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


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.

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.

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.

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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    • "Veterinary medical and food safety specialists adapted CONSORT to produce the " REFLECT statement " on Reporting Guidelines for Randomized Controlled Trials (O'Connor et al., 2010; Sargeant et al., 2010) for livestock trials, and guidelines for animal research have also been produced (Kilkenny et al., 2010). Papers in medical journals that endorse the CONSORT guidelines have more complete reporting of randomized controlled trials, although after many years, there is still room for improvement (Turner et al., 2012). "
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    ABSTRACT: Abundant evidence from the medical, veterinary, and animal science literature demonstrates that there is substantial room for improvement of the clarity, completeness, and accuracy of reporting of intervention studies. More rigorous reporting guidelines are needed to improve the quality of data available for use in comparisons of outcomes (or meta-analyses) of multiple studies. Because of the diversity of factors that affect reproduction and the complexity of interactions between these, a systematic approach is required to design, conduct, and analyze basic and applied studies of dairy cattle reproduction. Greater consistency, clarity, completeness, and correctness of design and reporting will improve the value of each report and allow for greater depth of evaluation in meta-analyses. Each of these benefits will improve understanding and application of current knowledge and better identify questions that require additional modeling or primary research. The proposed guidelines and checklist will aid in the design, conduct, analysis, and reporting of intervention studies. We propose an adaptation of the REFLECT (Reporting Guidelines for Randomized Controlled Trials for Livestock and Food Safety) statement to provide guidelines and a checklist specific to reporting intervention studies in dairy cattle reproduction. Furthermore, we provide recommendations that will assist investigators to produce studies with greater internal and external validity that can more often be included in systematic reviews and global meta-analyses. Such studies will also assist the development of models to describe the physiology of reproduction.
    Journal of Dairy Science 09/2015; DOI:10.3168/jds.2015-9445 · 2.57 Impact Factor
    • "Reporting guidelines such as CONSORT (published simultaneously by three top medical journals in 2001, i.e., Moher, Schultz, & Altman for the CONSORT Group and most recently updated in 2010 by Schultz, Altman, & Moher for the CONSORT Group) have had substantial impact on the completeness of reporting of study reports, i.e., randomized controlled trials (L. Turner, Shamseer, Altman, Schulz, & Moher, 2012; L. Turner, Shamseer, Altman, Weeks, et al., 2012). Their primary impact has been on titles (specifying the study design), methods sections (i.e., blinding of data collectors), and results sections (i.e., the well-known CONSORT flowchart). "
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    ABSTRACT: In this paper, we introduce the IM taxonomy of behavior change methods and its potential to be developed into a coding taxonomy. That is, although IM and its taxonomy of behavior change methods are not in fact new, because IM was originally developed as a tool for intervention development, this potential was not immediately apparent. Second, in explaining the IM taxonomy and defining the relevant constructs, we call attention to the existence of parameters for effectiveness of methods, and explicate the related distinction between theory-based methods and practical applications and the probability that poor translation of methods may lead to erroneous conclusions as to method-effectiveness. Third, we recommend a minimal set of intervention characteristics that may be reported when intervention descriptions and evaluations are published. Specifying these characteristics can greatly enhance the quality of our meta-analyses and other literature syntheses. In conclusion, the dynamics of behavior change are such that any taxonomy of methods of behavior change needs to acknowledge the importance of, and provide instruments for dealing with, three conditions for effectiveness for behavior change methods. For a behavior change method to be effective: 1) it must target a determinant that predicts behavior; 2) it must be able to change that determinant; 3) it must be translated into a practical application in a way that preserves the parameters for effectiveness and fits with the target population, culture, and context. Thus, taxonomies of methods of behavior change must distinguish the specific determinants that are targeted, practical, specific applications, and the theory-based methods they embody. In addition, taxonomies should acknowledge that the lists of behavior change methods will be used by, and should be used by, intervention developers. Ideally, the taxonomy should be readily usable for this goal; but alternatively, it should be clear how the information in the taxonomy can be used in practice. The IM taxonomy satisfies these requirements, and it would be beneficial if other taxonomies would be extended to also meet these needs. IM_Taxonomy_-_Tables_and_Figure.pdf.
    Health Psychology Review 08/2015; DOI:10.1080/17437199.2015.1077155 · 2.06 Impact Factor
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    • "Endorsement of CONSORT guidelines has been shown to positively affect the completeness of reporting of trials published in medical journals but inconsistencies remain [2] [9] [10]. Based on a systematic review and meta-analysis comparing completeness of reporting of CONSORT items in endorsing journals compared with non-endorsing journals , 25 of 27 outcomes were more favorable in journals endorsing CONSORT than in those that do not [2]. In the AJO-DO, a CONSORT endorser since 2004, compliance with CONSORT for published trials has been shown to be better than most competing dental journals being ranked second of six journals in a previous investigation [8]. "
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    ABSTRACT: Objective: To describe a novel CONsolidated Standards of Reporting Trials (CONSORT) adherence strategy implemented by the American Journal of Orthodontics and Dentofacial Orthopedics (AJO-DO) and to report its impact on the completeness of reporting of published trials. Study design and setting: The AJO-DO CONSORT adherence strategy, initiated in June 2011, involves active assessment of randomized clinical trial (RCT) reporting during the editorial process. The completeness of reporting CONSORT items was compared between trials submitted and published during the implementation period (July 2011 to September 2013) and trials published between August 2007 and July 2009. Results: Of the 42 RCTs submitted (July 2011 to September 2013), 23 were considered for publication and assessed for completeness of reporting, seven of which were eventually published. For all published RCTs between 2007 and 2009 (n = 20), completeness of reporting by CONSORT item ranged from 0% to 100% (Median = 40%, interquartile range = 60%). All published trials in 2011-2013, reported 33 of 37 CONSORT (sub) items. Four CONSORT 2010 checklist items remained problematic even after implementation of the adherence strategy: changes to methods (3b), changes to outcomes (6b) after the trial commenced, interim analysis (7b), and trial stopping (14b), which are typically only reported when applicable. Conclusion: Trials published following implementation of the AJO-DO CONSORT adherence strategy completely reported more CONSORT items than those published or submitted previously.
    Journal of clinical epidemiology 05/2014; 67(9). DOI:10.1016/j.jclinepi.2014.04.001 · 3.42 Impact Factor
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