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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    • "One reviewer developed a data extraction form based on the CONSORT checklists (Turner et al., 2012), which included relevant data regarding study identification information (authors, year of publication), sample characteristics (study country, intervention setting, and participants' age, sex, and race), study design, intervention, outcomes, and results. A second reviewer then performed a quality check. "
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    ABSTRACT: Objectives: The preschool period is a pivotal time for lifestyle interventions to begin the establishment of long-term physical activity and healthy eating habits. This systematic review sought to (a) examine the effects of prevention and management interventions on overweight/obesity among children aged 2-5 years, and (b) explore factors that may influence intervention effects. Design: A systematic review of randomized controlled studies was conducted. Data sources: Six databases, including PubMed, CINAHL, EMBASE, PsycINFO, ERIC, and Cochrane library, were searched for relevant studies. Review methods: Data were extracted and checked by two reviewers. Each study was appraised based on 4 quality indicators adapted from the Cochrane Handbook for Systematic Reviews of Interventions. A narrative summary technique was used to describe the review findings. Results: Thirty-seven articles describing 32 randomized controlled trials and 29 unique interventions were retained. Eight of 23 prevention and 4 of 6 management interventions resulted in significant weight loss, with 3 prevention and 5 management interventions showing sustained effects over 6 to 24 months. Of the 12 efficacious interventions, 10 included physical activity and nutrition components, 9 actively involved parents, and only 4 were theory-based. Interactive education was the most common strategy used for parents in prevention interventions, compared to behavioral therapy techniques in management interventions. For children, interactive education and hands-on experiences involving physical activity and healthy eating were equally used. Conclusions: Management interventions showed greater effects in weight loss compared to prevention interventions. Future prevention interventions in preschool children should target both parents and children, and focus on physical activity and nutrition through interactive education and hands-on experiences, although intervention effects were less than optimal. Management interventions should focus on parents as the "agents of change" for physical activity and nutrition while integrating behavioral therapy techniques and interactive education.
    Full-text · Article · Oct 2015 · International journal of nursing studies
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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.
    Full-text · Article · Sep 2015 · Interactive Cardiovascular and Thoracic Surgery
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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.
    Full-text · Article · Sep 2015 · Journal of clinical epidemiology
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