Abstract
The aim of this study was to assess the quality of randomized controlled trials (RCTs) on erectile dysfunction (ED) conducted from 2007 to 2018. We searched for RCT original articles on ED published between 2007 and 2018 using PubMed, Embase, and Cochrane Library databases. RCT quality assessment was performed using Jadad scale, van Tulder scale, and Cochrane Collaboration’s Risk of Bias Tool. The effects on RCT quality of including treatment methods, funding sources, institutional review board (IRB) approval statements, and intervention description to the studies were assessed. Blinding and allocation concealment were described in 67.9 and 8.7% of the RCTs, respectively. Blinding tended to decrease, but a sharp rise in blinding was observed in 2011–2012 and allocation in 2017–2018. Funding statement inclusion (60.3% overall) and intervention description (96.4% overall) tended to increase steadily. IRB statement inclusion (78.3% overall) increased (p = 0.05). Jadad scores rose significantly until 2011–2012 but decreased thereafter except 2017–2018 (p = 0.09). RCTs with funding statements had higher Jadad and van Tulder scores than unfunded RCTs (p < 0.01 and 0.02, respectively). Quality improvement has observed from 2007 to 2012 and 2017 to 2018 with Jadad scale because of increased funding, multicenter studies, and intervention description.
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References
Sackett DL, Rosenberg WM, Gray JA, Haynes RB, Richardson WS. Evidence based medicine: what it is and what it isn’t. BMJ. 1996;312:71–2.
Gluud C, Nikolova D. Likely country of origin in publications on randomised controlled trials and controlled clinical trials during the last 60 years. Trials. 2007;8:7.
Uetani K, Nakayama T, Ikai H, Yonemoto N, Moher D. Quality of reports on randomized controlled trials conducted in Japan: evaluation of adherence to the CONSORT statement. Intern Med. 2009;48:307–13.
Featherstone K, Donovan JL. Random allocation or allocation at random? Patients’ perspectives of participation in a randomised controlled trial. BMJ . 1998;317:1177–80.
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.
Moher D, Hopewell S, Schulz KF, Montori V, Gøtzsche PC, Devereaux PJ, et al. CONSORT 2010 explanation and elaboration: updated guidelines for reporting parallel group randomised trials. Int J Surg. 2012;10:28–55.
Juni P, Altman DG, Egger M. Systematic reviews in health care: Assessing the quality of controlled clinical trials. BMJ. 2001;323:42–6.
Hill J, Bullock I, alderson P. A summary of the methods that the national clinical guideline centre uses to produce clinical guidelines for the national Institute for Health and clinical excellence. Ann Intern Med. 2000;154:752–7.
Gagnier J, Boon H, Rochon P, Barnes J, Moher D, Bombardier C, CONSORT Group. Improving the quality of reporting of randomized controlled trials evaluating herbal interventions: implementing the CONSORT statement [corrected]. Explore. 2006;2:143–9.
Clark HD, Wells GA, Huët C, McAlister FA, Salmi LR, Fergusson D, et al. Assessing the quality of randomized trials: reliability of the Jadad scale. Control Clin Trials. 1999;20:448–52.
van Tulder M, Furlan A, Bombardier C, Bouter L. Editorial Board of the Cochrane Collaboration Back Review Group. Updated method guidelines for systematic reviews in the cochrane collaboration back review group. Spine. 2003;28:1290–9.
Higgins JP, Green S (eds). Cochrane handbook for systematic reviews of interventions. Ver. 5.1.0. The Cochrane Collaboration; 2011. Available at: http://www.cochrane-handbook.org. Accessed 7 Jan 2011.
NIH Consensus Conference. Impotence. NIH consensus development panel on impotence. JAMA. 1993;270:83–90.
Feldman HA, Goldstein I, Hatzichristou DG, Krane RJ, McKinlay JB. Impotence and its medical and psychosocial correlates: results of the Massachusetts Male Aging Study. J Urol. 1994;151:54–61.
Jadad AR, Moore RA, Carroll D, Jenkinson C, Reynolds DJ, Gavaghan DJ, et al. Assessing the quality of reports of randomized clinical trials: is blinding necessary? Control Clin trials. 1996;17:1–12.
Scales CD Jr, Norris RD, Keitz SA, Peterson BL, Preminger GM, Vieweg J, et al. A critical assessment of the quality of reporting of randomized, controlled trials in the urology literature. J Urol. 2007;177:1090–4.
Lee JY, Chung JH, Kang DH, Lee JW, Moon HS, Yoo TK, et al. Quality assessment of randomized controlled trials published in the korean journal of urology over the past 20 years. Korean J Urol. 2011;52:642–6.
Sutton AJ, Cooper NJ, Jones DR. Evidence synthesis as the key to more coherent and efficient research. BMC Med Res Methodol. 2009;9:29.
Gill P, Dowell AC, Neal RD, Smith N, Heywood P, Wilson AE. Evidence based general practice: a retrospective study of interventions in one training practice. BMJ . 1996;312:819–21.
Chalmers TC, Celano P, Sacks HS, Smith H Jr. Bias in treatment assignment in controlled clinical trials. N Engl J Med. 1983;309:1358–61.
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.
Kim KS, Jo JK, Chung JH, Kim JH, Choi HY, Lee SW. Quality analysis of randomized controlled trials in the International Journal of Impotence Research: quality assessment and relevant clinical impact. Int J Impot Res. 2017;29:65–69.
Jo JK, Autorino R, Chung JH, Kim KS, Lee JW, Baek EJ, et al. Randomized controlled trials in endourology: a quality assessment. J Endourol. 2013;27:1055–60.
Lee JW, Chung JH, Jo JK, Lee SW. Assessing the quality of randomized controlled trials published in neurourology and urodynamics from 1993 to 2012. Neurourol Urodyn. 2014;33:472–4.
Bridoux V, Moutel G, Roman H, Kianifard B, Michot F, Herve C, et al. Methodological and ethical quality of randomized controlled clinical trials in gastrointestinal surgery. J Gastrointest Surg. 2012;16:1758–67.
Schulz KF, Grimes DA. Allocation concealment in randomised trials: defending against deciphering. Lancet. 2002;359:614–8.
Hewitt C, Hahn S, Torgerson DJ, Watson J, Bland JM. Adequacy and reporting of allocation concealment: review of recent trials published in four general medical journals. BMJ. 2005;330:1057–8.
Clifford TJ, Barrowman NJ, Moher D. Funding source, trial outcome and reporting quality: are they related? Results of a pilot study. BMC Health Serv Res. 2002;2:18.
Chan AW, Altman DG. Identifying outcome reporting bias in randomised trials on PubMed: review of publications and survey of authors. Bmj. 2005;330:753.
Hong JH, Kwon YS, Kim IY. Pharmacodynamics, pharmacokinetics and clinical efficacy of phosphodiesterase-5 inhibitors. Expert Opin Drug Metab Toxicol. 2017;13:183–92.
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Kim, K.S., Chung, J.H. & Lee, S.W. Randomized controlled trials on erectile dysfunction: quality assessment and relevant clinical impact (2007–2018). Int J Impot Res 32, 213–220 (2020). https://doi.org/10.1038/s41443-019-0143-x
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DOI: https://doi.org/10.1038/s41443-019-0143-x