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How to communicate evidence to patients | Drug and Therapeutics Bulletin (bmj.com)

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Introduction

All medical treatments have potential harms as well as benefits, and it is vital that everyone has a good understanding of what these might be, how dramatic they might be and how likely. In fact, in the UK, the Montgomery judgement in the supreme court in 2015 (see Box 1) has made it a legal necessity for patients to be given comprehensible, personally relevant information about all reasonable treatment options, including none. 1 So, how should we ensure good, clear communication of relevant evidence?

"The doctor is therefore under a duty to take reasonable care to ensure that the patient is aware of any material risks involved in any recommended treatment, and of any reasonable alternative or variant treatments."

"The test of materiality is whether, in the circumstances of the particular case, a reasonable person in the patient's position would be likely to attach significance to the risk, or the doctor is or should reasonably be aware that the particular patient would be likely to attach significance to it. "

"The assessment of whether a risk is material cannot be reduced to percentages. The significance of a given risk is likely to reflect a variety of factors besides its magnitude"

"The doctor's advisory role involves dialogue, the aim of which is to ensure that the patient understands the seriousness of her condition, and the anticipated benefits and risks of the proposed treatment and any reasonable alternatives, so that she is then in a position to make an informed decision."

"This role will only be performed effectively if the information provided is comprehensible. The doctor's duty is not therefore fulfilled by bombarding the patient with technical information which she cannot reasonably be expected to grasp, let alone by routinely demanding her signature on a consent form." 1

This article therefore reviews what is known about how doctors can best communicate evidence so that patients can make informed decisions based on them, as the Montgomery Judgement demands. At first glance, it might seem that this should be a relatively simple question to answer, but there are a couple of big underlying problems.

Understanding the problem

One problem is what do we mean by 'good understanding' of a risk or benefit? Clearly, we do not just mean someone can recall a number-the percentage chance of something happening. Knowledge of a fact is not the same as understanding. We want a patient to imagine the range of things that might happen to them and to understand how likely each is compared with other things that they are familiar with; to slot these new scenarios into their personal framework of 'what might happen in my life' in an appropriate way, allowing them to weigh up evidence and to make a decision that is right for them. What an 'appropriate' way to imagine them is, will depend very much on their individual experiences and perception. That personalised, internalised concept of risk or chance is, then, very hard to define, let alone measure.

A patient's concept of the numbers involved is also only a part of what feeds into their final decision. Their emotions and personal values will all have a huge influence on their risk perception and decision-making, so we cannot assess their understanding of the facts by what decision they make either. 2 3 Some of these (such as their feelings about a particular outcome) are entirely appropriate factors to weigh in their decision. Others (such as their feelings towards their doctor) we may wish to minimise. There are so many things that can affect a patient's understanding, especially when we are considering a personal interaction, that minimising these unwanted biases is very hard.

This complexity means that it is not easy to create simple guidance on how to communicate evidence clearly to patients.

However, there are some useful findings from research that are worth every healthcare professional knowing.

Target information to the decision in hand

Research has shown how important it can be to cut to the chase when giving people information. For instance, studies of an online tool to help with the choice of adjuvant therapies after breast cancer surgery found that the standard format-bar graphs giving the potential outcomes of a range of four different options-was more easily understood if it was simplified, giving only the outcomes for the two options the patient was weighing up at that time. 4 5 It is important, then, to understand what the patient in front of you-or your patient population in general-really cares about and wants to know more about before launching into giving information.

The question of 'how much information is too much' is obviously tricky to answer in the abstract, but if you are giving information in person, you can tailor it, assessing how much an individual patient has taken in. Breaking up the conversation into chunks and at the end of each, using the 'teach back' method-asking patients to state back in their own words what they have understood-will help them process it and help you get the right level (see Box 2).

Use familiar everyday words and be careful of particularly emotive ones

Since we know that our emotions influence our decision-making, it is vital to be very careful not to arouse them unwittingly or too much. For instance, emotive terms like 'mad cow disease' can evoke fear that overwhelms any probabilistic information alongside it. 6 However, unfamiliar terms also appear more frightening and are deemed more risky. This also applies to words that are just difficult to pronounce (such as the fictional food additive hnegripitrom compared with the equally fictional magnalroxate)-they also seem to be judged riskier! 7 It may also be that labelling symptoms as a 'disease' or a 'syndrome' may make people more likely to over-ride information about evidence of (in)effectiveness of treatment options too. 8 9 Consult the plain resources in Box 2 and test out words with a suitably non-medical audience, such as patient representatives or a focus group, to find out which they find confusing or frightening (eg, the term 'side effects' is often preferred to 'adverse effects' by patients).

Don't rely on words, give numbers alongside them

Words mean different things to different people. Tests of what patients understand by the European Medicines Agency's recommended terms to convey the probabilities of adverse effects consistently show that they are misinterpreted by both healthcare professionals and patients. 10-12 For instance, when non-medically trained people were told an adverse effect was 'common', they tended to think that it will happen around 50% of the time. Doctors surveyed in one study put the probability of 'common' at around 25%. In fact, in official communications and patient information leaflets, this term is used for adverse effects that occur 1%-10% of the time. Crucially, these differences in people's perceptions of the risk also influenced their opinions on whether they would take the medication or not.

Never give just relative risks (and be careful with just absolute risks)

Medicine changes our risks: lowering some and raising others. But knowing just how much it has changed is not enough information to make a decision. The classic example is the famous contraceptive pill scare of 1995, which followed publication of official advice that newer contraceptive pills were associated with twice the risk of venous thromboembolism compared with older products. Not surprisingly, women reacted by stopping taking the contraceptive pill, and statistics show an excess of about 12 400 additional births and about 13 600 additional abortions in the following year. 13

The twofold increase referred to by the public statements around the contraceptive pill is a relative risk increase (see Box 3). What was the absolute risk that had increased twofold? About 1 in 7000 per year for women on the 'second-generation' oral contraceptive pill. Those on the 'third-generation' pill, about which the warning was made, had a doubled risk, then, of about 2 in 7000. For women who become pregnant, ironically, the absolute risk of venous thromboembolism is about 4 in 7000 per year. 14

Relative risks, then, can exaggerate the perception of difference, and this is especially prominent when the absolute risks are very small. They should never be used alone.

Conversely, absolute risks can also be misleading on their own, without context to tell whether that risk is relatively high or low (eg, 'the risk of you developing breast cancer at some point in your life is about 14%' can only be interpreted when given more information about population averages). Giving absolute numbers such as ARRs Box 3 is good in principle but, like everything, has to be looked at on a case-by-case basis. When absolute risks are very low, the numbers involved can be difficult for people to comprehend. In fact, a very small number (such as the chance that a test result could be wrong) is often 'rounded down' in our brains to zero over time. 15 If it is important for people to realise that although the absolute risk is very low, the change is very significant and warrants their attention, then it might be appropriate to use the relative risk or increase as well. We all need context to understand numbers, and relative risks can help do that.

Give risks in the form of both frequencies and percentages, unless you are asking people to compare multiple risks

To give numeric evidence, you need to choose the format to give those numbers in. Generally, the choice is between a percentage (eg, 20%) or a frequency (eg, 20 in 100). It is not clear which helps people the most, but what is clear is that everyone-regardless of education level-can easily get confused between them (eg, mistaking 20% for 1 in 20).

It is also worth being aware that people respond differently to the same number expressed as a percentage and as a frequency. In one study, professional forensic psychiatrists were asked to read biographies of violent patients and to assess their risk of harming someone in the 6 months after release. They were asked to record that risk both as 'low', 'medium' or 'high' and also to put a number on that risk, either as a frequency or as a percentage. It turned out that the psychiatrists assessed '20 out of 100' to be higher risk than '20%' (both when writing their own assessments and when reading others'). This is possibly because the act of thinking about '20 out of 100 patients like this are likely to cause harm to others on release' opens the imagination to those 20 vividly violent patients and makes the risk much more clear and present. 16

Given these issues, stating numbers as both a percentage and a frequency is probably safest to try to give people a balanced view if you are trying to help people understand a single number; but if you are asking people to compare risks, stick to just one or the other. The evidence is not strong, but comparing percentages seems to be easier than comparing frequencies. 17 18 The only time there is strong evidence to prefer a frequency is in the case illustrated in Box 4, where you have 'conditional probabilities' and should instead use their frequency equivalent: 'natural' or 'expected' frequencies.

If you are giving several frequencies, make them all 'out of x' rather than using '1 in...'

Frequencies are expressed as one number 'out of' another number: they are essentially a fraction, and comparing two fractions involves some maths if they each have a different number on the bottom (the denominator). For instance, which death rate is higher: 1286 out of 10 000 or 24.14 out of 100? You have to do some mental arithmetic (even though in this case it is simply shifting the decimal point). One study found that people tended to rate the first death rate (which translates as 12.86%) higher than the second (which is 24.14%) when given the two wildly different denominators ('out of 10 000' vs 'out of 100'). 19

A survey that asked the simple question: 'Which of the following numbers represents the biggest risk of getting a disease? 1 in 100, 1 in 1000, or 1 in 10?' to a large panel of people in Germany and in the USA found that 25% of the Americans and 28% of the Germans got the answer wrong. 20

The explanation for these is based around the theory that people tend to ignore or be confused by the denominator and fixate more on the first number, the numerator. If the first number is big, something is seen as likely. 21

Take care with your framing: talking about 'effectiveness' versus 'failure rate'

One of the most widely recognised ways to influence people's impression of a number is framing it positively or negatively. Whether or not people perceive something as giving them a possible improvement on their current situation, or a possible detriment to it, fires their emotions in different ways, influencing their decision-making. 22 One of the classic examples is a study that gave people the choice of two cancer treatments, one that gave survival rates after 1 and 5 years, and one that gave the same statistics in terms of mortality. The study was performed on clinicians, students and patients, and all showed the same effect: the framing switched their preferences. 23

There have been relatively few studies on ways to avoid the problems of framing, and none have given a convincing, real-world solution. 24 At the moment, the best advice is: for important health decisions, frame the information in both ways if possible (eg, both effectiveness and failure rate), and if you are talking to a patient in person then get them to talk through their reasoning for their decision when they first think they have made it. 25

Always use a graphic where you can

A picture is worth a thousand words as they say, and a good graphic can summarise and clarify a lot of numbers. If you have any opportunity to use one, do.

Bar charts and icon arrays have been shown to be fairly intuitive and help people understand numbers, 18 as well as overcome some of the biases caused by the emotional aspects of medical decision-making ( figure 1). 26

Icon arrays can double as bar charts, if they are visually laid out to aid the comparison of the areas in two adjacent arrays, and have an advantage over a traditional bar chart in showing those who are unaffected as well as those who are affected. There has been some research on whether dots, faces or people icons are best, but it is not a simple answer. 27 Some people find the anthropomorphic icons more emotional, and knowing how much emotions can affect decision-making, dots or blocks are probably safer. (For make-your-own icon arrays, go to iconarray.com.)

Another type of graphic worth considering is a risk ladder (see figure 2). This puts risks along a number line, showing an order of likelihood. These have been used to help people understand a range of potential risks of a treatment option. 28 However, how to help people understand the numbers on the scale (often logarithmic), or to choose any comparator risk that is shown on the scale to add context, is no simple task. 26

Be upfront and as precise as you can be about your uncertainties

No amount of evidence can give certainty about what might happen to an individual patient. All we can talk about is what appears to have happened to similar patients in the past if they took one treatment option or another. It is important to help patients understand that, and giving numbers as a range rather than as a precise-sounding point estimate could help. Our own experiments suggest that people understand the uncertainty around a number and do not lose trust in the provider of the statistics if it is given as a numerical range (rather than as a verbal qualifier, such as 'estimated' or 'about') (van der Bles et al, in prep).

For printed information: consider using fact boxes

Finally, for those who provide printed information about the evidence around treatment options, all of the above information has been combined to produce a standard, tested format known as a drugs fact box (see Box 5). 29 These are in the form of a table summarising the potential benefits and harms clearly. Work is still ongoing to add graphics to them and refine them, but they are increasingly being adopted and there are guides available on how to make them. 30

For those who are communicating evidence face-to-face, there is a free eLearning course now available on the eLearning for Healthcare platform or at moodle.wintoncentre.uk.

Conclusion

In summary, there is no right way to communicate evidence; although there are a few ways that are definitely wrong: those that confuse or push people in one direction or another. If you are preparing information for distribution, then test it with your intended audiences to see what they understand from it, 31 and if you are talking to patients in person, keep asking them what they have understood so far. Moreover, remember: decisions are based on far more than just factual information. If a patient makes a decision that seems to contradict the evidence, it does not mean they have necessarily misunderstood; they could be making the right decision for them, all things considered.

View Abstract

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All medical treatments have potential harms as well as benefits, and it is vital that everyone has a good understanding of what these might be, how dramatic they might be and how likely.

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Clearly Communicating Research Results across the Clinical Trials Continuum | National Institutes of Health (NIH)

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Introduction

The NIH's mission is "to improve health and reduce the burdens of disease and disability." And, along with the legions of volunteers who participate in clinical research, the NIH and the Nation rely on clinical research scientists to fulfill that essential mission. For people who are sick, injured, or who have a disability, clinical trials may provide life-changing treatments and or strategies for them. Or, clinical trials may be a step toward preventing, treating, easing or curing disease in the future. When clinical trials successfully recruit and retain participants from all backgrounds who become full partners in the process, science moves forward and we can all achieve better health.

Respect for potential and enrolled participants is a fundamental principle. Researchers know about this and other requirements and responsibilities of clinical research with human subjects. But it is critical that scientists also become knowledgeable about how to reach and communicate in their communities before, during and after a trial. Educating the public about clinical research may help raise general awareness about the important role this research plays in safeguarding health and quality of life, but these efforts are only the beginning.

Key to encouraging public support for and participation in clinical research is trust, and researchers must take the time and make the effort to build that trust. Communicating directly with participants as they join a study - and throughout the process - is critical to earning and maintaining trust. This includes explaining kindly and carefully why someone is not eligible to participate in a specific study.

Researchers also need to develop meaningful relationships in the communities from which they hope to recruit participants. Every community is different. Individuals or communities considering taking part in a clinical study often want to participate in the entire process, from the study design to dissemination of results. Engaging the community from the earliest phases of clinical research can strengthen the process and help ensure that a trial runs smoothly and efficiently.

Criteria for Pre-Recruitment Planning

Before even initially contacting individuals, organizations and agencies, pre-planning your outreach and setting up policies and procedures will help ensure thoughtful recruitment and retention of participants. Outreach efforts should be respectful and build a sense of partnership. Laying out communication interactions and creating timelines before the recruitment begins may save time and effort and build better working relationships. This gives the research team, as well as potential participants, a map for how recruitment, retention and reporting of results will proceed.

Consider the needs of the study participants.

Choose only protocol staff members to interact with potential participants who exhibit and practice cultural respect to ensure that participants are valued and empowered in the process. The scientific criteria for selecting individuals who are eligible and appropriate for enrollment in a study have been carefully considered. It is equally important, at the same time, to pay serious attention to other factors, such as:

Who are potential participants (e.g., women, diverse communities, children and families, older adults, people who have mental or physical disabilities, etc.) and what specific requirements might they have to participate in the study?

What benefits and motivators are there to encourage participation? How will this study benefit the participants or others?

What barriers and obstacles will potential participants need to overcome (e.g., invasive procedures, time of visits, transportation, language differences, unfamiliarity or mistrust, competing trials, etc.)? How can you help them?

Are there logistical adjustments you can make to the protocol or clinic operations to make it as easy as possible to participate? (e.g., weekend hours, use of in-home technology or mobile monitoring, etc.)

Will you provide appropriate incentives, such as transportation, gifts cards, or childcare?

Engage the community.

Once you have identified the community you will recruit from, think about how you might reach members of the community who could potentially participate in the study. Long-term relationships with communities require an ongoing commitment before, during and after the trial. Factors to consider include:

What current relationships and level of trust do you have within the community? Are these ongoing, or do they need to be established?

How does this study meet the priorities of the community? Is there a way to align the goals of the study with and the needs of the community?

How will you ask for and incorporate community input into the study?

Will you need to plan for native speakers to interpret the language of the community? This shows respect and interest in community engagement!

Have you considered how you may be able to contribute continuously to the community (such as participation in a health fair, sharing plans and presenting research results directly with the community, etc.)?

Plan messaging and informational materials.

Make sure your outreach and messages are culturally respectful and meaningful. They should be based on the needs of the study population and with input from the community. Ask yourself:

Who may be in the best position to deliver messages that connect with and build trust within the community? Is it the principal investigator/clinician or staff from the study community?

What are the best channels to deliver messages to your study population: Social media? Traditional media? Mobile channels? Mail? In-person events? Via advocacy organizations or other intermediaries?

Design educational materials for potential participants. What images, language, literacy level, etc. are appropriate, interesting, and effective?

Always consider the privacy implications of any outreach effort.

Think about the following logistical and administrative factors:

How will you respond to the questions and needs of potential participants? Are you prepared for phone/email inquiries? Initial screenings?

Will this community have access to computers, mobile devices, telephones? If not, alternative approaches will need to be considered.

How will people receive timely responses, and will this affect staff scheduling? What is a timely response? How will you communicate the response time (e.g. 2 days, by email, 48 hours)? Establish a standard and let the participants know what to expect.

Potential participants with cognitive difficulties (e.g., TBI, stroke, mild dementia) may require additional considerations to remember appointments, complete forms, know how to communicate with study staff, etc.

Do you have a plan for dealing with surges in inquiries?

How will you communicate the limitations for participation to a volunteer?

How will you handle volunteers who do not qualify for the trial? Is there a local registry? Is there another research study they may be eligible for?

Remember to thank them for offering to participate. It is CRITICAL that study participants be engaged throughout the entire study and that this interaction is ongoing.
Recruitment

Although there is overlap between pre-recruitment and recruitment, this phase could be your first interaction with a participant, so it is important to engage and empower them from the first correspondence or encounter. This rapport will set the foundation for effective communication between you and the individuals you seek to enroll. Think about communications strategies that will help you reach the communities and participants you're seeking. For example, many people think of "research" as including only clinical trials testing experimental drugs; they may be unaware that there are many types of studies involving different time commitments.

Attracting Participants

What recruitment methods will you use to ensure you reach and capture potential participant(s)?

Will it be through community engagement, one-on-one, or in combination? This might include talks to community groups, town meetings, informational materials for participants to take home to read and consider in multiple languages if needed.

What has been effective in the past? Have you reviewed data from similar studies to identify what recruitment strategies are preferred and effective to reach participants?

Screening Participants

What type of participant profile are you seeking, and why?

Explain to prospective participants the profile of the ideal study candidates you are seeking and, most importantly, why.

Describe the study's objectives, and why their participation matters.

Identifying and Engaging Participants

How can you make potential subjects feel valued and empowered in the process, starting with the recruitment phase?

Have you explained what type of research this is (e.g., clinical trial to test a new therapy, behavioral research, a survey)?

Have you explained the overall goals of the study and described to the potential participant why his/her involvement is significant? Have you explained in detail their rights as a participant?

Do they know how they will be contacted and with what frequency?

Do they know how to reach the research staff should they have any questions/concerns?

Enrollment

As individuals consider enrolling in the study, provide a complete discussion on what is involved in participating in the trial. This is not only to obtain consent, but to enhance understanding, what will happen along the way, and the individual's role. Does the consent document include any information about the study that a reasonable person would want to know?

Explain risks and benefits in clear terms. Provide a balanced approach when describing the risks and benefits of participating in the study.

What kinds of tests will the participant undergo? What samples will be obtained and what are the procedures for doing so? How often? Why?

Explain and emphasize that data security and privacy standards will be carefully followed in the study. This is a huge concern of many potential participants.

Encourage participants to ask questions. Wait for a response.

Make sure participants understand the logistics and any costs of participating in the study. Are there any tests and/or medications a participant might be responsible for paying, and what charges may or may not be covered by insurance?

Does the study provide childcare or cover transportation costs?

How frequent are appointments?

Do you have compensation answers ready for when questions arise?

Meet the literacy, language, and cultural needs of the participant all written and verbal communication.

Make informed consent documents easy to read and understand. Consider: white space, figures, diagrams, calendars, and simple outlines used to make the documents clearer.

Avoid unnecessary medical jargon. Explain medical and research terms, if you must use them.

Make sure there's mutual understanding.

How are you confirming a participant's comprehension of terms, study, and the informed consent process?

Do more than ask him or her "do you understand." Ask the person to describe the study in his or her own words and how he or she would participate.

Retention
Continuous communication throughout the clinical trial process is essential for retention.

Meet with volunteers at their first appointment to give them a packet of information. Provide contact phone numbers, a copy of their informed consent, and their visit schedule for the entire trial, so participants can plan accordingly. This will decrease the no-show rate.

Research staff should maintain consistent contact - by email, postcards or phone calls - with study participants for the duration of the trial.

Schedule updates for contacting participants about progress.

Let them know how you will contact them.

As before, encourage questions.

Protect privacy, and enforce ethical standards.

End of Study

You are really done twice. The first ending marker, for you and for the participants, is when data collection is complete. This is a time to thank participants for all that they have done. You will also want to promise to communicate the results of the study and in what expected timeframe.

Keeping participants informed about research findings is as important as gathering the data. Participants often cite their contribution to future medical discovery as the reason for their participation. A national survey found that the general public and particularly minority groups cited altruism as a key reason to participate in a clinical trial. The study revealed that "nearly half of African-Americans, Asians and Hispanics say they greatly admire individuals who volunteer for clinical trials, compared to 35% of non-Hispanic whites."

Principal investigators should establish a plan for informing participants about research results, by sharing published studies, or when possible, news releases, which are written in consumer-friendly language. According to The Center for Information and Study on Clinical Research Participation (CISCRP) almost all patients want to know the results of their trial yet almost no patients are being told their trial's results.

Researchers should assure participants that the line of communication is open and provide a contact email address. Consider making sure that all the explanations or links to study results are prefaced by a clearly written summary that puts the information in context for the reader ( Getting Started or Brushing Up).

Inform participants about how they can look for published study results. Clinical trial reports published in peer-reviewed scientific journals are searchable through the National Library of Medicine's PubMed database and the National Institutes of Health registry clinicaltrials.gov. Provide participants with the study's official name or Protocol ID number so they may search the database. In addition, provide participants with the research team contact information should they have follow-up questions.

After the Study is Published

When the study first becomes available in its entirety through public access, send participants a note and a link. Share other research papers that are published as a result of analyzing the data. The NIH Public Access Policy ensures that the public has free access within a year to the published results of NIH-funded research.It requires scientists to submit final peer-reviewed journal manuscripts that arise from NIH funds to the digital archive PubMed Central. To advance science and improve human health, NIH makes the peer-reviewed articles it funds publicly available on PubMed Central. The NIH public access policy requires scientists to submit final peer-reviewed journal manuscripts that arise from NIH funds to PubMed Central immediately upon acceptance for publication.

Comments often made by people dissatisfied with having participated in research focus on the lack of communication about the results. The participants want to know what you found. In turn, if their experience is good or bad they will share it broadly, often within communities. Informing participants about the published research results models both gratitude and provides them with the substantial addition of information pertaining to their disease or condition. It also helps to provide participants with a good experience that they will share with family, friends and their community.

References

Resources: Communicating Across the Clinical Trial Continuum

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clearly communicating research results across the clinical trials continuum

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Clearly Communicating Research Results across the Clinical Trials Continuum

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The NIH's mission is "to improve health and reduce the burdens of disease and disability." And, along with the legions of volunteers who participate in clinical research, the NIH and the Nation rely on clinical research scientists to fulfill that essential mission.

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blog - Clinical trials recruitment and retention of volunteers / subjects for medical research - Link2Trials Accelerating Clinical Research

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We will search on your behalf. Your recruitment is in good hands. Tailored to your needs, flexible and within your timelines. Only the subject you need! We will take care of the pre-selection. learn more

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blog - Clinical trials recruitment and retention of volunteers / subjects for medical research - Link2Trials Accelerating Clinical Research

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We will search on your behalf. Your recruitment is in good hands. Tailored to your needs, flexible and within your timelines. Only the subject you need! We will take care of the pre-selection. learn more

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The People's Trial - Powered by the Public

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The People's Trial is a new and exciting way to participate in scientific research, where you decide all the major steps of a randomised trial.

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Dissemination to Patients - Rethinking Clinical Trials

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Returning Individual Research Results to Participants

Historically, returning individual research results to study participants has not been a standard or common practice. The longstanding justifications for this are that 1) there are risks associated with the return of potentially inaccurate results to participants, 2) research is designed for the benefit of society, not individuals, and 3) participants may have a "therapeutic misconception" and mistakenly believe the research will yield results that will benefit their clinical care ( Botkin et al, 2018). Recently, the National Academies of Sciences, Engineering, and Medicine (NASEM) spearheaded a committee charged with determining if and when it is appropriate to return individual research results. The committee produced a NASEM Consensus Report in which they recommend that research results be shared with patients more often to support the development of trust and to demonstrate respect for participants ( Committee on the Return of Individual-Specific Research Results Generated in Research Laboratories et al. 2018).

As background, there are currently two contrasting rules regarding the return of results:

The NASEM committee recommends a transition away from these rules in favor of a process-oriented approach that emphasizes transparency and communication of results to research participants. Clinical information is potentially valuable to participants, and this value should be considered in balance with the feasibility of returning results on a study-by-study basis to determine whether and how to return these results. It may be more feasible to return results from a traditional, explanatory trial that uses informed consent, because investigators will be able to explain the timing and the content of the results that will be returned to participants. However, if consent is waived, as is often the case with ePCTS, then returning results to participants is more complicated. There are many questions to be answered when it comes to returning results, such as: What data should be returned? When and how often? How do we contextualize the results and minimize potential harms? How should clinicians be involved? ( Wong et al 2018). More work is needed to test processes and techniques and determine best practices for returning results, particularly for ePCTs. Additionally, effective communication strategies for returning results are needed, such as innovative methods for enhancing the quality of the reports for participants.

Dissemination Options for Trial Results

Lay audiences, including patients, caregivers, and others who are not experts in clinical research, often do not have access to clinical journals. Therefore, alternative dissemination media to scientific publications may be the most appropriate. Community-based stakeholders may already have communication channels open to patients and caregivers, and teaming with these stakeholders from the beginning can help formulate the appropriate messages and the best means for disseminating results.

Key Point: When communicating to stakeholders who are not routinely engaged in the clinical research enterprise, ensure that the information is accessible by disseminating through the following:

Patient advocacy groups

Government and study-specific websites

Newsletters

Emails

Social media

News media

An example of a study-specific website is the ADAPTABLE (Aspirin Dosing: A Patient-centric Trial Assessing Benefits and Long-Term Effectiveness) trial which is comparing the effectiveness of two daily doses of aspirin (81 mg vs 325 mg). The consent form and protocol for ADAPTABLE are available on the study website.

Case Study: Interactive Autism Network

A good example of a dissemination tactic aimed at patients and their caregivers comes from one of the Patient Centered Clinical Research Network's (PCORnet's) Patient-Powered Research Network partner, the Interactive Autism Network (IAN). Information about upcoming studies, opportunities to enroll in studies, and summary results from research are all disseminated through the network's website. Notably, the summary results from IAN studies are written in clear, easy-to-read language (see figure); at the end of each article, additional resources are provided, as well as a reference list for the scientific literature cited in the article.
Summary Results Posted at iancommunity.org

IAN research participants include approximately 15,000 children and 7,500 adults with autism, 22,000 parents, and 13,000 siblings.

IAN has connected people with autism and their families to 500 research studies, and, thanks to IAN research participants, the IAN team has produced 31 scientific research papers. IAN's research on elopement has influenced policy.

The IAN community website has about 1,000 articles highlighting research on autism treatments and therapies, challenging behaviors, early intervention, genetic discoveries, social issues, healthcare, the transition to adulthood, and adult issues.

Plain Language

When disseminating information to patients and other stakeholders, the use of plain language that is clear, professional, and easy to understand is recommended. The National Institutes of Health (NIH) has created a one-page guide to clarify the difference between observational studies and randomized clinical trials, but this guide does not communicate information about the unique aspects of pragmatic clinical trials, such as what is meant by embedded research, cluster randomized trials, or stepped wedge designs. Communications aimed at a broader audience, such as the public, should explicitly define these terms. For communicating the results, the NIH has also created a Checklist for Communicating Science and Health Research to the Public.

In brief, NIH recommendations for clinical trials are:

Describe the clinical trial phase

Give a breakdown of the study participants' demographics

Identify and explain the limitations of the study's endpoint

Surrogate endpoints

Composite endpoints

Check the study's sample size and address potential limitations

Clearly explain risk

Absolute risk

Relative risk/risk ratio

Discuss both the benefits and drawbacks

To communicate the results of pragmatic (or embedded) research, we recommend adding the following information:

Brief background about why the project is important and the gaps in knowledge the project is intended to address

Rationale for a pragmatic approach, including an explanation of the specific design (cluster randomized, stepped wedge, etc.)

Decisions the trial is intended to inform for the patient, caregiver, and clinician

Use of data from the EHR and the privacy protections

Generalizability of results

Storytelling

Another dissemination tactic is to use storytelling methods. Presenting factual data and personal stories has been found to help people use the information and results from studies. Brason Lee commented in an American Journal of Public Health commentary:

"It is about writing reports in a way that inspires readers to care enough to move forward. It is about showing readers rather than telling readers what it is like to be in a given situation....one of the greatest challenges in disseminating research for public policy use may ultimately rest in how the story is packaged for presentation." ( Lee 2015)

The communications departments in universities, research institutions, and healthcare systems can provide invaluable help in making a message clear and compelling.

Resources for Patients

CERTAIN Patient Advisory Network's INSPIRE Research Portal is an online library of resources designed for patients and researchers partnering on patient-centered outcomes research (PCOR), which is described as healthcare studies that actively engage patients in the research process from start to finish. The portal includes resources for patients and researchers to use together, as well as those specific to each group.

When patients are involved in research projects, it can be helpful to provide them with additional resources, including:

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Dissemination to Patients - Rethinking Clinical Trials

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Historically, returning individual research results to study participants has not been a standard or common practice. The longstanding justifications for this are that 1) there are risks associated with the return of potentially inaccurate results to participants, 2) research is designed for the benefit of society, not individuals, and 3) participants may have a "therapeutic misconception" and mistakenly believe the research will yield results that will benefit their clinical care ( Botkin et al, 2018).

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Getting the word out: how to talk to the public about your research | European Respiratory Society (ersjournals.com)

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Rachel Orritt , Pippa Powell

Abstract

Communicating to nonspecialist audiences about research has many benefits for both scientists and clinicians. By using techniques and tools for accessible communication, it is possible to convey complex topics in a clear, engaging and sensitive manner. http://bit.ly/39M1oym

Historically, science and medicine have been almost completely inaccessible to patients and the general public. This divide was created by many issues, including inequalities in access to education, latinised language, invitation-only academic societies and closed journals.

In many developed nations, this situation began to change with the advent of national education, alongside other societal changes including increased rights for marginalised groups, printed press, public libraries, improved literacy levels and more leisure time. These societal shifts and improvements in technology paved the way for the advent of the information age [ 1], in which widespread computer literacy and internet access started to break down the barriers between academia and the rest of society.

The rate of publication of academic papers has increased exponentially [ 2], fuelled by greater investment in research, the transition from print to online publishing and the notion of "publish or perish" [ 3]. Open access publications, greater press coverage and even pirating of academic papers means that more people than ever have access to scientific publications. It also means that patients can learn more about their conditions independently of their healthcare providers.

Many of the changes described so far confer direct benefits but the rate at which they have occurred has meant that there has not been a lot of time to understand and address the drawbacks of readily available research. One thing that is clear is that misinterpretation is common [ 4], as the skills needed to critically evaluate scientific studies and evaluate findings in light of previous research are not widely held.

In light of the age of information, and the benefits and risks it brings, people working in science and medicine have a shared responsibility to make science accessible to the public and to empower them to understand more. However, they also need to protect scientific evidence from misinterpretation. Learning how to proactively communicate research for the benefit of the general public is key to safeguarding against misinformation and could help researchers to direct the narrative of their findings in the public sphere.

In this article, we will cover some of the many and varied benefits of accessible communication, and address actual and perceived barriers to writing for and speaking to nonspecialist audiences. We will also work through several different tips and strategies for communicating to the general public, and how to use the correct tools to disseminate what you have produced effectively to increase impact and benefit ultimate stakeholders in your research.

Benefits of communicating effectively to nonspecialist audiences

Aside from protecting your results from conscious or unconscious misinterpretation, learning how to communicate findings more broadly has a wide range of benefits for researchers. Increasingly, "lay" reviewers are being used in research grant panels and as the ultimate stakeholder in medical research, their views are rightly valued [ 5]. These reviewers are also involved in decision panels for other academic awards, as well as conference abstracts and ethics committees. It is important to be able to communicate accurately, sensitively and, above all, accessibly for this audience.

In addition, communicating research proactively to the general public is part of an effective dissemination strategy and directly increases the impact of that research. This benefit is realised through various mechanisms, including attracting the attention of the news media and encouraging local community engagement. Accessible communication skills can also help researchers to advocate for policy change, which is particularly relevant to those working in medical fields.

There are other less direct benefits too. For example, talking to a broader audience about research could encourage children and young people to consider a career in science or medicine, talking to patients and other stakeholders to understand the current state of play in their disease area could raise new research questions, and greater visibility could lead to important collaboration opportunities.

Finally, protecting against the spread of misinformation is a critical function of careful public communication. A skilled science communicator can help to limit the risk to public health from pseudoscience, promote public trust in evidence-based medicine and positively influence behaviour change to improve quality of life.

What is nonspecialist communication?

To realise the various benefits of accessible communication, it is first necessary to understand what is and is not accessible. Throughout this article, the following definition is used:

Accessible communication is writing or speech that is specifically designed for a nonspecialist or general audience. This may include people with little or no professional or academic knowledge of the specified field, and/or of science in general.

The definition above is inclusive of communication designed for patients, who may have a great amount of knowledge about their own condition but still benefit from accessible communication. It is also inclusive of academics and professionals who work in other fields, as well as children, people with learning difficulties and disabilities, older people, journalists, policy makers, and many other groups of people with a wide range of different needs. Therefore, the approach will need to vary depending on the interests, background, reading age and comprehension capability of the audience in question.

Barriers to writing accessibly

Many people believe that some topics are too complicated to explain to a general audience. However, any topic can be explained in a simple way, particularly if the fine detail is not essential for comprehension.

Communicating for a general audience necessitates writing succinctly. One way of substantially condensing the volume of words needed is writing in an active voice (an example of this is given in a later section), which helps readers to stay with the narrative for long enough to grasp key points.

So, while it is not likely that someone can become well versed in a particular field of science from a short communication, there is a good chance that well-crafted content can relay the most critical points of a summary or argument.

One of the more difficult barriers to navigate is developing two succinct writing styles. Most academics have trained themselves to write in a style that is very specific for academic publications. This style is typified by long sentences, passive sentence structure and using all the key terms needed in their field.

An academic writing style can be particularly difficult to break away from for non-native English speakers. When English is only used academically, it is not as easy to practice conversational English, which has many more similarities to accessible communication than academic English. It follows, then, that the best way to overcome these barriers is to practice communicating for varying audiences.

How to write for the general public

In the following sections, features of lay communication are described with examples. However, it should be noted that none of the following features can function independently, so should be used together in accessible writing.

The cat sat on the mat.

The mat was sat on by the cat.

The mat was sat on.

The airway may become obstructed by an intraluminal mass such as a foreign body or tumour, in which case, surgical resection is often curative.

can be compared with:

An intraluminal mass (such as a foreign body or tumour) may obstruct the airway. In this case, the condition may be cured surgically.

Bronchiectasis can be characterised by the development of chronic cough with mucus production.

A chronic cough and excess mucus characterise bronchiectasis.

Variant infectious causes have been defined, being viral or bacterial in nature, and humans enter in contact with these pathogens principally via direct contact.

We have defined viral and bacterial pathogens. Humans are exposed to these pathogens via direct contact.

Radiotherapy, a treatment that uses radiation to destroy cancer cells...

Both gaseous and particulate airborne pollutants can contribute to chronic, severe, respiratory conditions in neonates.

Both gaseous and particulate pollutants can contribute to respiratory conditions in neonates. These conditions are often chronic and severely debilitating.

Writing to engage a nonspecialist audience

In the absence of a professional or academic interest, a general audience has less tolerance for communications that are not engaging. One of the most important ways of keeping an audience's interest is to make sure that the topic is relevant to them. However, there are other ways to increase engagement, which can be particularly useful when trying to connect with a broad audience or encourage interest in a novel topic.

Keeping writing concise is the first thing to consider, as it makes it easier to keep the reader's attention for the whole text. This can be achieved by simplifying the message, and then applying many of the techniques described above in "How to write for the general public".

Keeping sentence length varied is another way to keep the reader's attention and applied whether communicating through writing or speech. This is because it mirrors spoken language, where some phrases are short and others long. However, this should not come at the expense of clarity, so writing sentences that are overly long is discouraged.

A lively and engaging tone can be achieved through use of rhetorical questions and by using verbs to their full extent. This could include starting sentences and subheadings with verbs or turning nouns into verbs where possible as part of active sentences ( e.g. "treating cancer" rather than "the treatment of cancer").

Finally, writers can promote engagement by breaking the usual rules of grammar and using language creatively, particularly when writing for a less formal purpose. This could include starting sentences with prepositions ( e.g. "But did you know that...?") using alliteration ( e.g. "How to stop smoking sooner") and making use of idioms if the audience has a good degree of fluency in the language that is being used.

Writing conscientiously for a general or patient audience

Although writing informally and with the intention to engage has its place, there are many situations in which communicating conscientiously is more important. This is particularly important when communicating about medical topics to a nonspecialist audience. If writing offends or patronises, even to a minor degree, it is not achieving its purpose.

When writing, the audience can seem very distant, which makes it easier for unintentionally offensive terms and phrases to make it into text. Therefore, it is useful to imagine reading your text out to someone who is directly affected by what you are writing about or involve those people in writing or reviewing the text.

To complement this approach, there are some techniques that can help to make you understand your reader better. One of the most important is the use of people-centric language - referring to people first and foremost. Examples include "people affected by severe asthma", "children living with interstitial lung disease", and people who took part in the study' rather than "patients", "asthma sufferers" and "subjects".

There is also a fine line between writing accessibly and patronising the audience. To avoid the latter, make things clear but do not repeat yourself unnecessarily. For example, acronyms can be used where appropriate, as long as they areexpanded in brackets the first time they areused.

Finally, it is good practice to be mindful of how your text will affect readers. It may be that a disease that you describe affects some of your readers. In this case, consider how you can make the overall tone more positive, perhaps by talking about survival rather than mortality or explaining what can be done in the future to improve the situation for people with the disease in question. Try to avoid terms such as "suffering".

There is also the question of risk perception. In order to hook readers, journalists often use sensationalist or absolute language in their headlines and stories. Scientists and professionals are well positioned to counter sensationalism and safeguard against unnecessary anxiety by using more balanced language. This could be as simple as using qualifiers where a research finding is not well established ( e.g. "people with sleep apnoea could be at higher risk of atherosclerosis") or ensuring that findings are well contextualised and compared with the existing body of research where appropriate; for example, the risks of air pollution exposure being compared to smoking a cigarette.

Conclusion

By practising writing clearly, conscientiously and in an engaging manner for a general audience, researchers and clinicians can open up the world of science and medicine, and empower people to become involved and interested in these topics. In an age where information is more available and not always reliable, skills in communicating accessibly can help academics and professionals to direct the narrative around health and disease for the benefit of patients and the general public.

Although we have focussed in this article on communicating with the public, it should be stated that many of the points that make writing for a lay audience successful can also be advantageous in academia. In fact, many journals are now demanding a clear, concise and active style. Therefore, taking on board the tips in this article could improve your writing for many more scenarios.

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Getting the word out: how to talk to the public about your research

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Historically, science and medicine have been almost completely inaccessible to patients and the general public. This divide was created by many issues, including inequalities in access to education, latinised language, invitation-only academic societies and closed journals. Communicating to nonspecialist audiences about research has many benefits for both scientists and clinicians.

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The Complete Guide to Patient Engagement in Clinical Trials - mdgroup

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Patient engagement is vital for successful clinical trials - from recruitment all the way to completion. In our recent mdWebinar series, many of our panellists highlighted the need to improve patient engagement at every stage of the clinical journey and why it matters.

From increasing awareness of opportunities to take part in studies, through to treating patients as stakeholders in trial design, there are multiple opportunities for the industry to engage more effectively with patients at every touchpoint. As decentralised or fully virtual trials become more common, and with technologies replacing much in-person communication and home healthcare replacing site visits, effective patient engagement is more vital than ever.

In this in-depth guide, we look at all aspects of patient engagement across the entire clinical trial journey, and why it's important in ensuring diversity amongst participants and looking after patients' mental wellbeing. We also look at why effective communication is vital in delivering a remarkable patient experience, and how to communicate with patients in a way that keeps them engaged throughout the process.

Raising Public Awareness of Clinical Trials

Research has shown more than 75% of the general public are willing to participate in clinical trial studies. If this is the case, why do so many studies still struggle to meet their enrollment targets?

More effective engagement with eligible patient and volunteer populations is needed.

Lack of clinical trial awareness is one of the biggest barriers to engagement globally. Most people aren't aware of what clinical trials involve, why they're important, or how they can contribute. Most patients don't realise they are eligible to participate in trials, or where to find out about opportunities to enrol.

If patients don't fully understand what clinical trials involve or the benefit of taking part, why would they engage with the industry? A few key ways we can improve engagement with clinical trials amongst the wider public and patient populations are:

Using plain language in clinical trial literature which speaks directly to a patient's needs, addresses their concerns, clearly outlines study goals, and is transparent about risks and commitments

Sharing information with healthcare practitioners and media in a way that's straightforward and jargon-free, ensuring information about specific clinical trials is clear and accurate

Encouraging patient and volunteer advocacy by asking trial participants to share their experiences via social media, online patient forums, or word of mouth

Raising awareness and knowledge of clinical trials amongst Health Care Practitioners (HCPs) is also an essential part of the picture. Few patients are informed by their doctors or consultants of clinical research studies they might be eligible for, simply because the majority of HCPs don't have this knowledge.

Furthermore, most patients aren't aware that clinical trial participation can be an accessible and viable treatment option. If we work on raising awareness of these options, we will improve both public engagement with and perception of the industry.

Raising awareness of clinical trials and ensuring public engagement is more important than ever. Our goal should be for studies to be viewed favourably by patients around the world. They should be seen as a way of accessing exceptional healthcare and ongoing monitoring - especially as usual healthcare routes might be experiencing delays, cancellations, or less regular reviews for a significant while post-COVID.
Read more: How Can We Increase Public Awareness of Clinical Trials?
Addressing Barriers to Clinical Trial Accessibility

Raising awareness amongst the public and within patient communities is only the first step in increasing patient engagement with clinical trials. The crucial next step is to address barriers to accessibility, which will take a collective commitment from us as an industry.

As we work to engage more patients and volunteers, we must simultaneously work to break down socioeconomic, geographic and financial barriers that limit the ability to participate.

The biggest barriers to clinical trial participation currently are:

Geography - more than half of patients don't have access to clinical trials at their local treatment centres, meaning most have to travel long distances to a specific institution to participate.

Finance - clinical trial participation comes with associated costs and time commitments. As a global recession looms post-COVID, and more people are worried about finding jobs or requesting time off from work, financial barriers to clinical trial participation will only increase.

Education - if patients and volunteers simply don't know about clinical trials, they don't have any opportunity to engage at all.

To overcome these barriers, we need:

Decentralisation of trials - clinical research can be brought to specialists in smaller, local institutions. Where an appropriate local trial is not available, travel could be minimised by introducing home visits to replace some site visits.

Reducing financial burden - some site visits can be replaced with home visits to reduce upfront travel costs. Where costs are incurred by participants, processes must be in place and technologies used to ensure swift reimbursement.

Promote better health literacy - education can be provided through public events, awareness campaigns, as well as providing resources to allow for participants to educate themselves. This includes education around particular diseases and how the clinical industry is working to improve treatment.

Read more: How We Can Address Barriers to Clinical Trial Accessibility?
Patients are more likely to engage with and enrol in clinical trials when they are well-informed and can see an effort on the part of the study organisers to reduce potential barriers and make participation as easy as possible through models including decentralisation, home healthcare, and use of technology.

Improving Diversity in Clinical Trial Participants

Historically, a key issue in patient engagement has been a failure to engage diverse patient populations. As a result, people of white, European descent are over-represented in clinical trial participation. They're also less likely to be stopped by the barriers outlined above.

The key problem this presents to the clinical industry is that a less diverse participation base to work with can impact the advancement of health research, as treatments may be developed without being tested on people from different genders or ethnic backgrounds.

This makes engagement with, and recruitment from, diverse populations essential for research organisations to make progress that benefits everyone.

To make clinical research more diverse, we need to:

Engage with minority communities - bringing clinical trial knowledge and expertise into the places minority people are seeking care. Armed with this knowledge, primary care physicians and consultants can have conversations with eligible patients and make recommendations of clinical trials which are accessible and beneficial to them.

Increase diversity amongst researchers - patients are more likely to trust and participate in clinical research when they can relate to those involved with the studies

Invest in targeted outreach - CROs and sponsors should co-create clinical trial communications with patient groups and minority communities, and work together on outreach programmes.

Read more: Why We Need To Improve Diversity Amongst Clinical Trial Participants
Engaging diverse populations is vital for progression. Differences in age, gender, and racial background can lead to different effects from the same treatment, and some groups may experience completely different results from the majority.

For clinical studies to be truly patient-centric and for drug development to be effective for the highest number of patients, diversity must be a key focus. And that starts with engagement.

Looking After Patient Mental Health

Mental health has been brought to the forefront of many peoples' minds in 2020 - and the clinical industry is no exception. As patients generally express more anxiety around clinical trial processes - especially those who are more vulnerable or at risk - it has been vital that we engage in these conversations with patients.

The demands of a clinical trial may be too much for some patients to deal with, especially dealing with complex or rare diseases. For example, stressful travel and intrusive assessments are key reasons patients cite for dropping out of clinical trials - therefore, we can ask where these might be replaced by home health visits or technology-based solutions.

As well as leading to disengagement and impacting retention, poor mental health can also impact on reported side effects which might affect the outcome of a drug trial.
Read more: The Importance Of Looking After Patient Mental Health During Clinical Trials
Opening up conversations with participants and engaging with them around their mental health will increase our understanding of the links between mental health and clinical trial impact. It should be best practice to conduct a 'mental health impact assessment' on each element of the trial, attempt to reduce potential negative impact wherever possible, and record and assess behavioural changes as the study progresses.

By understanding external triggers for mental health issues, extending compassion towards participants suffering from mental health problems, and looking at where negative mental health impact can be mitigated CROs will see a positive effect on participant attraction and retention in clinical trials. Furthermore, including patients who are more diverse in terms of mental health will reflect positively on trial outcomes overall for the same reasons as age, gender, and racial diversity.

If our collective processes for recognising and looking after patient mental health were more robust and effective, we wouldn't need to exclude patients with known mental health issues from participating in clinical trials. Instead, if we can accommodate mental illness, we can develop research that not only takes care of its participants but also results in drugs that have more effective real-world application.

Involving Patients in Clinical Trial Design

We know the most common reasons patients cite for dropping out of clinical trials. The question is, how many of these issues might have been avoided if patients had more input in informing the end to end design? And what better way to ensure patient engagement than when patients have had input into study processes and protocols?

According to the UK's National Institute of Health Research, involving patients in the clinical development process has the potential to significantly improve study design and delivery, resulting in better recruitment, retention, and engagement throughout - including protocol adherence.
*From Patient Experience Pyramid - Copyright Trishna Bharadia.
To effectively engage patients in clinical trial design, CROs and sponsors will need to work closely with patient advocacy groups and informed patients. When these groups are brought in as consultants and partners, study organisers can better understand and address patient concerns and are better equipped to support them through the clinical journey.

However, the right patient groups must be involved at the right stages. There will be times when it's necessary to speak to 'expert' patients and highly informed advocacy groups, and times when it's vital to speak to patients who don't have as much knowledge of their condition, general health literacy, or advocacy experience.
Read more: How to Involve Patients in the Design of Decentralised Clinical Trials
Broadly, patients fall into three groups as potential consultants*:

Patients by experience who can offer feedback on elements of the trial process such as travel and logistics which have a direct impact on their lives

Expert patients who know a lot about the wider patient community, and can anticipate other patients' needs and share anecdotal advice from theirs and others' experiences

Pro patients who know different patient communities, are aware of issues affecting the healthcare system and can offer advice on the entire journey from recruitment through to completion

Consulting with patients on the clinical trial journey is all well and good - but then study designers must ensure patient input is integrated into trial design.

To bridge the disconnect between gathering patient input and putting it into action, sponsors and CROs must be willing to increase their budgets for a longer-term gain. For example, they may need to commit to creating more formal patient-led roles within their teams, ensure the consultancy process allows for additional rounds of feedback to fully translate patient input into the trial endpoints, or invest in necessary technologies and home health solutions to introduce virtual trial elements that reduce patient burden such as travel and up-front costs.

Communicating with Patients Effectively

Effective communication is essential for patient engagement and retention during a clinical trial - especially as more trials are moving to virtual or decentralised models where face to face contact with patients is limited.

While patient safety has always been paramount when it comes to clinical trial design, effective communication and the overall patient experience hasn't historically been prioritised in the same way. Now, this has to change.

Confusion around processes and protocols is a key reason patients drop out of a study, meaning poor communication can cost sponsors in lost time and revenue as well as jeopardising trust between study organisers and patients.

The core principles of exceptional patient communication are:
Read more: Effective Communication With Patients Throughout Decentralised Trials

Minimising jargon - avoid clinical terms and always use the simplest explanation of any process or procedure. If the patient wants more in-depth or complex information, make it clear that they can request this.

Being specific - provide clear, step-by-step instructions for every process and always specify exactly what will be involved and what's expected of the patient.

Using repetition - repetition helps reinforce key information. Ensure that core messages are highlighted and stated more than once.

Checking patient understanding - when you've explained something or provided information, check-in with patients. Perhaps ask them to repeat back what they understood, sit with them as they walk through the process, and ensure they have a contact who is available for them 24/7 during their participation should they run into any issues.

Leveraging technology effectively - from video calling to automated SMS reminders to dedicated apps for sharing essential information and facilitating regular check-ins. In order to work as an enabler rather than a barrier, technology must be intuitive, integrate into patients' existing lives and routines, be reliable, and be easy to use.

Above all, patients want to be treated as investors in clinical trials, not as guinea pigs. CROs must ensure processes are in place to check-in consistently with patients, creating a feedback loop that addresses and issues or concerns as they arise.

Key points in the patient journey where communication matters most are:

Explaining processes in depth while onboarding, including additional or unfamiliar measures that may be in place for decentralised trials.

Checking in with patients at regular intervals to offer a space for questions, explicitly enquire about any issues, and make them aware of additional support.

Showing appreciation at the end of the trial - acknowledge the role patients have played in their trial, thank them for it, and ensure they know they're appreciated.

Sharing results - patients are investors. Keep participants updated on the outcome of the study, so that they can see the difference they have made.

True patient-centricity means patients feel involved, heard and appreciated for their role in the clinical journey. Expecting patients to simply follow processes and be subject to procedures they don't fully understand isn't enough. Patients expect better - and that starts with communication.
Think remarkable. Expect remarkable. BE remarkable.
In Summary

Patient engagement is vital for clinical trial success, impacting everything from recruitment to advocacy. To recruit more diverse patients, a wider pool of patients needs to be engaged in clinical research as a concept - which means more public education drives are needed.

Engagement with a wider population isn't enough though. We need to actively address barriers to participation from a geographical and socio-economic perspective, as well as ensuring clinical trial protocols put patient wellbeing at the forefront and don't exclude participants who believe the toll on their mental wellbeing would be too much. The increasing movement towards decentralised trial models is going some way towards addressing many of these barriers.

Patients must have their mental health looked after throughout the clinical journey in order to engage fully with trial protocols and not drop out, and there needs to be a deeper understanding and willingness as an industry to engage patients with existing mental health conditions.

Patients will also be more engaged with a clinical trial when they and their communities have been actively consulted from the beginning as co-creators and stakeholders. In seeing their opinion listened to and translated into action, they'll feel like investors rather than guinea pigs.

Above all, effective communication end to end is vital in ensuring patients are engaged - and this is especially important when face to face contact is reduced or eliminated in the case of decentralised or fully virtual trials, where technologies replace real life interactions in many scenarios. Good communication underpins the entire patient journey, reducing the chance of dropouts and increasing the chance of patients becoming active advocates for trial participation in future.

We deliver remarkable patient experiences that improve clinical trial outcomes.

We empower healthcare providers with next-generation care management tools and technologies.

We help CROs deliver high-performance patient experience management, and support pharma / biotech to attract, engage, and maintain patient participation in clinical trials.

Remarkable means the right people, the right technologies and the right systems to deliver the best possible outcomes for you, your patients, and your clinical trial.

Let's make your next study remarkable. Contact us now to discuss how.

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The Complete Guide to Patient Engagement in Clinical Trials - mdgroup

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Patient engagement is vital for successful clinical trials - from recruitment all the way to completion. In our recent mdWebinar series, many of our panellists highlighted the need to improve patient engagement at every stage of the clinical journey and why it matters.

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Hemingway Editor (hemingwayapp.com)

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Hemingway Editor makes your writing bold and clear.

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https://www.youtube.com/watch?v=8LNnI8CntdY

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Preparing accessible and understandable clinical research participant information leaflets and consent forms: a set of guidelines from an expert consensus conference | Research Involvement and Engagement | Full Text (biomedcentral.com)

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Research article

Open Access

Published:

Eleanor Coleman 1 na1,

Lydia O'Sullivan orcid.org/0000-0002-7131-5048 2,3 na1,

Rachel Crowley orcid.org/0000-0003-1472-4117 4,

Moira Hanbidge 5,

Seán Driver 6,

Thilo Kroll orcid.org/0000-0003-2082-5117 7,

Aoife Kelly 8,

Alistair Nichol orcid.org/0000-0002-4689-1238 9,10,

Orlaith McCarthy 11,

Prasanth Sukumar orcid.org/0000-0003-3229-2661 12 &

...

Peter Doran orcid.org/0000-0003-2064-5335 13,14

Show authors
Research Involvement and Engagement 7, Article number: 31 (2021) Cite this article

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Abstract

Background

In line with Good Clinical Practice and the Declaration of Helsinki, it is the investigator's responsibility to ensure that research participants are sufficiently informed, to enable the provision of informed consent. The Participant Information Leaflet/Informed Consent Form is key to facilitating this communication process. Although studies have indicated that clinical research Participant Information Leaflets/Informed Consent Forms are not optimal in terms of accessibility, there is little or no specific guidance available. The aim of this research was to propose and agree a set of guidelines for academic researchers and sponsors for preparing accessible and understandable Participant Information Leaflets/Informed Consent Forms.

Methods

A literature review identified guidance for the preparation of patient-facing documents. Following critical appraisal, key recommendations were extracted and a set of recommendations which can be applied to clinical research Participant Information Leaflets/Informed Consent Forms were prepared. These recommendations were evaluated and amended by an Expert Consensus Conference consisting of a group of key stakeholders. The stakeholders included members of a Research Ethics Committee (both lay and expert), a patient advocate, experienced clinical researchers, a plain English editor and a Data Protection Officer. Consensus was reached regarding a final set of recommendations.

Results

44 recommendations were agreed upon and grouped into five categories: Layout, Formatting, Content, Language and Confirming Readability. These recommendations aimed to maximize accessibility for lay participants, including readers with dyslexia, literacy or numeracy challenges, thereby improving the quality of the consent process.

Conclusions

More empirical research is needed to further improve the informed consent process for research participants. However, these recommendations are informed by the current literature and have been ratified by expert stakeholders. It is hoped that these recommendations will help investigators and sponsors to consistently and efficiently produce more accessible clinical research Participant Information Leaflets/Informed Consent Forms.

Plain English summary

Researchers must make sure that research participants are given all of the relevant information about a research study or trial. This information helps research people to decide if they wish to take part. The Participant Information Leaflet/Informed Consent Form is an important source of information for potential research participants and their families and friends. However, Participant Information Leaflets/Informed Consent Forms are often not easy for lay readers to understand. They can be especially difficult for readers with dyslexia or those who have problems with reading, or understanding numbers. There are guidelines available for designing information leaflets for lay readers, for example, leaflets about medicines or different health problems. But it would be helpful for researchers if these guidelines were applied to clinical research Participant Information Leaflets/Informed Consent Forms.

We searched for and gathered guidance for designing and writing information leaflets for adult, lay readers and checked to see if the sources of the guidance were reliable. We then put together some recommendations for designing and writing information leaflets for research studies or trials. We formed an expert group, made up of both laypersons and researchers, who reviewed and discussed these recommendations. The expert group agreed on a final set of recommendations. We hope that these recommendations will help researchers to prepare Participant Information Leaflets/ Informed Consent Forms that are consistently easier to for participants to read and understand.

Peer Review reports

Background

Valid informed consent depends on disclosure of all pertinent information, capacity to consent and voluntariness [ 1]. In the context of clinical research, it is the investigator's responsibility to ensure that participants are fully informed before they provide freely-given, informed consent [ 2]. The use of understandable and accessible written information is an important element of communication with laypersons. Written information in addition to verbal communication can improve comprehension [ 3, 4]. However, studies that have used a broad range of criteria have indicated that clinical research Participant Information Leaflets/Informed Consent Forms (PILs/ICFs), are not optimal in terms of accessibility and understandability [ 5, 6, 7]. This may lead to research participants having difficulty understanding the information contained in PIL/ICFs prior to providing their consent to take part. Concerningly, a recent systematic review indicated that research participants often have a poor understanding of some of the key concepts needed to ensure valid informed consent [ 8].

Clinical research PILs/ICFs pose some unique communication challenges, since research participants frequently struggle to understand complex concepts such as randomization, placebo and the risks associated with participating [ 9, 10]. PILs/ICFs are becoming longer [ 11, 12] and changes in the regulatory landscape such as the introduction of the European Union General Data Protection Regulation (GDPR) also present challenges, as additional information must be provided to participants [ 13, 14]. Good Clinical Practice guidelines state that 'The language used in the oral and written about the trial, including the informed consent form, should be as non-technical as practical and should be understandable to the subject...' [ 15]. However, while some general guidance on creating accessible patient-facing documents is available [ 16, 17], to the knowledge of the authors, this guidance has not been applied to clinical research PILs/ICFs and remains an unmet need.

The Expert Consensus Conference (ECC) methodology is defined as " a forum for communication and participation of lay men and experts for societal decision making" [ 18]. The ECC methodology is commonly used in the health technology setting and in the preparation of clinical guidelines, as a means of rapidly summarizing the available literature and gaining a consensus from an appropriate group of stakeholders [ 18, 19]. In particular, the ECC methodology is useful where strong evidence is lacking and therefore the insights of an expert group are required to provide guidance. There is limited empirical evidence regarding the optimal presentation and content for patient-facing documents such as layout, formatting, the use of images, language and readability. However, a review of the literature indicated many areas of common ground among organizations seeking to communicate clearly for the benefit of lay readers [ 16, 20, 21]. The aim of this ECC was to produce a set of guidelines for academic researchers and sponsors for the preparation of accessible and understandable clinical research PILs/ICFs and to gain consensus from an expert group of stakeholders regarding their appropriateness. Having PILs/ICF which are clearer in format and layout and contain easily understandable information for research participants will ensure that they can provide valid informed consent.

Materials and methods

The below flowchart (Fig. 1) describes the methodology followed by this ECC.

Literature review and critical appraisal

A literature review was performed in July 2020 to identify guidance for the preparation of patient-facing documents. An initial scope of the literature indicated that guidelines relevant to this review could not be located within traditional academic databases. In fact, most of the relevant guidelines were in the form of reports from national literacy agencies, health authorities and regulatory bodies and were available on the organizations' websites. Therefore, all entries on a Google search were examined by a single researcher (EC), using the search terms 'Guidelines', 'writing' and 'Information Leaflets'. Following this, all reference lists were also checked. This process was independently repeated by a second researcher (LOS). The results from the search were combined and summarized by noting each result on an Excel spreadsheet. A piece of literature was deemed relevant if it purported to provide guidance on the preparation of public-facing documents for adult laypersons - this was not restricted to the medical or research context. A piece of literature was excluded if it provided guidance on preparing document for children or those with diminished or limited capacity, or wasn't available in English. Since the majority of the guidance identified was not supported by quantitative data, each relevant document was independently appraised by two researchers (EC and LOS) using the Johanna Briggs Institute Critical Appraisal Tool for Text and Opinion [ 22].

Compilation of recommendations

Guidance from each document which passed critical appraisal was extracted and tabulated. This data was synthesized and 44 recommendations were proposed from themes and findings that consistently recurred and were grouped into five categories by two researchers (EC and LOS) and reviewed by clarity and completeness by two additional researchers (RC and PD). These recommendations were circulated to the ECC participants prior to the ECC for their review.

Expert consensus conference meeting

Eight key stakeholders were invited and agreed to take part in the ECC, which comprised of the following:

Lay member of a Research Ethics Committee (REC)

Expert member of a REC

A patient advocate from the Irish Platform for Patient Organisations, Science and Industry

A plain English editor and trainer from the National Adult Literacy Agency

An experienced clinical research nurse

An experienced principal investigator

A senior academic researcher with experience in inclusive research

An experienced qualitative researcher

A hospital data protection officer

Efforts were made to ensure that the composition of the ECC members was balanced, including both laypersons and researchers and also persons from different operational perspectives. The lay and expert REC members and hospital data protection officer were invited from the affiliated hospital. The principal investigator, research nurse and researchers were invited from the affiliated research centre and university. The patient advocate and plain English editor/trainer were invited from their respective organisations, as listed above.

The ECC lasted for 2.5 h and took place via videoconferencing (using Zoom) in August 2020. The participants provided verbal consent to participate and for the session to be recorded. The ECC was facilitated by a Chairperson (RC), and a Discussant (LOS). The Chairperson presented each recommendation to the participants, led the discussion between the members and ensured equal representation from each participant. The Discussant presented the findings of the literature review, including the available evidence and rationale for each recommendation. During the ECC, alterations to the recommendations were proposed, and consensus was reached on each separate recommendation. For each recommendation, following discussion, a unanimous agreement was reached by the ECC participants.

Finalizing recommendations

The amended recommendations were compiled using the ECC recording to ensure no input was omitted. The amended recommendations were circulated to the ECC participants who indicated their approval or provided further amendments. The final recommendations were then circulated and all of the ECC participants provided their approval. All approvals were documented.

Ethical approval

This study was granted a low-risk ethical exemption by the University College Dublin Research Ethics Committee (REC) - Ref LS-E-20-94-OSullivan-Doran.

Patient and public involvement

Two laypersons (one patient advocate and one layperson who is a member of a REC) contributed to all aspects of this ECC. Wherever applicable, this study was reported in line with the GRIPP2 Long Checklist (see supplementary file).

Results

The searches yielded 189 (EC) and 163 (LOS) or 352 results in total. 284 documents were excluded for the following reasons: 15 (duplicates); 35 (related to paediatrics); 31 (not accessible e.g., books the researchers could not access) and 203 (not relevant - didn't contain any useful recommendations, advertising, related to adults who lack capacity or with an intellectual disability). 68 documents were then reviewed in detail, of which 44 were excluded as they were local adaptations of national guidelines, so didn't provide any additional insights. 24 documents underwent critical appraisal and two were excluded. Table 1 presents the 22 documents which were selected following review of the documents and critical appraisal. These documents were mainly grey literature sources - e.g., guidance produced by national literacy agencies, health authorities and regulatory bodies, along with some peer-reviewed literature. While all of the selected documents were aimed at improving clarity for adult readers in general, a number of them specifically referred to the benefits for readers with additional challenges, such as dyslexia and literacy or numeracy difficulties [ 16, 23, 24, 25, 26, 27, 28]. Documents were published in Ireland, the United Kingdom (UK), France, the United States of America (USA) and Australia. Individual recommendations were extracted using an Excel data extraction tool. Figure 2 shows the 44 individual recommendations which were extracted and the frequency with which they were mentioned within the literature. These 44 individual recommendations were grouped into five categories.

Final approved recommendations

In general, there was broad agreement between the ECC participants. However, there was two areas on which opinions differed. Firstly, the use of 1.2-1.5 line spacing in research PILs/ICFs can result in documents which become quite long and therefore could be off-putting for some potential research participants. Secondly, the use of readability assessment tools - it is recognised that such tools have significant limitations, however they may be of value, especially when making an initial assessment of e.g., sentence length or the percentage of passive sentences. The final recommendations, approved by the ECC, grouped into categories are as follows:

Category 1: Layout of Participant Information Leaflet / Informed Consent Form (PIL/ICF)

Purpose of recommendation

The purpose of this recommendation is for the PIL/ICF to be arranged in an easy-to-read and accessible layout. Images can break up the text and help to support or explain the main message(s) of the PIL/ICF - for example to illustrate the arms of a trial after randomization. Glossy paper reflects the light, which can make the PIL/ICF harder to read. Similarly, a cluttered PIL/ICF reduces legibility. These factors are particularly important for dyslexic or neurodiverse readers, or those with literacy challenges.

1. 1)
Leaflet format - PIL/ICF should be organized into a booklet format - for example: a bi-fold booklet: see Fig. 3 below.

2. 2)
(This is a general guidance, consideration must be given to the target Participant group; if dexterity is an issue for example, an A4 page layout may be more accessible).

3. 8)
Use left aligned text - see Fig. 4 below.

Category 2: Formatting of Participant Information Leaflet/Informed Consent Form (PIL/ICF)

Purpose of recommendation

The use of 'All Capitals' and underlining make it more difficult for the reader to discern the shape of the words. The text should not be too small or the reader will strain to read or avoid reading. The use of headings for each section and subsection of the leaflet is vital for breaking up blocks of text in the leaflet and making it more accessible to the reader. These factors are particularly important for dyslexic or neurodiverse readers, or those with literacy challenges.

6)
Headings - headings should be used and should be easily distinguished from the body of the text, using bold type face, a larger type size or a different colour. Each heading of the same level should have the same distinguishable format (for example, each section of the leaflet could be captioned by a larger heading, with each subsection within them having the same smaller subheading. The colours red or green should be avoided in the words of a heading.

Category 3: Language of Participant Information Leaflet/Informed Consent Form (PIL/ICF)

Purpose of recommendation

The purpose of this recommendation is to enhance the readability of the PIL/ICF and ensure that the message is as clear as possible. These factors are particularly important for dyslexic or neurodiverse readers, or those with literacy challenges.

1. 1)
Minimize the use of long sentences. Aim for an average sentence length of 15-20 words. Please see Table 2 which gives an example of reducing a sentence length.

2. 2)
Don't use long paragraphs. Break up blocks of text using subheadings.

3. 3)
Use questions in section headings for example: " What are the risks of taking part in this study?"

4. 4)
Use bullet points or numbered lists, rather than long sentences with lists of items, but ideally use no more than 7 bullet points.

5. 5)
Minimize the use of technical language or jargon, and where it is necessary, explain it immediately after it is used.

6. 6)
Use specific amounts, rather than words like 'multiple' - for example. "As part of this study, you will need to come to the hospital six times to see the study team ".

7. 7)
For the numbers 0-9, use their words, for 10+ use the digit, unless you are giving an example using a statistic. For example: " 1 in 6 people will get a skin rash".

8. 8)
Use whole numbers to explain risk or benefits - for example " 1 in 6 people will get a skin rash", rather than "16.67%". Consider using a visual to explain risks - for example: a group of stick figures with one of them in a different colour - see Fig. 5 below.

9. 9)
Avoid adding information using a subordinate clause (or adding to a sentence with a phrase which can't stand alone) - for example: Say " Keep your eye drops away from sunlight. Sunlight can damage the drops" instead of " Keep your eye drops away from sunlight, because sunlight can damage the drops".

Table 2 Example of dividing a sentence to reduce sentence length

Table 1 List of key literature sources

Category 4: Content of the of Participant Information Leaflet/Informed Consent Form (PIL/ICF)

Purpose of Recommendation:

The purpose of this recommendation is to enhance the readability of the PIL and ensure that the message is clear to a layperson. These factors are particularly important for dyslexic or neurodiverse readers, or those with literacy challenges.

1. 1)
Consider what information the participant would want or need to know.

2. 3)
Use the active voice, wherever possible. Aim for 80-90% active verbs. For example: " The tablets should be taken twice a day", rather than " Take the tablets twice a day ".

3. 6)
Use every day analogies - for example: " Rub a pea-sized amount of the cream into your skin". These must be clear and easy to interpret.

4. 8)
Context should be provided before giving new information - for example: " If you feel ill, phone the research team".

Category 5: Checking the Readability of the of Participant Information Leaflet/Informed Consent Form (PIL/ICF)

Purpose of Recommendation:

The purpose of this recommendation is to ensure that PILs/ICFs are assessed prior to submission for Research Ethics Committee (REC) review. This may result in a smoother REC review and ensure that every effort has been made to prepare clear and readable PILs/ICFs for research participants.

1. 4)
Use a recognized checklist - for example: the National Adult Literacy Agency Plain English checklist for documents or forms [ 41] Suitability Assessment of Materials [ 29]or Clear Communication Index [ 27] checklist.

2. 5)
Check that acronyms and abbreviations are explained.

3. 6)
Check that readers do not have to perform calculations.

For example: Say " Take 3 tablets every morning, afternoon and evening for a week" instead of " Take 21 tablets at equal intervals over a 7-day period".

4. 9)
Check that images/graphics are explained and captioned.

Discussion

Given the paucity of clear directions around best practice in the preparation of patient facing documents, this ECC sought to identify, evaluate and apply the available literature to ensure clinical research PILs/ICFs are appropriate for enabling the consent process. The finished product is a set of clear guidelines which can be used by academic investigators and sponsors when preparing PILs/ICFs. The aim of an ECC is not to replace empirical research, but rather to provide expert opinion where there is limited evidence or indeed an evidence gap. Future research is required to evaluate whether and how well these guidelines improve participants' understanding. Synthesizing and condensing all of the available evidence into this set of guidelines provides researchers with a time-efficient guide which can help to ensure that all PILs/ICFs are consistently more accessible and understandable, particularly for readers with literacy challenges. These guidelines could also form the basis of Standard Operating Procedures for sponsors for the preparation of PILs/ICFs, as part of a training resource for new researchers or when revising an institutional PIL/ICF template.

Limitations

A limitation of this study is the lack of empirical evidence, e.g., randomized trials or studies within trials, regarding what factors improve readability and understandability for research participants. Therefore, the study relied on guidance produced by national literacy agencies, regulatory bodies and health agencies for patient-facing documents, and on a group of key stakeholders to adapt these to the clinical research context. Another limitation is the nature of the literature review used in this study, as any non-systematic literature review involves a higher risk of bias and a greater chance of missing relevant sources. In particular, the use of Google may lead to results which are not reproducible.

Efforts were made to ensure this group of stakeholders was balanced in terms of diversity of backgrounds. However, the group was limited to eight persons, so the size of the group is another limitation. It is also recognised that non-native readers or speakers of the local language will experience additional challenges. While many of the recommendations from this research will apply to readers in any language, e.g., formatting and layout, specific advise for this group of participants is outside of the scope of this study. Finally, this piece of work applies to PILs/ICFs which are presented in paper format. Given the movement by some researchers toward multimedia tools and E-consent, additional consideration should be given to ensure these forms of communication are clear and accessible to users.

Conclusions

Further empirical research is required to identify what factors would improve the informed consent process for research participants. However, this list of recommendations is informed by the current literature and has been ratified by a group of expert stakeholders. It is hoped that these recommendations will help investigators and sponsors to produce more accessible and understandable clinical research PILs/ICFs in a time-efficient and consistent manner.

Availability of data and materials

Data will be made available by contacting the corresponding author.

Abbreviations

ECC:

Expert Consensus Conference

GDPR:

General Data Protection Regulations

PIL/ICF:

Participant Information Leaflet/Informed Consent Form

References

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Acknowledgements

The authors are grateful to all of the participants in this Expert Consensus Conference. The authors also thank the Health Research Board-Trials Methodology Research Network, the Irish Platform for Patients' Organisations Science and Industry, the National Adult Literacy Agency, the UCD Clinical Research Centre and the Saint Vincent's University Hospital Medical Research and Ethics Committee for their support of this project.

Funding

This work was supported by the Health Research Board-Trials Methodology Research Network as part of the HRB-TMRN-2017-1 grant through the Health Research Board-Trials Methodology Research Network Undergraduate Summer Research Program 2020.

Author information

Author notes

Eleanor Coleman and Lydia O'Sullivan contributed equally to this work.

Authors and Affiliations

1. School of Medicine, University College Dublin, Dublin, Ireland and Health Research Board-Trials Methodology Research Network, National University of Ireland, Galway, Ireland

Eleanor Coleman

2. School of Medicine and School of Nursing, Midwifery and Health Systems, University College Dublin, Dublin, Ireland and Health Research Board-Trials Methodology Research Network, National University of Ireland, Galway, Ireland

Lydia O'Sullivan

3. Postal Address: Clinical Research Centre, Catherine McCauley Education and Research Centre, Dublin, Ireland

Lydia O'Sullivan

4. School of Medicine, University College Dublin and Saint Vincent's University Hospital Medical Research and Ethics Committee, Dublin, Ireland

Rachel Crowley

5. Patient advocate, and graduate of the Irish Platform for Patients' Organisations, Science and Industry (IPPOSI) Patient Education Programme in Health Innovation, Dublin, Ireland

Moira Hanbidge

6. National Adult Literacy Agency, Dublin, Ireland

Seán Driver

7. Centre for Interdisciplinary Research, Education and Innovation in Health Systems, School of Nursing, Midwifery and Health Systems, University College Dublin, Dublin, Ireland

Thilo Kroll

8. Clinical Research Centre, School of Medicine, University College Dublin, Dublin, Ireland

Aoife Kelly

9. School of Medicine, University College Dublin, Dublin, Ireland; Clinical Research Centre, School of Medicine, University College Dublin, Dublin, Ireland; Australian and New Zealand Intensive Care Research Centre, Monash University, Melbourne, Australia

Alistair Nichol

10. Department of Intensive Care, Alfred Hospital, Melbourne, Australia

Alistair Nichol

11. Saint Vincent's University Hospital Research Ethics Committee, Dublin, Ireland

Orlaith McCarthy

12. Clinical Research Centre, School of Medicine, University College Dublin, Dublin, Ireland

Prasanth Sukumar

13. School of Medicine, University College Dublin, Dublin, Ireland; Clinical Research Centre, School of Medicine, University College Dublin, Dublin, Ireland

Peter Doran

14. Health Research Board-Trials Methodology Research Network, National University of Ireland, Galway, Ireland

Peter Doran

Contributions

EC contributed to the literature review, quality appraisal of the literature, synthesis of the findings and the preparation of the manuscript. LOS contributed to the study design, literature review, quality appraisal of the literature, synthesis of the findings, the preparation of the manuscript, and coordinated the project. RC contributed to the study design, chaired the Expert Consensus Conference and reviewed the manuscript. PD leads the research team, developed the concept, contributed to the study design, acquired the funding and reviewed the manuscript. All authors contributed to the Expert Consensus Conference and the resulting recommendations. All authors reviewed and approved the manuscript prior to submission.

Corresponding author

Correspondence to Lydia O'Sullivan.

Ethics declarations

Ethical approval and consent to participate

This study was granted a low-risk ethical exemption by the University College Dublin Research Ethics Committee (REC) - Ref LS-E-20-94-OSullivan-Doran.

Consent for publication

Not applicable.

Competing interests

The authors declare that they have no competing interests.

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Coleman, E., O'Sullivan, L., Crowley, R. et al. Preparing accessible and understandable clinical research participant information leaflets and consent forms: a set of guidelines from an expert consensus conference. Res Involv Engagem 7, 31 (2021). https://doi.org/10.1186/s40900-021-00265-2
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Keywords

Clinical research

Clinical trials

Informed consent

Participant information leaflets

Patient information leaflets

Patient and public involvement

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Preparing accessible and understandable clinical research participant information leaflets and consent forms: a set of guidelines from an expert consensus conference - Research Involvement and Engagement

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Background In line with Good Clinical Practice and the Declaration of Helsinki, it is the investigator's responsibility to ensure that research participants are sufficiently informed, to enable the provision of informed consent. The Participant Information Leaflet/Informed Consent Form is key to facilitating this communication process.

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Plain English summaries | NIHR

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Published: 05 April 2021

Version: 1.0 - April 2021

Who is this guidance for?

This guidance is for researchers writing plain English summaries, and board and panel members including public reviewers.

What is a Plain English Summary?

A plain English summary is a clear, brief summary of the research that has been written for members of the public, rather than researchers or professionals. It should be written clearly and simply, without jargon and with an explanation of any technical terms.

Why is it important?

A good quality plain English summary provides an easy to read overview of your whole study and will help:

those carrying out the review (reviewers and board and panel members) to have a better understanding of your research proposal

the research funders to publicise the research that they fund

members of the public, health professionals, policy makers and the media to understand the research

Many reviewers use this summary to inform their review of your funding application. They include clinicians and researchers who do not have specialist knowledge of your field as well as public reviewers. If your application for funding is successful, the summary will be used on NIHR and other websites. Therefore, the summary needs to be used on its own to describe the research, without the rest of the application.

Writing a good summary right now will save you time later, as you might want to use it in the future, for example on patient information sheets. Use this summary as a foundation to build on and adapt as your research develops.

NIHR 'make it clear' - Plain English summaries in NIHR funded research

The NIHR is committed to making sure that each research study it funds has a clear and concise plain English summary. It is important that this information explains the research as a whole and is easy to read and understand. A good quality plain English summary, submitted as part of the standard application form, is a requirement of NIHR funding.

If you are applying for NIHR funding, then many reviewers use this summary to inform their review of your funding application. They include clinicians and researchers who do not have specialist knowledge of your field as well as public reviewers. If your application for funding is successful, the summary will be used on NIHR and other websites.

The summary will be assessed by NIHR reviewers and board and panel members who will comment on the summary as part of the review process. If it is not considered to be of a good quality then the researchers will be advised through the current feedback processes, and may be required to amend the summary prior to final funding approval.

Individual NIHR Programmes will have different requirements for word length - some will be 300 words and others may be up to 750 words. The information will be available in their guidance for applicants.

NIHR strongly advises applicants to involve patients, carers and/or members of the public in developing a plain English summary.

"If the plain English summary is well written, somehow the whole application seems easier to assess - I have an idea of what it is about." Public reviewer

How to write a summary

Audience

First of all, think about your audience. The people who read your summary will be an interested audience, but are not specialists. A 2011 government survey of adult literacy skills found that approximately 15% of UK adults have a literacy level at or below that to be expected of 11-year-olds. You can use online tools to check the 'readability' of your summary, to assess your language reading age. Find out more in the Resources section below.

Simple rules

There are a few simple rules for writing in plain English. In summary these are:

avoid wherever possible using jargon, abbreviations and technical terms - if you have to use them provide a clear explanation

avoid complicated English or uncommon words

use active not passive phrases, for example say 'we will do it' rather than 'it will be done by us'

keep sentences short

plan out the order and structure of the summary

break up the text, for example use bullet lists or headings

ask patients / carers / colleagues to read a draft to find out if anything is unclear

It is often good to return to your first draft after a few hours. With fresh eyes you are likely to spot opportunities for improvement - such as words that can be removed - that you missed the first time. For example:

The draft community engagement proposal that was received from the local hospital

We are currently in the process of preparing a public involvement strategy to be launched in May 2014

The plain English summary is not the same as a scientific abstract - please do not cut and paste this or other sections of your application form to create the plain English summary. The NIHR Glossary has definitions of research terms developed with a panel of researchers and members of the public.

Remember that if your NIHR application for funding is successful, the summary will be used on NIHR and other websites. Therefore, the summary needs to be used on its own to describe the research, without the rest of the application.

What to include?

When writing the plain English summary consider including the following information where appropiate (these sub-headings are for guidance only):

Aim(s) of the research

what are you aiming to find out?

how will patients / carers / members of the public and services benefit from your research - either directly or in the longer term?

Background to the research

why does this research need to be done now?

what is the scale of the issue? For example:

how many patients / members of the public are affected?

what are the costs to services?

Design and methods used

what design and methods have you chosen and why?

who are your participants? (if appropriate)

Patient and public involvement

how have patients / the public been involved in developing this research to date?

how will patients / the public be involved in the conduct / management of the research?

Dissemination

how will the findings be communicated and to whom?

Guidance for reviewers and board and panel members

The plain English summary is intended for an interested audience, who are not necessarily specialists. The summary should be written at roughly the same level as an article in a newspaper. With this in mind, please comment on the following:

does the plain English summary give a clear explanation of the research?

does it help you carry out your review? If not, why not?

is the language used appropriate and clear? If not, where are there problems?

are scientific terms, abbreviations and jargon explained? If not, which terms need explanation?

could this plain English summary be used on its own to describe the proposed research? If not, what further information is needed?

Resources

Several organisations and groups have developed guidance to support the writing of plain English summaries.

Plain English Campaign produces a series of guides that can be downloaded free of charge including: How to write in plain English; How to write medical information in plain English.

' How to Write a Lay Summary'. Duke, M. (2012).DCC How-to Guides. Edinburgh: Digital Curation Centre. This publication has information, guidelines and resources for writing lay summaries.

Peninsula Cerebra Research Unit for Childhood Disability Research (PenCRU) write their plain language summaries with parents of disabled children from their Family Faculty. Plain language summaries for each project are written in partnership with this group of parents, who are involved in deciding the headline, content and style of the document.

Readability tools:

Contact your local NIHR Research Design Service for further advice and support

For further information from NIHR, contact ced@nihr.ac.uk

Acknowledgements

This resource was reviewed by the NIHR in March 2021 for accuracy and currency. The NIHR endorses this resource. It draws on previous content from the INVOLVE website on 'Plain English Summaries' and the 'make it clear' campaign.

This guidance is due for review in March 2023.

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Published: 05 April 2021 Version: 1.0 - April 2021 This guidance is for researchers writing plain English summaries, and board and panel members including public reviewers. A plain English summary is a clear, brief summary of the research that has been written for members of the public, rather than researchers or professionals.

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The Results Are In: Clear Communication Improves Clinical Trials! — CommunicateHealth

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NRR_A_207497 31..40 (dovepress.com)

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Current Research in Health Literacy | Pfizer

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Research on Risk Assessment and Screening Recognizing the signs of low health literacy: It is important for researchers and policy makers to understand that low health literacy is not intuitively obvious at the individual level.

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How health literacy can enhance the design and conduct of clinical trials from consent to conclusion - IOS Press

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1.Overview of health literacy in clinical trials

Health literacy initiatives initially focused on patients and caregivers who did not understand medical professionals. More recently, health literacy has started to address how medical and public health professionals fail to clearly communicate with people in clinical contexts.

However, the authors believe health literacy has a larger role to play in health and well-being. One important area the authors seek to expand is to introduce health literacy within the institutions and practices of scientific research, especially clinical trials, to enhance the public's understanding and engagement in science and clinical trials.

Clinical trials face a host of significant communication challenges. These challenges are often found in the deeper meaning of words like diversity, recruitment, informed, consent, retention, engagement, participation, equity, evidence, and reporting. The words and actions each word represents can undermine a successful clinical trial. As a result, health literacy has a great and largely untapped potential to renew and reaffirm the power of clinical trials to advance health and well-being in practical, equitable, and ethical ways.

Health Literacy Media (HLM) believes health literacy can make a positive and productive difference to clinical trials in terms of:

More broadly, whether patients enroll in a clinical trial or are engaged in general healthcare on a broader level, diverse issues often converge to define the challenges in the relationships between medical professionals, health research, health systems, science, and society. In 1966, more than 75 percent of Americans had great confidence in medical leaders, which has declined to around 34 percent [ 1]. Today's health and medical systems face a crisis in confidence they are not prepared to effectively respond to - and frequently are not fully aware of the breadth and depth of the calamity. The crisis is caused by the relatively narrow focus of professional training coupled with the significant financial pressures health care systems face and a resulting pressure on medical staff - all within an uncertain health economic and policy context.

In response, HLM uses health literacy as a mechanism to improve communication about and within health and medicine in order to rebuild public support for medicine, medical professionals, medical research, science, clinical trials, and health systems. In order to succeed, this effort must address a range of activities from research to sick care to prevention. HLM believes health literacy can inform and foster a necessary transformation to a healthier and more productive relationship between generally non-scientific publics and the people and institutions within health and medicine. Eventually, a shift can reverse the ongoing erosion of the public trust in the leaders of health, medical, and health care systems.

Clinical trials provide one of the most challenging contexts and case studies in which to apply the evidence-based strategy and practices of health literacy. All too often, health care professionals hear about a clinical trial being misunderstood by its participants, the press, or the public. For example, a lack of significant findings (statistically and/or clinically) in a clinical trial is often interpreted as a failure. Instead, the lack of statistical or clinically meaningful findings adds to knowledge, specifically regarding what not to pursue among specific study populations. This is just one small, yet important, example of the public misunderstanding of the processes and goals of clinical trials. HLM suggests the misunderstandings are due, in part, to how people and institutions who manage clinical trials talk about their own efforts and goals - especially during the recruitment process.

To improve public understanding, governments around the world are simultaneously working to implement new approaches, guidelines, and rules with the ultimate goal to increase the relevance and use of clinical trials.

While a well-established approach to communicate clinical trials to the public is the National Library of Medicine's website ClinicalTrials.gov, its information and data are not targeted toward lay audiences. Deborah Zarin M.D., the former director of ClinicalTrials.gov, acknowledged ClinicalTrials.gov information is provided so: "the results can be understood by an educated reader of the medical literature" [ 3]. However, the audiences many health care agencies need to reach are rarely the educated readers of medical literature. To put this another way, the diffusion of health literacy and numeracy skills (the understanding of quantitative information) is limited - especially within underserved geographic areas and populations [ 4- 12]. Moreover, health literacy-based misunderstandings occur among well-educated people. Recent research suggests physiological shock impacts cognition regardless of a person's educational or health literacy levels when they are faced with serious medical diagnoses and diseases [ 13].

Despite all these potential barriers, clinical trial participants want to learn, and have the right to learn, the results of clinical trials - especially when they directly participated in that trial [ 14, 15]. Providing those results in a health literate manner can increase participants' feelings of value and improve the likelihood they will participate in future trials [ 16, 17].

Thus, there is an unprecedented urgency to address the public understanding of science, specifically clinical trials. Health communication companies with a focus on health literacy, such as HLM, are uniquely positioned to lead efforts to integrate best evidence health literacy and plain language practices into the clinical trial process. While HLM is based in the United States, we work around the world.

Advances in international policy that mandate the creation of readable and usable clinical trial summaries are driving HLM's efforts in the public communication of clinical trial information. The work reported here is based on only one program in HLM's portfolio, the Clearly Communicating Clinical Trials program, and only details initial experiences in applying health literacy principles to public communication of clinical trial information. The remaining sections of this report will briefly: (1) contextualize the international policy that served as the impetus for HLM's focus on plain language clinical trial summaries; (2) discuss the potential impact of health literacy on the clinical trial process; and (3) provide one program example and key initial learnings.

2.European Medicines Agency mandate to create readable and usable clinical trial summaries of 2017

The currency of the issue of health literacy in clinical trial communication partially stems from a European Medicines Agency (EMA) 536/2014 regulation, and its further clarification published in a 2017 consultation document. The EMA regulations outline the need for sponsors of clinical trials to produce so-called 'plain language' summaries of clinical trials [ 18- 20]. The stated purpose of plain language clinical trial summaries is to provide clear information that people can use when making health decisions. More practically, the newly required summaries are discussed as a hopefully effective way to report on what occurred within a clinical trial to the participants.

In turn, the EMA's attempt to bring the reporting of clinical trial results into a more public space (based on both regulatory and ethical reasons), opens the door for trial participants and the lay public to enter a complex scientific communication sphere that historically has required medical background knowledge, familiarity with common research practices, a large clinical vocabulary, as well as the skills and access to learn, and apply the meaning of newly encountered clinical and scientific jargon.

3.How health literacy can impact clinical trials

As previously mentioned, health literacy can enhance every stage in the process of designing, conducting, and reporting on a clinical trial. To explain how this occurs, the authors will first introduce exactly what health literacy is - and what it is not.

While there are many current definitions of health literacy, in practice there is some agreement that health literacy helps everyone (e.g. the public at large and health and medical professionals) better communicate complex information about health and wellbeing in a way that elevates mutual understanding and encourages informed decision-making [ 2]. Hypothetically, better health literacy nurtures more informed consent among participants to join clinical trials as well as fosters a dialogue about the mutual goals of participants (and other stakeholders) when a new medical drug or technology is introduced.

Health literacy is not is a panacea, however. Health literacy requires hard work, close attention to detail, a plan to move from knowledge acquisition to action, and - most importantly - direct and honest engagement with each desired audience. Except for recruitment, informed consent, and recent public clinical trial summaries, the testing and improvement of the actual communication processes and content with clinical trial participants largely has been neglected, unnoticed, and underappreciated. The vast amount of what should be continual communication between clinical trial staff and participants has largely focused on one-way communication that often fails to make sure people arrive for their appointments on time and to report any adverse events they may have experienced, let alone seeking more information about experiences, preferences, and well-being.

At the heart of health literacy is a new-found respect for the expertise that people have in their own lives. While participants may not be research scientists, physicians, nurses, public health experts, molecular scientists, geneticists, or biologists, participants know their life better than any of these experts. Embracing that reality can shift communication efforts to bring a new level of awareness and respect of the important role participants should play in clinical trial processes.

Using the EMA guidelines, some health organizations have started to adopt plain language principles - to help participants understand exactly what did (or did not) occur within a clinical trial. While this is an important first step, it is incomplete. Patient understanding does not mean trust is established and trust alone does not always result in desired patient action. On the other hand, health literacy can target and produce informed understanding, trust, and therapeutic behavioral change. The challenge is how to best implement health literacy practices in clinical trial settings as well as the venues that report trial findings.

4.An opportunity of health literacy in clinical trials: The example of result summaries

Health literacy strives to explain health conditions and health care concepts in language that most people can understand and use. While this seems straightforward, biopharma companies are more accustomed to communicating directly with providers rather than patients. As a result, biopharma firms are understandably wary about how to engage in patient and public communication in a respectful and non-promotional way. Yet, some of the communication gaps in past practices now need to be addressed, as biopharma companies (who are engaged in EMA-oversight clinical trials) are required to communicate clinical trial results within public summaries.

To date, some companies have recognized the need for health literate clinical trial result summaries, which is a step in the right direction. Yet, obtaining a shared understanding of clinical trial results is only a small piece of health literacy. To be truly health literate, clinical trial information also has to move beyond plain language - and contain a context that an audience can relate to, rather than simply using words that meet an arbitrary reading level guideline (such as 5th or 8th grade levels).

Consequently, a health literate approach to communicating the results of a clinical trial is a process that, ideally, begins at a drug's protocol development and continues throughout the entire clinical trial process, culminating in the delivery of a summary of results. HLM suggests a comprehensive effort should include:

The evidence-based best practices of plain language in the choice of language(s) to reach the desired level of reading ease and preferred language of the audience

The evidence-based best practices of health literacy to substitute plain for scientific language to improve readers' skills, vocabulary, and knowledge. This extends the content beyond a simple reporting of data to assure that data are relevant and useful to people's lives.

Continual input and revisions from multiple perspectives - from clinical trial staff to participants to plain language and health literacy experts. This includes:

° A process that produces summaries tailored to the content and context of each clinical trial.

° An active review process engaging members of the intended audiences, especially people with the condition or disease focused on in the result summary.

° The latter should occur before publication in order to assure effectiveness and usability.

While the authors are using result summaries as the primary example, health literate attributes are critically important within other aspects of the clinical trial process from protocol development to recruitment, informed consent, and the reporting of results. When this entire process is conducted rigorously from day one of a clinical trial, result summaries will often - but not always - include:

Visual explanations of complex concepts, using charts, tables, and drawings

Analogies people can relate to based on their everyday lives

Clear language that explains complex science in accurate and understandable ways to help teach people the words they need to use to successfully communicate with medical staff

Publications tailored to the diverse channels that people use in their lives (e.g. social media, internet, print, and video)

A clinical trial staff that is prepared to communicate the trial's results directly to participants.

Successful, comprehensive public and patient communication also recognizes the value of tailoring content to audiences, which contrasts with the use of templates to communicate to the public. Tailoring is operationally defined as the process of personalizing messages for individuals and audiences based on their beliefs, traits, or abilities [ 21]. Tailoring can help weave context throughout materials. While a template approach to communication assumes all clinical trial results can fit within the same template, the effectiveness of tailoring lies in its ability to create potentially greater relevance to each intended audience [ 22].

Yet, the EMA guidelines have been widely used to create templates for the diverse sections a trial result summary should contain. Unfortunately, some communicators have taken those guidelines too literally and assume the order in which information is presented must follow the order they are listed in within the guidelines. In addition, strict adherence to template styles can result in a confusing focus on outcomes. For example, early phase 2 studies largely report data on safety without outcomes, while later phase studies largely report outcomes and also safety. Thus, a template that prioritizes outcomes would not be appropriate for a study largely focused on safety and vice versa. Conversely, a tailored approach - if taken too far - could mean each result summary would begin with a blank page, require extensive research of the target audience in advance, and quickly become a labor-intensive process that would outstrip the resources dedicated to creating the summary.

To remedy, HLM suggests a balanced approach, whereby a template may be used to create the initial draft of a clinical trial summary, which can then be tailored through a user testing process. Thus, HLM developed a clinical trial summary template built on the principles of: patient-centered communication; plain language; health literacy; logical idea structure; and an explanation of background knowledge to clearly explain the need and desired outcomes of a clinical trial. HLM then used a focus group to test the clinical trial summary template to create a more tailored clinical trial communication. Focus groups are considered to be a standard to assess an audience's preferences and their understanding of documents.

In this early development stage of HLM's clinical trial summary development process, two audience groups were identified and focus groups were conducted to develop and test a clinical trial result summary template [ 23, 24]. One group was recruited from an adult literacy education program and included adults with low literacy. The second group of participants was recruited from people who had the condition the template draft focused upon (breast cancer). In addition to testing the template, overall, the focus groups helped HLM identify and better understand the impact of language that might be unfamiliar to people who are more and less experienced with a particular medical condition. In addition, the focus groups suggested lay audiences appreciated more background information about a disease, as they may have less knowledge about medical conditions and treatments. This contrasted with breast cancer patients, who sometimes preferred more detail about treatments, side effects, and results than members of the general public [ 25]. Both lay audiences and people who are more directly impacted by a disease/illness sought additional context about what the results mean for patients as they consider treatment or other medical decisions. Thus, the value of tailoring became as apparent as the value of a template approach in an early, formative research process.

5.Key guidelines to creating a clinical trial summary based on HLM's research and experience

Fundamentally, all successful communication of complex information shares similar characteristics regardless of the specific content or audience - therein lies HLM's development and use of templates. Yet, all audiences for the communication of complex information are not the same - therein lies HLM's development and use of a research-based approach to engage audiences directly and tailor information to their needs within a template.

HLM suggests there are several principles to produce a usable and effective clinical trial summary. More specifically, HLM suggests:

° In very practical terms, this means to never include any information that is not contained within the core reports produced by the clinical trial team.

° State the main need for and findings of the study up front. This produces a flow of information that is generally the reverse order of a traditional journal and regulatory reporting in which the outcomes are often found near the end of an article or report.

° This can mean presenting information based as an answer to the main questions people have. Those questions are often used as headers for each 'chunk' of information within a summary.

° Describe who participated in a clinical trial in as clear and complete a style as the original scientific documents.

° Be clear that a health care decision should not be based on the findings of a single clinical trial and consulting health care professionals is always a vital part of an informed decision-making process.

In practice, HLM's approach and suggested principles are based upon effective methods to create clinical trial summaries. HLM acknowledges their suggested approach is not simple, and requires skilled personnel, health literacy training, and a meaningful investment of their time and energy.

For instance, HLM suggests a clinical trial summary creation process begin with a thorough review of the documentation available about the clinical trial as well as becoming familiar with the condition that each clinical trial focuses upon. Built into this process should be an opportunity to directly discuss with the scientific team the understandings and questions about the clinical trial. The latter direct communication, while invaluable, also can identify different approaches and perceptions of the value of communicating scientific information, and how information should be communicated between the writing of a summary and the researchers who designed and conducted the entire clinical trial.

HLM notes an enduring paradigm within science fosters a communication approach that sometimes is at odds with communicating directly with non-scientific audiences. For example, the use of scientific jargon has several underlying components, which frequently include:

The language, especially the vocabulary, unique to a particular trade, profession, or group

Unclear or meaningless (to certain audiences) talk or writing

A discussion section or writing that people do not understand

Language that is characterized by uncommon or pretentious vocabulary and convoluted syntax that is often vague in meaning.

While jargon enables scientists to more efficiently communicate with each other as they develop a shared understanding of jargon-derived meanings, the public rarely shares similar insights. The resulting gaps produce a choice about communication priorities that HLM suggests should be resolved on the basis of developing public understanding. Ultimately, the culture and needs of the audience must be prioritized to produce an understandable and usable clinical trial summary. The latter approach additionally favorably shifts the culture of science toward public engagement and away from a perspective that separates science from society.

6.Wrapping up

So, why does this all matter? Especially, why should this matter to an industry whose main goal is to create successful and profitable new approaches to medicine?

Clinical trials should not occur without honest and sincere public engagement. If done well, clinical trial summaries offer opportunities to engage the public and patients in new ways and helps create a more efficient clinical trial process. Overall, clinical trial summaries can help the pharmaceutical industry, researchers, clinical practitioners, hospitals and clinics, as well as government and non-governmental health agencies:

Show respect to trial participants

Help health care providers keep up with research advances

Show how clinical trial participation can lead to better medical solutions

Help people quickly learn more about new medical conditions, and what to do about it

Help people develop the critical questions they need to make decisions about their health.

Public clinical trial summaries also present an opportunity to create information from a perspective that can engage and involve people in their own medical care, while creating goodwill and a better understanding of the companies, agencies, and scientists who conduct medical research.

The authors believe that health literacy offers significant potential to improve and advance clinical trials when health literacy strategies are used throughout the entire clinical trial process. The latter can occur at every phase of a clinical trial to produce the best possible outcomes for companies, providers, and patients.

For all audiences, the application of health literacy to clinical trial processes can promote a shared understanding of the intent of a clinical trial, the outcomes of the clinical trial, as well as build trust in the clinical trial process. The application of health literacy processes also potentially accelerates the public adoption of clinical trial findings, which could improve patient adherence.

Finally, each step within this process needs to explain research ethics to produce more public trust in the outcomes of clinical trials. Based on our engagement in and understanding of the clinical trial process, the next steps involve extending the application of health literacy best practices into all aspects of the clinical trial process - from the development phase, to recruitment and retention efforts, and across dissemination and public communication. The authors' experiences, to date, suggest that undergirding all aspects of the clinical trial process with health literacy approaches will foster more sustainable science, the sustainability of organizations sponsoring and conducting clinical trials, and the sustainability of the health and wellbeing of patients and the public.

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How health literacy can enhance the design and conduct of clinical trials from consent to conclusion

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Health literacy initiatives initially focused on patients and caregivers who did not understand medical professionals. More recently, health literacy has started to address how medical and public health professionals fail to clearly communicate with people in clinical contexts. However, the authors believe health literacy has a larger role to play in health and well-being.

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Health Literacy: A Necessary Tool for Communicating the Science of Clinical Trials (diaglobal.org)

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ealth literacy is a powerful concept that successfully communicates the complex design, methods, processes, and outcomes of clinical trials to assure the information is understandable, relevant, and useful.

Key health literacy concepts include the following:

Health literacy and plain language principles are based on related yet distinct ideas and approaches. The essential goal is to first "meet people where they are," and then build up their knowledge and skills.

There is no step in the process of designing, conducting, and reporting a clinical trial that cannot be improved by introducing health literacy principles.

Science needs public engagement just as much as the public can benefit from a better understanding of scientific research.

Recent European Union (EU) regulations have drawn increased attention to the communication of scientific research, specifically clinical trials, around the world. Ethically, this is a welcome leap forward. Many wonder why this hasn't always been the case. Clinical trial participants are foundational for study implementation and, like all key stakeholders, deserve to learn the outcomes of the studies in which they participate. In addition, clear and understandable information may also improve public support for science, create much-needed goodwill for sponsors of clinical trials and actually increase patient participation in the clinical trials themselves.

People with medical conditions rarely find opportunities that offer hope for a healthier life or to contribute to society. Many study participants live with complex health conditions that significantly impact their own quality of life and that of others. In addition to meeting new regulatory requirements, sharing research findings with participants creates an opportunity to thank them for their significant contribution and to share hope for current or future treatments.

On the surface, communication of clinical trial results seems simple: to provide a written summary in "lay language" of the ten elements, listed below as they appear in Regulation (EU) No 536/2014, Annex V.

1. Clinical trial identification.

2. Name and contact details of the sponsor.

3. General information about the clinical trial.

4. Population of subjects.

5. Investigational medicinal product used.

6. Description of adverse reactions and their frequency.

7. Overall results of the clinical trial.

8. Comments on the outcome of the clinical trial.

9. Whether follow-up clinical trials are foreseen.

10. Where additional information can be found.

This entry point has encouraged many to begin creating "plain language" summaries. Practically, however, the ability to communicate these elements - in a way that is understandable, relevant, and usable to the diverse audience of specific trial participants - in languages that reflect widely varying literacy skills is an incredibly complex task.

Health Literacy Is More Than Plain Language

Plain language provides a strategy for clearly communicating written and spoken material. Health literacy expands the concept beyond the complexity of words and sentences, to address the processes, relationships and experiences when individuals interact with health professionals, health organizations and systems; and the complexity of evidence-based information about medicine, health, and wellness.

Health literacy has evolved from an effort to simply introduce plain language to health, to its current definition as a social determinant of health - influenced not only by the skills of individuals but also by the competencies of health professionals and the complexity of health systems and health information.

Most frequently, the desired outcome of plain language is understanding, while the desired outcome of health literacy is an informed decision. Simply put, people can't sustain their health without informed, healthy behaviors.

Despite the conceptual evolution in the understanding of health literacy, many organizations and individuals in the field continue to maintain a more narrow focus. It's not uncommon, for instance, to see plain language principles used without consideration of the true meaning and power of a full health literacy approach. For example, "lay summary"-a still overused phrase--inherently devalues the importance of the audience's role in extracting meaning and underestimates their expertise. An overly simplistic approach to health literacy also negates the global philosophy of the health literacy movement that values all stakeholders in the complex process of introducing science and society to each other.

A strict and outdated approach to plain language also adheres to some measure of reading grade level - for example, the use of the Flesch-Kincaid measure of reading difficulty with an arbitrary threshold, such as 5 th grade level or lower. Meeting that goal can serve as a helpful mental exercise, but when writing about a clinical trial there are some words that must be included but inevitably fall above the 5 th grade level, such as the name of the study drug.

An effective health literacy approach does not throw away all the complex ideas and words associated with a clinical trial. Instead, an effective health literacy approach to communicating the complex information inherent to clinical trials uses language to help readers build and connect concepts. The goal is to help them understand and use increasingly complex words and ideas. Plain language may introduce a complex concept, but that's only the beginning. Health literacy embraces complexity in a way that helps all readers fully understand the complexity of both the practice and the language of clinical trials.

Here is a published example that illustrates how communication about antibiotics provides factually correct information from a large population study, but stops short of contextualizing the information in a health literate manner to make it usable for the public:

"Almost two thirds (64 percent) of approximately 10,000 people who were surveyed across 12 countries say they know antibiotic resistance is an issue that could affect them and their families, but how it affects them and what they can do to address it are [sic] not well understood. For example, 64 percent of respondents believe antibiotics can be used to treat colds and flu, despite the fact that antibiotics have no impact on viruses. Close to one third (32 percent) of people surveyed believe they should stop taking antibiotics when they feel better, rather than completing the prescribed course of treatment."

A health literacy approach would offer recommendations to address this issue, including:

1. Plain language edit of the published paragraph.

2. Inclusion of additional need-to-know information to clarify when and how antibiotics should be used.

3. Use of the data to inform need-to-know written content and preferred terms. For example, from these data we can glean that, perhaps, more important than the words bacteria or virus, readers need to know if the disease was infectious or not, and what behavioral steps to take. The vast misunderstanding of the roles and functions of bacteria and viruses desperately needs to be addressed, but a plain language summary of a clinical trial is not the place to do that.

4. The complete health literacy approach can then be used in public facing materials, including clinical trial summaries.

With these points in mind, the published example can be re-written using our first health literacy principle above:

"A survey asked around 10,000 people about antibiotic resistance. Antibiotic resistance is when germs like bacteria aren't affected by the drugs made to kill them. About two out of three people (64 percent) said they knew about the issue, but about the same number of people didn't know how antibiotics work. They didn't know antibiotics can't treat colds or the flu, because they are caused by a virus, not by bacteria. About one out of three (32 percent) thought they should stop taking antibiotics when they feel better instead of finishing their prescription."

We Don't Need Simpler Words, We Need to Increase People's Skills

Our goal in using a health literacy approach is to build understanding to explain complex ideas in understandable, relevant, and useful ways. Complexity in language exists because a large amount of meaning is often built into a single word or phrase.

For instance, genomics is a word - and an entire body of science - that is relatively recent. The Flesch-Kincaid measure of reading difficulty tells us that genomics is roughly at a 6 th grade level or lower. Almost everyone should be able to read and understand it. However, while most adults may be able to read the word, few-including some health professionals-are likely to understand it. The complex information embedded into the word "genomics" takes ever-expanding volumes of words to fully explain.

If we turn to a dictionary, the definition of genomics is often akin to: "The branch of molecular biology concerned with the structure, function, evolution, and mapping of genomes." This definition registers at a 12 th grade reading level, doesn't give the reader any context, and uses the unhelpful reference to a "genome" which very few people know. Other complex concepts in this definition that need to be explained include "branch of molecular biology," "structure," "function," "evolution," and "mapping."

Instead, health literacy suggests that writers make definitions understandable, relevant, and usable without sacrificing scientific accuracy. This is a complex, yet entirely possible process.

Health Literacy and Clinical Trials

There is not a stage in the process of designing, conducting, and reporting a clinical trial that cannot be improved by introducing health literacy principles. This means planning, recruitment, informed consent, retention, reporting of results, evaluation of the process, and communication throughout the trial can all be improved by applying the best evidence-based practices of health literacy.

In the end, health literacy is not only focused on the simple communication of scientific concepts. Health literacy strongly suggests that professionals build the required connections with people to successfully communicate science, remembering that, by definition, communication is a two-way process. Doing so will increase the sustainability of the scientific enterprise within society. Without social support and participation, there will be no scientific research. Without scientific research, there will be no steady progress of human society. Health literacy is the pathway to making those connections real, vital, and sustainable.

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Health Literacy: A Necessary Tool for Communicating the Science of Clinical Trials

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ealth literacy is a powerful concept that successfully communicates the complex design, methods, processes, and outcomes of clinical trials to assure the information is understandable, relevant, and useful. Key health literacy concepts include the following: Health literacy and plain language principles are based on related yet distinct ideas and approaches.

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Home - Health Literacy in Clinical Research (mrctcenter.org)

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Home - Health Literacy in Clinical Research

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Principles of Health Literacy in Clinical Research

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IJERPH | Free Full-Text | Development and Evaluation of the Clinical Trial HEalth Knowledge and Beliefs Scale (CHEKS) | HTML (mdpi.com)

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Academic Editors: Gian Maria Galeazzi, Carel Jansen, Andrea F. de Winter and Burt Davis

Received: 22 April 2022 / Revised: 8 July 2022 / Accepted: 14 July 2022 / Published: 16 July 2022

1. Introduction

Clinical trial participation is one of the largest challenges in healthcare research [ 1]. Limited clinical trial knowledge, including the understanding of research beyond oncology or pharmacological studies, contributes to negative beliefs and attitudes towards research [ 2]. Clinical trials are not limited to just pharmacological studies, but also include epidemiological, behavioral, health-services and community-engaged research, that aim to improve lifestyle behaviors for individual or community health outcomes. Yet, patients may not be aware of this breadth or variety in clinical trial research beyond pharmacology. Research shows that patient health literacy, which refers to the ability to understand and act upon health information in order to successfully navigate the healthcare environment [ 3], is one of the key determinants of clinical trial enrollment [ 4]. Health literacy is the degree in which a person understands health information, and demonstrates the skills to act and make informed decisions. Understanding an individual's level of knowledge about clinical trials may help determine gaps that need to be addressed, to contribute to increased literacy levels. Psychometrically sound survey tools that assess clinical trial knowledge are absent from the literature.

Unfortunately, patient health literacy is relatively low among adults in the United States. Specifically, only 12% of Americans demonstrate adequate health literacy [ 5], whereas approximately 50% of adults in Europe demonstrate adequate health literacy [ 6]. Additionally, poor patient health literacy may lead to poor disease management and overall health status [ 7]. Most clinical trial knowledge, informed consent, or literacy assessments focus on cancer clinical trials [ 8]. Existing health literacy tools in research, training or program planning, include the Short Assessment of Health Literacy-Spanish and English, Rapid Estimate of Adult Literacy in Medicine-Short Form, and Short Assessment of Health Literacy for Spanish Adults [ 8, 9, 10]. These literacy instruments provide clinicians and researchers with an assessment of a person's ability to read, comprehend, understand and pronounce common health-related terms. Unfortunately, these instruments do not assess a patient's knowledge or beliefs of the different types of clinical trial research, to guide researchers and clinicians on how to overcome barriers to patient engagement. We aimed to address this gap by developing an instrument for evaluation of clinical trial knowledge and beliefs, that was not oncology or pharmacological based. We sought to create a tool that assessed patient clinical trial knowledge of observational and community-based research instead, as well as knowledge about safeguards in place to protect patient safety and patient rights, to identify how much people knew about the structures in place to overcome typical barriers to research engagement.

History of Mistrust and Barriers to Participation

Unethical research conducted in human populations throughout history has contributed to grave mistrust, particularly among Black, Indigenous, and People of Color (BIPOC). Moreover, institutional racism, and lack of transparency, awareness, culturally and linguistically appropriate research measures, tools, and research studies are a few of the driving factors behind BIPOC patient mistrust and low rates of clinical trial participation [ 11]. Choi and colleagues found that fear, lack of trust, and patient safety concerns were barriers to clinical trial research patient enrollment in Korea [ 12]. This includes an understanding of patient clinical trial knowledge on such topics as patient rights, the safeguards in place to protect them, and the different types of research opportunities available. Unfortunately, only one clinical trial survey to date evaluates participant understanding about clinical trial research. The assessment awareness and perceptions of clinical trials survey in India found that education and awareness were key to addressing knowledge gaps [ 13]. The 10-item survey assesses ethical concerns and basic understanding of clinical trials but is limited in its evaluation of the participant understanding of the process of clinical trial research, safety safeguards, participants' rights during research, and the potential benefits of community-based research with people of color. This survey tool was also weak in its methodological design, with a lack of inter-correlations and scale internal consistency reported.

High patient knowledge has been positively associated with willingness to join a clinical trial [ 14]. Cameron and colleagues found that patient education on study procedures and patient rights were critical topics for clinical trial participants. Higher patient education level attained, prior experience participating in a clinical trial, and participant perceived understanding of clinical trials were factors significantly associated with clinical trial knowledge among clinical trial participants. To this end, the focus of the instrument development in this report is knowledge pertaining to clinical trials. Adequate patient health literacy is not only being able to utilize the necessary skill sets to navigate the healthcare system but includes applying knowledge comprehension to understand medical jargon [ 15]. However, healthcare providers and researchers commonly use complex terms, language, and medical jargon in their interactions with patients in delivering information about clinical treatments and other risks [ 16]. In addition, people with low education levels have been associated with low reading comprehension and health literacy levels [ 17]. A degree of working knowledge about clinical trials may enhance health literacy, serving as a foundational building block to build comprehension, self-efficacy, and skills to navigate clinical trials in a confident manner [ 18]. For these reasons, we hypothesize that higher education levels will be associated with a higher Clinical trial HEalth Knowledge and belief Scale (CHEKS) score. This study provides a summary of the development and evaluation of a survey to assess clinical trial knowledge and beliefs of clinical trials. Our purpose was to create a tool that assessed patient clinical trial knowledge and beliefs of observational and community-based research, as well as knowledge about safeguards in place to protect patient safety and rights, to identify how much people knew about the structures in place to overcome typical barriers to research engagement.

2. Materials and Methods

2.1. Survey Development Phase

Survey item development began with a review of the literature to identify salient issues and concerns around clinical trial research. The authors brainstormed key search terms in consultation with NYU faculty knowledgeable about clinical trial research, and survey design and evaluation. The lead author (A.C.) reviewed the United States Department of Health and Human Services, what are Clinical Trials and Studies? And the Mayo Clinic Clinical Trials websites to generate initial terms. PubMed and GoogleScholar were searched in the month of October 2017 for peer-reviewed literature to generate search terms. The authors identified key concerns that may influence a person's decision to engage in a clinical trial, and developed survey items around these areas, such as safety, privacy, and the benefits of participant engagement. Survey item development was finalized by the survey developer, author (R.D.H.), and the lead author applied a community-engaged approach (See Figure 1 below) to iterate and vet survey items, before determining final items for inclusion. Once a consensus was reached, subject matter items for clinical trial knowledge items were determined: For example, because not all clinical trial studies are pharmacological, observational studies that are lifestyle interventions to improve health outcomes can take place in a community setting. Other subject matter items targeted patient safety, patient rights, the role of Institutional Review Board, and the role of people involved in the study to assess knowledge and beliefs identified as common barriers to clinical trial participation.

Search terms included: 'clinical trials', 'clinical trial participation', 'barriers to clinical trial enrollment', 'clinical trial knowledge', 'clinical trial beliefs', 'clinical trial survey(s)', and 'clinical trial literacy'. This review found that there was a gap in the literature on validated survey instruments that assess clinical trial knowledge and beliefs. Additionally, we found that low clinical trial participation was a global issue. Research articles from India, Korea, Canada, and the United States reported low clinical trial participation rates stemming from mistrust of research, misperceptions about research, and lack of knowledge about the research process [ 12, 13, 14]. All newly developed survey items and responses underwent an iterative process of reviews and editing until a final list of 31 items were constructed (See Table A1 for the full measure). Seven expert research faculty at NYU Grossman School of Medicine, Department of Population Health, on clinical trial research provided feedback on survey item development and content validity. Expert faculty were asked to review the items for any content gaps and if the items represented knowledge and beliefs. Four iterations of survey item refinement were undertaken with the research team, Community Steering Committee, and expert research faculty, to generate and develop the questions among the experts. We pretested the survey items with our Community Steering Committee and research associates on the study team. The study design included a combined patient-centered approach guided by a community-steering committee for user appropriateness, combined with the commonly used MTurk crowdsourcing panel study design [ 19]. The study setting for the patient-centered approach was at NYU Langone Health and on MTurk for study recruitment. The objective of this study was to develop a clinical trial knowledge and belief measure and evaluate its validity.

2.2. Patient Centered Approach

Health educators and community steering committee (CSC) members with prior clinical trial participation experience, provided feedback on survey items during their development. Health educators and community members were active members of their community board, activists, and public health advocates who were an integral part of the survey tool development to ensure that the items were relevant, and literacy level appropriate. The CSC reviewed survey items developed by the research team via focus group, iterated on survey item inclusion, and provided guidance on preferences to ensure privacy, confidentiality, and other safeguards to secure trust that their health information would be safe and protected. Their inclusion was essential to our patient-centered approach. Health educators and CSC members were recruited from referrals for the leader health educator at the Center for Healthful Behavior Change within the Department of Population Health, at NYU Langone Health. Iterative feedback on response options and level appropriateness was obtained to ensure survey items were tailored to patient needs. CSC members also provided input on survey length and content.

2.3. Participants

Participants completed the survey items on the Amazon Mechanical Turk in November 2017 to gather responses needed to establish content validity of the survey measure. Amazon Mechanical Turk (MTurk), an online survey panel supported by Amazon, was used for participant recruitment (n = 409). The MTurk survey panel setting has been recognized for its low-cost and quick access to survey large samples of respondents in a rapid timeframe [ 20]. Participants were required to be able to read and understand English and be at least 18 years of age. Eligible participants proceeded to the online consent page via an online advertisement. After informed consent was obtained participants continued to complete the survey.

Demographic information was collected on a subset of the sample. The demographic questions asked were the following: "What is your gender? What is your race? What is the highest degree or level of school you have completed? Employed? What is your age?".

The survey was estimated to take about 20 minutes to complete based on "think aloud" cognitive interviews with five adults [ 21]. Mturk participants were compensated $15/h, appropriated for the time needed to complete the survey. IRB approval was obtained in 2017 by NYU Langone School of Medicine (approval number: S17-00170). See Table A2 for a more detailed description of the sample.

2.4. Analysis

We hypothesized that a subset of the items could be combined to create an overall scale. Hence, we examined item-scale correlations (corrected for overlap) for the 31 items, eliminated items with item-scale correlations less than 0.30, and then estimated internal consistency reliability for the remaining items [ 22] (See Table A3). In addition, we fit a categorical confirmatory factor analytic model to evaluate whether the items were sufficiently unidimensional. Because chi-square is too sensitive to sample size, we rely on the comparative fit index (CFI) and the root mean squared error of approximation (RMSEA) to evaluate model fit.

To provide some initial information about construct validity, we estimated product-moment correlations of the simple-summated knowledge scale with age, gender, and education. We estimated a one-way ANOVA to assess the association of race with the knowledge scale score. We hypothesized that the CHEKS would be positively associated with age and education scores. We also hypothesized that African-Americans would have lower CHEKS scores than Whites.

Finally, we fit an item response theory graded response model and obtained item characteristic curves to evaluate whether the CHEKS response options were monotonically associated with the underlying concept of knowledge and beliefs (See Figure A1).

3. Results

3.1. Sample and Evaluation of Survey Items

The study sample size (n = 409) and was predominantly young adult White and Asian, low-middle income, and employed. The average age of the sample was 34 (SD = 15.7); 48% were female and 35% were White, 11% were Black or African American, 44% were Asian, and <1% were Native Hawaiian or Pacific Islander. Among participants, 56% had a bachelor's degree, and 79% were employed. Twenty-six percent reported an income between $20,000 to $39,000 and 20% reported an income between $40,000 to $59,000.

We initially began our survey with 31 items, and identified 6 of the 31 items that had item-scale correlations (corrected for overlap) lower than 0.30, that were omitted from the survey. The final survey items are in Table 1 below, and the full list of all 31 survey items that we began with can be found in the Appendix A. The survey response options were (4 = Definitely True, 3 = Somewhat True, 2 = Uncertain, 1 = Somewhat False, 0 = Definitely False.). Coefficient alpha for the remaining 25 items was 0.93. A one-factor categorical confirmatory factor analytic model, including factor loadings and standard errors, with 16 correlated errors was not statistically significant (chi-square = 791.610., df = 239, p < 0.0001) but fit the data well (RMSEA of 0.07 and CFI of 0.95). Internal consistency reliability of the 25-item CHEKS was 0.93 and ordinal alpha was 0.95. We recoded each item linearly to have a 0-100 possible range and averaged together the 25 items to produce the CHEKS scale score. The mean score was 75 (range 15-100, SD = 15).

Item characteristic curves from the graded response model are shown in Figure A1. These curves show estimated scale z-scores on the x-axis plotted against probability of responding on the y-axis. The response categories functioned well overall (i.e., monotonic association between response options and probability of response across the continuum), but the second response option was never most likely to be selected for items 10, 13, 20, 24, and 31.

3.2. Associations of Clinical Trial Knowledge with Demographic Variables

The CHEKS was not significantly associated with patient gender. As hypothesized, the CHEKS was significantly positively correlated with education (r = 0.15, p = 0.0365) and patient age (r = 0.20, p = 0.0051). The overall F-statistic for the association of race with CHEKS was significant (F = 2.73, p = 0.0207), but the Duncan multiple range test indicated no significant pairwise race subgroup differences.

4. Discussion

In the current study, we developed and evaluated the CHEKS tool for assessing clinical trial knowledge and beliefs. We confirmed our hypothesis that level of education, age and race were significantly associated with CHEKS scores. This is important, given that health knowledge has been established as a predictor of individuals' ability to process and evaluate health information [ 23]. Assessing patient health knowledge in the context of clinical trials ensures that each participant has a level of knowledge and skills needed to understand and use information that will empower them to make an informed decision regarding participation [ 24]. Understanding patient beliefs may help to address and overcome misconceptions around clinical trial research, that may impact participant participation.

Our patient-centered study design was a critical factor in developing question stems and response categories. The participant preferences related to troubleshooting, data privacy and confidentiality, data storage location and collection, and user access were an integral component of participant engagement with clinical trials on digital devices [ 25]. Questions for the CHEKS tool were guided by our CSC, expert research faculty and the literature. Participants' rights and safety, as well as the process and procedures of clinical trial research, funding, setting and benefits, were identified as critical areas to ensure patient understanding. These topic areas were agreed upon as survey items to include in the CHEKS tool given the historical mistrust of research and typical misconception of clinical trials only being pharmaceutical in nature [ 11, 12, 26]. Our approach is consistent with the literature, with our patient-centered input to the instrument development for key content areas guided by the literature, literacy level and cultural appropriateness guided by the CSC, data collection, troubleshooting user access processes, and survey ease of use administered online.

Finally, financial incentives offered through mTurk, was an effective motivator for a high response rate, despite the 31-item survey tool length [ 27, 28]. Questionnaire length did not affect response rate, but financial incentives were positive motivators. This finding is consistent with our monetary compensation to mTurk panel users of $15 USD/h. However, a more efficient shortened instrument without taking away its reliability may be a way to reduce participant burden. Mturk has been known to be useful for collecting a large amount of data quickly on more racially diverse populations, including more non-White participants [ 29]. However, in this study, the majority (44%) of respondents identified to be of Asian descent and there was no representation of Hispanic or Latinos. There was also a low percentage of Blacks, making our study less diverse than intended. Future research evaluating CHEKS among Hispanic and Black populations, may aid in overcoming barriers to research engagement, among a group who are largely not represented in research, yet disproportionately affected by health disparities.

This is an initial study to create and evaluate the CHEKS. Further research is needed to provide more information about reliability and validity. Further refinement of CHEKS to inform its reliability and validity could help ascertain patient reluctance to research, and aid in supporting clinical trial participation. Increased clinical trial participation, may help in developing health solutions for diverse populations. CHEKS has the potential to ascertain patient knowledge and belief gaps about clinical trial research, and aid researchers to develop targeted messaging and communication strategies to overcome these gaps, to optimize clinical trial literacy for patients to make informed decisions about engagement. This tool could help with increasing clinical trial engagement, enrollment, and retention via enhancing clinical trial literacy.

4.1. Implications for Future Research and Practice

Study implications for communication, practice, and research include leveraging this measure as a needs assessment or baseline intake tool of participant knowledge and beliefs about clinical trials to identify knowledge gaps and beliefs held about research. To this end, community health workers, public health researchers, health behavior scientists, population health researchers, and observational study and community-engaged researchers could potentially benefit from this tool. The CHEKS tool would be largely disseminated via national public health societies, and promoted on social media channels with partner organizations who share similar goals of increasing clinical trial knowledge, beliefs and literacy to optimize patient engagement, and encourage its use. This tool can be administered as a survey to gauge people's knowledge, beliefs and level of awareness, to create interventions and/or educational materials to counteract misperceptions about clinical trials research. The target audience for CHEKS is patients and research study participants in healthcare research, prevention, or treatment studies. Since there are age restrictions on some clinical research, this tool is geared towards people 18 years and older. In addition, our measure could be used as part of pre/posttest research analysis to determine how the research community is faring in improving recruitment and participation in trials from all communities. Examples of such interventions include the development of a tailored website to increase participant willingness to enroll in clinical trials [ 11], to understand knowledge content areas to bolster and beliefs or misconceptions to clarify.

Next, future studies in the U.S. are needed to evaluate the generalizability of the CHEKS measure. Our measure offers one item related to the inclusion of people of color. While limited, future studies could expand on this item to include a measure of clinical trial knowledge and beliefs, tailored and tested among BIPOC populations. This is particularly important because the tool used in this study was only available to respondents in English. Typically, when English is not your first language, it makes reading and comprehending medical jargon more daunting [ 30]. Future research may consider translating and evaluating CHEKS in different languages, which would present an opportunity to enhance communication between researchers and potential participants. Additionally, doing so could foster more collaboration between global health researchers and may improve research quality.

4.2. Limitations and Future Research

There are several limitations to using the MTurk online survey panels as a recruitment schema. First, data integrity is an issue, such that respondents may develop mechanisms to complete surveys quickly to receive the proposed incentive [ 31]. As such, participants are limited to those who can access online surveys through the MTurk platform, and may provide undesirable responses including, providing the same responses to the same questions, answering questions too quickly, or providing false answers [ 32]. As indicated in our limitations section, participants may have been in acquiescence due to the overwhelmingly positive responses on survey items, which may threaten data integrity. Given the low representation of Black Indigenous People of Color (BIPOC), among survey participants, the responses may not be representative of BIPOC communities, who have the greatest need for tailored measures on clinical trial knowledge and beliefs given their low representation in clinical trial research. Also, our survey was developed based on research in the United States, and survey items may not be applicable in other context or countries. Additionally, all of the survey item responses were in a positive response direction, with no negative response options. Including negative response options in future iterations of the survey, the tool may help to better ascertain knowledge versus participant acquiescence.

The Hawthorne effect is a well-documented phenomenon that affects many research experiments in the social sciences [ 31]. It describes the bias the participant may having knowing they are being observed in a study. By using MTurk, our participants had the intention to take our survey and be compensated. This may have changed some of their behaviors when answering questions. Future studies should include diverse sample size and culturally responsive question items that are reflective of the concerns of a racial and ethnically diverse population.

5. Conclusions

Assessing clinical trial knowledge and beliefs can provide useful information about patient understanding, and lead to targeted communication initiatives focused on addressing knowledge gaps and belief misconceptions. Overcoming these knowledge gaps and misconceptions could contribute to larger engagement in clinical trial research, and ultimately, more diverse racial and ethnic participants. This tool has the potential to benefit public health researchers, behavioral scientists, and populations health researchers, particularly given the focus of this tool to focus on observational and community-informed research, going beyond typical oncology and pharmacological clinical trial measures. Clinical trial knowledge, including understanding the process, procedures, and patient rights related to clinical trials is the first step to addressing participant concerns that may serve as barriers to enrollment. The evaluation of the Clinical trial HEalth Knowledge and beliefs Scale (CHEKS) in this study is the first step to assessing patient clinical trial knowledge and honing in on key knowledge gaps to address. CHEKS serves as a promising tool to assess clinical trial comprehension that could optimize patient participation in research.

Author Contributions

A.C. lead the clinical trial knowledge and belief scale development, as well as development of this manuscript, and oversaw project management of the clinical trial measure and contributed to the final edits and review of the manuscript. T.D. contributed to the writing of the Introduction and Discussion sections of the manuscript. R.D.H. conducted the methodological analysis for evaluating the clinical trial measure and wrote the methods and results sections. R.R. contributed to the methods and results writing sections. A.S. contributed to the conceptual development of the manuscript and editing. G.J.-L. secured the NIH funding to carry out this work, conceptual development and editing of this manuscript. All authors have read and agreed to the published version of the manuscript.

Funding

This research was funded by the National Institutes of Health, grant number NHLBI T32HL129953, R01HL142066, R01AG056531, and R01AG067523.

Institutional Review Board Statement

The study was approved by the Institutional Review Board of NYU School of Medicine (S17-00170 in 2017).

Informed Consent Statement

Informed consent was obtained from all subjects involved in the study.

Conflicts of Interest

The authors declare no conflict of interest.

Appendix A

Table A1. The full 31-items in the Clinical Trial HEalth Knowledge and belief Scale (CHEKS) that we began with during survey development.

Variable Name

Item Stem

Q1

A clinical trial is a research study that involves people.

Q2

Clinical trials test strategies designed to improve health.

Q3

An intervention is a new treatment or strategy that is being tested by the research team.

Q4

The goal of a Clinical Trial is to find out if an intervention works.

Q5

The goal of a clinical trial is to find out if an intervention is safe.

Q6

Clinical trials always involve medications.

Q7

A research team is led by a principal investigator.

Q8

Clinical trials can be funded by universities.

Q9

Clinical can be funded by private companies.

Q10

Clinical Trials can be funded by the government.

Q11

Clinical Trials can take place at a hospital or doctor's office.

Q12

Clinical Trials can take place in a doctor's office.

Q13

Clinical Trials can take place in my community.

Q14

Clinical trials follow a research plan called a protocol.

Q15

The research plan is explained to the participants before the start of the study.

Q16

The risks of research are explained to the volunteers before they agree to take part in the research study.

Q17

The potential benefits are explained to the volunteers before they agree to take part in the research study.

Q18

Participation in a clinical trial is voluntary.

Q19

You can choose to leave the research study at any time.

Q20

Research participants are kept updated as the study goes on.

Q21

If other participants experience side effects while in the study, I will not know until the study is over.

Q22

If you choose to leave the research study, you will not get good care from your doctor.

Q23

Patient medical information is kept private during a clinical trial.

Q24

The institutional review board exists to protect the patient's rights during a clinical trial.

Q25

The institutional review board is an ethics group that reviews the research plan before the start of a clinical trial.

Q26

If a clinical trial is found to be unsafe, the research study will stop.

Q27

If an intervention is found to be unsafe during a clinical trial the intervention will be discontinued.

Q28

If an intervention is found to work much better than the control, then the control group will be discontinued, even if the study is not completed.

Q29

People of color have low representation in clinical trials compared to Whites.

Q30

Not enough health information on people of color is available through research.

A31

Research is important to improve the health of people of color.

Table A2. Participant Characteristics.

Characteristic

Percent

Age (mean and range) in years

34 (18-73)

Median

29

Female gender

48%

Race

White

35%

Black or African American

11%

American Indian or Alaska Native

5%

Asian

44%

Native Hawaiian or Pacific Islander

<1%

Other

4%

Education

<High School

2%

High School or GED

7%

Some College, But No Degree

11%

Bachelor's Degree

56%

Graduate or Professional Degree

17%

Employed

79%

Income:

Less than $10,000

21%

$10,000-$19,999

15%

$20,000-$39,000

26%

$40,000-$59,999

20%

$60,000-$100,000

13%

Greater than $100,000

5%

Table A3. Descriptive Statistics and Item-Scale Correlations for the 25-item CHEKS.

Variable

Item Stem

Mean

SD

Item-Scale Correlations (Corrected for Item Overlap with Total)

p-Value

Figure A1. Item Characteristic Curves.

References

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Figure 1. Clinical Trial Health Knowledge and beliefs Scale Development Process.

Table 1. Final survey items included in the Clinical Trial Health Knowledge and Beliefs Scale (CHEKS).

Variable Name

Item Stem

Q1

A clinical trial is a research study that involves people.

Q2

Clinical trials test strategies designed to improve health.

Q3

An intervention is a new treatment or strategy that is being tested by the research team.

Q4

The goal of a Clinical Trial is to find out if an intervention works.

Q5

The goal of a clinical trial is to find out if an intervention is safe.

Q7

A research team is led by a principal investigator.

Q8

Clinical trials can be funded by universities.

Q9

Clinical can be funded by private companies.

Q10

Clinical Trials can be funded by the government.

Q11

Clinical Trials can take place at a hospital or doctor's office.

Q12

Clinical Trials can take place in a doctor's office.

Q13

Clinical Trials can take place in my community.

Q14

Clinical trials follow a research plan called a protocol.

Q15

The research plan is explained to the participants before the start of the study.

Q16

The risks of research are explained to the volunteers before they agree to take part in the research study.

Q17

The potential benefits are explained to the volunteers before they agree to take part in the research study.

Q18

Participation in a clinical trial is voluntary.

Q19

You can choose to leave the research study at any time.

Q20

Research participants are kept updated as the study goes on.

Q23

Patient medical information is kept private during a clinical trial.

Q24

The institutional review board exists to protect the patient's rights during a clinical trial.

Q25

The institutional review board is an ethics group that reviews the research plan before the start of a clinical trial.

Q26

If a clinical trial is found to be unsafe, the research study will stop.

Q27

If an intervention is found to be unsafe during a clinical trial the intervention will be discontinued.

A31

Research is important to improve the health of people of color.

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Development and Evaluation of the Clinical Trial HEalth Knowledge and Beliefs Scale (CHEKS)

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Patient health literacy is vital to clinical trial engagement. Knowledge and beliefs about clinical trials may contribute to patient literacy of clinical trials, influencing engagement, enrollment and retention. We developed and assessed a survey that measures clinical trial health knowledge and beliefs, known as the Clinical trial HEalth Knowledge and belief Scale (CHEKS).

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Videos in Health Literacy - CISCRP

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