Ethics and Law in Surgical Practice

Summary

Consent is the point where surgical ethics becomes surgical law, and the commonest misunderstanding is about what the form is for. A signed consent form is not proof that valid consent has been properly obtained, it is simply evidence that disclosure may have been attempted [1]. This page covers the disclosure required before consent, the three conditions that make consent valid, capacity and its absence, consent in children including Gillick competence, the doctrine of medical necessity, and the duty of candour. Failure to obtain proper consent exposes the surgeon to two distinct civil actions: battery and negligence [1].

Definition

In surgical practice, respect for autonomy translates into the clinical duty to obtain informed consent before treatment begins [1].

For consent to be valid, an adult patient must satisfy three conditions: have capacity to give it, able to understand, remember and deliberate over the information disclosed, and to communicate their choice; not be coerced into decisions reflecting the preferences of others; and have been given sufficient information for the choice to rest on an accurate understanding of the reasons for and against the treatment [1].

Virtue, consent and its legal roots in Schwartz's account

• Beyond the four principles, Schwartz grounds surgical ethics in Aristotle's cardinal virtues (practical wisdom, courage, justice and temperance) practical wisdom being learned only through experience, so that residency is moral as much as technical training; Bosk called the postgraduate training of surgeons "above all things an ethical training" [2].
• Simple consent dates from Schloendorff v.
• Society of New York Hospital (1914), where a uterus was removed after consent only to examination under anaesthesia and Justice Cardozo held that every adult of sound mind has the right to determine what is done with their body and that operating without consent is an assault, except in emergency; the "professional practice standard" (disclose what experienced surgeons customarily disclose) gave way in Canterbury v.
• Spence (1972) to the "reasonable person standard", everything a reasonable patient would want to know about diagnosis, options and risks, within practical limits, with later litigation over complication frequencies, life expectancy and surgeon-specific results, though a documented effort to involve the patient makes inadequate-consent claims hard to prosecute [2].
• Adequate consent has four elements: documented capacity, disclosure sufficient for an informed choice, demonstrated understanding, and free authorisation without undue influence, and patients retain little of what is disclosed, so autonomy is stressed precisely when illness strips it away [2].

Pathophysiology

The gap this body of law exists to close is one of understanding rather than of goodwill. It is easy to underestimate the gap in understanding between a surgeon and a patient, how many patients would recognise that unilateral eye surgery might lead to contralateral blindness? [1].

The risks and side effects of many operations are not intuitive, and the surgeon is not in a position to guess how a foreseeable complication might affect the patient's plans for employment, leisure and family life [1]. The worked example is a budding Olympic gymnast, who might decline surgery on a quiescent posterior triangle lesion knowing the consequences of division of the accessory nerve [1]. That is why patients need to be informed beforehand, so they can choose whether to take the risk [1].

Clinical features

Six items must be disclosed during a formal and tangible discussion [1]:

1. The condition, and the reasons it warrants surgery. 2. The type of surgery proposed and how it might correct the condition. 3. The anticipated prognosis and expected side effects. 4. The unexpected hazards of the proposed surgery. 5. Any alternative and potentially successful treatments. 6. The consequences of no treatment at all.

Four conditions should surround that discussion where possible: a quiet venue; written material in the patient's preferred language to supplement speech, with diagrams where appropriate; time and help to reach their own decision; and the person taking consent should ideally be the surgeon who will carry out the treatment, not, as sometimes happens, a junior who has never performed the procedure and may not understand it well enough to counsel properly [1].

Communication is checked, not assumed. Attention must be paid to whether the patient has understood, to avoiding overly technical language, to providing translators where English is not the first language, and to asking whether there are further questions [1]. Where there is any doubt, the surgeon should ask the patient to explain the information back in their own words [1].

Difficult consent settings in Schwartz's account

In emergencies, when delay would be grave and the patient cannot consent, law and ethics empower the surgeon to provide whatever treatment is judged necessary to preserve life and health, on the social consensus that most people want this, with later withdrawal once prognosis clarifies; children give age-appropriate "assent" while parents or guardians consent, and case law holds that parents cannot place minors at mortal risk by refusing transfusion, so medicolegal and ethics teams are consulted and care proceeds; consent for organ donation is now sought by trained designated requestors or "independent" intensivists without a therapeutic relationship, preserving neutrality and the treating team's relationship [2]. Living donor liver transplantation (child grafts since the late 1980s, adult-to-adult since the late 1990s) makes a healthy person unwell with a partial hepatectomy mortality of about 0.15%, raising non-maleficence concerns answered by full disclosure of local complication and death rates, time to decide free of pressure and ethics committee support against the pressure of a relative's critical illness [2].

Etiology

Two civil actions can follow inadequate consent, and they are distinct [1].

Battery, in law, intentionally touching another person without their consent. Surgeons must give the conscious and capacitous patient sufficient information "in broad terms" about the treatment proposed and why; if the patient agrees, no other treatment should ordinarily be administered without further explicit consent [1].

Negligence, a patient may have been told enough to agree to be touched as proposed, yet the surgeon may still be in breach of duty for not providing sufficient information about the risks the treatment carries [1].

Diagnosis

The standard of risk disclosure varies between nations, but the test is patient-centred: surgeons should inform patients of the hazards that any reasonable person in the position of that patient would wish to know [1].

Thresholds and severity

In England and Wales a person is a child until their 18th birthday, and 16- and 17-year-olds are additionally described as young people [1].

Citizens under 16 are presumed incompetent, but may rebut that presumption by demonstrating sufficient maturity and intelligence to understand fully what is proposed, Gillick competence [1].

Advance directives, withdrawal of treatment and the double effect in Schwartz's account

Living wills specify treatments (ventilation, resuscitation, artificial nutrition, dialysis, antibiotics, blood) to permit or refuse in terminal illness but are vague, limited to "terminal" conditions (silent on dementia, delirium or vegetative states) and undermined by "affective forecasting", the public rates dialysis quality of life at 0.39 against patients' own 0.56 and colostomy at 0.80 against 0.92; durable powers of attorney appoint surrogates who predict patients' preferences with only 68% accuracy in meta-analysis, yet respecting the chosen surrogate respects the patient; the 1991 Patient Self-Determination Act requires US facilities to inform patients of their right to directives and document them at admission, yet few have them, and the SUPPORT trial's nurse-facilitated communication changed neither DNR timing nor agreement, pain or resource use; patients should be reassured that DNR does not mean "do not treat", perioperative suspension of DNR discussed, and surrogates identified early before elective surgery [2]. Withdrawing and withholding are ethically equivalent: Karen Ann Quinlan (1975, New Jersey Supreme Court) established the right to withdraw "extraordinary" ventilator support and Nancy Cruzan (1983 injury; US Supreme Court) allowed tube feeding to be withheld on "clear and convincing evidence" of the incapacitated patient's wishes, erasing any legal distinction between ordinary and extraordinary care under the Fourteenth Amendment provided burdens outweigh benefits; the double effect principle permits an act whose good effect (relief of suffering) is intended and produced directly, whose bad effect (hastened death) is foreseen but not intended, which is not intrinsically wrong and whose good sufficiently outweighs the bad (the difference between titrating opioids to relief and a bolus meant to cause apnoea) though properly dosed opioids rarely need the rule invoked; practical principles are that any treatment may be withdrawn if one may, symbolic therapies (nutrition, hydration) carry meaning beyond palliation, a spiritual adviser and ethics consult are offered, options range from adding nothing new to withdrawing all but comfort measures, disagreement prompts second opinions and palliative or ethics input, and a surgeon need not provide futile treatment but remains responsible for the patient, including transfer to a willing colleague [2].

Treatment and Management

The doctrine of medical necessity permits operating without consent in an emergency, to save life and prevent permanent disability, historically employed daily where unconscious emergency patients undergo surgery to save life and limb [1]. No consent is provided and none is required, provided the treatment is in the patient's best interests [1].

Temporary incapacity is handled differently from permanent. Where incapacity results from the presenting illness, intoxication, or a situation encountered mid-anaesthetic, surgery should wherever possible be postponed until capacity is restored and the patient can consent or refuse for themselves [1].

The line to hold is between necessity and convenience. Surgeons must respect the distinction between procedures necessary to prevent death or irremediable harm and those done merely out of convenience: if the patient consents only to a dilatation and curettage, do not perform a hysterectomy "in her best interests" simply because she is anaesthetised [1].

Palliative care and care of the dying in Schwartz's account

• Palliative care (the term coined in 1975 by Canadian surgeon Balfour Mount) is interdisciplinary relief of suffering and promotion of quality of life offered alongside all other treatment and not confined to poor prognosis, defined by the WHO as improving quality of life in life-threatening illness through early identification and impeccable treatment of pain and physical, psychosocial and spiritual problems; no therapy including surgery is excluded, success is judged by relief of symptoms rather than effect on disease, and consultation is indicated for progressive life-limiting conditions with burdensome symptoms, functional or cognitive decline, clarification of goals, ethical dilemmas, a patient or surrogate choosing comfort measures only, imminent death, and bereavement support for staff; hospice is palliative care for a prognosis of 6 months or less (Medicare Part A, renewable on recertification), and although most Americans wish to die at home nearly 75% die in institutions [2].
• Kleinman located a "moral core to healing" in caring for the illness experience as well as controlling disease; Saunders' "total pain" sums physical, psychological, social and spiritual domains; Christakis charged physicians with abdicating prognosis, yet functional status is the strongest predictor, ECOG 2 (independent in basic ADLs) months, ECOG 3 (resting half the day, needing help) weeks to a few months, ECOG 4 (bed-to-chair, dependent) days to weeks, supplemented by APACHE and MODS in critical illness, the Karnofsky scale (100 to 0), the Palliative Performance Scale (ambulation, activity, self-care, intake, consciousness) and the 25-item Missoula-Vitas Quality of Life Index [2].
• Bad news follows six steps, setting and seating, what the patient knows, what they want to know, giving information, empathy, and expectations and aftercare, with a quiet private room, listening, a "warning shot", silence after the news and realistic hope of non-abandonment and symptom control, the empathic response naming the emotion rather than sharing it, and the most immediate distress relieved first [2].
• The syndrome of imminent demise brings bedbound dependence, waning appetite and thirst, a dry mouth (worsened by anticholinergics, mouth breathing and dry oxygen) mistaken for thirst, dysphagia forcing IV, subcutaneous, rectal, sublingual, buccal or transdermal routes, retained secretions ("death rattle"), Cheyne-Stokes breathing, cool mottled limbs, falling urine output, incontinence, somnolence, disorientation, altered sleep, vivid "waking dreams", and in cachexia open eyes from loss of retro-orbital fat, while apparently comatose patients may still be aware [2].
• Dyspnoea is treated with opioids titrated to 15–20 breaths a minute (starting at half to two-thirds the pain dose, or a 25–50% increment of the current breakthrough dose), a fan across the face and humidified oxygen at 2–3 L/min for subjective relief regardless of saturation; pain often eases as activity falls and renal clearance drops, but crises demand parenteral infusions, non-verbal signs (grimacing, tachypnoea) are watched and opioids are never stopped abruptly for somnolence or slowed breathing because withdrawal is distressing; somnolence responds to reassuring presence, agitated delirium may need neuroleptics, and opioids or benzodiazepines can worsen it in the elderly; pharmacotherapy principles are to believe the patient, avoid drugs not tied to symptoms, use multitasking agents (haloperidol for delirium and nausea), spare opioids with adjuvants, blocks and procedures, avoid fixed combinations, intramuscular injections and excess cost, dose orally and on schedule not as needed, "start low and go slow" in the old, hypoproteinaemic and azotaemic, climb the WHO ladder (non-opioid ± adjuvant for VAS 1–3; weak opioid plus non-opioid ± adjuvant for 4–6; strong opioid ± non-opioid ± adjuvant for 7–10) and convert at equianalgesic doses [2].
• Schwartz's analgesic table gives paracetamol 325–650 mg four times daily (maximum 3200 mg, under 2400 with other hepatotoxins), ibuprofen 200–400 mg (maximum 3200), naproxen 250 mg twice daily (maximum 1300), hydrocodone 5–7.5 mg or oxycodone 5 mg 4-hourly for moderate pain, morphine 10 mg orally 2–4-hourly or 2–4 mg IV/SC 1–2-hourly (caution in the old, renal and hepatic), hydromorphone 1–3 mg orally or rectally 4-hourly or 1 mg IV/SC, transdermal fentanyl 12 µg/h every 72 hours (never for acute pain or opioid-naive patients, unpredictable in cachexia), methadone as a cheap, multi-route second-line agent for neuropathic pain needing expert dosing, methylphenidate 2.5–5 mg twice daily for persistent sedation, bowel stimulant prophylaxis with every opioid, no place for pethidine, propoxyphene or mixed agonist-antagonists, and adjuvants, amitriptyline, nortriptyline, doxepin or imipramine 10–25 mg for burning pain and allodynia (avoided in the old), gabapentin 100–1200 mg three times daily to 3600 mg, carbamazepine 200 mg twice daily, pregabalin 25–50 mg three times daily or valproate 250 mg three times daily for shooting pain, 5% lidocaine patches (maximum three per 12 hours) and lidocaine-prilocaine for post-herpetic neuralgia, pamidronate or zoledronate for bone pain in myeloma and breast cancer (not in renal failure), nasal calcitonin, dexamethasone for bone, nerve-compression and visceral pain, strontium-89 for osteoclastic bone pain with a 4–6 week delay and prognosis over 3 months, and octreotide for secretory visceral pain [2].

Procedural interventions

Not every touch needs formal consent. Surgical care would grind to a halt if explicit informed consent were required every time a patient is touched; it is an elementary step to ask whether they mind being examined, and the usual answer is acceptance [1]. This illustrates that the legal and ethical rules governing a surgeon are often no more than an expression of good clinical practice, in this case, politeness [1].

Contemporaneous notes are the practical safeguard. Because a consent form often contains very little of what was actually communicated, and because patients can and do deny afterwards that appropriate information was given or that communication was effective, surgeons are well advised to make brief notes of the discussion [1].

Pronouncing death and aid in dying in Schwartz's account

Death is not declared in a hypothermic body until rewarming has been attempted; confirmation rests on unresponsiveness to voice and touch, absent heartbeat and respiration, fixed pupils, waxen colour as blood settles, poikilothermia and sphincter relaxation; home hospice deaths go to the on-call hospice nurse (some states require a brief police report), hospital deaths are told to the family in person, a coroner or medical examiner is involved for specific circumstances such as operating-room deaths, a death certificate is completed, autopsy and donation may be raised and religious rituals accommodated; bereavement is the experience of loss and mourning the adaptation to it, both beginning before death as independence, vitality and control are lost, and caregivers grieve too [2]. Five European countries, Canada and six US states have legalised some form of aid in dying, US laws permitting prescription of a lethal dose to mentally competent, terminally ill adults, raising questions of the benefit and harm of death, the relation between passive and active euthanasia and withholding or withdrawing treatment, the morality of participation and conscientious objection, so surgeons should know local legislation to inform patients who ask [2].

Complications

The failure mode of the consent process is that it becomes about the signature. The process can become overly focused on obtaining the patient's signature rather than ensuring appropriate disclosure has been provided and understood [1].

The two legal consequences (battery and negligence) follow from two different failures: touching without agreement, and agreeing without adequate information about risk [1].

Professional ethics: conflicts, research, innovation, authorship and error in Schwartz's account

• Conflicts of interest arise where the surgeon's gain (money, or in academia power, tenure or authorship, as when accruing patients to a series) competes with the patient's interest, the surgeon-scientist's dual role needing scrutiny; Emanuel's seven requirements for ethical research are value, scientific validity, fair subject selection, favourable risk–benefit ratio, independent review, informed consent and respect for enrolled subjects (privacy, withdrawal, monitoring); surgical research is mostly retrospective because surgeons struggle to hold equipoise (genuine uncertainty between arms) and Meakins proposed a modified evidence hierarchy for surgery; sham surgery is contested (every operation carries risk, yet without it the placebo effect of surgery cannot be excluded), demands that the operating surgeon not be the assessor, and is permissible only case by case under strict criteria [2].
• Innovation moved surgery forward, Korean and Vietnam War surgeons ignored guidelines mandating ligation and amputation and proved vascular reconstruction, and a modification for one patient within a surgeon's judgment may not need trial-style approval, but repeated use of a new technique with outcome study requires IRB approval, explicit consent and senior consultation, the process being far less regulated than FDA drug approval [2].
• Authorship confers credit and accountability and feeds promotion, tenure and intellectual property, but supervision or funding alone no longer qualifies and industry "ghost writing" under senior names is condemned; the ICMJE requires all four of substantial contribution to conception, design, acquisition, analysis or interpretation; drafting or critical revision; final approval; and accountability for integrity, others are acknowledged, funding, supervision, administration, writing assistance and editing excluded, each author vouching for co-authors, contributions disclosed at submission as The Lancet does, and authorship discussed early and throughout [2].
• The morbidity and mortality conference, a time-honoured peer-pressure ritual protected by peer-review privilege, is a poor method of analysing error and rarely shared with patients; "To Err Is Human" framed errors as preventable adverse events, and disclosure of one's own errors expresses candour and respect for persons, supports treatment of consequences and prevention, and is required by autonomy and justice, whereas concealment breaches professional ethics and public trust; disclosing another surgeon's apparent error (an injured duct, a stenotic anastomosis) calls for non-judgmental assessment and, where the mistake is clear, action as the patient's agent [2].

Outcomes

The measure of a consent process is not the form but the understanding. It is not good enough just to go through the motions of providing patients with the information required for considered choice [1].

Where that understanding is achieved, patients can link their clinical prospects to the management of the rest of their lives, and the lives of others for whom they are responsible [1], which is the whole purpose of the disclosure list at the top of this page.

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