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.