Evaluating ADHD medication trial representativeness: a Swedish population-based study comparing hypothetically trial-eligible and trial-ineligible individuals

作者：Miguel Garcia‐Argibay, Zheng Chang, Isabell Brikell, Ralf Kuja‐Halkola, Brian M. D’Onofrio, Paul Lichtenstein, Jeffrey H. Newcorn, Stephen V. Faraone, Henrik Larsson, Samuele Cortese · 发表于：The Lancet Psychiatry · 年份：2025 · DOI：10.1016/s2215-0366(24)00396-1 · 被引用次数：29 · 研究领域：Attention Deficit Hyperactivity Disorder、Pharmaceutical studies and practices、Neuroethics, Human Enhancement, Biomedical Innovations

BACKGROUND: Randomised controlled trials (RCTs) evaluating ADHD medications often use strict eligibility criteria, potentially limiting generalisability to patients in real-world clinical settings. We aimed to identify the proportion of individuals with ADHD who would be ineligible for medication RCTs and evaluate differences in treatment patterns and clinical and functional outcomes between RCT-eligible and RCT-ineligible individuals. METHODS: We used multiple Swedish national registries to identify individuals with ADHD, aged at least 4 years at the age of diagnosis, initiating pharmacological treatment between Jan 1, 2007, and Dec 31, 2019, with follow-up up to Dec 31, 2020. Hypothetical RCT ineligibility was established using exclusion criteria from the international MED-ADHD dataset, including 164 RCTs of ADHD medications. Cox models evaluated differences in medication switching and discontinuation within 1 year between eligible and ineligible individuals. Quasi-Poisson models compared eligible and ineligible individuals on rates of psychiatric hospitalisations, injuries or accidents, and substance use disorder within 1 year of initiating ADHD medications. People with lived experience of ADHD were not involved in the research and writing process. FINDINGS: Of 189 699 individuals included in the study cohort (112 153 men and boys [59%] and 77 546 women and girls [41%]; mean age 21·52 years [SD 12·83; range 4-68]) initiating ADHD medication, 53% (76 477 [74%] of 103 023 ad...