ESPE2023 Poster Category 1 Sex Differentiation, Gonads and Gynaecology, and Sex Endocrinology (56 abstracts)
An International Delphi Based Study For Developing A Core Outcome Set For Hypospadias Surgery
Tina. Leunbach 1,2 , Francisca Yankovic 3,4 , Alexander Springer 5 , Amy Wisniewski 6 , Berk Burgu 7 , Margarett Shnorhavorian 8,9 , Luis Braga 10 , Andreas Ernst 11 , Angela Lucas-Herald 12 , Stuart O'Toole 13 , S. Faisal Ahmed 12 & Yazan F. Rawashdeh 1
1Department of Urology, Section of Paediatric Urology, Aarhus University Hospital, Aarhus, Denmark. 2Department of Clinical Medicine, Aarhus University, Aarhus, Denmark. 3Department of Paediatric Urology, Hospital Dr. Exequiel González Cortés, San Miguel, Santiago, Chile. 4Facutad de Medicina de la Universidad de Chile, Departamento de Pediatría y Cirugía Pediátrica Sur, San Miguel, Santiago, Chile. 5Department of Paediatric Surgery, Medical University Vienna, Vienna, Austria. 6Department of Psychology, Oklahoma State University, Stillwater, USA. 7Ankara University, School of Medicine, Department of Paediatric Urology, Ankara, Turkey. 8Department of Pediatric Urology, Seattle Children's Hospital, Seattle, USA. 9University of Washington School of Medicine, Seattle, USA. 10Department of Surgery, Division of Urology, McMaster University, Hamilton, Canada. 11Department of Urology, Aarhus University Hospital, Aarhus, Denmark. 12Department of Child Health, School of Medicine, Dentistry and Nursing, College of Medical, Veterinary and Life Sciences, University of Glasgow, Glasgow, United Kingdom. 13Department of Paediatric Urology, Royal Hospital for Children, Glasgow, United Kingdom
Background: Heterogeneity in reported outcomes limits the ability to compare results of studies evaluating hypospadias surgery.
Objective: To identify a core outcome set (COS), a minimal number of defined outcomes, to be routinely measured and reported in all trials across the age span following hypospadias surgery.
Materials and Methods: A study protocol was drafted and the study registered on the COMET database (www.comet-initiative.org) prior to initiation. Age specific (<6 years, 6-10 years, 11-16 years, >16 years) outcomes identified in a literature review were presented in a three round online Delphi survey. Professionals from 25 countries and parents/patients older than 14 years from four centres were invited to participate. In the first Delphi round (DR), participants were asked to add missing relevant outcomes as well as to choose and rank up to five outcomes that were most important to them, for each age category. Free text responses were thematically analysed and presented in subsequent DRs with outcome lists ranked according to popularity. COS inclusion required more than 70% of votes in a round. By the end of DR 3, the most popular outcomes for each age-category were added to the COS until it included five outcomes.
Results: Professional respondents (DR 1, 2, 3 n= 75, 47, 40, respectively) mainly included paediatric urologists. Responses from parents/patients (DR 1, 2, 3 n= 16, 8, 3) were excluded due to low response rates. The COS for boys younger than 6 years and boys aged 10-11 years were identical (voiding, fistula, re-operation and urethral stricture) except for meatal stenosis (< 6 years) and curvature (6-10 years). The COS in boys aged 11-16 years were cosmesis, curvature, voiding, stricture and psychosocial status. For boys >16 years the COS included cosmesis, curvature, erection, voiding and psychosexual development. Assessment of the preferred method to measure voiding was uroflowmetry (n=39) and signs indicating infra-vesical obstruction (n=30) in non-toilet trained boys.
Discussion: Clear indicators for variables to include in a COS following hypospadias surgery were identified in younger boys. A larger spread in votes was observed in older boys likely reflecting that these boys are less often followed-up resulting in less clarity on relevant outcomes which emphasise the need to expand the work on long-term outcomes.
Conclusion: Collection and reporting of the COS across the age span will undoubtedly minimize the heterogeneity in reporting after hypospadias surgery and will inform best medical practice reporting.
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