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START - Trainee in difficulty station framework - 1a

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START - Refusal of treatment station framework - 1a

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START - Handover : Ward round station framework - 1a

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START - Conflict resolution station framework - 1a

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START - Business case station framework - 1a

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START - Dealing with a complaint station framework - 1a

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LSP START Preparation peer support evening 2024

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LSP START Preparation peer support evening 2024

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LSP START Preparation peer support evening 2024

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NACT UK: Managing Trainees in Difficulty

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NACT UK: Managing Trainees in Difficulty

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You are at home. Your registrar calls you about a 15 year old boy presented to ED with alcohol intoxication. He was found on a park bench 18.30 hours in the evening. Investigations are normal. He is sobering up now and now his mum has also come to ED. She is apologising that he wasted everybody's time. She wants to take him home. Your hospital guideline states that all paediatric alcohol/substance abuse need admission for mental health assessment. How would you approach this situation.

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Here's my circuit:

1. ST5 who still hasn't passed MRCPCH and is doing extra time on ST4 rota. Complaints from nurses and consultants about communication (swearing, undemining consultants) and discharging patients without discussing with bosses. Complaint from patient about being rude and dismissive. Previously a model trainee with great MSFs. How would you support as her ES?

-I talked about how she might be frustrated at being "held back". Making a plan for completing her exam. Doing some ward rounds together where she could lead and I could observe. Then also need to respond to complaint so go through that process with her.

2. Drunk 15y/o. Hospital policy is he has to have a CAMHs assessment as it counts as self harm. Its 10pm. He's got no socal/MH concerns and parents want to take him home. Now completely well

-This was touch as it's a pretty silly policy. Talked about trying to convince the parents but in the end said if they were adamant I would let him go home and do a concerns form

3. 3m/o linear fracture and intracranial bleed. Came in seizing. Delayed presentation - 3 days later. Parents divorced acrimoniously. Dad said he rolled off sofa, was fine, gave calpol. Nanny noticed hand twitching 3 days later and brought to ED. Reg asks you to speak to parents.

-Obvs needs safeguarding escalation. Said I would explain clinical picture first and then explain we need to refer as head injury under 1. I didn't specifically say that the mechanism didn't fit so had to be prompted on that. Got asked if I would call the police as well - not really sure tbh?!

4. Teaching - Sepsis 6!! Totally thrown as we don't use this in Paeds. Also asked to talk about PEWs monitoring which is really hard without a chart in front of you. Had three students on the call - 2 had done paeds before, 1 never had.

5. Baby with prolonged resus now ventilated and low BP - had 20ml/kg - reg calling you to ask if should have further boluses.

-Obvs come in. Baby meeting cooling criteria on the gases -talked about neuro exam, passive cooling, calling level 3, CFM, CrUSS. Also need to manage BP - needs lines. Peripheral inotropes in the meantime. Get extra help - pull SpR from Paeds. Need to update parents. Got prompted on what would you do after - mentioned hot debrief and trainee support. Also mentioned doing a Leader CBD for the Spr

6. Prescribing - 3 questions related to one scenario: 1) overdose of cefotaxime, mixed up with ceftriaxone - what would you do? - bloods, duty of candour, speak to trainee, datix 2) why did mistake happen - resus scenario, high stress, verbal request not written, "cef" easily mixed up as sound the same. 3) patient was epileptic - not on right dose of meds as parents had misunderstood, want to stop it as don't think it works - how would you explain?

7. Calcium extravasation in a child with tetany (bit of a wild card!) What do you do?

-Stop calcium. Child still needs emergency treatment - get access in big vein on other side. Call plastics. Elevate limb. Assess neurovascular, consider washout, duty of candour, datix

8. Handover - Can't remember all of them. 3 safeguarding cases on the ward - all needing referral, a T21 LRTI deteriorating, surgical kid that surgeons don't think is appendix and is getting worse, Gender dysphoria CAMHS not eating and getting dehydrated, Another CAMHs ready for discahrge, Patient given double dose gent - parents not told yet, kid in ED waiting for a bed with high urea and creatinine. Staff were F1, ST3, ST7, ANP and me. Quite hard to know who to send where, especially the ANP. I kept the F1 with me and saw the sick Down's, drug error and 1 of the safeguarding. Sent St7 to surgical and other safeguarding and split the rest between ST3 and ANP. Didn't spot 2 with the same name until after my time ran out :'(

9. Complex neurometabolic kid in resus with acute respiratory distress. Has DNAR but parents didn't tell team - was found by nurse on system. Reg calling you as getting worse and doesn't know what to do. Parents want full escalation

-Was unclear if they'd given any treatment at all. Talked about RESPECT document and finding out what plan was re: Abx, resp support, PICU. Asked difference between DNAR and RESPECT. Said it would be reasonable to treat infection, give oxygen and probs VT, Would want to speak to family, pall care team, lead consultant to get understanding of trajectory and previous discussions. Got really pressed on what would you do if child arrested and parents still wanted you to do everything

10. Paper - does melatonin work for sedated MRI (spoiler alert it doesn't)

In all 3 stations where I mentioned DATIX they wanted me to explain the whole process of what happens after a DATIX and who it goes to which I really sucked at so look that up!

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LSP START preparation evening 6th June 2024

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LSP START preparation evening 6th June 2024

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https://medtribe.com/courses/lsp-start-preparation-peer-support-evening?utm_medium=copy-link&utm_source=listing-page

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https://youtu.be/DziP-iZsjTw?si=Tb4vE2SNORbfRxo8

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Royal College of Paediatrics and Child Health

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Role and purpose of RCPCHStart - Webinar by Dr Tushar Vince

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https://www.rcpch.ac.uk/resources/rcpch-start-guidance-trainees

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What is RCPCH START?

Ordinarily, START is a three-hour assessment with consultant paediatricians which assesses your abilities relating to clinical decision-making as a new consultant. It helps you address any gaps that you may have in your training.

START has a circuit of stations, which cover different skills. The stations include scenario based discussions on acute disease, chronic problems, behaviour difficulties and neonatal care. Other scenarios include safeguarding, ward handover and ethics. There are also scenarios on critical appraisal and teaching. You can read more about the circuit, watch our videos and download example scenarios on our how it works page.

Who needs to, or should, take START?

You must take START if you are paediatric trainee expecting to attain a CCT (certificate of completion of training) or CESR Combined Programme, ie you will complete a UK Paediatric Training programme leading to entry on the Specialist Register.

You can also take part if you are a doctor in a non-approved training post, such as a Specialty Doctor, Trust Doctor, Associate Specialist, Staff Grade or Locum Approved for Service post. This is subject to availability and capacity, with trainees taking preference.

If you are not sure whether to take it, email us on training.services@rcpch.ac.uk.

When and where does START take place?

We normally host START twice a year, in the spring and autumn.

It is currently delivered online.

2024 - three diets

When do I need to apply for and take START?

We determine places for START based on your CCT date. This is detailed in either your latest ARCP outcome on your ePortfolio or in your Trainee-led Record for Completion of Training (CCT) Date form on your ePortfolio.

Notes on CCT date:

Make sure you apply to sit START at least 11 months before your CCT date. Feedback is published six weeks after the final date of the START diet, and we are not able to expedite feedback individually from the cohort. For example, if you are due to CCT in March 2026, you should apply to sit a START that is no later than April 2025.

If you are expecting to change your CCT date, you need to complete the form on your ePortfolio.

Do not expect to be guaranteed a place even if you have applied to START previously.
Whilst you may be allocated a date, this may not be definitive and might have to be changed if there are unforeseen circumstances which affect the availability of assessors or other circuit logistics.
What happens if I am in sub-specialty training (was called Grid)?

If you plan to complete training in an approved sub-specialty training programme, you must have START in that sub-specialty.

We advise that you apply after you have been accepted for a sub-specialty post and are working in that post. You should be confident that you are ready to be assessed in your sub-specialty before you apply.

You will need to include your sub-specialty on your application so we can place you on the relevant circuit.

If you are in a SPIN module, you will sit General Paediatrics START so do not select the subspecialty if doing a SPIN module.

How much does START cost, and how do I pay?

The fees (came into effect as of October 2020 START):

Run-through trainees who enrolled with RCPCH for training before 1 August 2019 pay between £268 and £559

Run-through trainees who enrolled with the RCPCH for training on or after 1 August 2019 (indicatively taking the START assessment in 2024) pay £850

Non run-through trainees - £850

For a fuller explanation on how the fees are determined, see our training guide

You'll pay after you are granted a place, and can pay online by card.

We are happy to issue receipts for the assessment fee - please email your request to us at training.services@rcpch.ac.uk

We do not pay for travel or accommodation costs.

How and when do I apply?
Notes on CCT date

Make sure you apply to sit START at least 11 months before your CCT date. Feedback is published six weeks after the final date of the START diet, and we are not able to expedite feedback individually from the cohort. For example, if you are due to CCT in March 2025, you should apply to sit the March 2024 diet.

Check your latest ARCP has the correct CCT date. We use this to prioritise placements for START. If the CCT date is not correct, get confirmation of your correct CCT date from your TPD or Head of School, and ask them to complete the Record of Completion of Training Date on your ePortfolio. If you do not wish to permanently amend your CCT date but have the support of your TPD or HoS that an earlier CCT date is anticipated please ask your TPD or HoS to email this confirmation to training.services@rcpch.ac.uk before the application window closes.

This table shows the recent and upcoming START dates and application information.

Spring 2024: 17, 19, 24 April and 1 May 2024

11 September - 11 November (midnight) 2023

Applications closed

Summer 2024: 2, 5, 11 July

1 February - 29 February (midnight) 2024

Applications closed

Winter 2024: 3, 5, 10, 12 December

1 July - 31 July (midnight) 2024

Open

To apply during an application window, log in to our online booking system with your RCPCH number and password (as used for your ePortfolio), and follow the on-screen instructions.

The application form will ask you for:

Your CCT date - so we can prioritise according to training time

Your whole time equivalent training time - so we can prioritise according to training time

Your current grade - so we can prioritise according to training time

Whether you are sub-specialty or general paediatrics (note: SPIN trainees are considered general paediatrics)

What if I need reasonable adjustments?

You are entitled to request reasonable adjustments for START and for all other College education and training activities. To support you having a comparable experience as others, please add any reasonable adjustments you require - in as much detail as needed - in your application form.

These can be the same adjustments that you need for workplace reasons. If they are, please advise us how the absence of such adjustments might affect the quality of your experience. Even if you have previously advised us of these adjustments, please add them so we can continue to support you in the best way we can.

A request for adjustment may be determined as not reasonable if it it has an impact on the integrity of the assessment, or if it involves immoderate or excessive costs.

If you have submitted your START application form without the reasonable adjustment request, you can email this to us at at training.services@rcpch.ac.uk. We'll fully consider all requests made within a reasonable time prior to your assessment, and inform you if supporting evidence is needed.

For more detail, read our reasonable adjustments policy.

How does RCPCH prioritise applications?

We recommend you apply for START early in the application period. We prioritise as follows:

1. Applicants in run-through training, particularly those in ST8 posts

2. Applicants with CCT dates closest to the assessment determined by training time left rather than chronologically - see 'Note on CCT date' above

3. Date application received

The number of times of you have applied will not be relevant if your CCT date does not warrant a place on the assessment. An expectation to complete your CCT early is insufficient evidence of a change and we will require confirmation from your Training Programme Director and CSAC, if GRID training, before we accept an earlier date. You are now able to submit a Record of Completion of Training Date on your ePortfolio to show us the most accurate CCT date possible.

If you think you may gain your CCT early, or you have any other information that you think would be useful for us to know, you must include this in your application. Make sure you use the comments box on the application form and send support for an earlier CCT date from Programme Director/Head of School or CSAC to training.services@rcpch.ac.uk.

If we don't receive the necessary information and email support before the application window closes, we may not be able to consider you for shortlisting or offer you a place. Please note, there is no guarantee of a place in the assessment even if you do have supporting emails as others may take priority.

The final decision on place allocation rests with the RCPCH office so we need all relevant information to make an informed decision.

Withdrawing and refunds

You can withdraw up to one week before the assessment date. You must inform us in writing to training.services@rcpch.ac.uk and we may ask you to provide supporting documentation. Swapping your assessment date with another trainee cannot be facilitated due to the operational burden and planning involved in facilitating the assessment.

If you are unable to attend the assessment due to unforeseen circumstances, please inform us in writing no later than the day of the assessment.

Refund policy

Up to 14 working days

Full refund if place can be filled by another trainee

If place cannot be filled, full refund minus £85 admin fee

Within 14 working days before

Full refund minus £85 admin fee

No refund will be given for non-attendance on the day or cancellation within 24 hours before the assessment, regardless of reason.
How do I prepare?

You aren't required to do any 'revision' - the scenarios should be examples of your 'day-to-day' work but you will approach them as if you're a day one consultant.

You will probably find it helpful to familiarise yourself and keep up to date with NICE guidance and GMC guidance on confidentiality, consent, capacity, duty of candour, colleague in difficulty, answering complaints and safeguarding. You may consider going through your drug charts with a pharmacist.

You will receive an email with your login details 1-2 weeks ahead of the assessment if you have been offered a place. Please follow those instructions carefully well ahead of the day making sure that you test your Wi-fi and system ensuring you have good signal strength. If you have any difficulty with connection or signal strength please contact the START team at training.services@rcpch.ac.uk urgently so that we can try to assist you. Ipads are not compatible with the assessment platform and NHS trust Wi-fi and laptops should not be used.

You can view our YouTube video on the role and purpose of START:

What do I need to know on the day?

At the moment, the assessment is virtual and all trainees are offered a briefing via webinar to explain how the assessment works, including the system used for the assessment.

There is no dress code. Do dress as you would when going to work. There's no need for a suit and tie, or dress - but if that's more comfortable for you, then that's fine, too!

If you experience issues with your Wi-fi/signal strength/have any technical issues that cannot be solved after two stations you will be placed on another diet and will not be able to continue your assessment. This is to ensure smooth running of the circuits and to ensure we can give you the best experience possible.

How do assessors judge my performance?

START has anchor statements which allow assessors to make judgments on trainees at each station.

This covers six domains and all stations cover all domains. These are: decision making and prioritising, knowledge, management of complexity, professional approach, safety and risk management, and communication.

A global rating is also made as an assessment of performance overall in the scenario.

Within each domain, the trainee is assessed at three levels - well above expected standard, performed at expected standard and further development required.

Well above equates to performing as if you've been a consultant for a few weeks. Performing at expected standard means day one consultant. Further development means you've performed at trainee standard and there are some areas to work on - this is fine and to be expected as part of the formative nature of the assessment.

You can download the benchmarking standards below.

The assessors complete an assessor feedback form at each station, also available to download below.

How do I get feedback?

We will send your feedback report about six weeks after the assessment. It will appear in your RCPCH ePortfolio, and you can search for it in your timeline.

Your report will include your global rating, your overall score, your performance against the competency domains and the written feedback for each station. It is similar to the MSF report.

There is no pass/ fail mark. However, trainees can under-perform and the feedback will include recommendations to address any development areas.

What do I do with the feedback?

You should discuss your feedback with your educational supervisor within four weeks of getting it. Your supervisor can help you interpret the feedback into a development plan.

You and your supervisor can use the Guide for START assessment feedback and targeted development for educational supervisors, available to download below.

If you are not in training, you will be asked to nominate a supervisor who can assist in the feedback process.

What happens if there are concerns?

The responsibility to remediate concerns will lie with your local education provider. The College works closely with all paediatric schools, College Tutors and educational supervisors to ensure a robust system is implemented in assisting those in training to address issues.

Trainees will not be expected to undertake the assessment again.

How does this relate to ARCPs (Annual Review of Competence Progression)?

START is not designed to gate‐keep progression through training and should not be the sole determinant of ARCP outcome. Rather it is another formative piece of evidence a trainee has in their portfolio on capabilities acquired through training that are relevant to completing training. There is a START feedback PDP form that we would strongly encourage you to use with your supervisor, when you have received your feedback.

We will not allow trainees to re-take START.

You can find out more in the START and ARCPs statement, as well as the Guide for educational supervisors, available to download below.

If you have any queries, please contact training.services@rcpch.ac.uk

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START means Specialty Trainee Assessment of Readiness for Tenure. It guides trainees as they prepare for completion of training and practice as a new consultant paediatrician. Find out how to check your eligibility, apply and pay, and how it fits in with your educational supervision.

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New Data Protection Guidance from 2018 - what you need to know?

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New Data Protection Guidance from 2018 - what you need to know?

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The introduction of the General Data Protection Regulation (GDPR) into EU law has some major implications for GP practices. Medicolegal expert Dr Rachel Birch answers some commonly asked questions about the new legislation.

What is GDPR and when will it come into force?

The General Data Protection Regulation (GDPR) is a new EU regulation that comes into force on 25 May 2018. The GDPR will, along with a new Data Protection Act (currently in draft Bill form), replace existing data protection legislation including the UK Data Protection Act 1998.[1]

Who does the GDPR apply to?

The GDPR applies to all individuals and organisations with day-to-day responsibilities for data protection. It therefore applies to GP practices, as 'data controllers', and their clinicians and administrative staff.

Will it be affected by Brexit?

The UK will still be part of the EU in May 2018 and practices must therefore comply with the GDPR. The Data Protection Bill 2017 is currently being debated in Parliament. When it becomes an Act, it will set out how the GDPR will be brought into UK law, after Brexit.

What are the main changes?

The Information Commissioner's Office (ICO) has published guidance 'Preparing for the General Data Protection Regulation - 12 steps to take now'.[2] The key regulation changes that affect practices are summarised below.

Definition of personal data has been expanded

Personal data is any information relating to an identified or identifiable natural person. It includes names, addresses, telephone numbers, dates of birth and GP and hospital numbers. Under GDPR, the definition has been expanded to include information processed via digital media.

In addition, special categories of personal data (formerly 'sensitive' data) - covering health, race, ethnicity, sexual orientation, religion and political views - now also include genetic and biometric data.

Practices must establish their legal basis for processing data

Practices must document both a lawful basis for processing personal data and also a condition for processing special categories of data.

The GDPR has six lawful bases for processing personal data - for general practice the relevant ones are explicit patient consent, that processing is necessary for the provision of a service/performance of a contract, or that processing is necessary in the vital interests of the data subject.

Meanwhile one of 10 conditions must be met for processing special categories of data - here the relevant options are explicit patient consent or that processing is necessary for provision of healthcare.

However, where 'consent' is chosen, the GDPR sets a high standard - it has to be specific, freely given, informed and should constitute an unambiguous indication of the patient's wishes, by clear affirmative action to the processing of their data. Pre-ticked boxes, for example on new patient registration forms, would not count as valid consent for data protection purposes and there must be a positive opt-in process. Patients must also be provided with an easy way to withdraw their consent.

Given these requirements, rather than relying on explicit consent to process data, practices are likely to use another appropriate lawful basis and special category condition for the processing of personal and special categories of data, respectively. The ICO has published specific guidance on this.[3]

For practices, this will mostly mean relying on 'necessary for the provision of healthcare' for processing sensitive data. As long as patients have been appropriately informed how their personal data will be used, in 'privacy notices', it would usually be reasonable for GPs to rely on implied consent for sharing relevant information in order to provide direct patient care - for example, when a patient agrees to a referral to another healthcare professional.

However, for some other purposes - for example, a request for confidential data from a third party such as an employer or insurance company, explicit consent will be needed.

Practices must provide more information in 'privacy notices'

Practices must inform individuals what they are doing with their data.[4] Privacy notices informing patients at the time of collecting their data should be available on the practice website, on posters in the practice and perhaps within leaflets provided at patient registration. The following information must be provided within such notices:

Practice name (identified as data controller)

Data protection officer's contact details

Purpose of processing patient data

Lawful basis for processing personal data

The categories of personal data concerned

Potential recipients of personal data

How long data will be retained

A list of the patient's rights

Safeguards if data transferred to a country outside the EU.

Patients must also be informed they can complain to the ICO if they are unhappy with how their data are being handled.

Practices will rarely be able to charge for access to medical records

You will no longer be able to charge patients for subject access requests, unless the request is 'manifestly unfounded or excessive' or is a repetitive request for copies of the same information, previously disclosed. Such situations are expected to be rare. The timescale for compliance with a patient's request will also be reduced, from 40 days to one month. If practices refuse a subject access request, they must tell the patient the reasons and inform them that they have a right to complain to the ICO.

You must report data breaches, and these incur bigger financial penalties

In the event of a data breach affecting a patient's privacy rights (for example, breach of confidentiality), data controllers must notify the ICO 'without undue delay', and where feasible no later than 72 hours after becoming aware of the breach. Practices will also have to notify the patient of the breach if it is likely to result in a high risk to their privacy rights. This is in addition to the duty of candour to inform patients of such breaches. The ICO will also be able to impose much higher fines for breaches and non-compliance.

Practices must demonstrate compliance with the GDPR

Accountability was always implicit in data protection law, but the GDPR makes it mandatory for practices to be able to demonstrate that they are compliant with GDPR. They should maintain accurate records of all data processing activities, document all advice provided by the DPO and data protection impact assessments (DPIAs) undertaken. Now is the time to revise and update internal data protection policies, and arrange and document staff training.

DPIAs are recommended, as a way of assessing the levels of protection in place to safeguard personal patient data. Whilst considered good practice in any case, DPIAs will be mandatory when the processing of personal data involves high risks to confidentiality, such as when practices engage in data sharing arrangements, or where new technologies are being used, for example a new computer system.

Practices need to designate a data protection officer

General practices will be required to appoint a Data Protection Officer to advise and monitor data security. The Data Protection Officer can be an employee or external to the practice, and should have professional experience and knowledge of data protection law; this should be proportionate to the type of processing the practice carries out, taking into consideration the level of protection the personal data requires.

Patients will have more rights

Individuals will have stronger rights to control their data under the GDPR, including the right to erasure, the right to rectification, the right to object to processing and the right to restrict processing. These rights are complex and not absolute. Practices should ensure they understand when they apply and have a process in place, should patients wish to exercise them.

Where can I get further information?

The ICO has published comprehensive guidance on the GDPR and how organisations must comply. However, the recommendations are not completely finalised and you should check the ICO website regularly to review updates.[5]

The ICO has also published the Data Protection Self-Assessment tool, with helpful checklists to assess your compliance and identify what steps you need to take now to be GDPR compliant on 25 May 2018.[6]

Dr Rachel Birch is medicolegal advisor at Medical Protection

References

1. GDPR Portal https://www.eugdpr.org/

2. Information Commissioner's Office. Preparing for the General Data Protection Regulation

3. Information Commissioner's Office. Guide to the General Data Protection Regulation: Lawful basis for processing

4. Information Commissioner's Office. Guide to Data Protection: Privacy notices, transparency and control

5. Information Commissioner's Office

6.Information Commissioner's Office. Resources and support: Data protection and self assessment

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New data protection regulations - what GP practices need to know

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EMIS Web medical record summary screen EMIS Web medical record summary screen Dr Rachel Birch

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National Child Death Review Statutory and Operational Guidance: Key Concepts for Practicing Paediatricians

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National Child Death Review Statutory and Operational Guidance: Key Concepts for Practicing Paediatricians

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National child death review statutory and operational guidance: Key concepts for practising paediatricians

Abstract

In October 2018, National Health Service England published new operational guidance for reviewing child deaths, which covers all children who die less than 18 years of age regardless of the cause of death. The Guidance is for all healthcare professionals caring for children as well as senior leaders who commission, provide or regulate children's services. It does not aim to be prescriptive but instead sets out a framework of expectations that intends to be flexible and proportionate. Its essential building blocks will be familiar to practising paediatricians: notification, investigation, review and reporting. It should be regarded as a key pillar in the hospital's governance program.

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National child death review statutory and operational guidance: Key concepts for practising paediatricians

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In October 2018, National Health Service England published new operational guidance for reviewing child deaths, which covers all children who die less than 18 years of age regardless of the cause of death. The Guidance is for all healthcare professionals caring for children as well as senior leaders who commission, provide or regulate children's services.

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The National Patient Safety Agency (NPSA)

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The National Patient Safety Agency (NPSA)

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The National Patient Safety Agency (NPSA) was a Special Health Authority created to co-ordinate the efforts of all those involved in healthcare, and more importantly to learn from, adverse incidents occurring in the NHS.

As well as making sure that incidents were reported in the first place, the NPSA aimed to promote an open and fair culture in hospitals and across the health service, encouraging doctors and other staff to report incidents and "near misses", when things almost go wrong. A key aim was to encourage staff to report incidents without fear of personal reprimand and know that by sharing their experiences others will be able to learn lessons and improve patient safety. The change of emphasis was more about the "how" than the "who".

The NPSA collected reports from across the country and initiated preventative measures, so that the whole country could learn from each case, and patient safety throughout the NHS would be improved every time.

The NPSA played a key role in bringing patient safety to a national level, enabling the entire NHS to learn from incidents and make itself safer and more stress free for patients.

Why have an organisation with a responsibility for patient safety?

With an estimated 850,000 incidents and errors occurring every year in the NHS, reducing medical errors and improving patient safety are critical issues in healthcare today. The costs in human tragedy and suffering to patients, with a third of adverse incidents leading to disability or death; the effects on healthcare staff involved; and the financial costs mean there has never been a greater need to improve patient safety and the patient environment.

In June 2000, the Government accepted all recommendations made in the report of an expert group, led by Dr Liam Donaldson, Chief Medical Officer, called An Organisation with a Memory. The report acknowledged that there has been little systematic learning from adverse events and service failure in the NHS in the past and drew attention to the scale of the problem of potentially avoidable events that result in unintended harm to patients.

An Organisation with a Memory proposed solutions based on developing a culture of openness, reporting and safety consciousness within NHS organisations. It proposed the introduction of a new national system for identifying adverse events and near misses in healthcare to gather information on causes and to learn and act to reduce risk and prevent similar events occurring in future.

How did the NPSA improve patient safety?

by collecting and analysing information on adverse incidents from local NHS organisations, NHS staff, patients and carers

by taking into account other safety-related information from a variety of existing reporting systems

by learning lessons and ensuring that they were fed back into health care and treatment is organised and delivered

by ensuring that where risks were identified, work is undertaken on producing solutions to prevent harm, specify national goals and establish mechanisms to track progress

Through its work and the new national reporting system, the NPSA worked towards the achievement of targets around specific risks and aim to:

reduced to zero the number of patients dying or being paralysed by maladministered spinal injections

reduced by 25% the number of instances of harm in the field of obstetrics and gynaecology which result in litigation

reduced by 40% the number of serious errors in the use of prescribed drugs

reduced to zero the number of suicides by mental health patients as a result of hanging from non-collapsible bed or shower curtain rails on ward

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The National Patient Safety Agency (NPSA) was a Special Health Authority created to co-ordinate the efforts of all those involved in healthcare, and more

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Trainee in difficulty (nice short presentation)

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Trainee in difficulty (nice short presentation)

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Managing conflict in teams Gloucester NHS

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Managing conflict in teams Gloucester NHS

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Blackpool Teaching Hospital Conflict Resolution Manual

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Blackpool Teaching Hospital Conflict Resolution Manual

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Patient association good practice standards for managing complaints

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Patient association good practice standards for managing complaints

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Twelve tips for integrating leadership into medical education

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Twelve tips for integrating leadership into medical education

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BMJ Careers - Effective teaching skills—how to become a better medical educator

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BMJ Careers - Effective teaching skills—how to become a better medical educator

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1. Shvaita Ralhan , specialist registrar in care of the elderly and general internal medicine, Royal Devon and Exeter NHS Foundation Trust, Exeter, UK ,

2. Paul Bhogal , interventional registrar, National Hospital for Neurology and Neurosurgery, London, UK,

3. Gauraang Bhatnagar , specialist registrar in clinical radiology, Peninsula Radiology Academy, Plymouth, UK,

4. Jane Young , consultant radiologist, Whittington Hospital NHS Trust, London, UK,

5. Matt Green , medical publisher director, BPP University College, London, UK

Abstract

Shvaita Ralhan, Paul Bhogal, Gauraang Bhatnagar, Jane Young, and Matt Green, authors of Effective Medical Teaching Skills, explore the importance of teaching in modern medicine and what steps you can take to enhance your teaching skills

In the past decade the principles of effective teaching for doctors have come of age. To earlier generations of doctors no training in specific teaching skills was provided. Teaching was a skill that you were expected to possess or acquire. Effective teaching techniques are now a requirement for doctors, as highlighted by the General Medical Council, 1 and can be learnt and perfected like any other medical skill. Every doctor is expected to deliver teaching, whether to medical students, allied health professionals, or postgraduate doctors. Furthermore, there is an expectation to show formal training in teaching methods. A passionate teacher will be an asset to any medical department. This, coupled with the personal satisfaction of being an effective teacher, is the motivation to become a better medical educator.

Skills required of an effective teacher

There are many skills that make a good medical educator. Figure 1 outlines some of these qualities. 2 It is important to remember that most teachers do not begin their careers with a full complement of these skills; becoming an effective teacher is a process of continual refinement.

How to improve your teaching skills

It is vital to have a basic grasp of how adults learn, the different learning styles, how to adapt your teaching to different situations, and an understanding of assessment. This can all be gained from self directed reading of general teaching texts; however, newer teaching manuals aimed specifically at teaching in medical education are often more digestible. A variety of medical education courses are also available, ranging from short focused training programmes that aim to provide doctors with the fundamentals of teaching to courses leading to a formal teaching qualification such as a certificate, diploma, or masters in medical education. Several of these can be undertaken through distance learning.

A great deal can also be learnt from observing and discussing teaching methods with experienced teachers. This can be taken further in the form of a mentor. The potential utilities of this role model are vast but can include advice, guidance, resource facilitation, and counselling about difficult teaching situations. The mentor is usually a senior colleague who can offer positive and negative feedback in a non-judgmental manner. The relationship may be a prolonged one, sometimes both professional and personal, and can be an asset to mentor and mentee.

Reflective practice and introspection help to develop a teaching philosophy to identify your personal approaches, objectives, and priorities. This process facilitates personal growth as a teacher and encourages you to incorporate new ideas regarding teaching.

Importance of providing feedback

Self improvement in any skill requires knowledge of how you are currently performing. It is well known that feedback improves performance. 3 Constructive feedback facilitates refinement and evolution of any teaching episode, whether it is a specific lecture or a whole curriculum. Appropriate feedback can be gained through several methods:

They all have their own merits and drawbacks, but a combination of all three will result in the most reliable opinion.

Medical schools have embraced the importance of feedback; most now incorporate formalised feedback systems to ensure that the quality of teaching remains high. However, some more immediate forms of feedback, such as the Harvard one minute questionnaire, have the unique advantage of giving the teacher an opportunity to improve the particular episode for the very group of students providing the feedback. 4 Self feedback allows the teacher to build a portfolio of reflective logs that help to identify pearls, pitfalls, and specific strengths and weaknesses. Self feedback is the most consistent method and thus, in some ways, the most reliable. Feedback from colleagues is more difficult to obtain, and some people believe that the intrusive nature of direct observation falsifies the teaching environment and is unreliable. In these situations, indirect feedback (from video playback) is often a reasonable alternative. Feedback is at its most effective when several methods are used simultaneously and interpreted in a positive light.

Enlisting the help of modern technology

The past decade has seen an exponential increase in the use of modern technology in the field of medical education (fig 2).

E-learning and webcasting are examples of educational strategies that have become commonplace in many medical institutions. More recently, interest has moved towards the use of mobile technologies to improve learning. Podcasts and vodcasts, audio and video files respectively, can be downloaded to portable computer devices such as an MP3 player. They are being increasingly used for lectures. Some of their many advantages include portability, facilitation of learning "on the go," and encouragement of self directed learning. Selective replay to consolidate particular weaknesses can also be useful.

Wikis and blogs are websites that allow easy creation and editing of material (links to websites, uploading files), together with a record of continual dialogue by numerous individuals simultaneously. These can be used for students who are geographically separated and are propagating distance learning. They have been useful for creating virtual journal clubs, for example.

Interactive white boards combine the traditional flipchart, overhead projector, and white board. They are large touch sensitive surfaces that are connected to a computer and a digital projector. They can be useful in problem based learning when working with a small group. This technology promotes student interaction and collaboration within the learning environment.

Simulation based medical education allows the learner to use a variety of resources that aim to mimic real life situations. Simulation includes simplistic (low fidelity) procedural models that have been used for many years to assist individuals in task specific clinical skills-for example, genitourinary models for catheterisation. In recent years, new software and hardware have been developed to produce immersive high tech and high fidelity simulators for complex procedures such as laparoscopic surgery and endoscopy. The most sophisticated simulators are often in dedicated centres and can replicate tasks and environments simultaneously. In many of these the model can have heart sounds, breath sounds, and selectable electrocardiogram traces, and it can be possible to cannulate and intubate the same model. These simulators can be used to re-create a scenario in an operating theatre, for example. Audiovisual recording equipment is usually available to facilitate the valuable feedback process. Sophisticated simulators are ideal for group training and development of non-technical skills, such as teamwork, leadership, and delegation.

Simulation has important advantages. In a culture where the patient safety agenda is central, learners and teachers value the way that simulation provides a means of risk free learning. As organisational pressures increase, simulators allow trainees and trainers to engage in educational activities at a time convenient to them. The standardisation and repeatability of exact situations are useful in the assessment process. 5

The use of modern technology in education is not a passing trend but a powerful tool to supplement traditional teaching methods. The next generation of undergraduate students will automatically embrace these changes, and as teachers we must do the same to maximise the potential benefits and improve ourselves as medical educators.

Importance of research (and its challenges)

As in clinical medicine, evidence based practice in clinical education is paramount. As medical educators it is essential to ensure that the methods used, in which there is considerable national financial investment, are improving the practice of future doctors and therefore patients' outcomes. The days of "see one, do one, teach one" are being replaced by teaching methods that are backed by research. High quality evidence is necessary to establish policy and practice of the highest standard and has resulted in the formation of specific organisations such as Best Evidence Medical Education.

Contemporary educational research faces numerous challenges. The traditional research methodologies that apply to trials of medical intervention do not necessarily suit educational research, and thus new research methodologies specific to educational practice are being developed. The difficulty in defining standardised outcomes can be further compounded by a lack of standardised and reliable assessment methods. Sometimes ethical difficulties arise. 6 All these challenges are slowly being tackled, and educational research is taking important steps in the right direction.

Conclusion

We can take heart from the progress that has been made over the preceding decades. We now have generations of students and doctors who consider training in teaching methods as part of the norm. Many students now have the opportunity to take formal qualifications and fellowships. Educational excellence, along with clinical excellence, is increasingly being recognised and rewarded appropriately. However, we cannot rest on our laurels and must continue to strive to improve how we teach and to embrace new ways of delivering teaching, while not losing sight of the main goal: to be better at treating patients and delivering high quality healthcare.

In times of limited resources and changes in delivery of services, we must also ensure that education is included, costed for, and not squeezed out.

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Effective teaching skills-how to become a better medical educator

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Shvaita Ralhan , Paul Bhogal , Gauraang Bhatnagar , Jane Young , and Matt Green , authors of Effective Medical Teaching Skills , explore the importance of teaching in modern medicine and what steps you can take to enhance your teaching skills

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Working Together to Safeguard Children A guide to inter-agency working to safeguard and promote the welfare of children

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Working Together to Safeguard Children A guide to inter-agency working to safeguard and promote the welfare of children

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Business Case Guide: Getting started on a business case

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Business Case Guide: Getting started on a business case

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How to Develop a Business Case

for Workforce Planning

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Business case - paper on preparing a business case for a pathology department. Useful summary section

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Business case - paper on preparing a business case for a pathology department. Useful summary section

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Correspondence to: Dr M J Galloway Consultant Haematologist, Department of Haematology, E Floor, Sunderland Royal Hospital, Kayll Road, Sunderland SR4 7TP, UK; mike.gallowaychs.northy.nhs.uk

Best practice guideline: writing a business case for service development in pathology

Abstract

This guideline reviews the introduction and development of business planning in the National Health Service. A guideline for writing a business case for service development that would form part of a pathology business plan has been developed. This guideline outlines six steps that are required in the preparation of a business case. The format of the guideline has been developed largely from other national guidelines that have been published for the development of capital projects. In view of the publication of these guidelines, the scope of this guideline excludes business cases for information, management, and technology projects and large capital projects.

business case

business planning

pathology

CPA, Clinical Pathology Accreditation

IM&T, information, management, and technology

NHS, National Health Service

SWOT, internal strengths and weaknesses versus external opportunities and threats

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Best practice guideline: writing a business case for service development in pathology
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This guideline reviews the introduction and development of business planning in the National Health Service. A guideline for writing a business case for service development that would form part of a pathology business plan has been developed. This guideline outlines six steps that are required in the preparation of a business case.

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Video from Kingsfund: How does the NHS in England work and how is it changing?

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Video from Kingsfund: How does the NHS in England work and how is it changing?

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Big changes are taking place across the health and care system.

What does this mean for the organisations that make up the NHS?

How will they collaborate with other parts of the system?

And what'll these changes mean for you and me?

When the NHS was set up, it focused on treating single conditions or illnesses.

Since then, our health and care needs have changed; more of us are living longer and many have multiple conditions that require regular, ongoing care.

However, this hasn't been reflected in the NHS's structure, a patchwork of organisations that often work independently from one another. Navigating this can be confusing and can have a negative impact on our experience of care.

So, for some years now, health and care staff and leaders, have been working to bring organisations closer together to better meet our needs by working in a joined-up way.

Primary and secondary care, social care, mental health and community health services have been seeking to partner with each other in different ways.

At a very local level, GP surgeries have been coming together to form primary care networks, groups of practices working together across areas called 'neighbourhoods'. By sharing resources and working closely with other local people and services, they can provide a wider range of services than a single GP surgery.

Health and care organisations have also been working together across larger areas called 'places' - often covering the same area as a local authority - where large parts of the NHS budget are spent. Here, local government, charities, residents and NHS partners can work together to understand and meet local health needs.

But previous laws have prevented services becoming even more joined-up.

The 2022 Health and Care Act aims to change this and make it easier for organisations to work together.

But what do these changes look like?

Organisations are now coming together across even larger areas to form integrated care systems, partnerships of health and care organisations that plan and pay for health and care services.

There are around 40 integrated care systems across England and although they've existed for some time, the Health and Care Act gives them legal status, as well as new powers and responsibilities.

Integrated care systems are made up of two parts: integrated care boards and integrated care partnerships.

Integrated care boards decide how the NHS budget for their area is spent and develop a plan to improve people's health, deliver higher-quality care and better value for money.

Integrated care partnerships bring the NHS together with other key partners, like local authorities, to develop a strategy to enable the integrated care system to improve health and wellbeing in its area.

NHS trusts are also coming together to form provider collaboratives, new partnerships that can bring together providers such as hospitals, mental health services and community services.

So, how are these new structures funded?

Integrated care systems get most of their money from NHS England, which is the national body for the NHS in England, and sets the operational priorities for the health system.

It's responsible for the health services you and I access day to day, which are inspected and regulated by the independent Care Quality Commission.

The Department of Health and Social Care sets out what the NHS is expected to deliver for the money it gets from the government - which comes from our taxes. It also holds budgets for some of the other areas that have an impact on our wellbeing, like public health.

Throughout these new structures, local authorities play a key role; they receive money locally and from national government, which goes towards funding a range of services that support our wellbeing and prevent ill health.

So, what does this all mean in practice?

The Health and Care Act has put in place a legal framework, that enables services to work more closely together, so it's easier for you and I to receive the care we need, when and where we need it.

For these changes to succeed, staff and local leaders will have to work with one another differently, alongside key partners in local government, the voluntary sector, and communities themselves.

Of course, services face other challenges, like workforce shortages, growing waiting lists and the impact of the Covid-19 pandemic.

While the new structures won't fix all these issues, by enabling services to work more closely together and join up services for patients, it's hoped that the health and care system will be better able to meet our changing health and care needs in the future.

Find out more about how the health and care system is changing at www.kingsfund.org.uk/explain

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How Does The NHS in England Work? | The King's Fund

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Watch our animation to discover the key organisations that make up the NHS and how they can collaborate with partners in the health and care system to deliver joined-up care.

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Child Protection Processes – The Lowdown

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Document: Useful child protection learning from cases summary

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Document: Useful child protection learning from cases summary

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While the protection of children from harm has always existed in legislation in some form throughout the 20th Century, the Children Act 1989 is seen as the first significant law which put in place most of the child protection structures and principles we use today. These included ensuring the needs and safety of a child is always put first, that professionals should initially attempt to work with parents to keep the child safe and that children should always be placed with their own family rather than in care unless it would put them at risk of significant harm to do so.

However, numerous child abuse cases over the previous two decades have prompted a series of overhauls to child protection procedures.
Victoria Climbie, Every Child Matters and The Children Act 2004
The most high profile case was the death of Victoria Climbie in February 2000. She died with 128 separate injuries on her body after months of abuse at the hands of her grant aunt Marie Therese Kouao and her boyfriend Carl Manning. Despite coming into contact with health, police and social services on several occasions and twice taken to hospital the abuse was not discovered until her death.

In the aftermath of her death and the court case convicting Kouao and Manning of murder, Lord Laming was instructed to undertake an iquiry into the circumstances leading up to Climbie's death and make recommendations on how the system should change.

As a result of this report the government published a green paper entitled "Every Child Matters" and consequently passed the Children Act 2004. The changes it put in place included scrapping child protection registers in favour of child protection plans and creating an integrated children's computer system (ICS) to ensure information was more routinely and robustly collected.

Structural changes included creating the post of a director of children's services in each council who would ultimately be accountable for the safety of all children in their area. A common assessment framework was created so practitioners within health, education and the police could instigate better support for families not deemed to reach child protection thresholds. Local safeguarding children boards were also set up taking on the responsibility for multi-agency child protection training and investigating the causes of deaths and incidents of serious harm which may have been preventable in their area. For more information see expert guide on children's services in England.
Jessica Chapman, Holly Wells and Vetting and Barring
In August 2002 two 10-year old girls, Jessica Chapman and Holly Wells, went missing from their home in Soham, Cambridgeshire. Less than two weeks later their bodies were found in a ditch at Lakenheath, Suffolk. In December 2003 Ian Huntley, a school caretaker in the village, was found guilty of the murders. After Huntley was convicted, it was revealed that he had been investigated in the past for sexual offences and burglary, but had still been allowed to work in a school as none of these investigations had resulted in a conviction.

An independent inquiry into the events was conducted by Sir Michael Birchard which questioned the way employers recruited people to work with vulnerable groups and in particularly the way in which background checks were carried out. One of his recommendations was for a single agency to vet all individuals who want to work or volunteer to work with children or vulnerable adults. The Vetting and Barring Scheme, run by the Independent Safeguarding Authority was set up and began rolling out voluntary registration in all countries except Scotland in 2009. However, business, community groups and others claimed the scheme was disproportionate, overly burdensome and infringed on civil liberties. Charities were concerned about it affecting recruitment of people to work with children.

In May 2010, following the change in government, coalition ministers put the scheme on hold pending a review which has so far yet to report. See also expert guide on Vetting and Barring
Baby P, the Second Laming Report and Working Together to Safeguard Children
In 2008 Peter Connelly (originally and still often referred to as Baby P or Baby Peter), a 17 month old toddler, died after suffering extensive internal and external injuries over a nine month period. Despite having been seen by a range of professionals on numerous times and been the subject of a child protection plan, social services were never aware the mother had a new boyfriend who who, along with a friend, were largely responsible for the injuries and the child's death. Because Connelly died in Haringey, the same borough where Victoria Climbie had also died it prompted a media frenzy, which resulted in major scrutiny of child protection procedures in England. For more information see Expert Guide on the Baby Peter case in Haringey.

Lord Laming was instructed to conduct a review of child protection procedures. As a result of his recommendations the government's official child protection guidance Working Together to Safeguard Children was strengthened and the ICS system guidance was relaxed. However, much of the issues identified lay in failures of practice rather than policy. As part of his review, Laming recommended the recruitment, training and supervision of social workers as a key issue to be tackled. The government set up the Social Work Taskforce and later the Social Work Reform Board to overhaul the profession and make it fit for purpose. For more information see expert guide on social work reform.
The Munro Review
Following the election in May 2010 the incoming Conservative/Liberal Democrat coalition government asked Professor Eileen Munro, of the London School of Economics, to review all child protection procedures in England on the basis that previous changes had now made the system too bureaucratic and stifled social worker initiative in making difficult decisions. Professor Munro published her first report analysing the problems in October 2010. These included issues around poor IT systems, high caseloads, limited supervision and not enough emphasis on reflective practice and decision making. She also highlighted that she wished to take a "systems approach" that would allow feedback on any unintended consequences of recommendations. Professor Munro will publish two more reports in 2011.
Relevant legislation and policy documents Children Act 1989 Every Child Matters Children Act 2004 The Victoria Climbié Inquiry The Protection of Children in England: A Progress Report by Lord Laming Working Together to Safeguard Children The Munro Review: Part One Key organisations Department for Education (formerly the Department for Children, Schools and Families) Association of Directors of Children's Services Local Government Association Independent Safeguarding Authority The Munro Review

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Children Act 1989While the protection of children from harm has always existed in legislation in some form throughout the 20th Century, the Children Act 1989 is seen as the first significant law which put in place most of the child protection structures and principles we use today.

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RCPCH: Safeguarding children and young people: roles and competences for health care staff

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RCPCH: Safeguarding children and young people: roles and competences for health care staff

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The changes clarify how you should apply the term "unexpected or unintended" to decide if something qualifies as a notifiable safety incident or not. See updated pages:
Health and Social Care Act 2008 (Regulated Activities) Regulations 2014: Regulation 20

The regulation in full

20.-

1. Registered persons must act in an open and transparent way with relevant persons in relation to care and treatment provided to service users in carrying on a regulated activity.

2. As soon as reasonably practicable after becoming aware that a notifiable safety incident has occurred a registered person must-

1. notify the relevant person that the incident has occurred in accordance with paragraph (3), and

2. provide reasonable support to the relevant person in relation to the incident, including when giving such notification.

3. The notification to be given under paragraph (2)(a) must-

1. be given in person by one or more representatives of the registered person,

2. provide an account, which to the best of the registered person's knowledge is true, of all the facts the registered person knows about the incident as at the date of the notification,

3. advise the relevant person what further enquiries into the incident the registered person believes are appropriate,

4. include an apology, and

5. be recorded in a written record which is kept securely by the registered person.

4. The notification given under paragraph (2)(a) must be followed by a written notification given or sent to the relevant person containing-

1. the information provided under paragraph (3)(b),

2. details of any enquiries to be undertaken in accordance with paragraph (3)(c),

3. the results of any further enquiries into the incident, and

4. an apology.

5. But if the relevant person cannot be contacted in person or declines to speak to the representative of the registered person -

1. paragraphs (2) to (4) are not to apply, and

2. a written record is to be kept of attempts to contact or to speak to the relevant person.

6. The registered provider must keep a copy of all correspondence with the relevant person under paragraph (4).

7. In this regulation-
"apology" means an expression of sorrow or regret in respect of a notifiable safety incident; "moderate harm" means-

1. harm that requires a moderate increase in treatment, and

2. significant, but not permanent, harm;

"moderate increase in treatment" means an unplanned return to surgery, an unplanned re-admission, a prolonged episode of care, extra time in hospital or as an outpatient, cancelling of treatment, or transfer to another treatment area (such as intensive care);
"notifiable safety incident" has the meaning given in paragraphs (8) and (9);
"prolonged pain" means pain which a service user has experienced, or is likely to experience, for a continuous period of at least 28 days;
"prolonged psychological harm" means psychological harm which a service user has experienced, or is likely to experience, for a continuous period of at least 28 days;
"relevant person" means the service user or, in the following circumstances, a person lawfully acting on their behalf-

1. on the death of the service user,

2. where the service user is under 16 and not competent to make a decision in relation to their care or treatment, or

3. where the service user is 16 or over and lacks capacity in relation to the matter;

​"severe harm" means a permanent lessening of bodily, sensory, motor, physiologic or intellectual functions, including removal of the wrong limb or organ or brain damage, that is related directly to the incident and not related to the natural course of the service user's illness or underlying condition.

8. In relation to a health service body, "notifiable safety incident" means any unintended or unexpected incident that occurred in respect of a service user during the provision of a regulated activity that, in the reasonable opinion of a health care professional, could result in, or appears to have resulted in-

1. the death of the service user, where the death relates directly to the incident rather than to the natural course of the service user's illness or underlying condition, or

2. severe harm, moderate harm or prolonged psychological harm to the service user.

9. In relation to any other registered person, "notifiable safety incident" means any unintended or unexpected incident that occurred in respect of a service user during the provision of a regulated activity that, in the reasonable opinion of a health care professional-

1. appears to have resulted in-

1. the death of the service user, where the death relates directly to the incident rather than to the natural course of the service user's illness or underlying condition,

2. an impairment of the sensory, motor or intellectual functions of the service user which has lasted, or is likely to last, for a continuous period of at least 28 days,

3. changes to the structure of the service user's body,

4. the service user experiencing prolonged pain or prolonged psychological harm, or

5. the shortening of the life expectancy of the service user; or

2. requires treatment by a health care professional in order to prevent-

1. the death of the service user, or

2. any injury to the service user which, if left untreated, would lead to one or more of the outcomes mentioned in sub-paragraph (a).

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Regulation 20: Duty of candour - Care Quality Commission

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Our guidance explains how care providers can meet this requirement, which is one of the Health and Social Care Act 2008 (Regulated Activities) Regulations 2014. Its intention is to ensure that providers are open and transparent with people who use services and other ‘relevant persons’ (people acting…

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really useful case studies at the end of the document

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GP mythbuster: Gillick competency and Fraser guidelines

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GP mythbuster: Gillick competency and Fraser guidelines

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We have updated and republished this mythbuster to provide even greater clarity about the difference between these two terms. We have also added a section about safeguarding concerns.

When consenting children to medical treatment, the terms 'Gillick competence' and 'Fraser guidelines' are frequently used interchangeably despite there being a clear distinction between them.

Gillick competence is concerned with determining a child's capacity to consent. Fraser guidelines, on the other hand, are used specifically to decide if a child can consent to contraceptive or sexual health advice and treatment. By confusing them, we lose crucial details necessary for obtaining consent. This mythbuster clarifies the principles, laws and guidelines used when we assess children's ability to make decisions about their treatment, as well as the differences between Gillick competence and Fraser guidelines.

Age of consent

In law, a person's 18th birthday draws the line between childhood and adulthood (Children Act 1989 s105) - so in health care matters, an 18 year old enjoys as much autonomy as any other adult. To a more limited extent, 16 and 17 year-olds can also take medical decisions independently of their parents. The right of younger children to provide independent consent is proportionate to their competence - a child's age alone is clearly an unreliable predictor of his or her competence to make decisions.

Gillick competence

Victoria Gillick challenged Department of Health guidance which enabled doctors to provide contraceptive advice and treatment to girls under 16 without their parents knowing. In 1983 the judgement from this case laid out criteria for establishing whether a child under has the capacity to provide consent to treatment; the so-called 'Gillick test'. It was determined that children under 16 can consent if they have sufficient understanding and intelligence to fully understand what is involved in a proposed treatment, including its purpose, nature, likely effects and risks, chances of success and the availability of other options.

If a child passes the Gillick test, he or she is considered 'Gillick competent' to consent to that medical treatment or intervention. However, as with adults, this consent is only valid if given voluntarily and not under undue influence or pressure by anyone else. Additionally, a child may have the capacity to consent to some treatments but not others. The understanding required for different interventions will vary, and capacity can also fluctuate such as in certain mental health conditions. Therefore each individual decision requires assessment of Gillick competence.

If a child does not pass the Gillick test, then the consent of a person with parental responsibility (or sometimes the courts) is needed in order to proceed with treatment.

Fraser guidelines

The 'Fraser guidelines' specifically relate only to contraception and sexual health. They are named after one of the Lords responsible for the Gillick judgement but who went on to address the specific issue of giving contraceptive advice and treatment to those under 16 without parental consent. The House of Lords concluded that advice can be given in this situation as long as:

1. He/she has sufficient maturity and intelligence to understand the nature and implications of the proposed treatment

2. He/she cannot be persuaded to tell her parents or to allow the doctor to tell them

3. He/she is very likely to begin or continue having sexual intercourse with or without contraceptive treatment

4. His/her physical or mental health is likely to suffer unless he/she received the advice or treatment

5. The advice or treatment is in the young person's best interests.

Health professionals should still encourage the young person to inform his or her parent(s) or get permission to do so on their behalf, but if this permission is not given they can still give the child advice and treatment. If the conditions are not all met, however, or there is reason to believe that the child is under pressure to give consent or is being exploited, there would be grounds to break confidentiality.

Fraser guidelines originally just related to contraceptive advice and treatment but, following a case in 2006, they now apply to decisions about treatment for sexually transmitted infections and termination of pregnancy.

Under 13

There is no lower age limit for Gillick competence or Fraser guidelines to be applied. That said, it would rarely be appropriate or safe for a child less than 13 years of age to consent to treatment without a parent's involvement. When it comes to sexual health, those under 13 are not legally able to consent to any sexual activity, and therefore any information that such a person was sexually active would need to be acted on, regardless of the results of the Gillick test.

16-17 year olds

Young people aged 16 or 17 are presumed in law, like adults, to have the capacity to consent to medical treatment. However, unlike adults, their refusal of treatment can in some circumstances be overridden by a parent, someone with parental responsibility or a court. This is because we have an overriding duty to act in the best interests of a child. This would include circumstances where refusal would likely lead to death, severe permanent injury or irreversible mental or physical harm.

Under 16: safeguarding considerations

If a young person under the age of 16 presents to a health care professional, then discloses a history raising safeguarding concerns:

If they are not deemed to be Gillick competent, the health professional is obliged to raise the issue as a safeguarding concern and escalate their concerns through the safeguarding process

If they are deemed to be Gillick competent and disclosure is considered essential to protect them from harm or to be in the public interest, the health professional should escalate concerns through the safeguarding processes

In both cases, the health professional should inform the young person of this action, unless doing so could pose significant additional risk for their safe care.

It is reasonable for the local authority or police to decide whether it is appropriate to inform the parents of the concerns raised. In some circumstances this may not be in the best interest of the young person.

Summary

Gillick competence is the principle we use to judge capacity in children to consent to medical treatment. Fraser guidelines are used specifically for children requesting contraceptive or sexual health advice and treatment. Where a person under the age of 16 is not Gillick competent and therefore is deemed to lack the capacity to consent, it can be given on their behalf by someone with parental responsibility or by the court. However, there is still a duty to keep the child's best interests at the heart of any decision, and the child or young person should be involved in the decision-making process as far as possible.

Further information

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GP mythbuster 8: Gillick competency and Fraser guidelines

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Infographic Outcome for babies born alive between 22 & 26 weeks’ gestation†

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Infographic Outcome for babies born alive between 22 & 26 weeks’ gestation†

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RCPCH online learning on paediatric prescribing principles

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After completing the module, you will be able to:

describe the physiological changes that occur during childhood, which affect drug metabolism, including the impact of genetics and chronic diseases

explain what adverse drug reactions are, see some examples of when they may occur, and understand what to do if they are suspected

understand the principles of safe prescribing and drug administration including why errors may occur and methods to improve prescribing practice and patient safety.

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Paediatric prescribing principles - online learning

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After completing the module, you will be able to: describe the physiological changes that occur during childhood, which affect drug metabolism, including the impact of genetics and chronic diseases explain what adverse drug reactions are, see some examples of when they may occur, and understand what to do if they are suspected understand the principles of safe prescribing and drug administration including why errors may occur and methods to improve prescribing practice and patient safety.

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Abstract

A number of anatomical and physiological factors determine the pharmacokinetic profile of a drug. Differences in physiology in paediatric populations compared with adults can influence the concentration of drug within the plasma or tissue. Healthcare professionals need to be aware of anatomical and physiological changes that affect pharmacokinetic profiles of drugs to understand consequences of dose adjustments in infants and children. Pharmacokinetic clinical trials in children are complicated owing to the limitations on blood sample volumes and perception of pain in children resulting from blood sampling. There are alternative sampling techniques that can minimize the invasive nature of such trials. Population based models can also limit the sampling required from each individual by increasing the overall sample size to generate robust pharmacokinetic data. This review details key considerations in the design and development of paediatric pharmacokinetic clinical trials.

Keywords: absorption, biopharmaceutics, clinical trial, paediatric drug development, paediatric, pharmacokinetics

Introduction

Although paediatric patients are now recognized as a special population for drug therapy, many physiological changes take place during childhood which may have an impact on the pharmacokinetics and dynamics of a compound. For that reason childhood can be divided into various classes of age where each group should be considered as a special population. Any classification of the paediatric population into age categories is to some extent arbitrary. For the purposes of this review International Conference on Harmonization (ICH) E11 classifications are used 1 where the paediatric population is divided into:

Infant (>28 days-12 months)

Toddler (>12 months-23 months)

Preschool child (2-5 years)

School age child (6-11 years)

Adolescents (12-18 years)

Although many anatomical and physiological differences between paediatric and adult populations will be highlighted within this review, this topic has been the subject of some excellent reviews and the reader is directed to these papers for a full discussion 2- 4.

Factors that influence tissue drug concentrations over time include absorption, distribution, metabolism and excretion (ADME). These ADME processes differ in paediatric populations compared with adults and have consequences on the pharmacokinetic profile of a drug. An understanding of these ADME differences and likely outcome is important to ensure effective therapy in paediatric populations.

Pharmacokinetic studies measure the concentration of drug found within body fluids, usually blood or plasma, over time. Such studies are particularly useful where there is a clear link between the pharmacokinetic profile and the pharmacodynamics of a drug. The aim of a pharmacokinetic study is typically to match the exposure in paediatric patients to that found in adults. In paediatric populations, particularly in the very young, pharmacokinetic analysis is usually simpler than pharmacodynamic studies owing to the complexity of the latter. For example, measurement of subjective symptoms such as pain requires different assessment instruments for patients of different ages 1.

There are many examples of drugs in which the pharmacokinetic profiles differ between children and adults, highlighting the importance of understanding paediatric physiology and the potential effects on drug concentration. The incidence of intra-operative awareness under anaesthesia is reported to be much higher in paediatric patients compared with adults. This is probably a consequence of poor understanding of the pharmacokinetic and pharmacodynamic characteristics of commonly used drugs within paediatric populations 5.

This review is limited to a discussion of key differences in physiology and anatomy of children compared with adults and how these factors affect the pharmacokinetic profile of drugs. A second element considers obtaining pharmacokinetic data from paediatric populations and how best this is currently managed and used.

Physiological processes involved in pharmacokinetics

Absorption

A lack of high quality pharmacokinetic data from clinical studies undertaken in paediatric populations limits exhaustive knowledge regarding absorption mechanisms within this population.

Liberation of drug from a formulation can differ in children since gut transit time and intestinal fluid composition (including pH) can significantly affect drug dissolution. Intestinal transit time has been reported to be shorter in young children which may reduce the amount of drug absorbed, particularly for poorly soluble drugs or sustained release products (e.g. theophylline) 6, 7.

It is generally agreed that gastric pH is neutral at birth although there is debate over the time taken for the pH to reduce following birth with reports of 24-48 h to reach pH 3 8 with a further rise to neutral after 72 h, or 10 days at neutral followed by a decrease to acidic values comparable with adults at 2 years 9. The impact of these differences in gastric pH can be significant, with greater peak concentrations of penicillin, an acid labile drug, observed in newborns where gastric pH is higher compared with infants and children 10. Weakly basic drugs, such as itraconazole (pKa = 3.7) are also affected by gastric pH, with higher serum concentrations being obtained at lower gastric pH levels. Therefore there may be lower than expected values in newborns 11.

Bile secretion in the first 2-3 weeks of life is known to be poor with luminal concentrations lower than in adult intestines (2-4 mm vs. 3-5 mm respectively) 12, 13. It is known that drug solubility increases with bile salt concentration and therefore a difference in concentration may have an impact on absorption in younger patients. This is a particular risk for poorly soluble drugs (e.g. hydrocortisone) 14.

Intestinal permeability is reported to be high at birth with progressive reduction during the first week of life 15. This may be related to the reduced surface area : volume ratio within the intestine owing to the villi being broader and providing a smaller overall surface area. This phenomenon is well documented in rats 16.

Intestinal permeability in preterm babies is typically assessed using sugar absorption tests. The differential excretion of lactulose and mannitol is measured in urine following enteral administration of a test solution. In a healthy intestine mannitol is readily absorbed via the transcellular pathway but larger disaccharides (e.g. lactulose) are only absorbed through the paracellular pathway. Therefore the ratio of lactulose : mannitol in the urine is a measure of intestinal integrity. Intestinal permeability, assessed using sugar absorption, was reported to be higher in preterm babies than in healthy newborns 17. A decrease in the first week of life following birth was also reported 18.

Kalach et al. reported a decrease in the lactulose : mannitol ratio from 0.5 months-14 years of age 19. This was due to an increase in mannitol permeability with age suggesting that the transcellular pathway becomes more permeable with age.

Active transport processes are usually responsible for the absorption of nutrients and ions in the intestine. These active transporters are typically expressed in line with the needs of the growing child. The absorption of lead, a compound absorbed by these transporters, was greater in infants (40-50%) compared with school children (10-15%) 20.

The few bioavailability studies that have examined the absorption of drugs (e.g. phenobarbital, sulfonamides and digoxin) and nutrient macromolecules (e.g. arabinose and xylose) suggest that the processes of both passive and active transport are fully mature in infants by approximately 4 months of age.

The enteral absorption of drugs has been studied in children. D(+)xylose, which is absorbed by an active mechanism in the upper small intestine, showed no difference in the amount absorbed with age 21. However, the rate constant, K a, for enteral absorption of D(+) xylose was non-linear with age where K a was less for newborns and infants compared with preschool children 21. Prolonged gastric emptying time and reduced intestinal motility may be somewhat responsible for the similarity observed in total mass absorbed despite the slower absorption rate of D(+)xylose in younger patients. A further study was conducted to measure the effects of intestinal motility on absorption of D(+)xylose using metoclopramide to reduce gastric emptying time. The results showed an increase in K a in both newborns and infants yet the ratio of K a : age remained constant 21. These results suggest that the reduced K a observed was not solely due to longer transit times or reduced motility but other factors are also involved. In conclusion, generally, the rate at which most drugs are absorbed is slower in newborns and infants; although the cause of this slower absorption is unknown 22.

The efflux transporter P-glycoprotein (P-gp) is responsible for cellular drug efflux, transporting substances from the intracellular to the extracellular compartments within the membranes of the gastrointestinal tract. P-gp can markedly affect the bioavailability of certain drugs, particularly those with low solubility. The ontogeny of expression of P-gp in the gastrointestinal tract in paediatric populations is unclear. Johnson & Thomson reported that the expression of P-gp appears to increase rapidly during the first 3-6 months of life, reaching adult levels by approximately 2 years of life 23, whereas Fakhoury et al. reported that P-gp expression in the intestine was not influenced by age with mature expression in neonates and infants 24.

Metabolism in the gut lumen and wall can decrease the absorption of a wide variety of drugs including ciclosporin, nifedipine, midazolam and verapamil 25- 28. The major enzyme family involved in gut wall metabolism of drugs is cytochrome P450 (CYPs). The CYP3A subfamily is predominant, accounting for approximately 70% of the cytochromes in the adult small intestine and is involved in the metabolism of more than 70% of currently administered drugs 29. CYP3A substrates (specifically CYP3A4 and CYP3A5) are present in abundance in the small intestine in adults, yet data regarding their expression in paediatric populations is limited. Fakhoury et al. demonstrated that CYP3A was expressed in duodenal biopsies from Caucasian children aged 6 months and older and in half those from 1-6 months of ages 24. However, CYP3A levels declined with age from 1-17 years 24. In contrast, a study by Johnson et al. reported that an increase in CYP3A expression was observed with age that was mirrored by a corresponding change in CYP3A4 enzyme activity 30.

Distribution

The distribution of drugs affects efficacy and duration of action. Ginsberg et al. compared the pharmacokinetic parameters of 45 drugs in children and adults and concluded that there was a tendency towards larger volumes of distribution of these compounds in children of all age groups 31.

The distribution of drugs is dependent upon body composition. Lipophilic drugs have a relatively larger volume of distribution in infants compared with older children owing to their higher comparative levels of fat (22.4% at 12 months vs. 13% at 15 years 32). For example, diazepam, a lipophilic drug has a ratio of adult volume of distribution to that of a newborn of 0.7 33.

Hydrophilic drugs also have larger volumes of distribution in preschool children as extracellular water decreases during development, from 70% total body weight in newborns to 61.2% in 1-year-old infants 32. As a consequence of higher volumes of distribution of water soluble drugs in infants, for example gentamicin 34, higher doses per kilogram bodyweight must be given to infants compared with adults to achieve comparable plasma and tissue concentrations 35.

Protein binding also affects the volume of distribution of drugs. The physiological variables that influence protein binding within paediatric populations are presented in Table  1 . In newborns, total plasma protein concentrations are 86% of adult values.

Table 1

Parameter

Neonate

Infant

Child
α₁-acid glycoprotein
Decreased

No data available

Equivalent

Examples of drugs where lower protein binding has been documented in newborn babies include phenytoin, salicylates, ampicillin, nafcillin, sulfisoxazole and sulfamethoxyphrazine 37- 40. Consequently, greater free fractions of these drugs are circulating and thus are able to penetrate various tissue compartments, yielding higher distribution volumes.

In general terms, one can assume that the influence of protein binding on free plasma drug concentrations is limited to drugs which have a high degree of protein binding (>95%). As protein levels reach adult values in infancy this effect is likely to be most pronounced in newborn babies and infants.

Metabolism

Recently the microsomal protein content within the liver has been reported to increase with age from an estimated of 26 mg g −1 in newborns rising to a maximum of 40 mg g −1 in a 30-year-old adult 41. Generally drugs that are highly metabolized are administered at a lower mg kg −1 dose in newborns compared with preschool children due to these differences in enzyme levels. However, the hepatic clearance of drugs can be higher in infants and preschool children as liver blood flow is increased compared with adults, owing to the larger ratio of liver to total body mass in the former population 42. This can increase the first pass effect where a drug is cleared on first passage through the liver although the level of enzyme activity will influence this parameter. The observed age-dependent clearances for theophylline, caffeine, carbamazepine, and valproic acid seem to reflect liver size to body weight differences rather than differences in intrinsic clearance per gram of liver weight 43. This has consequences in terms of dosage adjustment where scaling based on mg kg −1 is not appropriate.

Recently the microsomal protein content within the liver has been reported to increase with age from an estimated of 26 mg g −1 in neonates rising to a maximum of 40 mg g −1 in a 30-year-old adult 41. However, the ontogeny of specific metabolic pathways needs to be understood to enable extrapolation of adult data into paediatric populations. The example of the grey baby syndrome resulting from dosing chloramphenicol to neonates at doses extrapolated from adult data is often used to highlight the importance of understanding ontogeny of metabolic pathways 44. Differences in enzyme expression and activity can result in altered metabolism of drugs (e.g. midazolam and zidovudine 45, 46) or production of metabolites in paediatric populations that are not observed in adults (e.g. caffeine production in newborns receiving theophylline, differences in metabolite production in children with valproic acid, paracetamol, chloramphenicol, cimetidine and salicylamide 47). There are several extensive reviews on metabolism within paediatric populations including ontogeny of drug metabolizing enzymes 48, 49 and age related changes in the metabolism of drugs 8, 48, 50- 53.

Drug metabolism in the gut lumen and gut wall

An alteration in bacterial colonization of the intestine with age has implications in terms of drug metabolism within the gut. There are known differences in bacterial composition based on age and diet 54. Metabolism in the gut lumen and wall can decrease the bioavailability and the pharmacological effects of a wide variety of drugs including ciclosporin, nifedipine, midazolam and verapamil 25- 28.

The excretion of digoxin by inactivation within the gut lumen has been shown to increase with age from 1-3% in infants, 7% in school children, 10% in adolescents compared with 40% in adults 55. Yet Linday and co-workers demonstrated that digoxin-inactivating bacteria ( Eubacterium lentum) were present as early as the second week of life, indicating that metabolic activity rather than bacterial presence is critical for understanding the ultimate effects of digoxin within the gut lumen. The consequences of the differences in digoxin inactivation within the gut are factored into therapy with loading doses decreasing with age on a μg kg −1 basis from 45 μg kg −1 in infants to 35 μg kg −1 in pre-school children and 25 μg kg −1 in school children 56.

Andrieux and co-workers compared the activity of bacterial enzymes (β-galactoside, α-galactoside, β-glucoside, β-glucuronidase, neuraminidase, N-acetylgalactosaminidase, α-fucosidase, nitrate reductase and azoreductase) of the faecal microflora from children (3-15 years), adults and elderly adults. There were no significant differences in the enzyme activities between the three populations, although the data from children was more variable 57. This finding agrees with other sources reporting that intestinal colonization reaches adult-like composition by 1-4 years of age 58- 60.

Enzymes are responsible for gut wall metabolism. Therefore variations in enzyme expression and activity with age can affect pre-systemic metabolism of a range of drugs. The CYP3A subfamily is a predominant gut wall enzyme, which is involved in the metabolism of more than 70% of currently administered drugs 29. CYP3A4 and CYP3A5 are present in abundance in the small intestine of adults, yet there are limited data regarding their expression in paediatric populations. Expression of CYP3A has been measured in Caucasian children. Data showed expression in all children aged 6 months−18 years, with only 50% of those under 6 months expressing CYP3A in the duodenum 24.

Elimination

Elimination of drugs and their metabolites occurs predominantly via the kidneys.

The glomerular filtration rate (GFR) is 2 to 4 ml min −1 1.73 m −2 in term neonates, and it doubles by 1 week of age, reaching adult values by the end of the first year of life. This has been demonstrated by the similarity in time course of drug metabolism of three drugs (morphine, paracetamol and dexmedetomine), cleared by glucuronide conjugation in the kidney and GFR maturation 61.

The renal excretion of unchanged drug is generally lower in newborns owing to the immaturity of renal function. However a similar or greater rate of renal excretion has been observed in infants and preschool children compared with adult values for some drugs, including levetiracetam 62, cimetidine 63 and cetirizine 64. This is likely to be related to the observation that the kidney relative to age is several-fold greater in preschool children compared with adults 43. The ontogeny of renal tubular transport mechanisms can also influence the elimination of drugs. Digoxin serves as an excellent example for ontogeny of renal elimination. Digoxin is extensively secreted via P-gp within the tubular cell. Preschool children require three-fold higher doses of digoxin kg −1 body weight than adults, which may be linked to P-gp ontogeny 65.

Creatinine clearance is often used to estimate GFR in children 66 where a reduction in drug dose is advised if creatinine clearance is less than the normal GFR.

Urinary pH value can influence the reabsorption of weak acids or bases which, in turn, will influence the elimination. Infant urinary pH is lower than adult values which may increase the reabsorption of weakly acidic drugs 67.

A summary of pharmacokinetic differences in paediatric populations is provided in Table  2 .

Table 2

Developmental change

PK consequence

Drugs affected

Examples

Absorption
↓Intestinal transit

↓ C max and ↓AUC

Poorly solubles

Theophylline

Sustained release formulations

↓Gastric pH

↑ C max for weak acids

Weak acids

Penicillin

↓ C max for weak bases

Weak bases

Itraconazole

↓Intestinal bile concentration

↓ C max and ↓AUC

Poorly solubles

Hydrocortisone

Distribution
Body composition

↔ V d (neonates have relatively reduced fat whereas infants have relatively increased fat compared with adults; extracellular water is relatively higher in neonates compared with preschool children)

Lipophilic drugs ↓ V d in neonates and ↑ V d in infants compared with adults Hydrophilic drugs ↑ V d in infants compared with neonates

Diazepam Aminoglycosides (e.g. gentamycin)

↓plasma protein

↑free fraction of drug in plasma ↑ V d

Highly protein bound drugs

Phenytoin, salicylates, ampicillin, nafcillin, sulfisoxazole and sulfamethoxyphrazine

Metabolism
Larger relative size of liver

↑hepatic clearance of drugs

Those extensively metabolized

Theophylline, caffeine, carbamazepine and valproic acid

Ontogeny of liver enzymes

↔hepatic metabolism of drugs

Drugs metabolism by specific pathways eg UDP glucuronosyl transferase

Chloramphenicol

Bacterial colonization of the intestine

↑ C max and ↑AUC

Those metabolized within the gut

Digoxin

Elimination
Larger relative size of kidney

↑renal clearance in infants and preschool children

Those excreted unchanged in urine

Levetiracetam, cimetidine and certirizine

Ontogeny of tubular transporters

↔renal clearance of drugs

Those susceptible to tubular transport

Digoxin

Design and delivery of pharmacokinetic studies in children

Paediatric pharmacokinetic clinical studies are generally undertaken to support formulation development and determine plasma profile concentrations to support dosing recommendations. Recent regulations have increased the number of clinical trials conducted in children in the last 10 years although there is still a substantial discrepancy between paediatric burden of disease and the amount of clinical trial research within this population 68.

Pharmacodynamics in paediatric populations

Whilst pharmacokinetics involves absorption, distribution, metabolism and elimination of drugs and can be measured via blood/plasma sampling; pharmacodynamics comprises the physiological and biological response to the drug and is not always directly related to pharmacokinetics. The relationship between pharmacokinetics and pharmacodynamics in children is vital for rational dosing and cannot be ignored. Pharmacokinetic analysis uses biological samples to quantify drug concentration over time. Pharmacodynamic analysis requires endpoint measures that have been validated in children. For further details on pharmacodynamics and pharmacokinetic-pharmacodynamic relationships within paediatric populations the reader is directed to the following excellent reviews on this topic 69- 73.

Paediatric dose selection

Dose adjustment is undertaken to provide similar internal exposure and similar pharmacodynamic effects. However, these parameters are dependent upon specific drug properties and the ontogeny of relevant physiology of the patient.

There are several references indicating that children 'are not small adults', yet most methods of paediatric dose adjustments are based on simple algorithms, rather than pharmacokinetic data, that extrapolate an adult dose based on body weight, height or a combination of both expressed as body surface area. However, analysis of scaling models to predict maintenance doses for children demonstrated that body weight was the better method in terms of precision and bias for children from 1 month to 1 year, whereas, body surface area was better in older children 74, with the overall conclusion that there is not a single dosing algorithm appropriate for all age ranges. It was only in the March 2006 51st British National Formulary that the statement, 'children's doses may be calculated from adult doses by using age, body weight or body surface area or by a combination of these factors' was replaced by 'consult BNFc or seek advice from medicines information centre'. There are still instances where dosage information for children is unavailable and scaling from adult doses is the only available method to enable medication supply. In such cases the therapeutic index of the drug, its toxicity profile, the age of the child and the route by which the drug is cleared need to be carefully considered. In regulatory terms the FDA's paediatric decision tree highlights the importance of establishing whether disease progression is similar in paediatric and adult populations and if there is a similar response to the drug in terms of extrapolation of pharmacokinetics from an adult into a paediatric population 75.

A review conducted by Rodriguez and co-workers reported that dosing changes were made for more than 20% of 108 drugs in response to the results from a required paediatric pharmacokinetic study. This highlights the limitations of extrapolation of adult dosages into paediatric populations 76.

Paediatric clinical study design

Clinical study designs that reduce the burden on paediatric participants are preferred where possible with several innovative approaches referenced in relevant regulatory guidelines 1, 77. These novel methods include sequential design, adaptive design, Bayesian approach, randomized withdrawal design, randomized placebo phase design and three-stage clinical trial, which go some way to overcome the limitations of small sample numbers and of the ethical acceptability of the trial 78. Consideration of appropriate methods for a paediatric pharmacokinetic clinical study should involve the formulation, dose, route of administration, sampling interval and population.

The lack of an age-appropriate formulation has previously limited paediatric clinical studies. However, there are currently several initiatives to assist in the development of age-appropriate products for use in paediatric populations. Ideally paediatric formulations should be bioequivalent to the formulation used in adults, yet this is not always achievable. Therefore caution is required when switching products.

The drug assay used in paediatric studies needs to be sensitive as the volume of body fluid samples collected in paediatric patients is often much smaller compared with adult volumes (∼1-10 ml at a time) required by most drug assays. The size of blood samples is restricted in newborns by regulatory guidelines that state; 'trial-related blood loss should not exceed 3% of the total blood volume during a period of 4 weeks and should not exceed 1% at any single time' 79. In a newborn the total volume of blood is estimated at 80-90 ml kg −1 body weight. Therefore 1% corresponds to 3 ml per sample with an overall maximum volume of 9 ml over a period of 4 weeks. Alternatives to blood sampling have been used in some paediatric clinical studies and include saliva sampling 80, and urine sampling 81 which is often preferred by patients and their parents. Dried blood spots from finger or heel pricks are more common in newborns and have also been used in older children to avoid venipuncture 82. Combining drug analysis with routine clinical blood sampling can be useful in paediatric studies although it is essential that the timings of sampling relative to the dose administration are recorded accurately. These scavenged samples have been used successfully in studies in pre-term infants 83, 84.

Population based pharmacokinetic modelling

Population based pharmacokinetic modelling to support clinical trials can reduce the number of samples required from each individual within a population by increasing the overall population size. This technique was first introduced into paediatric clinical pharmacology in the mid-1980s 85, and has remained popular owing to the ability to analyze studies with sparse and unbalanced pharmacokinetic data, typical of paediatric trials with ethical and logistical constraints. Regulatory guidance now recommends this approach for paediatric pharmacokinetic studies 86, 87. Population based pharmacokinetic modelling allows a reduction to 2-3 samples per individual compared with in excess of 12 that is often required in traditional pharmacokinetic studies 82.

Physiologically based pharmacokinetic modelling

Physiologically based pharmacokinetic (PBPK) models have been developed that incorporate paediatric developmental physiology to predict drug exposure in children based on existing clinical data from adults. These models provide increased understanding of ADME processes for a drug and are useful to extrapolate between age groups within paediatric populations 88, 89. The physiological nature of model parameters means that age-related differences in biological components can be incorporated to simulate paediatric pharmcokinetics across all age categories. These models are proven to be superior to allometric scaling of many pharmacokinetic parameters including clearance 90, 91. The limitations of PBPK models are well documented. However, their development is reliant on accurate physiological input data from the relevant populations and this information is very limited in newborns and infants 92. This lack of accurate data limits extrapolation of findings across paediatric age brackets, as reported by Cella et al. 93. A further limitation of PBPK modelling lies in the appropriate validation (particularly statistical) of such models 89, 91. There are several excellent reviews on PBPK models in paediatric populations and the reader is directed to these for further information 92, 94, 95.

Additional advantages include the incorporation of compound-related and physiological information which can aid in predicting formulation performance or bioequivalence of products as well as dose or route of administration effects 94, 96. PBPK tools are then useful in the design of paediatric clinical studies, particularly with reference to sampling times and the number of subjects required. Such models are gaining favour with regulatory agencies. The FDA vision is that design of paediatric studies will be performed entirely by simulation in the future 97, 98.

Conclusions

Determining appropriate dosing regimes in paediatric populations is complex owing to the physiological and anatomical changes that occur during childhood. Pharmacokinetic data provide information to improve the fundamental understanding about these changes in order to extrapolate data better from adults into paediatric populations and also to extrapolate within paediatric populations. A recent review of registered clinical trials in children reported that pharmacokinetic data would be collected from only 24% of all eligible trials, with the majority conducted in children in North America aged over 2 years 99. However, the greatest differences from adult pharmacokinetic profiles are reported to exist in children below 2 years of age/ Therefore there is a mismatch in current trials and knowledge gaps. There is also a need to link pharmacokinetic and pharmacodynamics better within a paediatric population. There is a need to overcome ethical constraints and include the most vulnerable population in paediatric clinical trials.

Competing Interests

Both authors have completed the Unified Competing Interest form at http://www.icmje.org/coi_disclosure.pdf (available on request from the corresponding author) and declare: HKB had support from National Institute for Health Research Medicines for Children Research Network for the submitted work, no financial relationships with any organizations that might have an interest in the submitted work in the previous 3 years and no other relationships or activities that could appear to have influenced the submitted work.

HKB would like to thank the National Institute for Health Research Medicines for Children Research Network for their support for this research.

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Committee PF. British National Formulary for Children (BNFC) London: BMJ Group, Pharmaceutical Press, and RCPCH Publications; 2012. (Online). Available at [http://www.rcpch.ac.uk/what-we-do/rcpch-publications/british-national-formulary-children-bnfc/british-national-formulary-ch (last accessed 1 October 2013) Google Scholar]

Chae KM, Tharp MD. Use and safety of antihistamines in children. Dermatol Ther. 2000;13:374-383. [Google Scholar]

FDA. 2003. Guidance for industry. Exposure-response relationships - study design, data analysis, and regulatory applications. US Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research (CDER), Center for Biologics Evaluation and Research (CBER); Available at http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm072109.pdf (last accessed 11 October 2013)

EMA. 2006. Guideline on the role of pharmacokinetics in the development of medicinal products in the paediatric population, Corrigendum. EMEA/CHMP/EWP/147013/2004; Available at http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2009/09/WC500003066.pdf (last accessed 11 October 2013)

EMA. 2010. Guideline on the investigation of medicinal products in the term and preterm neonate. European Medicines Agency Commitee for medicinalproduicts for human use (CHMP) and paediatric committee (PDCO). Available at http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2009/09/WC500003754.pdf (last accessed 11 October 2013)

FDA. 1999. Guidance for industry. Population pharmacokinetics. US Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research (CDER), Center for Biologics Evaluation and Research (CBER); Available at http://www.fda.gov/downloads/ScienceResearch/SpecialTopics/WomensHealthResearch/UCM133184.pdf (last accessed 11 October 2013)

EMA. 2007. Guideline on the role of pharmacokinetics in the development of medicinal products in the paediatric population Committee for Medicinal Products for Human Use (CHMP); Available at http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2009/09/WC500003066.pdf (last accessed 11 October 2013)

Reigner B. 2013. Clinical pharmacology considerations in paediatric development. 'Paediatric Clinical Trials meeting' SMi, London, March 20-21.

Articles from British Journal of Clinical Pharmacology are provided here courtesy of British Pharmacological Society

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A number of anatomical and physiological factors determine the pharmacokinetic profile of a drug. Differences in physiology in paediatric populations compared with adults can influence the concentration of drug within the plasma or tissue. Healthcare ...

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Past paper for critical appraisal station for START evaluating a dehydration score

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Past paper for critical appraisal station for START evaluating a dehydration score

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Past paper for critical appraisal station from START

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Past paper for critical appraisal station from START

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Past paper for critical appraisal station from START

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Past paper for critical appraisal station from START

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Evaluating the cost-saving potential of switching prednisolone formulation in the treatment of childhood wheeze.

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Communication in Clinical Handover: Improving the Safety and Quality of the
Patient Experience

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«I’ve seen many, many examples of things that go terribly wrong,
because the communication of handover information has failed in some
way».

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Past paper for critical appraisal station from START

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Past paper for critical appraisal station from START

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MDU Medico-legal guide to 
The NHS complaints procedure

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MDU Medico-legal guide to 
The NHS complaints procedure

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On this page you will find links to articles in the BMJ that explain how to read and interpret different kinds of research papers: Papers that go beyond numbers (qualitative research) Trisha Greenhalgh, Rod Taylor Papers that summarise other papers (systematic reviews and meta-analyses) Trisha

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Scenario based around conflict and a difficult colleague 

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Scenario based around conflict and a difficult colleague 

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You are the newly appointed consultant running the nephrology service, but all consultants see patients with kidney problems. ST6 tells you that Dr. W asked for a DMSA scan on a 4 y old boy after a 1st uncomplicated UTI, but NICE guidelines suggest no investigations are warranted. When the ST6 asked why, Dr. W said that guidelines do not replace clinical acumen. He has previously been obstructive when challenged about his asthma management.

Trainee response: this scenario involves managing a difficult colleague-You need to approach situation with care given that you are the new consultant. Speak to your mentor for advice. DMSA is not warranted in this case however if one is already in place there is no need to prevent it from happening and then later speaking to consultant

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How to critically appraise an RCT in 10 minutes

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How to critically appraise an RCT in 10 minutes

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CASP - Critical Appraisal Skills Programme

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CASP Checklists - Critical Appraisal Skills Programme

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View or download our range of critical appraisal tools & checklists for free including our RCT, qualitative and quantitative checklists.

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Centre for Evidence-Based Medicine

Critical appraisal is the systematic evaluation of clinical research papers in order to establish:

1. Does this study address a clearly focused question?

2. Did the study use valid methods to address this question?

3. Are the valid results of this study important?

4. Are these valid, important results applicable to my patient or population?

If the answer to any of these questions is "no", you can save yourself the trouble of reading the rest of it.

This section contains useful tools and downloads for the critical appraisal of different types of medical evidence. Example appraisal sheets are provided together with several helpful examples.

Critical Appraisal Worksheets

English

Chinese - Translated by Chung-Han Yang and Shih-Chieh Shao

German - Translated by Johannes Pohl and Martin Sadilek

Lithuanian - Translated by Tumas Beinortas

Portuguese - Translated by Enderson Miranda and Luis Eduardo Fontes

Spanish - Translated by Ana Cristina Castro

See also:

Explanations & Examples

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Centre for Evidence-Based Medicine Critical appraisal is the systematic evaluation of clinical research papers in order to establish: Does this study address a clearly focused question? Did the study use valid methods to address this question? Are the valid results of this study important? Are these valid, important results applicable to my patient or population?

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Critical appraisal tools Diagnostic accuracy study

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Critical appraisal tools Diagnostic accuracy study

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Guidance article: Safe Handover Safe Patients BMA

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Guidance article: Safe Handover Safe Patients BMA

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Article: Maximising learning opportunities in handover

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Article: Maximising learning opportunities in handover

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Article: Communication in Clinical Handover: Improving the Safety and Quality of the Patient Experience

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Article: Communication in Clinical Handover: Improving the Safety and Quality of the Patient Experience

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Communication in Clinical Handover: Improving the Safety and Quality of the
Patient Experience

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«I’ve seen many, many examples of things that go terribly wrong,
because the communication of handover information has failed in some
way».

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Scenario Ethics, Consent and Law: Mother refuses exchange transfusion

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Scenario Ethics, Consent and Law: Mother refuses exchange transfusion

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a boys transcranial Doppler results in clinic are high but his mother refuses for him to go on exchange transfusion programme ... she doesn’t want him to have any blood products & is worried about the risks of infection - how do you approach the situation ?

Responses from trainees:

probably check with the mother what her reasons are for not wanting to do exchange programme e.g. cultural/ religious beliefs? previous bad experiences with transfusions? other children who didn't need them etc etc
need to check the age of child and what the child;s wishes are and is the child Gillick competent ?

I will start by explaining to the mother the risks of not starting her child on the transfusion program
I will reassure about the risks of infections related to blood transfusion and the precautions that normally taken to ensure the safety of the blood products before administering them to her child.
I will check in the family background of the family if any previous safeguarding issues ?

https://www.nhsbt.nhs.uk/what-we-do/blood-services/blood-transfusion/transfusion-faqs/

https://www.transfusionguidelines.org/

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Get the latest information on how we're working with the Infected Blood Inquiry.

Is a blood transfusion the best treatment for me?

Like all medical treatments, a blood transfusion will only be given if it is essential. A Healthcare Professional will balance the risk of you having a blood transfusion against the risk of not having one.

Will I be asked to give my consent for a blood transfusion?

The benefits and risks of blood transfusion should be fully discussed with you, so you can make an informed choice about giving your consent.
Get more information on consent and blood transfusion
Can I refuse a blood transfusion?

You do have the right to refuse a blood transfusion, but you need to fully understand the consequences of this before doing so. This is why it is important to talk about your questions or concerns with a healthcare professional. Some medical treatments or operations cannot be safely carried out without a blood transfusion being given.

Is there an alternative - if so, what?

Certain medical conditions causing anaemia may be managed by treating the cause rather than by giving a blood transfusion. If you are told that you might need a blood transfusion, you should ask why it is necessary and whether there are any alternative treatments.

Blood transfusion is only needed for a small number of patients having an operation. Sometimes it is possible to recycle your own blood during or after an operation. Ask if this is appropriate for you.

What will a blood transfusion involve?

A blood sample will be taken from you before the transfusion, to ensure that the blood you receive is a correct match to your own blood. It is important that staff identify you correctly by asking you your full name and date of birth, and then check these details against your identity band before taking the sample.

A blood transfusion is usually given through a tiny tube directly into a vein in the arm. Again it is important that staff identify you correctly by asking you your full name and date of birth, and then check these details against your identity band, before starting the transfusion.

Although there may be a little discomfort when the tube is put into the vein, you should not feel anything when the transfusion is in progress. If you do feel any discomfort or feel any different, then make sure you tell a member of staff straight away.

How long will it take?

It may take up to four hours to give each bag of blood, but it can be safely given more quickly in the majority of cases. You may be given more than one bag of blood as part of your treatment.

Why do I need it?

A blood transfusion may be given because of a shortage of red blood cells in the blood, either because the body is not making enough of them, or by loss of blood.

Sometimes the bone marrow, which produces blood cells, cannot make enough of them. This may be due to disease or a failure of the bone marrow to work properly. It may be temporary or a longer term problem. Some treatments, such as chemotherapy, can also affect the bone marrow in this way. In some cases the anaemia can be treated with medicines; in other cases, a blood transfusion may be the best treatment.

Most people can cope with losing a moderate amount of blood without needing a blood transfusion, as this loss can be replaced with other fluids. However, if larger amounts of blood are lost, a blood transfusion may be the best way of replacing blood rapidly.

A blood transfusion may be needed to treat severe bleeding, for example during or after an operation, childbirth or after a serious accident.

Is it safe?

Yes, the risk that a blood transfusion will make you ill is very low. One of the most important ways of achieving a safe transfusion is to make sure you get the right blood. You can help reduce the small risk of being given the wrong blood by asking your nurse or doctor to check that it is the right blood for you.

Compared to other everyday risks the likelihood of getting an infection from a blood transfusion is very low. All blood donors are unpaid volunteers. They are very carefully selected and tested to make sure that the blood they donate is as safe as possible.

Although the risk of getting variant Creutzfeldt - Jakob disease (vCJD) from a blood transfusion is probably low with a single blood transfusion, the risk of any infection will increase with additional blood transfusions. Each year, approximately 2.5 million units of blood are transfused in the United Kingdom and there have been just a handful of cases where patients are known to have become infected with vCJD from a blood transfusion.

How will it feel?

Most people do not feel anything whilst receiving a blood transfusion.

You will be observed before, during and after your blood transfusion. If you feel unwell during or after it, you should inform your doctor or nurse immediately.

Some people may develop a temperature, chills or a rash. These reactions are usually mild and are easily treated with medicines such as paracetamol or antihistamines, or by slowing down or stopping the blood transfusion.

Severe reactions to blood are extremely rare. If they do occur, staff are trained to recognise and treat them.

Could my relatives give me their blood?

The UK transfusion services discourage donation by parents, relatives or friends (so-called 'directed donation') for medical reasons.

Patients or parents may assume that there is a lower risk of disease transmission if the chosen person's blood is used rather than blood from the blood bank. However, published data show that blood from voluntary donors is in fact likely to be safer for the patient.

In some studies there has been a higher incidence of signs of infection in those who want to be directed donors than in the normal donor population. This is especially a concern when the directed donor is a first-time donor rather than a regular blood donor, as there is no history of previous testing.

The donor may not have a blood group that is compatible with the patient's; even if the blood group is the same, there are still potential problems with blood reactions, similar to those when an organ is transplanted - often called 'rejection'.

Can I give some blood before my operation, so I can get it back if needed?

This technique, known as Pre-operative Autologous Donation (PAD), is not routinely available in the UK.
Blood contains many different cells. The red cells contain haemoglobin (Hb) and are essential for carrying oxygen around the body. A lack of these red blood cells is called anaemia.

In PAD, the patient goes for surgery with a lower than normal Hb, which may cause problems when they are put to sleep for the operation, and many patients still receive donated blood. Also, blood has a shelf life of only 35 days, so if surgery is postponed or cancelled, then the blood will be wasted as it cannot be given to anyone else.

In rare cases of unusual antibody formation or in a situation of blood shortage, PAD may be considered, but it can only be carried out in premises specially licensed by the Medicines and Healthcare products Regulatory Agency (MHRA).

I am a blood donor. Will I still be able to donate blood if I have a transfusion?

As a precautionary measure to reduce the risk of transmitting vCJD, people who have received a blood transfusion since 1980 are not currently able to donate blood.

Where can I find out more about blood transfusion?

If you are interested in finding out more about blood transfusion and have access to the internet, you may find the following websites useful:

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Find out everything you need to know about having a blood transfusion.

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A preterm died of severe NEC and care was withdrawn after an open abd closed Lapatotomy

Coroner happy for you to write a death certificate.

Parents wanted to know about full post Mortem and limited post Mortem.

How would anyone proceed with this?

Response from trainee:

This is tricky! My understanding is that if the death was during an operation, coroner's post mortem is mandatory. Here it suggests that this was not the case and family are just requesting. Families can request for limited PM (i.e. just the abdomen here presumably), but would be a discussion with coroner as to what extra info they would gain. I would probably talk lots about supporting the family and getting another consultant to talk to them and offer a second opinion before going down that route.
Anyone else any thoughts?

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Amazing 20 page guide to START from Seb Gray Wessex trainee (at least 5 years old now)

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Amazing 20 page guide to START from Seb Gray Wessex trainee (at least 5 years old now)

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Medicines Management - including forumularies, licenced v unlicenced, medicine shortages and commissioning of new meds

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Medicines Management - including forumularies, licenced v unlicenced, medicine shortages and commissioning of new meds

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Designed for pharmacists bur really useful around medicine funding and licensed v unlicensed

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☞ Why this subject matters...

The NHS can be a confusing place, and the overall structure of the health service is complicated. If you're not sure you understand how the different organisations in the English NHS work together, then this video from the King's Fund will help to explain things.

But Pharmacy has its own complexities too. When you first start working in a hospital pharmacy, you may be puzzled by some of the abbreviations you hear. A colleague might ask you about a patient's PODs, discuss the latest NICE 'TA', or tell you about the PGD that was approved at the APC... And it's not just abbreviations either. What's 'homecare'? What's a 'special'? This is the world of hospital pharmacy jargon, and you will soon be an expert, but it's not always easy at the beginning of your career to work out what it all means. In this tutorial we hope to give you a brief introduction to these and other topics.

It is only a basic overview, so some of this material will be known to you already. It's designed to make sure that you are familiar with some essentials, and you might find this tutorial helpful to refer back to.

Click here to start or you can look at an individual section via the links below:

When you've finished this tutorial, why not record a CPD entry via myGPhC?

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This tutorial is aimed at trainee hospital pharmacists and new foundation pharmacists: the learning outcomes for this topic are here . ☞...

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Opportunities from the LSP Trainee's Committee (including the START evenings) are often shared first on the LSP WhatsApp Community. Join- https://londonpaediatrics.co.uk/blog/lsp-whats-app-community/

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It is a one way communication system so only the LSP chair, subgroup leads and our head of school can send messages to every trainee & trainer in London!

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https://www.youtube.com/@LondonSchoolOfPaediatrics

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Clinical Education videos from The London School of Paediatrics. These videos should not be used for clinical management. They are for learning, education and reflection, but are not intended to direct clinical management, even it may appear so.

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Run regularly before each assessment diet. Previous recorded sessions on YouTube.

https://medtribe.com/courses/lsp-start-preparation-evening?utm_medium=copy-link&utm_source=listing-page

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Patient details Situation Background Assessment Recommendations
1 AB 6years Nephrotic syndrome, day 5 steroids not pu’d abdominal pain ? needs Albumin infusion
2 BC 2years Known HbSS ?parvovirus, parents Jehovah’s Witnesses HB 3.9 in oxygen and on iv fluids ?transfusion
3 DE 9Years Seizures, fitting on and off since admission Known epilepsy syndrome, neurodegenerative disorder had lorazepam and loaded with phenytoin. Parents want everything doing
4 FG 2/52 RSV +ve Bronchiolitis Fit and well on nasal cannula oxygen and iv fluids ? ready for feeds.
5 HJ 21 months UTI Previous UTIs On oral antibiotics Ready for Home Parents are doctors
6 IK 4 years HSP Parents travellers Normal blood pressure and urine dipstick ?Follow Up
7 KL 3 years Gastroenteritis On oral feeds Nurses not happy
8 LM 14 Years Paracetamol overdose Previous OD and self harm On parvolex, LFTs and coagulation Normal ?stop parvolex
? needs CAMHS

This is all the information I you are provided by the night team. You have an ST1, ST4 and a senior sister. How would you proceed?

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11 year old with behavioural problems, ?ASD. Been at secondary school for 6 months and on 2 week suspension for violence at school. When he returns he will be receiving extra educational support. Recently moved back to the UK from Germany, dad in army. Private assessment showed non-verbal skills in the normal range, but a specific verbal problem. He has recently been refusing meals, scratching himself and leaving red marks. He was managing fine in his school in Germany, but did have extra support in place there.