Abstract
Randomized controlled trials (RCTs) are the cornerstone of evidence based medicine. Ιt is crucial that RCTs have transparent reporting to facilitate their interpretation. The purpose of the present study is the evaluation of the reporting quality of RCTs for novel oral anticoagulants (NOACs) in venous thromboembolism (VTE) based on the CONSORT statement. MEDLINE was meticulously searched, while quoted references by retrieved RCTs were manually screened. The primary objective was to establish the mean CONSORT compliance of RCTs for NOACs in VTE. Secondary objectives were the calculation of compliance per CONSORT item and the investigation for probable determining factors with regards to the reporting quality of RCTs. Reporting above 70% of the items was defined as adequate compliance to the CONSORT statement. A total of 83 articles were considered eligible. Mean adherence to the CONSORT statement was 61.84%, standard deviation (SD) = 18.72. Among retrieved studies, 35 (42.17%) reported above 70% of the items, while 48 (57.83%) described less than 70% of the items. Inter-rater agreement was satisfactory (Cohen’s kappa ≥ 0.75). Items with respect to randomization and blinding were principally underreported, whereas the rest of the methodological features and results were more sufficiently reported. Logistic regression failed to demonstrate significant effect for any of the factors investigated. Impact factor [odds ratio (OR) = 1.347, 95% confidence interval (CI) (0.994, 1.826), p = 0.055], number of authors [OR = 1.277, 95% CI (0.975, 1.672), p = 0.076] and presentation of participant flow-diagram [OR = 55.358, 95% CI (0.914, 3351.765), p = 0.055], came closer to significance. Exploratory analysis revealed significant, strong, positive correlation between abstract and article adherence to the CONSORT guidelines (r = 0.851, p < 0.001). Reporting quality of RCTs for NOACs in VTE is moderate. A superior reporting quality is desirable, especially relating to randomization and blinding.
Similar content being viewed by others
References
Concato J, Shah N, Horwitz RI (2000) Randomized, controlled trials, observational studies, and the hierarchy of research designs. N Engl J Med 342:1887–1892. https://doi.org/10.1056/NEJM200006223422507
Altman DG, Bland JM (1999) Statistics notes. Treatment allocation in controlled trials: why randomise? BMJ 318:1209. https://doi.org/10.1136/bmj.318.7192.1209
Moher D, Pham B, Jones A et al (1998) Does quality of reports of randomised trials affect estimates of intervention efficacy reported in meta-analyses? Lancet 352(9128):609–613. https://doi.org/10.1016/S0140-6736(98)01085-X
Hodkinson A, Gamble C, Smith CT (2016) Reporting of harms outcomes: a comparison of journal publications with unpublished clinical study reports of orlistat trials. Trials 17: 207. https://doi.org/10.1186/s13063-016-1327-z
Pildal J, Hrobjartsson A, Jorgensen KJ et al (2007) Impact of allocation concealment on conclusions drawn from meta-analyses of randomized trials. Int J Epidemiol 36:847–857. https://doi.org/10.1093/ije/dym087
Moher D, Simera I, Schulz KF, Hoey J, Altman DG (2008) Helping editors, peer reviewers and authors improve the clarity, completeness and transparency of reporting health research. BMC Med 6:13. https://doi.org/10.1186/1741-7015-6-13
Hopewell S, Dutton S, Yu LM et al (2010) The quality of reports of randomised trials in 2000 and 2006: comparative study of articles indexed in PubMed. BMJ 340:723. https://doi.org/10.1136/bmj.c723
Plint AC, Moher D, Morrison A et al (2006) Does the CONSORT checklist improve the quality of reports of randomised controlled trials? A systematic review. Med J Aust 185:263–267
Begg C, Cho M, Eastwood S et al (1996) Improving the quality of reporting of randomized controlled trials the CONSORT statement. JAMA 276:637–639
Moher D, Schulz KF, Altman D (2001) The CONSORT statement: revised recommendations for improving the quality of reports of parallel-group randomized trials. JAMA 285:1987–1991
Schulz KF, Altman DG, Moher D, CONSORT Group CONSORT (2010) Statement: updated guidelines for reporting parallel group randomised trials. BMC Med 8:18. https://doi.org/10.1136/bmj.c332
Altman DG, Schulz KF, Moher D et al (2001) The revised CONSORT statement for reporting randomized trials: explanation and elaboration. Ann Intern Med 134:663–694
Moher D, Hopewell S, Schulz KF et al (2010) CONSORT 2010 explanation and elaboration: updated guidelines for reporting parallel group randomised trials. BMJ 340:869. https://doi.org/10.1136/bmj.c869
Egger M, Jüni P, Bartlett C, CONSORT Group (Consolidated Standards of Reporting of Trials) (2001) Value of flow diagrams in reports of randomized controlled trials. JAMA 285(15):1996
Huwiler-Müntener K, Jüni P, Junker C et al (2002) Quality of reporting of randomized trials as a measure of methodologic quality. JAMA 287(21):2801–2804
Kearon C, Akl EA, Ornelas J et al (2016) Antithrombotic therapy for VTE disease: CHEST guideline and expert panel report. Chest 149(2):315–352. https://doi.org/10.1016/j.chest.2015.11.026
Ingrasciotta Y, Crisafulli S, Pizzimenti V, Marcianò I, Mancuso A, Andò G, Corrao S, Capranzano P, Trifirò G (2018) Pharmacokinetics of new oral anticoagulants: implications for use in routine care. Expert Opin Drug Metab Toxicol 14(10):1057–1069. https://doi.org/10.1080/17425255.2018.1530213
Cohen AT, Hamilton M, Mitchell SA, Phatak H, Liu X, Bird A, Tushabe D, Batson S (2015) Comparison of the novel oral anticoagulants apixaban, dabigatran, edoxaban, and rivaroxaban in the initial and long-term treatment and prevention of venous thromboembolism: systematic review and network meta-analysis. PLoS ONE 10(12):e0144856. https://doi.org/10.1371/journal.pone.0144856
Groff H, Azboy I, Parvizi J (2018) Differences in reported outcomes in industry-funded vs nonfunded studies assessing thromboprophylaxis after total joint arthroplasty. J Arthroplasty 33(11):3398–3401. https://doi.org/10.1016/j.arth.2018.06.025
Xiao Zhai MD, Yiran Wang MD, Qingchun Mu MD et al (2015) Methodological reporting quality of randomized controlled trials in 3 leading diabetes journals from 2011 to 2013 following CONSORT statement: a system review. Medicine (Baltimore) 94(27):e1083. https://doi.org/10.1097/MD.0000000000001083
Adie S, Harris IA, Naylor JM et al (2013) CONSORT compliance in surgical randomized trials: are we there yet? A systematic review. Ann Surg 258(6):872–878. https://doi.org/10.1097/SLA.0b013e31829664b9
Liu LQ, Morris PJ, Pengel LH (2013) Compliance to the CONSORT statement of randomized controlled trials in solid organ transplantation: a 3-year overview. Transpl Int 26(3):300–306. https://doi.org/10.1111/tri.12034
Gnech M, Lovatt CA, McGrath M et al (2019) Quality of reporting and fragility index for randomized controlled trials in the vesicoureteral reflux literature: where do we stand? J Pediatr Urol 15:204–212. https://doi.org/10.1016/j.jpurol.2019.02.014
Devos F, Ibrahim N, Foissac F et al (2018) Comparison of the quality of pediatric randomized controlled trials published in both nursing and medical journals: adherence to the CONSORT statement. Worldviews Evid Based Nurs 15(6):447–454. https://doi.org/10.1111/wvn.12329
Huang YQ, Traore K, Ibrahim B et al (2018) Reporting quality of randomized controlled trials in otolaryngology: review of adherence to the CONSORT statement. J Otolaryngol Head Neck Surg 47:34. https://doi.org/10.1186/s40463-018-0277-8
Chen YP, Chen L, Li WF et al (2017) Reporting quality of randomized, controlled trials evaluating combined chemoradiotherapy in nasopharyngeal carcinoma. Int J Radiat Oncol Biol Phys 98(1):170–176. https://doi.org/10.1016/j.ijrobp.2017.01.214
Agha R, Cooper D, Muir G (2007) The reporting quality of randomised controlled trials in surgery: a systematic review. Int J Surg 5(6):413–422. https://doi.org/10.1016/j.ijsu.2007.06.002
Chen M, Cui J, Zhang AL et al (2018) Adherence to CONSORT items in randomized controlled trials of integrative medicine for colorectal cancer published in Chinese journals. J Altern Complement Med 24(2):115–124. https://doi.org/10.1089/acm.2017.0065
Ziogas DC, Zintzaras E (2009) 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. Ann Epidemiol 19(7):494–500. https://doi.org/10.1016/j.annepidem.2009.03.018
Nagai K, Saito AM, Saito TI et al (2017) Reporting quality of randomized controlled trials in patients with HIV on antiretroviral therapy: a systematic review. Trials 18(1):625. https://doi.org/10.1186/s13063-017-2360-2
Rikos D, Dardiotis E, Tsivgoulis G et al (2016) Reporting quality of randomized-controlled trials in multiple sclerosis from 2000 to 2015, based on CONSORT statement. Mult Scler Relat Disord 2016:135–139. https://doi.org/10.1016/j.msard.2016.07.013
Janackovic K, Puljak L (2018) Reporting quality of randomized controlled trial abstracts in the seven highest-ranking anesthesiology journals. Trials 19(1):591. https://doi.org/10.1186/s13063-018-2976-x
Baulig C, Krummenauer F, Geis B et al (2018) Reporting quality of randomised controlled trial abstracts on age-related macular degeneration health care: a cross-sectional quantification of the adherence to CONSORT abstract reporting recommendations. BMJ Open 8(5):e021912. https://doi.org/10.1136/bmjopen-2018-021912
Chow JTY, Turkstra TP, Yim E et al (2018) The degree of adherence to CONSORT reporting guidelines for the abstracts of randomised clinical trials published in anaesthesia journals: a cross-sectional study of reporting adherence in 2010 and 2016. Eur J Anaesthesiol 2018:942–948. https://doi.org/10.1097/EJA.0000000000000880
Sriganesh K, Bharadwaj S, Wang M et al (2017) Quality of abstracts of randomized control trials in five top pain journals: a systematic survey. Contemp Clin Trials Commun 7:64–68. https://doi.org/10.1016/j.conctc.2017.06.001
Higgins JPT, Green S, eds (2011) Cochrane handbook for systematic reviews of interventions version 5.1.0. Cochrane, London
Atkins D, Best D, Briss PA et al (2004) Grading quality of evidence and strength of recommendations. BMJ 328:1490
Agha RA, Fowler AJ, Limb C et al (2016) Impact of the mandatory implementation of reporting guidelines on reporting quality in a surgical journal: a before and after study. Int J Surg 30:169–172. https://doi.org/10.1016/j.ijsu.2016.04.032
Zheng SL, Chan FT, Maclean E et al (2016) Reporting trends of randomised controlled trials in heart failure with preserved ejection fraction: a systematic review. Open Heart 3(2):e000449. https://doi.org/10.1136/openhrt-2016-000449
Chatzimanouil MKT, Wilkens L, Anders HJ (2019) Quantity and reporting quality of kidney research. J Am Soc Nephrol 30(1):13–22. https://doi.org/10.1681/ASN.2018050515
Stevanovic A, Schmitz S, Rossaint R et al (2015) CONSORT item reporting quality in the top ten ranked journals of critical care medicine in 2011: a retrospective analysis. PLoS ONE 10(5):e0128061. https://doi.org/10.1371/journal.pone.0128061
Tardy MP, Gal J, Chamorey E, Almairac F et al (2018) Quality of randomized controlled trials reporting in the treatment of adult patients with high-grade gliomas. Oncologist 23(3):337–345. https://doi.org/10.1634/theoncologist.2017-0196
Lee SY, Teoh PJ, Camm CF et al (2013) Compliance of randomized controlled trials in trauma surgery with the CONSORT statement. J Trauma Acute Care Surg 75(4):562–572. https://doi.org/10.1097/TA.0b013e3182a5399e
Kim DY, Park HS, Cho S et al (2018) The quality of reporting randomized controlled trials in the dermatology literature in an era where the CONSORT statement is a standard. Br J Dermatol 180:1361–1367. https://doi.org/10.1111/bjd.17432
Parish AJ, Boyack KW, Ioannidis JPA (2018) Dynamics of co-authorship and productivity across different fields of scientific research. PLoS ONE 13(1):e0189742. https://doi.org/10.1371/journal.pone.0189742
Barry HC, Ebell MH, Shaughnessy AF, Slawson DC, Nietzke F (2001) Family physicians' use of medical abstracts to guide decision making: style or substance? J Am Board Fam Pract 14:437–442
Funding
This research did not receive any specific grant from funding agencies in the public, commercial, or not-for-profit sectors.
Author information
Authors and Affiliations
Corresponding author
Ethics declarations
Conflict of interest
The authors declare no conflicts of interest.
Ethical approval
The present paper is based on the evaluation of published studies. Therefore, patient consent and ethical approval of the study are not required.
Additional information
Publisher's Note
Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.
Rights and permissions
About this article
Cite this article
Liampas, I., Chlinos, A., Siokas, V. et al. Assessment of the reporting quality of RCTs for novel oral anticoagulants in venous thromboembolic disease based on the CONSORT statement. J Thromb Thrombolysis 48, 542–553 (2019). https://doi.org/10.1007/s11239-019-01931-9
Published:
Issue Date:
DOI: https://doi.org/10.1007/s11239-019-01931-9