Empirical Evaluation of the Association Between Methodological Shortcomings and Estimates of Adverse Events. Technical Review No. 13

摘要

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. 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.