Statistics, Ethics & Law Flashcards

What is 'Bolam test' in the context of medical negligence law in the UK?

Answer: A standard that a doctor is not negligent if their practice is accepted by a responsible body of medical opinion

The Bolam test (Bolam v Friern Hospital Management Committee, 1957) states that a doctor is not negligent if they act in accordance with a practice accepted by a responsible body of medical professionals, even if other practitioners would have acted differently. The Bolitho modification (1997) requires that the body of opinion must also be logically defensible.

A patient has signed a consent form but during surgery a new finding is discovered that requires an additional procedure not discussed preoperatively. The patient is unconscious. What is the appropriate action?

Answer: Only perform the additional procedure if it is immediately necessary to save life or prevent serious harm

Consent is specific to what was discussed and agreed preoperatively. Under anaesthesia, the patient cannot consent to additional procedures. The additional procedure should only be performed without consent if it is immediately necessary to save life or prevent serious harm, and if delaying poses unacceptable risk. Non-urgent procedures should be deferred.

What is the ethical principle of 'non-maleficence' in surgery?

Answer: The duty to avoid causing unnecessary harm through actions or omissions

Non-maleficence ('first, do no harm' — primum non nocere) is the duty to avoid causing unnecessary harm. In surgery, it requires weighing the risks of intervention against benefits, ensuring procedures are technically performed to the highest standard, and not proceeding when risk outweighs benefit.

What does the Montgomery ruling (2015) require regarding informed consent?

Answer: Patients must be informed of any risks a reasonable patient would want to know about, not merely what the clinician considers material

Montgomery v Lanarkshire Health Board (2015) replaced the Bolam-based approach to consent with a patient-centred standard: clinicians must disclose all material risks that a reasonable patient in that patient's position would want to know. This shifts the standard from 'what doctors consider material' to 'what patients consider material'.

A patient who is a competent adult refuses an amputation that is likely to save their life from gas gangrene. What is the surgeon's legal and ethical obligation?

Answer: Respect the refusal, ensure the patient has full information, document extensively, and seek ethics support

A competent adult's refusal of treatment is legally and ethically binding, even when it results in death. The surgeon must ensure the decision is informed, not subject to undue influence, and made with capacity. Detailed documentation, ethics consultation, and support for the patient and family are essential.

Which type of research bias occurs when patients lost to follow-up are systematically different from those who remain?

Answer: Attrition bias

Attrition bias occurs when participants drop out or are lost to follow-up in a non-random manner — often those who drop out are sicker, poorer, or have experienced adverse effects. If these patients are different from those retained, the results may overestimate or underestimate the treatment effect.