Study Preregistration: Measuring What Matters: Development and Dissemination of a Core Outcome Set for Pediatric Anxiety Disorders Clinical Trials - 25/05/23
Doi : 10.1016/j.jaac.2023.01.016
Suneeta Monga, MD, FRCPC a, ⁎ 
, Riddhi Desai, MSc b, Samantha J. Anthony, PhD, MSW a, Paul D. Arnold, MD, PhD, FRCPC i, Alexa Bagnell, MD, FRCPC e, Boris Birmaher, MD m, Leslie Anne Campbell, PhD, RN f, Rachel Churchill, PhD o, Kristin Cleverley, PhD, CPMHN(C) g, Darren B. Courtney, MD, FRCPC g, Gina Dimitropoulos, PhD i, Sarah E. Hetrick, DPsych n, Karolin R. Krause, PhD c, Lidwine B. Mokkink, PhD p, Scott B. Patten, MD, PhD i, Megan C. Patton, HBASc b, Matthew J. Prebeg, HBSc b, Beth K. Potter, PhD h, Erin Romanchych, PhD b, Jai L. Shah, MD, FRCPC j, Maureen Smith, MEd d, S. Evelyn Stewart, MD, FRCPC l, Peter Szatmari, MD, RSC c, Andrea C. Tricco, PhD k, Peter Tugwell, MD, FRCPC h, John T. Walkup, MD q, Vivian A. Welch, PhD r, Bonnie T. Zima, MD, MPH s, Nancy J. Butcher, PhD a, Martin Offringa, MD, PhD a
, Riddhi Desai, MSc b, Samantha J. Anthony, PhD, MSW a, Paul D. Arnold, MD, PhD, FRCPC i, Alexa Bagnell, MD, FRCPC e, Boris Birmaher, MD m, Leslie Anne Campbell, PhD, RN f, Rachel Churchill, PhD o, Kristin Cleverley, PhD, CPMHN(C) g, Darren B. Courtney, MD, FRCPC g, Gina Dimitropoulos, PhD i, Sarah E. Hetrick, DPsych n, Karolin R. Krause, PhD c, Lidwine B. Mokkink, PhD p, Scott B. Patten, MD, PhD i, Megan C. Patton, HBASc b, Matthew J. Prebeg, HBSc b, Beth K. Potter, PhD h, Erin Romanchych, PhD b, Jai L. Shah, MD, FRCPC j, Maureen Smith, MEd d, S. Evelyn Stewart, MD, FRCPC l, Peter Szatmari, MD, RSC c, Andrea C. Tricco, PhD k, Peter Tugwell, MD, FRCPC h, John T. Walkup, MD q, Vivian A. Welch, PhD r, Bonnie T. Zima, MD, MPH s, Nancy J. Butcher, PhD a, Martin Offringa, MD, PhD a a Hospital for Sick Children, and the University of Toronto, Ontario, Canada
b Hospital for Sick Children, Toronto, Ontario, Canada
c The Cundill Centre for Child and Youth Depression, Centre for Addiction and Mental Health, Toronto, Ontario, Canada
d patient partner from Ottawa, Ontario, Canada
e IWK Health Centre, Halifax, Nova Scotia, Canada
f Dalhousie University, Halifax, Nova Scotia, Canada
g Centre for Addiction and Mental Health, and the University of Toronto, Toronto, Ontario, Canada
h University of Ottawa, Ottawa, Ontario, Canada
i University of Calgary, Calgary, Alberta, Canada
j Douglas Mental Health University Institute, and McGill University, Montreal, Quebec, Canada
k Unity Health Toronto, Toronto, Ontario, Canada
l University of British Columbia, Vancouver, British Columbia, Canada
m University of Pittsburgh Medical Center, Pittsburgh, Pennsylvania, USA
n University of Auckland, Auckland, New Zealand
o University of York, Heslington, England, United Kingdom
p UMC, Virje Universiteit Amsterdam, Amsterdam, the Netherlands
q Ann and Robert H Lurie Children’s Hospital Chicago, Chicago, Illinois, USA
r Bruyère Research Institute, Ottawa, Ontario, Canada
s University of California, Los Angeles (UCLA), Los Angeles, California, USA
∗Correspondence to Suneeta Monga, MD, FRCPC, 555 University Avenue, Toronto, Ontario M5G 1X8, Canada555 University AvenueTorontoOntarioM5G 1X8Canada
Résumé |
Pediatric anxiety disorders (AD) are prevalent disorders with an impact on all aspects of a child’s life and functioning.1 Although evidence supports commonly used treatments, there are notable concerns with the research to date.2 Heterogeneity in outcome selection, measurement, analysis, and reporting is a contributing factor to the hinderance of the translation of research into clinical practice.3 Recognition for outcome standardization in pediatric mental health disorders is evolving and there are several initiatives of importance, including the International Consortium for Health Outcomes Measurement (ICHOM), which has developed standardized outcome sets for use in the routine clinical mental health treatment of children and adolescents.4 Similarly, the International Alliance of Mental Health Research Funders5 advocate for use of 1 specific outcome measurement instrument (OMI) in the youth mental health research that they fund. Development of a Core Outcome Set (COS), a minimal set of outcomes that should be measured and reported in clinical trials, has been a solution in other areas of medicine to address heterogeneity in outcome selection and measurement across trials.6 The Core Outcomes and Measures in Pediatric Anxiety Clinical Trials (COMPACT) Initiative will develop a harmonized, evidence- and consensus-based COS that is meaningful to youth and families for use in future trials in pediatric AD.
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| This trial is funded by the Canadian Institutes of Health Research (CIHR). |
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| The research was performed with permission from The Hospital for Sick Children Research Ethics Board. |
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| This work has been prospectively registered: 1701. |
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| Author Contributions Conceptualization: Monga, Desai, Krause, Potter, Szatmari, Tugwell, Butcher, Offringa Data curation: Monga, Desai, Krause, Patton, Potter, Prebeg. Smith, Butcher, Offringa Formal analysis: Monga, Desai, Cleverley, Courtney, Krause, Patton, Prebeg, Potter, Smith, Butcher, Offringa Funding acquisition: Monga, Desai, Tugwell, Butcher, Offringa Investigation: Monga, Arnold, Bagnell, Birmaher, Campbell, Courtney, Dimitropoulos, Prebeg, Romanchych, Smith, Offringa Methodology: Monga, Anthony, Churchill, Cleverley, Courtney, Dimitropoulos, Hetrick, Krause, Mokkink, Potter, Smith, Szatmari, Tricco, Tugwell, Welch, Butcher, Offringa Project administration: Monga, Desai, Prebeg Resources: Monga, Arnold, Bagnell, Birmaher, Campbell, Churchill, Courtney, Dimitropoulos, Hetrick, Romanchych, Smith, Stewart, Welch, Zima Supervision: Monga, Desai, Bagnell, Dimitropoulos, Mokkink, Patton, Prebeg, Smith, Butcher Validation: Monga, Desai, Anthony, Dimitropoulos, Krause, Mokkink, Prebeg, Butcher, Offringa Writing – original draft: Monga, Desai, Butcher, Offringa Writing – review and editing: Monga, Desai, Anthony, Arnold, Bagnell, Birmaher, Campbell, Churchill, Cleverley, Courtney, Dimitropoulos, Hetrick, Krause, Mokkink, Patten, Patton, Prebeg, Potter, Romanchych, Shah, Smith, Stewart, Szatmari, Tricco, Tugwell, Walkup, Welch, Zima, Butcher, Offringa |
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| Disclosure: Dr. Monga has reported receiving grant support from the TD Bank Financial Group Chair in Child and Adolescent Psychiatry, Canadian Institutes of Health Research (CIHR), and the Cundill Centre for Child and Youth Depression at the Centre for Addiction and Mental Health and royalties from Springer Publishing for her book, Assessing and Treating Anxiety Disorders in Young Children. Dr. Arnold has reported receiving grant support from the Alberta Innovates Translational Health Chair in Child and Youth Mental Health, CIHR, Canadian Foundation for Innovation, and the Alberta Children’s Hospital Foundation; research support from Biohaven Pharmaceuticals; and has served as a consultant (unpaid) for Headversity. Dr. Birmaher has received research support from the National Institute of Mental Health and royalties from Random House, UpToDate, and Lippincott, Williams and Wilkins. Dr. Campbell has reported receiving salary support from the Sobey Family Chair in Child and Adolescent Mental Health Outcomes; grant support from CIHR and Research Nova Scotia; and an honorarium for chairing the Canadian Agency for Drugs and Technologies in Health (CADTH) Health Technology Expert Review Panel. Dr. Cleverley has reported receiving grant support from the CAMH Chair in Mental Health Nursing Research, Operating Grants from CIHR, Ontario Early Research Award from Government of Ontario, and the Connaught Global Challenge Award, University of Toronto. Dr. Courtney has reported receiving grant support from CIHR and salary support from the Cundill Centre for Child and Youth Depression and Academic Scholars Award from the Department of Psychiatry at the University of Toronto. Dr. Hetrick has reported being the coordinating editor for the Cochrane Common Mental Health Disorders Group and the Principal Clinical Advisor for the Suicide Prevention Office, Ministry of Health, New Zealand. Dr. Krause has reported receiving grant support from CIHR and from AIM Youth Mental Health, as well as advising the International Alliance of Mental Health Research Funders (IAMHRF) on the adoption of common measures in mental health research and has received fees from the International Consortium for Health Outcomes Measurement (ICHOM) for acting as a research fellow. Dr. Potter has reported receiving grant support from CIHR, as well as grant support from the following matched partners for a CIHR-funded rare disease clinical trials network (see www.informrare.ca): Biomarin, Cambrooke Ajinomoto, the National Food Distribution Centre, Nutricia, Perkin Elmer, Roche, Takeda, Ultragenyx, and Vitaflo. Dr. Shah has reported receiving grant funding from CIHR, the National Institutes of Health, and SickKids Foundation as well as salary support from the Fonds de Recherche du Québec - Santé. Dr. Stewart has reported receiving grant/research support from CIHR, Social Sciences and Humanities Research Council (Canada), BC Ministry of Health COVID-19 Research Priorities Fund, BC Centre for Disease Control, University of British Columbia Faculty of Medicine (Strategic Investment Fund), British Columbia Children’s Hospital, and BC Mental Health and Substance Use Services Research Institute; has served on advisory boards/DSMB / Speakers Bureau / travel expenses from the International OCD Foundation (IOCDF); has served on the advisory boards/DSMB of Anxiety Canada, Youth Development Instrument Provincial Practice and Policy Group, and British Columbia Ministry of Mental Health and Addictions; has served as consultant / honoraria from Misophonia Research Foundation and Milken Institute; has served on the editorial board of Canadian Journal of Psychiatry and Annals of Clinical Psychiatry; has reported authorship of assessment tools: Abramovitch A, Abramowitz JS, McKay D, Cham H, Anderson KS, Farrell L, Geller DA, Hanna GL, Mathieu S, McGuire JF, Rosenberg DR, Stewart SE, Storch EA, Wilhelm S. A Revision of the Obsessive-Compulsive Inventory – Child Version: The OCI-CV-R. Journal of Anxiety Disorders (accepted manuscript, January 2022). Dr. Szatmari has reported receiving grant funding from CIHR; salary support from the Centre for Addiction and Mental Health, the Department of Psychiatry at the University of Toronto, and the Hospital for Sick Children; and royalties from Guilford Press for his book A Mind Apart: Understanding Children with Autism and Asperger Syndrome and from Simon & Schuster Publishers for his co-authored book Start Here: A Parent’s Guide to Helping Children and Teens Through Mental Health Challenges. Dr. Tugwell has reported receiving an honorarium as a member of an independent advisory panel for the Reformulary Group and as a member of a Safety and Monitoring Committee for a biologic for Parexel International and has reported co-chairing the OMERACT executive committee. Dr. Walkup has reported serving on the advisory board and Speaker’s Bureau of the Tourette Association of America and has received royalties from Oxford Press, Guilford Press, and Wolters Kluwer. Dr. Zima has reported receiving grant/research support from the California Mental Health Service Act, the National Institute on Drug Abuse, the Betty Moore Foundation, and the California Cannabis Bureau. Dr. Butcher has reported receiving research funding from CIHR and consulting fees from Nobias Therapeutics Inc. Drs. Anthony, Bagnell, Churchill, Dimitropoulos, Mokkink, Patten, Romanchych, Tricco, Welch, and Offringa, Mss. Desai and Patton, Mr. Prebeg, and Ms. Smith have reported no biomedical financial interests or potential conflicts of interest. |
© 2023
American Academy of Child and Adolescent Psychiatry. Publié par Elsevier Masson SAS. Tous droits réservés.
Vol 62 - N° 6
P. 696-698 - juin 2023 Retour au numéro
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