Quality assessment of observational studies in a drug-safety systematic review, Comparison of two tools: The Newcastle-Ottawa scale and the RTI item bank

Margulis, Andrea V., Pladevall, Manel, Riera-guardia, Nuria, Varas-Lorenzo, Cristina, Hazell, Lorna, Berkman, Nancy D., Viswanathan, Meera and Perez-Gutthann, Susana (2014) Quality assessment of observational studies in a drug-safety systematic review, Comparison of two tools: The Newcastle-Ottawa scale and the RTI item bank. Clinical Epidemiology, 6, 981-993. (doi:10.2147/CLEP.S66677).

Abstract

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.

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.

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.

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Contributors

Author: Lorna Hazell

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