Development of the HYPOSPADIAS-Q: A New Patient-Reported Outcome Instrument for Patients with Hypospadias.
Melise A. Keays, MD MSc1, Elena Tsangaris, PhD2, Sonia Gulati, PhD3, Daniel Keefe, MD4, Luis Guerra, MD5, Anne Klassen, PhD6.
1Boston Children's Hospital and Children's Hospital of Eastern Ontario, Boston, MA, USA, 2Boston Children's Hospital and Brigham and Women's Hospital, Boston, MA, USA, 3Carleton University, Ottawa, ON, Canada, 4IWK Health Center, Halifax, NS, Canada, 5Children's Hospital of Eastern Ontario, Ottawa, ON, Canada, 6McMaster University, Hamilton, ON, Canada.
BACKGROUND: The collection of patient-reported outcomes (PRO) data in patients with hypospadias may inform the improvement of care quality and outcomes of treatment and enhance comparative effectiveness research. Currently available PRO instruments have limited breadth of content, and none have been developed according to best practice guidelines, including input from the patient perspective. The purpose of this abstract is to describe the development of novel scales for a novel PRO instrument, the HYPOSPADIAS-Q, developed from qualitative interviews with patients.
METHODS: Interview guides were developed based on a systematic review of hypospadias outcome measures and from a focus group of patients, caregivers, and lay and medical experts. Semi-structured interviews with patients (age 7 and older) and their caregiver-proxies (including fathers with hypospadias) were conducted pre- or post-operatively. Post-operative patients included patients with and without surgical complications. Interviews were audio-recorded, transcribed verbatim and coded line by line by three reviewers.
RESULTS: Forty-two participants were interviewed including 15 patients (7-22 years), 27 caregiver-proxies (12 of these were conducted with child pair, 3 were fathers who also had hypospadias). Interviews were double coded and generated over 2100 unique patient codes. Codes were mapped to themes and recurrent patient quotes generated items for the PRO instrument. The first draft of the HYPOSPADIAS-Q consists of 147 items measuring 14 constructs: appearance (penis, meatus/‘pee-hole’, foreskin, scrotum), function (penis sensation, urinary function), surgical outcome, sexual well-being, quality of life (psychological wellbeing, social distress), process of care (satisfaction with information, urology/hypospadias team members, urology/hypospadias clinic), and recovery/adverse effects.CONCLUSIONS: Extensive qualitative interviews with patients, adults and parents of children with hypospadias have identified priority domains for a PRO instrument for patients with hypospadias. The next steps in developing the HYPOSPADIAS-Q will include further qualitative and cognitive interviews to assess the relevance, comprehensiveness, and understandability of the preliminary items, instructions, and response options. The finalized patient reported outcome measure will be field tested and validated against available gold standard objective scoring scales to be used as a clinical and research tool.
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