Good Research Practices for Comparative Effectiveness Research: Defining, Reporting and Interpreting Nonrandomized Studies of Treatment Effects Using Secondary Data Sources: The ISPOR Good Research Practices for Retrospective Database Analysis Task Force Report—Part I

摘要: Objectives: Health insurers, physicians, and patients worldwide need information on the comparative effectiveness safety of prescription drugs in routine care. Nonrandomized studies treatment effects using secondary databases may supplement evidence based from randomized clinical trials prospective observational studies. Recognizing challenges to conducting valid retrospective epidemiologic health services research studies, a Task Force was formed develop guidance document state art approaches frame questions report findings for these Methods: The commissioned Chair selected by International Society Pharmacoeconomics Outcomes Research Board Directors October 2007. This Report, first three reported this issue journal, addressed issues framing question reporting interpreting findings. Results: Report proposes four primary characteristics— relevance, specificity, novelty, feasibility while defining question. Recommendations included: practice priori specification question; transparency prespecified analytical plans, provision justifications any subsequent changes plan, results plans as well significant modifications, structured abstracts with scientific neutrality; reasoned interpretations help inform policy decisions. Conclusions: Comparative form nonrandomized can be designed rigorous elements conducted sophisticated statistical methods improve causal inference effects. Standardized careful interpretation aid decision-making.