Quality assessment of observational studies in a drug-safety systematic review, comparison of two tools: the Newcastle–Ottawa Scale and the RTI item bank

Abstract

Andrea V Margulis,1 Manel Pladevall,1 Nuria Riera-Guardia,1 Cristina Varas-Lorenzo,1 Lorna Hazell,2,3 Nancy D Berkman,4 Meera Viswanathan,4 Susana Perez-Gutthann,1 1RTI Health Solutions, Barcelona, Spain; 2Drug Safety Research Unit, Southampton, UK; 3Associate Department of the School of Pharmacy and Biomedical Sciences, University of Portsmouth, Portsmouth, UK; 4RTI International, Research Triangle Park, NC, USA Background: The study objective was to compare the Newcastle–Ottawa Scale (NOS) and the RTI item bank (RTI-IB) and estimate interrater agreement using the RTI-IB within a systematic review on the cardiovascular safety of glucose-lowering drugs. Methods: We tailored both tools and added four questions to the RTI-IB. Two reviewers assessed the quality of the 44 included studies with both tools, (independently for the RTI-IB) and agreed on which responses conveyed low, unclear, or high risk of bias. For each question in the RTI-IB (n=31), the observed interrater agreement was calculated as the percentage of studies given the same bias assessment by both reviewers; chance-adjusted interrater agreement was estimated with the first-order agreement coefficient (AC1) statistic. Results: The NOS required less tailoring and was easier to use than the RTI-IB, but the RTI-IB produced a more thorough assessment. The RTI-IB includes most of the domains measured in the NOS. Median observed interrater agreement for the RTI-IB was 75% (25th percentile [p25] =61%; p75 =89%); median AC1 statistic was 0.64 (p25 =0.51; p75 =0.86). Conclusion: The RTI-IB facilitates a more complete quality assessment than the NOS but is more burdensome. The observed agreement and AC1 statistic in this study were higher than those reported by the RTI-IB's developers. Keywords: systematic review, meta-analysis, quality assessment, AC1