Article type
Year
Abstract
Introduction: The use of methylphenidate for ADHD in children and adolescents has increased during the past decade. However, in our systematic review of randomised clinical trials (RCTs), we found that the very low quality of the evidence made it uncertain as to whether methylphenidate offers more benefits than harms compared with placebo or no treatment. Because of the limitations of identifying and reporting adverse events in RCTs, a thorough systematic assessment of harms reported in non-randomised studies is needed.
Aim: To assess the harmful effects of methylphenidate for children and adolescents with ADHD in non-randomised studies.
Methods: This review is being conducted according to Cochrane guidelines for systematic reviews and based on a comprehensive search for literature in scientific medical databases, unpublished data from the US Food and Drug Administration and European Medicines Agency, and data received from pharmaceutical companies. The primary outcome is the number of serious adverse events as defined within international guidelines. The secondary outcomes are all other adverse events.
We included 322 studies in total: cohort studies, case-control studies, follow-up periods from RCTs, cross-sectional studies, and single participant studies. Through data obtained from non-randomised studies, the review identifies rare adverse events, as well as long-term harms. Depending on study design, measures of prevalence, incidence and risk ratio are used to estimate harms. Results are interpreted according to the study design, and different subgroup analyses are conducted according to co-occurring conditions, sex, age, and type of ADHD.
This review is one of the first Cochrane Reviews to evaluate bias by using A Cochrane Risk of Bias Assessment Tool: for Non-Randomized Studies of Interventions.
Discussion: The study will contribute to a wider knowledge on harms of methylphenidate usage for children and adolescents with ADHD. We will present the results of both primary and secondary outcomes. Furthermore, we will discuss the methodological topic of bias and confounding in studies assessing harms from the use of methylphenidate.
Aim: To assess the harmful effects of methylphenidate for children and adolescents with ADHD in non-randomised studies.
Methods: This review is being conducted according to Cochrane guidelines for systematic reviews and based on a comprehensive search for literature in scientific medical databases, unpublished data from the US Food and Drug Administration and European Medicines Agency, and data received from pharmaceutical companies. The primary outcome is the number of serious adverse events as defined within international guidelines. The secondary outcomes are all other adverse events.
We included 322 studies in total: cohort studies, case-control studies, follow-up periods from RCTs, cross-sectional studies, and single participant studies. Through data obtained from non-randomised studies, the review identifies rare adverse events, as well as long-term harms. Depending on study design, measures of prevalence, incidence and risk ratio are used to estimate harms. Results are interpreted according to the study design, and different subgroup analyses are conducted according to co-occurring conditions, sex, age, and type of ADHD.
This review is one of the first Cochrane Reviews to evaluate bias by using A Cochrane Risk of Bias Assessment Tool: for Non-Randomized Studies of Interventions.
Discussion: The study will contribute to a wider knowledge on harms of methylphenidate usage for children and adolescents with ADHD. We will present the results of both primary and secondary outcomes. Furthermore, we will discuss the methodological topic of bias and confounding in studies assessing harms from the use of methylphenidate.