• Charlotte C Kik and SpoorJochem K HJKHDepartment of Neurosurgery, Erasmus Medical Center, Rotterdam, The Netherlands. Electronic address: j.spoor@erasmusmc.nl..
• Department of Neurosurgery, Erasmus Medical Center, Rotterdam, The Netherlands.
• World Neurosurg. 2022 May 1; 161: 418-423.

BackgroundClassic randomized controlled trials (RCTs) form the cornerstone for medical guidelines and protocols. However, in neurosurgery, RCTs are not always applicable to everyday clinical practice. Pragmatic controlled trials aim to incorporate real-life data with the preservation of the methodologic quality. This study is a systematic literature review of all pediatric neurosurgical RCTs published between 2000 and 2020 and an analysis of their pragmatism.MethodsAn electronic database search was performed in PubMed, EMBASE, and the Cochrane Library to identify all relevant trials. Pragmatism was evaluated retrospectively on 9 domains: eligibility, recruitment, setting, organization, flexibility (delivery and adherence), follow-up, primary outcome, and primary analysis.ResultsOf the 1862 studies included, 15 met the inclusion criteria. On average, studies scored between equally pragmatic/explanatory and rather pragmatic (M = 3.59, standard deviation [SD] = 0.56). Lowest ratings were seen for setting (M = 2.80, SD = 1.66) and eligibility (M = 3.20, SD = 1.66). Highest scores of pragmatism were given to analysis (M = 4.67, SD = 0.82) and intervention organization (M = 4.60, SD = 1.06). There was no significant difference between studies based on number of patients included, main subject, or publication year.ConclusionsPediatric neurosurgical RCTs scored reasonably well on overall pragmatism. In the future, there will be a greater need for pragmatic controlled trials in pediatric neurosurgery to bridge the divide between real-life data and reliable methodological quality. There is an opportunity to develop further applications of pragmatism tailored to surgical interventions.Copyright © 2021 The Authors. Published by Elsevier Inc. All rights reserved.

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