A CONSORT Clinical Trial Reporting Compliance Audit of the Oncology Randomized Controlled Trial Literature

Abstract

Introduction: The Consolidated Standards for Reporting Trials (CONSORT) checklist has been formulated to improve the reporting of randomized controlled trials (RCTs). This investigation aims to determine predictors of CONSORT checklist compliance in the oncology literature. Methods: Eight-hundred and fifty articles assessing interventions in adult breast, prostate, colorectal, and lung cancer between 1992-2010 were identified by a systematic search. Exclusion criteria included investigations reporting interim/secondary/long-term update analyses, pilot/phase 2/non-parallel design studies. After full article review, 408 RCTs were eligible for inclusion. RCT descriptive variables including number of authors/study patients, 2009 journal impact factor/journal classification, type of cancer and therapeutic intervention, publication year, primary study country, and cooperative group involvement were captured for all trials. Two qualified auditors assessed all manuscripts in order to generate average and difference CONSORT checklist scores related to the observers. Results: Mean average CONSORT score was 16.6 (SD 3, max 25) and median difference score was two (interquartile range one to three). Kappa agreement for each checklist item ranged from (0.02-0.92) with an overall two-way intra-class correlation coefficient of 0.71 (95% Cl: 0.61-0.78) for comparison of overall CONSORT score between raters. Recent year of publication, increasing author number, and higher impact factor were associated with higher average CONSORT scores (p<0.0001). Conclusions: Improvements in RCT reporting have been observed over time. Further work in the assessment of the inter-observer reliability of individual CONSORT items is warranted.