Obtaining consent for major and minor surgical procedures

1. Obtaining consent for major and minor surgical procedures Dr. Paul Lai Department of Surgery CUHK

2. Questions to consider: • Why should we obtain informed consent from patients? • What are the requirements for an ‘ethically’ and ‘legally’ acceptable informed consent? • What should the doctor say?

3. Consideration for the patient: • Essential component of the consent • Does the patient have the capacity to understand relevant information and make a decision? • Is the procedure necessary?

4. Minimum requirements for informed consent are well defined : • Patients should receive information regarding: • nature of the procedure (including whether it is diagnostic or therapeutic) • risk involved, especially those that are severe and likely to occur • benefits of the procedure • alternatives to the procedure, along with their risks and benefits

5. Failure occurs due to • doctors think one procedure is too ‘routine’ or ‘trivial’ so that a complete informed consent is unnecessary • doctors are too busy • failure to recognise those decisions as warranting the same kind of attention to patient involvement as an invasive procedure • failure to assess the patient’s understanding of the procedure and the consent

6. Write it down ! • As there is no ideal consent form in the world, it is always the best to document everything relevant in the case notes. • It protects everybody, your patients, your colleagues and most importantly, yourself. • Verbal consent in medico legal actions will always be challenged

7. Practical tips • remember successful relationships between doctors and patients depend on trust; • respect patients’ right which is well written by the law; • effective communication is the key to enabling patients to make informed consent or decision about their treatment • providing sufficient information to patient and respond to question honestly, don’t withhold information necessary for patients to make decision • refer difficult patients/relatives to your senior before the situation is too sour

8. Informed ConsentinHospital Authority

9. Consent from Patients • Not something new • An essential part of daily medical practice • Part of quality care

10. Why Consent is Necessary ? • Every competent person has the right to decide whether to undergo any medical intervention even if a refusal may result in harm or death. • Basic personal right • Legal requirement • Ethical requirement

11. What is informed Consent ? • To support full disclosure to the patient regarding treatment options • A process of information exchange that allows the patient to make an informed choice

12. Basic Principles: • Patients have a fundamental legal and ethical right to determine what happens to their own bodies • Health professional must ensure the patients know enough to enable them to decide about treatment.

13. What is the Change ? • Change of yardstick From “ Reasonable Doctor” (Bolam) to “ Reasonable Patient”  a significant risk would affect the judgment of a reasonable patient

14. Recent Australian Cases • Perforation of uterus and pelvic inflammatory disease after insertion of intrauterine device • Anal stenosis after haemorrhoidectomy • Failure of elective eye surgery with vision worse after surgery • Hypertrophic scarring • Recanalisation after laparoscopic sterilisation • Nerve damage after surgery to remove LN from neck • Gastroparesis after stomach surgery • Accidental dural puncture during anaesthetic

15. Too little information  consent not valid • Poor handled Informed Consent can lead to • Complaint • Medico-legal litigation • Discipline for negligence

16. Consent  a patient’s signature on a consent form

17. A valid consent requires that the • Patient is competent; • Patient has sufficient information (and understanding); • Patient consents voluntarily (i.e. free from coercion, fear and deceit) Informed consent: lessons from Australia BMJ Vo.324, 39-41, 5 June 2002

18. UK – General Medical Council Principle of informed consent “ Successful relationships between doctors and patients depend on trust. To establish that trust you must respect patients’ autonomy – their right to decide whether or not to undergo any medical intervention……” (They) …… must be given sufficient information, in a way that they can understand, in order to enable them to make informed decisions about their own care.”

19. Sufficient Information Comprises explanation in person, and where applicable with the aid of consent forms and fact sheets Treat Fact sheet + consent forms as AIDE-MEMOIRE

20. Sufficient Information Information Particular to the Patient Verbal + documented in medical records: • Patient’s medical condition • What if not treated • Uncertainties in the doctor’s diagnosis • Options available, including non-treatment • Known concerns

21. Sufficient Information Information Particular to the Procedure Explanation as per fact sheet + documentation in medical records • Nature/Brief Description of the procedure • Common risk/complications • Uncommon risks/complications • What to expect before/after the procedure

22. Sufficient Information Additional Procedures • Anaesthesia and blood transfusion Explanation as per fact sheet documentation in medical records Additional Questions from the Patient

23. Surgical Interventions • Significant risk • Alternative management

24. Who should obtain consent? • The doctor undertaking the medical intervention is primarily responsible for obtaining consent • May delegate the task to a junior who • is competent in obtaining consent • has sufficient knowledge of the proposed procedure & the risks involved

25. How Long is a Consent Valid For? • The Court has not laid down any specific time limit • Advisable to review consent prior to procedure if • considerable time has elapsed • material changes in patient’s condition • material changes in procedure ( nature, purpose and risk) • new treatment options has become available

26. Documentation Best Practice in Informed Consent a written record

27. HA Informed Consent Exercise • Is not just another form • Is not just another exercise  “Proper Informed Consent management to benefit the patients and to protect our staff”

28. Working Group on Informed Consentunder HO Risk Management Committee Objectives: • To develop a set of procedures, guidelines and revised forms on informed consent in accordance to custom, laws, rights and practices • To develop a framework for information provided for patients • To facilitate the promulgation and operation implementation of the procedures, guidelines and revised informed consent forms Chairman: • Dr W C Yip, CCC(SI)/COS(Surg) Members: • Include cluster representatives

29. Actions taken: • review current consent procedures • reference from overseas best practices • revise Legal Principles (endorsed in HORMC) • revise forms, reference from NHS and Australia • wide spread consultation (HCEs, HORMC, Clusters, COCs, e.g. Psychiatry, Anesthesia, Nursing, etc.) • pilot new forms– KWH(Surg) and NDH(O&T), 3Q03

30. Key: A change of culture to ensure that patients become informed partners in their own care Informed Consent Package • Legal principles (revised) • New consent forms (3) • Informed Consent Standards AP S3 • Patient information leaflets • FAQ on Informed Consent • E-learning on informed Consent

31. The new forms • Consent for Operation/Procedure/Treatment 同意接受手術／醫療程序／治療表格 (For mentally competent adult, minor, or mentally incompetent patient with legal guardian) • Consent for Minor Operation/Procedure/Treatment 同意接受小手術／醫療程序／治療表格 (For cases where it is envisaged that the patient will remain alert throughout the procedure and no anaesthetist will be involved in their care) • Form for Patients who are Unable to Consent for Operation/Procedure/Treatment 無能力給予同意接受手術／醫療程序／治療表格 (For patient who is either unconscious or patient (child or adult) who is conscious and mentally incapable of consent and without guardian vested with power to consent)

32. Features Comprises explanation in person, and where applicable with the aid of consent forms and fact sheets. Information Particular to the Procedure • Nature/Brief Description of the procedure • Common risks/complications • Uncommon risks/complications • What to expect before/after the procedure Information Particular to the Patient • Patient’s medical condition • What if not treated • Uncertainties in the doctor’s diagnosis • Options available, including non-treatment • Known concerns Additional Procedures • Anaesthesia and blood transfusion Additional Questions from the Patient

34. Information sheet – GastrectomyINFORMATION SHEET FOR MEDICAL STAFF Gastrectomy • Nature of Operation The stomach is removed either partially or in total, and continuity to the small bowel is restored by reconstruction. • Risks and Complications The following 3 sentences are good introductory remarks: “1.There are risks and complications. 2. Common complications and those with important implications even though rare will be explained. 3. Medical staff will take every step to reduce their likelihood.” 1 Acute: Anastomotic bleeding and dehiscence Duodenal stump blow out (1-5%) Delayed gastric emptying Mortality (1-5%) Medical Cx : Atelectasis / Pneumonia Wound infection Bleeding : Anastomotic / Intra-peritoneal 2 Long Term: Dumping syndrome (<20%) Food bolus obstruction Adhesions Afferent loop obstruction Recurrent disease (cancer cases) Recurrent ulceration (ulcer disease) Gastric Remnant cancer (1-5% ≧ 20 years)