Fellowship of the Royal College of Surgeons (FRCS) Professional Practice, Ethics and Leadership Syllabus

What did the Montgomery v Lanarkshire (2015) ruling establish about consent?

It replaced the doctor-led (Bolam) standard for disclosure with a patient-centred standard: doctors must disclose any material risk a reasonable person in the patient's position would attach significance to, or that this particular patient would. It established informed consent based on the reasonable patient, not the reasonable doctor.

State the Bolam test for medical negligence (standard of care).

A doctor is not negligent if they acted in accordance with a practice accepted as proper by a responsible body of medical opinion skilled in that field (Bolam v Friern Hospital, 1957). It is the 'responsible body' standard.

How did Bolitho modify the Bolam test?

Bolitho v City & Hackney HA (1997) held that the body of medical opinion relied upon must itself be capable of withstanding logical analysis (be reasonable and responsible). The court can reject expert opinion if it is not logically defensible, even if a body of doctors holds it.

State the four elements a claimant must prove in clinical negligence.

(1) Duty of care owed; (2) Breach of that duty (failure to meet the required standard); (3) Causation (the breach caused the harm, on the balance of probabilities / 'but for' test); (4) Harm/damage that is foreseeable and not too remote.

What is the 'but for' test in causation?

The claimant must show that 'but for' the defendant's breach of duty, the harm would not have occurred, on the balance of probabilities (>50% likely). It links the breach to the damage.

Define Gillick competence and Fraser guidelines.

Gillick competence: a child under 16 who has sufficient maturity and understanding can consent to their own treatment without parental knowledge. Fraser guidelines: specific criteria for providing contraceptive/sexual health advice to under-16s without parental consent (understands advice, cannot be persuaded to inform parents, likely to continue activity, physical/mental health at risk, in their best interests).

Can a competent adult refuse life-saving treatment? Can a Gillick-competent child refuse it?

A competent adult may refuse any treatment, even if life-saving, for any or no reason. A Gillick-competent child can consent to treatment but their refusal of life-saving treatment can be overridden by a person with parental responsibility or the court (in England and Wales).

What is an Advance Decision to Refuse Treatment (ADRT)?

A legally binding decision made by a person with capacity (under the MCA 2005) to refuse a specified treatment in the future should they lose capacity. To refuse life-sustaining treatment it must be in writing, signed, witnessed, and explicitly state it applies even if life is at risk.

What does DNACPR stand for, and does it affect other treatments?

Do Not Attempt Cardiopulmonary Resuscitation. It is a clinical decision applying only to CPR in the event of cardiorespiratory arrest. It does NOT affect any other aspect of treatment (e.g. antibiotics, fluids, surgery), which continue as appropriate.

What did the Tracey judgment (2014) establish regarding DNACPR?

R (Tracey) v Cambridge University Hospitals established that there is a legal duty to consult with and inform the patient (if they have capacity) when making a DNACPR decision, unless doing so would cause the patient physical or psychological harm. Failure to involve the patient breaches Article 8 (right to private life).

In England and Wales, which deaths must be referred to the coroner?

Deaths that are: violent/unnatural, sudden and of unknown cause, occurring in custody/state detention, where the cause is unknown, related to medical treatment/surgery/anaesthesia, due to industrial disease, or where no doctor attended during the last illness/can certify the cause.

What is the role of the medical examiner in death certification (England and Wales)?

Independent senior doctors who scrutinise all deaths not referred to the coroner, providing independent oversight of the proposed cause of death, agreeing the MCCD, liaising with bereaved families, and identifying deaths needing coroner referral or further review.

What is a coroner's inquest and what four questions does it answer?

A public inquiry into a death. It establishes: (1) who the deceased was, (2) when they died, (3) where they died, and (4) how (by what means) they died. It does not apportion blame or determine criminal/civil liability.

What is the SPIKES protocol for breaking bad news?

Setting up the interview; Perception (assess what the patient knows); Invitation (how much they want to know); Knowledge (give information, warning shot, avoid jargon); Emotions (respond with empathy); Strategy and Summary (plan and next steps).

Name the principal duties under the GMC's 'Good Medical Practice' four domains.

Domain 1: Knowledge, skills and performance. Domain 2: Safety and quality. Domain 3: Communication, partnership and teamwork. Domain 4: Maintaining trust (probity, honesty, integrity).

What is the duty of candour?

A professional and statutory duty to be open and honest with patients (or their families) when something goes wrong that has caused, or could cause, harm. It requires telling the patient promptly, apologising, offering remedy, and explaining the effects, and reporting/recording the event.

What is information governance and name a key legal framework underpinning it.

The framework for handling personal and patient information securely, legally and ethically, ensuring confidentiality, integrity and availability. Key frameworks: the Data Protection Act 2018, UK GDPR, the common law duty of confidentiality, and the Caldicott Principles.

State the Caldicott Principles (purpose).

Principles governing the use of confidential patient information: justify the purpose; don't use it unless necessary; use the minimum necessary; access on a strict need-to-know basis; everyone must be aware of their responsibilities; comply with the law; the duty to share information for care can be as important as the duty to protect confidentiality; inform patients about how their data is used.

When can patient confidentiality be lawfully breached?

With patient consent; where required by law/statute (e.g. notifiable diseases, court order); or in the public interest where disclosure prevents serious harm to the patient or others (e.g. risk to the public, safeguarding, informing the DVLA). Disclosure should be the minimum necessary.

Define leadership versus management in healthcare.

Management focuses on planning, organising and controlling resources to maintain existing systems efficiently ('doing things right'). Leadership focuses on setting direction, inspiring, motivating and creating change/vision ('doing the right thing'). Both are needed; they overlap.

Name and describe the leadership styles in Goleman's (Daniel Goleman) framework.

Six styles: Coercive/Commanding ('do what I say'), Authoritative/Visionary ('come with me'), Affiliative ('people come first'), Democratic ('what do you think?'), Pacesetting ('do as I do, now'), Coaching ('try this'). Effective leaders flex between styles to fit the situation.

Contrast transactional and transformational leadership.

Transactional leadership motivates through rewards and penalties for performance within existing systems (exchange-based). Transformational leadership inspires followers to exceed expectations through vision, inspiration, intellectual stimulation and individualised consideration, driving change and growth.

What does the NHS Leadership Academy Healthcare Leadership Model emphasise?

Nine leadership dimensions (e.g. inspiring shared purpose, leading with care, evaluating information, connecting our service, sharing the vision, engaging the team, holding to account, developing capability, influencing for results). It applies to all staff regardless of role, promoting 'leadership at all levels'.

State the levels of the evidence-based medicine hierarchy from highest to lowest.

(Top) Systematic reviews and meta-analyses of RCTs; randomised controlled trials; cohort studies; case-control studies; case series/case reports; expert opinion/bench research (bottom). Higher levels carry less bias.

Define a systematic review and a meta-analysis.

A systematic review uses an explicit, reproducible methodology to identify, appraise and synthesise all relevant studies on a question. A meta-analysis is the statistical combination (pooling) of quantitative results from multiple studies to produce a single overall effect estimate with greater power.

In critical appraisal, define sensitivity and specificity.

Sensitivity = proportion of those WITH the disease who test positive $= \frac{TP}{TP + FN}$ (true positive rate; SnNout - a Sensitive test, if Negative, rules out). Specificity = proportion of those WITHOUT the disease who test negative $= \frac{TN}{TN + FP}$ (SpPin - a Specific test, if Positive, rules in).

Define positive predictive value (PPV) and negative predictive value (NPV).

PPV = probability that a person with a positive test truly has the disease $= \frac{TP}{TP + FP}$. NPV = probability that a person with a negative test is truly disease-free $= \frac{TN}{TN + FN}$. Both depend on disease prevalence.

Define relative risk (RR) and give the formula.

Relative risk (risk ratio) is the ratio of the risk of an event in the exposed group to the risk in the unexposed group: $$RR = \frac{a/(a+b)}{c/(c+d)}$$ where $a$ = exposed with event, $b$ = exposed without, $c$ = unexposed with event, $d$ = unexposed without. $RR=1$ means no effect.

Define the odds ratio (OR) and its formula in a 2x2 table.

The odds ratio is the ratio of the odds of exposure in cases to the odds of exposure in controls (used in case-control studies): $$OR = \frac{a/c}{b/d} = \frac{a \cdot d}{b \cdot c}$$ $OR=1$ indicates no association; $>1$ increased odds; $<1$ decreased odds.

What is the Number Needed to Treat (NNT) and how is it calculated?

The number of patients who must be treated to prevent one additional adverse outcome. It is the reciprocal of the absolute risk reduction (ARR): $$NNT = \frac{1}{ARR} = \frac{1}{|CER - EER|}$$ where CER = control event rate and EER = experimental event rate. A smaller NNT indicates a more effective treatment.

What is a p-value and what does p < 0.05 conventionally mean?

The p-value is the probability of obtaining the observed result (or more extreme) if the null hypothesis were true. $p < 0.05$ conventionally indicates statistical significance: a less than 5% probability the result is due to chance, leading to rejection of the null hypothesis. It does not measure effect size or clinical importance.

Define Type I and Type II statistical errors.

Type I error ($\alpha$): rejecting a true null hypothesis (a false positive) - concluding an effect exists when it does not. Type II error ($\beta$): failing to reject a false null hypothesis (a false negative) - missing a real effect. Power $= 1 - \beta$.

What is statistical power and what determines it?

Power is the probability that a study correctly detects a true effect (rejects a false null hypothesis), $= 1 - \beta$. Conventionally set at 80% or 90%. It increases with larger sample size, larger effect size, lower variability, and a higher significance level ($\alpha$).

What does a 95% confidence interval represent, and how does it relate to significance?

A range within which the true population value is expected to lie with 95% confidence (if the study were repeated, 95% of such intervals would contain the true value). For a ratio (RR/OR), if the 95% CI crosses 1 the result is non-significant; for a difference, if it crosses 0 it is non-significant.

What is randomisation in an RCT and why is it important?

The process of allocating participants to intervention or control groups by chance. It minimises selection bias and distributes known and unknown confounding factors evenly between groups, allowing causal inference about the intervention's effect.

Define blinding and distinguish single, double and triple blinding.

Blinding conceals group allocation to reduce bias. Single-blind: participants are unaware of their allocation. Double-blind: participants and investigators/assessors are unaware. Triple-blind: participants, investigators, and the data analysts/outcome assessors are all unaware.

What is allocation concealment and how does it differ from blinding?

Allocation concealment ensures the person enrolling participants cannot foresee the next assignment (preventing selection bias at the point of randomisation). Blinding occurs after allocation and keeps participants/investigators unaware of which treatment was given (preventing performance and detection bias).

What is intention-to-treat (ITT) analysis and why use it?

Analysing participants in the groups to which they were originally randomised, regardless of whether they completed or adhered to the intervention. It preserves the benefits of randomisation, avoids attrition/non-compliance bias, and gives a pragmatic, conservative estimate of real-world effect.

Define confounding with an example.

A confounder is a variable independently associated with both the exposure and the outcome, distorting the apparent relationship between them. Example: in studying coffee and lung cancer, smoking is a confounder because smokers tend to drink more coffee and smoking causes lung cancer.

What is the purpose of a CONSORT statement?

CONSORT (Consolidated Standards of Reporting Trials) is a checklist and flow diagram providing standardised guidance for the transparent and complete reporting of randomised controlled trials, improving quality and reproducibility.

List the standard phases of clinical trials (Phase I-IV).

Phase I: first-in-human, small group, assesses safety, dosing and pharmacokinetics. Phase II: assesses efficacy and side-effects in a larger group. Phase III: large RCT comparing with standard treatment for efficacy and safety (basis for licensing). Phase IV: post-marketing surveillance for long-term effects/rare adverse events.

What is the Declaration of Helsinki?

A set of ethical principles developed by the World Medical Association (1964, regularly revised) governing medical research involving human subjects, emphasising informed consent, risk-benefit assessment, protection of vulnerable groups, and the primacy of the participant's wellbeing over scientific interests.

In the UK, what approvals are required before conducting research on NHS patients?

Favourable opinion from a Research Ethics Committee (REC) via the Integrated Research Application System (IRAS), Health Research Authority (HRA) approval, and local NHS Trust R&D/capacity-and-capability confirmation. Clinical trials of medicines also need MHRA authorisation.

What are the four principles of surgical training described by Halsted, and the classic teaching adage?

The Halstedian model: graded responsibility, repetition, close supervision within a hierarchy, and a scientific basis to practice. The classic adage is 'See one, do one, teach one,' now superseded by competency-based, simulation-supported progressive autonomy.

Describe Miller's pyramid of clinical competence.

A four-level hierarchy of assessment: 'Knows' (knowledge) at the base, 'Knows how' (applied knowledge/competence), 'Shows how' (performance in a controlled setting, e.g. OSCE), and 'Does' (performance in real practice, e.g. workplace-based assessment) at the apex.

What does Kolb's experiential learning cycle consist of?

Four stages: (1) Concrete Experience (doing), (2) Reflective Observation (reviewing the experience), (3) Abstract Conceptualisation (concluding/learning), (4) Active Experimentation (planning/trying out). Learning is most effective when the full cycle is completed.

Name common surgical workplace-based assessment (WBA) tools.

PBA (Procedure-Based Assessment), DOPS (Direct Observation of Procedural Skills), CBD (Case-Based Discussion), Mini-CEX (Mini Clinical Evaluation Exercise), and MSF/360-degree multi-source feedback. Used to assess and document progression of competence.

What is Pendleton's model of feedback?

A structured feedback method: (1) the learner states what went well, (2) the teacher states what went well, (3) the learner states what could be improved, (4) the teacher states what could be improved and how, ending with an action plan. It is positive-first and learner-led.

What is revalidation and how often does it occur for UK doctors?

Revalidation is the process by which licensed doctors demonstrate to the GMC that they remain up to date and fit to practise, usually every five years. It is based on annual appraisals and a recommendation from the doctor's Responsible Officer.

What are the six types of supporting information required for medical appraisal/revalidation?

(1) Continuing professional development (CPD); (2) Quality improvement activity (e.g. audit); (3) Significant events; (4) Feedback from patients; (5) Feedback from colleagues (MSF); (6) Review of complaints and compliments.

Define CPD (Continuing Professional Development) and its typical annual requirement.

CPD is the continuing maintenance, development and broadening of a doctor's knowledge, skills and professional performance throughout their career. UK colleges typically require around 50 CPD credits/points per year (averaged over the appraisal cycle), with reflection on the learning.

What is a Responsible Officer (RO)?

A senior doctor (usually the Medical Director) with a statutory role to oversee the conduct, performance and revalidation of doctors in their organisation, ensuring appraisals occur and making revalidation recommendations to the GMC.

Outline a structured approach to handling a patient complaint.

Acknowledge promptly; listen and apologise (without necessarily admitting liability); investigate thoroughly and impartially; respond clearly with findings and any actions taken; offer learning and remedy; follow local NHS complaints procedure (with escalation to PHSO/Ombudsman if unresolved). Maintain candour throughout.

What is the 'second victim' phenomenon in patient safety?

When a healthcare professional involved in an unanticipated adverse patient event, error or near-miss becomes traumatised, suffering psychological harm (guilt, anxiety, loss of confidence). Recognising and supporting the 'second victim' is important for staff wellbeing and a just safety culture.

What is a 'just culture' in clinical governance?

An organisational culture that fairly distinguishes between human error, at-risk behaviour and reckless behaviour: it supports learning and openness rather than blame for honest mistakes and system failures, while still holding individuals accountable for willful misconduct or gross negligence.

What is situational awareness and why is it important in theatre safety?

Situational awareness is the perception of elements in the environment, comprehension of their meaning, and projection of their future status (Endsley's three levels). Loss of situational awareness is a major contributor to surgical errors; maintaining it underpins effective decision-making and crisis management.

What are the 'five rights' of safe handover/care transfer?

Originally the medication 'rights' (right patient, right drug, right dose, right route, right time) and in handover the principles of transferring the right information, about the right patient, to the right person, at the right time, with the right responsibility/accountability clearly assigned.