Clinical Ethics and Law Past Paper (OCR) 2024

**[Ultimate Markscheme ]** **Clinical Ethics and Law\ ** **Improving Health\ ** **Short Answer Questions (SAQ) Examination\ Friday 12th January 2024** **\ ** **[High--Yield Points]** **State the 4 principles for investigating and resolving a complaint where patient care has fallen below the ex...

**[Ultimate Markscheme ]** **Clinical Ethics and Law\ ** **Improving Health\ ** **Short Answer Questions (SAQ) Examination\ Friday 12th January 2024** **\ ** **[High--Yield Points]** **State the 4 principles for investigating and resolving a complaint where patient care has fallen below the expected standard due to a staff member \[4 marks\]** 1. Ensure patient is now receiving appropriate treatment and follow-up 2. Investigation into standard of care provided (to prevent it happening again) 3. Action planning 4. Resolving the complaint with the patient. **What is the legal test for negligence? \[3 marks\]** 3 components for a defendant (D) to be found liable, the plaintiff (P) must establish on the balance of probabilities that: 1. D owed P a duty of care ([always applies] when there is a Doctor-Patient relationship in a medical consultation) 2. D was in breach of the duty of care (Bolam/Bolitho Tests -- did the Doctor act in accordance with body of reasonable/appropriate medical opinion) 3. P suffered injury/loss/harm as a result of the breach **How does rude behaviour (speaking harshly to a Latvian patient) contravene GMC's Duties of a Doctor -- Good Medical Practice? \[5 marks\] ** 1. Knowledge, skills, and performance -- make the care of the patient your first concern, this includes emotional--wellbeing which rudeness compromises 2. Safety and quality -- Promote and protect health 3. Communication, teamwork, and partnership -- treat patients as individuals and respect their identity and dignity; treat patients politely and considerately 4. Communication, teamwork, and partnership -- work in partnership with patients 5. Maintaining trust -- never discrimination unfairly against patients or colleagues **What steps would you take in response to overhearing a doctor being rude to a patient? \[4 marks\]** 1. Follow principles of GMP -- take [prompt action] if patient [safety] or [comfort] is [compromised]; relevant if Dr is treating some patients belonging to a group with a protected characteristic less favourably than other 2. Speak to Dr, especially if you think this is a one-off behaviour triggered by stress 3. Speak to your consultant and your educational supervisor 4. Escalate concerns within the organisation if your consultant or educational supervisor don't take action/there is a pattern of behaviour; speak to medical director/clinical director/head of department \**NB: if you're unsure what to do you can seek advice from BMA/GMA/medical defence organisation\ \ \ \ ***State 3 components needed for approach to a question about 'legal justification' \[3 marks\]** 1. State the relevant facts 2. State the relevant laws 3. [Apply] the law to the facts **Which types of clinical data are confidential? \[2 marks\]** 1. All data collected by doctors working in their professional capacity are confidential (according to BMA) 2. Anonymous information, which cannot foreseeably be used to identify a patient, is not treated as confidential/may be used for legitimate purposes without consent **What 3 situations can confidentiality be legally breached? \[3 marks\]** 1. Appropriate consent / best interests 2. Law requires disclosure i.e. legal obligation or statutory permission 3. Public interest justification **How should you apply legal principles for confidentiality/disclosure when disseminating results of a local service evaluation? \[4 marks\]** 1. Anonymise information (i.e. make it not identifiable) if you can do so without affecting all the necessary information needed to complete the project 2. Consider if implied consent is relevant -- information has been collected and will be disclosed to third parties in the course of completing treatment under the service so falls under heading of clinical governance 3. Seek explicit consent from patients before disclosing data that could be used to identify them to third parties if anonymity/implied consent aren't possible 4. There is no legal justification/public interest justification which applies in this scenario, therefore [appropriate consent is required] **\ \ State the factors that should be considered when disclosing confidential information about a person's health record to a third party, in the context of a [medical report] on patient's condition/sick certificate \[2 marks\]** 1. Consent of the patient to disclose information in their medical notes to a third party 2. Consent of any other parties mentioned in the patient's medical notes to disclose to third party 3. Duty to be truthful and report how impaired patient is by their illness (no exaggeration) 4. Don't speculate about the causes of health problems and prognosis of return to work if you don't know the answers **Explain the principles of legally granting request for treatment in an under 16-year-old that comes to you asking for treatment without their parents? \[6 marks\]** 1. Treatment cannot be provided without valid consent 2. There is no presumption that under 16s have capacity/competence to give consent. 3. In the absence of capacity/competence to give consent, proxy consent from parents must be sought (*necessitating a breach of confidentiality*) 4. However, if patient demonstrates 'Gillick' competence (can understand the nature and purpose of the treatment, retain, weigh and communicate),\ then can give their own consent 5. In which case, there is no need to breach confidentiality\ -- despite not being with parents 6. Therefore, it is necessary to determine whether patient is competent\ to give their own consent **Discuss the main ethical considerations in a dilemma (i.e. what are the 4 ethical principles and then apply to context, use Beauchamp and Childress) \[4 marks\]** 1. Beneficence -- duty to do good (help the patient, try to improve their health) 2. Non-maleficence -- duty to avoid harm. 3. Autonomy -- patient's prima facie right to decide what will happen to them 4. Justice -- patient's right not to be treated differently to others without good reason and using resources fairly \*NB: If appropriate, comment on when the principles may conflict with each other, and comment on the need to give appropriate weight and balance applied to each one.\ *A [prima facie right] is a right that can be [outweighed] by [other considerations]. It stands in contrast with absolute rights, which cannot be outweighed by anything.\ \ \ ***What is utilitarianism? \[3 marks\]** 1. Based on outcomes/consequences of actions rather than duties/qualities of agents (ends justify the means) 2. Outcome being sought (goal) is to maximise happiness/wellbeing/good for persons 3. Impartiality -- happiness/good of everyone affected by the decision counts equally **\ What are the advantages to a utilitarian approach to resource allocation? \[4 marks\]** 1. Simplicity -- relatively easy to understand and apply 2. Transparency -- derives from simplicity 3. Flexibility -- no fixed rules/duties so possible to take account of the circumstances 4. Impartiality -- everyone's happiness counts, so more equitable *\ \ * **Ethical arguments for and against abortion/termination of pregnancy. \[4 marks\]** Arguments against termination (illustrative list, **both for/against needed for full marks**): Sanctity of human life Argument from potentiality Arguments based on viability Slippery slope arguments Arguments for termination (illustrative list): Arguments from personhood Arguments from consequences Pragmatic harm reduction **\ Approach and principles to discussing domestic violence with a woman? \[4 marks\]** Note: 2 points per mark and can split answer into do's and don'ts **Do's**: Create a supportive environment ; See the woman (or man) alone ;\ Be direct 'has your partner ever hit you' and honest 'I don't think that explains your injury' so that there is no misunderstanding ; let her know she's not alone, sign--post relevant resources ; support the woman in her decision. **Don'ts**: Assume someone else will ask ; Rush or push her into revelations ;\ Advise a woman to leave her partner ; Make decisions on their behalf for her/ act as a go between (paternalism) ; Forget to make a safety plans. **\ Child may be at risk, who should GP contact? \[2 marks\]** 1\. Contact the local child safeguarding lead. 2. Children\'s Services will perform a CAF assessment. **Discuss the ethical arguments for and against assisted suicide \[6 marks\]** Arguments in favour (illustrative list): - Discriminates against the disabled who cannot end their own lives (a lawful act-- suicide is no longer criminalised, but not everyone can do it) without assistance, so this would actually add [consistency] in the law and avoid ablism. - Lack of assisted suicide drives people to commit suicide sooner than they would otherwise/earlier in their disease progression (Debbie Purdy's argument: *'Purdy said that if her husband would be exposed to prosecution for helping her travel to Switzerland to a Dignitas clinic to die, she would make the journey sooner whilst she was able to travel unassisted'*). - Respects individual autonomy -- allows people to choose how they die just as we generally allow people to choose how to live (including [refusal] of live-saving treatment). - More humane than the withdrawal of life-sustaining treatment when the consequences are inevitably the same -- the patient will die. Arguments against (illustrative list): - Protects vulnerable people from pressure to avoid 'burdening' loved ones. - Avoids erosion of the case & effort for excellent palliative care. - 'Slippery slope' into voluntary or even involuntary euthanasia. - Potentially incompatible with the concept of sanctity of life. - Kantian argument that a decision to end one's life can never be reasonable therefore cannot be an exercise of the autonomous will. **Factors to consider when deciding to treat a terminally ill patient that is confused with a palliative intervention? \[5 marks\]** 1. Assess whether benefits outweigh risk for the intervention, if treatment is futile it should not be offered 2. Assess whether patient has capacity to decide whether to have the intervention 3. If patient has capacity then they should make the decision, if the patient lacks capacity then can their capacity be enhanced/maximised? 4. If they lack capacity, then make a decision in the best interests of the patient -- considering [benefits] and [burdens] of treatment, patients [past and present wishes], [values and beliefs] etc. 5. Consult with someone that knows the patient well, to determine his best interests e.g. partner, or family member **If a terminally ill patient has previously made a living will, how do you decide whether to withhold lifesaving treatment? \[5 marks\]** 1. Is this 'living will' a valid Advance Decision to refuse treatment? (Made before patient lost capacity and, given that this is a statement about with-holding life-saving treatment, the AD must be in writing, signed and witnessed and covers explicitly withholding "life preserving treatment".) 2. Does it set out the circumstances in which it should apply and the treatment that is to be refused and are those the relevant ones here? 3. If the AD is valid, it must be respected 4. If there is doubt about the validity of the AD, you should make a 'best interests' decision and you should err on the side of preserving life 5. However, a document that does not meet criteria for a valid AD may still give a helpful indication of patient's past wishes, feelings, beliefs and values. You must take these into account when making the best interests decision. 6. 1. **Why is randomisation important? \[2 marks\]** 1. Minimising Selection Bias 2. Statistical Validity: random assignment allows researchers to use probability theory to assess the likelihood that any observed differences between groups are due to the treatment rather than chance. 3. Ethical Considerations: Helps avoid the perception or reality of favouritism in assigning participants to treatment groups. 4. Generalisability/External Validity: Randomisation increases the likelihood that the results of the trial can be generalised to a broader population, as the sample is more representative of the population. 5. Control of Confounding Variables: Distributing these known/unknown variables enables the research to isolate the impact of the treatment itself.\ \*Randomisation, standardisation, stratification, and regression to reduce confounding factors. **Why do you think the assessor was masked to the intervention status (blinded)? \[2 marks\]** 1. Avoid observer-expectancy/measurement bias -- when a researcher\'s expectations, opinions, or prejudices influence what they perceive or record in a study 2. If the assessors were aware which interventions the groups received this could have biased their assessment of the outcome one way or the other. **What do you understand by the term "intention to treat analysis",\ and why is this important? \[4 marks\]** 1. A method of analysis for randomised trials in which all patients randomly assigned to one of the treatments/treatment group are analysed together 2. regardless of whether or not they completed or received that treatment. 3. Preserves the baseline comparability between groups achieved by randomisation 4. guards against bias introduced when the dropping out of subjects is related to the outcome. **Can causality be inferred from case-control studies? \[1 mark\]** 1. No, can only be inferred from interventional studies e.g. RCT. 1. **What is the definition of an odds ratio? \[1 mark\]** **What is the definition of a risk ratio? \[2 mark\]?** 1. Measure of treatment effect; 2. incidence of outcome of interest in exposed group\ to the incidence of outcome of interest in unexposed group **What is the 95% confidence interval? \[1 mark\]** 1. Shows that 95% of the time the [value] would lie within the interval. 2. Thus, it is a statistical range that is used to estimate the precision or uncertainty of a point estimate, such as a mean, proportion, or risk ratio, in inferential statistics. 3. If the CI of the risk/odds ratio contains 1 in the overlap range, results are likely due to chance; if 1 is not in this range, then this assumption cannot be made. **What is a cost-effectiveness analysis? \[3 marks\]** 1. Form of economic analysis that assesses relative costs and outcomes 2. For two or more interventions addressing the [same problem] 3. Expressed in terms of a ratio; numerator is the cost associated with health gain and denominator is a gain in health outcome relevant to the intervention (e.g. premature death avoided, smoker quitted) \[i.e. *£X per Health Benefit*\]. **What is a cost utility analysis? \[3 marks\]** 1. Form of economic analysis that assesses relative costs and outcomes 2. For two or more interventions addressing same or different problem\ i.e. enables [wider comparison] 3. Expressed in terms of generic measure of health gain e.g. quality-adjusted life year (QALY) **State the six criteria for determining whether a new intervention e.g. drug should be recommended for treatment of a condition \[4 marks\]: A.C.C.c.E.S.** 1. Acceptability to the population 2. Clinical effectiveness 3. Cost effectiveness 4. \^(clinical effectiveness/cost-effectiveness) Comparison to current standard of treatment 5. Efficacy 6. Safety to patients **Before wider adoption of a programme/clinical intervention, what other information would you like to see (always mention A.C.C.c.E.S)? \[3 marks\]** 1. What were the specific [resources] needed to make this intervention,\ and can they be [routinely replicated] in clinical practice? 2. Cost effectiveness - Before the scarce health care resources are deployed;\ all clinical effective interventions may not be always cost effective. 3. Reproducibility -- can these results be replicated by others using similar methods. **Where would you find information about drug criteria to make a judgement about its suitability for use in treatment? \[2 marks\]** 1. Clinical Effectiveness -- Clinical Evidence, NICE, journals containing relevant RCTs 2. Cost-effectiveness -- NICE, Scottish Medicines Consortium 3. Efficacy -- NICE, Medline, Cochrane Database 4. Safety -- MHRA (Government Agency), European Medicines Evaluation Agency **What interventions have been shown effective for weight loss? \[4 marks\]** 1. Goal setting and behaviour modification -- realistic goal 5-10% weight loss associated with health benefits 2. Diet -- calorie deficit 500-600kcal/day below recommended (2500 men, 2000 women) 3. Physical activity -- 60 to 90 mins of activity/day 4. Drugs e.g. orlistat -- offer therapeutic trial/stop if not effective after ½ months **What are the 4 key components for service evaluation according to Donebedian?\ Give at least 2 examples for each component (context is primary care endoscopy service). Donebedian SPOO \[8 marks\]** 1. Structure (What?) a. Availability of building space b. Availability of relevant equipment c. Availability of suitably qualified staff 2. Process (How?) d. Referral pathway to access the service/does it fit with local or national guidelines e. Number of sessions held, number of patients referred to the service f. Number of successful procedures carried out g. Number of false positives/false negatives h. Complication rates 3. (Outputs) i. No of cases of disease being detected j. Stage at which (malignant) disease is being detected 4. Outcomes k. Increase in early detection of disease, enabling treatment l. Increased survival of people detected through screening m. Cost savings compared with existing services n. Improvements in patient satisfaction *\*NB outputs and outcomes may be grouped together as outcomes, so note if the question asks for 3 or 4 groups.* **Describe factors commissioners should consider when deciding whether to fund a (new) service? [Template Answer] \[6 marks\]** 1. Evidence for risks and benefits for proposed service. 2. Cost effectiveness of proposed services (compared to existing comparative service) 3. Has the service been evaluated by NICE? 4. What is the likely demand for this proposed service (and its affordability)? 5. Are the resources available/exist (clinics, expertise) locally in order to enable such a service to be set up? 6. Opportunity cost of funding this service on other (existing) services. 7. Do other areas of the country have this new service/how well does it work for them 8. Would a decision to fund this service be equitable -- potential discrimination/injustice. 9. Views and priorities of the local population (on funding this new service)? 10. What is the population need for this service? What data can back this up? a. What are the future needs and current needs likely to be. b. How will this service help with this? 11. Availability of similar local services **What information would a CCG (Clinical Commissioning Group) need to consider when planning a local service (End of Life Services)? \[5 marks\]** 1. Local needs based on relevant statistics e.g. mortality rates 2. Local data concerning locations of death, especially % of deaths occurring at home / care home 3. The availability of local services e.g. home care services and hospice beds 4. The availability of expertise for this service in all settings (especially acute hospital) 5. The availability of palliative care advice 24 / 7. 6. A local strategy for the service, with plans to address gaps in service provision 7. An awareness that nationally (and it will be true locally as well) most patients would prefer to die at home, but most currently die in acute hospital **Factors to consider when planning a local service? *(context new Eastern European migrant population)\ * \[7 marks\]** 1. Present local needs (based on current morbidity rates) 2. Future local needs (based on demographic trends)\ \*include details about incoming new population e.g. if it's younger adults, this may need fewer services for old people e.g. dementia & more services for maternity 3. Does the incoming population have different health needs compared to the existing population 4. Availability of local resources (staff, clinics, buildings etc.) to meet needs of existing + incoming population 5. Consider need for local strategy for migrant health care (plus plans to address gaps in services) **What are the 4 components of the audit cycle? \[4 marks\]** 1. Set and agree standards/outcomes 2. Monitor performance against those standards 3. Identify deviations from agreed standards, and reasons they arise 4. Implement changes to correct unwanted deviations from the standard, and repeat the cycle to assess their effectiveness *\*NB: the question may ask you to apply these 4 general terms to the context of a [specific] audit* **How can the stages of an audit cycle be achieved? \[4 marks\]** 1. Setting and agreeing standards (e.g. via retrospective records using clinical codings, literature search etc) 2. Monitoring performance against those standards, such as according to NICE, national databases, or literature 3. Identifying deviations from standards (may identify high performers to share best practice/underperformers to learn from mistakes) 4. Productively discuss measures to be implemented in order to correct unwanted deviation from standard before repeating the cycle **What are the 4 components of the audit cycle (applied to mental health treatment)? \[4 marks\]** 1. Select appropriate outcome to audit e.g. mental health relapse/remission rates 2. An acceptable standard must be identified, possible with reference to national standards, outcomes must then be measured and compared against the standard 3. If performance falls below the expected standard, measures for improving the service must then be identified and implemented 4. Re-audit closes the cycle, to ensure that the service improvement measures have been effective *\ * **What are the criteria for a good screening programme? Con.Te.Tre.Sc. \[8 marks\]** **Need 2 points from each category to get full marks** 1. **Condition** a. Condition must be an important health problem (prevalent or serious harm) b. Epidemiology and nature of the condition is adequately understood, including development from latent to declared disease; and there needs to be a detectable disease marker/detectable risk factor,\ latent period/early symptomatic period c. All cost-effective primary prevention measures must have been implemented first, before having this screening programme 2. **Test** d. Should be a simple, precise, safe, validated screening tests e. Distribution of the test values within in the target population should be known and a cut-off level defined and agreed f. Screening test should be acceptable to the population g. Agreed--on policy for what further diagnostic investigations to do in those with a positive test result and on the choices available to the individual 3. **Treatment** h. There should be an effective treatment for the patients picked up early through screening and evidence to support better outcomes for treating earlier rather than later i. There should be evidence-based policies which clearly say who should be offered treatment and what the appropriate treatment option is j. Clinical management of the condition should be optimised by healthcare providers prior to participation in a screening programme 4. **Screening programme** k. Should be evidence from high quality RCTs that the programme is effective in reducing morbidity or mortality l. Should be evidence that the complete screening programme is clinically/socially/ethically acceptable to public and professionals m. Benefits of the screening programme should outweigh physical/psychological harm (caused by test, diagnostics, treatment etc) n. Opportunity cost of the screening programme should be economically balanced in relation to expenditure on medical care as a whole i.e.\ cost--effective/value for money o. Adequate staffing and facilities for testing/diagnosis/treatment should be in place prior to starting the programme p. Evidence based information should be made available to potential participants to assist them in making an informed choice (explains consequences of testing, investigation and treatment) **Relate screening to the ethics of non--malfiecience?\ Psychological harms from false positive** ** Unwarranted reassurance from false negatives** ** Preventable deaths resulting false negative tests** ** Iatrogenic harm from diagnostic testing** **What are the sinister S.T.E.E.E.P. six dimensions of healthcare quality?\ ** \* The Institute of Medicine (IOM) established six aims, or domains, of health care quality: safe, timely, effective, efficient, equitable, patient-centred. **State the approach for population level strategies for health promotion // disease prevention\ to prevent a public health problem (e.g. obesity). \[5 marks\]** Ottawa Charter For Health Promotion (WHO) 1. Build healthy public policy (agricultural policies/food subsidies make healthier foods cheaper, ban junk food advertising) 2. Create supportive environment (bike racks and shower facilities at school/work, safe walking, cycling routes to school/work) 3. Strengthen community action and communities (Safe accessible parks) 4. Empower individuals to develop personal skills (better food labelling) 5. Re-orient health services towards health promotion and illness prevention (train healthcare professionals to screen for weight loss, offer practical advice etc) **Approach to answering a question on assessing the prevalence of a condition \[3 marks\]** 1. Definitions \[measure of the frequency of a disease or health condition in a population at a particular point in time\] 2. Data sources: where you get the data from e.g. healthcare records 3. Data availability: how much of the info is in the data source (e.g. ppl may not have the fact they were DV in the sources) **What 2 approaches are there how to prevent public health problem X (e.g. X=domestic violence, disease etc.)** 1. Primary/secondary/tertiary prevention measures a. Primary prevention = prevent public health problem from developing in first place e.g. relationship education in schools to prevent DV b. Secondary prevention = reduce severity/recurrence of a public health problem once it has developed e.g. training frontline healthcare staff to identify/counsel those at risk of DV, screening (in general practice ) c. Tertiary prevention = reduce the consequences of an established public health problem e.g. counselling services for identified victims of DV 2. Measures taken at local/regional/national/international levels **All forms of '[screening'] are [secondary prevention].\ **\*Reduces the severity/recurrence of disease via an 'identify and treat' approach.\ \ **What are the aims of 1\', 2\' and 3\' prevention?** 1\' - prevents disease from happening in the first place. 2\' - reduces severity/recurrence - identify and treat disease. 3\' - deal with long term sequelae, to prevent further morbidity/mortality.**[\ ]** **[Clinical Ethics & Law ]** **Fundamental Ethical Principles** **Sources of law?** **International law** - e.g. European Convention on Human Rights, European Court of Justice\ **Acts of Parliament** - e.g. Mental Capacity Act 2005\ **Case (common) law** - rules developed by courts from Acts and previous decisions where no existing law applied; new law developed by judges following reasoning from previous **Statutory law** - derived from Acts of Parliament, enforced through the courts by judges\ **Public law** - a case brought against the state/a state body (e.g. the NHS)\ **Private law** - a case brought against individuals or a company\ **Criminal law** - individual prosecuted by state in magistrate\'s/crown court with aim of proving guilt beyond reasonable doubt, leading to conviction and sentencing\ **Civil law** - plaintiff sues defendant in country or High Court with aim of proving guilt on the balance of probabilities in order to pay damages/desist conduct. **How to approach [medicolegal] problems?**\ 1. Describe the problem or conflict \[**state issue**\]\ 2. State relevant medical and demographic facts \[**medical fact: relevant**\]\ 3. State relevant law and legal principles \[**legal fact: identify applicable law**\]\ 4. Apply the law to the facts \[**link them together**\]\ 5. Generate a defensible plan \[**explain reasoning**\] **Main branches \[3\] of medical ethics?** Virtue ethics Utilitarianism\ Deontology **Principals of each branch of medical ethics?** ** Virtue ethics -** the idea that moral actions are those which embody certain virtues. Virtuous actions are the mean between extremes. Acquiring the habit of virtue ('good character') will lead a person to experience \'eudaimonia\' or \'flourishing\'**.** ** Utilitarianism - *\*type of Consequentialism,*** the idea that moral actions are those which produce the greatest good for the greatest number; the end justifies the means.\ Bentham: happiness is simply the avoidance of pain and the maximising of pleasure; JJ Mill: liberty is essential to happiness and that no individual has the right to harm other in their pursuit of happiness\ (this is the \'Harm Principle\')**.** ** Deontology -** the idea that moral actions are those which abide by rationally generated rules that consistently dictate right and wrong; people should never be a means to achieving an end. \*Ask whether it would be reasonable for everyone to act in the same way; this branch assumes we are rational, and lacks flexibility to adapt to context. **What principles of medical ethics must be considered?**\ Beauchamp v Childress (1979) laid out the following: **Beneficence**: the requirement to help and do good\ **Non-maleficence**: the requirement to avoid harming others\ **Respect for autonomy**: the requirement to respect individuals\' wishes and preferences\ **Justice**: the requirement to treat people fairly and equitably in comparison with others\ \ **\*Doctors should consider:** [Codes of Conduct] (GMC's GMP), [Regulations] (Law),\ [Ethical Principles] (3 branches, 4 pillars), [Values] (of people). **Consent, Capacity, & Best Interests** **What is one of the aims of the law surrounding capacity and consent?\ **Attempts to balance the principles of beneficence with respect for autonomy.\ Legislation around consent protects patients\' bodily autonomy and the legal liability of doctors to charges of assault. **What is medical paternalism?**\ Interfering with a person against their wishes on the grounds that it is for their own good. **What are the different forms of medical paternalism?\ \'Weak\' paternalism -** interfering with means in order to achieve a person\'s own ends ** \'Strong\' paternalism -** interfering in order to prevent a person achieving \'unwise\' ends ** \'Soft\' paternalism -** interfering only to ensure a person is acting voluntarily and knowledgably ** \'Hard\' paternalism -** interfering even when a person\'s actions are informed and voluntary\ \*The law rejects both strong and hard paternalism. **What is required for [valid] consent?\ ** **Voluntary** - not coerced or obtained under duress/in a vulnerable situation (e.g. undressed) **Competent** - able to understand, retain, use and weigh relevant information, and communicate a decision.\ **Informed** - provided with information about all options including no treatment, the nature and purpose of these options, and the material (i.e. not vanishingly unlikely/insignificant) risks associated with each option; information must include:\ **→** **The information this patient wants to know,\ ***\*Rogers vs Whitaker (1992): 1/14,000 risk of sight loss in one eye not communicated to Mrs W although this was more significant as she was already blind in the other eye; Hence, information should be tailored to the requirements of individuals*\ **→** **Any information a reasonable patient wants to know \[material risks + alternative options\]\ ***\*Montgomery vs Lanarkshire Health Board (2015): obstetrician did not inform NM of the risks of shoulder dystocia or discussed option of a CS; Hence, information should be given that any reasonable patient would want, or alternative treatment discussed.\ \** *Montgomery Ruling replaced the Bolam Test; the law now requires a doctor to take "reasonable care to ensure that the patient is aware of any material [risks] involved in any recommended treatment, and of any reasonable [alternative or variant] treatments".* **What determines if a patient lacks capacity?** According to the **Mental Capacity Act (2004)**, a person lacks capacity to make a [specific decision] (may have capacity for others) if they [both]: **1. Have an impairment of, or disturbance in the functioning of, the mind or brain** *\ E.g. dementia, unconsciousness (necessary, but not sufficient), delirium, intoxication, mental illness, learning difficulty* **2. They are unable to** ([only one] of the following criteria need be impaired)**:\ **Understand relevant information,\ Retain that information,\ Use or weigh information as part of the decision-making process,\ Communicate this decision.\ \ **→** **MCA authorises treatment of MH condition [and] physical illness/injury.** **Delirium will generally be dealt with via the MCA: It is likely that recovery will be fairly swift via antibiotics-- not requiring psychiatric input-- and detaining someone to a psychiatric hospital under the care of a consultant psychiatrist (MHA) with Section S17 whom must rescind the Section which could result in delayed discharge, thus being restrictive.\ ** **\ \ \ \ \ \ \ \ \ \ \ \ \ \ \ \ \ \ \ \ \ \ \ \ \ \ \ \ \ \ Name the 5 Mental Capacity Act Principles?** - **1**: 'A person must be [assumed] to have capacity unless it is established that he lacks capacity.' - **2**: 'A person is not to be treated as unable to make a decision unless [all practicable steps] to [maximise capacity]/help him to do so have been taken without success.' - **3**: 'A person is not to be treated as unable to make a decision merely because he makes an [unwise decision].' - **4**: 'An act done, or decision made, under this Act for or on behalf of a person who lacks capacity must be done, or made, in his [best interests].' - **5**: 'Before the act is done, or the decision is made, regard must be had to whether the purpose for which it is needed can be as effectively achieved in a way that is [less restrictive] of the person's [rights] and [freedom of action].' **\*Generally, MCA less restrictive than MHA.** **\ \ What should be done if help is refused?\ *Specific example of [Adult Safeguarding]:*** - Presume capacity until proven otherwise - Respect capacitous decisions but keep lines of communication and offers of support open - Work to restore and maximise capacity - If capacity cannot be restored, usually appropriate to report the abuse to Adult Safeguarding Lead (without their consent/no consent required for this) **What consideration (regarding capacity) arise in this case?\ ** All adults (including \>16) should be assumed to have capacity unless proven otherwise\ Maximum support should be provided to enhance and maximise capacity, and the potential for competent consent An unwise decision does not equal a lack of capacity, and a bad decision should not be treated as the patient lacking capacity\ Capacity is decision-specific, and can fluctuate (i.e. capacity for one decision ≠ capacity for another)\ If a person lacks capacity, decisions should be taken in their best interests (should include consulting NOK/next--of--kin or an IMCA/independent...advocate for major decisions)\ The least restrictive option should be used where possible **What additional legislation applies to capacity in children?** ** Gillick competency** - if a child can understand the nature and purpose of the treatment, parental consent is not required to accept treatment, otherwise, the consent of a parent must be sought to give treatment \***Fraser guidelines** for sexual health/contraception specifically.\ ** Family Law Reform Act (1969**) - people aged 16-17 are assumed to have capacity and the MCA therefore applies (i.e. assumed to have capacity unless otherwise established...)**\ Zone of parental control:** Any refusal of treatment by a children under 18 may be overruled by a parent, as long as it falls within the \'zone of parental control\' - this is a decision considered normal for a parent to make, provided the parent is acting in the child\'s best interests (if not, then court proceedings needed). **What treatment does the Mental Health Act enable?** Permits treatment for mental (but not purely physical) health problems without consent where people are detained under S2 or S3. \* Mental illness does not prevent capacity--based decisions relating to physical health, e.g. a man diagnosed with chronic schizophrenia was found able to get an advance directive to prevent amputation or a gangrenous foot. **Patient [has] capacity, what next?** ○ Proceed with consent\ ○ Respect a refusal of treatment (unless MHA applies)\ ○ Remember, no obligation to provide requested treatment if not indicated **Patient [hasn't] got capacity, what next?** ○ Take steps to enhance and maximise capacity ○ Respect a valid ADRT ○ Consult an LPA (Health and Welfare LPA, specifically)\ ○ Make a best interests' decision **What is an Advance Decision to Refuse Treatment (ADRT)?\ **A legally--binding decision made when a person has capacity, in the event that they lose capacity in future; they can be altered or withdrawn at any time, and a withdrawal need not be in writing. The person must be \>18. **What is required for an ADRT to be valid?\ **Relating to life-sustaining treatment, must: -- Acknowledge life is at risk if treatment is refused.\ -- in writing, -- signed, -- witnessed (doesn\'t have to be be a doctor). **What invalidates an ADRT?\ ** The person withdraws the decision while they have capacity\ The person has given LPA for this decision (assuming they are acting in Px's best interest)\ The person has acted in a manner inconsistent with the ADRT e.g. appointed an LPA\ The circumstances have changed in a way not predicted by the person when they made it **What should you do if unsure whether an ADRT is valid?**\ Apply to the [Court of Protection].\ \*However, there is legal protection for i) giving treatment if the ADRT is thought not to apply, and ii) not giving treatment if the ADRT is thought to be valid (this is justified as long as it is in good faith). **Define a Lasting Power of Attorney (LPA), and when are they used?\ **LPA: a person given legal power to make decisions on behalf of an adult without capacity, nominated at a time when they do still have capacity. \* This could be for: ○ Health and personal welfare - including life-saving treatment when expressly permitted, ○ Property and affairs - including financial decision. **What should be done when an LPA is untrustworthy/alternatives?\ **A Personal Welfare Deputy may be appointed by the Court of Protection in the [absence] of an LPA OR if there is [doubt] over whether decisions will be in a person\'s best interests, such as if the family disagree about care. **When should a 'best interests decision' be considered?\ **Without an ADRT or LPA, a person giving treatment must act in the best interests of the person without capacity. **What constitutes a best interests decision?** Consider the person\'s medical, emotional, social and ethical welfare\ Respect their known wishes and feelings, and beliefs and values that may have affected this decision *(for a pregnant woman, this can include her wish for a live birth/healthy baby)*\ Be equitable and non-discriminating\ Take into account the views of close family members and carers\ (or IMCA if serious decision and no NOK)\ Consider the possibility of the person regaining capacity, and take the least restrictive option (treatment that preserves life is generally preferred) if this is thought to be likely.\ Not be motivated by a desire to hasten a person\'s death - this would be non-voluntary euthanasia (but withdrawal is justified if the treatment is futile and burdensome, or if treatment is given according to the Doctrine of Double Effect e.g. opiates in palliative care). \ \***Note:** 'Right to Refuse Medical Treatment' and 'Right to Liberty' are **Prima Facie Rights,\ **and thus circumstances outlined in the [MHA/MCA] can outweigh these. **Disclosure, Confidentiality, & Information Governance** **Name 3 principles of good communication** Trustworthy - communicate effectively, with plain language, and be open to challenge\ Open - provide the information needed to make autonomous choices\ Honest - tell the truth as far as possible **What cases form the legal obligation to disclose information to patients?\ ** **Duty of Candour** - 2014 NSCA legislation means care providers must disclosure all errors in treatment that cause moderate/severe mental or physical harm ** Montgomery vs Lanarkshire Health Board (2015)** - sufficient information must be given to allow [informed consent\ ]\*Beauchamp vs Childress: Autonomy, Justice, Beneficence, Non--Maleficence. **What cases justify [not] disclosing information to patients?**\ ** Sokol (2004)** suggests that on dire occasions [deception] in medicine may be justified (\'the [therapeutic exemption\']) if: -- it is necessary to prevent grave physical and psychological harm, -- non-deceptive means will not be sufficient,\ -- and the deception will not be discovered. \*He says a doctor should be confident they could defend this to the GMC and that a reasonable patient would consent (e.g. telling a patient they will be alright before undergoing an emergency surgical procedure with a very poor prognosis) **What data should be considered confidential?\ **[All data] collected by doctors in the course of work should be considered confidential.\ *Unless genuinely anonymised, it should not be shared for any reason other than clinical care (or clinical governance).* **When is it justified to share patient data?** The patient consents to sharing their data\ The disclosure is in the [best interests] of a person [lacking capacity] to consent\ The disclosure is required/permitted by law\ The disclosure is in the public interest *\[example of legal defence\]* Between clinical staff for the patient's care **When is disclosure legally required, or permitted by [law]?\ \ Court Orders**, including orders from Coroner courts.\ ** GMC Investigations** may require disclosures. ** Statutory Obligations:**\ ** NHS Act (2006): service improvement** where there is no practical alternative\ (e.g. for very large cohort studies)**\ Notifiable diseases** should be reported to appropriate bodies (**PHE** usually),\ and **contact tracing** (including informing partner about HIV) \~ **Health Protection Act 2010\ The Road Traffic Act (1988)** means [all citizens] have an obligation to given information relating to perpetrators of traffic offences**\ ** An obligation to seek the person\'s **advice/consent for treatments** - for example, the **parent of a child who is not Gillick competent**, or the LPA of an adult without capacity**\ The Controlled Drugs Regulations (2013)** - responsible bodies must cooperate when sharing information relating to management/use of controlled drugs**\ The Care Act (2014)** means NHS trusts/CCGs must cooperate with enquiries about adults **at risk of abuse** (especially they are not the only person at risk of harm; also consider [elder] neglect/abuse) ** The Children Act (1989)** must make enquiries when there is reasonable cause to suspect that a **child is at risk of harm\ The FGM Act (2003)** means the police must be notified when a girl under 18 is found to have undergone FGM**\ The Abortion Regulations (1991)** mean doctors must notify the CMO of all terminations**\ The Terrorism Act (2000)** makes it a criminal offence to fail to disclosure information that may be relevant in preventing a terrorist act; generally also disclose **in** **public interests\ ** **What are the justifications for disclosure relating to adults at risk?\ ** With their consent Without their consent-- if they lack capacity\ If there is a statutory obligation: ○ There is [also] a child at risk ○ Request from Adult Safeguarding Board e.g. in elder abuse\ Public interest defence (risk of serious crime e.g. murder) **What type of injuries must be disclosed to the police?\ Anyone** presenting with a **gunshot wound** should be notified to the police**\ Knife wounds** that are the result of an **attack** should also usually be reported, **\ **[unless] it might cause the patient [harm or distress], or [damage their trust] in doctors. **Define the GDPR, and its key principles** The General Data Protection Regulations (2018) [govern storage] of [personal information].\ 6 key principles in data management: 1\. Information should be processed fairly, legally and transparently\ 2. This should only be for specified, explicit and legitimate purposes\ 3. Information must be adequate, relevant and limited\ 4. It should be accurate and corrected if not so 5\. Information should not be kept for longer than necessary\ 6. Information must be processed securely.  **What are the four rights patients have with respect to their data** (under GDPR)**?** **The right to be [informed]** - this means a concise and transparent Privacy Notice etc.\ **The right of [access]** - people can request to see their data as part of a '[SAR]'\ Data Subject Access Request (with third party data redacted)\ **The right to [rectification]** - people can expect errors to be corrected\ **The right to be [forgotten]** - unless there is a legitimate reason to keep the data, people can expect their data to be erased when it is no longer being used.**\ ** **End of Life Care** +-----------------------+-----------------------+-----------------------+ | *Legality of EoL | **By The | **By The | | Actions* | [Patient] | [Doctor]* | | | ** | * | +=======================+=======================+=======================+ | **[Active]{.underline | **Suicide**\ | **Medication given** | | } | Not a crime. | for **symptom** | | Interventions** | | **control** that | | | **Assisted suicide**\ | **may shorten life**\ | | | Criminal offence | Not a crime due to | | | for relatives and | Doctrine of Double | | | doctors to aid or | Effect, must be done | | | abet (Suicide Act | with | | | 1961). | [intention]{.underlin | | | | e} | | | | to [alleviate | | | | symptoms] | | | | !\ | | | | \ | | | | **Medication given** | | | | to **hasten** death\ | | | | Criminal offence - | | | | (attempted) murder | | | | even if patient | | | | consents (voluntary | | | | euthanasia) | +-----------------------+-----------------------+-----------------------+ | **[Passive]{.underlin | **Voluntary, | **Withdrawal of | | e} | capacitous** | treatment** as it is | | Omissions** | **refusal** **of | **futile** and of | | | life-saving | **no overall | | | treatment**\ | benefit**\ | | | Must be respected | Best interests | | | in a capacitous | decision -- which | | | person;\ | constitutes good | | | treatment | practice, therefore | | | continuation w/o | not a crime.\ | | | consent is unlawful | **\ | | | assault. | Withdrawal of | | | | treatment** as it is | | | | \"in patient\'s | | | | **best interests to | | | | die**\" paternalism\ | | | | May constitute | | | | murder/non-voluntary | | | | euthanasia if a | | | | substantial cause for | | | | death. | +-----------------------+-----------------------+-----------------------+ **Name the GMC principles of Good Palliative Care** ** Equality** - treat people at the end of life as well as any other**\ Presumption in favour of preserving life** - unless they have [specified otherwise] **\ Presumption of capacity\ Maximising capacity\ Overall benefit** - **best interests decisions** can include the [decision not to treat] **Name Case Law relevant in refusals of treatment** **Re B (2002)** - Ms B requested her ventilator (in place for C-spine injury) be turned off. Ruled to be capacitous refusal and transferred to another hospital for this to happen *○ Competent patient has absolute right to refuse treatment\ ○ Withdrawing ventilation is not the same as unlawful killing - the underlying injury caused her respiratory arrest\ ○ There is a right to conscientious objection for doctors but alternative arrangements must be made* **\ Name Case Law relevant in euthanasia** **R vs Adams (1957)** - GP charged with murder after administering large doses of opioids and barbiturates. Court found that these were given with the aim of attenuating suffering hence he was found not guilty *○ Established the Doctrine of Double Effect* **R vs Cox (1992)** - Dr Cox gave KCl to a patient in unbearable pain who had requested it - found guilty of attempted murder (i.e. Doctrine of Double Effect did not apply) *○ Confirms that death cannot be consented to/in patient\'s best interests* **Pretty vs the United Kingdom (2002)** - Ms Pretty argued that being deprived of the ability to die by suicide constituted unlawful discrimination. Rejected by courts *○ Confirms that there is no \'right to die\' in law* **\ Name Case Law relevant in assisted dying** ** R (Purdy) vs DPP (2009)** - Ms Purdy argued that the lack of clarity over whether her husband would be prosecuted for assisting her to travel to Dignitas constituted an impingement of her human rights, as it forced her to travel before she was ready to.\ *○ Court accepted this.* *○ Establishes that family members acting on compassion grounds where the individual has made a settled and voluntary decision are unlikely to be prosecuted, especially where the family member sought to dissuade/acted reluctantly/gave minimal assistance and\ co-operated with police.* *○ [However], factors in [favour of prosecution] include e.g. victim is a [child], [history of abuse],* *potential for [financial gain], [incapacitous decision] to die, etc.* **Airedale NHS Trust vs Bland (1993)** - allowed doctors and to make a best interests decision to withdraw ventilation, nutrition and hydration from Tony Bland, who was in a persistent vegetative state *○ Establishes precedent for best interest decisions about treatment withdrawal* *○* He became the first patient in English legal history to be allowed to die by the courts through the withdrawal of life-prolonging treatment including food and water. **What are the key ethical arguments FOR assisted dying?**\ **Equality** - disabled people are denied the ability to control their death, and can lead people with progressive illness to end their lives [earlier], while they are still able to\ **Consequentialism** - there is no valid distinction between acts and omissions - some active euthanasia may cause less suffering than withdrawal of treatment, [end benefit matters]\ **Autonomy** - respecting autonomy includes respecting [\'rational] suicide\'\ **Beneficence** - ending unbearable suffering may be overall in a person\'s [best interests]\ \ **What are the key ethical arguments AGAINST assisted dying?**\ **Coercion** - [vulnerable people] may feel a pressure to [hasten] their deaths due to [pressure] on families or services, including 'feeling like a burden'\ **Necessity** - if [palliative care] were truly effective, assisted dying would be irrelevant\ **Slippery slope** - implies a [progression] from voluntary to in/non-voluntary euthanasia\ **Sanctity** - the aims of medicine must be the [preservation of life and health] (Kantian view) **When should DNACPRs be considered?\ **Should be considered for anyone with a reasonable chance of having an arrest and recorded on a RESPECT form. They are most often made on the grounds that they are unlikely to be successful or are of no overall benefit. \*People can also [refuse] CPR, as with anything else. **When should you [not attempt] CPR, even if there is [no valid DNACPR] in place?\ ** The burdens outweigh the benefits\ The patient is known to have refused\ They are in the terminal phase of illness **When to refer to a coroner:**\ Unknown cause of death\ Death during operation or anaesthetic; Death at work of due to industrial causes\ Death was sudden and unexplained; Death was unnatural\ Death was due to violence or neglect; Death was under suspicious circumstances\ Death was in prison or custody (incl. immigration detention)\ Not seen by a doctor during last illness/doctor is unavailable **Fitness to Practice** **What are the [four domains] of Good Medical Practice according to the GMC?\ **[For Medical Students]: **\ **1. **Knowledge, skills and performance** - engage, respond to feedback, reflective practice\ 2. **Safety and quality** - raise concerns about systems/staff/peers that put patients at risk\ 3. **Communication, partnership and teamwork** - collaboration, treat all with respect\ 4. **Maintaining trust** - not pursuing relationships with patients, not expressing your beliefs in a distressing way, not plagiarising, being open about health concerns, avoiding drugs/alcohol misuse, criminal convictions/cautions. **What are the [four domains] of Good Medical Practice according to the GMC?**\ [For Doctors, 'Good Medical Practice and Duties of a Doctor']:\ **1. Knowledge, Skills and Performance\ **○ Make the care of the patient your [first concern]\ ○ Keep knowledge and skills [up to date] (to provide a good standard of care)\ ○ Recognise and work within the limits of your [competence]\ **2. Safety and Quality\ **○ Take prompt action if patient safety, dignity or comfort is [at risk]\ ○ Work for the health of patients and the [public]\ **3. Communication, Partnership and Teamwork\ **○ Treat patients as individuals and respect their rights to [dignity and confidentiality]\ ○ Work in [partnership] with patients (information sharing, shared decision-making and supporting independent self-care)\ ○ Work with [colleagues] in a way that serves patient interests **\ 4. Maintaining Trust\ **○ Be honest and open, act with [integrity]\ ○ Never [discriminate unfairly] against patients or colleagues\ ○ Never abuse patients\' trust in [you] or public's trust in the [profession] **What is the statutory duty of the GMC?\ **To "protect, promote and maintain the health and safety of the public by ensuring proper standards in the practice of medicine\". \*Doctors may be referred by their [employer], [colleagues] and [members] of the public. **What are the reasons for referral to the GMC?\ ** Professional [misconduct]/disregard of clinical responsibilities/abuse of trust\ Deficient [performance] - inadequate training and knowledge, and dishonesty/fraud\ Physical or mental ill-health *(though this cannot be the sole reason for erasure - must be a [serious condition] and the doctor must be [failing to follow appropriate medical advice] about [modifying their practice])*\ [Criminal conviction] or [caution] *(in the UK, or equivalent elsewhere)*\ Determination by a regulatory body\ Inability to speak or understand [English] well enough to safely practice **\ \ What two actions might the GMC take?\ ** Recommend informal action\ Refer the doctor to the Medical Professional Tribunal Service \[MPTS\] **What are actions the MPTS may take?\ **The MPTS aims to impose the [least serious sanction] that will [maintain] the public\'s safety and trust in the profession. The MPTS may either: Take no action (rare)\ Recommend conditions on the doctor\'s practice for \