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 (x 2=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.

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Some Questions of Ethics in RCTs

10.31235/osf.io/fgxun ◽

2021 ◽

Author(s):

Reetika Khera

Keyword(s):

Adverse Events ◽

Randomized Controlled Trials ◽

Ethical Issues ◽

Human Subjects ◽

Belmont Report ◽

Institutional Review Boards ◽

Controlled Trials ◽

Randomized Controlled ◽

Institutional Review ◽

Areas Of Concern

Questions of ethics in Randomized Controlled Trials (RCTs) in development economics need greater attention and a wider perspective. RCTs are meant to be governed by the three principles laid out in the Belmont Report, but often violated them, e.g. when local laws are flouted. In other cases, the framework of the Belmont Report itself has proved inadequate: for instance, when there are unintended outcomes or adverse events for which no-one is held accountable. Primarily using RCTs conducted in India, this paper highlights eight areas of concern. RCTs also have a disproportionate influence on shaping research agendas and on policy. Though ethical issues have been raised, there has been little engagement from the RCT community – a manifestation of its power in the profession. As current safeguards (such as oversight by Institutional Review Boards) have failed to protect human subjects, the concluding section discusses possible ways to resolve these issues.

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Assessing the quality of reporting of harms in randomized controlled trials published in high impact cardiovascular journals

European Heart Journal - Quality of Care and Clinical Outcomes ◽

10.1093/ehjqcco/qcz050 ◽

2019 ◽

Vol 6 (2) ◽

pp. 177-179

Author(s):

Muhammad Shahzeb Khan ◽

Rohan Kumar Ochani ◽

Asim Shaikh ◽

Muthiah Vaduganathan ◽

Safi U Khan ◽

...

Keyword(s):

Randomized Controlled Trials ◽

High Impact ◽

Controlled Trials ◽

Quality Of Reporting ◽

Randomized Controlled

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The Quality of Randomized Controlled Trials in High-impact Rheumatology Journals, 1998–2018

The Journal of Rheumatology ◽

10.3899/jrheum.191306 ◽

2020 ◽

Vol 47 (9) ◽

pp. 1446-1449

Author(s):

Michael S. Putman ◽

Ashley Harrison Ragle ◽

Eric M. Ruderman

Keyword(s):

Randomized Controlled Trials ◽

Patient Reported Outcome Measures ◽

High Impact ◽

Controlled Trials ◽

Industry Funding ◽

Primary Analysis ◽

Randomized Controlled ◽

Patient Reported ◽

Over Time

Objective.Well-designed randomized controlled trials (RCT) mitigate bias and confounding, but previous evaluations of rheumatology trials found high rates of methodological flaws. Outside of rheumatoid arthritis, no studies in the modern era have assessed the quality of rheumatology RCT over time or regarding industry funding.Methods.We identified all RCT published in 3 high-impact rheumatology journals from 1998, 2008, and 2018. Quality metrics derived from a modified Jadad scale were analyzed by year of publication and by funding source.Results.Ninety-six publications met inclusion criteria; 82 of these described the primary analysis of an RCT. Over time (1998–2008–2018), trials were less likely to adequately report dropouts and withdrawals (100% vs 82% vs 60%; p < 0.01) or include an active comparator (44% vs 12% vs 13%; p = 0.01). Later trials were more likely to evaluate biologic therapy (11% vs 38% vs 83%; p < 0.01) and report adequate randomization procedures (39% vs 29% vs 60%; p = 0.04). Seventy-nine percent of trials received industry funding. Industry-funded trials were more likely to report double-blinding (86% vs 53%; p < 0.01), patient-reported outcome measures (77% vs 41%; p < 0.01), and intention-to-treat analyses (86% vs 65%; p = 0.04).Conclusion.Industry-funded trials comprise the majority of RCT published in high-impact rheumatology journals and more frequently report metrics associated with RCT quality. RCT assessing active comparators and nonbiologic therapies have become less common in high-impact rheumatology journals.

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Eligibility Criteria of Randomized Controlled Trials Published in High-Impact General Medical Journals

JAMA ◽

10.1001/jama.297.11.1233 ◽

2007 ◽

Vol 297 (11) ◽

pp. 1233 ◽

Cited By ~ 540

Author(s):

Harriette G. C. Van Spall ◽

Andrew Toren ◽

Alex Kiss ◽

Robert A. Fowler

Keyword(s):

Randomized Controlled Trials ◽

High Impact ◽

Controlled Trials ◽

Eligibility Criteria ◽

Medical Journals ◽

Randomized Controlled ◽

General Medical Journals

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Ethical issues of randomized controlled trials

Bangladesh Journal of Bioethics ◽

10.3329/bioethics.v5i1.18441 ◽

2014 ◽

Vol 5 (1) ◽

pp. 1-4 ◽

Cited By ~ 1

Author(s):

Jyotirmoy Sarker

Keyword(s):

Randomized Controlled Trials ◽

Ethical Issues ◽

Human Subjects ◽

Research Result ◽

Controlled Trials ◽

Medical Interventions ◽

Randomized Controlled ◽

Institutional Review ◽

Human Participants ◽

Selection Of

Clinical trials involve the application of different medical interventions on human participants. Randomized controlled trials involve different groups of human subjects undergoing different clinical interventions. This process ensures bias free subject allocation which leads to a way to statistically establish the research result. Strict ethical guidance is necessary from selection of participants to the analysis of trial results. Without proper guidance the trial participants would be subjected to unethical experiments. Before starting the randomized controlled trials the investigators must meet all ethics issues. The institutional review board (IRB) must check whether all ethical demands are met or not before permitting the research. DOI: http://dx.doi.org/10.3329/bioethics.v5i1.18441 Bangladesh Journal of Bioethics 2014 Vol.5(1): 1-4

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A Systematic Review and Analysis of Factors Associated with Methodological Quality in Laparoscopic Randomized Controlled Trials

Digestive Surgery ◽

10.1159/000381886 ◽

2015 ◽

Vol 32 (3) ◽

pp. 217-224 ◽

Cited By ~ 1

Author(s):

Stavros Athanasios Antoniou ◽

Alexandros Andreou ◽

George Athanasios Antoniou ◽

Antonios Bertsias ◽

Gernot Köhler ◽

...

Keyword(s):

Impact Factor ◽

Randomized Controlled Trials ◽

Methodological Quality ◽

Demographic Data ◽

Controlled Trials ◽

Factors Associated ◽

Intention To Treat ◽

Randomized Controlled ◽

Acceptable Quality ◽

Pubmed Search

Several methods for assessment of methodological quality in randomized controlled trials (RCTs) have been developed during the past few years. Factors associated with quality in laparoscopic surgery have not been defined till date. The aim of this study was to investigate the relationship between bibliometric and the methodological quality of laparoscopic RCTs. The PubMed search engine was queried to identify RCTs on minimally invasive surgery published in 2012 in the 10 highest impact factor surgery journals and the 5 highest impact factor laparoscopic journals. Eligible studies were blindly assessed by two independent investigators using the Scottish Intercollegiate Guidelines Network (SIGN) tool for RCTs. Univariate and multivariate analyses were performed to identify potential associations with methodological quality. A total of 114 relevant RCTs were identified. More than half of the trials were of high or acceptable quality. Half of the reports provided information on comparative demographic data and only 21% performed intention-to-treat analysis. RCTs with sample size of at least 60 patients presented higher methodological quality (p = 0.025). Upon multiple regression, reporting on preoperative care and the experience level of surgeons were independent factors of quality.

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Randomized controlled trials in ophthalmology: a bibliometric study

F1000Research ◽

10.12688/f1000research.20673.1 ◽

2019 ◽

Vol 8 ◽

pp. 1718

Author(s):

Saif Aldeen AlRyalat ◽

Areen Abukahel ◽

Khaled Ali Elubous

Keyword(s):

Randomized Controlled Trials ◽

Controlled Trials ◽

Retinal Diseases ◽

Randomized Controlled ◽

Hierarchy Of Evidence ◽

The Status ◽

Pubmed Search ◽

Mesh Database ◽

Based Medicine ◽

Number Of Citations

Background: Randomized controlled trials (RCTs) are situated at the top of hierarchy of evidence-based medicine, where its number and quality are important in the assessment of quality of evidence in a medical field. In this study, we aim to assess the status of RCTs in Ophthalmology. Methods: On 15th of May 2019, we performed a PubMed search for randomized controlled trials published in the field of ophthalmology using relevant filters and search terms. We categorized the results into specific topics in ophthalmology according to Medical Subject Heading (MeSH) database classification system. We used Altmetric explorer to identify journals and articles with the highest number of RCTs and highest citations. Results: We found a total of 540,427 publications in the field of ophthalmology, of which only 11,634 (2.15%) of them were RCTs. ‘Retinal diseases’ was the topic with the highest number of RCTs, followed by ‘glaucoma’ and ‘conjunctival diseases’. The trial with highest number of citations was on retinal diseases. Only around 18% of all ophthalmology RCTs are published in the top 10 ophthalmology journals, with a maximum percentage of RCTs was (5.53%) published in Ophthalmology. Conclusion: RCTs in ophthalmology primarily concern the retina, glaucoma, and a few other sub-topics, with little focus on sclera, orbit, and the eyelids. Most of the high impact RCTs are published in non-ophthalmology journals.

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Evaluation of ‘spin’ in the abstracts and articles of randomized controlled trials in pain literature and general anesthesia

Pain Management ◽

10.2217/pmt-2020-0009 ◽

2021 ◽

Vol 11 (1) ◽

pp. 23-28

Author(s):

Jaime W Thompson ◽

Ross Tanzer ◽

Tate Triska ◽

Jay Thompson ◽

Trevor Bright ◽

...

Keyword(s):

Chronic Pain ◽

Randomized Controlled Trials ◽

General Anesthesia ◽

A Priori ◽

Controlled Trials ◽

End Points ◽

Randomized Controlled ◽

Pubmed Search ◽

Clinical Consequences ◽

Period Data

Aim: To evaluate the abstracts and articles of randomized controlled trials (RCTs) in pain literature and general anesthesia for the evidence of spin. Materials & methods: Following a priori protocol, we used a PubMed search for RCTs from a 2-year period. Data extracted using the Boutron spin definition for criteria. Results: A total of 163 articles were identified as RCTs with clear primary and secondary end points. A total of 33 trials were identified with nonsignificant primary end points. An 18/33 were found to have spin (54.5%). The spin was identified in the results, title and conclusion 12/18, 3/18 and 3/18, respectively. Conclusion: Spin was found in 54% of pain RCTs. With sensitive clinical concerns, such as chronic pain, any misrepresentation of validity could prove to have significant clinical consequences.

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