Lancet PsychiatryPub Date : 2025-01-06DOI: 10.1016/s2215-0366(24)00396-1
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
{"title":"Evaluating ADHD medication trial representativeness: a Swedish population-based study comparing hypothetically trial-eligible and trial-ineligible individuals","authors":"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","doi":"10.1016/s2215-0366(24)00396-1","DOIUrl":"https://doi.org/10.1016/s2215-0366(24)00396-1","url":null,"abstract":"<h3>Background</h3>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.<h3>Methods</h3>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.<h3>Findings</h3>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 adults [aged >17 years], 12 658 [35%] of 35 681 adolescents [aged 13–17 years], and 10 643 [21%] of 50 995 children [aged <13 years]) would have been ineligible for RCT participation. Ethnicity data were not available. Ineligible individuals had a higher likelihood of treatment switching (hazard ratio 1·14, 95% CI 1·12–1·16) and a decreased likelihood of medication discontinuation (0·96, 0·94–0·98) compared with eligible individuals. Individuals ineligible for RCTs had significantly higher rates of psychiatric hospitalisations (ncidence rate ratio 9·68, 95% CI 9·57–9·78) and specialist care visits related to substance use disorder (14·78, 14·64–14·91), depression (6·00, 5·94–6·06), and anxiety (11·63, 11·56–11·69).<h3>Interpretation</h3>Individuals ineligible for ADHD medication trials face higher risks of adverse outcomes. This study provides the first empirical evidence for the limited generalisability of ADHD RCTs to real-world clinical populations, by applying eligibility criteria extracted from a comprehensive dataset of RCTs to a large real-world cohort. Triangulating evidence from RCTs and real-world studies is crucial to inform rigorous evidence-based treatment guidelines.<h3>Funding</h3>National Institute of Healthcare and Research, European Union's Horizon 2020, and Swedish Research Council.","PeriodicalId":48784,"journal":{"name":"Lancet Psychiatry","volume":"27 1","pages":""},"PeriodicalIF":64.3,"publicationDate":"2025-01-06","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142934728","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Lancet PsychiatryPub Date : 2025-01-01Epub Date: 2024-07-04DOI: 10.1016/S2215-0366(24)00203-7
Florence Butlen-Ducuing, Francisca Silva, Ivana Silva, Pavel Balabanov, Steffen Thirstrup
{"title":"Applying the EU regulatory framework for the clinical use of psychedelics.","authors":"Florence Butlen-Ducuing, Francisca Silva, Ivana Silva, Pavel Balabanov, Steffen Thirstrup","doi":"10.1016/S2215-0366(24)00203-7","DOIUrl":"10.1016/S2215-0366(24)00203-7","url":null,"abstract":"","PeriodicalId":48784,"journal":{"name":"Lancet Psychiatry","volume":" ","pages":"7-9"},"PeriodicalIF":30.8,"publicationDate":"2025-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141555767","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Lancet PsychiatryPub Date : 2024-12-19DOI: 10.1016/s2215-0366(24)00401-2
Jakub S Bil
{"title":"Advancing global mental health diplomacy through a rights-based approach","authors":"Jakub S Bil","doi":"10.1016/s2215-0366(24)00401-2","DOIUrl":"https://doi.org/10.1016/s2215-0366(24)00401-2","url":null,"abstract":"No Abstract","PeriodicalId":48784,"journal":{"name":"Lancet Psychiatry","volume":"20 1","pages":""},"PeriodicalIF":64.3,"publicationDate":"2024-12-19","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142857904","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Lancet PsychiatryPub Date : 2024-12-19DOI: 10.1016/s2215-0366(24)00363-8
{"title":"The global epidemiology and health burden of the autism spectrum: findings from the Global Burden of Disease Study 2021","authors":"","doi":"10.1016/s2215-0366(24)00363-8","DOIUrl":"https://doi.org/10.1016/s2215-0366(24)00363-8","url":null,"abstract":"<h3>Background</h3>High-quality estimates of the epidemiology of the autism spectrum and the health needs of autistic people are necessary for service planners and resource allocators. Here we present the global prevalence and health burden of autism spectrum disorder from the Global Burden of Diseases, Injuries, and Risk Factors Study (GBD) 2021 following improvements to the epidemiological data and burden estimation methods.<h3>Methods</h3>For GBD 2021, a systematic literature review involving searches in PubMed, Embase, PsycINFO, the Global Health Data Exchange, and consultation with experts identified data on the epidemiology of autism spectrum disorder. Eligible data were used to estimate prevalence via a Bayesian meta-regression tool (DisMod-MR 2.1). Modelled prevalence and disability weights were used to estimate health burden in years lived with disability (YLDs) as the measure of non-fatal health burden and disability-adjusted life-years (DALYs) as the measure of overall health burden. Data by ethnicity were not available. People with lived experience of autism were involved in the design, preparation, interpretation, and writing of this Article.<h3>Findings</h3>An estimated 61·8 million (95% uncertainty interval 52·1–72·7) individuals (one in every 127 people) were on the autism spectrum globally in 2021. The global age-standardised prevalence was 788·3 (663·8–927·2) per 100 000 people, equivalent to 1064·7 (898·5–1245·7) autistic males per 100 000 males and 508·1 (424·6–604·3) autistic females per 100 000 females. Autism spectrum disorder accounted for 11·5 million (7·8–16·3) DALYs, equivalent to 147·6 (100·2–208·2) DALYs per 100 000 people (age-standardised) globally. At the super-region level, age-standardised DALY rates ranged from 126·5 (86·0–178·0) per 100 000 people in southeast Asia, east Asia, and Oceania to 204·1 (140·7–284·7) per 100 000 people in the high-income super-region. DALYs were evident across the lifespan, emerging for children younger than age 5 years (169·2 [115·0–237·4] DALYs per 100 000 people) and decreasing with age (163·4 [110·6–229·8] DALYs per 100 000 people younger than 20 years and 137·7 [93·9–194·5] DALYs per 100 000 people aged 20 years and older). Autism spectrum disorder was ranked within the top-ten causes of non-fatal health burden for people younger than 20 years.<h3>Interpretation</h3>The high prevalence and high rank for non-fatal health burden of autism spectrum disorder in people younger than 20 years underscore the importance of early detection and support to autistic young people and their caregivers globally. Work to improve the precision and global representation of our findings is required, starting with better global coverage of epidemiological data so that geographical variations can be better ascertained. The work presented here can guide future research efforts, and importantly, decisions concerning allocation of health services that better address the needs of all autistic individuals","PeriodicalId":48784,"journal":{"name":"Lancet Psychiatry","volume":"111 1","pages":""},"PeriodicalIF":64.3,"publicationDate":"2024-12-19","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142857903","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}