Assessing risk of bias in randomized controlled trials of methylphenidate for children and adolescents with attention deficit hyperactivity disorder (<scp>ADHD</scp>)

Raissa, Rodrigues-Tartari; Swardfager, Walter; Salum, Giovanni Abrahão; Rohde, Luís Augusto; Cogo-Moreira, Hugo

doi:10.1002/mpr.1586

Cited by 7 publications

(8 citation statements)

References 20 publications

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“…Finally, although the items from our model show better indices, the results of this study were consistent with those of Rodrigues-Tartari et al ( 8 ), who found that the RoB model for RCTs for trials of methylphenidate for children and adolescents with ADHD have poor reliability. Therefore, the Cochrane RoB tool is insufficient when applied to ASD clinical trials.…”

Section: Discussionsupporting

confidence: 91%

“…Similarly, though less frequently, these techniques are applied to measure non-human attributes in the healthcare field. To the best of our knowledge, there is only one study using CFA to provide construct validity of RoB ( 8 ). This study is thus innovative in the application of CFA to RoB in the field of ASD.…”

Section: Methodsmentioning

confidence: 99%

“…The first study in the literature evaluating the construct validity of RoB was recently conducted by Rodrigues-Tartari et al ( 8 ). In a review of RCTs evaluating methylphenidate for ADHD, the authors found that the Cochrane Risk of Bias Tool has poor evidence of construct validity and was an unreliable instrument (ω = 0.642) for the RCTs under review.…”

Section: Introductionmentioning

confidence: 99%

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Assessing Risk of Bias in Randomized Controlled Trials for Autism Spectrum Disorder

et al. 2017

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AimTo determine construct validity and reliability indicators of the Cochrane risk of bias (RoB) tool in the context of randomized clinical trials (RCTs) for autism spectrum disorder (ASD).MethodsConfirmatory factor analysis was used to evaluate a unidimensional model consisting of 9 RoB categorical indicators evaluated across 94 RCTs addressing interventions for ASD.ResultsOnly five of the nine original RoB items returned good fit indices and so were retained in the analysis. Only one of this five had very high factor loadings. The remaining four indicators had more measurement error than common variance with the RoB latent factor. Together, the five indicators showed poor reliability (ω = 0.687; 95% CI: 0.613–0.761).ConclusionAlthough the Cochrane model of RoB for ASD exhibited good fit indices, the majorities of the items have more residual variance than common variance and, therefore, did not adequately capture the RoB in ASD intervention trials.

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Section: Discussionsupporting

confidence: 91%

Section: Methodsmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

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Assessing Risk of Bias in Randomized Controlled Trials for Autism Spectrum Disorder

et al. 2017

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“…Additionally, we analysed only Cochrane reviews, which use Cochrane RoB tool. Recent studies have indicated that the RoB instrument did not adequately capture the risk of bias in RCTs [18, 19]. Future studies on Cochrane RoB 2.0 tool are warranted to see how the new tool compares to the current one.…”

Section: Discussionmentioning

confidence: 99%

Risk of bias judgments for random sequence generation in Cochrane systematic reviews were frequently not in line with Cochrane Handbook

Barčot

Borić

Peričić

et al. 2019

BMC Med Res Methodol

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Background Assessing the risk of bias (RoB) in included studies is one of the key methodological aspects of systematic reviews. Cochrane systematic reviews appraise RoB of randomised controlled trials (RCTs) with the Cochrane RoB tool. Detailed instructions for using the Cochrane RoB tool are provided in the Cochrane Handbook for Systematic Reviews of Interventions (The Cochrane Handbook). The purpose of this study was to analyse whether Cochrane authors use adequate judgments about the RoB for random sequence generation of RCTs included in Cochrane reviews. Methods We extracted authors’ judgments (high, low or unclear RoB) and supports for judgments (comments accompanying judgments which explain the rationale for a judgment) for random sequence generation of included RCTs from RoB tables of Cochrane reviews using automated data scraping. We categorised all supporting comments, analysed the number and type of various supporting comments and assessed adequacy of RoB judgment for randomisation in line with recommendations from the Cochrane Handbook. Results We analysed 10,103 RCTs that were included in 704 Cochrane reviews. For 5,706 RCTs, randomisation was not described, but for the remaining RCTs, it was indicated that randomisation was performed using computer/software/internet ( N = 2,850), random number table ( N = 883), mechanical method ( N = 359) or it was incomplete/inappropriate ( N = 305). Overall, 1,220/10,103 trials (12%) did not have a RoB judgment in line with Cochrane Handbook guidance about randomisation. The highest proportion of misjudgements was found for trials with high RoB (28%), followed by those with low (20%) or unclear (3%). Therefore, one in eight judgments for the analysed domain in Cochrane reviews was not in line with Cochrane Handbook, and one in four if the judgment was "high risk". Conclusion Authors of Cochrane reviews often make judgments about the RoB related to random sequence generation that are not in line with instructions given in the Cochrane Handbook, which compromises the reliability of the systematic reviews. Our results can help authors of both Cochrane and non-Cochrane reviews which use Cochrane RoB tool to avoid making common mistakes when assessing RoB in included trials. Electronic supplementary material The online version of this article (10.1186/s12874-019-0804-y) contains supplementary material, which is available to authorized users.

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“…Additionally, we analyzed only Cochrane reviews, which use Cochrane RoB tool. Recent studies have indicated that the RoB instrument did not adequately capture risk of bias in RCTs [13,14]. Future studies on Cochrane RoB 2.0 tool are warranted to see how the new tool compares to the current one.…”

Section: Cochrane Handbook Explicitly Warnsmentioning

confidence: 99%

Judgments of risk of bias associated with random sequence generation in trials included in Cochrane systematic reviews are frequently erroneous

Barčot

Borić

Poklepovic

et al. 2018

Preprint

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Assessing risk of bias in randomized controlled trials of methylphenidate for children and adolescents with attention deficit hyperactivity disorder (ADHD)

Cited by 7 publications

References 20 publications

Assessing Risk of Bias in Randomized Controlled Trials for Autism Spectrum Disorder

Assessing Risk of Bias in Randomized Controlled Trials for Autism Spectrum Disorder

Risk of bias judgments for random sequence generation in Cochrane systematic reviews were frequently not in line with Cochrane Handbook

Judgments of risk of bias associated with random sequence generation in trials included in Cochrane systematic reviews are frequently erroneous

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