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      Completeness of reporting in abstracts of randomized controlled trials in subscription and open access journals: cross-sectional study

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          Abstract

          Background

          Open access (OA) journals are becoming a publication standard for health research, but it is not clear how they differ from traditional subscription journals in the quality of research reporting. We assessed the completeness of results reporting in abstracts of randomized controlled trials (RCTs) published in these journals.

          Methods

          We used the Consolidated Standards of Reporting Trials Checklist for Abstracts (CONSORT-A) to assess the completeness of reporting in abstracts of parallel-design RCTs published in subscription journals ( n = 149; New England Journal of Medicine, Journal of the American Medical Association, Annals of Internal Medicine, and Lancet) and OA journals ( n = 119; BioMedCentral series, PLoS journals) in 2016 and 2017.

          Results

          Abstracts in subscription journals completely reported 79% (95% confidence interval [CI], 77–81%) of 16 CONSORT-A items, compared with 65% (95% CI, 63–67%) of these items in abstracts from OA journals ( P < 0.001, chi-square test). The median number of completely reported CONSORT-A items was 13 (95% CI, 12–13) in subscription journal articles and 11 (95% CI, 10–11) in OA journal articles. Subscription journal articles had significantly more complete reporting than OA journal articles for nine CONSORT-A items and did not differ in reporting for items trial design, outcome, randomization, blinding (masking), recruitment, and conclusions. OA journals were better than subscription journals in reporting randomized study design in the title.

          Conclusion

          Abstracts of randomized controlled trials published in subscription medical journals have greater completeness of reporting than abstracts published in OA journals. OA journals should take appropriate measures to ensure that published articles contain adequate detail to facilitate understanding and quality appraisal of research reports about RCTs.

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          Most cited references22

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          Randomized, Controlled Trials, Observational Studies, and the Hierarchy of Research Designs

          New England Journal of Medicine, 342(25), 1887-1892
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            CONSORT for reporting randomised trials in journal and conference abstracts.

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              Reporting bias in medical research - a narrative review

              Reporting bias represents a major problem in the assessment of health care interventions. Several prominent cases have been described in the literature, for example, in the reporting of trials of antidepressants, Class I anti-arrhythmic drugs, and selective COX-2 inhibitors. The aim of this narrative review is to gain an overview of reporting bias in the medical literature, focussing on publication bias and selective outcome reporting. We explore whether these types of bias have been shown in areas beyond the well-known cases noted above, in order to gain an impression of how widespread the problem is. For this purpose, we screened relevant articles on reporting bias that had previously been obtained by the German Institute for Quality and Efficiency in Health Care in the context of its health technology assessment reports and other research work, together with the reference lists of these articles. We identified reporting bias in 40 indications comprising around 50 different pharmacological, surgical (e.g. vacuum-assisted closure therapy), diagnostic (e.g. ultrasound), and preventive (e.g. cancer vaccines) interventions. Regarding pharmacological interventions, cases of reporting bias were, for example, identified in the treatment of the following conditions: depression, bipolar disorder, schizophrenia, anxiety disorder, attention-deficit hyperactivity disorder, Alzheimer's disease, pain, migraine, cardiovascular disease, gastric ulcers, irritable bowel syndrome, urinary incontinence, atopic dermatitis, diabetes mellitus type 2, hypercholesterolaemia, thyroid disorders, menopausal symptoms, various types of cancer (e.g. ovarian cancer and melanoma), various types of infections (e.g. HIV, influenza and Hepatitis B), and acute trauma. Many cases involved the withholding of study data by manufacturers and regulatory agencies or the active attempt by manufacturers to suppress publication. The ascertained effects of reporting bias included the overestimation of efficacy and the underestimation of safety risks of interventions. In conclusion, reporting bias is a widespread phenomenon in the medical literature. Mandatory prospective registration of trials and public access to study data via results databases need to be introduced on a worldwide scale. This will allow for an independent review of research data, help fulfil ethical obligations towards patients, and ensure a basis for fully-informed decision making in the health care system.
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                Author and article information

                Contributors
                +385 21 557 812 , ana.marusic@mefst.hr
                Journal
                Trials
                Trials
                Trials
                BioMed Central (London )
                1745-6215
                2 December 2019
                2 December 2019
                2019
                : 20
                : 669
                Affiliations
                [1 ]ISNI 0000 0004 0366 9017, GRID grid.412721.3, Center for Transfusion Medicine, , University Hospital Center Split, ; Split, Croatia
                [2 ]ISNI 0000 0004 0644 1675, GRID grid.38603.3e, Department of Research in Biomedicine and Health, , University of Split School of Medicine, ; Šoltanska 2, 21000 Split, Croatia
                Author information
                http://orcid.org/0000-0001-6272-0917
                Article
                3781
                10.1186/s13063-019-3781-x
                6889688
                31791393
                7f366633-de7e-457e-b0a2-a9bbb6827bcc
                © The Author(s). 2019

                Open AccessThis article is distributed under the terms of the Creative Commons Attribution 4.0 International License ( http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. The Creative Commons Public Domain Dedication waiver ( http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated.

                History
                : 1 June 2019
                : 9 October 2019
                Funding
                Funded by: FundRef http://dx.doi.org/10.13039/501100004488, Hrvatska Zaklada za Znanost;
                Award ID: IP-2014-09-7672
                Categories
                Research
                Custom metadata
                © The Author(s) 2019

                Medicine
                reporting guidelines,randomized controlled trial,consort for abstracts,open access publishing,subscription journals

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