Are randomized controlled trials in urology being conducted with justification?
- PMID: 34019751
- DOI: 10.1515/jom-2021-0078
Are randomized controlled trials in urology being conducted with justification?
Abstract
Context: Considering the substantial increase in research funding in the field of urology, minimizing research waste should be a top priority. Systematic reviews (SRs) compile available evidence regarding a clinical question into a single critical resource. If properly utilized, SRs can help minimize redundant studies, focus attention to unsubstantiated treatments, and reduce research waste.
Objectives: To appraise the use of SRs as justification for conducting randomized controlled trials (RCTs) published in high impact urology journals, and to report the ways SRs were incorporated into RCT manuscripts published in the top four urology journals by h5 index.
Methods: On December 13, 2019, a PubMed search was conducted for RCTs published in the top four urology journals according to the Google Scholar h5-index: European Urology, BJU International, The Journal of Urology, and Urology. For an article to be eligible for inclusion in this study, it must have been a full length RCT, published between November 30, 2014, and November 30, 2019 in one of the identified journals, reported only human subjects, and been accessible in English. The following data points were extracted independently by select investigators from each included RCT: manuscript title, year of publication, journal title, type of intervention (drug, medical device, procedure, other), funding source (government, hospital/university, industry, mixed) type of trial (parallel groups, crossover, cluster), and total number of participants reported in each RCT. The included RCTs were searched for reference to an SR, which was then recorded as "yes - verbatim," "yes - inferred," or "not used as justification" and the location in the manuscript where the SR was cited was recorded.
Results: Of the 566 articles retrieved, 276 were included. Overall, 150 (54.3%) RCTs cited an SR as either verbatim (108; 39.1%) or inferred (42; 15.2%) trial justification, while 126 (45.7%) did not use an SR for RCT justification. Of those 126, 107 (84.9%) RCTs did not cite an SR to any extent. A significant association was noted between verbatim justification and type of intervention (x2=20.23, p=0.017), with 18 of 31 (58.1%) "other" interventions (i.e. psychosocial intervention, exercise programs, and online therapy) having an SR cited as verbatim justification. Only 39 of 118 (33.1%) pharmaceutical trials referenced an SR as verbatim justification. Of 403 systematic review citations, 205 (50.8%) appeared in the Discussion section, while 15 (3.7%) were in the Methods section.
Conclusions: We found that RCTs published in four high impact urology journals inconsistently referenced an SR as justification and 39.1% of our entire sample did not reference an SR at all. These findings indicate that a divide exists between the instruction and implementation of evidence based medicine in the field of urology concerning RCTs published in the top four journals. Educating clinicians and researchers on the use of SR as justification for RCTs in urology may reduce research waste and increase the quality of RCTs in the field.
Keywords: RCT; SR; evidence based medicine; randomized controlled trial; research; systematic review; urology.
© 2021 Samuel Shepard et al., published by De Gruyter, Berlin/Boston.
Similar articles
-
The use of systematic reviews to justify phase III ophthalmology trials: an analysis.Eye (Lond). 2020 Nov;34(11):2041-2047. doi: 10.1038/s41433-020-0771-x. Epub 2020 Jan 21. Eye (Lond). 2020. PMID: 31965083 Free PMC article.
-
The use of systematic reviews to justify orthopaedic trauma randomized controlled trials: A cross-sectional analysis.Injury. 2020 Feb;51(2):212-217. doi: 10.1016/j.injury.2019.11.004. Epub 2019 Nov 5. Injury. 2020. PMID: 31711650
-
Are randomized controlled trials being conducted with the right justification?J Evid Based Med. 2020 Aug;13(3):181-182. doi: 10.1111/jebm.12405. Epub 2020 Jul 2. J Evid Based Med. 2020. PMID: 32615030
-
The reporting quality of randomised controlled trials in surgery: a systematic review.Int J Surg. 2007 Dec;5(6):413-22. doi: 10.1016/j.ijsu.2007.06.002. Epub 2007 Oct 29. Int J Surg. 2007. PMID: 18029237 Review.
-
Defining the publication source of high-quality evidence in urology: an analysis of EvidenceUpdates.BJU Int. 2016 Jun;117(6):861-6. doi: 10.1111/bju.13392. Epub 2016 Jan 9. BJU Int. 2016. PMID: 26663761 Review.
Cited by
-
Justification of research using systematic reviews continues to be inconsistent in clinical health science-A systematic review and meta-analysis of meta-research studies.PLoS One. 2022 Oct 31;17(10):e0276955. doi: 10.1371/journal.pone.0276955. eCollection 2022. PLoS One. 2022. PMID: 36315526 Free PMC article.
-
Systematic reviews are rarely used to contextualise new results-a systematic review and meta-analysis of meta-research studies.Syst Rev. 2022 Sep 5;11(1):189. doi: 10.1186/s13643-022-02062-8. Syst Rev. 2022. PMID: 36064741 Free PMC article.
-
Use of Evidence-Based Research Approach in RCTs of Acupuncture-Related Therapies for Primary Dysmenorrhea: A Meta-Research.Chin J Integr Med. 2024 Jun;30(6):551-558. doi: 10.1007/s11655-023-3711-3. Epub 2023 Nov 21. Chin J Integr Med. 2024. PMID: 37987960
References
-
- Speich, B, von Niederhäusern, B, Schur, N, Hemkens, LG, Fürst, T, Bhatnagar, N, et al.. Systematic review on costs and resource use of randomized clinical trials shows a lack of transparent and comprehensive data. J Clin Epidemiol 2018;96:1–11. https://doi.org/10.1016/j.jclinepi.2017.12.018.
-
- Duley, L, Antman, K, Arena, J, Avezum, A, Blumenthal, M, Bosch, J, et al.. Specific barriers to the conduct of randomized trials. Clin Trials 2008;5:40–8. https://doi.org/10.1177/1740774507087704.
-
- Collier, R. Rapidly rising clinical trial costs worry researchers. CMAJ (Can Med Assoc J) 2009;180:277–8. https://doi.org/10.1503/cmaj.082041.
-
- Emanuel, EJ, Schnipper, LE, Kamin, DY, Levinson, J, Lichter, AS. The costs of conducting clinical research. J Clin Oncol 2003;21:4145–50. https://doi.org/10.1200/JCO.2003.08.156.
-
- Chalmers, I, Glasziou, P. Avoidable waste in the production and reporting of research evidence. Lancet. 2009;374:86–9. https://doi.org/10.1016/S0140-6736(09)60329-9.
MeSH terms
LinkOut - more resources
Full Text Sources
Other Literature Sources
Research Materials