Article

Does use of the CONSORT Statement impact the completeness of reporting of randomised controlled trials published in medical journals? A Cochrane Review

Systematic Reviews 11/2012; 1(1):60. DOI: 10.1186/2046-4053-1-60
Source: PubMed

ABSTRACT

Background
The Consolidated Standards of Reporting Trials (CONSORT) Statement is intended to facilitate better reporting of randomised clinical trials (RCTs). A systematic review recently published in the Cochrane Library assesses whether journal endorsement of CONSORT impacts the completeness of reporting of RCTs; those findings are summarised here.

Methods
Evaluations assessing the completeness of reporting of RCTs based on any of 27 outcomes formulated based on the 1996 or 2001 CONSORT checklists were included; two primary comparisons were evaluated. The 27 outcomes were: the 22 items of the 2001 CONSORT checklist, four sub-items describing blinding and a ‘total summary score’ of aggregate items, as reported. Relative risks (RR) and 99% confidence intervals were calculated to determine effect estimates for each outcome across evaluations.

Results
Fifty-three reports describing 50 evaluations of 16,604 RCTs were assessed for adherence to at least one of 27 outcomes. Sixty-nine of 81 meta-analyses show relative benefit from CONSORT endorsement on completeness of reporting. Between endorsing and non-endorsing journals, 25 outcomes are improved with CONSORT endorsement, five of these significantly (α = 0.01). The number of evaluations per meta-analysis was often low with substantial heterogeneity; validity was assessed as low or unclear for many evaluations.

Conclusions
The results of this review suggest that journal endorsement of CONSORT may benefit the completeness of reporting of RCTs they publish. No evidence suggests that endorsement hinders the completeness of RCT reporting. However, despite relative improvements when CONSORT is endorsed by journals, the completeness of reporting of trials remains sub-optimal. Journals are not sending a clear message about endorsement to authors submitting manuscripts for publication. As such, fidelity of endorsement as an ‘intervention’ has been weak to date. Journals need to take further action regarding their endorsement and implementation of CONSORT to facilitate accurate, transparent and complete reporting of trials.

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Available from: Douglas Altman, Jan 26, 2014
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    • "Endorsement and implementation of reporting guidelines appears to improve the completeness of reporting. For example, a systematic review examining the completeness of reporting in more than 16,000 randomized trials in journals that endorsed the CONSORT statement, compared to journals that did not, found more complete reporting[9]. Similarly, examining 300 systematic reviews published in February 2014 found that mention of PRISMA was associated with better report- ing[1]. "

    Full-text · Article · Dec 2016 · Systematic Reviews
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    • "Such tools promote the consistent reporting of a minimal set of information for scientists and researchers reporting studies and the editors and peer reviewers assessing them for publication. Endorsement of reporting guidelines by journals for randomized controlled trials[47]and systematic reviews[48]has been shown to improve the quality of reporting. The incorporation of reporting guidelines within the peer-review process could potentially contribute to improvements in the quality of reports of cost-effectiveness analyses. "
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    ABSTRACT: Background Cost-effectiveness analysis has been recognized as an important tool to determine the efficiency of healthcare interventions and services. There is a need for evaluating the reporting of methods and results of cost-effectiveness analyses and establishing their validity. We describe and examine reporting characteristics of methods and results of cost-effectiveness analyses conducted in Spain during more than two decades. Methods A methodological systematic review was conducted with the information obtained through an updated literature review in PubMed and complementary databases (e.g. Scopus, ISI Web of Science, National Health Service Economic Evaluation Database (NHS EED) and Health Technology Assessment (HTA) databases from Centre for Reviews and Dissemination (CRD), Índice Médico Español (IME) Índice Bibliográfico Español en Ciencias de la Salud (IBECS)). We identified cost-effectiveness analyses conducted in Spain that used quality-adjusted life years (QALYs) as outcome measures (period 1989–December 2014). Two reviewers independently extracted the data from each paper. The data were analysed descriptively. Results In total, 223 studies were included. Very few studies (10; 4.5 %) reported working from a protocol. Most studies (200; 89.7 %) were simulation models and included a median of 1000 patients. Only 105 (47.1 %) studies presented an adequate description of the characteristics of the target population. Most study interventions were categorized as therapeutic (189; 84.8 %) and nearly half (111; 49.8 %) considered an active alternative as the comparator. Effectiveness of data was derived from a single study in 87 (39.0 %) reports, and only few (40; 17.9 %) used evidence synthesis-based estimates. Few studies (42; 18.8 %) reported a full description of methods for QALY calculation. The majority of the studies (147; 65.9 %) reported that the study intervention produced “more costs and more QALYs” than the comparator. Most studies (200; 89.7 %) reported favourable conclusions. Main funding source was the private for-profit sector (135; 60.5 %). Conflicts of interest were not disclosed in 88 (39.5 %) studies. Conclusions This methodological review reflects that reporting of several important aspects of methods and results are frequently missing in published cost-effectiveness analyses. Without full and transparent reporting of how studies were designed and conducted, it is difficult to assess the validity of study findings and conclusions. Keywords Cost-effectiveness analysis Cost-utility analysis Quality-adjusted life years Methodology Reporting Spain
    Full-text · Article · Jan 2016 · Systematic Reviews
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    • "The Consolidated Standards of Reporting Trials (CONSORT) statement resulted quite quickly (Begg et al. 1996). A recent Cochrane review suggested that journal endorsement of CONSORT has improved certain aspects of the reporting of RCTs, but that endorsement in itself is not enough (Turner et al. 2012), and that editors, reviewers and authors should be actively involved. More importantly, the review concluded that journal endorsement of CONSORT has not hampered trial reporting. "

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