Quality of reporting in abstracts of RCTs published in emergency medicine journals: a systematic survey of the literature suggests we can do better

ObjectiveWe investigated the association between the publication of the Consolidated Standards of Reporting Trials extension for abstracts (CONSORT-EA) and other variables of interest on the quality of reporting of abstracts of randomised controlled trials (RCTs) published in emergency medicine (EM) journals.MethodsWe performed a survey of the literature, comparing the quality of reporting before (2005–2007) with after (2014–2015) the publication of the dedicated CONSORT-EA in 2008. The quality of reporting was measured as the sum of items of the CONSORT-EA checklist reported in each abstract, ranging from 0 to 15. The main explanatory variable was the period of publication: pre-CONSORT-EA versus post-CONSORT-EA public. Other explanatory variables were journal’s endorsement of the CONSORT statement, number of centres participating in the study, study’s sample size, type of intervention, significance of results, source of funding and study setting. We analysed the data using generalised estimation equations, performing a univariate and a multivariable analysis.ResultsWe retrieved 844 articles, and randomly selected 60 per period for review, after stratifying for journal. The mean (SD) number of items reported was 6.4 (1.9) in the period before and 6.9 (1.8) in the period after the publication of the CONSORT-EA, with an adjusted mean difference (aMD) of 0.47 (95% CI −0.13 to 1.06). Abstracts of trials of pharmacological interventions had a significantly larger mean number of reported items than those of trials of non-pharmacological interventions (aMD 1.59; 95% CI 0.94 to 2.24).ConclusionsThe quality of reporting in abstracts of RCTs published in EM journals is low and was not significantly impacted by the publication of a dedicated CONSORT-EA.

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Assessment of the quality of reporting in randomised controlled trials of acupuncture in the Korean literature using the CONSORT statement and STRICTA guidelines

BMJ Open ◽

10.1136/bmjopen-2014-005068 ◽

2014 ◽

Vol 4 (7) ◽

pp. e005068-e005068 ◽

Cited By ~ 17

Author(s):

K. H. Kim ◽

J. W. Kang ◽

M. S. Lee ◽

J.-D. Lee

Keyword(s):

Randomised Controlled Trials ◽

Consort Statement ◽

Controlled Trials ◽

Quality Of Reporting ◽

Korean Literature ◽

The Consort Statement ◽

Randomised Controlled

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Improving the Quality of Reporting of Randomised Controlled Trials Evaluating Herbal Interventions: Implementing the CONSORT Statement

Planta Medica ◽

10.1055/s-2008-1075181 ◽

2008 ◽

Vol 74 (03) ◽

Author(s):

JJ Gagnier ◽

H Boon ◽

P Rochon ◽

D Moher ◽

J Barnes ◽

...

Keyword(s):

Randomised Controlled Trials ◽

Consort Statement ◽

Controlled Trials ◽

Quality Of Reporting ◽

The Consort Statement ◽

Randomised Controlled

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Improving the Quality of Reporting of Randomised Controlled Trials Evaluating Herbal Interventions: Implementing the Consort Statement

Drug Safety ◽

10.2165/00002018-200629100-00096 ◽

2006 ◽

Vol 29 (10) ◽

pp. 911-1010 ◽

Cited By ~ 1

Author(s):

J.J. Gagnier ◽

H. Boon ◽

P. Rochon ◽

D. Moher ◽

J. Barnes ◽

...

Keyword(s):

Randomised Controlled Trials ◽

Consort Statement ◽

Controlled Trials ◽

Quality Of Reporting ◽

The Consort Statement ◽

Randomised Controlled

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Assessment of the Quality of Reporting of Randomised Controlled Trials in Otorhinolaryngologic Literature – Adherence to the CONSORT Statement

PLoS ONE ◽

10.1371/journal.pone.0122328 ◽

2015 ◽

Vol 10 (3) ◽

pp. e0122328 ◽

Cited By ~ 15

Author(s):

Jeroen P. M. Peters ◽

Lotty Hooft ◽

Wilko Grolman ◽

Inge Stegeman

Keyword(s):

Randomised Controlled Trials ◽

Consort Statement ◽

Controlled Trials ◽

Quality Of Reporting ◽

The Consort Statement ◽

Randomised Controlled

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Using the CONSORT statement to evaluate the completeness of reporting of addiction randomised trials: a cross-sectional review

BMJ Open ◽

10.1136/bmjopen-2019-032024 ◽

2019 ◽

Vol 9 (9) ◽

pp. e032024 ◽

Cited By ~ 5

Author(s):

Matthew Vassar ◽

Sam Jellison ◽

Hannah Wendelbo ◽

Cole Wayant ◽

Harrison Gray ◽

...

Keyword(s):

Reporting Quality ◽

Consort Statement ◽

Quality Of Reporting ◽

Cross Sectional ◽

The Consort Statement ◽

Pubmed Search ◽

Randomised Controlled ◽

Poor Reporting ◽

Completeness Of Reporting

ObjectivesEvaluate the completeness of reporting of addiction randomised controlled trials (RCTs) using the Consolidated Standards of Reporting Trials (CONSORT) statement.SettingNot applicable.ParticipantsRCTs identified using a PubMed search of 15 addiction journals and a 5-year cross-section.Outcome measuresCompleteness of reporting.ResultsOur analysis of 394 addiction RCTs found that the mean number of CONSORT items reported was 19.2 (SD 5.2), out of a possible 31. Twelve items were reported in <50% of RCTs; similarly, 12 items were reported in >75% of RCTs. Journal endorsement of CONSORT was found to improve the number of CONSORT items reported.ConclusionsPoor reporting quality may prohibit readers from critically appraising the methodological quality of addiction trials. We recommend journal endorsement of CONSORT since our study and those previous have shown that CONSORT endorsement improves the quality of reporting.

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Assessment of Reporting Quality in Randomised Controlled Trials of Acupuncture for Post-Stroke Rehabilitation Using the Consort Statement and Stricta Guidelines

Acupuncture in Medicine ◽

10.1136/acupmed-2016-011062 ◽

2017 ◽

Vol 35 (2) ◽

pp. 100-106 ◽

Cited By ~ 10

Author(s):

Jingchun Zeng ◽

Guohua Lin ◽

Lixia Li ◽

Liming Lu ◽

Chuyun Chen ◽

...

Keyword(s):

Stroke Rehabilitation ◽

Randomised Controlled Trials ◽

Reporting Quality ◽

Consort Statement ◽

Allocation Concealment ◽

Controlled Trials ◽

Quality Of Reporting ◽

Post Stroke ◽

Randomised Controlled

Objectives To evaluate the completeness of reporting of randomised controlled trials (RCTs) of acupuncture for post-stroke rehabilitation in order to provide information to facilitate transparent and more complete reporting of acupuncture RCTs in this field. Methods Multiple databases were searched from their inception through September 2015. Quality of reporting for included papers was assessed against a subset of criteria adapted from the Consolidated Standards for Reporting Trials (CONSORT) 2010 statement and the Standards for Reporting Interventions in Controlled Trials of Acupuncture (STRICTA) guidelines. Each item was scored 1 if it was reported, or 0 if it was not clearly stated. Descriptive statistical analysis was performed. Cohen's κ-statistics were calculated to assess agreement between the two reviewers. Results A total of 87 RCTs were included in the full text. Based on CONSORT, good reporting was evident for items “Randomised’ in the title or abstract’, ‘Participants’, ‘Statistical methods’, ‘Recruitment’, ‘Baseline data’, and ‘Outcomes and estimation’, with positive rates >80%. However, the quality of reporting for the items ‘Trial design’, ‘Outcomes’, ‘Sample size’, ‘Allocation concealment’, ‘Implementation’, ‘Blinding’, ‘Flow chart’, ‘Intent-to-treat analysis’, and ‘Ancillary analyses’ was very poor with positive rates <10%. Based on STRICTA, the items ‘Number of needle insertions per subject per session’, ‘Responses sought’, and ‘Needle type’ had poor reporting with positive rates <50%. Substantial agreement was observed for most items and good agreement was observed for some items. Conclusions The reporting quality of RCTs in acupuncture for post-stroke rehabilitation is unsatisfactory and needs improvement.

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Revised Standards for Reporting Interventions in Clinical Trials of Acupuncture (Stricta): Extending the Consort Statement

Acupuncture in Medicine ◽

10.1136/aim.2009.001370 ◽

2010 ◽

Vol 28 (2) ◽

pp. 83-93 ◽

Cited By ~ 113

Author(s):

Hugh MacPherson ◽

Douglas G Altman ◽

Richard Hammerschlag ◽

Youping Li ◽

Taixiang Wu ◽

...

Keyword(s):

Clinical Trials ◽

Expert Panel ◽

Case Reports ◽

Consort Statement ◽

Quality Of Reporting ◽

Revision Process ◽

Face To Face ◽

Journal Editors ◽

The Consort Statement

The STandards for Reporting Interventions in Clinical Trials of Acupuncture (STRICTA) were published in five journals in 2001 and 2002. These guidelines, in the form of a checklist and explanations for use by authors and journal editors, were designed to improve reporting of acupuncture trials, particularly the interventions, thereby facilitating their interpretation and replication. Subsequent reviews of the application and impact of STRICTA have highlighted the value of STRICTA as well as scope for improvements and revision. To manage the revision process a collaboration between the STRICTA Group, the CONSORT Group and the Chinese Cochrane Centre was developed in 2008. An expert panel with 47 participants was convened that provided electronic feedback on a revised draft of the checklist. At a subsequent face-to-face meeting in Freiburg, a group of 21 participants further revised the STRICTA checklist and planned dissemination. The new STRICTA checklist, which is an official extension of CONSORT, includes 6 items and 17 subitems. These set out reporting guidelines for the acupuncture rationale, the details of needling, the treatment regimen, other components of treatment, the practitioner background and the control or comparator interventions. In addition, and as part of this revision process, the explanations for each item have been elaborated, and examples of good reporting for each item are provided. In addition, the word ‘controlled’ in STRICTA is replaced by ‘clinical’, to indicate that STRICTA is applicable to a broad range of clinical evaluation designs, including uncontrolled outcome studies and case reports. It is intended that the revised STRICTA checklist, in conjunction with both the main CONSORT statement and extension for non-pharmacological treatment, will raise the quality of reporting of clinical trials of acupuncture.

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Assessment of quality of reporting of Helicobacter pylori related randomized controlled trials: a focus on highly ranked gastroenterology journals

International Journal of Clinical Trials ◽

10.18203/2349-3259.ijct20180127 ◽

2018 ◽

Vol 5 (1) ◽

pp. 21

Author(s):

Mahmood E. Elrggal ◽

Morooj Al-Muwallad ◽

Areej Al-Otaibi ◽

Jomanah Alsiddik ◽

Alaa Shahbar ◽

...

Keyword(s):

Clinical Trials ◽

Helicobacter Pylori ◽

Randomized Controlled Trials ◽

Consort Statement ◽

Allocation Concealment ◽

Controlled Trials ◽

Quality Of Reporting ◽

Randomized Controlled ◽

Randomised Controlled

Background: Randomized controlled trials are often considered as the gold standard for measuring the effectiveness of an intervention. However, inappropriate or poor reporting in randomized controlled trials can produce biased estimates of treatment effects. Clinical trials that do not use the CONSORT statement for reporting their findings will have limited value to the clinicians and researchers due to the risk of bias in their results. This review aims to assess the quality of reporting of randomized controlled trials in Helicobacter pylori associated infections by using the CONSORT 2010 checklist.Methods: All issues of 20 highly ranked gastroenterology journals published from Jan 2011 up to November 2017 were searched. Searches were conducted in November 2017. Randomized controlled trials reporting on Helicobacter pylori associated infections were included in the review.Results: 21 randomized controlled trials published in gastroenterology journals were included in the study. All included studies adequately reported (100%) on items including description of interventions, outcomes assessed, total number of participants analysed, baseline characteristics and results of outcome assessed. However, items including blinding and mechanism of allocation concealment were reported in only 12 randomized controlled trials (50%). The maximum and minimum scores and percentage of compliance of included randomised controlled trials were 24 (100%) and 15 (62.5%) respectively.Conclusions: The finding of this review suggests that the overall quality of reporting in the included randomized controlled trials was adequate. However, items including trial design, trial registration and protocol and sample size calculations should be reported adequately in the future randomized controlled trials to improve the quality of reporting and replicability of clinical trials.

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