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

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START assessment March 2013

1. Journal: placebo controlled double blinded RCT of drug for breath holding attacks. On the basis of this evidence would you prescribe this drug for your patient?

2. Prescribing: 30 day old infant, off feeds for 12h, temp 39, not shocked. 4.5Kg. Prescribe fluclox & gent and maintenance fluids.

3. 6 years old, CP, previous PICU admission with chest infection. Recent vomiting illness. Cardiac arrest at home. Intubated, IO access. In resus 6 x adrenaline and 2 fluid boluses. Reg calls to ask if he should stop resus and what should you do next?

4. Psychologist in your department does joint clinics in epilepsy and diabetes and attends various MDTs and is available for referrals. As part of the local efficiency savings management have decided not to renew his contract. Make a case for keeping the psychologist. How would you gather evidence?

5. Telephone referral back from PICU (role-play). 5 y old with CP and chest infection. Now SVIA, iv antibiotics, NG feeds

6. 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.

7. 15 y old girl admitted o/n with vomiting. B-HCG positive, doesn’t want parents to be told and has an appointment with gynae to discuss TOP. Boyfriend is 18y.

8. Teaching for FY1s on safe prescribing in children

9. Reg calls you at 3am: 7y old with asthma on reg beclomethasone, montelukast and prn salbutamol with previous HDU admx brought in by father with RR50, sats 88%. Some improvement after 1 neb but dad refused admx, took oxygen off, was abusive to staff and said he needed to go and look after other children. Self-discharged. History of domestic violence, 3 other children at home. Reg has queue of patients to see and asks you what he should do?

10. Family from Mozambique, dad has good English and usually translates for mum. Baby 3d old, brought in cyanosed. Seen by local cardiologist – congenital heart defect, guarded prognosis, needs shunt and then a series of operations. Dad says they do not want any further treatment and have decided to take the baby home to die.

11. DC planning in NICU. 24 weeker now corrected to 35 weeks. PDA, on oxygen and diuretics. Past history of prolonged ventilation, then CPAP and line infection. Still mostly NG fed. Mum doesn’t want to go home on oxygen.

12. 11y 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.

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OPD case. 13y male with back pain, fit and plays lots of sports. FH of a slipped disc. Seen a physio, now not walking so well.

What would you do next?

Complex case arrived in ED. 9y male with 24h cough and fever. Been in UK 2 months from Nigeria, background HbSS post splenectomy, neonatal insult leading to 4 limb cerebral palsy, fed on liquid diet via a spoon at home. How would you manage?

Critical appraisal. RCT into mite-impermeable bedcovers and their role in preventing asthma attacks.

Teaching. teach 4 x medical students about paediatric epilepsy.

Handover. You have 1 x GPST2 1 x APNP your SpR is off sick, 1 x PA and 2 x med students.

-13d baby 15% wt loss and lethargic

-3y boy abdo pain vomiting, dehydrated Inc. pain

-8y 4d fever, rash, red eyes, d+v

-2y asthma/LRTI with sats 85% CO2 9.4

-10d ? sepsis/meningitis CSF WCC 13

-8m ex prem LRTI

-15y post paracetamol OD

-4m Inconsolable crying ? NAI

How would you prioritise

Ethics. In ED 16y girl abdo pain and PV d/c discloses unprotected sex with multiple partners, here with 17y boyfriend.

Prescribing. 11y psoriasis just stopped methotrexate, on urstekinumab. rew rash, pain ? shingles. Rxd paracetamol, urstekinumab and IV aciclovir. Weight 68kg ht 147cm.

3m George likely cardiac failure, seen at Gp at 6w, told NAD, seen in your dept by SpR 3 weeks ago with FTT, told NAD, tachycardic, gallop rhythm, no murmur, 4cm liver. SpR often struggles and ? trainee in difficulty

Complaint letter. from a parent of 9m old baby came in vomiting, told meningitis, delays, poor comms, 3 x attempts at LP, waited 2h for abx, then vomited green, when night team arrived finally re-reviewed and recognised surgical and needed t/f out and gut resection. respond to complaint letter

safeguarding case

15y girl in coma from alcohol, now medically fit for d/c. 2nd presentation, missing school, not interested in education, parents here on ward. what would you do pre d/c

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How should medicines be dosed in children who are obese?

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Review on how to calculate medicine doses in children who are obese which includes a table on commonly prescribed medicines.

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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.

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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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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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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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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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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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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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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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Psychologist in your department does joint clinics in epilepsy and diabetes, attends various MDTs and is available for referrals. As part of the local efficiency savings management have decided not to renew his contract. Make a case for keeping the psychologist. How would you gather evidence?

Responses from trainees:

worth noting that having a psychologist is part of the best practice tariffs for diabetes (mandatory) and epilepsy (recommended), hence the Trust would lose money by not having one for these services!

All the above i feel is good. Its similar when we are trying to devlop a new service I think.
Where are the gaps and what are the requirements. What funding is available in terms of cost effectiveness. Demonstrating the need of a service. What percentage require psychologist input, what is the quality of patient care with or without this service ie patient benefits etc
Income from every bed day from clinic referral
New patient(aprox-350) and follow up (£100)
Income generated from getting inhouse psychologist compared to when out sourced.
Waiting time when referred outside plus delays.. what do you guys think

Thanks for this. - looks like you covered everything! Good idea to get patient feedback,
I think also - what would be the potential effects of not having a psychologist. I guess this is similar to what you have said - i.e. expensive admissions.
but perhaps increasing load on nursing staff / consultants etc
I wonder if there is any data on the service prior to the introduction of the psycologist?

Local evidence:
Local audit of psychologist's case load - volume of children seen, type, complexity
Parent and child feedback questionnaire on psychology input
Example cases of when psychology input has been particularly effective e.g. preventing disengagement with service leading to v expensive ITU admission of child with DKA

National:
NICE/Paediatric Diabetes and Epilepsy Guidelines - importance of psychology input in these 2 paediatric conditions

Must be a lot more to add - what do other's think?

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Lets get some discussion on this handover station.
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?

Some responses from trainees:

Would you speak about sending your team to see some of the patients? Currently at my job, the consultant see ALL the patients with the whole team. If timing is not an issue would it be correct to say you would see everyone and speak about the priority in which you would see the patients? I would mention that I would see bed 1, 2 and 3 as a priority. For bed one I would ensure ABC is ok and that BP is stable and U&Es are stable, prescribe HAS with furosemide and after that would get ST1 to call tertiary renal centre . For 2 I would get hospital legal team and Jehovah witness liaison involved. If patient presented acutely- there is no time to build up hb with haematinics and erythropoietin and so I would also be informing safe guarding and speaking candidly to parents as this situation is grave and the child is in heart failure due to the severe anaemia(oxygen requirement) and would benefit from a blood transfusion. bed 3 has been loaded with pheytoin so probably stable for a few hours. Explain to parents the situation and be ready to follow APLS seizure control algorithm should
further seizures occur-RSI with need for PICU management. Consider transfer of patient to a centre with PICU and inform tertiary neurology team. The reg can see quickly the ones who are going home. For the chld with UTI- parents are doctors. What does that mean? Do they have questions to ask. Registrar should be able to see and answer give advice on wiping from front to back if a female child as poor hygiene might account for recurrence. For the travelling family speak to family of need to be registered as follow up is necessary in HSP to monitor for renal complications--BP and urinalysis monitoring and get health visitor and community nursing team involved. Child with gastroenteritis; unhappy nurses- find out reason for concern from nurse in charge and try to address any concern otherwise reg can see

Getting in extra support too - if you have PICU on site, then getting them to come review the case with seizures. And surgical colleagues to review the child with gastroenteritis/abdo pain (? why are the nurses not happy with this one?)

Yes I would probably do same delegation - but would also ask nurse in charge who they’re most concerned about

Me to the sickle- legal likely needed. ST4 to seizure child as? Heading to Picu, ST1 to the nephrotic- impending AKI. And the nurse to??? The one the nurses are worried about maybe- feel like I need more info on that one. What do others think?

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15 y old girl admitted overnight with vomiting. B-HCG positive, doesn’t want parents to be told and has an appointment with gynaecologist to discuss termination of pregnancy. Boyfriend is 18y.

Responses:

The age gap.. what does that mean? anyone? Is that illegal?

Patient safety as a absolute priority
As 15yrs must assess Gillick competence (and Fraser comp for consent to contraception)
If GC then has right to termination (under Fraser competence law) and confidentiality
However, age of boyfriend means could be prosecuted and that she is at potential risk so safeguarding must be a priority. Need to information gather about boyfriend, other red flags for abuse
Would first assess her, privacy, supportive environment
Encourage her to tell her parents
Involve my paeds and O+G colleagues and named nurse/doctor as difficult case

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Scenario Based Discussion: Acute Disease: Stopping Resuscitation

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Scenario Based Discussion: Acute Disease: Stopping Resuscitation

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6 years old, cerebral palsy, previous PICU admission with chest infection. Recent vomiting illness. Cardiac arrest at home. Intubated, IO access. In resus 6 x adrenaline and 2 fluid boluses. Registrar calls to ask if he should stop resuscitation and what should you do next?

Responses from trainees:

I will check first for how long the resuscitation is going on
Any care plan known about the patient from previously?
6x Adrenaline seems a lot, if no response at all and resusc. going on for more than 20 minutes then will consider stopping
I will ensure updating the parents before stopping resuscitation if situation allowed so?

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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.

1. Referral to SaLt

2. Smaller group or 1:1 support

3. Explore if understands sign language

4. Occupational therapy, time spent at sensory room at school

5. Refer to community paediatrician for

6. ASD assessment

7.Identify if sleep issues

8.Support family with consent through early help

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Scenario: Leaving A+E against medical advice with suggested responses 

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Scenario: Leaving A+E against medical advice with suggested responses 

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Registrar calls you at 3am: 7 year old with asthma on regular beclomethasone, montelukast and prn salbutamol with previous HDU admission brought in by father with RR50, sats 88%. Some improvement after 1 nebuliser, but father refused admission, took oxygen off, was abusive to staff and said he needed to go and look after other children. Self-discharged. History of domestic violence, 3 other children at home. Registrar has queue of patients to see and asks you what he should do?

Some responses from trainees:

1. registrar to call the police to return the child to hospital (police protection order) while you (consultant) are on their way to support
then call duty social worker to facilitate safety of the other children at home - may need to be removed to a place of safety, but thats up to children's services
once child back in hospital treat the conditions as per guidelines/clinical need
safeguarding wise: concerns of neglect as non-compliance with treatment, previous HDU admission makes you wonder if ongoing non-compliance with maintenance therapy at home
if father returns with child - safety of child, other children on the ward and staff to be considered, needs to be told that abuse towards staff is not acceptable and wont be tolerated
in the morning - d/w lead Dr for safeguarding and liaise with social care, may need strat meeting before discharge; may already be known due to previous DV concerns so establish SC involvement and proceed accordingly

2. Thank you Maggiejrose. Yes I believe the right think to do is to call the police to get the child returned to the hospital as child is sick and call SS immediately. There are already social concerns in the household(DV) and so the child not being allowed to stay in hospital is already concern as case of neglect. You need to think about the safety of the other 3 children at home and so SS should sort that out. I will want to come in as the consultant to help support the registrar in view of this case but also because there are a queen of patients to see.

3. It would be appropriate to call the police to return the child to the ED as child sounds quite sick. I think child would be subject to PPO in this instance?
Refer to safeguarding/duty social worker regarding any existing safeguarding issues - do the other children need to be removed to a place of safety?

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Senario: Logistics and Organisation: Priorities

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Senario: Logistics and Organisation: Priorities

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Gp
Sends you 4 ref
1. Exprem discharged from neonates
Mild hemiplegia
Growth and weight concerns
2. 1 year old right U descended testis
3. Child from travellers family with asthma kind symptoms
Brother lost to follow up( DNA)
Mum pregnant with fifth one
No imms
Only on salbutamol prn
4. Child with early morning headache , vomiting
FH migraine

prioritise which one need to be seen urgently and which needs referral and with what time frames

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Child Safeguarding: ?Non accidental injury

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Child Safeguarding: ?Non accidental injury

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Ex preterm, global developmental delay and epilepsy presenting with fractured left femur. X-ray findings from radiology reg rib fracture. Previous X Ray 2 months ago there was no fracture. What do you do?

Response from trainee:

concern of NAI as there is now an injury that cannot be explained. Parents need to be informed of the concern. Child will be admitted anyway to be seen by orthopedicians however concern of NAI must be discussed and ruled out. It might be possible that injury is accidental given the hx of prematurity - might have metabolic bone dx with brittle bones but you cannot say especially as injury was not seen in previous imaging 2 months ago. Skeletal survey and CT head and blood investigation and ophthalmology. I would have a discussion with the safeguarding lead for advice as well

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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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Scenario Based Discussion: DSH in adolescent

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Scenario Based Discussion: DSH in adolescent

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15 year old boy is admitted to the ward with deliberate self harm. He is now very aggressive at the ward,nobody can calm him down.the registrar is busy and the nurse called you. How are you going to handle the situation?

Responses from trainees:

https://www.youngminds.org.uk/parent/parents-a-z-mental-health-guide/challenging-behaviour/

https://www.piernetwork.org/uploads/4/7/8/1/47810883/pier_rapid_tranquillisation_oct_2018.pdf

As he is 15, you may be able to draw on adult resources more used to dealing with these situations too, for example there may be an adult mental-health liason nurse on call who can get to you quicker than the CAMHS consultant may.

Need to think about how you will calm him - low level lighting, non-confrontational and open body language, low slow voice...

Agreed. Get his family/parents on board to help with calming him down. Need to sedate him if this escalates because there are other patients on the ward who are vulnerable. Ask security to be present. I would speak to our CAHMS consultant on call first because I have no experience in sedating aggressive patients so will get advice first.

I would try my best to calm the situation down, try to remove anyone aggravating the situation - if still acting aggressively safety first, Call security, consider IM benzo, then later speak to Camhs / social services

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Scenario Based Discussion: Headaches and Abdominal Pain

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Scenario Based Discussion: Headaches and Abdominal Pain

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A 14 year old girl who has been complaining of chronic right leg pain since a trivial fall five months ago. She has had an MRI scan which is normal but continues to have pain despite paracetamol, codeine, ibuprofen, diclofenac and co codamol. She now has recurrent headaches and abdominal pain. Other than some muscle wasting examination is normal. She reports that she has not lost but in fact gained weight over the past 5 months. She has not been attending school and has been going out less with her friends due to the pain. She is seeing you in clinic.

What is your differential diagnosis?
What are you going to do?

might be developing complex regional pain syndrome - can often be triggered by a trivial injury. Involves a MDT approach as detailed below - early psychological intervention and physiotherapy to help conditioning and muscle strength. Try to normalise by involving school and family. Some limited role for targeted analgesia; nerve blocks sometimes used in regional pain. chronic pain clinics at tertiary level offer specialised support.
Good learning from Scottish guideline:

https://www.gov.scot/publications/management-chronic-pain-children-young-people/pages/1/

I would take a thorough social history and try to explore any life changing events that might have occurred that might have triggered the onset of this pain as a symptom. The abdo pain and headache could be due to the several analgesics she is taking. My differential would be psychological and I would want to make a referral to the clinical psychologist for review and would try to make it non medical and reduce the amount of analgesia she is taking. If she presents with her parents I would like to speak with her parents and her separately to see if there are any social concerns or underlying other matters that might be triggering this.

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1. Introduction

Patient View

"From a patient perspective I feel these recommendations should be adhered to, to improve patient experience within paediatric chronic pain services. Highlighting the positive experiences of other patients can have an effect on how willing the patient is to cooperate with the multi-disciplinary team.

Drawing from my own experience, it is important that all professionals are delivering the same advice to the patients and families. At present, many patients feel there are discrepancies amongst the different professionals and the advice they have received.

I personally believe these guidelines will play an important role in the improvement of paediatric pain services, and will be an important resource for those experiencing chronic pain."

The International Association for the Study of Pain ( IASP) defines pain as "an unpleasant sensory and emotional experience associated with actual or perceived tissue damage or described in terms of such damage" [1]. Pain can be described as acute, where it is of recent onset, or chronic, which is commonly defined as longer than three months. However, in reality there is often no clear dividing line between acute and chronic pain. Epidemiological studies indicate a prevalence of chronic and recurrent pain in children of 15-30%, with 8% of children reported as having severe and frequent pain [2-4]. In a systematic review of the epidemiology of chronic pain in children and adolescents the prevalence rates varied. Generally pain prevalence rates were higher in girls and increased with age for the majority of pain types. In addition, lower socioeconomic status was correlated with higher pain prevalence, particularly in headache conditions [5].

Most chronic pain in children can be effectively managed in primary care, with appropriate investigations to exclude treatable causes. There should be an early emphasis on the biopsychosocial nature of pain with access to reliable information and self-management resources for the child and family. There is a significant minority of children where chronic pain can be severely debilitating, affecting all aspects of the child's life and that of their parents and family members. The impact of pain is wide-ranging affecting school attendance, participation in sports or social activities as well as increased healthcare seeking and medication use. The deleterious effects of untreated pain in children can extend into adulthood [6]. It has also been shown that chronic pain can have a serious negative impact on financial wellbeing. In a cost of illness study in this population, the financial burden of adolescent chronic pain on the UK economy in one year was calculated to be £3840 million [7]. In a study of 149 young adults (aged 10-17) presenting at interdisciplinary pain services in the US it was found that the average cost of care per patient was $11,787 annually [8]. The total cost of moderate to severe chronic pain in the US was estimated to be $19.5 billion a year. The long-term effects of chronic pain on pain processing are not well understood, but it is likely that changes occur leading to excess sensitivity and altered signalling in the nervous system, even without any ongoing tissue damage or injury.

Specialist chronic pain services for children and young people are patchy and have developed through the enthusiasm and commitment of a small number of clinicians. There is very limited access to multidisciplinary pain management and this can be particularly difficult for teenage young people, falling into a gap between children's and adult services or not having an organised transition from one to the other [9, 10]. It is essential that there should be more healthcare professional and public education and resources to effectively manage pain. This is in keeping with the gold standard that care is responsive, and personalised care incorporates a multidimensional pain assessment. Any management plan should address these dimensions of a child or young person's pain experience, taking account of challenges such as geographical limitations to accessing this care.

The Scottish Intercollegiate Guidelines Network ( SIGN) guideline on the Management of Chronic Pain in Primary Care ( SIGN 136) did not include paediatric pain in remit as the limited evidence base was thought to be insufficient for a full SIGN Guideline [11]. During the development of SIGN Guideline 136, there was feedback from key stakeholders that there is a need for expert guidance on managing paediatric chronic pain [12]. While recognising that in many areas, there is limited high quality evidence, this working group has drawn together multidisciplinary expertise to review the available evidence, and to reach consensus on areas where evidence is limited. Wider consultation out with this group has also been sought.

Delivery of good quality, timely care underpinned by the best available evidence is important. Moreover, routine and accurate assessments of pain must consider the child's developmental stage, experiences and communication abilities. Thus, this guideline aims to provide a useful practical resource, improving quality of life and reducing the risks of longer term harms for children and young people with chronic pain.

Remit of guideline

The current evidence for the key areas identified has been reviewed with the support of SIGN, using their methodology [13]. Chronic pain was defined as pain lasting longer than three months, or beyond the expected time of wound healing. Neither acute nor cancer pain were included. As chronic pain is caused by many underlying conditions, it was not the focus of this guideline to target specific conditions. The impact of chronic pain is wide-ranging which suggests that the data can be extrapolated to chronic pain as a whole.

The main guideline summarises available evidence, combined with consensus group agreement on key recommendations and suggested patient pathways. We have followed the methodology of SIGN 136 and hope that this guideline will facilitate the transition to adult services. Our aim is that this will ensure all health professionals are delivering a consistent, evidence-based approach. Research gaps have not been specifically listed, as these are clear from the key recommendations and current level of evidence associated with these.

The guideline's definition of 'child' is derived from the UN Convention of the Right of a Child ( UNCRC): termed as a person under 18 years of age. At the national level, the Children and Young People (Scotland) Act 2014 similarly define a child as an individual who has not yet attained 18 years of age [14].

Treatment Pathways

Figure 1 overleaf represents a Paediatric Pain Pathway, which can be utilised by both clinicians and patients to guide management.

Recommendations

Recommendations ( Section 2 and Figure 3) in this guideline are based on:

a synthesis of the quality of the evidence;

expert consensus opinion of the multidisciplinary guideline development group.

Where there is moderate to high quality evidence, this is highlighted with the recommendations. Due to the limitations in the evidence base, unless otherwise stated, the majority of recommendations are based on expert opinion (4), informed by current evidence.

Prior to any prescribing, the licensing status of a medication should be checked in the summary of product characteristics ( SPC). The prescriber must be competent, operate within the professional code of ethics of their statutory bodies and the prescribing practices of their employers [15].

Key to evidence statements

Levels Of Evidence

High quality meta-analyses, systematic reviews of RCTs, or RCT s with a very low risk of bias

Well conducted meta-analyses, systematic reviews of RCTs, or RCT s with a low risk of bias

1

Meta-analyses, systematic reviews of RCTs, or RCT s with a high risk of bias

High quality systematic reviews of case control or cohort studies High quality case control or cohort studies with a very low risk of confounding or bias
and a high probability that the relationship is causal

Well conducted case control or cohort studies with a low risk of confounding or bias
and a moderate probability that the relationship is causal

2

Case control or cohort studies with a high risk of confounding or bias
and a significant risk that the relationship is not causal

3

Non-analytic studies, e.g. case reports, case series

Figure 1: Paediatric Pain Pathway [1]

Figure 2: Key Recommendations ( KR)

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Management of chronic pain in children and young people: summary

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A Scottish Government summary of the available evidence, combined with a consensus group agreement on key recommendations and suggested patient pathways.

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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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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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Article: Maximising learning opportunities in handover

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Article: Maximising learning opportunities in handover

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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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Critical appraisal tools Diagnostic accuracy study

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Critical appraisal tools Diagnostic accuracy study

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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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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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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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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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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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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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Past paper for critical appraisal station from START

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Past paper for critical appraisal station from START

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

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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 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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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.

References

EMA. 2001. ICH Topic E11. Clinical investigation of medicineal products in the paediatric population. CPMP/ICH/2711/99. Available at http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2009/09/WC500002926.pdf (last accessed 11 October 2013)

Mushak P. Gastro-intestinal absorption of lead in children and adults: overview of biological and biophysico-chemical aspects. Chem Spec Bioavail. 1991;3:87-104. [Google Scholar]

Von Richter O, Greiner B, Fromm MF, Fraser R, Omari T, Barclay ML, Dent J, Somogyi AA, Eichelbaum M. Determination of [in vivo absorption, metabolism, and transport of drugs by the human intestinal wall and liver with a novel perfusion technique. Clin Pharmacol Ther. 2001;70:217-227. [PubMed] Google Scholar]

Barter ZE, Bayliss MK, Beaune PH, Boobis AR, Carlile DJ, Edwards RJ, Houston JB, Lake BG, Lipscomb JC, Pelkonen OR, Tucker GT, Rostami-Hodjegan A. Scaling factors for the extrapolation of [in vivo metabolic drug clearance from in vitro data: reaching a consensus on values of human microsomal protein and hepatocellularity per gram of liver. Curr Drug Metab. 2007;8:33-45. [PubMed] Google Scholar]

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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RCPCH online learning on paediatric prescribing principles

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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.

The course is self-paced and will take you no more than 1.5 hours to complete, spread over as long a period as convenient to you.

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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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Top tips for paediatric prescribing 1 page 

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Top tips for paediatric prescribing 1 page 

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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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Police powers of protection & Emergency protection orders

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Police powers of protection & Emergency protection orders

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This information page will set out the law surrounding Police protection and Emergency Protection Orders which are options available to use in an emergency when a child is at risk of imminent harm. Please see the table below to find out further information. Police protection powers/Emergency protection orders The table below is divided into two [...]

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The child death review: A Guide for parents and carers

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The child death review: A Guide for parents and carers

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Ethics Making decisions to limit treatment in life-limiting and life-threatening conditions in children: a framework for practice FREE

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Ethics Making decisions to limit treatment in life-limiting and life-threatening conditions in children: a framework for practice FREE

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CEASE: A Guide for Clinicians on How to Stop Resuscitation Efforts

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Multi-agency guidelines for care and investigation

The report of a working group convened by The Royal College of Pathologists

and endorsed by The Royal College of Paediatrics and Child Health

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Article: A 16-year-old girl is admitted with a paracetamol overdose, but refuses treatment. This article explores the legal, ethical and practical aspects of this case, which led ultimately to an application to the court for a judicial order

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Article: A 16-year-old girl is admitted with a paracetamol overdose, but refuses treatment. This article explores the legal, ethical and practical aspects of this case, which led ultimately to an application to the court for a judicial order

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Managing trainees- PowerPoint for educational supervisors

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Managing trainees- PowerPoint for educational supervisors

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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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A brief outline of the right of children to consent to medical examination and treatment, and the differences between Gillick competence and Fraser guidelines.

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really useful case studies at the end of the document

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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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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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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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Child Protection Processes – The Lowdown

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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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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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# data[].attributes.attachment_link.description
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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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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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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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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Twelve tips for integrating leadership into medical education

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Twelve tips for integrating leadership into medical education

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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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Blackpool Teaching Hospital Conflict Resolution Manual

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Blackpool Teaching Hospital Conflict Resolution Manual

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Managing conflict in teams Gloucester NHS

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Managing conflict in teams Gloucester NHS

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Trainee in difficulty (nice short presentation)

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Trainee in difficulty (nice short presentation)

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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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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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Read the full text or download the PDF:

# data[].attributes.attachment_link.title
National child death review statutory and operational guidance: Key concepts for practising paediatricians

# data[].attributes.attachment_link.description
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.