title: Comparative effectiveness research for the clinician researcher: a framework for making a methodological design choice.
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.
authors.affiliation: Peninsula Health, Community Health, PO Box 52, Frankston, Melbourne, Victoria, 3199, Australia. cyliewilliams@phcn.vic.gov.au.|Monash University, School of Physiotherapy, Melbourne, Australia. cyliewilliams@phcn.vic.gov.au.|Monash Health, Allied Health Research Unit, Melbourne, Australia. cyliewilliams@phcn.vic.gov.au.
authors.forename: Cylie M
authors.initials: CM
authors.lastname: Williams
authors.affiliation: Monash University, School of Physiotherapy, Melbourne, Australia.|Western Health, Allied Health, Melbourne, Australia.
authors.forename: Elizabeth H
authors.initials: EH
authors.lastname: Skinner
authors.affiliation: Peninsula Health, Community Health, PO Box 52, Frankston, Melbourne, Victoria, 3199, Australia.
authors.forename: Alicia M
authors.initials: AM
authors.lastname: James
authors.affiliation: Monash University, School of Physiotherapy, Melbourne, Australia.
authors.forename: Jill L
authors.initials: JL
authors.lastname: Cook
authors.affiliation: Queensland University of Technology, School of Public Health and Social Work, Brisbane, Australia.
authors.forename: Steven M
authors.initials: SM
authors.lastname: McPhail
authors.affiliation: Monash University, School of Physiotherapy, Melbourne, Australia.|Monash Health, Allied Health Research Unit, Melbourne, Australia.
authors.forename: Terry P
authors.initials: TP
authors.lastname: Haines
mesh_terms: D000465:Algorithms; D002755:Choice Behavior; D002985:Clinical Protocols; D002986:Clinical Trials as Topic / Q000191:economics / Q000379:methods*; D057186:Comparative Effectiveness Research / Q000191:economics / Q000379:methods*; D003362:Cost-Benefit Analysis; D023381:Endpoint Determination; D017048:Health Care Costs; D006801:Humans; D012107:Research Design; D016896:Treatment Outcome
keywords: dissent and dispute; health economics; hospital; patient safety; research design