Abstract
BackgroundThe extended Consolidated Standards of Reporting Trials (CONSORT) Statement for s was developed to improve the quality of reports of randomized controlled trials (RCTs) because readers often base their assessment of a trial solely on the abstract. To date, few data exist regarding whether it has achieved this goal. We evaluated the extent of adherence to the CONSORT for statement for quality of reports on RCT abstracts by four high-impact general medical journals.MethodsA descriptive analysis of published RCT abstracts in The New England Journal of Medicine (NEJM), The Lancet, The Journal of American Medical Association (JAMA), and the British Medical Journal (BMJ) in the year 2010 was conducted by two reviewers, independently extracting data from a MEDLINE/PubMed search.ResultsWe identified 271 potential RCT abstracts meeting our inclusion criteria. More than half of the abstracts identified the study as randomized in the title (58.7%; 159/271), reported the specific objective/hypothesis (72.7%; 197/271), described participant eligibility criteria with settings for data collection (60.9%; 165/271), detailed the interventions for both groups (90.8%; 246/271), and clearly defined the primary outcome (94.8%; 257/271). However, the methodological quality domains were inadequately reported: allocation concealment (11.8%; 32/271) and details of blinding (21.0%; 57/271). Reporting the primary outcome results for each group was done in 84.1% (228/271). Almost all of the abstracts reported trial registration (99.3%; 269/271), whereas reports of funding and of harm or side effects from the interventions were found in only 47.6% (129/271) and 42.8% (116/271) of the abstracts, respectively.ConclusionsThese findings show inconsistencies and non-adherence to the CONSORT for abstract guidelines, especially in the methodological quality domains. Improvements in the quality of RCT reports can be expected by adhering to existing standards and guidelines as expressed by the CONSORT group.
Highlights
The extended Consolidated Standards of Reporting Trials (CONSORT) Statement for Abstracts was developed to improve the quality of reports of randomized controlled trials (RCTs) because readers often base their assessment of a trial solely on the abstract
With respect to the recent recommendations from CONSORT for Abstracts [7], the reporting quality of RCT abstracts published in four major general medical journals, The Journal of American Medical Association (JAMA), British Medical Journal (BMJ), The Lancet, and The New England Journal of Medicine (NEJM) in 2006 was found to be suboptimal [12]
Under the article submission instructions for the authors, the two journals, BMJ and The Lancet, clearly recommended following the CONSORT for Abstracts guidelines, whereas JAMA and NEJM referred to the International Committee of Medical Journal Editors (ICMJE)’s ‘Uniform Requirements for Manuscripts Submitted to Biomedical Journals’ where the abstract section is required to prepare in accordance with the CONSORT for Abstracts guidelines [13,14,15,16]
Summary
The extended Consolidated Standards of Reporting Trials (CONSORT) Statement for Abstracts was developed to improve the quality of reports of randomized controlled trials (RCTs) because readers often base their assessment of a trial solely on the abstract. With respect to the recent recommendations from CONSORT for Abstracts [7], the reporting quality of RCT abstracts published in four major general medical journals, The Journal of American Medical Association (JAMA), British Medical Journal (BMJ), The Lancet, and The New England Journal of Medicine (NEJM) in 2006 was found to be suboptimal [12]. This evaluation will offer an update as to whether CONSORT for Abstracts improves the quality of reports, given the suboptimal reporting by these highly esteemed journals
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