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


BACKGROUND: An overwhelming body of evidence stating that the completeness of reporting of randomised controlled trials (RCTs) is not optimal has accrued over time. In the mid-1990s, in response to these concerns, an international group of clinical trialists, statisticians, epidemiologists, and biomedical journal editors developed the CONsolidated Standards Of Reporting Trials (CONSORT) Statement. The CONSORT Statement, most recently updated in March 2010, is an evidence-based minimum set of recommendations including a checklist and flow diagram for reporting RCTs and is intended to facilitate the complete and transparent reporting of trials and aid their critical appraisal and interpretation. In 2006, a systematic review of eight studies evaluating the "effectiveness of CONSORT in improving reporting quality in journals" was published. OBJECTIVES: To update the earlier systematic review assessing whether journal endorsement of the 1996 and 2001 CONSORT checklists influences the completeness of reporting of RCTs published in medical journals. SEARCH METHODS: We conducted electronic searches, known item searching, and reference list scans to identify reports of evaluations assessing the completeness of reporting of RCTs. The electronic search strategy was developed in MEDLINE and tailored to EMBASE. We searched the Cochrane Methodology Register and the Cochrane Database of Systematic Reviews using the Wiley interface. We searched the Science Citation Index, Social Science Citation Index, and Arts and Humanities Citation Index through the ISI Web of Knowledge interface. We conducted all searches to identify reports published between January 2005 and March 2010, inclusive. SELECTION CRITERIA: In addition to studies identified in the original systematic review on this topic, comparative studies evaluating the completeness of reporting of RCTs in any of the following comparison groups were eligible for inclusion in this review: 1) Completeness of reporting of RCTs published in journals that have and have not endorsed the CONSORT Statement; 2) Completeness of reporting of RCTs published in CONSORT-endorsing journals before and after endorsement; or 3) Completeness of reporting of RCTs before and after the publication of the CONSORT Statement (1996 or 2001). We used a broad definition of CONSORT endorsement that includes any of the following: (a) requirement or recommendation in journal's 'Instructions to Authors' to follow CONSORT guidelines; (b) journal editorial statement endorsing the CONSORT Statement; or (c) editorial requirement for authors to submit a CONSORT checklist and/or flow diagram with their manuscript. We contacted authors of evaluations reporting data that could be included in any comparison group(s), but not presented as such in the published report and asked them to provide additional data in order to determine eligibility of their evaluation. Evaluations were not excluded due to language of publication or validity assessment. DATA COLLECTION AND ANALYSIS: We completed screening and data extraction using standardised electronic forms, where conflicts, reasons for exclusion, and level of agreement were all automatically and centrally managed in web-based management software, DistillerSR(®). One of two authors extracted general characteristics of included evaluations and all data were verified by a second author. Data describing completeness of reporting were extracted by one author using a pre-specified form; a 10% random sample of evaluations was verified by a second author. Any discrepancies were discussed by both authors; we made no modifications to the extracted data. Validity assessments of included evaluations were conducted by one author and independently verified by one of three authors. We resolved all conflicts by consensus.For each comparison we collected data on 27 outcomes: 22 items of the CONSORT 2001 checklist, plus four items relating to the reporting of blinding, and one item of aggregate CONSORT scores. Where reported, we extracted and qualitatively synthesised data on the methodological quality of RCTs, by scale or score. MAIN RESULTS: Fifty-three publications reporting 50 evaluations were included. The total number of RCTs assessed within evaluations was 16,604 (median per evaluation 123 (interquartile range (IQR) 77 to 226) published in a median of six (IQR 3 to 26) journals. Characteristics of the included RCT populations were variable, resulting in heterogeneity between included evaluations. Validity assessments of included studies resulted in largely unclear judgements. The included evaluations are not RCTs and less than 8% (4/53) of the evaluations reported adjusting for potential confounding factors. Twenty-five of 27 outcomes assessing completeness of reporting in RCTs appeared to favour CONSORT-endorsing journals over non-endorsers, of which five were statistically significant. 'Allocation concealment' resulted in the largest effect, with risk ratio (RR) 1.81 (99% confidence interval (CI) 1.25 to 2.61), suggesting that 81% more RCTs published in CONSORT-endorsing journals adequately describe allocation concealment compared to those published in non-endorsing journals. Allocation concealment was reported adequately in 45% (393/876) of RCTs in CONSORT-endorsing journals and in 22% (329/1520) of RCTs in non-endorsing journals. Other outcomes with results that were significant include: scientific rationale and background in the 'Introduction' (RR 1.07, 99% CI 1.01 to 1.14); 'sample size' (RR 1.61, 99% CI 1.13 to 2.29); method used for 'sequence generation' (RR 1.59, 99% CI 1.38 to 1.84); and an aggregate score over reported CONSORT items, 'total sum score' (standardised mean difference (SMD) 0.68 (99% CI 0.38 to 0.98)). AUTHORS' CONCLUSIONS: Evidence has accumulated to suggest that the reporting of RCTs remains sub-optimal. This review updates a previous systematic review of eight evaluations. The findings of this review are similar to those from the original review and demonstrate that, despite the general inadequacies of reporting of RCTs, journal endorsement of the CONSORT Statement may beneficially influence the completeness of reporting of trials published in medical journals. Future prospective studies are needed to explore the influence of the CONSORT Statement dependent on the extent of editorial policies to ensure adherence to CONSORT guidance.

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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.
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    • "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.
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    • "Patients were randomly assigned to ketamine or placebo group in 1:1 ratio and no changes to methods after trial commencement as type of randomization or eligibility criteria were noted. The study design, planned according to the CONSORT guideline [12], was approved by the Ethical Committee of Second University of Naples (Trial number: 513/12). "
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    ABSTRACT: To evaluate if the pre-emptive administration of ketamine would potentiate the effect of intravenous morphine analgesia in the management of post-thoracotomy pain. This was a unicentre, double-blind, placebo-controlled, parallel-group, prospective study. Patients were randomly assigned to receive 1 mg/kg ketamine (ketamine group) or an equivalent dose of normal saline (placebo group) before thoracotomy in 1:1 ratio. All patients received postoperatively intravenous morphine administration as additional analgesic regimen. Primary end-point was the pain relief measured with Visual Analogue Scale at rest. The secondary end-points were the reduction of inflammatory response expressed by plasma C-reactive protein levels, the morphine consumption and the rate of side effects. The measurements were carried out 6, 12, 24, 36 and 48 hours postoperatively. A total of 75 patients were randomized of whom 38 were allocated to ketamine group and 37 to placebo group. Baseline characteristics were comparable. Ketamine compared with placebo group showed a significant reduction of pain scores (P = 0.01), C-reactive protein (P < 0.001) and morphine consumption (P < 0.001). No acute psychological side effects related to the use of ketamine were registered. The administration of ketamine before surgery may be an effective adjunct to intravenous morphine analgesia in acute post-thoracotomy pain management. In ketamine group, satisfaction of pain relief was significantly higher with a significant reduction of inflammatory response and morphine consumption compared with placebo group. Our results, if confirmed by larger studies, may be of clinical relevance in situations where epidural analgesia or other analgesic procedures different from systemic opioid analgesia are unavailable or contraindicated. © The Author 2015. Published by Oxford University Press on behalf of the European Association for Cardio-Thoracic Surgery. All rights reserved.
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