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Reporting Quality of Journal Abstracts for Surgical Randomized Controlled Trials Before and After the Implementation of the CONSORT Extension for Abstracts.

ABSTRACT: BACKGROUND:Adequate reporting is crucial in full-text publications but even more so in abstracts because they are the most frequently read part of a publication. In 2008, an extension for abstracts of the Consolidated Standards of Reporting Trials (CONSORT-A) statement was published, defining which items should be reported in abstracts of randomized controlled trials (RCTs). Therefore, we compared the adherence of RCT abstracts to CONSORT-A before and after the publication of CONSORT-A. METHODS:RCTs published in the five surgical journals with the highest impact factor were identified through PubMed for 2005-2007 and 2014-2016. Adherence to 15 CONSORT-A items and two additional items for abstracts of non-pharmacological trials was assessed in duplicate. We compared the overall adherence to CONSORT-A between the two time periods using an unpaired t test and explored adherence to specific items. RESULTS:A total of 192 and 164 surgical RCT abstracts were assessed (2005-2007 and 2014-2016, respectively). In the pre-CONSORT-A phase, the mean score of adequately reported items was 6.14 (95% confidence interval [CI] 5.90-6.38) and 8.11 in the post-CONSORT-A phase (95% CI 7.83-8.39; mean difference 1.97, 95% CI 1.60-2.34; p?

SUBMITTER: Speich B

PROVIDER: S-EPMC6722149 | biostudies-literature | 2019 Jun

REPOSITORIES: biostudies-literature

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Reporting Quality of Journal Abstracts for Surgical Randomized Controlled Trials Before and After the Implementation of the CONSORT Extension for Abstracts.

Speich Benjamin B Mc Cord Kimberly A KA Agarwal Arnav A Gloy Viktoria V Gryaznov Dmitry D Moffa Giusi G Hopewell Sally S Briel Matthias M

World journal of surgery 20190620 10

<h4>Background</h4>Adequate reporting is crucial in full-text publications but even more so in abstracts because they are the most frequently read part of a publication. In 2008, an extension for abstracts of the Consolidated Standards of Reporting Trials (CONSORT-A) statement was published, defining which items should be reported in abstracts of randomized controlled trials (RCTs). Therefore, we compared the adherence of RCT abstracts to CONSORT-A before and after the publication of CONSORT-A.< ...[more]

PMID: 31222645

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Project description:BackgroundClear, transparent, and sufficiently detailed abstracts of conferences and journal articles related to randomized controlled trials (RCTs) are important, because readers often base their assessment of a trial solely on information in the abstract. Here, we extend the CONSORT (Consolidated Standards of Reporting Trials) Statement to develop a minimum list of essential items, which authors should consider when reporting the results of a RCT in any journal or conference abstract.Methods and findingsWe generated a list of items from existing quality assessment tools and empirical evidence. A three-round, modified-Delphi process was used to select items. In all, 109 participants were invited to participate in an electronic survey; the response rate was 61%. Survey results were presented at a meeting of the CONSORT Group in Montebello, Canada, January 2007, involving 26 participants, including clinical trialists, statisticians, epidemiologists, and biomedical editors. Checklist items were discussed for eligibility into the final checklist. The checklist was then revised to ensure that it reflected discussions held during and subsequent to the meeting. CONSORT for Abstracts recommends that abstracts relating to RCTs have a structured format. Items should include details of trial objectives; trial design (e.g., method of allocation, blinding/masking); trial participants (i.e., description, numbers randomized, and number analyzed); interventions intended for each randomized group and their impact on primary efficacy outcomes and harms; trial conclusions; trial registration name and number; and source of funding. We recommend the checklist be used in conjunction with this explanatory document, which includes examples of good reporting, rationale, and evidence, when available, for the inclusion of each item.ConclusionsCONSORT for Abstracts aims to improve reporting of abstracts of RCTs published in journal articles and conference proceedings. It will help authors of abstracts of these trials provide the detail and clarity needed by readers wishing to assess a trial's validity and the applicability of its results.

Project description:BACKGROUND:Randomised controlled trials (RCTs) are used to evaluate social and psychological interventions and inform policy decisions about them. Accurate, complete, and transparent reports of social and psychological intervention RCTs are essential for understanding their design, conduct, results, and the implications of the findings. However, the reporting of RCTs of social and psychological interventions remains suboptimal. The CONSORT Statement has improved the reporting of RCTs in biomedicine. A similar high-quality guideline is needed for the behavioural and social sciences. Our objective was to develop an official extension of the Consolidated Standards of Reporting Trials 2010 Statement (CONSORT 2010) for reporting RCTs of social and psychological interventions: CONSORT-SPI 2018. METHODS:We followed best practices in developing the reporting guideline extension. First, we conducted a systematic review of existing reporting guidelines. We then conducted an online Delphi process including 384 international participants. In March 2014, we held a 3-day consensus meeting of 31 experts to determine the content of a checklist specifically targeting social and psychological intervention RCTs. Experts discussed previous research and methodological issues of particular relevance to social and psychological intervention RCTs. They then voted on proposed modifications or extensions of items from CONSORT 2010. RESULTS:The CONSORT-SPI 2018 checklist extends 9 of the 25 items from CONSORT 2010: background and objectives, trial design, participants, interventions, statistical methods, participant flow, baseline data, outcomes and estimation, and funding. In addition, participants added a new item related to stakeholder involvement, and they modified aspects of the flow diagram related to participant recruitment and retention. CONCLUSIONS:Authors should use CONSORT-SPI 2018 to improve reporting of their social and psychological intervention RCTs. Journals should revise editorial policies and procedures to require use of reporting guidelines by authors and peer reviewers to produce manuscripts that allow readers to appraise study quality, evaluate the applicability of findings to their contexts, and replicate effective interventions.

Project description:ObjectiveTo assess the impact of the 2004 extension of the CONSORT guidelines on the reporting and methodological quality of cluster randomised trials.DesignMethodological review of 300 randomly sampled cluster randomised trials. Two reviewers independently abstracted 14 criteria related to quality of reporting and four methodological criteria specific to cluster randomised trials. We compared manuscripts published before CONSORT (2000-4) with those published after CONSORT (2005-8). We also investigated differences by journal impact factor, type of journal, and trial setting.Data sourcesA validated Medline search strategy. Eligibility criteria for selecting studies Cluster randomised trials published in English language journals, 2000-8.ResultsThere were significant improvements in five of 14 reporting criteria: identification as cluster randomised; justification for cluster randomisation; reporting whether outcome assessments were blind; reporting the number of clusters randomised; and reporting the number of clusters lost to follow-up. No significant improvements were found in adherence to methodological criteria. Trials conducted in clinical rather than non-clinical settings and studies published in medical journals with higher impact factor or general medical journals were more likely to adhere to recommended reporting and methodological criteria overall, but there was no evidence that improvements after publication of the CONSORT extension for cluster trials were more likely in trials conducted in clinical settings nor in trials published in either general medical journals or in higher impact factor journals.ConclusionThe quality of reporting of cluster randomised trials improved in only a few aspects since the publication of the extension of CONSORT for cluster randomised trials, and no improvements at all were observed in essential methodological features. Overall, the adherence to reporting and methodological guidelines for cluster randomised trials remains suboptimal, and further efforts are needed to improve both reporting and methodology.

Project description:ObjectiveTo investigate the effect of the CONSORT for Abstracts guidelines, and different editorial policies used by five leading general medical journals to implement the guidelines, on the reporting quality of abstracts of randomised trials.DesignInterrupted time series analysis.SampleWe randomly selected up to 60 primary reports of randomised trials per journal per year from five high impact, general medical journals in 2006-09, if indexed in PubMed with an electronic abstract. We excluded reports that did not include an electronic abstract, and any secondary trial publications or economic analyses. We classified journals in three categories: those not mentioning the guidelines in their instructions to authors (JAMA and New England Journal of Medicine), those referring to the guidelines in their instructions to authors but with no specific policy to implement them (BMJ), and those referring to the guidelines in their instructions to authors with an active policy to implement them (Annals of Internal Medicine and Lancet). Two authors extracted data independently using the CONSORT for Abstracts checklist.Main outcomeMean number of CONSORT items reported in selected abstracts, among nine items reported in fewer than 50% of the abstracts published across the five journals in 2006.ResultsWe assessed 955 reports of abstracts of randomised trials. Journals with an active policy to enforce the guidelines showed an immediate increase in the level of mean number of items reported (increase of 1.50 items; P=0.0037). At 23 months after publication of the guidelines, the mean number of items reported per abstract for the primary outcome was 5.41 of nine items, a 53% increase compared with the expected level estimated on the basis of pre-intervention trends. The change in level or trend did not increase in journals with no policy to enforce the guidelines (BMJ, JAMA, and New England Journal of Medicine).ConclusionActive implementation of the CONSORT for Abstracts guidelines by journals can lead to improvements in the reporting of abstracts of randomised trials.

Dataset Information

Reporting Quality of Journal Abstracts for Surgical Randomized Controlled Trials Before and After the Implementation of the CONSORT Extension for Abstracts.

Publications

Reporting Quality of Journal Abstracts for Surgical Randomized Controlled Trials Before and After the Implementation of the CONSORT Extension for Abstracts.

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