Attention-Deficit/Hyperactivity Disorder Treatment Pattern and Its Associated Outcomes Among Children Referred to Psychiatry and Mental Health Services in Malaysia: Protocol for a Retrospective Cohort Study

Background: Attention-deficit/hyperactivity disorder (ADHD) is a common neurodevelopmental disorder associated with significant impairments in academic, social, and daily functioning. Despite the availability of clinical practice guidelines in Malaysia, evidence on real-world treatment patterns and outcomes remains limited. The lack of multicenter data on treatment use and clinical outcomes hinders the evaluation of current ADHD care and opportunities for service improvement. Objective: The primary objective of this study is to observe treatment patterns among children with ADHD referred to psychiatry and mental health services in Malaysia after receiving treatment for 18 months. This study will also compare treatment outcomes between children with ADHD who do receive treatment and those who do not receive any ADHD treatment. Methods: This multicenter retrospective cohort study will use secondary data from clinical records of children aged 4 to 16 years with a confirmed diagnosis of ADHD. Data on sociodemographic characteristics, clinical features, ADHD subtype and comorbidities, treatment modalities, health care use, treatment trajectories, and clinical outcomes will be extracted using a standardized case report form and will be anonymized prior to analysis. Data collection will be undertaken by trained site investigators and medical officers across participating centers. Statistical analyses will be conducted using R software (R Foundation for Statistical Computing). Descriptive statistics will be used to summarize characteristics, treatment patterns, health care use, and clinical outcomes of children with ADHD. Treatment patterns will be characterized according to pharmacological and nonpharmacological interventions, treatment modifications, and service use. Comparative analyses will be performed to examine associations between treatment patterns and clinical outcomes across children with ADHD and clinical subgroups. Results: This study will be funded through a Ministry of Health Research Grant obtained in August 2026. It will commence in August 2026 and end in December 2028. Based on the sample size calculation, a minimum of 2771 eligible children with ADHD records will be included in the study. The study will be reported in accordance with the STROBE (Strengthening the Reporting of Observational Studies in Epidemiology) guidelines for retrospective cohort studies. The findings will be disseminated through presentations and article publications at the national and international levels. Conclusions: This study will address a critical evidence gap in ADHD care by providing comprehensive real-world data on treatment patterns and outcomes among Malaysian children with ADHD. Findings will identify variations in treatment approaches, treatment trajectories, and clinical outcomes across hospitals and regions, assess the alignment of real-world practice with national recommendations, and highlight potential disparities in access to ADHD specialist services. The findings are expected to support evidence-based clinical decision-making, guide strategic health care planning, optimize resource use, and contribute to the development of a more coordinated, efficient, and equitable system of ADHD care across diverse health care settings in Malaysia.