What Are Our Moral Duties? Critical Reflections on Clinical Equipoise and Publication Ethics, Clinical Choices, and Moral Theory

Cherry, Mark J.

doi:10.1093/jmp/jht053

Cited by 3 publications

(2 citation statements)

References 16 publications

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“…The investigators and hospital ethics committee judged that clinical equipoise existed for LuFla because the consequences of stopping immunosuppression for patients lacking clinical evidence of LN activity but with persistent histologic activity are unknown. [14][15][16] Patients with an estimated glomerular filtration rate < 60 ml/min per 1.73 m 2 were excluded at the request of the ethics committee because of concern that patients who already had impaired kidney function and less renal reserve may have been at risk for kidney failure if LN flared. The investigators and ethics committee were less confident that equipoise extended to such patients.…”

Section: Methodsmentioning

confidence: 99%

A prospective observational cohort study highlights kidney biopsy findings of lupus nephritis patients in remission who flare following withdrawal of maintenance therapy

Rosa

Azzato

Toblli

et al. 2018

Kidney International

126

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One of the most difficult management issues in lupus nephritis (LN) is the optimal duration of maintenance immunosuppression after patients are in clinical remission. Most patients receive immunosuppression for years, based mainly on expert opinion. Prospective data are unavailable. Complicating this issue are data that patients in clinical remission can still have histologically active LN; however, the implications of this are unknown. To study this, the Lupus Flares and Histological Renal Activity at the end of Treatment study (ClinicalTrial.gov, NCT02313974) was designed to examine whether residual histologic activity predisposes to LN flares in class III and IV LN. Patients in complete clinical remission for at least 12 months who had received at least 36 months of immunosuppression were eligible. Patients consented to a second kidney biopsy, were tapered off maintenance immunosuppression and were then followed prospectively for LN flares over 24 months. Forty-four patients were enrolled, and 36 completed the study. LN flares occurred in 11 patients, and ten of these had residual histologic activity on the second biopsy. All patients with an NIH activity index over two flared. The activity index and duration of systemic lupus erythematosus at the second biopsy were independent predictors of flare. A predictive equation based on these variables discriminated between flare and no flare with a sensitivity of 100%, specificity of 88%, and a misclassification rate of 8.3%. Thus, a repeat kidney biopsy may be useful in managing maintenance immunosuppression in LN, and patients in histologic remission may be candidates for withdrawal of therapy.

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Section: Methodsmentioning

confidence: 99%

A prospective observational cohort study highlights kidney biopsy findings of lupus nephritis patients in remission who flare following withdrawal of maintenance therapy

Rosa

Azzato

Toblli

et al. 2018

Kidney International

126

View full text Add to dashboard Cite

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“…While Freedman's conception of 'clinical equipoise' remains the standard of clinical trial ethics, his publications leave many important questions unanswered. For example, how is the diversity of opinion in the medical community to be determined, and how much disagreement is required to justify a clinical trial (35)? Most importantly, how is the relevant community to be defined with regards to the existence of 'clinical equipoise' around a specific question?…”

Section: Clinical Equipoise Opinion and Consensusmentioning

confidence: 99%

Fallibility: A New Perspective on the Ethics of Clinical Trial Enrollment

Shamy

Stahnisch

Hill

2014

International Journal of Stroke

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The ethical principle of 'equipoise', introduced in 1974, represents the most widely influential justification for the enrollment of patients into randomized clinical trials. However, definitions of equipoise vary, and its terms are not universally accepted. In this paper, we suggest a new way of approaching the ethics of clinical trial enrollment, which we call fallibility. The principle of fallibility argues that all physician opinions are sufficiently uncertain to warrant investigation, and that the ethical justification for any trial becomes a question of its epistemic validity, by which we mean the strength of its hypotheses and methods. The principle of fallibility can be translated into practice through the virtues of humility, skepticism and caring. While we cite recent examples from stroke medicine to demonstrate the limitations of equipoise, we propose that fallibility may offer a more general means of addressing the controversies that arise surrounding randomized controlled trials in many disciplines of medicine.

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Duties of a Friend and to the Profession are Many and Great- “Amici et Professionis Officia Multa et Magna Sunt”

Colenda

2024

The American Journal of Geriatric Psychiatry

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What Are Our Moral Duties? Critical Reflections on Clinical Equipoise and Publication Ethics, Clinical Choices, and Moral Theory

Cited by 3 publications

References 16 publications

A prospective observational cohort study highlights kidney biopsy findings of lupus nephritis patients in remission who flare following withdrawal of maintenance therapy

A prospective observational cohort study highlights kidney biopsy findings of lupus nephritis patients in remission who flare following withdrawal of maintenance therapy

Fallibility: A New Perspective on the Ethics of Clinical Trial Enrollment

Duties of a Friend and to the Profession are Many and Great- “Amici et Professionis Officia Multa et Magna Sunt”

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