Authors' objectives:

Accurate harms data are necessary to appropriately assess the balance between benefits and harms of interventions. Numerous deficiencies in the quality and reporting of harms associated with clinical interventions have been reported. Little is known, however, about whether such perceived methodological shortcomings are associated with lower estimates of harms.

Authors' results and conclusions: In 111 studies of CEA for symptomatic stenosis, meeting five of the eight quality criteria was associated with significantly higher rates of stroke or death. A quality-rating instrument with four of the five criteria predicted adverse events (5.7 percent in studies rated "adequate", compared to 3.9 percent in studies rated "inadequate" [p=0.0003]). In multivariate analyses, the quality rating assignment remained significant when controlling for other clinical and study-related variables. Different quality criteria, however, predicted lower estimates of risk for myocardial infarction in 16 trials of rofecoxib, and none of the quality criteria predicted lower estimates of stroke of death in 18 studies of CEA for asymptomatic stenosis. Evaluation of the latter two data sets was limited by small numbers of trials and low rates of evaluated adverse events.

Authors' recommendations: The presence of methodological shortcomings can predict lower estimates of serious harms. Clinicians and researchers should carefully consider the potential effects of individual methodological shortcomings when evaluating estimates of harms associated with clinical interventions. However, we were unable to develop a generic summary quality-rating instrument for studies of harms because specific methodological shortcomings were not consistently predictive across data sets.

Authors' methods: Review

Project Status: Completed

URL for project: http://www.ahrq.gov/clinic/tp/adeventtp.htm

Year Published: 2006

English language abstract: An English language summary is available

Publication Type: Not Assigned

Country: United States

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)