Article Text

Protocol
Outcomes and outcome measurement instruments reported in randomised controlled trials of anxiety disorder treatments in children and adolescents: a scoping review protocol
  1. Megan C Patton1,
  2. Riddhi Desai1,
  3. Yasmine Noureddine2,
  4. Matthew J Prebeg1,3,
  5. Karolin Rose Krause4,5,
  6. Sunita Vohra6,
  7. Nancy J Butcher7,
  8. Suneeta Monga1,8
  1. 1Department of Psychiatry, The Hospital for Sick Children, Toronto, Ontario, Canada
  2. 2Neurosciences and Mental Health, The Hospital for Sick Children, Toronto, Ontario, Canada
  3. 3Margaret and Wallace McCain Centre for Child, Youth & Family Mental Health, Centre for Addiction and Mental Health, Toronto, Ontario, Canada
  4. 4Cundill Centre for Child and Youth Depression, Centre for Addiction and Mental Health, Toronto, Ontario, Canada
  5. 5Educational and Health Psychology, University College London, London, UK
  6. 6Pediatrics, University of Alberta, Edmonton, Alberta, Canada
  7. 7Child Health Evaluative Sciences, The Hospital for Sick Children, Toronto, Ontario, Canada
  8. 8Faculty of Medicine, University of Toronto, Toronto, Ontario, Canada
  1. Correspondence to Dr Suneeta Monga; Suneeta.monga{at}sickkids.ca

Abstract

Introduction Paediatric anxiety disorders (AD) are prevalent and persistent mental health conditions worldwide affecting between 10% and 20% of children and adolescents. Despite the high prevalence of paediatric AD, there is limited understanding of which treatments work best. Outcome heterogeneity across paediatric mental health trials has been a significant factor in hindering the ability to compare results and assess the efficacy of such trials. This scoping review will help to identify and synthesise the outcomes reported in paediatric AD trials to date.

Methods and analysis Following the Joanna Briggs Institute scoping review methodology, a comprehensive electronic bibliographic database search (MEDLINE, APA PsycINFO, Embase, CINAHL) strategy will be applied to identify articles examining interventions for children diagnosed with an AD. Articles will be eligible for inclusion if they assess at least one AD intervention (eg, psychological), in children 4–18 years of age inclusive. Initial title and abstract screening will be completed by two trained reviewers independently and in duplicate. Full-text screening of each included article will be completed independently and in duplicate by two of three trained reviewers. Identified outcomes will be mapped to a standard outcome taxonomy developed for core outcome sets. Trial and outcome characteristics will be synthesised using quantitative metrics (counts and frequencies).

Ethics and dissemination As this is a scoping review of the literature and patient information or records were not accessed, institutional ethics approval was not required. Results of this scoping review will be disseminated to clinicians, researchers inclusive of trialists and other stakeholders invested in outcome selection, measurement and reporting in paediatric AD trials. In addition, scoping review results will inform the development of a Core Outcome Set for paediatric AD trials—a minimum set of outcomes that should be measured across trials in an area of health, without precluding the inclusion of other outcomes.

  • Anxiety disorders
  • Protocols & guidelines
  • Child & adolescent psychiatry
http://creativecommons.org/licenses/by-nc/4.0/

This is an open access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited, appropriate credit is given, any changes made indicated, and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/.

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Footnotes

  • Twitter @MeganPatton_, @NancyJButcher

  • Contributors SM was responsible for study conception (planning). SM, NJB and KRK were responsible for study design (planning). MCP, RD, YN and MP were responsible for methodology, writing the original draft, reviewing, and editing (conducting the work). MCP, RD, YN, MP, SM, NJB, KRK and SV critically reviewed and provided feedback on the study design and manuscript (reporting). MCP, RD, YN, MP, SM, NJB, KRK and SV read and approved the protocol prior to its submission (reporting).

  • Funding This research was funded in part by a Canadian Institute of Health Research (CIHR) grant titled 'Measuring What Matters: Development and Dissemination of a Core Outcome Set (COS) for Clinical Trials in Pediatric Anxiety Disorders'.

  • Competing interests None declared.

  • Patient and public involvement Patients and/or the public were involved in the design, or conduct, or reporting, or dissemination plans of this research. Refer to the Methods section for further details.

  • Provenance and peer review Not commissioned; externally peer reviewed.

  • Supplemental material This content has been supplied by the author(s). It has not been vetted by BMJ Publishing Group Limited (BMJ) and may not have been peer-reviewed. Any opinions or recommendations discussed are solely those of the author(s) and are not endorsed by BMJ. BMJ disclaims all liability and responsibility arising from any reliance placed on the content. Where the content includes any translated material, BMJ does not warrant the accuracy and reliability of the translations (including but not limited to local regulations, clinical guidelines, terminology, drug names and drug dosages), and is not responsible for any error and/or omissions arising from translation and adaptation or otherwise.