Criteria for distinguishing effectiveness from efficacy trials in systematic reviews
Gartlehner G, Hansen RA, Nissman D, Lohr KN, Carey TS
Record ID 32006000313
English
Authors' objectives:
The aim of this review was to propose and test a simple instrument based on seven criteria of study design to distinguish effectiveness (pragmatic) from efficacy (explanatory) trials while conducting systematic reviews.
Authors' results and conclusions:
Based on the rationale to identify effectiveness studies reliably with minimal false positives (i.e., a high specificity), a cut-off of six criteria produced the most desirable balance between sensitivity and specificity. This setting produced a specificity of 0.83 and a sensitivity of 0.72.
Authors' recommendations:
When applied in a standardized manner, our proposed criteria can provide a valid and simple tool to distinguish effectiveness from efficacy studies. The applicability of systematic reviews can improve when analysts place more emphasis on the generalizability of included studies. In addition, clinicians can also use our criteria to determine the external validity of individual studies given an appropriate population of interest.
Authors' methods:
Review
Details
Project Status:
Completed
URL for project:
http://www.ahrq.gov/clinic/tp/efftrialtp.htm
Year Published:
2006
English language abstract:
An English language summary is available
Publication Type:
Not Assigned
Country:
United States
MeSH Terms
- Clinical Trials as Topic
- Evidence-Based Medicine
Contact
Organisation Name:
Agency for Healthcare Research and Quality
Contact Address:
Center for Outcomes and Evidence Technology Assessment Program, 540 Gaither Road, Rockville, MD 20850, USA. Tel: +1 301 427 1610; Fax: +1 301 427 1639;
Contact Name:
martin.erlichman@ahrq.hhs.gov
Contact Email:
martin.erlichman@ahrq.hhs.gov
Copyright:
Agency for Healthcare Research and Quality (AHRQ)
This is a bibliographic record of a published health technology assessment from a member of INAHTA or other HTA producer. No evaluation of the quality of this assessment has been made for the HTA database.