Randomized controlled trials in testicular cancer: A demographic and quality assessment

Abstract Background Randomized controlled trials (RCT) provide the strongest evidence to justify interventions in patients. However, trials with inadequate methods are associated with bias and exaggerated treatment effects. A search of the literature was conducted to review RCTs in testicular cancer...

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Published in:Urologic oncology 2016-02, Vol.34 (2), p.60.e7-60.e13
Main Authors: Nayan, Madhur, M.D., C.M, Jayalath, Viranda H., M.Sc, Jewett, Michael A.S., M.D, Bedard, Philippe L., M.D, Hamilton, Robert J., M.D
Format: Article
Language:English
Subjects:
Chemotherapy
CONSORT statement
Humans
Male
Quality Assurance, Health Care
Randomized controlled trials as topic
Reporting of methodological factors
Testicular neoplasms
Testicular Neoplasms - drug therapy
Urology
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Summary:Abstract Background Randomized controlled trials (RCT) provide the strongest evidence to justify interventions in patients. However, trials with inadequate methods are associated with bias and exaggerated treatment effects. A search of the literature was conducted to review RCTs in testicular cancer (TC) to assess demographic and trial reporting quality patterns over time. Methods MEDLINE and CENTRAL were queried for TC RCTs from 1989 to 2014. Demographic information was abstracted and reporting quality score was evaluated using the Consolidated Standards of Reporting Trials criteria. Linear regression was used to assess the trend in reporting quality over time. Results A total of 39 RCTs were identified, of which 25 were published from 1989 to 2001 and 14 were published from 2002 to 2014. Most (59%) of the RCTs involved chemotherapy as the intervention, had a medical oncologist as the first author (87%), and took place in Europe (59%). RCTs published between 2002 and 2014 had longer enrollment periods (mean = 6.1 [2.7] vs. 3.7 [1.5] years, P = 0.007), whereas the number of patients randomized, median follow-up, or time from manuscript submission to acceptance were not significantly different between the periods. For each increasing year of publication, there was a significant improvement of 1.34% points (95% CI: 0.86–1.83, P
ISSN:1078-1439
1873-2496
DOI:10.1016/j.urolonc.2015.09.007