Ethical Care Requires Pragmatic Care Research to Guide Medical Practice Under Uncertainty

Overview

Journal Trials

Publisher Biomed Central

Specialties General Medicine
Pharmacology

Date 2021 Feb 16

PMID 33588946

Citations 6

Authors

Tim E Darsaut

Jean Raymond

Affiliations

Soon will be listed here.

Abstract

Background: The current research-care separation was introduced to protect patients from explanatory studies designed to gain knowledge for future patients. Care trials are all-inclusive pragmatic trials integrated into medical practice, with no extra tests, risks, or cost, and have been designed to guide practice under uncertainty in the best medical interest of the patient.

Proposed Revision: Patients need a distinction between validated care, previously verified to provide better outcomes, and promising but unvalidated care, which may include unnecessary or even harmful interventions. While validated care can be practiced normally, unvalidated care should only be offered within declared pragmatic care research, designed to protect patients from harm. The validated/unvalidated care distinction is normative, necessary to the ethics of medical practice. Care trials, which mark the distinction and allow the tentative use of promising interventions necessarily involve patients, and thus the design and conduct of pragmatic care research must respect the overarching rule of care ethics "to always act in the best medical interest of the patient." Yet, unvalidated interventions offered in contexts of medical uncertainty cannot be prescribed or practiced as if they were validated care. The medical interests of current patients are best protected when unvalidated practices are restricted to a care trial protocol, with 1:1 random allocation (or "hemi-prescription") versus previously validated care, to optimize potential benefits and minimize risks for each patient.

Conclusion: Pragmatic trials can regulate medical practice by providing (i) a transparent demarcation between unvalidated and validated care; (ii) norms of medical conduct when using tests and interventions of yet unknown benefits in practice; and eventually (iii) a verdict regarding optimal care.

Citing Articles

Keeping Up With Technological Innovation: The Moral Imperative for Pragmatic Clinical Trials in Interventional Pulmonology.

Maldonado F, Paez R, Lentz R, Ratwani A, Casey J Chest. 2024; 167(3):892-898.

PMID: 39577764 PMC: 11882772. DOI: 10.1016/j.chest.2024.11.010.

Reply.

Raymond J, Darsaut T AJNR Am J Neuroradiol. 2023; 44(8):E36-E37.

PMID: 37500283 PMC: 10411846. DOI: 10.3174/ajnr.A7958.

Stent-Assisted Coiling in the Treatment of Unruptured Intracranial Aneurysms: A Randomized Clinical Trial.

Boisseau W, Darsaut T, Fahed R, Drake B, Lesiuk H, Rempel J AJNR Am J Neuroradiol. 2023; 44(4):381-389.

PMID: 36927759 PMC: 10084896. DOI: 10.3174/ajnr.A7815.

Intervention Fidelity in Pain Pragmatic Trials for Nonpharmacologic Pain Management: Nuanced Considerations for Determining PRECIS-2 Flexibility in Delivery and Adherence.

Kerns R, Davis A, Fritz J, Keefe F, Peduzzi P, Rhon D J Pain. 2022; 24(4):568-574.

PMID: 36574858 PMC: 10079571. DOI: 10.1016/j.jpain.2022.12.008.

Reply.

Darsaut T, Chagnon M, Raymond J AJNR Am J Neuroradiol. 2022; 44(1):E9-E10.

PMID: 36574315 PMC: 9835901. DOI: 10.3174/ajnr.A7732.

References

Raymond J, Long H . [Science and ethics, therapeutic misconception and mirage]. J Neuroradiol. 2008; 35(5):268-72. DOI: 10.1016/j.neurad.2008.04.004. View

McRae A, Weijer C, Binik A, Grimshaw J, Boruch R, Brehaut J . When is informed consent required in cluster randomized trials in health research?. Trials. 2011; 12:202. PMC: 3184061. DOI: 10.1186/1745-6215-12-202. View

Lyerly A, Little M, Faden R . The second wave: Toward responsible inclusion of pregnant women in research. Int J Fem Approaches Bioeth. 2009; 1(2):5-22. PMC: 2747530. DOI: 10.1353/ijf.0.0047. View

Horn A, Weijer C, Grimshaw J, Brehaut J, Fergusson D, Goldstein C . An Ethical Analysis of the SUPPORT Trial: Addressing Challenges Posed by a Pragmatic Comparative Effectiveness Randomized Controlled Trial. Kennedy Inst Ethics J. 2018; 28(1):85-118. DOI: 10.1353/ken.2018.0003. View

Fahed R, Finitsis S, Khoury N, Deschaintre Y, Daneault N, Gioia L . A randomized pragmatic care trial on endovascular acute stroke interventions (EASI): criticisms, responses, and ethics of integrating research and clinical care. Trials. 2018; 19(1):508. PMC: 6146964. DOI: 10.1186/s13063-018-2870-6. View

Smith-Bindman R, Miglioretti D, Johnson E, Lee C, Feigelson H, Flynn M . Use of diagnostic imaging studies and associated radiation exposure for patients enrolled in large integrated health care systems, 1996-2010. JAMA. 2012; 307(22):2400-9. PMC: 3859870. DOI: 10.1001/jama.2012.5960. View

Zarin D, Goodman S, Kimmelman J . Harms From Uninformative Clinical Trials. JAMA. 2019; 322(9):813-814. DOI: 10.1001/jama.2019.9892. View

Carlo W, Finer N, Walsh M, Rich W, Gantz M, Laptook A . Target ranges of oxygen saturation in extremely preterm infants. N Engl J Med. 2010; 362(21):1959-69. PMC: 2891970. DOI: 10.1056/NEJMoa0911781. View

Fahed R, Darsaut T, Raymond J . The Introduction of Innovations in Neurovascular Care: Patient Selection and Randomized Allocation. World Neurosurg. 2018; 118:e99-e104. DOI: 10.1016/j.wneu.2018.06.127. View

10.

Raymond J, Darsaut T, Kotowski M, Bojanowski M . Unruptured intracranial aneurysms: why clinicians should not resort to epidemiologic studies to justify interventions. AJNR Am J Neuroradiol. 2011; 32(9):1568-9. PMC: 7965366. DOI: 10.3174/ajnr.A2764. View

11.

Raymond J, Darsaut T, Altman D . Pragmatic trials can be designed as optimal medical care: principles and methods of care trials. J Clin Epidemiol. 2014; 67(10):1150-6. DOI: 10.1016/j.jclinepi.2014.04.010. View

12.

Raymond J, Darsaut T, Roy D . Care and research concepts should be revised to practice outcome-based medical care. J Clin Epidemiol. 2019; 116:155-160. DOI: 10.1016/j.jclinepi.2019.05.025. View

13.

Krugman S . Experiments at the Willowbrook State School. Lancet. 1971; 1(7706):966-7. DOI: 10.1016/s0140-6736(71)91462-0. View

14.

Brower R, Matthay M, Morris A, Schoenfeld D, Thompson B, Wheeler A . Ventilation with lower tidal volumes as compared with traditional tidal volumes for acute lung injury and the acute respiratory distress syndrome. N Engl J Med. 2000; 342(18):1301-8. DOI: 10.1056/NEJM200005043421801. View

15.

Raymond J, Darsaut T, Molyneux A . A trial on unruptured intracranial aneurysms (the TEAM trial): results, lessons from a failure and the necessity for clinical care trials. Trials. 2011; 12:64. PMC: 3060834. DOI: 10.1186/1745-6215-12-64. View

16.

CHALMERS T . Randomization of the first patient. Med Clin North Am. 1975; 59(4):1035-8. DOI: 10.1016/s0025-7125(16)32001-6. View

17.

Joffe S, Miller F . Bench to bedside: mapping the moral terrain of clinical research. Hastings Cent Rep. 2008; 38(2):30-42. DOI: 10.1353/hcr.2008.0019. View

18.

Appelbaum P, Roth L, Lidz C . The therapeutic misconception: informed consent in psychiatric research. Int J Law Psychiatry. 1982; 5(3-4):319-29. DOI: 10.1016/0160-2527(82)90026-7. View

19.

Raymond J, Fahed R, Darsaut T . Randomize the first patient. J Neuroradiol. 2017; 44(5):291-294. DOI: 10.1016/j.neurad.2017.03.004. View

20.

Prasad V, Vandross A, Toomey C, Cheung M, Rho J, Quinn S . A decade of reversal: an analysis of 146 contradicted medical practices. Mayo Clin Proc. 2013; 88(8):790-8. DOI: 10.1016/j.mayocp.2013.05.012. View