Diagnostic Accuracy and economic value of a Tiered Assessment for Fetal Alcohol Spectrum Disorder (DATAforFASD): Protocol
Amanda J Wheeler,
Robert S Ware,
Wei Liu,
Joshua Byrnes,
Sarah Horton,
Sheena Reilly,
Karen Moritz,
Natasha Reid,
Katrina Harris,
Dianne C Shanley,
Melanie Zimmer-Gembeck,
Gabrielle Simcock,
Codi White,
Marjad Page,
Doug Shelton,
Haydn Till,
Ianthe Mills,
Carly Hislop,
Alison Crichton,
Kerryann Walsh,
Sharyn Rundle-Thiele,
Erinn Hawkins
Affiliations
Amanda J Wheeler
School of Pharmacy and Medical Sciences, Griffith University, Brisbane, Queensland, Australia
Robert S Ware
Faculty of Health, Griffith University, Southport, Queensland, Australia
Wei Liu
1 State Key Laboratory of Experimental Hematology, National Clinical Research Center for Blood Diseases, Haihe Laboratory of Cell Ecosystem, Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College, Tianjin, China
Joshua Byrnes
5 Centre for Applied Health Economics, Griffith University, Brisbane, Queensland, Australia
Sarah Horton
Family Health, Gidgee Healing, Mt Isa, Queensland, Australia
Sheena Reilly
Griffith University, Nathan, Queensland, Australia
Karen Moritz
Faculty of Medicine, The University of Queensland, Brisbane, Queensland, Australia
Natasha Reid
Specialist Intellectual Disability Health Team, South Western Sydney Local Health District, Fairfield, New South Wales, Australia
Katrina Harris
1 Department of Paediatrics, Monash University, Clayton, Victoria, Australia
Dianne C Shanley
School of Applied Psychology, Griffith University, Gold Coast, Queensland, Australia
Melanie Zimmer-Gembeck
Menzies Health Institute of Queensland, Griffith University, Gold Coast, Queensland, Australia
Gabrielle Simcock
Menzies Health Institute of Queensland, Griffith University, Gold Coast, Queensland, Australia
Codi White
Menzies Health Institute of Queensland, Griffith University, Gold Coast, Queensland, Australia
Marjad Page
Menzies Health Institute of Queensland, Griffith University, Gold Coast, Queensland, Australia
Doug Shelton
Menzies Health Institute of Queensland, Griffith University, Gold Coast, Queensland, Australia
Haydn Till
Menzies Health Institute of Queensland, Griffith University, Gold Coast, Queensland, Australia
Ianthe Mills
Child and Adolescent Unit, Sunshine Coast Hospital and Health Service, Nambour, Queensland, Australia
Carly Hislop
Child Development Service, Townsville Hospital and Health Service, Townsville, Queensland, Australia
Alison Crichton
1 Department of Paediatrics, Monash University, Clayton, Victoria, Australia
Kerryann Walsh
School of Early Childhood and Inclusive Education, Queensland University of Technology, Brisbane, Queensland, Australia
Sharyn Rundle-Thiele
Social Marketing, Griffith University, Nathan, Queensland, Australia
Erinn Hawkins
Menzies Health Institute of Queensland, Griffith University, Gold Coast, Queensland, Australia
Introduction Australian practices for diagnosing fetal alcohol spectrum disorder (FASD) are lengthy and require specialist expertise. Specialist teams are based in urban locations; they are expensive and have prolonged waitlists. Innovative, flexible solutions are needed to ensure First Nations children living in rural/remote communities have culturally appropriate and equitable access to timely diagnosis and support. This study compares the accuracy of rapid assessments (index tests) that can be administered by a range of primary healthcare practitioners to specialist standardised FASD assessments (reference tests). The cost-efficiency of index tests will be compared with reference tests.Methods and analysis At least 200 children aged 6–16 years at-risk of FASD will be recruited across at least seven study sites. Following standards for reporting diagnostic accuracy study (STARD) guidelines, all children will complete index and reference tests. Diagnostic accuracy statistics (including receiver operating curves, sensitivity, specificity, positive and negative predictive values and likelihood ratios) will identify whether rapid assessments can accurately identify: (1) the presence of an FASD diagnosis and (2) impairment in each neurodevelopmental domain, compared to comprehensive assessments. Direct and indirect healthcare costs for index tests compared to reference tests will be collected in primary healthcare and specialist settings.Ethics and dissemination of results Children’s Health Queensland Hospital and Health Service Human Research Ethics Committee (HREC/20/QCHQ/63173); Griffith University Human Research Ethics Committee (2020/743). Results will assist in validating the use of index tests as part of a tiered neurodevelopmental assessment process that was co-designed with First Nations community and primary healthcare practitioners. Outcomes will be summarised and provided to participating practitioners and sites, and disseminated to community health services and consumers. Findings will be presented at national and international conferences and published in peer-reviewed journals.Trial registration number ACTRN12622000498796.
