Review of quality assessment tools for the evaluation of pharmacoepidemiological safety studies

George A. Neyarapally · Tarek A. Hammad · Simone P. Pinheiro · Solomon Iyasu

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Meta-analysis and systematic reviews Pharmacovigilance and Adverse Drug Reactions Statistical Methods in Epidemiology

Abstract

OBJECTIVES: Pharmacoepidemiological studies are an important hypothesis-testing tool in the evaluation of postmarketing drug safety. Despite the potential to produce robust value-added data, interpretation of findings can be hindered due to well-recognised methodological limitations of these studies. Therefore, assessment of their quality is essential to evaluating their credibility. The objective of this review was to evaluate the suitability and relevance of available tools for the assessment of pharmacoepidemiological safety studies. DESIGN: We created an a priori assessment framework consisting of reporting elements (REs) and quality assessment attributes (QAAs). A comprehensive literature search identified distinct assessment tools and the prespecified elements and attributes were evaluated. PRIMARY AND SECONDARY OUTCOME MEASURES: The primary outcome measure was the percentage representation of each domain, RE and QAA for the quality assessment tools. RESULTS: A total of 61 tools were reviewed. Most tools were not designed to evaluate pharmacoepidemiological safety studies. More than 50% of the reviewed tools considered REs under the research aims, analytical approach, outcome definition and ascertainment, study population and exposure definition and ascertainment domains. REs under the discussion and interpretation, results and study team domains were considered in less than 40% of the tools. Except for the data source domain, quality attributes were considered in less than 50% of the tools. CONCLUSIONS: Many tools failed to include critical assessment elements relevant to observational pharmacoepidemiological safety studies and did not distinguish between REs and QAAs. Further, there is a lack of considerations on the relative weights of different domains and elements. The development of a quality assessment tool would facilitate consistent, objective and evidence-based assessments of pharmacoepidemiological safety studies.

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References

2007The Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) Statement: Guidelines for Reporting Observational Studies 2008The Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) statement: guidelines for reporting observational studies 2010Critical evaluation of the Newcastle-Ottawa scale for the assessment of the quality of nonrandomized studies in meta-analyses 2011GRADE guidelines: 3. Rating the quality of evidence 1998The feasibility of creating a checklist for the assessment of the methodological quality both of randomised and non-randomised studies of health care interventions.2003The development of QUADAS: a tool for the quality assessment of studies of diagnostic accuracy included in systematic reviews 2003Evaluating non-randomised intervention studies 2007The Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) Statement: Guidelines for reporting observational studies

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