Protocol of investigation into reporting quality of RCT abstracts on COVID-19 pursuant to CONSORT (CoCo study)—a review

Abstract Background In 2020, the COVID-19 pandemic developed into a global crisis, the enormity and urgency of which accelerated research activities in the field. At the same time, manuscripts describing these research projects underwent fast-track peer review procedures and were published in freely accessible formats. Although full texts about COVID-19 are currently available for free, abstracts continue to play a key role since they provide essential information and possibly a decision basis for therapies. Abstracts are particularly important in case the full texts are not free, not all reports have been published in English and in emergency situations when there is less time for comprehensive analysis of all full texts. It is therefore necessary to ensure that abstracts—as publications in miniature format—contain comprehensive and transparent information. The CONSORT statement for abstracts (CONSORT-A) offers guidelines to authors how to include all necessary information in an abstract. Prior to the COVID-19 pandemic, the quality of reporting in medical research had already been the object of debate and criticism. The current crisis makes comprehensive documentation all the more important. Abstracts of COVID-19 RCTs should therefore report the criteria listed in the CONSORT-A statement fully and verifiably. The objective of this study is to check the completeness of abstracts of all COVID-19 RTCs published to date. Methods Based on a literature search in PubMed, Embase and the Cochrane Library, all publications up to 29 October 2020 are identified and examined in terms of the subject matter (reported results from COVID-19 studies) and their study design (RTC). Subsequently, suitable publications are examined for completeness and quality of abstracts. The CONSORT checklist for RTC abstracts serves as a basis in this procedure. The primary endpoint of the study is the percentage of correctly implemented items of the CONSORT statement for abstracts. The frequency of correct reporting of each individual item is checked in a second step. Discussion The study is expected to contribute to evaluating the reporting quality on COVID-19 studies, and specifically the completeness of abstracts of RTCs. It may thus support the assessment of current research into COVID-19. Trial registration Registration was not required as the study investigated existing literature.

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Evaluation of reporting quality of randomized controlled trials in patients with COVID-19 using the CONSORT statement

PLoS ONE ◽

10.1371/journal.pone.0257093 ◽

2021 ◽

Vol 16 (9) ◽

pp. e0257093

Author(s):

Yuhuan Yin ◽

Fugui Shi ◽

Yiyin Zhang ◽

Xiaoli Zhang ◽

Jianying Ye ◽

...

Keyword(s):

Randomized Controlled Trials ◽

Reporting Quality ◽

Consort Statement ◽

Cochrane Library ◽

Controlled Trials ◽

Multivariate Linear Regression Analysis ◽

Randomized Controlled ◽

Adherence Score ◽

The Consort Statement

Objective To evaluate the reporting quality of randomized controlled trials (RCTs) regarding patients with COVID-19 and analyse the influence factors. Methods PubMed, Embase, Web of Science and the Cochrane Library databases were searched to collect RCTs regarding patients with COVID-19. The retrieval time was from the inception to December 1, 2020. The CONSORT 2010 statement was used to evaluate the overall reporting quality of these RCTs. Results 53 RCTs were included. The study showed that the average reporting rate for 37 items in CONSORT checklist was 53.85% with mean overall adherence score of 13.02±3.546 (ranged: 7 to 22). The multivariate linear regression analysis showed the overall adherence score to the CONSORT guideline was associated with journal impact factor (P = 0.006), and endorsement of CONSORT statement (P = 0.014). Conclusion Although many RCTs of COVID-19 have been published in different journals, the overall reporting quality of these articles was suboptimal, it can not provide valid evidence for clinical decision-making and systematic reviews. Therefore, more journals should endorse the CONSORT statement, authors should strictly follow the relevant provisions of the CONSORT guideline when reporting articles. Future RCTs should particularly focus on improvement of detailed reporting in allocation concealment, blinding and estimation of sample size.

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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 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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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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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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Assessment of the reporting quality of RCTs for novel oral anticoagulants in venous thromboembolic disease based on the CONSORT statement

Journal of Thrombosis and Thrombolysis ◽

10.1007/s11239-019-01931-9 ◽

2019 ◽

Vol 48 (4) ◽

pp. 542-553 ◽

Cited By ~ 7

Author(s):

Ioannis Liampas ◽

Antonios Chlinos ◽

Vasileios Siokas ◽

Alexandros Brotis ◽

Efthimios Dardiotis

Keyword(s):

Oral Anticoagulants ◽

Reporting Quality ◽

Consort Statement ◽

Thromboembolic Disease ◽

Novel Oral Anticoagulants ◽

Venous Thromboembolic Disease ◽

The Consort Statement ◽

Venous Thromboembolic

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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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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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