Consolidated Standards of Reporting Trials (CONSORT) and the completeness of reporting of randomised controlled trials (RCTs) published in medical journals

Ottawa Hospital Research Institute, 501 Smyth Rd, Box 201B, Ottawa, ON, Canada, K1H 8L6.
Cochrane database of systematic reviews (Online) (Impact Factor: 6.03). 11/2012; 11(11):MR000030. DOI: 10.1002/14651858.MR000030.pub2
Source: PubMed


A group of experts has developed a checklist and flow diagram called the CONSORT Statement. The checklist is designed to help authors in the reporting of randomised controlled trials (RCTs). This systematic review aims to determine whether the CONSORT Statement has made a difference to the completeness of reporting of RCTs. Reporting of RCTs published in journals that encourage authors to use the CONSORT Statement with those that do not is compared. We found that some items in the CONSORT Statement were fully reported more often when journals encouraged the use of CONSORT. While the majority of items are reported more often when journals endorse CONSORT, the data only showed a statistically significant improvement in reporting for five of 27 items. No items suggest that CONSORT decreases the completeness of reporting of RCTs published in medical journals. None of the evaluations included in this review used experimental designs, and their methodological approaches were mostly poorly described and variable when they were described. Furthermore, evaluations assessed the completeness of reporting of RCTs within a wide range of medical fields and in journals with a wide variation in the enforcement of CONSORT endorsement. Our results do have some limitations, but given the number of included evaluations and the number of assessed RCTs, we conclude that while most RCTs are incompletely reported, the CONSORT Statement beneficially influences their reporting quality.

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    • "This clinical trial was also conducted according to the Good Clinical Practice Guidelines and the Declaration of Helsinki. The study design was planned according to the CONSORT guideline [5] and approved by the Ethical Committee of our hospital (trial number: 2014/27). "
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    ABSTRACT: Objectives: In this randomized, controlled and parallel-group prospective study, the feasibility of total pericardial closure with an intrapericardial drain and a pericardio-pleural window (pericardial cavity intervention) was investigated by examining postoperative outcomes, including atrial fibrillation and pericardial effusion, following coronary artery surgery. Methods: Cases were classified into two groups using a random procedure: the closure group and the open group. Insertion of an intrapericardial drain along the right atrium, pericardio-pleural window and total closure of the pericardium were performed in patients in the closure group. Partial closure of the pericardium was performed in patients in the open group. A straight semi-rigid drain was inserted into the extrapericardial anterior mediastinum and a right angle drain was inserted into the left chest in all patients. The primary endpoint was to evaluate the impact of surgical technique on the rate of postoperative in-hospital atrial fibrillation in the closure group. The secondary endpoint was to evaluate the relationship between the surgical technique and postoperative amount of pericardial effusion. Results: A total of 142 isolated, on-pump cases were examined: 72 in the open group and 70 in the closure group. Postoperative atrial fibrillation occurred in 27.78% of the cases in the open group and 8.57% of the patients in the closure group (P = 0.003). Another statistically significant outcome was the lower incidence of small pericardial effusion in the patient group with a closed pericardium during the second day of postoperative care (P = 0.039). The length of both critical care unit (P = 0.008) and hospital stay (P = 0.047) were also significantly shorter in the patient group with a closed pericardium. Conclusions: Total pericardiorrhaphy with pericardial cavity intervention can be acceptable and favourable in terms of its outcomes, including reducing incidence of postoperative atrial fibrillation, pericardial effusion and length of hospitalization.
    Interactive Cardiovascular and Thoracic Surgery 09/2015; 21(6). DOI:10.1093/icvts/ivv259 · 1.16 Impact Factor
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    • "See Box 1 for a description of the terminology related to disadvantaged populations that is used in this paper. Reporting guidelines have been shown to improve reporting of different study designs [12] [13]. "
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    ABSTRACT: Background: The promotion of health equity, the absence of avoidable and unfair differences in health outcomes, is a global imperative. Systematic reviews are an important source of evidence for health decision-makers, but have been found to lack assessments of the intervention effects on health equity. The Preferred Reporting Items for Systematic Reviews and Meta-Analysis (PRISMA) is a 27 item checklist intended to improve transparency and reporting of systematic reviews. We developed an equity extension for PRISMA (PRISMA-E 2012) to help systematic reviewers identify, extract, and synthesise evidence on equity in systematic reviews. Methods and findings: In this explanation and elaboration paper we provide the rationale for each extension item. These items are additions or modifications to the existing PRISMA Statement items, in order to incorporate a focus on equity. An example of good reporting is provided for each item as well as the original PRISMA item. Conclusions: This explanation and elaboration document is intended to accompany the PRISMA-E 2012 Statement and the PRISMA Statement to improve understanding of the reporting guideline for users. The PRISMA-E 2012 reporting guideline is intended to improve transparency and completeness of reporting of equity-focused systematic reviews. Improved reporting can lead to better judgement of applicability by policy makers which may result in more appropriate policies and programs and may contribute to reductions in health inequities.
    Journal of clinical epidemiology 09/2015; 14(1). DOI:10.1016/j.jclinepi.2015.09.001 · 3.42 Impact Factor
    • "Only with more complete and transparent reporting can potential biases in alcohol treatment trials be gauged. Although the CONSORT statement and its extensions (Boutron et al., 2008; Calvert et al., 2013; Schulz et al., 2011) have generally improved reporting practices for RCTs, much improvement is still needed in trial reporting for all diseases (Turner et al., 2012), including AUDs (Ladd et al., 2010). We have highlighted several areas of particular relevance to AUD RCTs, including eligibility criteria, retention of participants, procedures for random assignment, descriptions of the interventions and interventionists, and several considerations in the reporting of statistical analyses consistent with trial registration. "
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    ABSTRACT: The primary goals in conducting clinical trials of treatments for alcohol use disorders (AUDs) are to identify efficacious treatments and determine which treatments are most efficacious for which patients. Accurate reporting of study design features and results is imperative to enable readers of research reports to evaluate to what extent a study has achieved these goals. Guidance on quality of clinical trial reporting has evolved substantially over the past 2 decades, primarily through the publication and widespread adoption of the Consolidated Standards of Reporting Trials statement. However, there is room to improve the adoption of those standards in reporting the design and findings of treatment trials for AUD. This paper provides a narrative review of guidance on reporting quality in AUD treatment trials. Despite improvements in the reporting of results of treatment trials for AUD over the past 2 decades, many published reports provide insufficient information on design or methods. The reporting of alcohol treatment trial design, analysis, and results requires improvement in 4 primary areas: (i) trial registration, (ii) procedures for recruitment and retention, (iii) procedures for randomization and intervention design considerations, and (iv) statistical methods used to assess treatment efficacy. Improvements in these areas and the adoption of reporting standards by authors, reviewers, and editors are critical to an accurate assessment of the reliability and validity of treatment effects. Continued developments in this area are needed to move AUD treatment research forward via systematic reviews and meta-analyses that maximize the utility of completed studies. Copyright © 2015 by the Research Society on Alcoholism.
    Alcoholism Clinical and Experimental Research 08/2015; 39(9). DOI:10.1111/acer.12797 · 3.21 Impact Factor
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