Richard Huxtable

Research ethics committees and paternalism

In this paper the authors argue that research ethics committees (RECs) should not be paternalistic by rejecting research that poses risk to people competent to decide for themselves. However it is important they help to ensure valid consent is sought from potential recruits and protect vulnerable people who cannot look after their own best interests. The authors first describe the tragic deaths of Jesse Gelsinger and Ellen Roche. They then discuss the following claims to support their case: (1) competent individuals are epistemologically and ethically in the best position to say which risks are reasonable for them, so RECs should be no more restrictive than the “normal” constraints on people taking risks with themselves; (2) RECs do not judge individual competence (that is for researchers and psychiatrists); (3) individual liberty is mostly limited by what serves the public interest, and RECs do not determine public interest; (4) RECs may have a paternalistic role in preventing exploitation of competent people vulnerable to the use of incentives, and in protecting the interests of incompetent people; however, (5) the moral and political authority of RECs has not been established in this respect.

A systematic review of outcome reporting in colorectal cancer surgery

Evaluation of surgery for colorectal cancer (CRC) is necessary to inform clinical decision‐making and healthcare policy. The standards of outcome reporting after CRC surgery have not previously been considered.

Core Outcomes for Colorectal Cancer Surgery: A Consensus Study.

Background Colorectal cancer (CRC) is a major cause of worldwide morbidity and mortality. Surgical treatment is common, and there is a great need to improve the delivery of such care. The gold standard for evaluating surgery is within well-designed randomized controlled trials (RCTs); however, the impact of RCTs is diminished by a lack of coordinated outcome measurement and reporting. A solution to these issues is to develop an agreed standard “core” set of outcomes to be measured in all trials to facilitate cross-study comparisons, meta-analysis, and minimize outcome reporting bias. This study defines a core outcome set for CRC surgery. Methods and Findings The scope of this COS includes clinical effectiveness trials of surgical interventions for colorectal cancer. Excluded were nonsurgical oncological interventions. Potential outcomes of importance to patients and professionals were identified through systematic literature reviews and patient interviews. All outcomes were transcribed verbatim and categorized into domains by two independent researchers. This informed a questionnaire survey that asked stakeholders (patients and professionals) from United Kingdom CRC centers to rate the importance of each domain. Respondents were resurveyed following group feedback (Delphi methods). Outcomes rated as less important were discarded after each survey round according to predefined criteria, and remaining outcomes were considered at three consensus meetings; two involving international professionals and a separate one with patients. A modified nominal group technique was used to gain the final consensus. Data sources identified 1,216 outcomes of CRC surgery that informed a 91 domain questionnaire. First round questionnaires were returned from 63 out of 81 (78%) centers, including 90 professionals, and 97 out of 267 (35%) patients. Second round response rates were high for all stakeholders (>80%). Analysis of responses lead to 45 and 23 outcome domains being retained after the first and second surveys, respectively. Consensus meetings generated agreement on a 12 domain COS. This constituted five perioperative outcome domains (including anastomotic leak), four quality of life outcome domains (including fecal urgency and incontinence), and three oncological outcome domains (including long-term survival). Conclusion This study used robust consensus methodology to develop a core outcome set for use in colorectal cancer surgical trials. It is now necessary to validate the use of this set in research practice.

Synthesis and summary of patient‐reported outcome measures to inform the development of a core outcome set in colorectal cancer surgery

Patient‐reported outcome (PRO) measures (PROMs) are standard measures in the assessment of colorectal cancer (CRC) treatment, but the range and complexity of available PROMs may be hindering the synthesis of evidence. This systematic review aimed to: (i) summarize PROMs in studies of CRC surgery and (ii) categorize PRO content to inform the future development of an agreed minimum ‘core’ outcome set to be measured in all trials.

Clarifying the Data on Double Effect

In the first edition of Palliative Medicine this year, we published Seale’s paper on end of life decisions made by UK medical practitioners. This paper sparked much interest in the media. This is unsurprising given the contemporaneous publicity surrounding cases of socalled ‘death tourism’ and the revival of the Lord Joffe Bill. Correspondents extrapolated the small percentage of deaths in the UK, reported as involving end of life decisions, to estimate the number of deaths that occur in the UK secondary to voluntary euthanasia, involuntary or non-voluntary euthanasia, withdrawal or withholding of treatment (non-treatment decisions) and situations where alleviation of symptoms might have shortened life. The questionnaire used in the Seale paper was translated from a Dutch questionnaire, which has been used for similar surveys in Australia, New Zealand, and Europe. The data generated are important, however, in asking doctors to state whether they or a colleague intensified the alleviation of pain or symptoms ‘taking into account the probability or certainty’ or ‘partly with the intention’ of hastening the end of life, the questionnaire makes some questionable assumptions. We know that surveys of practice and attitudes in relation to end of life decisions are notoriously problematic, and experience of teaching medical students and qualified doctors about medico-legal and ethical issues at the end of life also suggests there is much misunderstanding in this area. Against this background, the questionnaire may encourage misleading responses to these particular questions. It is well documented that professionals have poor knowledge and inappropriate attitudes about the use of opioids at the end of life, believing, for instance, that addiction and tolerance are inevitable, respiratory depression limits dose escalation and that opioids shorten life. The literature suggests these attitudes and beliefs lead to inadequate prescribing of opioids for patients in pain at the end of life, resulting in sub-optimal symptom control. It is possible these attitudes and beliefs also exist in doctors who, nevertheless, prescribe opioids for patients at the end of life because they wish to control their pain. The work of Bilsen et al . suggests doctors ‘intensify the alleviation of pain and suffering’ considering the ‘possibility or certainty that this would hasten the patient’s death or with the explicit intention of hastening the patient’s death’ in 19 26% of deaths, depending on the European country surveyed. This implies that doctors believe they are hastening death, though the majority of these patients are taking only moderate doses of opioids (B/300 mg oral morphine equivalent per day). The doctrine of double effect is largely irrelevant in everyday practice. The doctrine states that a doctor can use measures (usually opioids) to alleviate symptoms at the end of life which might, as a secondary effect, shorten life, provided the doctor’s intention is the good outcome (symptom relief) rather than the bad (death). Critics of the doctrine argue only the doctor can ever know his or her intention, however common sense suggests intent could usually be judged by the drug, dose and route of administration chosen in relation to the patient’s circumstances and previous opioid requirement. Sykes and Thorns have reviewed the use of both opioids and sedatives in end of life care and conclude there is no evidence that their use ‘in palliative care requires the doctrine of double effect as a defence’. The problem with some questionnaires used in studies of end of life decisions is thus that the questions are based on the assumption that alleviation of symptoms may hasten death and are asked of doctors who believe it does. A close reading of the legal cases, along with experience of teaching and discussing these issues with clinicians and medical students, suggests there are three groups of doctors. The first, probably representing a tiny minority of the profession, intensifies symptom control significantly or uses other measures with the intention of hastening death, ie, practices euthanasia illegally. A second group of doctors are knowledgeable about care at the end of life and know that they very rarely, if ever, hasten death by achieving symptom control. The third group of doctors manages patients’ symptoms at the end of life appropriately, albeit believing, and reporting, they are hastening death. We propose this model explains the apparently high level of deaths involving end of life decisions reported, particularly hastening of death due to alleviation of pain and symptom control measures. Doctors who fall within the first and third groups are certainly a source of concern and we have yet to ascertain how best to educate and support them in providing palliative care of the highest standard for patients. However, it is also a Palliative Medicine 2006; 20: 395 396

Law, Ethics and Compromise at the Limits of Life : To Treat or not to Treat?

1. Judging Law and Ethics at the Limits of Life 2. Law at the Limits of Life: Children, Welfare and Best Interests 3. Law at the Limits of Life: Adults, Incapacity and Precedent Autonomy 4. The Limits of Law at the Limits of Life: To Treat or Not to Treat? 5. Calculating the Value of Life at the Limits of Life 6. A Case for Compromise at the Limits of Life 7. Crafting Compromise: Courts or Clinical Ethics Committees? 8. Committees, Courts and Compromise at the Limits of Life

Advance directives and suicidal behaviour

How do you manage a patient who has self harmed but states she doesn’t want life saving treatment? Anthony David and colleagues draw on the case of Kerrie Wooltorton to discuss the difficulties, and in an accompanying article Navneet Kapur and colleagues consider the validity of advance directives

THE ETHICS OF SHAM SURGERY IN PARKINSON'S DISEASE: BACK TO THE FUTURE?

Despite intense academic debate in the recent past over the use of ‘sham surgery’ control groups in research, there has been a recent resurgence in their use in the field of neurodegenerative disease. Yet the primacy of ethical arguments in favour of sham surgery controls is not yet established. Preliminary empirical research shows an asymmetry between the views of neurosurgical researchers and patients on the subject, while different ethical guidelines and regulations support conflicting interpretations. Research ethics committees faced with a proposal involving sham surgery should be aware of its ethical complexities. An overview of recent and current placebo-controlled surgical trials in the field of Parkinsons Disease is provided here, followed by an analysis of the key ethical issues which such trials raise.

‘In a twilight world’? Judging the value of life for the minimally conscious patient

The recent ruling from England on the case of M is one of very few worldwide to consider whether life-sustaining treatment, in the form of clinically assisted nutrition and hydration, should continue to be provided to a patient in a minimally conscious state. Formally concerned with the English law pertaining to precedent autonomy (specifically advance decision-making) and the best interests of the incapacitated patient, the judgment issued in Ms case implicitly engages with three different accounts of the value of human life, which respectively emphasise its self-determined, intrinsic and instrumental value. The judge appeared to be most persuaded by the intrinsic value of life and he concluded that treatment ought to continue. Assessing whether his approach or conclusion were ethically appropriate involves significant substantive and evidential questions regarding where the burden of proof should lie and what standard of proof should be required when decisions are to be made about the fates of patients inhabiting ‘twilight worlds’.

Whatever you want? Beyond the patient in medical law.

Simon Woods proposes that we ought to re-orientate clinical decisions at the end of life back towards the patient, so as to honour his or her account of their “global” interests. Woods condemns the current medico-legal approach for remaining too closely tethered to the views of doctors. In this response, I trace the story of Mrs Kelly Taylor, who sought to be sedated and have life-sustaining treatment withdrawn, and I do so in order to show not only why Woods is right to detect an asymmetry in the law but also why there is more to the legal landscape than first appears. I argue that patient choice is indeed bounded—most obviously by the views of the doctors (and the judges), but no less significantly by so-called “public interest” concerns. Woods’ proposal implicitly, and rightly, forces reconsideration of these public interest dimensions of medico-legal decision-making. This often invisible boundary is not presently granted the attention it deserves (not least by the judges themselves). However, as soon as we delve into the ethical values at stake, then it becomes apparent that there are many more questions to be asked regarding their meaning and interaction before we can determine the appropriate ethical prism through which to view the health care endeavour in English medical law.