Premature Discontinuation of Pediatric Randomized Controlled Trials: A Retrospective Cohort Study.

OBJECTIVES: To determine the proportion of pediatric randomized controlled trials (RCTs) that are prematurely discontinued, examine the reasons for discontinuation, and compare the risk for recruitment failure in pediatric and adult RCTs. STUDY DESIGN: A retrospective cohort study of RCTs approved by 1 of 6 Research Ethics Committees (RECs) in Switzerland, Germany, and Canada between 2000 and 2003. We recorded trial characteristics, trial discontinuation, and reasons for discontinuation from protocols, corresponding publications, REC files, and a survey of trialists. RESULTS: We included 894 RCTs, of which 86 enrolled children and 808 enrolled adults. Forty percent of the pediatric RCTs and 29% of the adult RCTs were discontinued. Slow recruitment accounted for 56% of pediatric RCT discontinuations and 43% of adult RCT discontinuations. Multivariable logistic regression analyses suggested that pediatric RCT was not an independent risk factor for recruitment failure after adjustment for other potential risk factors (aOR, 1.22; 95% CI, 0.57-2.63). Independent risk factors were acute care setting (aOR, 4.00; 95% CI, 1.72-9.31), nonindustry sponsorship (aOR, 4.45; 95% CI, 2.59-7.65), and smaller planned sample size (aOR, 1.05; 95% CI 1.01-1.09, in decrements of 100 participants). CONCLUSION: Forty percent of pediatric RCTs were discontinued prematurely, owing predominately to slow recruitment. Enrollment of children was not an independent risk factor for recruitment failure.

Evidence-based plastic surgery: controlled trials in three plastic surgical journals (1990 to 2005).

Although a myriad of original articles is published annually in plastic surgical journals assessment of the level of evidence-based medicine has rarely been conducted. A hand search was conducted identifying randomized controlled (RCTs) and controlled clinical trials in 3 plastic surgical journals from 1990 to 2005. The quality of reporting was assessed and additional parameters investigated including report of statistical significance, type of institution, and country affiliation of the first author. Nine thousand four hundred twenty-eight original articles were analyzed of which 172 and 139 articles met the inclusion criteria for RCTs and controlled clinical trials, respectively. Fifty-nine RCTs reported on successful double-blinding with only 20 RCTs reporting the allocation concealment appropriately. Description of participant drop-outs was detected in 64 RCTs and a statistically significant result was reported in 118 RCTs. The annual publication of controlled trials has increased over the last 16 years, with the majority of controlled trials being from North-America and Europe. Execution and publication of controlled trials has increased in the plastic surgical literature. However, the quality of reporting deserves improvement.

Evidence-based plastic surgery: controlled trials in three plastic surgical journals (1990-2005).

Although a myriad of original articles is published annually in plastic surgical journals, assessment of the level of evidence-based medicine has rarely been conducted. A hand search was conducted identifying randomized controlled trials (RCTs) and controlled clinical trials in 3 plastic surgical journals from 1990-2005. The quality of reporting was assessed and additional parameters investigated including report of statistical significance, type of institution, and country affiliation of the first author. Of the 9428 original articles that were analyzed, 172 and 139 articles met the inclusion criteria for RCTs and controlled clinical trials, respectively. Fifty-nine RCTs reported on successful double-blinding with only 20 RCTs reporting the allocation concealment appropriately. Description of participant drop-outs was detected in 64 RCTs and a statistically significant result was reported in 118 RCTs. The annual publication of controlled trials has increased over the last 16 years, with the majority of controlled trials being from North-America and Europe. Execution and publication of controlled trials has increased in the plastic surgical literature. However, the quality of reporting deserves improvement.