Document Detail

AHRQ series paper 4: assessing harms when comparing medical interventions: AHRQ and the effective health-care program.
MedLine Citation:
PMID:  18823754     Owner:  NLM     Status:  MEDLINE    
Comparative effectiveness reviews (CERs) are systematic reviews that evaluate evidence on alternative interventions to help clinicians, policy makers, and patients make informed treatment choices. Reviews should assess harms and benefits to provide balanced assessments of alternative interventions. Identifying important harms of treatment and quantifying the magnitude of any risks require CER authors to consider a broad range of data sources, including randomized controlled trials (RCTs) and observational studies. This may require evaluation of unpublished data in addition to published reports. Appropriate synthesis of harms data must also consider issues related to evaluation of rare or uncommon events, assessments of equivalence or noninferiority, and use of indirect comparisons. This article presents guidance for evaluating harms when conducting and reporting CERs. We include suggestions for prioritizing harms to be evaluated, use of terminology related to reporting of harms, selection of sources of evidence on harms, assessment of risk of bias (quality) of harms reporting, synthesis of evidence on harms, and reporting of evidence on harms.
Roger Chou; Naomi Aronson; David Atkins; Afisi S Ismaila; Pasqualina Santaguida; David H Smith; Evelyn Whitlock; Timothy J Wilt; David Moher
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Publication Detail:
Type:  Journal Article; Review     Date:  2008-09-26
Journal Detail:
Title:  Journal of clinical epidemiology     Volume:  63     ISSN:  1878-5921     ISO Abbreviation:  J Clin Epidemiol     Publication Date:  2010 May 
Date Detail:
Created Date:  2010-03-29     Completed Date:  2010-08-16     Revised Date:  -    
Medline Journal Info:
Nlm Unique ID:  8801383     Medline TA:  J Clin Epidemiol     Country:  United States    
Other Details:
Languages:  eng     Pagination:  502-12     Citation Subset:  IM    
Oregon Evidence-based Practice Center, Oregon Health & Science University, Department of Medicine, 3181 SW Sam Jackson Park Road, Mail Code: BICC, Portland, OR, USA. <>
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MeSH Terms
Bias (Epidemiology)
Evidence-Based Medicine / methods*
Outcome Assessment (Health Care) / methods
Research Design
Review Literature as Topic*
Terminology as Topic
Therapeutics / adverse effects*
United States
United States Agency for Healthcare Research and Quality

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