Overinterpretation and misreporting of prognostic factor and biomarker studies in medical oncology.
e14023 Background: To generate empirical evidence, classify and estimate the frequency of distorted presentation and overinterpretation of results in prognostic factor (PF) studies in oncology. Methods: We selected 17 oncology journals with an impact factor of 7 or more. PubMed was searched to identify primary clinical studies evaluating one or more PFs published in 2015. Each article was independently evaluated by 2 reviewers using a data extraction form that was extensively pilot-tested. We classified aspects of overinterpretation as misleading reporting, interpretation and extrapolation. Results: Our search identified 10 844 articles, 98 met eligibility criteria. The PF was assessed prospectively in 8 of 56 observational studies, and in 16 of 42 clinical trials. The median number of PFs per study was 2 (Q1-Q3, 1-5). Overall survival was used as the outcome in 77 studies. The median number of statistical analyses reported with regards to the PF effect assessment was 42.5 per study (Q1-Q3, 15.5-86.5). Thirty-three reports reported using 2 or more different multivariable models to assess the PF effect and 21 did not adjust. Misleading reporting included selective and incomplete reporting of the PF effect (n = 26 and n = 8, respectively). The conclusions focused solely on significant results in 80 reports, and in those where there was at least one NS result, 80% of studies focused their conclusions solely on the significant results. Misleading interpretation included not reporting the PF effect within a multivariable model (n = 23 and n = 54 in full-texts and abstracts, respectively). One out of 5 conclusions used linguistic spin with strong statements in both full-text and abstract. Linguistic spin of NS results was found in 28 Results sections in the full-text and in 18 abstract conclusions. The conclusions were inconsistent with the study findings in one out of five articles (both in the full-text and abstract). Discrepancies between the conclusions presented in the full-text and in the abstract were found in 18 reports. Conclusions: Our study provides insight into the level of reporting and overinterpretation of findings that were frequently inconsistent with the results in oncology journals with high impact factors.