Methylphenidate for attention deficit hyperactivity disorder (ADHD) in children and adolescents - assessment of harmful effects in non-randomised studies

Storebø, Ole Jakob; Pedersen, Niels Wisbech; Ramstad, E; Krogh, Helle B; Maia, Carlos Renato Moreira; Magnusson, Frederik Løgstrup; Holmskov, Mathilde; Nilausen, Trine Danvad; Skoog, Maria; Rosendal, Susanne; Groth, Camilla; Gillies, Donna; Rasmussen, Kirsten; Gauci, Dorothy; Zwi, Morris; Kirubakaran, Richard; Forsbøl, Bente; Håkonsen, Sasja Juul; Aagaard, Lise; Simonsen, Erik; Gluud, Christian

doi:10.1002/14651858.cd012069

Cited by 7 publications

(7 citation statements)

References 81 publications

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“…What procedures resulted in these conclusions? The peer‐reviewed Cochrane protocols published in 2012 and 2016 specified most of the procedures implemented for the reviews for assessing risk of bias. In the 2012 protocol, Storebø et al .…”

Section: Risk Of Bias and Quality Of Evidence In The Cochrane Reviewsmentioning

confidence: 99%

“…The 2015 review of randomized trials provided the rationale for the 2018 Cochrane review of nonrandomized trials, and a detailed protocol was prepared and published describing the methods to be used . One conclusion of this review was that “… information on long‐term adverse events in the use of methylphenidate is very limited” [and the] “… high degree of under‐reporting in these studies [is] of great concern.” Despite the large number of trials (260), only 3 of the 11 comparative studies and only 50 of the 249 noncomparative studies reported serious adverse events.…”

Section: The 2018 Cochrane Review: Will the Debate Continue?mentioning

confidence: 99%

“…What procedures were used to assess risk of bias in the nonrandomized trials? The published protocol specified the use of an early version of the Risk of Bias in Non‐randomized Studies of Intervention (ROBINS‐I) tool. ROBINS‐I evaluates seven domains of bias: confounding bias, selection bias, measurement bias, intervention bias, missing data bias, outcome bias, and selective reporting bias.…”

Section: The 2018 Cochrane Review: Will the Debate Continue?mentioning

confidence: 99%

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Risk of Bias and Quality of Evidence for Treatment of ADHD With Stimulant Medication

Swanson

2018

Clin Pharma and Therapeutics

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Storebø et al. provide a concise summary of two Cochrane reviews about benefits and harms of treatment of attention-deficit/hyperactivity disorder (ADHD) with methylphenidate: (1) a review of 185 randomized controlled trials that estimated benefits (e.g., moderate-to-large reduction in teacher-rated ADHD symptoms) and (2) a review of 260 nonrandomized trials that estimated harms (e.g., infrequent serious but frequent nonserious adverse events). They also mention (without providing much detail) additional information from the structured Cochrane method about the risk for bias in the trials reviewed (assessed as being high) and quality of evidence of the outcomes considered (rated as being very low). This led to the conclusion that "the jury is still out on benefits and harms." A similar conclusion of the first review generated an extensive debate in the literature. Some details will be summarized and discussed herein to provide context in case the recent review and the summary by Storebø et al. revive the debate.

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Section: Risk Of Bias and Quality Of Evidence In The Cochrane Reviewsmentioning

confidence: 99%

Section: The 2018 Cochrane Review: Will the Debate Continue?mentioning

confidence: 99%

Section: The 2018 Cochrane Review: Will the Debate Continue?mentioning

confidence: 99%

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Risk of Bias and Quality of Evidence for Treatment of ADHD With Stimulant Medication

Swanson

2018

Clin Pharma and Therapeutics

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“…On the basis of our other protocol on methylphenidate for ADHD, we are presently examining the reporting of adverse events in observational studies 15. This work is not yet complete.…”

Section: Serious Adverse Effects Of Methylphenidatementioning

confidence: 99%

Evidence on methylphenidate in children and adolescents with ADHD is in fact of ‘very low quality’

Storebø

Zwi

Krogh

et al. 2016

Evid Based Mental Health

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Banaschewski and colleagues from the European Attention Deficit Hyperactivity Disorder (ADHD) guideline group make a number of critical comments regarding our systematic review on methylphenidate for children and adolescents with ADHD. In this article, we present our views, showing that our trial selection was not flawed and was undertaken with scientific justification. Similarly, our data collection and interpretation was systematic and correct. We have followed a sound methodology for assessing risk of bias and our conclusions are not misleading. We acknowledge that different researchers might make risk of bias judgments at higher or lower thresholds, but we have been consistent and transparent in applying our pre-defined and per reviewed protocol. Although we made minor errors, we demonstrate that the effects are negligible and not affecting our conclusions. We are happy to correct such errors and to engage in debate on methodological and ethical issues. In terms of clinical implications, we are advocating that clinicians, patients and their relatives should weight carefully risks and benefits of methylphenidate. Clinical experience seems to suggest that there are people who benefit from this medication. Our systematic review does, however, raise questions regarding the overall quality of the methylphenidate trials.

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“…God rådgiving i forbindelse med bruk av metylfenidat er derfor å lytte til pasienters ønsker, samt å rådgive om den eksterne evidens på en objektiv måte, hvor man også inndrar klinikerens erfaring. Evidensbasert behandling må ikke bli et «behandlertyrani» (1,5).…”

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Evidensen for medisinsk behandling av AD/HD er usikker

Storebø¹

2018

Tidsskriftet

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Methylphenidate for attention deficit hyperactivity disorder (ADHD) in children and adolescents - assessment of harmful effects in non-randomised studies

Abstract: Methylphenidate for attention deficit hyperactivity disorder (ADHD) in children and adolescents-assessment of harmful effects in non-randomised studies.

Cited by 7 publications

References 81 publications

Risk of Bias and Quality of Evidence for Treatment of ADHD With Stimulant Medication

Risk of Bias and Quality of Evidence for Treatment of ADHD With Stimulant Medication

Evidence on methylphenidate in children and adolescents with ADHD is in fact of ‘very low quality’

Evidensen for medisinsk behandling av AD/HD er usikker

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