alexa Quality of Reporting of Modern Randomized Controlled Trials in Medical Oncology: A Systematic Review
Medicine

Medicine

Family Medicine & Medical Science Research

Author(s): Julien Pron, Julien Pron Gregory R Pond, Gregory R Pond, Hui K Gan, Eric X Chen

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Background The Consolidated Standards of Reporting Trials (CONSORT) guidelines were developed in the mid-1990s for the explicit purpose of improving clinical trial reporting. However, there is little information regarding the adherence to CONSORT guidelines of recent publications of randomized controlled trials (RCTs) in oncology. Methods All phase III RCTs published between 2005 and 2009 were reviewed using an 18-point overall quality score for reporting based on the 2001 CONSORT statement. Multivariable linear regression was used to identify features associated with improved reporting quality. To provide baseline data for future evaluations of reporting quality, RCTs were also assessed according to the 2010 revised CONSORT statement. All statistical tests were two-sided. Results A total of 357 RCTs were reviewed. The mean 2001 overall quality score was 13.4 on a scale of 0–18, whereas the mean 2010 overall quality score was 19.3 on a scale of 0–27. The overall RCT reporting quality score improved by 0.21 points per year from 2005 to 2009. Poorly reported items included method used to generate the random allocation (adequately reported in 29% of trials), whether and how blinding was applied (41%), method of allocation concealment (51%), and participant flow (59%). High impact factor (IF, P = .003), recent publication date (P = .008), and geographic origin of RCTs (P = .003) were independent factors statistically significantly associated with higher reporting quality in a multivariable regression model. Sample size, tumor type, and positivity of trial results were not associated with higher reporting quality, whereas funding source and treatment type had a borderline statistically significant impact. Conclusion The results show that numerous items remained unreported for many trials. Thus, given the potential impact of poorly reported trials, oncology journals should require even stricter adherence to the CONSORT guidelines. Randomized controlled trials (RCTs) are the gold standard for evaluating new therapies or strategies in medicine (1). However, the results of poorly designed or poorly reported RCTs can have widespread detrimental consequences for routine clinical practice and may impair the quality of pooled analyses such as meta-analyses (2,3). Therefore, the Consolidated Standards of Reporting Trials (CONSORT) statement was developed by trial methodologists and editors of biomedical journals in the mid-1990s for the explicit purpose of improving clinical trial reporting (4). The CONSORT statement, which provides guidance to authors regarding essential items that should be included in RCT reports, was updated in 2001 (and again in 2010) to incorporate new elements (5,6). Since its original publication in 1996, CONSORT has been supported by more than 400 journals (www.consort-statement.org) and editorial groups, including the International Committee of Medical Journal Editors (7). As a result, the overall quality of RCT reporting has improved (8–11). There is little information regarding the adherence of oncology trials to the CONSORT guidelines. Although RCT reporting quality has previously been assessed in rare tumor subtypes (8,10,12), it has never been systematically and comprehensively investigated in all tumor types. Therefore, the primary objective of this study was to assess the overall reporting quality of oncology RCTs published between 2005 and 2009 according to the 2001 CONSORT statement. In addition, we investigated manuscript characteristics associated with better reporting quality. To provide baseline data for future evaluations of reporting quality, each RCT was also assessed with the more recent 2010 CONSORT guidelines.

This article was published in Journal of National Cancer Institute and referenced in Family Medicine & Medical Science Research

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