Article type
Year
Abstract
Background: adults diagnosed with attention deficit hyperactivity disorder (ADHD) are offered methylphenidate as first-line treatment. However, appraising the treatment effect is challenging since most available tools to diagnose and evaluate symptoms of ADHD were developed to be applied in children, and mostly rated by their teachers and parents. Currently, the available evidence is controversial and it is not possible to precisely determine the benefits and harms associated with the use of methylphenidate in adults with ADHD.
Objectives: to describe the experience of appraising the evidence involving a health condition with different clinical assessment scales.
Methods: we conducted a systematic review of randomized controlled trials (RCTs) following standard Cochrane methodology. The review was carried out through sensitive searches on CENTRAL, MEDLINE, CINAHL, LILACS, Embase, PsycINFO, Web of Science, DARE and Clinical Trials Registry Platforms - up to May 2018. We included RCTs evaluating immediate-release methylphenidate administered at any dosage as part of any treatment regimen, compared with placebo or other pharmacological intervention. The primary outcomes evaluated were symptoms of ADHD and serious adverse effects. Data symptoms of ADHD were based on clinical assessment by a physician or by self-report, or measured by any validated clinical scale reported in the trials.
Results: we included eight studies involving 515 participants aged between 18 and 60 years. The included studies comprised parallel (n = 4) and cross-over (n = 4) RCTs. These studies applied 14 different clinical assessment scales to measure the symptoms of ADHD; four of them specially adapted to adults. Five of the studies reported a benefit of the use of methylphenidate in adults with ADHD. However, accounting for the heterogeneity on the rating scales, we were able able to pool results of only two cross-over RCTs (83 participants). The meta-analysis did not demonstrate superiority of methylphenidate when compared to placebo (standardized mean difference 0.10, 95% confidence interval −0.93 to 1.13; I2 = 82%, P = 0.02).
Conclusions: the high heterogeneity among the clinical rating scales used to ascertain the effect of methylphenidate on the treatment of adults with ADHD precludes robust statistical pooling and interpretation of the available evidence. Contrary to the isolated conclusions from individual RCTs' reports, a meta-analysis of the only comparable data available does not suggest benefits of methylphenidate when compared to placebo. Core outcome sets and core outcome measurement instruments are vital initiatives to inform research in this field. Obtaining standardized, comparable results from clinical trials is essential to allow proper synthesis and appraisal of the evidence.
Patient or healthcare consumer involvement: patients' or consumers' perspectives will be included during the upcoming peer-review stage.
Objectives: to describe the experience of appraising the evidence involving a health condition with different clinical assessment scales.
Methods: we conducted a systematic review of randomized controlled trials (RCTs) following standard Cochrane methodology. The review was carried out through sensitive searches on CENTRAL, MEDLINE, CINAHL, LILACS, Embase, PsycINFO, Web of Science, DARE and Clinical Trials Registry Platforms - up to May 2018. We included RCTs evaluating immediate-release methylphenidate administered at any dosage as part of any treatment regimen, compared with placebo or other pharmacological intervention. The primary outcomes evaluated were symptoms of ADHD and serious adverse effects. Data symptoms of ADHD were based on clinical assessment by a physician or by self-report, or measured by any validated clinical scale reported in the trials.
Results: we included eight studies involving 515 participants aged between 18 and 60 years. The included studies comprised parallel (n = 4) and cross-over (n = 4) RCTs. These studies applied 14 different clinical assessment scales to measure the symptoms of ADHD; four of them specially adapted to adults. Five of the studies reported a benefit of the use of methylphenidate in adults with ADHD. However, accounting for the heterogeneity on the rating scales, we were able able to pool results of only two cross-over RCTs (83 participants). The meta-analysis did not demonstrate superiority of methylphenidate when compared to placebo (standardized mean difference 0.10, 95% confidence interval −0.93 to 1.13; I2 = 82%, P = 0.02).
Conclusions: the high heterogeneity among the clinical rating scales used to ascertain the effect of methylphenidate on the treatment of adults with ADHD precludes robust statistical pooling and interpretation of the available evidence. Contrary to the isolated conclusions from individual RCTs' reports, a meta-analysis of the only comparable data available does not suggest benefits of methylphenidate when compared to placebo. Core outcome sets and core outcome measurement instruments are vital initiatives to inform research in this field. Obtaining standardized, comparable results from clinical trials is essential to allow proper synthesis and appraisal of the evidence.
Patient or healthcare consumer involvement: patients' or consumers' perspectives will be included during the upcoming peer-review stage.
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