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Editorial
. 2016 Aug 17;17(1):406.
doi: 10.1186/s13063-016-1535-6.

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

Cylie M Williams  1   2   3 , Elizabeth H Skinner  4   5 , Alicia M James  6 , Jill L Cook  4 , Steven M McPhail  7 , Terry P Haines  4   8
Affiliations
Editorial

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

Cylie M Williams et al. Trials. .

Abstract

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.

Keywords: dissent and dispute; health economics; hospital; patient safety; research design.

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Figures

Fig. 1
Fig. 1
Comparative effectiveness research decision-making framework. Treatment A represents any treatment for a particular condition, which may or may not be a component of usual care to manage that condition. Treatment B is used to represent our treatment of interest. Where the response is unknown, the user should choose the NO response
See this image and copyright information in PMC

References

    1. Munteanu SE, Landorf KB, Menz HB, Cook JL, Pizzari T, Scott LA. Efficacy of customised foot orthoses in the treatment of Achilles tendinopathy: study protocol for a randomised trial. J Foot Ankle Res. 2009;2:27. doi: 10.1186/1757-1146-2-27. - DOI - PMC - PubMed
    1. Miller FG, Brody H. What makes placebo-controlled trials unethical? Am J Bioeth. 2002;2(2):3–9. doi: 10.1162/152651602317533523. - DOI - PubMed
    1. Altman DG. Statistics and ethics in medical research: misuse of statistics is unethical. Br Med J. 1980;281(6249):1182–4. doi: 10.1136/bmj.281.6249.1182. - DOI - PMC - PubMed
    1. Emanuel EJ, Wendler D, Grady C. What makes clinical research ethical? JAMA. 2000;283(20):2701–11. doi: 10.1001/jama.283.20.2701. - DOI - PubMed
    1. Temple R, Ellenberg SS. Placebo-controlled trials and active-control trials in the evaluation of new treatments. Part 1: ethical and scientific issues. Ann Intern Med. 2000;133(6):455–63. doi: 10.7326/0003-4819-133-6-200009190-00014. - DOI - PubMed

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