Comparative effectiveness research for the clinician researcher: a framework for making a methodological design choice

Comparative effectiveness research compares two active forms of treatment or usual care in comparison with usual care with an additional intervention element. These types of study are commonly conducted following a placebo or no active treatment trial. Research designs with a placebo or non-active t...

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Bibliographic Details
Published in:Current controlled trials in cardiovascular medicine 2016-08, Vol.17 (1), p.406-406, Article 406
Main Authors: Williams, Cylie M, Skinner, Elizabeth H, James, Alicia M, Cook, Jill L, McPhail, Steven M, Haines, Terry P
Format: Article
Language:English
Subjects:
Algorithms
Analysis
Choice Behavior
Clinical Protocols
Clinical Trials as Topic - economics
Clinical Trials as Topic - methods
Comparative Effectiveness Research - economics
Comparative Effectiveness Research - methods
Cost-Benefit Analysis
Decision making
Endpoint Determination
Evidence-based medicine
Health Care Costs
Humans
Intervention
Medical research
Medicine, Experimental
Research Design
Treatment Outcome
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Summary:Comparative effectiveness research compares two active forms of treatment or usual care in comparison with usual care with an additional intervention element. These types of study are commonly conducted following a placebo or no active treatment trial. Research designs with a placebo or non-active treatment arm can be challenging for the clinician researcher when conducted within the healthcare environment with patients attending for treatment.A framework for conducting comparative effectiveness research is needed, particularly for interventions for which there are no strong regulatory requirements that must be met prior to their introduction into usual care. We argue for a broader use of comparative effectiveness research to achieve translatable real-world clinical research. These types of research design also affect the rapid uptake of evidence-based clinical practice within the healthcare setting.This framework includes questions to guide the clinician researcher into the most appropriate trial design to measure treatment effect. These questions include consideration given to current treatment provision during usual care, known treatment effectiveness, side effects of treatments, economic impact, and the setting in which the research is being undertaken.
ISSN:1745-6215
1745-6215
DOI:10.1186/s13063-016-1535-6