We have extracted administrative information, study methods, patient characteristics and study results from each clinical trial. Furthermore, the risk of bias has been assessed.
Complete citation of all study publications and web pages, study authors and their affiliations, location of the study, number of participating centres, study funding, and authors’ conflicts of interest.
Study inclusion and exclusion criteria, clinical trial design (parallel, crossover, factorial), objective of the study (efficacy, maintenance of efficacy), method used to generate the randomization sequence and to conceal the randomization sequence, study interventions blinding method, existence of a wash-out phase and its duration, existence of a run-in or lead-in period and its duration and results, existence of a follow-up study on completing the randomized clinical trial, and compensation offered to patients for participating in the trial.
We have included the effects of treatment on the following study variables: ADHD symptoms, inattention, hyperactivity / impulsivity, oppositional defiant disorder (ODD), anxiety, depression, clinical global impression, quality of life, psychosocial functioning, treatment discontinuation and its causes, neuropsychological variables, neuroimaging, behaviour in a laboratory school, reaction in a driving simulator, academic performance, and physiological variables such as weight, height, heart rate or blood pressure. Data on the scale and version of psychometric variables used was also collected. Regarding safety, we have compiled information on dropouts due to adverse events, the incidence of any adverse event, serious adverse events, and each type of adverse event. Regarding statistical analysis, we have documented the type of analysis performed and the method of missing data imputation.
We have compiled the drugs investigated, their ATC code, pharmaceutical formulation, minimum, maximum and average dose, administration schedule, duration of treatment and the method used to assess medication adherence. Information on concomitant pharmacological and psychotherapeutic treatments administered has also been compiled.
- Sociodemographic characteristics: age, gender, and race, among others.
- Type of ADHD, medical history and comorbidities.
- Baseline score of ADHD, ODD, anxiety and depressive symptom severity, quality of life, psychosocial functioning and baseline measures of physiological variables (see Results).
- Past pharmacological and psychological ADHD treatments.
Efficacy on ADHD symptom severity, clinical global impression, ODD symptom severity, drug use, depressive and anxiety symptoms, quality of life, psychosocial functioning, treatment discontinuation and causes thereof, incidence of all adverse events published, results on physiological variables (blood pressure, HR, QT interval, weight, height, and so on).
Regarding efficacy, we have also compiled information on the instrument used to assess symptom severity (e.g. ADHD-RS, Conners scales, and so on) and who rated the symptoms (patient, parents, clinician, teacher, or others). The compiled results are expressed as final scores, change scores and response rates.
Both raw and standardized data (e.g. T-score) have been extracted. Study outcomes have been extracted separately for each study arm. Relevant missing information has been requested from the corresponding authors.