Quality of observational studies of clinical interventions: a meta-epidemiological review

Abstract

Abstract Background This meta-epidemiological study aimed to assess methodological quality of a sample of contemporary non-randomised clinical studies of clinical interventions. Methods This was a cross-sectional study of observational studies published between January 1, 2012 and December 31, 2018. Studies were identified in PubMed using search terms ‘association’, ‘observational,’ ‘non-randomised’ ‘comparative effectiveness’ within titles or abstracts. Each study was appraised against 35 quality criteria by two authors independently, with each criterion rated fully, partially or not satisfied. These quality criteria were grouped into 6 categories: justification for observational design (n = 2); minimisation of bias in study design and data collection (n = 11); use of appropriate methods to create comparable groups (n = 6); appropriate adjustment of observed effects (n = 5); validation of observed effects (n = 9); and authors interpretations (n = 2). Results Of 50 unique studies, 49 (98%) were published in two US general medical journals. No study fully satisfied all applicable criteria; the mean (+/−SD) proportion of applicable criteria fully satisfied across all studies was 72% (+/− 10%). The categories of quality criteria demonstrating the lowest proportions of fully satisfied criteria were measures used to adjust observed effects (criteria 20, 23, 24) and validate observed effects (criteria 25, 27, 33). Criteria associated with ≤50% of full satisfaction across studies, where applicable, comprised: imputation methods to account for missing data (50%); justification for not performing an RCT (42%); interaction analyses in identifying independent prognostic factors potentially influencing intervention effects (42%); use of statistical correction to minimise type 1 error in multiple outcome analyses (33%); clinically significant effect sizes (30%); residual bias analyses for unmeasured or unknown confounders (14%); and falsification tests for residual confounding (8%). The proportions of fully satisfied criteria did not change over time. Conclusions Recently published observational studies fail to fully satisfy more than one in four quality criteria. Criteria that were not or only partially satisfied were identified which serve as remediable targets for researchers and journal editors.

Keywords

• Observational studies
• Methodology
• Quality
• Case series