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J Clin Epidemiol. 2014 Oct;67(10):1150-6. doi: 10.1016/j.jclinepi.2014.04.010. Epub 2014 Jul 16.

Pragmatic trials can be designed as optimal medical care: principles and methods of care trials.

Author information

1
Department of Radiology, Centre hospitalier de l'Université de Montréal (CHUM), Notre-Dame Hospital, 1560 Sherbrooke East, Pavilion Simard, Suite Z12909, Montreal, Quebec, Canada H2L 4M1. Electronic address: jean.raymond@umontreal.ca.
2
Division of Neurosurgery, Department of Surgery, Mackenzie Health Sciences Centre, University of Alberta Hospital, 8440 112th Street, Edmonton, Alberta, Canada T6G 2B7.
3
Centre for Statistics in Medicine, University of Oxford, Botnar Research Centre, Windmill Road, Oxford, UK OX3 7LD.

Abstract

OBJECTIVES:

The way clinical research and care are currently separated encourages the practice of unverifiable medicine. Some pragmatic trials can be designed (1) to guide proper medical conduct in the presence of uncertainty and (2) to govern the distinction between unvalidated and validated care.

METHODS:

Care trials are simple randomized trials integrated into a practice they regulate in the interest of present patients. The fundamental principle guiding the design of a care trial is the protection of the patient being offered medical care that has not yet been validated. Selection criteria are inclusive, to assist most current patients confronted with the problem. The trial entails no extra tests or risks beyond what is proven beneficial. Endpoints are pre-defined, simple, valuable and resistant to bias. Follow-up visits and tests are routine. Data is collected in simple case-report forms.

RESULTS:

Care trials protect present patients from both unverifiable medicine and research performed for extraneous interests. They provide prudent care when evidence is lacking. They should not be obstructed by the need for separate funding, or by bureaucracy.

CONCLUSION:

Care trials can identify which medical alternative should be standard therapy. In the meantime, they provide optimal care in the presence of uncertainty.

KEYWORDS:

Clinical practice; Clinical trials; Evidence-based medicine; Methodology; Pragmatic trials; Research ethics

PMID:
25042688
DOI:
10.1016/j.jclinepi.2014.04.010
[Indexed for MEDLINE]

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