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Role of Single Group Studies in Agency for Healthcare Research and Quality Comparative Effectiveness Reviews
Research White Papers
Investigators: Stanley Ip, MD, Jessica K Paulus, ScD, Ethan M Balk, MD, MPH, Issa J Dahabreh, MD, MS, Esther E Avendano, BA, and Joseph Lau, MD.
Author Information and AffiliationsStructured Abstract
Background:
When systematically comparing procedures and therapies in the setting of a comparative effectiveness review (CER), the evidence base often includes single group studies, those that evaluate a single intervention given to all subjects included in the study design. The utility and limitations of single group studies to resolve clinical questions that are inherently comparative in nature should be described clearly.
Purpose:
The purpose of this paper is to review the use and interpretation of single group studies in primary clinical research and to summarize current practices to using single group studies in CERs conducted by Agency for Healthcare Research and Quality (AHRQ) Evidence-based Practice Centers.
Methods:
We extracted information about the use of single group studies in all published CERs prepared for the AHRQ Effective Health Care (EHC) Program through January 2012. Summary descriptive statistics across the different reports were tabulated.
Findings:
Of 33 eligible reviews, 21 included single group studies. Ten used single group studies to report only harms, 2 reported only nonharm effects, while the remaining 9 reported both harms and nonharm effects. Ten of 21 did not provide the rationale for including single group studies. Of the 11 that did, the reasons cited included provision of supplementary long-term effect data on surgical interventions, hypothesis generation, and to address a paucity of existing comparative studies. Of the 12 CERs that did not include single group studies, 3 provided reasons for excluding these types of studies. They included specific concerns about confounding, avoidance of bias, and that sufficient data were expected from comparative studies. The terminology used to describe single group studies and their subtypes is not consistent across CERs.
Conclusions/recommendations:
The reporting of inclusion or exclusion of single group studies in the EHC Program's CERs is suboptimal. Our review of published CERs to date indicates that single group studies are commonly included in CERs, but the rationale for including them is not consistently reported, and the methods relevant to their use are not clearly defined. Clarity and transparency in the rationale for including or excluding single group studies in CERs should be promoted. A working group should be convened to develop guidance on the circumstances under which single group studies should be included or excluded from a CER, to discuss how they should be integrated with evidence from other designs and how they may inform the strength of evidence assessment.
Contents
Prepared for: Agency for Healthcare Research and Quality, U.S. Department of Health and Human Services1, Contract No. 290-2007-10055-I. Prepared by: Tufts Evidence-based Practice Center, Tufts Medical Center, Boston, MA
Suggested citation:
Ip S, Paulus JK, Balk EM, Dahabreh IJ, Avendano EE, Lau J. Role of Single Group Studies in Agency for Healthcare Research and Quality Comparative Effectiveness Reviews. Research White Paper. (Prepared by Tufts Evidence-based Practice Center under Contract No. 290-2007-10055-I.) AHRQ Publication No. 13-EHC007-EF. Rockville, MD: Agency for Healthcare Research and Quality; January 2013. www.effectivehealthcare.ahrq.gov.
This report is based on research conducted by the Tufts Evidence-based Practice Center (EPC) under contract to the Agency for Healthcare Research and Quality (AHRQ), Rockville, MD (Contract No. 290-2007-10055-I). The findings and conclusions in this document are those of the authors, who are responsible for its contents; the findings and conclusions do not necessarily represent the views of AHRQ. Therefore, no statement in this report should be construed as an official position of AHRQ or of the U.S. Department of Health and Human Services.
The information in this report is intended to help health care decisionmakers—patients and clinicians, health system leaders, and policymakers, among others—make well-informed decisions and thereby improve the quality of health care services. This report is not intended to be a substitute for the application of clinical judgment. Anyone who makes decisions concerning the provision of clinical care should consider this report in the same way as any medical reference and in conjunction with all other pertinent information, i.e., in the context of available resources and circumstances presented by individual patients.
This report may be used, in whole or in part, as the basis for development of clinical practice guidelines and other quality enhancement tools, or as a basis for reimbursement and coverage policies. AHRQ or U.S. Department of Health and Human Services endorsement of such derivative products may not be stated or implied.
None of the investigators have any affiliation or financial involvement that conflicts with the material presented in this report.
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.ahrq.gov
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