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

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.