Ian H. Arra

Date of Award


Degree Type


Degree Name

Master of Science


Epidemiology and Biostatistics


Dr. George Rodrigues


Introduction: The Consolidated Standards for Reporting Trials (CONSORT) checklist has been formulated to improve the reporting of randomized controlled trials (RCTs). The purpose of this investigation is to determine predictors of CONSORT checklist compliance in the oncology literature over the past two decades.


Eight-hundred and fifty parallel two-arm RCTs assessing oncological interventions in adult breast, prostate, colorectal, and lung cancer between 1992-2010 were identified by a systematic search of the medical literature. Exclusion criteria included investigations reporting interim/secondary/long-term update analyses, pilot or phase 2 studies, and studies not employing a parallel design. After full article review, 408 articles were eligible for inclusion into the CONSORT audit database. 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. CONSORT guideline compliance was assessed by two qualified auditors in order to generate average and difference CONSORT checklist scores.


Mean average CONSORT score was 16.6 (SD 3, max 25) and median difference score was 2 (interquartile range 1-3). Kappa agreement for each individual CONSORT checklist item ranged from (0.02-0.92) with an overall two-way intraclass correlation coefficient of 0.71 (95%CI 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). Recent year of publication was the only factor associated with a decrease in the CONSORT difference score.

Conclusions: In this large reported CONSORT compliance audit in the medical

literature, improvements in RCT reporting have been observed over

\ time in the cancer literature. Further work in the assessment of the

inter-observer reliability of individual CONSORT items is warranted given the observed kappa agreement heterogeneity.



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