use the Attitudes toward Patient Safety Questionnaire III to compare patient safety culture across different medical schools and grades in Heilongjiang province, China.

We covered almost all the medical colleges in Heilongjiang province.

The study is limited by the potential non-response bias. Students who responded to the survey might have been more interested than their peers in patient safety, which might have inflated the attitude ratings.

The results might not be generalisable to all medical colleges in China, although our sample size was large.

Introduction

Providing patients with a safe and comfortable medical environment is an important task for medical and healthcare organisations worldwide. Indeed, in 1999, the Institute of Medicine (IOM) released a report called 'To Err Is Human: Building a Safer Health System' to highlight the importance of patient safety. 1 Studies conducted in several countries have shown that a lack of attention to patient safety can lead to medical errors, which in turn can harm patients and increase their hospitalisation time. 2 3 Hence, the maintenance and promotion of patient safety is of utmost importance.

The advancement of patient safety requires a fundamental change in the healthcare culture. Reducing harm through an improved safety culture is a global priority. 4 Policymakers, payers and groups such as the Agency for Healthcare Research and Quality, National Patient Safety Agency and WHO have developed numerous safety initiatives at the national and institutional levels. 5 However, most of these initiatives targeted doctors, managers and other healthcare professionals and rather less attention has been paid to medical students, who are the next generation of medical workers. 6 It is essential for medical students to have a good understanding of the patient safety culture because it will doubtlessly influence their attitude towards patient safety issues throughout their working lives

In 1980, Hilfiker reported that medical graduates lack the ability to handle medical errors. 7 Even by 1998, Pilpel and his colleagues found that there was not yet any formal document for medical students that described how to handle medical errors. 8 While the launch of the 'Building a Safer Health Care System' in 1999 triggered a global discussion of patient safety issues, 1 a later study by Leape et al concluded that the status of patient safety education is not optimal. 9 The Australian Health Safety and Quality Committee published the National Patient Safety Education Framework (NPSF) in 2005. 10 Then, in 2008, the WHO constituted the first expert committee on patient safety issues in undergraduate medical curricula. 11 Subsequently, the Patient Safety Alliance conducted pilot studies in 11 schools worldwide, and proposed that advocacy for patient safety activities is one of the most important WHO initiatives in the 21 st century globally.

The primary prerequisite for the implementation of education on patient safety culture is to understand medical students' current awareness of safety culture. To this end, Carruthers et al used the Attitudes toward Patient Safety Questionnaire (APSQ) to study medical students' perceptions of the patient safety culture. 12 Similarly, Liao et al surveyed 367 medical students at three medical colleges in the United States about the patient safety culture, 5 while Bowman et al explored knowledge of patient safety culture among 170 medical students at the University of California at San Francisco. 13 Leung et al surveyed second year students at medical schools in Hong Kong and Singapore about their perceptions of patient safety culture and compared their different educational needs. 14 However, patient safety education in areas with low medical standards and high medical risks-for example, in developing countries like China-is still in its infancy. 15 One thing we do understand, from a report exploring safety education content and teaching methods in China, 16 is that patient safety education has not been fully implemented within the curricula and clinical practice therein.

Heilongjiang province, as the healthcare centre of Northeast China, has the largest area and availability of health resources, with a population of more than 30 million people. 17 Heilongjiang province has four prominent medical schools that provide medical and health service personnel training for the entire province: Harbin Medical University, Qiqihar Medical University, Mudanjiang Medical University and the Medical College of Jiamusi University. Of these, Harbin Medical University has the best reputation for education and most stringent entrance requirements, although the others (along with their affiliated tertiary hospitals) enjoy a good reputation as well. However, there are no studies examining perceptions of patient safety culture among medical students in Heilongjiang province, and few in China as a whole. Understanding current perceptions of patient safety culture and identifying medical students' most urgent educational needs in that area is critical for the effective design and successful implementation of education programmes at Heilongjiang's medical institutions. Consequently, we evaluated the students' perceptions of the patient safety culture at these four medical schools, with the goal of identifying domains critical to transforming patient safety perspectives and addressing students' educational needs.

Results

Of the students who responded to the demographic questions, 1055 (42.4%) were male, and 1435 (57.4%) were female. The response rates varied among the school year cohorts: first year, 399 (16%); second year, 483 (19.3%); third year, 587 (23.5%); fourth year, 746 (29.9%); and fifth year, 283 (11.3%) ( table 1).

Table 2 summarises the patient safety culture perceptions, by survey domain, for the total sample and the four subgroups by medical school. The overall highest positive response rates were for the following domains: 'patient safety training received', 'patient involvement in reducing errors', 'I have a good understanding of patient safety issues as a result of my undergraduate medical training' and 'patients have an important role in preventing medical errors'. The lowest positive response rates were for the domains 'professional incompetence as an error cause', 'disclosure responsibility', 'medical errors are a sign of incompetence' and 'it is not necessary to report errors, which do not result in adverse outcomes for the patient'.

When looking at specific medical schools, the highest positive response rates were found in Mudanjiang Medical College for the domain 'patient safety training received'. Jiamusi Medical College had the second highest rates overall, and its highest positive response rate was for the domain 'working hours as an error cause'. In Qiqihar Medical University, the highest positive response rate was for 'patient involvement in reducing errors'. In all four institutions, the lowest positive response rate was for 'professional incompetence as an error cause'. The overall lowest positive response rates came from Harbin Medical University; the highest positive response rate was for the domain 'patient safety training received' and the lowest for 'error reporting confidence'. We observed statistically significant differences among the schools in their responses to all nine key patient safety domains.

Table 3 summarises the patient safety culture perceptions for the total sample and five school-year cohorts, according to the APSQ-III domains. Perceptions of patient safety culture varied noticeably according to school year. All five cohorts had a positive perception of 'patient safety training received' and 'patient involvement in reducing errors'. However, first and second year students had more positive perceptions of 'working hours as an error cause', while third year students had a more positive view of 'team functioning'. Besides the aforementioned domains, fourth and fifth year students had high positive response rates for 'error inevitability'. The lowest positive response rates were for 'professional incompetence as an error cause' and 'importance of patient safety in the curriculum' for all cohorts. As shown in table 4, there was a significant difference (p<0.05) among cohorts in their positive response rates for 'patient safety training received', 'error reporting confidence', 'working hours as an error cause', 'error inevitability', 'team functioning', 'patient involvement in reducing errors', and 'importance of patient safety in the curriculum'.

Discussion

Patient safety is a top healthcare priority, and all medical undergraduates must have the necessary capacity to minimise patient harm as they embark on their future career. Education and training are key to achieving this goal. 5 Medical students' experiences at medical school, as well as their perceptions about the patient safety culture, have an important influence on their attitudes toward patient safety and their behaviours within this domain. 21 Therefore, screening their perceptions of the key areas of patient safety, as in the present study, offers an opportunity to improve their clinical acumen and future medical education. It can also be utilised by medical directors and clinical service supervisors for real-time assessment in promoting a safety culture. We also conducted the present study to demonstrate how the APSQ-III can be used to identify differences among school-year cohorts across several medical universities in Northeast China.

The findings of this study highlight that medical students tend to have generally positive perceptions of the patient safety culture. 22 Interestingly, although none of our participants had received any formal teaching on the subject, students from all four universities tended to report that they had been trained in this subject well (84.9%). This finding is similar to that of a previous study by Leung et al in Hong Kong, 14 who proposed that the result could be due to students' misunderstanding or an inability to distinguish teaching from they have learnt from public media. We also believe that this is because of a rather common psychological phenomenon among students in China-that is, escaping responsibility. This phenomenon refers to the idea that Chinese students are struggling to cope with and protect themselves in an intensely hierarchical environment, which manifests as a fear of telling the truth because of its potential impact on teachers' evaluations of them. Accordingly, many students do not want to acknowledge errors or defects, and may be unwilling to report problems to avoid poor evaluations or to fit in within their teams. 5 Therefore, more attention should be paid to this reluctance to 'speak up' in Chinese culture, and greater vigilance is required to prevent the fear of exposing deficiencies.

Leung et al found the highest positive response rates for 'working hours as an error cause', 'error inevitability' and 'importance of patient safety in the curriculum', whereas 'patient involvement in reducing error' and 'team functioning' had the lowest overall positive response rates. 14 By contrast, in the present study, 'patient involvement in reducing errors' and 'patient safety training received' had the highest positive response rates, while 'professional incompetence as an error cause' and 'disclosure responsibility' had the lowest. In contrast with students in Hong Kong, students in mainland China responded positively to items relating to 'patient involvement in reducing errors'. A probable reason for this finding is that patients in Hong Kong must adhere to the illness-specific arrangements made by public medical institutions regarding waiting lists, hospitalisation and surgery. Additionally, they cannot choose their own doctors (however, they are generally trusting of doctors and hospitals). In mainland China, however, patients' understanding of their diagnosis and treatment has been continuously improving, and the traditional medical model is gradually being replaced with more active patient participation. 23 The doctor and patient undertake the process of medical decision-making together, and the patient has the right to choose their doctor independently. In addition, medical staff in mainland China often encourage patients and their families to participate in diagnosis- and treatment-related procedures. 24 This might include encouraging patients or family members to participate in examining the label on an infusion bottle to obtain the name of the drug, reading drug information and so on. Previous research has shown that patient participation can reduce the occurrence of medical errors. 25 All these points might explain why Chinese medical students show positive attitudes for this domain.

We found that responses to the 'professional incompetence as an error cause' domain were more negative compared with responses in the other domains, especially for the following items: 'medical errors are a sign of incompetence' (32.5%), 'medical students generally consider errors as inevitable' (74.9%) and 'even the most experienced and competent doctors make errors' (84.3%). These findings suggest that students lack a proper understanding of the causes for certain errors. Our results are similar to those of Moskowitz et al, who found that students in the USA were uncertain as to what constituted an error and what caused errors. 18

Medical students generally agreed that medical errors are caused by humans and a sign of incompetence (32.5%), showing that they lacked awareness about systematic errors. Furthermore, a number of students agreed that long working hours and medical staff incompetence were important causes of errors. This finding indicates that the students emphasised human factors in judging the causes of errors, which aligns with findings from a previous study on students from Hong Kong: in that study, most students reported that 'if they work hard, they can eliminate errors' was an effective strategy for preventing future errors. 26 These findings suggest a need for emphasising the potential role of other factors (eg, systemic errors and procedural complexity) during the occurrence of medical errors.

Several students reported positive perceptions of their error reporting confidence, but had less positive perceptions of their responsibility for reporting (ie, what and how to report a problem with patient care when they witness it). Their highly positive views on reporting medical errors (74.9%) are similar to the results of a Turkish study conducted by Karaoglu et al, 27 28 who found that 60.7% (n=147) of students stated that they would report an error to the hospital committee if they had made it themselves. Furthermore, 68.6% (n=166) of the students in that study stated that they would report a medical error if they witnessed one.

In Flin et al's study, most students reported that they would speak up about an error. However, this result was somewhat confusing, since students also had high positive response rates for the item, 'it is not necessary to report errors that do not result in adverse outcomes for the patient' (60.8%). 29 More than 50% of the students attending the Medical College at Jiamusi University agreed with this statement. All members of the medical team, including medical students, should be able to recognise unsafe conditions, report errors and strive to improve error disclosure in settings where it is lacking. This persistent cultural change should contribute to the eradication of errors and reduce patient safety concerns. 30-32

Numerous students agreed with the following statements: 'my training is preparing me to understand the causes of medical errors' (84.8%) and 'I have a good understanding of patient safety issues because of my undergraduate medical training' (85.2%). This finding illustrates that medical students tend to have grand expectations regarding patient safety education, which is in line with the findings of Madigosky et al. 33 This US-based study also revealed that awareness of patient safety and medical errors can be increased and sustained via an experiential curriculum, which students rated as a valuable experience. 13 33

Insights can be gleaned from the differences observed among the four medical schools. The four universities ranked as follows in their positive response rates, in descending order: Mudanjiang Medical University, the Medical College of Jiamusi University, Qiqihar Medical University and Harbin Medical University. Notably, we found no evidence of different reporting practices between the four medical schools. Possibly, the differences in local patient safety cultures, as well as students' social and cultural backgrounds, are significant contributing factors to these different positive response rates. 30 However, the present study design did not enable an exploration of these factors; we could only determine the focal aspects of future teaching. For example, Mudanjiang Medical University, the Medical College of Jiamusi University, and Qiqihar Medical University might target education toward the classification and underlying mechanisms of medical errors. In contrast, Harbin Medical University might target students' confidence in error reporting as an area for improvement.

Our results run counter to those from other countries. For example, Flin et al's study in the UK found that most first-year students reported 'medium low' or 'average' levels of knowledge regarding errors and patient safety issues. 34-38 Our results revealed that positive perceptions of a patient safety culture tended to decrease as students progressed through medical school. As seen in table 3, more senior students appeared to have less positive perceptions of 'error reporting confidence' and 'the importance of patient safety in the curriculum'. Possible reasons for these findings include senior students' experience of working in strong clinical hierarchies, which is known to have a negative influence on error reporting and disclosure of medical errors. 39 Furthermore, this decrease in medical error disclosure might emerge as a result of increasing awareness and more realistic self-assessment that students develop during the process of medical education. 40 It could also be the result of inadequate training and preparation of young doctors. More senior students also appeared to have less positive perceptions of 'the importance of patient safety in the curriculum'. A likely reason for this finding is that because students face an increasing number of courses and pressure of examinations as they progress from their first to their fifth year, they do not want to add new courses to their curriculum. Still, the precise reason for this remains to be determined.

A limitation of this study is the possible non-response bias. Students who agreed to respond to the survey might have been more interested in patient safety than their non-responding peers. This greater level of interest might have led to the inflation of attitude ratings. Another limitation is that we made use of a non-standardised survey instrument. In addition, the APSQ-III is a self-assessment questionnaire that addresses students' own perceptions of a patient safety culture rather than their actual teachings in this area. Therefore, the present results might not be indicative of students' actual skills and knowledge. Moreover, extrapolation of our findings to other medical colleges should be done with caution. Nevertheless, this is the first use of the APSQ-III to compare patient safety cultures across different schools and school-year cohorts within mainland China. While the present sample was taken from only one region in China, we covered almost all the medical colleges within this rather large province. Furthermore, we recruited a cohort of medical students across all 5 years of their programmes; therefore, this study represents an important advancement in research on patient safety education in China. We believe that our findings can help educators develop suitable curricula for a patient safety education.

In conclusion, our study explored perceptions of the patient safety culture among medical students in China. These findings suggest that medical students' perceptions of patient safety culture can provide a tool for guiding medical education. Institutions should focus more on issues related to the causes of medical errors and error reporting. Shifts in patient safety culture should also be based on situations affecting different schools and cohorts, especially among third-year medical students. Longitudinal studies using a validated instrument should also be conducted to better evaluate patient safety education programmes and their relative impact on local healthcare development. Further studies should also explore the culture of reporting errors and how students in nursing and healthcare education programmes address these errors.

View Abstract

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Perceptions of patient safety culture among medical students: a cross-sectional investigation in Heilongjiang Province, China

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Objectives Medical school education plays an important role in promoting patient safety. In this study, we assess medical students' perceptions of patient safety culture, identify their educational needs and provide evidence on the most important content relating to patient safety for the medical school curriculum.

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Medical Student Perspectives: Patient Safety & Medical School Curricula

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Medical Student Perspectives: Patient Safety & Medical School Curricula

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Medical Student Perspectives: Patient Safety & Medical School Curricula

Some time ago, a departmental morbidity and mortality conference reminded me that thinking about medical errors is akin to understanding a raging river. The attendings and residents were discussing a case in which physician error had caused the patient harm and hotly debated how it could have been avoided. The ideas came from all perspectives - some said that it was "just how things were," while others put blame on nurses, physicians from other specialties, and even colleagues within their field - but the focus was invariably placed on personal responsibility. At one point in the thirty-minute discussion, a voice from the front row suggesting that at its root, the unfortunate turn of events was a systems, not individual, problem. The idea was not received well: some ignored the comment and tapped at their phones while others glanced around, distracted, and others still shook their heads and whispered into each others' ears. Two attendings quickly reiterated that while that was a "nice idea," the mistakes could have been avoided if residents and other healthcare workers had just paid more attention. Several heads nodded in swift affirmation, and three minutes later we were dismissed.

The experience, along with many similar ones my classmates and I have experienced on clinical rotations, brought the image of a raging river to mind because it reminded me of the distinct difference between the water and the riverbed around it. When we see a river with violent eddies and currents, the most intuitive and natural response is to conclude the river itself is intrinsically violent. But if we could drain the water and inspect the riverbed - to see the rocks, the uneven shelves of soil, the protruding branches - we might instead more rightly conclude that the violent currents resulted from these external forces, and not intrinsic qualities of the water. So it often is with medical error and quality. Because without downplaying the human element in healthcare and physician responsibility in thinking clearly and acting correctly, the medical community has found time and time again since the Institute of Medicine published its seminal work To Err Is Human in 1999 that quality of the system (the riverbed) within which we work often contributes far more than individual factors in instances of comprised patient safety (violent currents). And the "quality movement" that has emerged over the last twelve years to study these riverbeds around healthcare continues to gain momentum behind a growing body of literature that supports the strong relationship between the structures of the delivery systems and the level of safe, effective care we provide.

Even as students, it has become increasingly hard to ignore the implications of these findings. Because while the majority of existing work in the last decade has focused on physicians, the medical community is realizing the need to engage future physicians on these issues, early in their education. The Accreditation Council for Graduate Medical Education (ACGME) has required that all US residencies integrate "systems-based practice" as a core competency for trainees, and a number of medical schools are following with similar changes. Additionally, groups like the World Health Organization (WHO) and the Association of American Medical Colleges (AAMC) have stressed the importance of incorporating these components into undergraduate medical curricula, and the Liaison Committee on Medical Education (LCME) has surveyed patient safety content in accredited schools as a component of the standards for their programming. Moreover, in the current political, regulatory and economic climates, it is becoming crucial for students who want to eventually serve as leaders in medicine to understand and navigate the areas of quality and safety to best promote cost-effective medicine.

To date, however, only a handful of institutions have evaluated and developed patient safety components in their core curriculum, despite work showing that medical students can be integral in preventing patient harm in the clinical setting and that the level of patient safety knowledge is limited among medical trainees across a broad range of training levels and specialties. But the progress is promising. Through a number of different methods - workshops, independent study, web-based curricula, one-or two-day seminars - a number of institutions are trying to identify crucial areas of safety knowledge and integrate these components into their course hours. At my institution, we are currently looking thoughtfully at how to both incorporate safety and quality into the core curriculum and provide interested students with additional resources through a four-year track/concentration. And as more and more schools adopt these changes and research clarifies which methods most effectively educate while allowing students to retain and apply what they learn, the quality of undergraduate medical education in patient safety issues will only improve.

Our involvement as students in patient safety is important, if for no other reason than because these issues are directly linked to how well we treat, and learn from, our patients. Processes like root cause analyses and PDSA (plan, do, study, act) cycles matter the most when we realize how many patients are saved from the financial burden of prolonged hospital stays and morbidity from catheter-based infections. The concepts of proximal cause and latent error are far less tedious when they translate into grateful patients and families. And we can more fully learn from our patients through things like morbidity and mortality conferences when we can see that the systems and processes within which we work have large impacts on whether problems are solved or remain perpetually unresolved.

In summary, patient safety is an inescapably important, emerging issue in our profession with far-reaching implications. There are growing initiatives to integrate it into undergraduate medical education. But because many of these are currently either nonexistent or in their infancy at the local level, there is a great opportunity and need for student involvement. I would echo what many have already rightly stated by encouraging all interested students to take a few simple steps and get involved in this area (see below for some good starting points). For all of us who want to practice clinically, it is part of becoming competent, conscientious physicians in 21st century medicine who do not "confuse the riverbed for the river." For those of us who find themselves passionate about these issues, it provides the opportunity to carefully study these systems early in our careers and improve them behind the vision of promoting health among individual patients and their communities.

Resources for Students Interested in Learning and Getting Involved in Patient Safety:

1. Institute of Healthcare Improvement - a well-respected, non-profit group with information for students from a variety of healthcare professions; also provides the opportunity for students to start their own local IHI chapters and utilize the "IHI Open School" curriculum, a comprehensive, introductory web-based curriculum that is free to students who want to learn more about leadership, patient safety and quality improvement.

2. Improve Healthcare - a student-led initiative through which medical students can learn about issues in patient safety through lectures and case studies, as well as contribute case studies from local experience to share with others

3. WHO Patient Safety Curriculum Guide for Medical Schools - published in 2009 to encourage and facilitate patient safety topics in medical school curricula

4. Association of American Medical Colleges - provides helpful information to students and schools interested in assessing the current state of patient safety and quality improvement in undergraduate medical education curricula as well as helpful suggestions for future directions; also contains many helpful articles in its publication,Academic Medicine.

Joshua Liao, MS III
Baylor College of Medicine
E-mail:jmliao@bcm.edu

Back to May 2011 Issue of IMpact

More Articles Like This

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Medical Student Perspectives: Patient Safety & Medical School Curricula

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Medical Student Perspectives: Patient Safety & Medical School Curricula Some time ago, a departmental morbidity and mortality conference reminded me that thinking about medical errors is akin to understanding a raging river. The attendings and residents were discussing a case in which physician error had caused the patient harm and hotly debated how it could have been avoided.

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Patient Safety in Medical Education: Students’ Perceptions, Knowledge and Attitudes

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Patient Safety in Medical Education: Students’ Perceptions, Knowledge and Attitudes

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Abstract

Patient safety is a new and challenging discipline in the Iranian health care industry. Among the challenges for patient safety improvement, education of medical and paramedical students is intimidating. The present study was designed to assess students' perceptions of patient safety, and their knowledge and attitudes to patient safety education. This cross-sectional analytical study was conducted in 2012 at Urmia University of Medical Sciences, West Azerbaijan province, Iran. 134 students studying medicine, nursing, and midwifery were recruited through census for the study. A questionnaire was used for collecting data, which were then analyzed through SPSS statistical software (version 16.0), using Chi-square test, Spearman correlation coefficient, F and LSD tests. A total of 121 questionnaires were completed, and 50% of the students demonstrated good knowledge about patient safety. The relationships between students' attitudes to patient safety and years of study, sex and course were significant (0.003, 0.001 and 0.017, respectively). F and LSD tests indicated that regarding the difference between the mean scores of perceptions of patient safety and attitudes to patient safety education, there was a significant difference among medical and nursing/midwifery students. Little knowledge of students regarding patient safety indicates the inefficiency of informal education to fill the gap; therefore, it is recommended to consider patient safety in the curriculums of all medical and paramedical sciences and formulate better policies for patient safety.

Citation: Nabilou B, Feizi A, Seyedin H (2015) Patient Safety in Medical Education: Students' Perceptions, Knowledge and Attitudes. PLoS ONE 10(8): e0135610. https://doi.org/10.1371/journal.pone.0135610

Editor: Mojgan Hodaie, University Health Network and University of Toronto, CANADA

Received: February 4, 2015; Accepted: July 24, 2015; Published: August 31, 2015

Copyright: © 2015 Nabilou et al. This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited

Data Availability: All relevant data are within the paper.

Funding: This work was funded by Urmia University of Medical Sciences. The funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript.

Competing interests: The authors have declared that no competing interests exist.

Introduction

Health care services have improved considerably in the light of medical advances; however, these advancements were considered as major threats to health care industry [ 1]. For example, in 1999 the US Institute of Medicine (IOM) estimated 44000-99000 deaths every year as a result of preventable medical errors [ 2]. Other studies have indicated adverse events as an international concern [ 3, 4].

In developed countries, with sufficient funds and modern technology, one out of ten patients is injured [ 5]. A study estimated ten to eighteen percent of hospitalized patients are injured due to medical error [ 6]. While, the burden of unsafe care is unclear in developing countries where inappropriate infrastructure, technology and insufficient or even unskillful human resources have caused higher possible risk of harm to the patient in hospitals and in primary care compared with developed countries [ 5]. Lack of a well-developed system of medical error reporting in these countries has increased the ambiguity. In Iran, there are no official statistics on the incidence of medical errors; however, the results of some studies increase concern regarding the rate of medical errors [ 7, 8].

Over the past decade, many interventions have been used to address medical errors and improve patient safety, but the prevailing organizational culture in health care environment has been one of the major obstacles. Attitude of physicians to medical errors is one of the most important components of safety culture. A suitable education is suggested as the best strategy to improve appropriate attitude toward patient safety [ 9]. Some studies suggested the empowerment education for medical and paramedical staff in hospitals and health centers and some others focused on formal educational programs [ 10] and suggested including patient safety in undergraduate educational programs as a necessity [ 9]. In some fields, such as medical education this is a necessity [ 11]. Without a proper educational environment and appropriate training of quality and safety, responding to legitimate demands of the public will be ineffective and temporary [ 12].

Declaration of Helsinki endorsed the role of education: "Education plays a key role in improving patient safety and we entirely support the development, publishing and provision of patient safety education" [ 13]. The World Health Organization has recently developed a comprehensive patient safety curriculum [ 14]. Considering these changes in the educational curriculum of students at all educational levels is a challenge and demands appropriate policy and genuine commitment from senior managers [ 15].

After a health reform in 2009 in Iran and using clinical governance as a model of health care quality improvement, the issue of patient safety was taken into consideration as a key element of the clinical governance [ 7, 16]. The Iranian Ministry of Health and Medical Education established a clinical governance office in the Ministry to assure implementation of clinical governance in all hospitals and develop a supportive culture for health care quality. Also, the accreditation system of Iran in health care started to bring the issue of patient safety into the consideration [ 17]. This means that the health system demonstrates its commitment to patient safety. Well-educated human resources and their perceptions and attitudes play crucial roles in this regard [ 18]. This study aimed to investigate perceptions, knowledge and attitudes of students toward patient safety education. Students' perceptions encompasses causes and management of errors and students' attitudes include their interest in education and skills related to patient safety.

Material and Methods

This cross-sectional study was conducted in 2012 in teaching hospitals affiliated with Urmia University of Medical Sciences (UUMS), West Azerbaijan province, Iran. The study population (N = 134) included students with two month experience in the field, all medical interns, nursing and midwifery students taking their clinical training in teaching hospitals. Because of the small number of students and the possibility of their unwillingness to participate in the study, all of the students were included. Questionnaire completion was voluntary and anonymous. Those who volunteered, their verbal consents were obtained. The study was approved by the ethic committee located in deputy of research affairs at UUMS with the reference number of 76 in Nov, 2011.

A two-part questionnaire was used to collect the data. The first part was about demographic information of the students; including age, sex and educational level. The second part consisted of 26 questions: 12 questions asked students' perceptions of patient safety, including two categories of causes of error and error management, 6 questions were about students' knowledge on patient safety, and 8 questions were about students' attitude towards the teaching of patient safety in the university. A five-point Likert scale (1 = strongly disagree/very poor, 2 = disagree/poor, 3 = neutral/fair, 4 = agree/good, 5 = strongly agree/very good) was used to measure the perceptions and attitudes of the students.

The questionnaire was adapted from the studies of Madigosky et al. [ 19] and Leung [ 20]. Translation and back-translation was used to develop a Persian version of the questionnaire. To test the validity of the questionnaire it was reviewed by the research team and four experts in patient safety. They were members of the patient safety committee of the University and were involved in running patient safety seminars at the University with nursing, medical or medical information management specialty. A pilot study was conducted with a sample (N = 15). Cronbach's Alpha test indicated that the items were internally consistent (α = 0.723). Questionnaires were distributed by one of the researchers among students of medicine in hospitals and nursing and midwifery students in nursing and midwifery school of Urmia. Data were analyzed using SPSS statistical package (16.0 Version). Results are expressed as Spearman rank correlation coefficient to explore the relationship between patient safety and nominal variables, and one-way analysis of variance (ANOVA) to compare the mean scores of the students' perceptions, knowledge and attitudes.

Results

121 out of 134 students (90% return rate) completed the questionnaires. Sixty two (52%), 34 (29%) and 23 (19%) of the students were medical interns, nursing and midwifery students, respectively. Forty-six students were male and 75 were female. Students of nursing and midwifery were on their third or last years of their studies.

Sixty percent of the students agreed with the statement that "medical errors are unavoidable". Eighty percent of the students believed that the provided care was not the best possible care. Sixty four percent of students disagreed with the statement that "health care providers do not make harmful medical errors". Sixty four percent of students agreed with the following statement: "Most errors are due to things that physicians cannot do anything about".

In risk management questions (5-12), more than 50% of students disagreed to report errors after its occurrence and 67% of students disagreed with the statement, "medical errors mean imminent harm to the patient". Seventy three percent of students had negative opinions about "medical error reporting". There was a significant difference between medical, nursing and midwifery students' perceptions towards patient safety ( Table 1).

In five specific questions about knowledge on patient safety, 40%-50% of the students' self-appraisal of their own knowledge was "good". However, when asked to rate their own knowledge in a general manner, more than 40% of students rated their own knowledge as "poor", and only 20% of them rated their own knowledge as "good". There were some differences among medical, nursing and midwifery students in this regard ( Table 2).

About 80% of students required more education on patient safety topics. The findings showed that nursing and midwifery students were more interested in learning patient safety topics than the students of medicine ( Table 3).

There were not significant relationships between students' perception of patient safety and their field of study, gender and year of entry to the university. The findings of this study showed that there were significant relationships between students' interest in patient safety education and their gender (p = 0.001), field of study (p = 0.017), and year of entry to university (p = 0.003). Nursing students, males and junior and senior students were more interested in patient safety education. The results of Pearson product moment correlation coefficient showed a significant relationship between students' perceptions of patient safety and their attitudes towards patient safety education (r = 0.344, p = 0.01).

Nursing and midwifery students obtained significantly higher scores on perception towards patient safety than medical students ( Table 4).

Discussion

After the selection of clinical governance as a model of health care quality improvement in 2009, the Iranian Ministry of Health and Medical Education initiated patient-safety-friendly hospitals in 2010 started with a pilot phase in 10 hospitals and expanded to other hospitals. Therefore, patient safety culture is a relatively new field in this country [ 21]. Medical and paramedical staff are the most important components of patient safety [ 18]. On the other hand, to think strategically and considering long term objectives, focusing on attitudes, preferences and knowledge of medical and paramedical students is necessary for a successful plan for patient safety in the future and making cultural changes sustainable [ 9, 11].

This study showed some important points regarding patient safety education. The noticeable findings of the study were: inadequate knowledge on patient safety, a relative difference between students of medicine and nursing/midwifery students, and the necessity of patient safety education.

Regarding the causes of medical errors, the majority of respondents claimed that medical errors are inevitable, human factors play an important role; and failure in providing the best care for patients. This represents a basic misconception about the nature and type of human error. The results regarding the causes of errors and quality of care were in line with the studies of Leung [ 20] and Yoshikawa [ 22], as well as Abdi's, except the result on the inevitability of errors [ 23].

In the field of medical error management as a subdivision of perception, the following factors were taken into consideration: Error-reporting system, near miss, determining the causes of errors, use of effective strategy, acceptance of uncertainty and cultural factors of medicine. In this subdivision, the first five items were in line with Leung study [ 20]. Regarding error management, the results related to error reporting, near miss, determining the causes of errors items were in line with Abdi's investigation while the error reporting system and culture of medicine items were not compatible with his study [ 23].

In the category of error management, the results were similar to the findings of Yoshikawa. Regarding patient safety, nursing/midwifery students have deeper perceptions comparing to the students of medicine. This can be explained by the emphasis which was given by the faculty of nursing/midwifery to the subject of patient safety training. According to the Yoshikawa, there was no significant difference between the perceptions of nursing/midwifery and students of medicine regarding patient safety [ 22]. Kohestani reported an error rate report of 75% by nursing students [ 24]. In this study the error rate's report by students of nursing/midwifery, and medicine were 64 and 42%, respectively.

Concerning the level of knowledge about patient safety, the students of nursing and midwifery dedicated more knowledge on patient safety compared with the students of medicine. Leung's study appeared to have the same duality in patient safety [ 20]. The results of this study are consistent with those of Abdi in the form of direct and detailed questions [ 23].

In this study, 25% of nursing-midwifery students and in the survey of Khalili, half of respondents were aware of relevant state authorities which formulate and manage patient safety activities across the country [ 25]. In this study also, knowledge level of nursing/midwifery students was higher than that of the students of medicine which is inconsistent with Kerfoot study. In Kerfoot study, patient safety knowledge varied by the degree and discipline of the students [ 26].

The respondent's attitudes toward patient safety education were positive. In his study, Leung indicated that the majority of respondents emphasized the necessity of patient safety education, necessary training skills and time allocation in the related courses [ 20]. Bowman has reported the necessity of student's desire to teaching patient safety [ 27]. Patey has reported lack of adequate knowledge of the students on patient safety [ 28]. Abdi also has reported low knowledge and negative attitude of the students to patient safety in pre-intervention phase [ 23].

A group of students (33%) did not accept the inevitability of errors and about one quarter of them stated that the expert doctors never make errors, which reflects a misunderstanding of the nature and pattern of human errors [ 20]. Failure to report of near miss errors indicates unawareness of its consequences and potential effects on the improvement of services. Using effective strategy after error occurrence indicates lack of understanding of the complexity of the system and the processes of treatment and care. One third of respondents were neutral about medicine culture that reflects their confusion and lack of proper induction of the safe care, error management and statutory formal training of patient safety.

Conclusion

Medical and paramedical students in Iran were familiar with medical errors as an unavoidable barrier between 'best care' and what is actually provided. However, there was little knowledge about the multi-factorial mechanisms underlying occurrence of errors. Also, a knowledge gap and interest to learn patient safety was found. Establishing formal curriculum on patient safety and maintaining this change in health care culture is essential. Also, it is recommended to formulate better policies for patient safety. These will finally reduce all types of errors in complex environments such as hospitals and will make quality improvement in clinical practice.

Acknowledgments

This paper was prepared based on the results of a project supported financially by Urmia University of Medical Sciences. Hereby the researches would like to thank the vice chancellor of research and technology, and authorities that helped us in conducting and funding the project.

Author Contributions

Conceived and designed the experiments: BN AF. Performed the experiments: BN AF. Analyzed the data: BN AF HS. Contributed reagents/materials/analysis tools: BN AF. Wrote the paper: BN AF HS.

References

1. 2. Kohn LT, Corrigan JM, Donaldson MS.To Err Is Human: Building a Safer Health System. Washington, DC: National Academy Press; 2000.

2. 10. Hindle D, Braithwaite J, Iedema R. The Centre for Clinical Governance Research, Patient Safety Research: A review of the technical literature. Sydney: University of New South Wales; 2005.

3. 17. Jafari G, Khalifegari S, Danaii K, Dolatshahi P, Ramezani M, Roohparvar R, et al.Hospital accreditation standards in Iran. 1, editor. Tehran: Seda Publication Center; 2010.

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Patient Safety in Medical Education: Students' Perceptions, Knowledge and Attitudes

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Patient safety is a new and challenging discipline in the Iranian health care industry. Among the challenges for patient safety improvement, education of medical and paramedical students is intimidating. The present study was designed to assess students' perceptions of patient safety, and their knowledge and attitudes to patient safety education.

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Organizational Behavior Management in Health Care: Applications for Large-Scale Improvements in Patient Safety

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Organizational Behavior Management in Health Care: Applications for Large-Scale Improvements in Patient Safety

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Introduction

Organizational behavior management (OBM) focuses on what people do, analyzes why they do it, and then applies an evidence-based intervention strategy to improve what people do. The relevance of OBM to improving health care is obvious. While poorly designed systems contribute to most medical errors, OBM provides a practical approach for addressing a critical component of every imperfect health care system-behavior. Behavior is influenced by the system in which it occurs, yet it can be treated as a unique contributor to many medical errors, and certain changes in behavior can prevent medical error. This paper reviews the principles and procedures of OBM as they relate to reducing medical error and improving health care.

First, we need to define medical error. This task is neither simple nor straightforward because the definition of a medical error varies markedly across different hospitals and health care systems. For example, the National Patient Safety Foundation defines a "health care error" as: "[A]n unintended health care outcome caused by a defect in the delivery of care to a patient." According to the Institute of Medicine (IOM), a health care error is "a problem in the process of care itself or failure of a planned action to be completed as intended or the use of a wrong plan to achieve an aim." Thus, while some refer to medical error as any act, or failure to act, which results in harm to a patient, others refer to medical error as any action within the process of care that may have the potential to cause harm. This latter prevention-focused definition best fits the application of OBM.

This distinction is relevant to interpreting the patient safety literature, since research results typically focus on frequencies of adverse events (outcomes) rather than process-level errors (or behaviors) occurring during health care. However, a single error does not guarantee that a patient will experience a medical injury. An examination of case studies of errors presented in the Annals of Internal Medicine suggests as many as 17 separate individual errors may occur before a patient is actually harmed. Thus, process measures need to be addressed in designing patient safety programs.

Dimensions of Medical Errors

The Agency for Healthcare Research and Quality (AHRQ) Patient Safety Indicators (PSIs) are the most commonly used measures of patient safety performance. They include 16 classes of patient safety incidents ( Table 1). Although this is a useful classification system, prevention requires a specification of actions leading to these types of patient safety incidents.

Leape has provided a brief and practical typology of medical errors that includes four main domains:

Within these domains is a more specific list of 14 types of errors that can be seen as a hierarchy of severity ( Table 1). In comparing these two methods of classification, the difference between outcome and process measurement is salient. Although various patient safety incidents could be caused by a number of factors, Leape's taxonomy reflects specific problem behaviors.

The most common types of preventable errors resulting in adverse events have been identified as: technical errors (44 percent); errors in diagnosis (17 percent); failures of prevention (12 percent); and errors in the use of a drug (10 percent). In terms of overall numbers, preventable technical complications of surgery (10,891) and wound infections (9,659) were most common, indicating areas where hospitals should focus their intervention efforts.

A more recent report suggests that almost 60 percent of all patient safety incidents include: failure to rescue (delayed diagnosis and treatment); decubitus ulcer (bed sores); or postoperative sepsis (blood infection). This report also suggests the most lethal patient safety incidents-or those most closely associated with mortality-include failure to rescue and unexpected death during a low-risk hospitalization.

Between 1995 and 2000, an increasing trend of certain types of events suggested a need for special attention. These included postoperative medical- and nursing-related adverse events, such as respiratory failure (31 percent); infection due to medical care (14 percent); decubitus ulcer (19 percent); septicemia (41 percent); thromboembolism (42 percent); and accidental punctures and lacerations (7 percent).

Certain signs of progress are also noteworthy. Specifically, anesthesia reactions and complications decreased by 18 percent, and foreign bodies left during procedures were reduced by 7 percent. While small, these improvements are encouraging in terms of current proactive efforts to address patient safety.

Preventing Errors in Health Care

As depicted in Figure 1, patient safety outcomes are influenced by a number of factors, including several sources external to the hospital (e.g., relevant legislation, agency mandates, and special interest groups). Within-hospital sources include the health care culture, the institutional patient safety agenda, the specific environmental context in which the health care worker operates (which includes the patient), and the focus of this paper-the behavior of the caregiver. These multiple influences are, in turn, affected by patient safety outcomes in a reciprocal system most certainly affected by innumerable additional factors in varying degrees.

Errors Addressed by System Change

Medical mistakes caused by latent errors, such as similar sounding drug names or delays in treatment due to lack of staff, are best addressed by system change. For example, it would be reasonable to expect these errors to be reduced if drug names were altered and more personnel were hired. Yet, additional room for improvement often remains even after quality gains from system change are realized.

Advances in infection control often have been addressed by increasing hand hygiene among caregivers. One relevant system change has been the installation of antibacterial, alcohol-based rub dispensers in patient rooms and near sinks. This change should lead to improved infection control, because alcohol rubs reduce the volume of infection-related microorganisms by 88 percent, compared to hand washing with soap and water, which reduces the volume by only 49 percent.

The use of information technology (IT) is a key component of system change for error reduction. For example, implementation of "computerized physician order entry" (CPOE) and clinical decision support systems are among specific IT practices recommended to help reduce errors. Early evaluations suggest that implementation of CPOE leads to significant improvements in patient safety., , , , , Thus, a major contributor to medical errors (e.g., physicians' poor handwriting) is removed from the process. However, despite these promising initial findings, adoption of CPOE has been slow.

This paper reviews practical solutions to motivating the adoption and sustained practice of patient safety behaviors that have produced large-scale community and organizational change. In the medical literature, this approach is alluded to simply as "behaviorism" or "behavior modification," but the technical term should be "organizational behavior management" (OBM).

Organizational Behavior Management

OBM is defined as the application of behavior analysis to organizational settings. The three-term contingency, or "A-B-C model" (i.e., Antecedent-Behavior-Consequence) is the foundation upon which most behavior-based interventions used by OBM practitioners is developed., , ,

An antecedent (A) is a stimulus that precedes a behavior (B) and encourages performance of that behavior. These can take many forms, such as signs, reminder prompts, or even noises that direct behavior. One example of an antecedent strategy shown to be especially useful in improving organizational safety is goal setting (see Locke and Latham for a review of the goal-setting literature).

A consequence (C) is an event that follows a given behavior and increases the probability the behavior will recur. Like antecedents, consequences can take many forms, such as behavioral feedback, monetary rewards, or a supervisor's praise for a job well done. For this reason, it can be said that consequences motivate behavior, since we tend to act in response to the consequences we expect to receive.

Behavior-Based Feedback

One type of consequence used in numerous settings to affect behavior change is "feedback." In general, a feedback intervention involves measuring a targeted behavior and then delivering information (e.g., frequency, rate, or percent correct) about this behavior to relevant individuals or groups. This approach has been shown to successfully increase safe behavior and decrease at-risk behavior in a variety of different nonmedical settings., , , ,

Behavioral Maintenance

Establishing desired behavior change during an intervention phase is not sufficient. The long-term objective of OBM is the institutionalization of contingencies needed to support the desired behavior in the absence of intervention agents., Ideally, the intervention techniques become part of the organization's day-to-day practices. Several factors are critical for behavioral maintenance, including: a) educating and training; b) involving indigenous personnel in customizing and delivering an intervention process; c) developing organizational structure to monitor the intervention process and outcome; d) providing ongoing social and organizational support; and e) generating "self-rules" that individuals can use to motivate their own intervention-relevant behavior., ,

Behavior is also maintained within an organization when influenced by natural (or intrinsic) contingencies. Thus, when a particular behavior's natural consequences are rewarding, external contingencies (e.g., feedback from another source) are not necessary for motivation. This occurs, notably, when physicians learn how to use CPOE and eventually find it more efficient and reliable than ordering prescriptions by hand. However, it often takes time to experience the intrinsic qualities that reinforce a behavior. People need to engage in a behavior fluently to experience its inherent, beneficial consequences. This means that external contingencies are often necessary to motivate the initiation of a target behavior.

Organizational Applications for Large-Scale Change

Target observable behavior.

Focus on external factors to explain and improve behavior.

Direct with antecedents and motivate with consequences.

Focus on positive consequences to motivate behavior.

Design interventions with consideration of internal feelings and attitudes.

Apply the scientific method to improve intervention.

Use theory to integrate information, not to limit possibilities.

Safety-Related OBM Research in Health Care Settings

Intervening to Improve the Safety of Health Care Workers

This line of OBM research informed an intervention to decrease injuries from sharps among surgical team members during operations by increasing the use of a "hands-free" method for exchanging sharp instruments. The intervention package, which included task clarification, pre-intervention feedback, goal setting, and weekly intervention feedback, led to dramatic increases in the use of this injury-reduction technique from 32 to 64 percent).

Whereas these examples of OBM research targeted the safe behavior of caregivers, each of these interventions indirectly advanced patient safety. Patient safety cannot be separated from caregiver safety.

An OBM Approach to System Change

A behavioral approach also can be useful in evaluating the impact of system change. For example, a systematic, behavior-based evaluation of a gradual, voluntary CPOE implementation found that CPOE medication orders were safer and more efficient compared to the standard paper-based ordering method. However, OBM may be needed to increase CPOE use.

For example, a number of strategies were evaluated to increase the use of CPOE among physicians. These included a) presenting evidence in support of CPOE use; b) rewarding CPOE use with small trinkets; c) providing individual access to computers; d) adding clinical decision support; e) instigating relevant peer pressure; and f) providing financial compensation for the extra time required to become proficient with the CPOE system. The financial compensation strategy was found to be most effective in the short term, increasing CPOE use from 35 to 57 percent. After financial compensation was discontinued, though, CPOE use declined to 42 percent after several months but did not fall to baseline levels.

The maintenance of CPOE use following the withdrawal of the financial incentive probably occurred because some physicians experienced intrinsic or natural reinforcement. However, the lack of peak maintenance raises the concern that external consequences of a financial incentive may over-control or over-justify the behaviors targeted for intervention, reducing self-persuasion or the influence of intrinsic consequences.

OBM for Patient Safety

In one study, providing feedback to caregivers on their frequency of hand washing led to an increase in hand washing following patient contacts (from 63 percent at baseline to 92 percent post-intervention). The impact of this intervention was significantly greater than adding an emollient hand washing agent to the environment.

A number of other OBM intervention studies have demonstrated significant increases in hand washing among caregivers., , The intervention programs varied substantially among these studies, but all included a behavior-based feedback component. Moreover, nonbehavioral attempts to increase hand washing among caregivers suggest that hand-hygiene interventions targeting attitude change, intentions, or self-reported practice are likely to fail at altering actual behavior.

Other examples of OBM interventions targeting patient safety include the following:

A quota system (antecedent strategy) for emergency patients' admission to internal medicine departments resulted in reduced length of stay with no difference in outcomes.

Education, discussion, and feedback on proper laboratory tests reduced the overall number of tests ordered without any decrement in patient outcomes.

Standardizing the handoff communication procedure using antecedent reminders and feedback improved patient satisfaction, medication administration record-keeping, completion of cardiac enzyme regimens, and patient transportation without a cardiac monitor, thereby making an additional 67.5 hours of nursing time available each month.

This is not an exhaustive review, yet the OBM approach to patient safety certainly appears promising. However, additional field research in this domain is clearly needed.

Medical Errors to Target with OBM

Errors Remaining After System Change

It is acknowledged that several types of errors are already being addressed by well-informed system-based changes, but a number of categories of errors persist. These include technical errors during care procedures, failures in communication among caregivers and between provider and patient, contamination errors due to ineffective employee and patient hygiene, and lapses in patient monitoring.

To be of maximum benefit to medical professionals and OBM practitioners, the categories of errors discussed here are based on already established classification methods and priority areas (e.g., Table 1; The 100,000 Lives Campaign). Also, given the aim of proactive measurement and intervention, they are process- rather than outcome-based and include:

Diagnosis errors, such as using the wrong test, delays in diagnosis, and failing to act as indicated on test results.

Treatment errors, such as ordering a wrong drug or dosage, accidental puncture or laceration, and incorrectly executing a procedure.

Monitoring errors, such as bedsores, failure to rescue, and patient falls.

Infection-control errors, such as failing to wash hands, lack of glove use, and compromising sterile-field maintenance.

Communication errors, such as failing to inform other caregivers of acute risk, changes in care, and critical hand-off information, as well as ineffective communication with patients.

These intervention targets are not identified as independent of system influences, but rather as activators for specific kinds of OBM intervention. Behavior is a part of the health care system, which can be targeted for change within a supportive or unsupportive culture.

OBM Interventions to Address Medical Errors

Behavioral antecedents, including prompts, pledge cards, and communication strategies, as well as consequences, are the primary types of OBM intervention techniques (for a comprehensive description of available OBM techniques, see Geller et al). The overarching theme of the intervention approach suggested here is to reduce the probability of error by increasing the frequency of safe standards of practice. Several behavioral targets might be relevant for a particular type of medical error, and one target behavior may be related to several categories of error.

Table 2 depicts a framework for classifying OBM interventions and specific behavioral targets for error prevention. As the IOM suggests in Crossing the Quality Chasm, "Attention to improving quality includes continuous monitoring, often based on small samples of events that can provide organizations with timely data at the front lines to manage the processes of concern." This is precisely what OBM brings to the domain of patient safety.

System-Change Participation

Much of the patient safety literature calls for improved incident reporting systems that include less focus on finding fault and greater attention to the context in which the error occurred., , , , Adding OBM to this directive could have an immediate positive impact. Winokur and Beauregard offer a checklist for ensuring that investigations of caregiver errors are performed with a process focus, placing emphasis on specific task demands and contextual factors, rather than on the identification of individuals at fault. Anonymous error reporting and group feedback can influence individual behavior without assigning personal blame for poor performance.

Additionally, improved tracking systems include more uniform, reliable, and freely given close-call reporting. A close call is likely to have been previously paired with negative feelings, such as guilt, shame, or fear, thus leading to underreporting of close calls or "near misses." Increasing the quantity and quality of close call reports is a critical behavioral target for OBM. The close call report should be portrayed as an event of success, whereby one or more holes in the system can be fixed and thereby prevent harm to a patient.

The best way to support close-call reporting is to visibly show knowledge gained from the report, which might be a change in the system that prevents similar errors from occurring. In other words, the close call report should be treated as a trophy for patient safety. It offers the kind of feedback needed to develop a corrective action plan, and it suggests a possible target for an OBM intervention.

Another key target behavior for patient safety is the adoption of emerging technologic innovations. Implementing CPOE is more easily accomplished with hospital-employed caregivers rather than with professionals operating under contract, because more immediate contingencies are available for these individuals. Increasingly intense levels of intervention are needed for individuals resistant to adopting system changes such as CPOE. Incentive and reward strategies have increased this target behavior, but other strategies such as promise card commitments may be more effective in the long term, since this approach tends to be perceived as imposing less external control and promoting self-persuasion.,

Social comparison feedback (SCF) is another OBM option for intervening with groups and individuals resistant to adopting system changes. SCF involves providing caregivers with objective data comparing their own use of patient safety devices or methods with that of their peers. It should be most effective for groups with more individualistic and competitive tendencies.

Diagnosis Errors

Diagnosis errors are among the most difficult to address because despite system changes, they remain devastating in terms of their overall high frequency of occurrence and potential to harm patients. Furthermore, diagnosis is mainly the responsibility of physicians. One technique already being used in the training of symptom identification is a behavioral checklist. Following training, the trainer's checklist becomes a mental checklist to direct the behavior of a skilled caregiver.

A variation of the behavioral checklist for training is the behavior-based observation and feedback process, which has dramatically reduced injury rates in numerous industrial applications., This OBM process involves workers in the development of a checklist of critical safety-related behaviors for a particular task. Subsequently, the checklist is used to conduct systematic peer-to-peer behavioral observations, followed by a review of the checklist data.

Treatment Errors

Some types of treatment errors may lend themselves to direct observation and feedback. Many complicated surgical procedures, which are problematic in terms of frequency and severity, provide a clear opportunity for peer-to-peer coaching. Often, observation is already sought for highly complicated cases among surgeons and for hands-on training of caregivers. However, there are no known reports of the regularity with which such strategies are used for more common types of health care procedures performed by experienced caregivers.

Peer-to-peer coaching can also ensure compliance with recommended practices and offer opportunities for corrective feedback. In the context of a patient safety culture looking for success, this is a learning opportunity rather than an event to be dreaded and avoided. The observation and feedback process also fits with the burgeoning team approach to health care.,

Monitoring Errors

Failure-to-rescue errors seem to warrant a call for increased vigilance among all levels of caregivers. This is a highly desirable, yet difficult to attain objective without clear definitions of what behaviors make up "increased vigilance." Geller and Johnson propose using a list of behavior-based expectations to specifically target behaviors linked to a patient safety objective, in this case increased vigilance on the medical unit floor. Once these behaviors are defined, they can be observed and recorded, and once a baseline level of performance is established, they can be targeted for OBM intervention. Continued data collection indicates whether the intervention is effective and should be continued.

Other types of monitoring errors may be addressed adequately by using process-based data for group feedback, which would also compliment a team-based approach. Group data allow for the diffusion of responsibility so individuals do not fear personal consequences from disclosing an error.

Infection Control Errors

Communication Errors

Regardless of advances in information technology, medical care will continue to involve direct communication between individuals. Handoff errors are a major type of communication error affected by multiple factors, including staffing shortages and caregiver fatigue. Providing all relevant patient care data to oncoming physicians and nursing staff is an obvious target for OBM. With signs in the locker room or other salient locations, oncoming caregivers might be prompted to ask end-of-shift coworkers about each patient.

Conclusion

Much of the patient safety improvement literature calls for moving away from a negative, punishment-governed culture of blame to a more empathic, interdependent, and positive context for discussing and preventing medical errors. However, for optimal patient safety improvement, the culture of health care needs to be modified so caregivers and their patients feel safe reporting and learning from medical mistakes observed or anticipated. OBM can increase and maintain desirable behavior, but it is necessary to define the behaviors that need to be avoided and those that need to be increased.

If medical errors are to be fully understood and adequately addressed, a health care culture of interpersonal trust, success seeking, and positive behavior change is needed. The effective and achievement-focused technology of OBM enables the development of this type of culture within the context of continuous learning and beneficial behavior change.

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# data[].attributes.attachment_link.title
Organizational Behavior Management in Health Care: Applications for Large-Scale Improvements in Patient Safety

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Medical errors continue to be a major public health issue. This paper attempts to bridge a possible disconnect between behavioral science and the management of medical care. Epidemiologic data on patient safety and a sampling of current efforts aimed at patient safety improvement are provided to inform relevant applications of organizational behavior management (OBM).

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Factors contributing to patient safety incidents in primary care: a descriptive analysis of patient safety incidents in a French study using CADYA (categorization of errors in primary care)

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Factors contributing to patient safety incidents in primary care: a descriptive analysis of patient safety incidents in a French study using CADYA (categorization of errors in primary care)

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Research article

Open Open Peer Review

Published:

Abstract

Background

Patient safety incidents (PSIs) frequently occur in primary care and are often considered to be preventable. Better knowledge of factors contributing to PSIs is required to build safer care. The aim of this work was to describe the underlying factors, specifically the human factors, that are associated with PSIs in primary care using CADYA ("CAtégorisation des DYsfonctionnements en Ambulatoire" or "Categorization of Errors in Primary Care").

Methods

We followed a mixed method with content analysis and coding in CADYA of PSIs reported in the ESPRIT study, a French cross-sectional survey of primary care. For each incident, a main contributing factor (MD) and, if applicable, a secondary contributing factor (SD) were identified. Several descriptive keywords from an incremental glossary have been suggested to describe each identified human factor (attitudes or behaviours). A descriptive statistical analysis was then conducted.

Results

Among the 482 PSIs reported in the ESPRIT study, from 13,438 acts reported by 127 participating general practitioners (GPs), we identified 590 contributing factors (482 MDs and 178 SDs). Overall, 35% were related to the care process, 30% to human factors, 22% to the healthcare environment and 13% to technical factors. The contributing factors, in decreasing order of frequency, were communication errors (13.7%), human factors related to healthcare providers (12.9%) and human factors related to patients (12.9%). The human factors were mainly related to 'lack of attention', 'stress', 'anger' and 'fatigue'.

Conclusions

Our results tend to prove that human factors are often involved in PSIs in primary care, with GPs and patients being equally responsible. Beyond the identification of communication errors, often found in other international research, we have described the attitudes and behaviours contributing to unsafe care. Further research exploring the links between working conditions and human factors is required.

Background

Patient safety incidents (PSIs) have been reported in primary care under various names [ 1]. Fifteen years ago, the report 'To err is human' led to an international awareness of the frequency and gravity of PSIs [ 2]. In 2007 [ 3], the frequency of PSIs in primary care was estimated to be from 2 to 240 incidents per 1000 encounters, and 45-76% were considered to be preventable. The wide range in PSI frequencies can be explained by the type of study (prospective or retrospective), the data collection methods, the multiple proposed definitions of PSIs and the trend of underreporting [ 3, 4]. In France, two prospective studies [ 5, 6] have estimated the frequency of PSIs in primary care to be between 0.5 and 1 event per day per general practitioner (GP). PSIs in the primary care setting significantly differ from those in hospitals [ 7, 8, 9] regarding their contributing factors [ 10]. To classify PSIs, several taxonomies, both specific and not specific to primary care, exist [ 11, 12, 13, 14, 15, 16, 17, 18]. The World Health Organization (WHO) classification [ 18] is the most universal, but the consequent number of items that compose this taxonomy limits its current use. The first results of the French national survey on PSIs in primary care (ESPRIT) study [ 5] were based on the Threats to Australian Patient Safety (TAPS) version of the International Taxonomy of Medical Error in Primary Care [ 12] (ITME-PC) and the Tempos classification [ 14]. The TAPS Taxonomy [ 12] describes the nature of the incident according to 2 main types of errors: errors related to the care process with 5 sublevels and errors of knowledge or skills of the actors with 2 sublevels (diagnosis and patient management). The Tempos classification [ 14] uses time in classifying factors contributing to incidents according to five categories: the tempo of illness and treatment, the tempo of the physician, the tempo of the office, the tempo of the patient and the tempo of the health system. CADYA (Additional file 1: Appendix S1), which can be translated as Categorization of Errors in Primary Care, is a French taxonomy [ 17] that provides a complementary approach by describing more accurately the factors contributing to PSIs, especially the human factors, as suggested by research in aeronautics [ 19]. Four main levels are explored: technical factors, the environment (action background), processes related to the decision or care process (skills), and human factors (physical conditions, psycho-relational elements, attitudes or behaviours).

The main objective of the present study was to describe the incidents of the ESPRIT study [ 5] using the CADYA taxonomy to have better knowledge of their contributing factors.

Methods

A mixed method approach, combining qualitative analysis (content analysis) and quantitative analysis (descriptive analysis), has been used. Because the work is based on the results of the ESPRIT study [ 5], we only present the most relevant methodological elements.

ESPRIT study's methodological aspects

The ESPRIT study [ 5] was a cross-sectional study. Its aim was to describe the incidence and nature of PSIs in primary care general practice settings. The incidence was defined as the ratio of the number of medical encounters (or patient contacts) with one PSI and the total number of medical encounters included during the study period.

The target population was all of the patients seen or contacted by GPs working in France. The source population in the ESPRIT study [ 5] was composed of all of the patients seen or contacted by a GP from the GROG (Groupes régionaux d'observation de la grippe). The GROG was a nationwide network for influenza surveillance in France that included more than 800 volunteer GPs. The GROG was considered sufficiently representative of the French GPs to support several epidemiological studies in general practice in France and Europe. The sample was composed of GPs that were randomly selected from the GROG physicians. A minimum sample size of 120 GPs, with a gender distribution consistent with the national distribution (70 men and 50 women), was achieved. The GPs were invited to participate in the study by telephone. The GROG coordination team trained all participating GPs on the study protocol and on the data collection method by phone and by a written procedure sent by mail. A specific training on PSIs in primary care was also provided by phone or by web with a video (available on the study website). The aim was to ensure that all GPs had a same understanding of what constituted an incident to be reported in an effort to reduce the selection bias and reporting bias.

Data collection method

Data collection for each GP occurred for one week, which was chosen by the GP within the six-week data collection period from May 2013-June 2013. The definition of an incident was proposed by focus groups and approved by consensus among primary care experts and GP representatives. An incident was defined as "an event or circumstance that could have resulted, or did result, in harm to a patient, and which should not be repeated again" [ 20]. An "act" was defined as any patient contact, including a consultation, visit, or intervention, in a nursing home or by telephone. Participating GPs completed a daily PSI reporting webform throughout the data collection period. That form was developed by the ESPRIT study expert group after a literature review. Three forms were used: a GP profile form, a register of acts (all acts during the collection week) and a PSI reporting form containing 25 questions capturing a description of each PSI along with contributing factors and consequences. The data that were collected were compiled on a secure website; data quality was reviewed by an expert group (eight GPs competent in the patient safety field and two epidemiologists). At the end of the data collection process, each reported event was reviewed during an expert group seminar to verify the situation as a PSI. The data quality control process was thus carried out in several stages.

Ethical aspects

No nominative, sensitive or personal health data concerning patients were systematically collected. The ESPRIT study [ 5] was therefore not, strictly speaking, in the field of biomedical research (fields of application of the French reference methodology MR 001), nor was it within the framework of Chapter X of the French Data Protection Act. For this practice-oriented study, the only nominative data collected were GP profile data that were available in a database declared to the French CNIL (number 1684220). GPs provided their written informed consent to participate by email. The National Council of the French Medical Association was also informed due to the indemnification of the participating GP. All ethical approvals of the study were given by the Ile-de-France Paris III committee and by the CNIL (French Data Protection Authority).

Work methodological aspects

Recruiting coders

Two GPs from the Family Medicine Department of the Claude Bernard University Lyon 1 (DK and TM) volunteered to analyse the ESPRIT study PSIs. An expert GP (MC) who was involved in patient safety in primary care trained the two recruiting coders to reach a shared understanding of, and a similar level of expertise on, the root cause analysis and the use of CADYA.

Coding process

All of the PSIs related to a patient were extracted from the ESPRIT study database. For each PSI, the investigators were required to independently search for the underlying factors contributing to their occurrence according to a qualitative approach (content analysis). Then, the investigators had to select a main contributing factor (MD), called "dysfunction" in French, and, if relevant, a secondary contributing factor (SD) in CADYA [ 17]. The choice between designating the factor as a MD or SD depended on the estimated impact of the contributing factor to the PSI. In the case of a factor related to a human attitude or behaviour, the investigators had to specify a keyword to describe its nature (e.g., "anger", "stress" or "tiredness") according to an incremental glossary (a keyword that was already identified, or, if necessary, a new keyword). The investigators had to describe the human factor with as much accuracy as possible. They regularly compared their coding after every 50 reports. In cases of disagreement, the investigators were required to reach a consensus. At the end of data extraction, all coding was approved by the expert GP (MC). The review of each investigator, the consensus and the expert final review were compiled into a single Excel® file. Finally, the investigators checked, for a second time, that there were no redundant keywords in the thesaurus. If necessary, they gathered redundant keywords into a single consensual keyword to obtain a reduced, but more precise, thesaurus.

Statistical analysis

Descriptive data analysis was conducted according to the dimensions of CADYA. The frequencies of agreements between the two coders and between coders and experts were estimated. The inter-rater reliability was analysed with a kappa coefficient [ 21], which was expressed as follows: (% observed agreement - % agreement due to chance) / (1 -% agreement due to chance). The interpretation of the calculated kappa coefficients followed the six classes by Landis and Koch [ 22].

Results

Main ESPRIT study results [5]

A total of 13,438 acts were recorded by the 127 participating GPs; 82% ( n = 11,023) were office consultations, 8% ( n = 1090) were telephone contacts, 8% ( n = 1022) were home visits and 2% ( n = 303) were visits at nursing homes. The GPs in the sample were older and worked more often in groups and more often in rural areas than the population of GPs in France (Table 1). The average number of patient encounters per day was 21. The average age of the patients was 48 years, and 4013 patients (30%) had a chronic or long-term condition.

A total of 694 events were reported by the participating GPs, 674 (97%) of which were reported as being related to a patient and 20 (3%) of which were reported as being not related to a particular patient. Additionally, of these 694 PSIs, 212 (31%) were not PSIs as defined. Thus, 482 (69%) PSIs were validated by experts, 475 (99%) of which were related to one patient and 7 (1%) of which were non-patient related (usually computer glitches affecting a whole range of medical encounters). Of these 475 PSIs, 52% occurred in the office, 37% occurred in patients' homes and 12% occurred in nursing homes. Additionally, 55% of the patients were women. The average age of the patients was 56 years (standard deviation: 25 years), with a range from zero years (four patients) to 100 years (one patient). Nearly half of the patients (40%) were retirees.

There were no clinical consequences for 73% of PSIs, and for 25%, there was a temporary disability. Only 2% of the PSIs were serious in the ESPRIT study ( n  = 9), being associated with a life-threatening or permanent disability (i.e., 0.07% of the 13,438 patient encounters observed in the study).

General data

The investigators reviewed the 482 validated PSI reports. They excluded 74 incidents due to unpredictable adverse drug reactions (no identifiable contributing factors). Therefore, 408 reports were ultimately included for review. The investigators identified 408 MDs and 182 SDs (ratio of 0.45) for a total of 590 factors (TDs).

Frequency and nature of contributing factors

Table 2 shows the distributions of the MDs, SDs and TDs according to the CADYA items.

Table 3 shows some examples of the factors identified by the dimensions and sub-dimensions of CADYA.

Figures 1 and 2 show the distributions of the 590 contributing factors according to the main dimensions and sub-dimensions of CADYA, ranked in order of frequency.

Analysis of main contributing factors (Fig. 3)

The MDs were related primarily to the care process (39%), communication errors (14.5%) and cognitive aspects (13.8, 6.4% of which were due to training defects) and secondarily to environmental factors (22.8%) and human factors (21.8%). Regarding the environmental factors, the management of workload (5.4%) and the occurrence of a disruptive element (6.6%), such as a phone call during the consultation, were responsible for more than half of these MDs. Human factors were more often related to the patient (11%) than to the health professionals (8.6%). When these factors were due to a technical factor (16.4%), it was mainly related to issues in the information system (8.3% due to missing or incorrect data in the medical chart).

Secondary contributing factors (Fig. 4)

Almost half of the SDs were related to human factors (47.3%) and were linked more frequently to the GP (22.5%) than to the patient (17%). More than one quarter (27.5%) of the errors in the care process were identified as being from SDs, including communication errors (15%). Technical factors were still relatively low (4.9%), while those related to the environment (20.3%), including workload (6.6%) and place of care (4.4%), remained stable.

Nature of human factors

Overall, we identified 175 factors related to human attitudes or behaviours, divided similarly between MDs ( n = 89) and SDs ( n = 86), consisting of more than a quarter of all of the TDs (29.7%). These factors represented more than one-fifth of all MDs (21.8%) and almost half of all SDs (47.3%). In total, human factors related to either the GP or the patient constituted 87% of all the identified human factors (13% due to a third party and other caregivers). Figures 5 and 6 display the frequencies of keywords used to describe the human factors that are linked to the patient and to the GP, respectively. Table 4 shows a glossary of 15 keywords resulting from semantic harmonization by the investigators. Overall, 5 keywords represented 2/3 of all the human factors: 'lack of attention', 'stress', 'lack of involvement', 'nervousness' and 'tiredness'.

Reproducibility analysis

The levels of agreement between the investigators were 64.5% for the main dysfunctions (311 of 482) and 67.4% for the secondary dysfunctions (325 of 482). The kappa coefficient for agreement between the investigators at the first level of CADYA (main dimensions) was estimated to be 0.685, suggesting a strong agreement. The statistical analysis was completed with the calculation of the kappa coefficient for the agreement between the investigators and the expert. The result was 0.028, which corresponds to a very low agreement.

Discussion

Key results

If we consider the overall contributing factors, our results suggest that errors in care processes are frequent. As highlighted in other research, communication errors are indeed of primary importance. More remarkably, our analysis has identified several attitudes and behaviours that contribute to unsafe care. Those attitudes and behaviours regard both professionals and patients and could often be described with only a 15-word glossary.

Process of care

Among the contributing factors related to the process of care, miscommunication between healthcare professionals constitutes a main source of errors, as suggested by several international studies [ 11, 23, 24, 25]. This result suggests the need to develop communication training for health professionals (students or graduates). 'Good communication skills' is one of the seven pillars of a safety culture according to Sammer et al. [ 26]. For that reason, we think that it may be useful to share some training programmes among all students across all health disciplines. The students could then better understand the mutual roles of all primary care professionals. Other actions should be implemented and evaluated, e.g., promoting learning via games and simulations during medical studies to develop relationship skills in healthcare. To train primary care professionals to better structure their communication (especially oral), some standardized tools such as 'SBAR' ('Situation-Background-Assessment-Recommendation') [ 27], which is already used in some hospitals, could be deployed. Patients should also play a leading role in their safety. They should have access to similar tools to better communicate with professionals [ 28]. If these standardized communication tools were implemented in primary care, such tools could reduce the number of PSIs [ 29].

Contributing factors related to cognitive dimensions have been more frequently identified as being MDs rather than SDs. This difference seems to be related to the importance of the cognitive processes themselves. Indeed, even a small error at this level can produce a diagnostic or therapeutic issue, sometimes serious [ 30]. This issue leads to more frequent identification as a MD. In the ESPRIT study [ 5], 17% of the PSIs were related to 'knowledge and skill errors' according to the taxonomy of Makeham [ 12] and 30% to a 'lack of knowledge or skills' with the Tempos method [ 14]. Our analysis using CADYA is consistent with these results. As a consequence, to improve the quality and safety of primary care, it seems necessary to strongly promote the continuing education of all health professionals.

Missing or incorrect protocols constituted a marginal source of error in our research. However, GPs in the ESPRIT study [ 5] and, more broadly, French GPs do not write protocols in their daily practices. To explain the flaws in procedure executions, we must consider the independence in primary care of patients and professionals. The patient may choose to not take or insufficiently take the prescribed treatment, as shown by several studies [ 31], or they may defer an examination or new appointment. A health care professional may not always follow all of the guidelines, even if he or she knows that they exist. However, it is not necessarily a question of resistance to change [ 31, 32] but may be an evidence-based medicine approach [ 33]. Thus, decisions are also made in relation to the patient's expectations and wishes, as well as to the caregiver's context of care and representations.

Human factors

Unsafe attitudes and behaviours have frequently been found and may be due to the particular patient-provider relationship in primary care. In French healthcare, as in many countries, the patient chooses professionals with more freedom in the primary care setting than in the hospital. CADYA distinguishes cognitive processes from other types of human factors. Other tools, such as the ALARM method (Association of Litigation And Risk Management) [ 34], have included these human factors in cognitive or decision process levels. The literature does not provide a definitive answer as to which is the best option. CADYA has been designed for educational purposes, e.g., university trainings, where the identification of unsafe attitudes and behaviours of healthcare workers is important for the development of a proper safety culture.

Overall, analysis of the glossary of terms used to describe the nature of human factors (GP and patient) showed three main types of factors: first, those related to a physical or mental impairment (e.g., 'stress', 'extreme tiredness', 'worry', or 'distraction'); second, those related to a mental disorder (e.g., 'aggressiveness', 'extreme nervousness', or 'addictive disease'); and finally, attitudes of relatively conscious disengagement of individuals during care ('negligence', 'lack of commitment', or 'lack of compliance and absence of authority').

It is tempting to establish a link between some human factors, especially those designating impaired performances, with unfavourable conditions of care. The 'stress' of GP and the 'nervousness' and 'aggressiveness' of some patients were sometimes secondary to a significant delay in the schedule of the appointments. Currently, providers in primary care are often confronted with multiple, sometimes paradoxical, injunctions, e.g., 'to provide fewer appointments but with sufficient time to allow for patient-centred care' but also 'to open appointment access to have more consultations so that more patients can consult'. Therefore, human factors likely contribute to other factors, especially those related to cognitive processes.

Environmental factors: Importance of favourable care conditions

Two elements are quite significant: an inadequate management of the workload and the existence of a "parasitic" or "disruptive element". There is a wide variety of disruptive elements, including the interruption of the consultation by a third party in the office or by a phone call. The effect of this disruptive element is twofold. On the one hand, this disruption causes a break during the consultation, which can potentially alter the care provider's reasoning process (blackout). On the other hand, it can induce "human impairment", e.g., during the consultation, the GP answers the phone and learns of the death of a patient; this can induce a considerable emotional charge that is stressful for the healthcare provider. It seems logical, then, to limit the risk for disturbance during care, but there is a paradox: if they are unreachable or less easily reachable, the providers are less able to manage emergencies. In the ESPRIT study [ 5], unexpected emergencies were seldom identified because they were probably responsible for problems in the workload. This situation is consistent with the limited number of "true" emergencies in primary care [ 35] in modern health systems, where these acute events are ideally supported by dedicated services. To our knowledge, no study has specifically quantified the impact of an improvement in the environment of care on safety. However, this seems pragmatic, as it is known that anything that impairs communication within a team is likely to generate PSIs [ 36].

Technical factors: First, gaps in information systems

GPs perform a small number of technical acts, which is consistent with a rather low frequency of 'purely technical' errors. Moreover, with the development of communication technologies in the past twenty years, many doubt that this type of error is experiencing a substantial decrease. The widespread use of secured software (including prescription-assistance modules) and electronic patient records help to limit some errors (e.g., illegible handwritten prescriptions), but this has also contributed to other issues, e.g., common 'click' errors in medication lists.

CADYA

CADYA is complementary to the taxonomy of Makeham [ 12] and to the Tempos method [ 14], as it specifically explores processes related to medical decision-making and the unsafe attitudes and behaviours of actors. Regarding the main dimensions, the strong coefficient kappa between investigators argues for the robustness of CADYA. The poor kappa between the investigators and the expert seems paradoxical. This result is explained by the paradox of Feinstein and Ciccheti [ 37]: with a similar level of observed agreement, the estimated kappa is lower when the symmetrical balance is perfect. Despite a very high level of agreement, we obtained an abnormally low kappa coefficient.

CADYA is used in France by several morbidity and mortality review groups [ 17] and was supported by the French High Health Authority. It was also used during specific trainings on patient safety at Claude Bernard University Lyon 1, especially in those on Family Practice.

In its first version, CADYA did not provide a glossary to describe human factors related to attitudes and behaviours, and users could use any descriptive terms they wished. However, this flexibility created a limitation for a more standardized use. In addition, some users regretted the absence of a glossary that would facilitate the identification of human factors. The Glossary of human factors constitutes a useful upgrade in the most recent version of CADYA. This version is currently being used as part of the ongoing PRisM national study, which is dedicated to the assessment of a multifaceted programme on risk management in primary care. A full and validated English adaptation of CADYA is in progress, following the recommendations of the WHO [ 38].

Strengths and limitations

Some limitations are inherent to the ESPRIT study [ 5]. The GPs were randomly selected within a network that was potentially biased towards reporting. According to us, this strategy was preferable to improve the number of PSIs reported by GPs and to have a better data collection quality. Yet, there is no indication that physicians enrolled in GROG are more concerned by issues related to patient safety. For that reason, we think that the findings - based on over 12,000 medical encounters - were not necessarily affected by this choice and the generalizability still remains acceptable. More than 200 events of the 694 incidents reported by GPs were deemed to not be PSIs by the expert group. This finding suggests that the level of understanding of the definition of PSI by participant GPs was not high, despite the time spent in GP training. This issue has been already described in previous studies [ 3, 4]. The main limitation of the ESPRIT study is that information on the patient health statuses remains limited. However, the literature on PSIs in primary care has already shown that factors such as an older patient age and an increased number of comorbidities have been associated with an increased risk for adverse events.

Regarding our work, the coding of the PSIs was performed by only 2 investigators. However, they have been previously trained to use the CADYA grid, and they regularly compared their coding results. The lack of information in some clinical descriptions, as well as the absence of time constraints to code the PSIs, may have also constituted a subjective bias in coding. For that reason, an expert validated the consistency of all the codes. The number of contributing factors identified was consistent with the limited information reported by the GPs in the ESPRIT study [ 5]. Thus, the reported events have often been reduced to one sentence or a few words. The investigators were instructed to only consider information without interpreting it to limit the risk of bias. Finally, the glossary consists of only 15 keywords; our experience is that attitudes and behaviours can, most of the time, be described with these keywords.

Conclusions

PSIs are common in primary care, and research is needed to better understand them, as they differ from those in hospitals. We conducted an original study on a French national cohort of several hundred PSIs identified by GPs to describe their contributing factors. Our work confirms that, while there is a wide variety of contributing factors, the factors related to the process of care (in particular miscommunication) and the human factors related to unsafe attitudes and behaviours (e.g., stress, tiredness, etc.) represent major sources of PSIs.

We propose a 15-keyword glossary to describe these human factors. This glossary is applicable to all the actors, patients and caregivers alike engaged in care and can be useful in the initial training of medical students and in the continuing education of health providers. It remains, however, necessary to explore the links between these human factors and the working conditions of healthcare providers (e.g., the influence of the number of daily appointments and the influence of access without an appointment for patients), the patient's life context and the healthcare system to improve patient safety in primary care.

Abbreviations

ALARM:

Association of Litigation And Risk Management

CADYA:

CAtégorisation des DYsfonctionnements en Ambulatoire (or Categorization of Errors in Primary Care)

CNIL:

Commission Nationale de L'informatique et des Libertés

GP:

General practitioner

GROG:

Groupes régionaux d'observation de la grippe

ITME-PC:

International Taxonomy of Medical Error in Primary Care

MD:

Main contributing factor

PSI:

Patient safety incident

SD:

Secondary contributing factor

TAPS:

Threats to Australian Patient Safety

WHO:

World Health Organization

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Acknowledgements

We would like to thank AJE for their contribution in the revision of the English version of this manuscript.

Funding

With respect to the ESPRIT study, funds were provided by the Direction Générale de l'Offre de Soins, from the French Ministry of Health. The funder had no role in research design, data collection and analysis, decision to publish, or preparation of the manuscript. No other funding was provided for this research.

Availability of data and materials

The datasets used and/or analysed during the current study are available from the corresponding author upon reasonable request.

Author information

Affiliations

1. Family Medicine Department, Université Claude Bernard Lyon 1, 8 avenue Rockefeller, 69008, LYON, France

M. Chaneliere

, D. Koehler

& T. Morlan

2. Hospices Civils de Lyon, 3 quai des Célestins, 69002, Lyon, France

M. Chaneliere

, J. Berra

, C. Colin

& P. Michel

3. University of Lyon, Université Claude Bernard Lyon 1, Université Saint-Etienne, HESPER EA 7425 69008 LYON, F-42023, Saint-Etienne, France

M. Chaneliere

, C. Colin

& P. Michel

4. Société de Formation Thérapeutique du Généraliste, 233 Bis Rue de Tolbiac, 75013, Paris, France

Contributions

MC, DK and TM contributed to the design of the research (extracting data, coding); MC, DK, TM, JB, PM, and CC contributed to the analysis of the results; MC, PM and ID contributed to the writing and revising of the manuscript. All the authors have approved the manuscript for submission.

Corresponding author

Correspondence to M. Chaneliere.

Ethics declarations

Ethics approval and consent to participate

Ethical approvals for the ESPRIT study were given by the Ile-de-France III committee and by the CNIL (French data protection authority). The participating GPs provided their written informed consent to participate by email.

Consent for publication

Not applicable.

Competing interests

Competing interests are limited to the membership of the authors (MC, PM, ID) on the ESPRIT study advisory board. The other authors have declared that no competing interests exist.

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Factors contributing to patient safety incidents in primary care: a descriptive analysis of patient safety incidents in a French study using CADYA (categorization of errors in primary care)

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Patient safety incidents (PSIs) frequently occur in primary care and are often considered to be preventable. Better knowledge of factors contributing to PSIs is required to build safer care. The aim of this work was to describe the underlying factors, specifically the human factors, that are associated with PSIs in primary care using CADYA ("CAtégorisation des DYsfonctionnements en Ambulatoire" or "Categorization of Errors in Primary Care").

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Incidence of Adverse Events and Negligence in Hospitalized Patients — Results of the Harvard Medical Practice Study I

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Incidence of Adverse Events and Negligence in Hospitalized Patients — Results of the Harvard Medical Practice Study I

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BURNOUT AND ITS INTERFACE WITH PATIENT SAFETY

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BURNOUT AND ITS INTERFACE WITH PATIENT SAFETY

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Abstract

We articulate an intellectual history and a definition, description, and model of patient safety. We define patient safety as a discipline in the health care professions that applies safety science methods toward the goal of achieving a trustworthy system of health care delivery. We also define patient safety as an attribute of health care systems that minimizes the incidence and impact of adverse events and maximizes recovery from such events. Our description includes: why the field of patient safety exists (the high prevalence of avoidable adverse events); its nature; its essential focus of action (the microsystem); how patient safety works (e.g., high-reliability design, use of safety sciences, methods for causing change, including cultural change); and who its practitioners are (i.e., all health care workers, patients, and advocates). Our simple and overarching model identifies four domains of patient safety (recipients of care, providers, therapeutics, and methods) and the elements that fall within the domains. Eleven of these elements are described in this paper.

Introduction

A defining realization of the 1990s was that, despite all the known power of modern medicine to cure and ameliorate illness, hospitals were not safe places for healing. Instead, they were places fraught with risk of patient harm. One important response to this realization has been the growth of interest in patient safety. It is increasingly clear that patient safety has become a discipline, complete with an integrated body of knowledge and expertise, and that it has the potential to revolutionize health care, perhaps as radically as molecular biology once dramatically increased the therapeutic power in medicine.

Patient safety is now recognized in many countries, with global awareness fostered by the World Health Organization's World Alliance for Patient Safety. And yet there continue to be significant challenges to implementing patient safety policies and practices. One fundamental requirement for adopting any new approach is a clear articulation of its premises and manifestations. Components of patient safety have been expressed by thought leaders, and models have been presented. However, a single rendition that can help a thorough adoption of patient safety throughout health care has not been available. This paper aims to offer that. After introducing salient points in the intellectual history of patient safety, we offer a definition, a description, and finally, a model of patient safety. We call on organizations to adopt a definition and model for patient safety.

Intellectual History of Patient Safety

Critical assumptions in health care were rewritten by patient safety thinking. How to understand why people make errors that lead to adverse events shifted from a single cause, legalistic framework to a systems engineering design framework, and in so doing, it changed forever the way people think about health care delivery.

Limiting Blame

The first quantum leap defined patient safety's entry into health care thought. The realization that adverse events often occur because of system breakdowns, not simply because of individual ineptitude prompted the change. The traditional approach assumed that well-trained, conscientious practitioners do not make errors. Traditional thinking equated error with incompetence and regarded punishment as both appropriate and effective in motivating individuals to be more careful.

The use of this kind of blame had a toxic effect. Practitioners rarely revealed mistakes, and patients and supervisors were frequently kept in the dark. Low reporting made learning from errors nearly impossible, and legal counsel often supported and encouraged this approach in order to minimize the risk of malpractice litigation. This mind-set lent a wary, antagonistic backdrop to the therapeutic interaction. It also created a locked-in paralysis for all concerned when failure did occur.

Thinking began to change in the 1990s in response to several kinds of new information. First, medical injury was acknowledged as occurring far more often than heretofore realized, with most of these injuries deemed preventable. Second was the idea that "active" errors at the "sharp end"-where practitioners interact with patients or equipment-result from "latent" errors, as demonstrated by James Reason. Latent errors are upstream defects in the design of systems, organizations, management, training, and equipment ("blunt end") that lead individuals at the sharp end to make mistakes. To punish individuals for such mistakes seemed to make little sense, since errors are bound to continue until underlying causes are remedied.

Systems Thinking

Thought leaders in health care offered persuasive arguments that errors could be reduced by redesigning systems and processes using human factors principles. These could reduce mistakes through design features, including standardization, simplification, and the use of constraints. One such constraint is a "forcing function," which is a design characteristic that makes error impossible (e.g., incompatible connectors that prevent connecting an anesthetic gas to the oxygen port of an anesthesia machine).

Another corollary quantum leap to view health care as a system took place as people applied engineering design concepts to health care. Some of these systems changes were related to tools and technology, such as using better intravenous pumps or computerizing physician medication prescribing. Others were related to organizations and people, such as training doctors and nurses to work better in teams or including a pharmacist in the team during rounds. Some were more successful than others, but the important change was that people were thinking of health care delivery in terms of systems.

Interestingly, in earlier phases of medical history, different forms of systems thinking were dominant. However, these forms focused on the biologic systems within the individual patient, rather than on care and interactions between individuals in the environment of care. The notion of humors and the understanding of the circulatory system are two examples from the period prior to the modern scientific era. As the scientific era dawned and the field of medicine began applying the scientific method with success, systems thinking within physiology continued. Perhaps this was helpful, as clinicians took on a systems understanding of the delivery of health care as well.

Initially, perhaps, blunt-end factors were typically thought of as organizational policies and processes that shaped the behavior of individuals at the sharp end-point of service. However, an awareness also emerged of extra-organizational blunt-end factors, including regulators, payers, insurance administrators, economic policymakers, and technology suppliers. These parties often influence and shape incentives and demands within the health care organization. Thus, health care had to be seen as an open, not closed, system, and policy too began to be thought of as a feature of the system.

Transparency and Learning

The idea that adverse events could yield information was not new, but as it was newly applied in health care, it acquired a new potency. The notion that sharing information about medical errors was essential for effective patient safety outcomes became urgent. Commentators asserted that the more error-related information was shared, the better lessons could be implemented industry-wide. The possibility that knowledge of systems might require an understanding of how things go wrong was demanding attention.

Culture and Professionalism

Clinicians, governing boards, executive leaders, and middle managers of health care delivery organizations were being increasingly encouraged to think in terms of building high-reliability organizations. This required a culture change to one that refrained from assigning "sharp-end" blame for mistakes; that incentivized learning by fully disclosing information about mistakes, failure, and near misses; that trained and provided support to clinicians involved in inherently risky work; and that disclosed all relevant facts to injured parties.,

These transformations in thinking resulted in approaches that were remarkably well-rooted in the essential ethical underpinnings of the profession. The call for safety went directly to the central medical professional imperative to "above all, do no harm." The value at issue was nonmalfeasance. As a matter of justice, human rights, or the fiduciary obligations intrinsic to the unequal power structure of the provider/patient relationship, the call for systemwide transparency coexisted with fundamental professional standards requiring honesty and disclosure of material facts to the patient., ,

Accountability for Delivering Effective, Safe Care

Early Western medical traditions were organized through guilds that kept the special knowledge and skills involved in medical practices a secret. At a time when many medical methods were of dubious foundation, rarely beneficial, and frequently harmful, the challenge of securing the trust of society was significant. The primary method was to root out the charlatans. As modern concepts of negligence developed, emphasizing litigation to deter substandard behavior and individual accountability for procedures and actions causally linked to adverse outcomes became embedded in both medicine and law.

In an important parallel development, as treatments became increasingly effective, the medical field began to establish methods for accountability, and the profession's credibility in society rose. The scientific method was essential in that development, and with good reason, medicine has adhered to it. The three-phase approach to establishing the efficacy and safety of new medical therapies-Phase 1, clinical trials to assess safety; Phase 2, clinical trials to ascertain efficacy; and Phase 3, trials to compare it with another standard intervention-was essential, too. The dependence on the randomized clinical trial as the touchstone of the scientific method was critical to that process. The goal was to be sure that medicine was, and was seen as, a clinical research-driven, reliable practice. The effort was successful; society recognized that medicine merited its standing as a profession with specialized expertise to use powerful methods applied appropriately. Consequently, these scientific and clinical research methods and their associated ways of thinking became well entrenched.

The growth of medical sciences also changed standards in medical education, licensure, and peer review. The early apprenticeship model was supplemented by requirements for a phase in which didactically acquired knowledge was transmitted prior to the apprenticeship. As specialties developed, these sought to codify and legitimize their expertise through testing and certification. With the development of safer and more effective surgery, medical care delivery systems began focusing on hospitals; standards for these delivery systems were understood to be necessary. Certification of hospitals and other health care delivery systems followed, often with professional groups, such as the Accreditation Council for Graduate Medical Education (ACGME) and the Joint Commission, serving quasi-government oversight and public protection roles.

The nascent realization that health care, including the clinician and other components, also needed to be accountable for learning from error was harder to grapple with. Faltering moves were made toward tort reform and institutional accountability for safety practices. A model for accountability of clinicians that included accountability for continuous learning set the stage for, but stopped short of, a full rendition of what accountability for understanding and optimally designing safe health care systems required.

Health Care as an Industry

Beginning in the first half of the 20 th century, the industrial era phased into the service industry era. Systems thinking was an established part of industrial engineering and applied in production lines and service industries. Yet medicine maintained a separation from these changes. This may have been possible mainly due to medicine's standing as a revered profession with a privileged relationship to society, but in part, it also may have occurred because both providers and patients protected the one-to-one model of the doctor-patient relationship. Thus, the health care paradigm remained focused on the patient-physician relationship and on a therapy's point of application, rather than on the systems of application. The practitioner was trained and certified to apply therapy at the point of the illness-causing disorder. Even in the more expansive bio-psychosocial model, safety-oriented systems thinking was missing, even though the roles of the patient's immediate relationship circle and of the community and society were acknowledged.

Rising and apparently uncontrollable health care costs, coupled with increasing evidence of poor quality, ushered in the managed care era, along with demands from the public for accountability. Additionally, increased media exposure of preventable medical errors raised troubling questions that propelled a search for new solutions. Leape's earlier publication of the theoretical possibility of applying industrial human-factors engineering concepts to health care, and the subsequent demonstration with Bates and colleagues of the utility of systems analysis in understanding medication error later that year, provided that new type of thinking. The first conference on patient safety and systems error at the Annenberg Center for Health Sciences in 1996 was a natural next step toward a new type of thinking.

Rethinking Risk

Thought leaders from medicine and policymakers began to carve a new way of understanding risk, new ways to reaffirm relationships with patients, and a new way of addressing the shocking realities that epidemiologic studies, such as Leape's 1994 landmark study, Error in Medicine, had presented. A decade earlier, anesthesiology had made substantial improvements by applying systems thinking translated from methods used in aviation and mechanical engineering, but the rest of medicine had failed to generalize it. Quality improvement and risk management had both developed as disciplines within health care, with an emphasis on health services delivery research and measurement. These and other developments produced a readiness for looking at what might be learned and adapted from other high-risk industries and complex organizations.

Emphasizing Teamwork as Well as Dyadic Relationships

Early attempts at systems change revealed one Achilles heel of implementation: dysfunctional relationships between clinicians and other workers. Mirroring some of the developments in aviation-in which a focus on teamwork complemented attention to refinement of mechanical systems-health care began to recognize the importance of team functioning, particularly for communicating across authority gradients. Training in teamwork became a foundational building block for the new field of patient safety.

The discipline of patient safety rejected the concept of health care delivery as an exclusive dominion of the medical profession over the patient-physician relationship. The vision was more inclusive and demanding. It included patient-centered care and the biomedical model, and it focused on interdisciplinary teams and families. It also included the technical and administrative aspects of health care delivery in a complex system.

Defining Patient Safety

As the intellectual history of patient safety developed, it became increasingly important to define patient safety. Thought leaders began to examine their different assumptions. Is patient safety a way of doing things-i.e., a philosophy (with its own explanatory framework, ethical principles, and methods) and a discipline (with a body of expertise)? Or is it an attribute-i.e., a goal and a condition (being safe), a property that emerges from the system? Existing definitions seemed to vary on the question.

Although the Institute of Medicine (IOM) defined safety as "freedom from accidental injury," patient safety as a discipline or field of inquiry and action has not been fully defined to date in the major consensus statements of the organizations that have propelled its existence. Part of the challenge lies in distinguishing safety from quality, a line that remains important to some, while being dismissed by others as an exercise in semantics. In 1998, the IOM convened the National Roundtable on Health Care Quality, which adopted the following definition of quality that was widely accepted: "Quality of care is the degree to which health care services for individuals and populations increase the likelihood of desired health outcomes and are consistent with current professional knowledge."

Health care quality problems were classified into three categories: underuse, overuse, and misuse, all of which the evidence shows are common. Misuse was further defined as the preventable complications of treatment. Although the IOM Roundtable was careful to distinguish misuse from error (the latter may or may not cause complications), the misuse category became a common reference point for conceptualizing patient safety as a component of quality.

In 2006, Leape and Berwick observed that, as attention to patient safety has deepened, the lines between the overuse, underuse, and misuse categories have blurred. "It seems logical," they wrote, "that patients who fail to receive needed treatments, or who are subjected to the risks of unneeded care, are also placed at risk for injury every bit as objectionable as direct harm from a surgical mishap."

The National Patient Safety Foundation identified the key property of safety as emerging from the proper interaction of components of the health care system, thereby leading the way to a defined focus for patient safety, namely systems. Its goal has been defined as: "[t]he avoidance, prevention, and amelioration of adverse outcomes or injuries stemming from the process of care."

Our Definition of Patient Safety

We use the following definition of patient safety:

Patient safety is a discipline in the health care sector that applies safety science methods toward the goal of achieving a trustworthy system of health care delivery. Patient safety is also an attribute of health care systems; it minimizes the incidence and impact of, and maximizes recovery from, adverse events.

This definition acknowledges that patient safety is both a way of doing things and an emergent discipline. It seeks to identify essential features of patient safety.

The Why, What, Where, How, and Who of Patient Safety

Going farther with the definition, each of its components is expanded here to offer a deeper description of patient safety:

Why does the field of patient safety exist? Patient safety as a discipline began in response to evidence that adverse medical events are widespread and preventable, and as noted above, that there is "too much harm." The goal of the field of patient safety is to minimize adverse events and eliminate preventable harm in health care. Depending on one's use of the term "harm," it is possible to aspire to eliminate all harm in health care.

What is the nature of patient safety? Patient safety is a relatively new discipline within the health care professions. Graduate degree programs are currently being introduced in recognition of patient safety as a discipline. It is a subject within heath care quality. However, its methods come largely from disciplines outside medicine, particularly from cognitive psychology, human factors engineering, and organizational management science. That, however, is also true of the biomedical sciences that propelled medicine forward to its current extraordinary capacity to cure illnesses. Their methods came from biology, chemistry, physics, and mathematics, among others. Applying safety sciences to health care requires inclusion of experts with new source disciplines, such as engineering, but without any divergence from the goals or inherent nature of the medical profession.

Patient safety is a property that emerges from systems design. Patient safety must be an attribute of the health care system. Patient safety seeks high reliability under conditions of risk. Illness presents the first condition of risk in health care. Patient safety applies to the second condition: the therapeutic intervention. Sometimes the therapeutic risk is audacious, such as when a patient's heart is lifted, chilled, cut, and sewn during cardiac transplantation surgery. Risk and safety are flip sides of the therapeutic coin.

Patient safety demands design of systems to make risky interventions reliable. Two tenets of complexity theory apply: First, the greater the complexity of the system, the greater is the propensity for chaos. Second, in open, interacting systems, unpredictable events will happen. The better the therapeutic design, the more resilient it is in the face of both predictable and unpredictable possible or impending failures, so they can be prevented or rescue can be achieved. Safety systems include design of materials, procedures, environment, training, and the nature of the culture among people operating in the system.

Berwick and others have collaborated with Amalberti to apply Shewhart's notion of statistical quality or error levels to health care. Systems are categorized by their level of adverse events. Barriers to progression from one level to another are identified. Interestingly, leaders of high-reliability organizations in other industries view the level of adverse events in medicine as so high that many of them would consider the health industry as existing in a state of chaos. The patient safety discipline seeks systems that can move health care to higher and higher levels of safe care.

Patient safety is a property that is designed for the nature of illness. High-reliability design is a concept that was not originally developed for health care. However, health care has some essential features in common with how high-reliability design has evolved. While often complex and unpredictable, it can have the ultimate high-stakes outcome: preservation of life.

A unique feature of patient care is its highly personal nature. Provision of care almost always requires health care workers to cross significant personal boundaries, both psychological and physical. To protect patient integrity, the health professions have developed codes of professional ethics that guide how best to provide health care without doing dishonor to the ill person. Patient safety designs must allow for these important restrictions, which include confidentiality, physical privacy, and others. At times, these needs conflict directly with the transparency and vigilance needed for optimal patient care, including safety.

Another unique feature is the natural progression of illness. By definition, when illness care begins, something has already gone wrong. Thus, in many medical situations, failure to provide the correct intervention causes harm to the patient. A missed diagnosis of meningococcal meningitis, for example, usually results in patient death. The patient safety discipline acknowledges the need to include harm due to omission of action, as well as the obvious harm due to actions taken.

The vast diversity of possible etiologies and manifestations of illness makes systems design in health care a unique challenge. Nonetheless, the reality is that most conditions are common and of common etiology, which allows for optimal design, if not infallible outcomes. If most patients with a condition such as breast cancer are best treated according to protocol but some require off-protocol, tailored treatment, systems can be designed to meet that need for the majority of protocols with tailoring options.

Patient safety is a property dependent on open learning. Patient safety has another inherent feature that derives directly from its dependence on errors and adverse events as a main source of understanding. It depends on a culture of openness to all relevant perspectives in which those involved in adverse events are treated as partners in learning. In this sense, patient safety espouses continuous cycles of learning, reporting of adverse events or near misses, dissemination of lessons learned, and the establishment of cultures that are trusted to not cast unfair blame. The patient safety field marries principles of adult education and effective behavioral learning with the traditional approaches of the medical profession. Known from its early days as the field that seeks to move "beyond blame" to a culture trusted by all to be just patient safety, patient safety pioneers have pushed for a much deeper understanding of the mechanisms of errors that often lie beyond the actions or control of the individual.

Patient safety advocates turn away from the traditions of the guild in which social standing and privileged knowledge shielded practitioners from accountability. They also reject the defensive posture of old risk management approaches in which physicians and leaders of health care organizations were advised to admit no responsibility and to defend all malpractice claims, whether or not they were justified. Patient safety embraces organizational and personal accountability, but it also recognizes the importance of moving beyond blame in both its organizational and its personal dimensions, while maintaining accountability and integrity in interactions with patients and families who have suffered avoidable adverse events.

Trustworthiness is essential to the concept of patient safety. The health care system designed for patient safety is trustworthy. This is not because errors will not be made and adverse events will never happen, but because the health care system holds itself accountable to applying safety sciences optimally. Patient safety (as an attribute) prevents avoidable adverse events by paying attention (as a discipline) to systems and interactions, including human interactions, and allowing learning by all parties from near misses and actual adverse events. Through a concerted, conscientious effort, all those involved act to minimize the extent and impact of unavoidable adverse events by creating well-designed systems and well-motivated, informed, conscientious, and vigilant personnel, and by seeking to repair damage honestly and respectfully when it occurs.

Where does patient safety happen? The ultimate locus of patient safety is the microsystem. That is, the immediate environment in which care occurs-the operating room, the emergency department, and so on. It is in the microsystem where the "sharp end" resides, where patient-caregiver interactions occur, where failures of safety emerge, and where patients are harmed. Breaches in safety may have occurred in many blunt-end components, and as described above, events constitute properties of interacting components of the overall system. Therefore, patient safety is irreducibly a matter of systems. Nonetheless, as the setting where the patient receives health care, the microsystem is the locus where the successes or failures of all systems to ensure safety converge.

At the same time, patient safety must be concerned with the entire system. Importantly, patient safety recognizes that the microsystem is inherently unpredictable. Although it takes a mechanistic view of causation, patient safety acknowledges that each microsystem is open in that it can be influenced by another microsystem. This may result in something unpredictable. Thus, for instance, the microsystem of concern in surgical safety might be the operating suite, but if a local emergency demands that two members of the surgical team leave the operating room, the microsystem has been unpredictably affected.

How is patient safety achieved? A number of mechanisms are involved in achieving patient safety, including:

High-reliability design. The fundamental mechanism by which patient safety can be achieved is high-reliability design, which includes many components. Thus, the irreducible unit of patient safety delivery is multifaceted; all components of health care delivery must be integrated into a system that is as reliable as possible under complex conditions.

A unique feature of high-reliability design comes from complexity theory, which notes that open, interacting systems will produce some level of chaos or inherently unpredictable events. High-reliability designs are resilient even when unpredictable events occur.

Additional design features that guide health systems engineers include "lean process" and a notion of breaking through reliability boundaries in leaps from one safety level to another. These levels of reliability are often known as sigma levels-through the use of simplified and better processes.

The concept of a multilayered system, in which the failures within each of the layers must be aligned for an error to occur, is known as the "Swiss cheese" model of accident causation. The components that make up the system include the institution and its organization, the professional team and the individuals it includes, and the technology in use.

Error traps (i.e., unpredictable situations in which error is highly likely) are another vivid concept on which safety sciences focus. The notion is that health care delivery is not only complex; it is also an open interacting system, in which illness is also a given, so the opportunities for making errors are many and endemic. Health care workers and health systems designers must therefore take this into account.

Safety systems design in health care is early in its development. Practical approaches to design for safety have been pioneered by the Institute for Healthcare Improvement (IHI), the Agency for Healthcare Research and Quality (AHRQ), and the World Health Organization's (WHO) World Alliance for Patient Safety (see also "Applying the Patient Safety Model," below), among others. For instance, patient safety designs can be thought of as falling into two types: those that are for types of routine care that vary little and can best be managed with protocols allowing for little deviation, and those that are for unique situations where on-the-spot innovation and significant deviation from protocol are required.

Safety sciences. The term "safety science" refers to the methods by which knowledge of safety is acquired and applied to create high-reliability designs. The objective is to design systems that approach "fail-safe" conditions-i.e., those that ensure proper execution. The ideal design is one in which the operator cannot perform the function improperly. Short of that ideal, much of the effort in the past has been directed toward developing defenses, which are barriers that prevent an unsafe act from resulting in harm. Over the years, health care has developed many of these barriers, and usually several must be breached for patient harm to occur.

Acquisition of objective knowledge is a matter of science. Patient safety uses methods that are appropriate to the purpose, and these can be drawn from a range of disciplines. Some, such as understanding human error, come from human physiology and psychology. Some, such as systems analysis and quality improvement, come from engineering and management. Others, such as organizational behavior, come from the social sciences. Still other methods come from health services research. The disciplines that contribute to safety use the methods that are appropriate to each field. These include controlled experiments, repeat tests, and other traditional scientific methods. Human factors engineering is built on, as appropriate, randomized controlled trials of human performance, anthropometry, anatomy, physiology, physics, and mathematics.

A strong claim can be made that although safety sciences are scientifically grounded, the fundamental drive toward and the cutting edge of inquiry in patient safety uses the narrative; i.e., the stories of adverse events yield insights and drive adjustments. Stories provide pattern recognition for patient safety practitioners. Stories of patient safety, like other stories, are specific and yet have insights that can be applied to other settings. This feature is well suited to the need for dealing with events that might be either familiar or entirely unpredictable.

Importantly, however, one of the founding contributors to the safety sciences had a critical reason and unique standing to claim the term "science" for the safety sciences. Philosopher Karl Popper-famous for his work in defining the scientific method-working with MacIntyre, identified error (and by extension, one can include systems failures more generally) as analogous to data that refute a hypothesis in the scientific method. Sciences, such as chemistry or biology, use as their core method a cycle that comprises observation, hypothesis generation, testing, and hypothesis verification or alteration, depending on the results of testing. Deviation from this method causes the knowledge to be unreliable and the deviant methods to be discarded as unsound.

The patient safety discipline uses an analogous cycle-observation, design, testing, then use-as its method, and system adjustment is based on analyzing how adverse events came about. This, in turn, is based on Deming's assertion that making a change is a key source of knowledge for systems. The rather close analogue of method warrants the use of the term "science" in the safety sciences.

To understand how human performance slips up, psychology, physiology, or social science must be used. To understand how a machine fails, engineering methods must be used. Each method must be used with its full insistence on rigor so that the new knowledge is as reliable and objective as possible. However, in contrast to the application of the scientific method in the physical sciences, for ethical and practical reasons, in patient care there rarely can be a control or a repeat of the same event to check for reproducibility, except in a simulated environment. Nonetheless, when the analytic method has yielded to the best of its capacity a new insight, then this-like the new data in the process of science-generates a new cycle of adjusted design, testing, and use. In short, the analytic method must be unique to the adverse event, but then the safety sciences use the insight generated to create a new cycle of improved understanding and system design.

In short, patient safety applies many methods and techniques. However, two analytic methods have become widely associated with the field. One is retrospective. The analysis of what went wrong when an adverse event has occurred is known as "root cause analysis" (RCA). Perhaps the close identification (probably excessively so) of patient safety with RCA is a result of heightened attention that occurs after a bad event. RCA is an approach to finding out what underlying features of a situation contributed to an adverse event. Adopting the idea that the immediate cause of an event is almost always the end result of multiple systems failures, RCA seeks, by review of data and interviews, to identify and understand all contributing causes in order to redesign the systems to make them safer in the future.

The other characteristic method of patient safety is prospective. Attempting to anticipate and prevent adverse events through safety design is known as "failure modes and effects analysis" (FMEA). FMEA is an engineering approach, usually taken early in the development of a product, that seeks to imaginatively identify potential failures and their effects. Knowledge from past failures might contribute to a designer's ability to foresee potential failures in their design.

Designs are then adjusted to make failure less likely. FMEA is used in analyzing every aspect of a system's design, including the system's global functioning, its components and their interactions, the functioning of equipment, the programming of equipment, and the procedures for activities.

Nevertheless, no one method is enough to produce the range of knowledge and types of understanding required for patient safety. In contrast to the clinical sciences in which the randomized controlled trial is the research method of choice, patient safety eschews the notion that the field can have confidence in a single "gold standard." In patient safety, contributions are sought from engineering, social sciences, psychology, psychometrics, health services research, epidemiology, statistics, philosophy (theories of justice, accountability), ethics, education, computer sciences, and more. Each discipline uses its own particular methods; patient safety takes each on its own merits and selects the method most suited to the topic or question at hand.

Measurement remains an important area for development in patient safety. Many needed measures have not yet been developed. The IHI talks of three types of measurement: process, outcome, and balance. Process measures may need to be developed and validated for a complete bundle of carefully selected procedures for a given clinical setting. Outcome measures might need to be developed for the particular outcome in question, but they might also need to be used in a fashion that has been developed to allow for balance-i.e., to look at the impact of intervention in one place in the system on other places in the system.

Methods for causing change. With its emphasis on making changes in health care workers' actions, patient safety seeks to engage methods to bring about improvements that go beyond transmission of knowledge and acquisition of skills to the effective implementation of appropriate skills. In this regard, patient safety builds on the insights and techniques of quality improvement. By its nature, separation between acquisition of new knowledge and service delivery is minimal.

Rapid cycles of feedback and response methods for institutional improvement were pioneered in health care by Berwick and others. These processes are derived from continuous quality improvement methods originally designed by Deming and others. The methods focus on the systems of health care delivery more than on the medical issues and the knowledge that the rapid cycles produced are of the specific local system. The methods are designed to improve services in areas where a gap between acknowledged standards and actual practices exists. Usually, a guideline or protocol that has already been endorsed by an expert medical body or bundle of established practices is to be applied. The rapid cycles tend to keep the guideline or protocol or bundle the same, altering its application only to optimize its full use in the local system. Once the implementation is done, quality indicators are monitored to maintain the new standards.

Patient and family voice is important throughout. Adverse events are subjected to analysis, which feeds into redesign or adjusted design of the systems of care. More traditional health services research and other methods of acquiring understanding are also fed into the recomposition of the systems.

Dissemination of change is not a characteristic of the approach that uses rapid cycles or of quality improvement more generally. This is in great part because the methods are designed to be tailored to the local system; therefore, they do not readily generalize, and measures of success might vary for the same reason. However, approaches that standardize measures and quality improvement methods are being used, which will allow for better dissemination. Alternatively, more traditional campaigns to get individual health care sites to each do their own improvement work can be used, as has been done by the IHI.

Who is a patient safety practitioner? Most health-related disciplines are characterized by specialists who devote themselves to the full-time practice of the discipline. Similarly, patient safety is emerging as a specialty in which education at the masters' level is offered and to which patient safety offices and patient safety officers devote their full-time effort.

However, patient safety requires that all members of the health care service delivery team be "patient-safety minded." It also depends on both hands-on patient safety practices and leadership within every discipline in health care. As a quintessentially collaborative activity, patient safety needs leaders in each area of clinical administration and in each clinical discipline-including doctors, nurses, pharmacists, and others-in addition to information management, equipment and plant management, and other areas. Patient safety practitioners truly include everyone in health care.

For those who have an advanced degree in patient safety or a role determined by patient safety, it could be a primary professional identity. For most, it will be a personal and professional commitment-a part of their identify, but not their primary identity, which will remain cardiology or plant management, etc. Nonetheless, since all in health care should acquire the characteristics needed for practicing safety, it is important to know what characteristics a patient safety practitioner (whether by primary or secondary identity) should have.

What skills or unique characteristics should a patient safety practitioner possess? A professional who provides direct care needs to have a kind of wariness or patient safety vigilance. This quality is most often informed by a rich knowledge about adverse events and how to help avert them or minimize their damage. This kind of practical wisdom or "safety savvy" grows continuously from experience and an ability to recognize when something is not right. Often an adverse event that is about to unfold can be averted or its impact minimized if it is caught in action.

Patient safety practitioners are well storied. The role of narrative in patient safety has been emphasized, both as a vehicle for acquiring safety-relevant knowledge and as a vehicle for becoming, what Weick has called, mindful or safety wary. They understand that health care systems are full of "error traps," and they are vigilant in foreseeing and preempting, mitigating, and rescuing patients from them. Reason envisions a future for patient safety in which its practitioners share many true stories of adverse events in their training and educational venues. He sees this as the normative method for making members of the health care community "safety wise." For example, studies of pediatric cardiac surgeons found that those surgeons-who were inclined to detect their errors and fix them, even at the price of having a longer and less elegant operation-had the best outcomes and reputations.

Patient safety practitioners must also become excellent team members, whether they are natural leaders or better in other roles. They must be able to substitute for one another and appreciate the other's perspective. Importantly, since vigilance is essential for patient safety and is also tiring, working in teams during shift work is essential.

A Patient Safety Model of Health Care

With the above aspects of patient safety lined up, it is possible to see a simple model of patient safety. While good models of patient safety have been constructed, we seek an overarching model that is simple, fully authentic to the subject matter, and compatible with the good existing models. At the same time, it should be simple enough that it can be seen in a readily sketched diagram and stated in a simple, short sentence that can be easily recalled. Only such a simple model can ubiquitously permeate the interstices of daily thought among all the necessary people throughout health care.

We offer the following simple model with which to view patient safety. It divides health care systems into four main domains:

Those who work in health care.

Those who receive health care or have a stake in its availability.

The infrastructure of systems for therapeutic interventions (health care delivery processes).

The methods for feedback and continuous improvement.

These four domains are represented graphically in Figure 1. Each domain interacts with the other domains and with the environment, as depicted by the semipermeable divisions (dotted lines) between them and at their outer edges. The result is a core, overarching model for patient safety.

The model is consistent with the descriptors of patient safety stated above: What...? and Where...? correspond to the third domain, i.e., "Systems for therapeutic action." How...? corresponds to the fourth, "the Methods"; Who...? corresponds to the first and second, i.e., "people who work in health care" and "people who receive it or have a stake in its availability."

The model is also consistent with existing frameworks of thinking that underpin patient safety. Each framework defines categories or elements that fall coherently within one or more of the four domains, as displayed in Table 1.

Deming's notion of "deep knowledge" of quality design required an understanding of (1) the system; (2) variation in its performance; (3) how to use change as a source of knowledge; and (4) the psychology of people in the organization. All of these elements drive quality improvement, and they belong within the domain of "methods."

Donabedian divided health care into structure, process, and outcomes for the purpose of measurement. It is also a helpful way of categorizing the health system for the purposes of understanding how elements of the system interact. For this reason, the categories can be thought of as cutting across all four domains in the patient safety model.

Vincent identified seven elements that influence safety:

These factors distribute among the three domains: systems for therapeutic action, the people who work in health care, and the people who receive it or have a stake in its availability.

Carayon and colleagues proposed a Systems Engineering Initiative for Patient Safety (SEIPS) model for design in health care. In the SEIPS model, elements are helpfully depicted with intersecting arrows that illustrate how the elements can interact with one another, so indicating the notion of emergent properties.

The above 11 elements do not represent an exhaustive list. In addition, elements can be subdivided into their content areas, which is not attempted here. For instance, external environment has been divided into physical, social, and biologic areas. The elements can also be categorized in different ways. For example, team factors could be included within work environment. The purpose of this simple, broad model of domains is to capture the largest category of essential components in patient safety and their interaction with one another.

The fashion in which this or any patient safety model applies must vary by setting as dramatically as the settings vary. The nature of the illnesses and social setting, the nature of the therapies, the nature of the human resources, and the nature of the physical infrastructure all will contribute to defining the very different systems. These systems must be analyzed and options identified for improvement. However, the fundamental concepts in any good patient safety model are applicable to most settings.

What is the utility of this model and of the other models with which ours is built to be compatible? Our model and other models provide a way of seeing the component elements involved in patient safety and how they interact. So, when designing a system, improving a system, analyzing an adverse event, researching an issue, or measuring a new intervention, such models provide a ready map of matters that should be considered. Given the human tendency to limit the scope of focus, models provide a countervailing stimulus to include the whole universe of domains and their elements that could be involved in the patient safety issue at hand.

Conclusion

The field of patient safety has emerged in response to a high prevalence of avoidable adverse events. However, many do not use a clear definition or have a clear model of understanding of the field. We call on organizations to adopt a definition and model for patient safety. To assist the process, we provide a definition and describe the nature of the field by going through each component in the definition. We identify its primary focus of action as the microsystem and its essential mechanisms as high-reliability design and the use of safety sciences and other methods for causing improvement, including cultural change. We describe key attributes of those who practice safety, and we identify its practitioners as all involved in health care. To provide an easy-to-recall, overarching model of patient safety, we offer one that identifies four main domains of patient safety (1) people who receive health care, (2) people who provide it, (3) systems of therapeutic action, and (4) methods and elements within each domain. We hope that this description, definition, and model will assist the integration of patient safety practices throughout health care.

Acknowledgments

We appreciate the helpful comments of Ben-Tzion Karsh and the invaluable assistance of Maia Feigon, Andrew Harris, and Jonathan Masia-Peters.

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# data[].attributes.attachment_link.authors[].name
Linda Emanuel, Don Berwick, James Conway, John Combes, Martin Hatlie, Lucian Leape, James Reason, Paul Schyve, Charles Vincent, Merrilyn Walton

# data[].attributes.attachment_link.description
We articulate an intellectual history and a definition, description, and model of patient safety. We define patient safety as a discipline in the health care professions that applies safety science methods toward the goal of achieving a trustworthy system of health care delivery.

# data[].attributes.attachment_link.readable_text
The simplest definition of patient safety is the prevention of errors and adverse effects to patients associated with health care. While health care has become more effective it has also become more complex, with greater use of new technologies, medicines and treatments. Health services treat older and sicker patients who often present with significant co-morbidities requiring more and more difficult decisions as to health care priorities. Increasing economic pressure on health systems often leads to overloaded health care environments.

Unexpected and unwanted events can take place in any setting where health care is delivered (primary, secondary and tertiary care, community care, social and private care, acute and chronic care). Every 10th patient in Europe experiences preventable harm or adverse events in hospital, causing suffering and loss for the patient, their families and health care providers, and taking a high financial toll on health care systems. Safety is part of the quality agenda and therefore a dimension of the quality culture, requiring broad commitment from both the organization and the community. WHO/Europe is committed to enhancing the quality of health care, and patient safety is a crucial element of that quality. This encompasses:

developing active networks of patients and providers;

sharing experiences;

learning from failure and pro-active risk assessment;

facilitating effective evidence-based care;

monitoring improvement;

empowering and educating patients and the public, as partners in the process of care.

The diversity in the WHO European Region's 53 Member States is reflected in wide disparities in health systems' development, funding mechanisms and resources. Varying paces of socioeconomic growth and changes in demography and lifestyle practices have resulted in widening gaps in life expectancy between groups of countries, and sometimes within countries. At the same time, expectations of health system performance are mounting, challenging its readiness to change and adjust to technological development and emerging health threats.

Evidence has shown that to maintain and increase the health status of their populations, countries in the European Region must strengthen their health systems in terms of addressing patient safety and quality of care. The 2008 Tallinn Charter: Health Systems for Health and Wealth renewed the concerted political commitment of its Member States to strengthen the quality agenda.

# data[].attributes.attachment_link.description
The simplest definition of patient safety is the prevention of errors and adverse effects to patients associated with health care. While health care has become more effective it has also become more complex, with greater use of new technologies, medicines and treatments.

# data[].attributes.headline
Adverse events in British hospitals: preliminary retrospective record review

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Adverse events in British hospitals: preliminary retrospective record review

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Abstract

Number of adverse events.

Introduction

Retrospective studies of hospital case records in the United States and Australia have shown a substantial rate of adverse events, defined as unintended injuries caused by medical management rather than the disease process. The Harvard medical practice study found that 3.7% of hospital admissions led to adverse events. In 70% of these patients the adverse event led to slight or short lived disabilities, but in 7% the disabilities were permanent and in 14% they contributed to death. Similar rates were found in a study from Colorado and Utah. The quality in Australian healthcare study identified adverse events in 16.6% of admissions, half of which were considered preventable. This study included a wider range of adverse events of minor or moderate severity. Other methodological differences also exaggerate the difference between the United States and Australian figures. The Australian study estimated that adverse events accounted for 8% of hospital bed days and cost the Australian healthcare system $4.7bn a year. Adverse events also result in huge personal cost to the affected individuals, both patients and staff.

The epidemiology of adverse events has not been studied in Britain. We report preliminary findings from a pilot study that examined the feasibility of applying United States and Australian methods and the potential value of a parallel study in the United Kingdom.

Methods

Design and procedure

The study was carried out at two acute hospitals in the London area. We reviewed 500 randomly drawn records from site 1 between July and September 1999 and 514 records from site 2 between December 1999 and February 2000. In both sites the index admissions studied occurred in two months in 1998, about a year before the review periods. We reviewed 273 (26.9%) records from general medicine (including geriatrics), 290 (28.6%) from general surgery, 277 (27.3%) from orthopaedic surgery, and 174 (17.2%) from obstetrics. Admissions to the four specialties studied in 1998-9 were 19 397 in site 1 and 18 335 in site 2. The proportions of admissions studied were 2.6% and 2.8% respectively.

Review process

The review team consisted of an experienced nurse who worked as project manager with four part time research nurses. A consultant physician acted as lead medical assessor, working with five part time surgical and obstetric colleagues, each of whom had been qualified for a minimum of 10 years. Each reviewer screened sets of notes under supervision until they were judged to be fully conversant with the review process.

The nurse reviewers used 18 predefined screening criteria to assess the case records. Records that screened positive (n = 405) were then reviewed by clinicians, who identified any adverse events and completed a detailed questionnaire. The clinicians assessed the impact of each adverse event on the patient in terms of disability and additional bed days, likely cause, place and date of occurrence, type of adverse event (for example, whether related to a particular procedure or treatment), and preventability and recorded detailed clinical information. Records were reviewed once only, although difficult issues were resolved after duplicate review and discussion between two or more assessors. Criteria for adverse events are given on the BMJ 's website. A full description of the methods has been published. Copies of the British review forms are available from the authors.

Results

In all, 110 (10.8%) of 1014 patients experienced an adverse event (table ). However, some patients experienced multiple events, and the overall number of events was 119 (11.7%). There was no significant difference in sex between patients who did and did not experience an adverse event. However, patients with adverse events were older than those who did not experience an adverse event (P<0.001; see tables A and B on BMJ 's website)

Table 1

Specialty

No (%) of records reviewed

No of patients with adverse events detected

Total No of adverse events detected

All (% of records)

Preventable (% of events)

All (% of records)

Preventable (% of events)

Seventy three (66%) patients who suffered an adverse event had minimal impairment or recovered within one month; 37 (34%) patients developed an injury or complication that resulted in moderate impairment (21 patients; 19%) or permanent impairment (seven patients; 6%) or contributed to death (nine patients; 8%). Overall, 53 (48%) adverse events were judged preventable. The box shows an example of a patient who experienced serious adverse events.

The 119 adverse events resulted in a total of 999 extra bed days, of which 460 (46%) were judged preventable and therefore could have been saved. Each adverse event led to an average of 8.5 additional days in hospital (range 0-70 days) with additional direct costs of £290 268 to the trusts concerned (table ).

Table 2

Specialty

No of patients with adverse events

Mean (SD) extra bed days for all adverse events

Daily cost of bed (£)

Total cost of additional bed days for study sample (£1000s)

Discussion

Our pilot study has established the feasibility of conducting a major record review of adverse events in the United Kingdom. We found that 10.8% of patients admitted to hospital experience an adverse event, with an overall 11.7% rate of adverse events when multiple adverse events are included. About half of these events were judged preventable. A third of adverse events led to moderate or greater disability or death. Some adverse events are serious and are traumatic for both staff and patients. Others are frequent, minor events that go unnoticed in routine clinical care and yet together have massive economic consequences.

This study is primarily a pilot and has certain limitations. The study was small and based on only two hospitals. In addition, the case mix does not accurately reflect hospital practice. The specialties included in the review could have higher rates of adverse events than other specialties. Nevertheless, the specialties we chose constitute a large proportion of inpatient care.

Although we cannot extrapolate with any precision, our findings strongly suggest that adverse events are a serious problem in the NHS, as they are in the United States and Australia. We estimate that around 5% of the 8.5 million patients admitted to hospitals in England and Wales each year experience preventable adverse events, leading to an additional three million bed days. The total cost to the NHS of these adverse events in extra bed days alone would be around £1bn a year.

In the United States and Australia retrospective case record analysis has provided the foundation and driving force for initiatives to reduce harm to patients and to make more efficient use of expensive hospital resources. Our findings indicate that a full national study would be justified in the United Kingdom, as indicated in the chief medical officer's recent report. We believe that the investigation should cover at least 20 general hospitals (of varying size and type) and include 500 representative case records from each hospital. This would yield around 1000 adverse events for detailed analysis. Such a study would provide reliable information on the numbers, types, and costs of adverse events occurring in NHS hospitals. This would allow the principal causes to be explored and specific risk reduction strategies to be identified and costed. The total cost of such a study would probably be equivalent to the money lost through preventable adverse events in less than eight hours in the NHS.

Acknowledgments

We thank our international colleagues Bob Gibberd, John Hamilton, Bernie Harrison, Eric Thomas, and Ross Wilson for their time and support, and Alastair Gray for advice on economic aspects of the study. We also thank the clinical reviewers: Justice U-Lois, Sebastian Borges, Aubyn Marath, Deirdre Murphy, and Robert Downes; the nurse/midwife screeners: Jayne Moore, Jane Weaver, Sinéad Trainor, Marcia Persaud, and Katie Major; and the staff at the two trusts.

Notes

Footnotes

Funding: King's Fund, Nuffield Trust, London Region NHS Research and Development Programme, and the Dunhill Medical Trust. The views and opinions expressed in this article do not necessarily reflect those of these bodies.

Competing interests: None declared.

The criteria for adverse events and tables of results is available on the BMJ's website

References

# data[].attributes.attachment_link.title
Adverse events in British hospitals: preliminary retrospective record review

# data[].attributes.attachment_link.description
Number of adverse events. Retrospective studies of hospital case records in the United States and Australia have shown a substantial rate of adverse events, defined as unintended injuries caused by medical management rather than the disease process. The Harvard medical practice study found that 3.7% of hospital admissions led to adverse events.

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Incidence and types of adverse events and negligent care in Utah and Colorado

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Incidence and types of adverse events and negligent care in Utah and Colorado

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The occurrence, types, consequences and preventability of in-hospital adverse events – a scoping review

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The occurrence, types, consequences and preventability of in-hospital adverse events – a scoping review

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Research article

Open Open Peer Review

Published:

Abstract

Background

Adverse events (AEs) seriously affect patient safety and quality of care, and remain a pressing global issue.

This study had three objectives: (1) to describe the proportions of patients affected by in-hospital AEs; (2) to explore the types and consequences of observed AEs; and (3) to estimate the preventability of in-hospital AEs.

Methods

We applied a scoping review method and concluded a comprehensive literature search in PubMed and CINAHL in May 2017 and in February 2018. Our target was retrospective medical record review studies applying the Harvard method-or similar methods using screening criteria-conducted in acute care hospital settings on adult patients (≥18 years).

Results

We included a total of 25 studies conducted in 27 countries across six continents. Overall, a median of 10% patients were affected by at least one AE (range: 2.9-21.9%), with a median of 7.3% (range: 0.6-30%) of AEs being fatal. Between 34.3 and 83% of AEs were considered preventable (median: 51.2%). The three most common types of AEs reported in the included studies were operative/surgical related, medication or drug/fluid related, and healthcare-associated infections.

Conclusions

Evidence regarding the occurrence of AEs confirms earlier estimates that a tenth of inpatient stays include adverse events, half of which are preventable. However, the incidence of in-hospital AEs varied considerably across studies, indicating methodological and contextual variations regarding this type of retrospective chart review across health care systems. For the future, automated methods for identifying AE using electronic health records have the potential to overcome various methodological issues and biases related to retrospective medical record review studies and to provide accurate data on their occurrence.

Background

Adverse events (AEs) seriously affect patient safety and quality of care in hospitals. The epidemiology of harm due to medical care remains a pressing issue on a global scale. In the US, a recent report reviewing earlier studies ranked iatrogenic causes, especially medical errors, as the third leading cause of death [ 1]. Specifically, up to 1.1% of hospital admissions led to deaths due to medical errors. Extrapolating this percentage to the annual patient numbers for all registered US hospitals, this would account for more than 400,000 deaths in 2013 alone. While such a high volume of patient harm associated with hospital care is shocking, the projected annual cost of measurable medical errors is mind-boggling: in the US alone, based on data from that year, AEs have been dubbed "the 17.1 billion dollar problem" [ 2].

The two most frequent classes of AE, postoperative infections and pressure ulcers, accounted for the largest annual costs (6.5 billion USD). Following these, central venous catheter infections and infections following infusions, injections and similar procedures resulted in a combined total of more than one billion USD in extra healthcare costs.

The authors conclude that the most frequent errors result from rather common medical services for which cost-cutting efforts compromise patient safety [ 2]. That is, the majority of medical errors leading to in-hospital AEs are not caused by poorly performing physicians, nurses, or other clinicians. More commonly, they arise from care delivery problems that result from conditions at the levels of the individual patient or staff member, the task or the health care team. They may even be rooted in the overall work environment. If safeguards along this causal pathway fail, AEs can result. Thus, current, accurate information on AEs is crucial both for individual learning and for improving and developing more reliable health care systems [ 3].

Despite the existence of various national AE registries, such as the US Food and Drug Administration's system for voluntary reporting of serious drug- or medical device-related AEs [ 4], or the Dutch Healthcare Inspectorate for mandatory reporting of sentinel events [ 5], comprehensive, prospective national-level data on in-hospital AEs are severely limited [ 1]. Thus, the available evidence is based mainly on retrospective chart review studies aimed at detecting AE occurrences. The two most frequently used review methods are the 'Harvard method' [ 6] and the Institute of Healthcare Improvement's Global Trigger Tool [ 7]. Both involve two-stage medical record reviews and were designed to provide data on the frequency and types of AEs. Stage 1, an evaluation of the presence of certain screening criteria-triggers-is followed by a more in-depth manual review of the medical record to detect an AE (Stage 2). Table 1 provides a brief overview of the characteristics and differences between the two methods [ 8].

Table 1 Brief overview on the characteristics and differences between the 'Harvard method' and the 'Global Trigger Tool method' to detect AEs through retrospective medical record review based on Unbeck et al. [8]

The Global Trigger Tool (GTT) has the demonstrated advantage of identifying AEs more accurately than other readily available methods, including voluntary reporting of critical incidents or the Patient Safety Indicators put forth by the Agency for Healthcare Research and Quality [ 9]. Consequently, it has become an increasingly popular method for post hoc safety measurement and monitoring [ 10]. In a recent systematic review on 48 general inpatient studies using the GTT, rates of AEs varied between 7 and 40%. Of those identified, the most common event types were complications related to infections, surgical procedures and medication [ 11]. An earlier systematic review [ 12] indicated similar findings in eight studies, including a total of more than 70,000 hospital inpatient records, using the Harvard method or comparable approaches. Their analyses revealed that nearly every 10th patient was affected by an adverse event, of which 43% were deemed preventable, and 7.4% were lethal. This time, the majority of AEs were related to surgical procedures (39.6%) and medications (15.1%), while medical procedure- (7.8%), diagnostic- (7.5%) and therapeutic-related (7%) events were less frequent, they remained noteworthy [ 12].

Despite increasing interest among clinical practitioners and researchers to further investigate and develop the GTT, e.g., studies of the accuracy of automated methods for identifying AEs from electronic health record data [ 13, 14], retrospective chart review methods such as the Harvard method remain widely used to identify AEs [ 8]. In particular, these have been used in large-scale studies to estimate national-level AE prevalence. As a consequence, since de Vries's 2008 systematic review on the topic, numerous retrospective chart review studies have applied Harvard-style methodologies [ 9].

Methods

Aim

The purpose of this study was to update recent in-hospital adverse event figures according to three objectives: (1) to describe the proportions of patients affected by in-hospital AEs; (2) to report the types and consequences of observed AEs; and (3) to estimate the preventability of in-hospital AEs.

Design

We conducted a scoping review based on the framework outlined by Arksey and O'Malley [ 15]. A scoping review's purpose is to summarize "a range of evidence in order to convey the breadth and depth of a field" [ 16]. It differs from a systematic literature review in that it requires broader research aims (as opposed to a narrowly focused question) and more refined post hoc (rather than a priori) selection criteria for papers during the review process, but suspends critical appraisal of bias risk or other quality indicators until after the selection process is complete [ 15, 17, 18, 19].

Literature search

A first literature search of the Medline (PubMed) and CINAHL databases was conducted in May 2017 using the terms " Incidence" [tiab] AND "adverse events" [tiab] AND "patient safety." The records retrieved were screened independently by CB and SD for hospital adverse event studies conducted between 1991 and 2017. A manual search of the returned articles' bibliographies was also performed to identify additional relevant studies. In February 2018, in line with our scoping review methodology, a second comprehensive database search was conducted to confirm and complement the results of the first PubMed literature search using an elaborate search string using Hausner et al.'s approach: ((adverse [tiab] AND events [tiab] AND patient*[tiab]) OR incidents [tiab]) AND preventable [tiab])) [ 20]. Following Hausner et al.'s model, we developed our search string based on a primary set of relevant records (a development set) identified in the first search. The relevant records' titles and abstracts contained keywords (e.g., MeSH terms) and free text terms that served as the building blocks of the final search string. Variations of the search string were then tested against a second set of relevant records (validation set). In our case, as no MeSH term for "adverse events" existed and no promising alternative keywords could be identified, a free text only search string was compiled. All records retrieved were screened independently by RS and DA (see Fig. 1).

Flow diagram of article retrieval

Study selection

In order to reliably compare the data, we defined an AE according to the Harvard Medical Practice Study definition: "an unintended injury or complication that results in disability at the time of discharge, death or prolonged hospital stay caused by health care management rather than by the patient's underlying disease process" [ 21]. All primary studies that (1) used this or a similar definition of an AE, (2) applied a retrospective medical record review according to the Harvard method or a similar method, (3) used a two-stage record review with primary criteria-driven screening by trained reviewers (mostly nurses) and a secondary review of their findings by a physician, (4) were conducted in acute care hospital settings (e.g., medical, surgical, ICU), and (5) included hospitalized adult patients (≥18 years), were eligible for inclusion. Studies restricted to specific clinical areas (e.g., pediatrics, emergency department), studies from non-acute care settings (e.g., rehabilitation, long-term care, primary care), as well as those that evaluated only specific types of AE (e.g., adverse drug events), were excluded. Systematic reviews or studies applying prospective methods (e.g., critical incident reporting systems) were also excluded. Likewise, given that differences in review methodologies result in disparities in AE detection [ 8], and that a systematic literature review on the application of the GTT had recently been published [ 11], studies applying the GTT method were excluded. Final inclusion of studies was achieved by consensus between the authors (RS and DA).

Data charting and analysis

From the selected studies, we extracted information on the prevalence (i.e., the proportion of affected patients), types, frequencies, and related consequences of AEs, those AEs' preventability, and relevant study details (i.e., methods, number of hospitals, setting and sample size) (see Table). Critical appraisal of the included studies and meta-analysis of AE rates across studies were not undertaken due to methodological heterogeneity (e.g., differences in setting, retrospective chart review methods, number of screening criteria, number of reviewers, detection and inclusion of AEs before index admission). Medians and ranges of occurrence, types, consequences and preventability of AEs were calculated using Microsoft Office Excel 2016.

Results

Study selection

We included 25 studies conducted between 1991 and 2017 in 27 countries in Europe, Asia, Africa, North and South America, and Australia/New Zealand (see Table 2). All included studies used two-stage retrospective medical record reviews to detect in-hospital AEs based on the 'Harvard method' [ 6] or modified versions of it, such as those developed in Canada [ 22] and the United Kingdom [ 23]. Of the 25 studies used, 19 were multi- and 6 single-centre studies. In the multicentre studies, the number of hospitals ranged from two to 58, with sample sizes ranging from 354 [ 24] to 30,121 [ 6] patients/records. The single-centre studies' samples ranged from 500 [ 25] to 1501 [ 26] patients/records (see Table 2).

Table 2 Frequencies of occurrence, characteristics/types, consequences and preventability reported in the included studies on in-hospital AEs

Frequencies of AEs

Across all studies, the frequencies of patients with AEs spanned between 2.9% [ 27] and 21.9% [ 28]. The overall median was 10%, with multicentre studies showing a median of 9.3% (range: 2.9% [ 27] - 21.9% [ 28]). Single centre studies reported a median of 11.2% with an overall range of 3.3% [ 26] to 13.5% [ 29] patients affected by AEs.

Types of AEs

The most common and most consistently reported types of AE in the included studies were operative/surgical-related events, often resulting from procedural complications and injuries such as post-op bleeding or return to surgery. These accounted for a median of 40% of those detected (range: 27% [ 30] - 74.9% [ 28]). The second most frequent type was medication- or drug/fluid-related events such as medication errors, which accounted for a median of 19.3% of those detected (Range: 4% [ 31] - 73% [ 25]). In third position, healthcare-associated infections and allergic reactions were responsible for a median of 17.7% of all detected events (Range: 0.2% [ 28] - 25.3% [ 32]).

Severity and preventability of AEs

AEs' consequences were mostly temporary and minimal (recuperation < 1 month) (Median: 53.5%; Range: 16.1% [ 33] - 73.4% [ 34]) or caused no patient harm. However, 21.2% of those affected suffered from moderate impairment (recuperation 1-12 months) (Range: 4.1% [ 30] - 56.5% [ 33]). A median of 7.3% of AEs resulted in permanent disability (< 50% and > 50% disability) (Range: 3.9% [ 34] - 17% [ 28]). Death occurred in a median of 7.3% of patients affected by at least one AE (Range: 0.6% [ 35] - 30% [ 31]). Across all included studies, a median of 51.2% of events were considered preventable (Range: 34.3% [ 34] - 83% [ 31]). In the reviewed studies, an AE was classified as preventable based on the chart reviewer's professional judgement of the given incident and consent. In most of the selected studies, preventability of AEs was determined based on a 6-point scale range from "virtually no evidence of preventability" (1 point) to "virtually certain evidence of preventability" (6 points), with a cut-off score of 4.

Discussion

We conducted a scoping review and provided an updated international overview of studies on the prevalence, characteristics/types, consequences and preventability of reported hospital AEs. Included studies that applied a retrospective chart review methodology based on the 'Harvard Medical Practice Study' approach or similar methods published after 2008 confirmed the findings of de Vries et al.'s systematic review on the worldwide magnitude of in-hospital AEs [ 12]: one out of ten hospitalized patients is affected by at least one AE, with one out of 14 such events resulting in fatality and half of all cases considered preventable. These findings on AEs' occurrence are comparable to those reported in studies either applying the Global Trigger Tool methodology [ 11] or relying on patients' reports of having experienced medical errors [ 36]. Applying these figures to the Swiss context in 2015 [ 37] would mean that roughly 140,500 in-patients in Swiss hospitals experienced AEs, resulting in about 9′400 fatalities.

Although we included studies that used similar definitions for AEs and retrospective record review methodologies similar to the Harvard Medical Practice Study [ 38], the occurrence of in-hospital AEs varied considerably across studies. A number of methodological differences including setting/sample (e.g., medical and/or surgical patients), inclusion of events before or after index admission, the number and types of screening criteria, thresholds for defining causation and preventability or the number, professional background, and the chart reviewers' level of experience [ 39, 40], may partly account for the variability observed in in-hospital AEs across countries. It must be acknowledged that retrospective record review methodology is at risk of bias, including hindsight and performance bias, which would lead respectively to over- or underestimation. However, reducing methodological heterogeneity is crucial to achieving accurate comparisons between countries and meta-analyses of AE rates across studies. The development of a reporting guideline on retrospective chart review studies, e.g., based on the "Strengthening the Reporting of Observational Studies in Epidemiology" (STROBE) statement [ 41], could contribute to standardization of the performance and reporting of AE studies.

Moreover, contextual factors within healthcare systems, such as variation in the quality and methods of medical and patient record documentation across countries and hospitals, might be a key source of variation in AE detection. In combination with the GTT, electronic health records (EHR) are currently gaining the interest of researchers and clinical practitioners alike, as they offer tremendous opportunities to develop automated AE identification methods [ 14]. While such an approach appears to be time-saving and less resource intensive compared to manual retrospective record review, it demands consistent documentation and representation of key EHR data elements. However, using machine learning and natural language processing in electronic health records, the possibilities to detect and monitor AEs are expanding rapidly. The most advanced systems are already providing real-time feedback to healthcare professionals, thereby offering hospitals advanced quality improvement and learning opportunities [ 42]. While the results obtained via EHR analyses are surprisingly similar to those available via manual review, computerized searches are virtually instantaneous and cost very little after the initial infrastructure is in place.

Despite variations between in-hospital AE incidence and measurement, our findings confirm both AEs' harmful impacts on patients and the persistent need for effective preventive measures. As noted above, the three main types of AEs reported in the included studies were related to surgery, medication/drugs and healthcare-associated infections. In recent years, the study of quality improvement interventions has led to major progress in patient safety [ 43], with evidence on effective strategies readily available [ 44]. For example, hospitals can adopt individual or bundled interventions. Adapted from aviation industry methodology, these are aimed at reducing the three major types of AEs, and include the use of checklists in the operating room [ 45], care bundles for the insertion of central venous catheters [ 46, 47], hand hygiene adherence [ 48], and medication reconciliation practices [ 49]. Acute care hospitals need to utilize comprehensive and balanced frameworks such as those available to measure, monitor [ 50] and improve care safety, as well as to foster a culture of safety, especially concerning the three main AE types. Accurate monitoring of in-hospital AEs, including via retrospective record reviews, is essential for the implementation and evaluation of evidence-based strategies to reduce their occurrence and patient harm.

Limitations

This scoping review should be read in view of certain limitations. First, we conducted our literature search in the two major electronic databases, Medline (Pubmed) and CINAHL, but did not search for "gray" literature. Therefore, additional relevant studies might have been missed. Second, in line with the scoping review methodology, we did not assess the included studies' risk of bias. Although we observed methodological heterogeneity in the included studies we did not include/exclude studies based on a quality assessment, as would be necessary in a systematic review. Therefore, caution is advised when drawing conclusions based on these studies' combined data.

Conclusions

This scoping review included 25 studies conducted in 27 countries. All had applied the 'Harvard Method' of detecting AEs. The median overall occurrence was 10%. Of this number, half were regarded as preventable and 7.3% led to fatal outcomes. However, the occurrence of in-hospital AEs varied considerably across studies, indicating methodological variation and cultural/contextual differences in conducting this type of retrospective chart review. Further research, such as on automated methods of identifying AEs in electronic health records, is needed to overcome methodological issues and bias related to this type of retrospective medical record review and to provide accurate data on their occurrence. As the three most common and most consistently reported types of in-hospital AEs were related to surgery, medication and nosocomial infections, further efforts to measure and monitor these three areas will make hospital care safer and more reliable.

Abbreviations

AE:

Adverse events

EHR:

Electronic Health Record

GTT:

Global Trigger Tool

ICU:

Intensive care Unit

MeSH:

Medical Subject Headings

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Acknowledgements

The authors would like to thank Natascha Baumann and Marian Struker for tabulating the reviewed studies and Chris Shultis for professional editing of the manuscript. The authors would like to thank Dr. Natasha Rafter for providing additional information to their study.

Availability of data and materials

The data supporting our findings are included in the published article.

Author information

Affiliations

1. University Hospital Basel, Patient Safety Office, Spitalstr. 22, 4031, Basel, Switzerland

2. Department Public Health Institute of Nursing Science, University of Basel, Basel, Switzerland

René Schwendimann

, Catherine Blatter

, Suzanne Dhaini

, Michael Simon

& Dietmar Ausserhofer

3. American University of Beirut, School of Nursing, Beirut, Lebanon

4. Inselspital Bern University Hospital, Nursing Research Unit, Bern, Switzerland

5. College of Health Care-Professions Claudiana, Bozen, Italy

Contributions

RS: conceptualization and study design, formulation of search strategies; screening of titles, abstracts and full texts; planning of the analysis and interpretation of data; quality assessment; writing of the manuscript. CB: literature search; screening of titles, abstracts and full texts; and data acquisition. SD: literature search; screening of titles, abstracts and full texts; and data acquisition. MS: interpretation of data; quality assessment. DA: supervision of the study including review methodology, data extraction, data analysis, writing of the manuscript. All authors read and approved the final version of the manuscript to be published.

Corresponding author

Correspondence to René Schwendimann.

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About this article

Keywords

Adverse events

Patient safety

Medical error

Hospitals

Scoping review

# data[].attributes.attachment_link.title
The occurrence, types, consequences and preventability of in-hospital adverse events - a scoping review

# data[].attributes.attachment_link.description
Adverse events (AEs) seriously affect patient safety and quality of care, and remain a pressing global issue. This study had three objectives: (1) to describe the proportions of patients affected by in-hospital AEs; (2) to explore the types and consequences of observed AEs; and (3) to estimate the preventability of in-hospital AEs.

# data[].attributes.headline
First do no harm: Patient Safety needs to be public health issues 

# data[].attributes.subject
First do no harm: Patient Safety needs to be public health issues 

# data[].attributes.attachment_link.readable_text
Public Health is a discipline in Medicine, like Obstetrics and Gynaecology, Surgery and Internal Medicine.

There is more than one definition of Public Health. A commonly used one is "the art and science of preventing disease, prolonging life and promoting health through the organised efforts of society" ( Acheson, 1988; World Health Organization [WHO]).

Public health focuses on the entire spectrum of health and wellbeing, and not only the eradication of particular diseases.

Whilst healthcare facilities are crucial in helping and supporting the sick, Public Health contributes to the reduction of the causes of ill-health and improvement of the population's health and wellbeing.

Many communicable diseases have been eradicated or controlled globally through Public Health measures, which include health protection from environmental threats like mosquito-borne diseases or food poisoning; health improvement such as smoking cessation; and ensuring healthcare services are effective, efficient and accessible.

Hazards of healthcare

Three landmark studies in the United States, United Kingdom and Australia in the 1990s alerted the healthcare professions to the hazards of healthcare.

This was summed up by Cyril Chantler's statement in 1998: "Medicine used to be simple, ineffective, and relatively safe. It is now complex, effective, and potentially dangerous."

Medical error has been defined as an act of omission or commission in planning or execution that contributes or could contribute to an unintended outcome; the failure of a planned action to be completed as intended (error of execution); the use of a wrong plan to achieve an aim (error of planning); or a deviation from the process of care that may or may not cause harm to the patient.

The role of error in healthcare is complex. Many errors are non-consequential, but some lead to harm to the patient.

The WHO's facts on patient safety are:

One in 10 patients may be harmed while in hospital.

Hospital infections affect 14 out of every 100 patients admitted.

Most people lack access to appropriate medical devices.

Unsafe injections decreased by 88% from 2000 to 2010.

Delivery of safe surgery requires a teamwork approach.

About 20%-40% of all health spending is wasted due to poor-quality care.

A poor safety record for healthcare, with a one-in-a-million chance of being harmed while in an aircraft compared to a one-in-300 chance of a patient being harmed during healthcare.

Patient and community engagement and empowerment are key.

Hospital partnerships can play a critical role.

Medical errors have been estimated to be the third leading cause of death in the US.

The data in developed economies is not very different.

There is no data of medical errors in Malaysia. However, the voluntary incident reporting by 120 hospitals of the Health Ministry in 2017, provides some clues.

The top five incidents that resulted in severe harm were patient falls (191 incidents); medication error (86 incidents); adverse outcome of clinical procedure (62 incidents); dislodgement of catheter (46 incidents); and injury to neonate (39 incidents). (Source: http://patientsafety.moh.gov.my/v2/?page_id=486 Accessed Apr 3.)

Deaths do not tell the whole story about medical errors.

Preventable adverse events in hospitals have also resulted in serious harm, such as requirement for additional procedures and/or resuscitation; extended hospitalisation; and permanent disability.

Whilst the data from clinics and pharmacies is sparse, it would be very brave for anyone to claim that they do not have any preventable adverse events.

That there is a serious problem is reflected in the number of medical negligence claims, settlements, court awards, and complaints to healthcare facilities, regulators and media.

It is clear that the current data about the harm from healthcare is just the tip of a large iceberg.

Going forward

Healthcare-associated harm impacts on the affected individual and family. That it is a public heath issue has been recognised by the WHO, which launched its Patient Safety Programme back in 2004.

Currently, adverse events due to medical errors are not measured in an organised manner.

Discussions about its causes and prevention are limited and confidential, involving management and selected clinicians.

The lessons learnt are usually not disseminated beyond the department or healthcare facility.

Regardless of its exact toll, harm to patients is inarguably among the most pressing of public health issues, and it must be treated as such.

The question is, what actions are being taken by policymakers and healthcare providers.

Human error is a fact of life as no one is perfect. Although human error cannot be eliminated altogether, there is much scope for improvement in the design of healthcare systems to reduce the frequency, visibility and consequences of medical error.

The strategies taken by an increasing number of countries are by making medical errors more visible when they occur so that early intervention(s) can prevent or mitigate their effects; and by reducing the frequency of errors through adherence to principles that take into account human limitations.

The Public Health discipline has contributed much to one aspect of patient harm prevention - infection control.

The tools and techniques of Public Health, such as epidemiology and application of social and behavioural science to healthcare have much to offer to Patient Safety. Would policymakers consider applying Public Health tools to Patient Safety?

What can patients and their families do? For a start, they can ask questions of the healthcare facilities, particularly hospitals, doctors and nurses.

For example, what are the existing patient safety measures in the healthcare facility? Are surgical and maternity check lists used?

What measures are in place to reduce medication errors and healthcare-acquired infections?

They can also ask doctors and nurses if and why they do not wash their hands before and after examining a patient.

Medical errors cannot be totally eliminated, but they can be reduced considerably.

It requires effort from policymakers, healthcare providers, patients and their families. The role of policymakers in this public issue is particularly crucial.

Dr Milton Lum is a past president of the Federation of Private Medical Practitioners Associations and the Malaysian Medical Association. The views expressed do not represent that of organisations that the writer is associated with. The information provided is for educational and communication purposes only and it should not be construed as personal medical advice. Information published in this article is not intended to replace, supplant or augment a consultation with a health professional regarding the reader's own medical care. The Star disclaims all responsibility for any losses, damage to property or personal injury suffered directly or indirectly from reliance on such information.

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Patient Safety Needs To Be A Public Health Issue | Star2.com

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Public Health is a discipline in Medicine, like Obstetrics and Gynaecology, Surgery and Internal Medicine. There is more than one definition of Public Health. A commonly used one is "the art and science of preventing disease, prolonging life and promoting health through the organised efforts of society" ( Acheson, 1988; World Health Organization [WHO]).

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Knowledge, beliefs and attitudes report on patient care and safety in undergraduate students: validating the modified APSQ-III questionnaire

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Knowledge, beliefs and attitudes report on patient care and safety in undergraduate students: validating the modified APSQ-III questionnaire

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Key Words: patient safety, quality of care, undergraduate medical education, reliability and validity

INTRODUCTION
Patient safety aims to achieve healthcare free of damage. The World Health Organization indicates that this objective is achieved through communication, analysis, and prevention of adverse events in patients. Organizational culture has been identified as one of the main factors for interventions aimed to reduce medical errors; and an essential component of safety culture is the attitude of health professionals towards medical error. Attitudes can be improved through appropriate education in biomedical careers but its inclusion in Argentina is scarce. The Attitudes Questionnaire for Patient Safety, measures knowledge, beliefs, and attitudes about patient safety and could be a useful tool in our country.

OBJECTIVES
To validate the modified attitudes for patient safety questionnaire to measure knowledges, beliefs, and attitudes of medical students at CEMIC University Institute. To describe the level of knowledges, beliefs, and attitudes in patient safety of medical students at CEMIC University Institute in 2012, 2015 and 2016.

METHODS
Design: descriptive study. Scope: Exploratory. Setting: the CEMIC University Institute in Buenos Aires, Argentina. Population: medical students of 4th and 5th year. Sampling: a sample size of 100 participants was estimated to derive meaningful estimates as per a Cronbach's alpha> 0.60.

RESULTS
The reliability of the instrument (internal consistency) by Cronbach's alpha showed an overall correlation of 0.695. Suitable Cronbach's alpha values were obtained in all categories, except in two: importance of patient safety in the curriculum and the inevitability of error. The responses on knowledge, attitudes and perceptions about patient safety in the three cohorts showed that 57% of students believe they understand concepts about patient safety, 53% consider their training prepares them to understand the cause of medical errors, only 59% believe that human error is inevitable and 98% believe that real professionals do not make mistakes. Lastly, 64% believe that this knowledge is only acquired from clinical experience.

CONCLUSION
This study shows that the APSQ-III modified survey is valid and could be used in Argentina and the region to measure the impact of incorporating patient safety topics in the medical curriculum.

Introduction

Patient safety aims to achieve harmless health care. The conceptual framework of the World Health Organization (WHO) [1] indicates that this goal is achieved through communication, analysis and prevention of patient's adverse events. The frequency of adverse events and the consequence of errors in health care affects more than 10% of hospitalized patients [2], [3], [4].

Organizational culture has been identified as one of the main factors for the success of interventions to reduce medical errors and to improve patient safety [2]. An essential component of a safety culture is the attitude of healthcare professionals towards medical error. Attitudes can be improved through appropriate education in biomedical careers [5], [6]. The World Health Organization recommends the inclusion of these contents [7] in the curricula of biomedical careers. Their inclusion in Argentinian programs is scarce [8], [9].

Education programs should be evaluated to establish their impact. The Attitudes for Patient Safety Questionnaire (APSQ III) [10] measures knowledge, beliefs, and attitudes about patient safety.

This study sought to answer if it is valid to use the modified APSQ III instrument for the measurement of knowledge, beliefs and attitudes in medical students of the CEMIC University Institute (Instituto Universitario Centro de Educación Médica e Investigaciones Clínicas), in patient safety and to describe their level of knowledge, beliefs and attitudes in 2012, 2015 and 2016.

Methods

For this study, a descriptive, exploratory study was carried out at CEMIC University Institute (IUC), in Buenos Aires, Argentina. The subjects of the study were fourth and fifth year medical students. A sample size of 100 participants was estimated necessary to obtain significant estimates according to Cronbach's alpha> 0.6 [11].

The inclusion criteria were to be a medical student at the CEMIC University Institute attending the fourth or fifth year. All the students of the population could be included, without exclusion criteria.

The study was carried out in two phases, the first phase was the modification of the British questionnaire APSQ-III of 26 items [10]. The APSQ III questions are distributed in nine categories: training received in patient safety, confidence in communication of error, working hours as a cause of error, inevitability of error, professional incompetence as a cause of error, responsibility in communication, functioning of the team, commitment of the patient in reducing errors and the importance of patient safety in the curricula. The tool is useful to understand knowledge, beliefs and attitudes toward patient safety in biomedical career students, and for comparing the effectiveness of including patient safety in curricula. It was adapted in the year 2014 [12] with a Likert scale of seven items, similar to the original instrument.

To carry out this study, through the consensus of experts and literature review [13] we decided to readjust the Likert scale to five points (strongly disagree to strongly agree), maintaining the original statements of the questions. For those questions posed from a negative orientation, the values of the answers were established conversely.

In the second phase of implementation, the questionnaire was delivered to medical students in 2012, 2015 and 2016, with a response rate of 100%.

The variables of interest were attitudes, beliefs and knowledge. As a conceptual definition, Rokeach [14] defines attitude as a set of predispositions for action (beliefs, valuations, modes of perceptions, etcetera) that is organized and related to an object or situation. Thus, attitude has three components: a cognitive one that includes beliefs and opinions about facts; an affective one that gives account of feelings, positive or negative emotion related to the object; and an action component, which refers to the state of predisposition or tendency to act in a certain way. The set of these three components results in the predisposition.

As an operational definition, according to the original questionnaire authors [10], a positive attitude towards patient safety is one that considers the system, not the individual as the cause of error. Therefore, this person recognizes the importance of learning about patient safety (items 24, 25 and 26), sees the patients with an important role in their health (items 22 and 23), is confident to report incidents (item 4- 6, 17-19) and recognizes the influence of specific circumstances related to patient safety (item 7-16).

Surveys were collected and transcribed into an on-line form for its analysis.

The results were analyzed with descriptive statistics adequate to the nature of the variable and its distribution. A univariate analysis of age, clinical experience, content in patient safety received during a student's career and year the student was attending, was performed.

The reliability (internal consistency) of the instrument was explored using Cronbach's alpha. Measurement of reliability using the Cronbach's alpha assumes that the items (measured on a Likert scale) measure the same construct and are highly correlated. The closer the alpha value is to 1, the greater the internal consistency of the items analyzed. We also analyzed the answers about knowledge, attitudes and perceptions about patient safety in the three cohorts of medical students, described as percentages.

The collected data was evaluated using STATA 13.0

All included students received information about the motivation to do the study. The study was approved by the CEMIC Bioethics Committee to be conducted without written consent. The participation of the interviewees was voluntary and the anonymity and confidentiality of their answers were ensured through surveys issued without registration of personal data.

Results

In the year 2012, 42 medical students completed the questionnaire, 29 students in 2015 and 32 students in 2016. Eighty five percent of all students were attending their fourth year (of a total of six years), and the rest were attending their fifth year. The survey did not include a question about the gender of the respondents. The response rate was 100%.

Table 1. Description of the population according to age, year of study and exposure to patient safety contents and clinical experience.

The reliability (internal consistency) of the instrument using Cronbach's alpha showed an overall correlation of 0.695.

The average relationship between items, measures the internal consistency of the instrument. The average relationship between items is shown in Table 2.

Table 2. Cronbach's alpha values and relation between items.

Responses about knowledge, attitudes, and perceptions of patient safety showed that 57% believed they understood patient safety concepts, only 53% felt that their training prepared them to understand the cause of error. Seventy-four percent feels more comfortable communicating their own mistakes than other people's mistakes and only 59% considers human error as inevitable. Ninety-eight percent believes that a true professional does not make mistakes and 69% believes that medical errors are a sign of incompetence. Only 52% of students considers that the patient has an important role in error prevention, although 85% believe that encouraging patient participation in their care can reduce the risk of medical error. Ninety-nine percent believe that patient safety is a priority in the curricula, although 64% believe that this knowledge is acquired only from clinical experience, not through formal learning.

Discussion

Based on these results we have been able to validate the modified APSQ-III questionnaire. There are a few validated instruments available for measuring medical student attitudes to patient safety, and none has been validated in our setting, except for the pilot test of Lamponi et al [12]. In all but two categories, adequate Cronbach alpha values were obtained, similar to those published by Carruthers et al [10] while validating the original instrument. The low value of Cronbach's alpha coefficient in the category of importance of patient safety in the curricula and inevitability of error would indicate that some items do not identify attitudes in the same way as others [15], which implies that the formulation of items included in this category should be reconsidered.

Finally, it should be noted that these differences could also be due to an immature culture of patient safety in our environment, which makes it difficult for medical students to recognize error.

Although CEMIC University Institute medical students receive isolated contents of patient safety and quality of care throughout their career, exploratory findings from this study show inadequate concepts of knowledge, beliefs, and attitudes regarding patient safety in medical students of this university institute.

The limitations of this study were the small sample size and the lack of data for years 2013 and 2014. In light of these findings, we understand that the obtained response rate compensates for the aspects required for validation and suggests that the questionnaire is feasible to respond.

Conclusions

We have been able to validate the modified APSQ-III questionnaire. This instrument can be used, both locally and in the region, to measure the impact of including contents related to this discipline.

This instrument may also foster future research on the impact of the inclusion of these contents in educational plans of undergraduate biomedical careers.

From the editor
The authors originally submitted this article in Spanish and subsequently translated it into English. The Journal has not copyedited this version.

Ethical considerations
The Journal is aware that the ethical scientific committee of the Center for Medical Education and Clinical Research "Norberto Quirno" was informed about this study and its possible publication in a biomedical dissemination journal.

Conflicts of interest
The authors completed the ICMJE conflict of interest declaration form, translated to Spanish by Medwave, and declare not having received funding for the preparation of this report, not having any financial relationships with organizations that could have interests in the published article in the last three years, and not having other relations or activities that might influence the article´s content. Forms can be requested to the responsible author or the editorial direction of the Journal.

Financing
This research was self-financed by the main researcher.

Esta obra de Medwave está bajo una licencia Creative Commons Atribución-NoComercial 3.0 Unported. Esta licencia permite el uso, distribución y reproducción del artículo en cualquier medio, siempre y cuando se otorgue el crédito correspondiente al autor del artículo y al medio en que se publica, en este caso, Medwave.

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Knowledge, beliefs and attitudes report on patient care and safety in undergraduate students: validating the modified APSQ-III questionnaire - Medwave

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Medwave es una revista electrónica revisada por pares y de acceso gratuito, que contiene artículos originales de revisión sobre determinantes clínicos, sociales, políticos y económicos en salud, y de investigación en el ámbito clínico y biomédico.