CHAPTER 16: ETHICS AND MISCELLANEOUS Flashcards
What special ethical obligations might the surgeon have when replacing a well-established operation with a new technological approach?
A. DETAILED DESCRIPTION of the OPERATION during the INFORMED CONSENT process, stressing that he has not used the device / procedure to treat this condition before.
B. WRITE to the HEAD OF DEPT and CLINICAL DIRECTOR about his intentions.
C. AD HOC COMMITTEE with CD to consider a formal written plan of the proposed operation.
D. Provide the patient a GENERALISED DESCRIPTION of the operation to patients. Avoid overcomplicated technical details.
E. Obtain APPROVAL from his INSTITUTIONAL REVIEW BOARD (IRB) and ETHICS committee.
What are the stages of introducing a new procedure?
Assessment
- Prior to evaluation
- Training and experience
Approval
- Clinical governance
- Application forms
- Conflict of interest / perception of bias
- Ethical and social considerations
- Predicted throughput
- Informed consent and patient information
- Conditional approval
Introduction and Monitoring
- Learning curve
- Informed consent
- Monitoring
Research, Audit
What information is needed before presenting the new procedure to the committee?
Prior to evaluation
Has the technique been evaluated before?
- by international / national systematic review: similar to NICE elsewhere
- RCT
- case series / case reports
- reports of experiences from other institutions
How reliable is the evaluation?
How wide-ranging (wide application) or complex / technological is the procedure?
What training and experience does the operator and other staff involved have of the procedure?
Who is involved in the approval process?
- Head of Dept / Clinical Director / Dept of Surgery
- Credentials committee
- Clinical governance committees
- Technology / clinical practice committees
- Royal College representative
- Hospital / Health Service / Regional ethics committee
- Hospital / Health Board may have application form
- Outline draft patient information and informed consent for treatment
- Declare any conflict of interest / financial involvement
- Cost considerations for the future, predicted throughput - business plan
- Ethical and social considerations
What is a conditional approval?
- only by surgeons with a specified level of experience and expertise
- only for certain indications
- only for certain patient categories within a certain indication
- only under certain experimental conditions e.g. in the context of a controlled clinical trial.
What should be included in the informed consent for innovative / experimental procedures?
- The patient needs to be advised that technique is new and/or experimental.
- Potential risks of the new procedure, including any areas of uncertainty, should be outlined as accurately as possible.
- Information should be provided about criteria for selection of patients for the new procedure, as well as alternative treatments available.
- Patients should be able to access information about how many of these procedures have been performed at the hospital and by the surgeon who will perform the procedure.
How is monitoring carried out?
Indications, outcomes.
Record data reliably so performance comparisons can be made.
Standardise study designs.
Do audits / controlled trials as part of multi-centre study.
Must report any adverse events.
Involve the research, audit and academic surgery division.
NICE Guidelines to Hand Allotransplantation - GUIDANCE
GUIDANCE
- inform clinical governance leads in their Trust
- ensure patients understand the uncertainty about procedure safety and efficacy, longterm immunosuppression need and risks, functional recovery and rejection (early / delayed), alternative treatments
- performed in units experienced in hand reimplantation and transplant medicine
- pt assessed in line with NHS Blood and Transplant guidelines
- in accordance with Human Tissue Act
- submit data to the International Registry on Hand and Composite Tissue Transplantation (www.handregistry.com) and Transplant UK
- collect data on long-term functional outcomes, and any occurrence of malignancy associated with long-term immunosuppression
NICE Guidelines to Hand Allotransplantation - PROCEDURE
PROCEDURE
Preop
- assess patient motivation, compliance, psychological status
- match cadaveric hand for sex, size, appearance, and sometimes genetic matching
Operative procedure
- as per replant
What is the evidence for the efficacy of hand transplant?
70% reported improved quality of life
100% graft survival yr 1-2
25% graft failure later due to non-compliance to immunosuppression meds
90% of patients achieved tactile sensibility
72% developed discriminative sensibility
Outcome measures
- hand function
- rejection-free survival of hand transplant
- patient satisfaction
What are the risks of hand transplantation?
arterial thrombosis - 1/37 pts case series
venous thrombosis - 1/37
multiple AV fistulae - 1/37
marginal zone lymphoma 1/5 pts case series
opportunistic infections 65%
metabolic complications secondary to immunosuppression - 52%
Adverse events reported
- acute & chronic rejection
- poor neurological function of hand
- immunosuppression induced diabetes
- malignant changes
- graft vs host disease
What is the maximum dose of LA?
Lignocaine
- 3mg/kg plain
- 7mg/kg with adrenaline
- 200mg = 20ml of 1%
- 500mg = 50ml of 1%
Bupivacaine
- 2mg/kg with or without adrenaline
- 150mg = 30ml of 0.5% - high affinity for cardiac muscle
Prilocaine
- 6mg/kg
- Least toxic, but gives methaemoglobinaemia with toxicity
Cocaine
- 1.5mg/kg
- Topical only
Tumescent
- lidocaine 0.05 - 0.1%, 1:1,000,000 adr
- max 35-50mg/kg
What is LA’s mechanism of action?
Reversibly block Na/K Pump
Small sensory C-Fibres (pain) more sensitive than larger motor A-fibres (need many nodes of Ranvier to be affected) so may still be able to move.
Blocks pain first then cold, heat, light touch, deep pressure in turn
Increased lipid solubility causes faster penetration of lipid plasma membrane and therefore faster action
- Amides: Lidocaine, Bupivicaine, Prilocaine (2 ‘i’) - metabolised by liver
- Esters: Procaine, Benzocaine, Cocaine - metabolised by plasma pseudochlinesterase (to PABA) and excreted by kidney
What symptoms are associated with LA toxicity?
CNS Effects
o Stimulation: Restlessness, circumoral tingling, tinnitus, visual disturbance, shivers, tremors, clonic convulsions.
o Depression: Medulla - respiration, hypotension, bradycardia, arrhythmia, coma.
CVS Effects
o Myocardial Depression, decreased contractile force, excitability, increased refractory period.
Local Toxicity
o Depression of Ca activity leads to decreased excitability & contractility.
Allergic reaction – more with esters.
Malignant hyperpyrexia – more with amides.
What is the GMC Guidance on Duties of a Doctor?
- Make the care of the patient your first concern.
- Treat every patient politely and considerately.
- Respect patients dignity and privacy.
- Give patients information in a way they understand.
- Allow patients to be fully involved in decisions about their care.
- Keep professional knowledge and skills up to date.
- Recognise your professional limits.
- Be honest and trustworthy.
- Respect and protect confidential information.
- Make sure your personal beliefs do not prejudice patient care.
- Act quickly to protect patients from risk if you have good reason to believe that your colleague may not be fit to practise.
- Avoid abusing your position as a doctor.
- Work with colleagues in the way that best serves the patient.g
How does the GMC regulate doctors and their fitness to practice?
Powers
Prevent doctor from practising
Suspend a doctor from register
Place conditions on their registration
Formal action if
Behaved badly/inappropriately
Not done their job properly
Criminal conviction or caution
Been found guilty by another regulatory body
Fitness to practice impaired by physical/mental health
What is your duty regarding fitness to practice and conduct and performance of colleagues?
Duty to protect pts from risk posed by another doctors:
- Conduct
- Performance
- Health (including alcohol and substance abuse)
Chain of command to inform
- Clinical director
- Medical director
- Chief executive
- Director of public health
- If in doubt talk to own defence union/GMC
What are the ethical considerations to consent?
What is required for consent to be valid?
Success requires:
- Effective communication
- Patient trust
- Sufficient delivery of information – allowing informed decisions
- Respect of patient autonomy and right to decline
Valid consent requires patient who
- must be competent
- must have sufficient info to make a choice
- be able to give consent freely
How is consent obtained and what is sufficient delivery of information?
Consent – sufficient information
Details of diagnosis & prognosis
Uncertainties re: diagnosis
Options for Rx including option not to Rx
The purpose of the proposed Ix or Rx
The likely benefits & probability of success
Any serious or frequently occurring risks
Whether proposed Rx is experimental
How the patient will be monitored post Rx
The name of the responsible doctor
Must all be discussed in the context of: Patients beliefs Patients culture Patient occupation Ensure voluntary decision making
Tell me about the update on the UK law on consent.
Supreme Court ruling on Montgomery v Lanarkshire Health Board (11/3/15).
Mother with gestational diabetes was not told risk and baby was born with shoulder dystocia (9-10% risk). The court held that the obstetrician should have informed the mother of the risk and discussed the option of Caesarean section.
The Bolam test (whether a doctor’s conduct would be supported by a responsible body of medical opinion) no longer applies to the issue of consent.
Instead, the judgment now rests with “a reasonable person in the patient’s position.”
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.”
So what is required in the consent process now?
- Does the patient know about the material risks of the treatment I am proposing?
(a) What sort of risks would a reasonable person in the patient’s circumstances want to know?
(b) What sorts of risks would this particular patient want to know? - Does the patient know about reasonable alternatives to this treatment?
- Have I taken reasonable care to ensure that the patient actually knows all this?
- Do any of the exceptions to my duty to disclose apply here?
- Have I properly documented my consent process?
What counts as “material risk”?
A risk to which a reasonable person in the patient’s position would be likely to attach significance or a risk that a doctor knows—or should reasonably know—would probably be deemed of significance by this particular patient.
How do you obtain consent on a patient who lacks capacity?
Adults with Incapacity Act 2000 An adult is considered to be incapable if they are unable to: - Make decisions - Act on decisions - Communicate decisions - Understand decisions - Retain the memory of decisions.
Mental Capacity Act 2005 - proxy decision makers for incapacitated adults may be appointed
If there isn’t 1 / not available - principle of necessity to treat without consent applies, if it is in pt’s best interest
Must discuss with family if available
If unavailable - need to discuss with IMCA
What are the five key principles of the Mental Capacity Act
Principle 1: Capacity should always be assumed. A patient’s diagnosis, behaviour, or appearance should not lead you to presume capacity is absent.
Principle 2: A person’s ability to make decisions must be optimised before concluding that capacity is absent. All practicable steps must be taken, such as giving sufficient time for assessments; repeating assessments if capacity is fluctuating; and, if relevant, using interpreters, sign language, or pictures.
Principle 3: Patients are entitled to make unwise decisions. It is not the decision but the process by which it is reached that determines if capacity is absent.
Principle 4: Decisions (and actions) made for people lacking capacity must be in their best interests.
Principle 5: Such decisions must also be the least restrictive option(s) for their basic rights and freedoms.
How do you assess capacity?
Lack of capacity requires demonstration of both:
• Impairment of or disturbance in functioning of mind or brain (e.g. cognitive impairment, mental disorder, delirium, or intoxication)
• Inability to do any of the following:
- Understand information relevant to decision
- Retain relevant information for long enough to use it for the decision
- Use or weigh information
- Communicate decision
What are the principles of treatment for incapacitated adults?
Any intervention in the care of an incapacitated adult, either by healthcare professionals or by their welfare attorney or guardian, must:
- Benefit the patient
- Take account of the patient’s wishes
- Take into account the views of others involved in the care of the patient
- Allow the patient to retain as much of their independence as possible.
How are medical treatment decisions made for incapacitated adults?
- if a welfare attorney or guardian has been appointed, you must seek his or her consent on behalf of the patient where possible.
- if no welfare attorney or guardian, a certificate of incapacity with a specified validity period is issued.
- if there is any disagreement - seek Mental Welfare Commission for a specialist 2nd opinion
- in an emergency, you can treat an adult with incapacity if your actions will either save a life or avoid deterioration of the patient’s condition.
What is advanced decisions / advanced directive?
Advance decisions can be drawn up by anybody to specify treatments they would not want if they lost capacity.
They cannot demand treatments.
Provided advance decisions are made when the person had capacity, and they are sufficiently specific to cover the patient’s current predicament, clinicians must respect them.
They can be made verbally and can be reversed by the individual if they regain capacity.
Advance decisions that refuse life sustaining treatments (such as ventilation) have to be written, signed, and witnessed to be valid.
It is incumbent on clinicians to find out if an advance decision exists and assess whether it is valid.
What do you do to decide on treatment if a patient lacks capacity?
Decide on what treatment (if any) is in patient’s best interests
• Try to establish what the patient would have wanted if he or she had capacity. Research known opinions and values. Consult, but do not necessarily follow (unless a lasting power of attorney covers the decision), the opinions of family and friends
• Consider involving the IMCA (independent mental capacity advocates) service if the patient has no family or friends
• Beware of assuming that “best interests” is what the clinical team feels should happen; remember principle 3 of the Mental Capacity Act (the right to make unwise decisions)
What is an Independent Mental Capacity Advocate’s role?
- to support and represent a person who lacks capacity in making a specific decision, and who has no-one (other than paid carers) to support them.
The service comprises the independent organisations that assign someone to support and represent “unbefriended” people who lack capacity.
Their recommendations do not need to be adhered to by clinicians, although they should be taken into account as part of the decision making process.
Each local authority (borough) has appointed its own IMCA service.
When to instruct an IMCA.
- for care reviews or adult protection cases
- when serious medical treatment is being proposed (such as ventilation, major surgery, chemotherapy, and discontinuation of artificial nutrition or hydration)
- when accommodation for more than 28 days in hospital or 8 weeks in a care home is being arranged or changed
What is a lasting power of attorney?
A person could appoint a named person (the “donee”) with the authority to make decisions on their behalf if they lost capacity. Previously this only applied to property and affairs.
The Mental Capacity Act widens this authority to decisions about personal welfare, including health care and social affairs. It includes all decisions except those about the withdrawal of life saving treatment, unless explicitly authorised in the agreement.
Property and affairs lasting power of attorney agreements can start before a person has lost capacity, but personal welfare ones cannot.
Clinicians treating people without capacity must follow the decision of a donee, unless they are thought not to be acting in the person’s best interests or to be abusing the person lacking capacity, in which case you should follow the guidance of the code of practice. In serious cases you may need to seek a decision from the court of protection.
When making a lasting power of attorney agreement, the limits of the powers granted are specified—this is known as the “nature and effect.” Decisions about life sustaining treatment must be specified in the lasting power of attorney, and a signed statement from the attorney and a certificate completed by an independent third party are required.
A parallel system exists where the court of protection can appoint a deputy for someone who already lacks capacity. The deputy is likely to be a family member or director of social services. The deputy can consent on the person’s behalf but can never consent to decisions that will shorten the person’s life.
What is the court of protection?
Previously it was involved in the adjudication of the financial matters of people without capacity, but its role has widened to include health and welfare decisions. It will be more accessible and available to arbitrate on disputes and is now able to “establish precedent” with the same powers as the High Court.
Consent in children
Age 16 = adult with capacity to decide
< 16 = may have capacity depending on ability to understand (Gillick competence = Fraser ruling)
Where a competent child refuses Ix & Rx the following parties can authorise it if in their best interest
- Person with parental responsibility
- Court
(If parents want GC child to have an Ix & Rx but child (< 16) doesn’t want to then you can proceed despite their refusal – i.e. minors can consent but can’t refuse)
Under 16 - a person with parental responsibility may authorise or refuse Ix & Rx
but if deemed not in their best interest then can apply to court
Evidence based medicine - strength of recommendations
A - good evidence to support the use of the procedure
B - fair “”
C - poor “”
D - fair evidence to support the rejection of the use of the procedure
E - good “”
What is the ‘clinical negligence pre action protocol’?
Aims to resolve claims without going to court
Timescale
- if pt / lawyer requests pt’s health records, request must be acknowledged within 14 days and records supplied within 40 days
- pts must then send the dr a ‘letter of claim’ (their version of events, alleged injury and compensation sought)
- dr must respond within 4mths, outline what you did, reasoning behind decision you made, what your notes say
Who has parental responsibility?
- Not all parents have parental responsibility
Both do if
- Married at time of conception
- Married at some point after child’s birth
- Neither lose responsibility on divorce
- Unmarried fathers of children born after 1/12/2003 in England and Wales, provided his name is on birth certificate
- Adoptive parents (biological parents lose rights after adoption)
- If never married, mother only has responsibility but father can apply to courts
- A legal guardian can be appointed by courts
- If child is under local authority care, parents share responsibility with LA (who can restrict parental resp)
Quality of evidence (Therapy/Prevention/Etiology/Harm)
RCT Cohort Case control Case series Expert opinion
1a: Systematic reviews (with homogeneity) of RCTs.
1b: Individual RCTs (with narrow confidence interval)
1c: All or none RCTs
2a: Systematic reviews (with homogeneity) of cohort studies
2b: Individual cohort study or low quality RCTs (e.g.
What is a clinical negligence claim?
A demand for financial compensation for alleged harm caused by substandard clinical care
For claim to be successful, pt has to prove:
- BREACH OF DUTY - that the treatment was such that no reasonable practitioner would have delivered that care.
- CAUSATION - that the breach of duty / negligence caused or contributed to the injury, loss or damage suffered, and the pt wound not have suffered that injury w/o the breach.
