Analysis of the quality of reporting of randomized controlled trials in anticoagulant versus antiplatelet medication for
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Analysis of the quality of reporting of randomized controlled trials in anticoagulant versus antiplatelet medication for venous thromboembolism prophylaxis as governed by the CONSORT statement Eirini Beneki1,2 · Christos Vrysis3 · Elias Zintzaras1,4,5 · Chrysoula Doxani1 Accepted: 9 October 2020 © Springer Science+Business Media, LLC, part of Springer Nature 2020
Abstract Randomized controlled trials (RCTs) are the gold standard research in evaluating healthcare interventions. The CONSORT (Consolidated Standards of Reporting Trials) statement improves the quality of RCTs in an evidence-based approach. To evaluate the reporting quality of published RCTs concerning the use of anticoagulants versus antiplatelet agents for venous thromboembolism prophylaxis according to the CONSORT statement. Electronic databases were searched for Englishlanguage RCTs involving patients who received either anticoagulant or antiplatelet medication for prophylaxis of deep vein thrombosis and pulmonary embolism published from 2000 to 2019. Trials were considered eligible when the included patients received either anticoagulant or antiplatelet medication for primary and secondary prevention of deep vein thrombosis or pulmonary embolism and were randomly assigned to at least two treatment arms. Quality of reporting was assessed using a 37-item questionnaire based on the CONSORT 2010 checklist. Reporting was assessed in 2 publication periods (2000–2009) and (2010–2019). The effect of CONSORT statement in high- and low-ranked medical journals, according to their impact factor, has also been evaluated. The search identified 13 eligible articles for analysis. Only 12 of the 37 items of the checklist were addressed in 75% or more of the studies. Most items concerning the methodological issues were reported by fewer than 50% of the studies. Improvements over time were seen for items that assessed the methodological quality with no statistically significant difference. RCTs published in high-ranked journals showed better quality of reporting. Quality of reporting in RCTs focusing on the use of anticoagulants versus antiplatelet agents for venous thromboembolism prophylaxis remains unsatisfactory. Further improvement of reporting is necessary to assess the validity of clinical research. Keywords CONSORT · Randomized controlled trials · Anticoagulants · Antiplatelet medication · Pulmonary embolism · Deep vein thrombosis * Eirini Beneki [email protected] 1
Department of Biomathematics, University of Thessaly School of Medicine, Papakyriazi 22, 41222 Larissa, Greece
2
Department of Cardiology, Karditsa General Hospital, Karditsa, Greece
3
Department of Internal Medicine, 251 Hellenic Airforce General Hospital, Athens, Greece
4
Center for Clinical Evidence Synthesis, The Institute for Clinical Research and Health Policy Studies, Tufts Medical Center, Tufts University School of Medicine, Boston, MA, USA
5
Pharmacology & Drug Development Program, Sackler School of Graduate Biomedical Sciences, Tufts University School of Medici
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