Assessing the reporting quality of randomized-controlled clinical trials involving novel oral anticoagulants in patients with atrial fibrillation based on the CONSORT statement
Keywords:Atrial fibrillation, Novel oral anticoagulants, Stroke prevention, CONSORT statement, Quality of reporting, Randomized clinical trials
Background: Inadequate reporting of the published randomized controlled trials (RCTs) may restrict the generalizability of treatment effectiveness and tolerability of non-vitamin K antagonist oral anticoagulants (NOACs) in patients with atrial fibrillation (AF). The main objective of this study was to assess the reporting quality of RCTs for efficacy and safety of NOACs vs. warfarin in patients with AF based on the consolidated standards of reporting trials (CONSORT) statement.
Methods: Pubmed was searched for relevant english-language RCTs. Eligible articles included pivotal RCTs and articles reporting results from sub-populations or post-hoc secondary analysis of the pivotal trials (non-pivotal trials). Eligible articles were assessed according to 37-item/sub-item checklist of CONSORT statement 2010. The assessment was overall and according to trial’s type, NOAC treatment and impact factor (IF) of journals.
Results: Search identified 92 articles eligible for evaluation. Half of CONSORT items were reported by more than 90% of the articles and 25% of items were reported in all articles. The majority of pivotal studies (94%) answered >75% of CONSORT items, while only half of non-pivotal studies had similar compliance (p<0.01). NOACs showed similar pattern in reporting quality (p>0.05), while IF had a significant effect in quality (p<0.01).
Conclusions: RCTs for efficacy and safety of NOACs vs. warfarin in AF patients found to be well reported. Though, the quality of reporting is affected by type of trial and journals’ IF.
Djulbegovic B. Loughran TP Jr,, Hornung CA, Kloecker G, Efthimiadis EN, Hadley TJ, et al. The quality of medical evidence in hematology-oncology. Am J Med. 1999;106:198-205.
Schulz KF, Altman DG, Moher D. CONSORT 2010 Statement: updated guidelines for reporting parallel group randomised trials. BMC Med. 2010;8:18,
Juni P, Altman DG, Egger M. Systematic reviews in health care: Assessing the quality of controlled clinical trials. Br Med J. 2001;323:42-6.
Begg C, Cho M, Eastwood S, Horton R, Moher D, Olkin I, et al. Improving the quality of reporting of randomized controlled trials. The CONSORT statement. JAMA. 1996;276:637-9.
Mills EJ, Wu P, Gagnier J, Devereaux PJ. The quality of randomized trial reporting in leading medical journals since the revised CONSORT statement. Contemporary Clinical Trials. 2005;26:480-7.
Moher D, Pham B, Jones A, Cook DJ, Jadad AR, Moher M, et al. Does quality of reports of randomised trials affect estimates of intervention efficacy reported in meta-analyses? Lancet. 1998;352:609-13.
Schulz KF, Chalmers I, Hayes RJ, Altman DG. Empirical evidence of bias. Dimensions of methodological quality associated with estimates of treatment effects in controlled trials. JAMA. 1995;273:408-12.
Dwan K, Altman DG, Arnaiz JA, Bloom J, Chan AW, Cronin E, et al. Systematic review of the empirical evidence of study publication bias and outcome reporting bias. PloS One. 2008;3:e3081.
Glasziou P, Meats E, Heneghan C, Shepperd S. What is missing from descriptions of treatment in trials and reviews? Br Med J. 2008;336:1472-4.
Hopewell S, Dutton S, Yu LM, Chan AW, Altman DG. The quality of reports of randomised trials in 2000 and 2006: comparative study of articles indexed in PubMed. Br Med J. 2010;340:c723.
Chan AW, Altman DG. Epidemiology and reporting of randomised trials published in PubMed journals. Lancet. 2005;365:1159-62.
Pildal J. Hróbjartsson A, Jørgensen KJ, Hilden J, Altman DG, Gøtzsche PC. Impact of allocation concealment on conclusions drawn from meta-analyses of randomized trials. Int J Epidemiol. 2007;36:847-57.
Moher D, Schulz KF, Altman DG, Consort G. The CONSORT statement: revised recommendations for improving the quality of reports of parallel-group randomized trials. Annals Internal Med. 2001;134:657-62.
Altman DG, Schulz KF, Moher D, Egger M, Davidoff F, Elbourne D, et al. The revised CONSORT statement for reporting randomized trials: explanation and elaboration. Annals of Internal Med. 2001;134, 663-94.
Moher D, Fortin P, Jadad AR, Jüni P, Klassen T, Le Lorier J, et al. Completeness of reporting of trials published in languages other than English: implications for conduct and reporting of systematic reviews. Lancet. 1996;347:363-6.
Papathanasiou AA, Zintzaras E. Assessing the quality of reporting of observational studies in cancer. Annals Epidemiol. 2010;20:67-73.
Partsinevelou A, Zintzaras E. Quality of reporting of randomized controlled trials in polycystic ovary syndrome. Trials. 2009;10:106.
Ziogas DC, Zintzaras E. Analysis of the quality of reporting of randomized controlled trials in acute and chronic myeloid leukemia, and myelodysplastic syndromes as governed by the CONSORT statement. Annals Epidemiol. 2009;19:494-500.
Chugh SS, Havmoeller R, Narayanan K, Singh D, Rienstra M, Benjamin EJ, et al. Worldwide epidemiology of atrial fibrillation: a Global Burden of Disease 2010 Study. Circulation. 2014;129(8):837-47.
Colilla S, Crow A, Petkun W, Singer DE, Simon T, Liu X. Estimates of current and future incidence and prevalence of atrial fibrillation in the U.S. adult population. Am J Cardiol. 2013;112(8):1142-7.
Kirchhof, P. et al. 2016 ESC Guidelines for the management of atrial fibrillation developed in collaboration with EACTS. European Heart J. 2016;18:1609-78.
Zoni-Berisso M, Lercari F, Carazza T, Domenicucci S. Epidemiology of atrial fibrillation: European perspective. Clinical Epidemiol. 2014;6:213-20.
Hart RG, Benavente O, McBride R, Pearce LA. Antithrombotic therapy to prevent stroke in patients with atrial fibrillation: a meta-analysis. Annals of Internal Med. 1999;131:492-501.
Morimoto T, Crawford B, Wada K, Ueda S. Comparative efficacy and safety of novel oral anticoagulants in patients with atrial fibrillation: A network meta-analysis with the adjustment for the possible bias from open label studies. J Cardiol. 2015;66:466-74.
CONSORT Trasnsparent Reporting of Trials. Available at http://www.consort-statement.org. Accessed on 20 June 2017.
Kober T, Trelle S, Engert A. Reporting of randomized controlled trials in Hodgkin lymphoma in biomedical journals. J National Cancer Institute. 2006;98:620-5.
Bagul NB, Kirkham JJ. The reporting of harms in randomized controlled trials of hypertension using the CONSORT criteria for harm reporting. Clinical Experimental Hypertension. 2012;34:548-54.
Zheng SL, Chan FT, Maclean E, Jayakumar S, Nabeebaccus AA. Reporting trends of randomised controlled trials in heart failure with preserved ejection fraction: a systematic review. Open Heart. 2016;3:e000449.
Caldeira D, Barra M, Ferreira A, Rocha A, Augusto A, Pinto FJ, et al. Systematic review with meta-analysis: the risk of major gastrointestinal bleeding with non-vitamin K antagonist oral anticoagulants. Aliment Pharmacol Ther. 2015;42(11-12):1239-49.
Ruff CT, Giugliano RP, Braunwald E, Hoffman EB, Deenadayalu N, Ezekowitz MD, et al. Comparison of the efficacy and safety of new oral anticoagulants with warfarin in patients with atrial fibrillation: a meta-analysis of randomised trials. Lancet. 2014;383:955-962.
Tereshchenko LG, Henrikson CA, Cigarroa J, Steinberg JS. Comparative Effectiveness of Interventions for Stroke Prevention in Atrial Fibrillation: A Network Meta-Analysis. J Am Heart Associat. 2016;5(5):e003206.