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      Reporting quality of randomised controlled trial abstracts among high-impact general medical journals: a review and analysis

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          Abstract

          Objective

          The aim of this study was to assess adherence to the Consolidated Standards of Reporting Trials (CONSORT) for Abstracts by five high-impact general medical journals and to assess whether the quality of reporting was homogeneous across these journals.

          Design

          This is a descriptive, cross-sectional study.

          Setting

          Randomised controlled trial (RCT) abstracts in five high-impact general medical journals.

          Participants

          We used up to 100 RCT abstracts published between 2011 and 2014 from each of the following journals: The New England Journal of Medicine ( NEJM), the Annals of Internal Medicine ( Annals IM), The Lancet, the British Medical Journal ( The BMJ) and the Journal of the American Medical Association ( JAMA).

          Main outcome

          The primary outcome was per cent overall adherence to the 19-item CONSORT for Abstracts checklist. Secondary outcomes included per cent adherence in checklist subcategories and assessing homogeneity of reporting quality across the individual journals.

          Results

          Search results yielded 466 abstracts, 3 of which were later excluded as they were not RCTs. Analysis was performed on 463 abstracts (97 from NEJM, 66 from Annals IM, 100 from The Lancet, 100 from The BMJ, 100 from JAMA). Analysis of all scored items showed an overall adherence of 67% (95% CI 66% to 68%) to the CONSORT for Abstracts checklist. The Lancet had the highest overall adherence rate (78%; 95% CI 76% to 80%), whereas NEJM had the lowest (55%; 95% CI 53% to 57%). Adherence rates to 8 of the checklist items differed by >25% between journals.

          Conclusions

          Among the five highest impact general medical journals, there is variable and incomplete adherence to the CONSORT for Abstracts reporting checklist of randomised trials, with substantial differences between individual journals. Lack of adherence to the CONSORT for Abstracts reporting checklist by high-impact medical journals impedes critical appraisal of important studies. We recommend diligent assessment of adherence to reporting guidelines by authors, reviewers and editors to promote transparency and unbiased reporting of abstracts.

          Related collections

          Most cited references 23

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          Systematic Review of the Empirical Evidence of Study Publication Bias and Outcome Reporting Bias

          Background The increased use of meta-analysis in systematic reviews of healthcare interventions has highlighted several types of bias that can arise during the completion of a randomised controlled trial. Study publication bias has been recognised as a potential threat to the validity of meta-analysis and can make the readily available evidence unreliable for decision making. Until recently, outcome reporting bias has received less attention. Methodology/Principal Findings We review and summarise the evidence from a series of cohort studies that have assessed study publication bias and outcome reporting bias in randomised controlled trials. Sixteen studies were eligible of which only two followed the cohort all the way through from protocol approval to information regarding publication of outcomes. Eleven of the studies investigated study publication bias and five investigated outcome reporting bias. Three studies have found that statistically significant outcomes had a higher odds of being fully reported compared to non-significant outcomes (range of odds ratios: 2.2 to 4.7). In comparing trial publications to protocols, we found that 40–62% of studies had at least one primary outcome that was changed, introduced, or omitted. We decided not to undertake meta-analysis due to the differences between studies. Conclusions Recent work provides direct empirical evidence for the existence of study publication bias and outcome reporting bias. There is strong evidence of an association between significant results and publication; studies that report positive or significant results are more likely to be published and outcomes that are statistically significant have higher odds of being fully reported. Publications have been found to be inconsistent with their protocols. Researchers need to be aware of the problems of both types of bias and efforts should be concentrated on improving the reporting of trials.
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            Improving the quality of reporting of randomized controlled trials. The CONSORT statement.

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              What is missing from descriptions of treatment in trials and reviews?

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                Author and article information

                Journal
                BMJ Open
                BMJ Open
                bmjopen
                bmjopen
                BMJ Open
                BMJ Publishing Group (BMA House, Tavistock Square, London, WC1H 9JR )
                2044-6055
                2016
                28 July 2016
                : 6
                : 7
                Affiliations
                [1 ]Department of Medicine, Uniformed Services University , Bethesda, Maryland, USA
                [2 ]Department of Internal Medicine, Walter Reed National Military Medical Center , Bethesda, Maryland, USA
                Author notes
                [Correspondence to ] Dr Meredith Hays; mhays24@ 123456gmail.com
                Article
                bmjopen-2016-011082
                10.1136/bmjopen-2016-011082
                4985789
                27470506
                Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/

                This is an Open Access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/

                Product
                Categories
                Medical Publishing and Peer Review
                Research
                1506
                1711
                1709
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