Department of Urology, University of North Carolina School of Medicine, 170 Manning Drive, Chapel Hill, NC, 27599, USA.
Research Jam, Indiana Clinical and Translational Sciences Institute, Indianapolis, IN, USA.
J Pediatr Urol. 2024 Dec;20(6):1072-1081. doi: 10.1016/j.jpurol.2024.07.028. Epub 2024 Aug 2.
INTRODUCTION/BACKGROUND: Patient-reported outcome measures (PROMs) for hypospadias care are lacking, and most existing instruments were developed without patient input.
The objective of this study was to 1) use our previously developed Hypospadias Journal for concept elicitation in a sample of adolescent and young adult hypospadias patients and 2) develop a new hypospadias PROM.
We recruited English-speaking males ages 13-30 living in the United States with a self-reported history of hypospadias through targeted advertisements on Facebook and Instagram from March to June 2022. Using a Qualtrics screening survey ineligible respondents were identified using automated fraud detection and manual review. Consenting participants were sent an electronic Hypospadias Journal containing brief creative writing exercises and multiple-choice scales to facilitate participant reflections about genital appearance, urination, sexual function, and psychosocial well-being. Demographics were summarized using descriptive statistics. Human-centered design researchers synthesized the journals' key themes to 1) create an affinity diagram with hypospadias-related quality of life (QOL) domains and 2) draft items for the PROM covering each domain and sub-domain. Journal participants were asked to complete a survey to 1) rank hypospadias QOL domains, subdomains, and draft items for the PROM, and 2) explore their preferences for item phrasing. In a small group virtual interview, a urologist and a hypospadias patient reviewed and revised draft PROM items, and a final PROM was created.
Of the 411 completed screening surveys, 391 were ineligible. Journals were sent to 20 eligible participants. Of these, 12 completed journals: 8 adults; 4 adolescents (11 surgical/1 non-surgical): 66.7% White, 8.3% Black, 16.7% Asian, 8.3% >1 race. The meatal location was distal for 41.7%, proximal for 41.7%, unknown/missing for 16.7%. We identified four hypospadias-related quality-of-life domains and 13 respective sub-domains (Extended Summary Figure) of these, two were novel domains: 1) knowledge about the condition/treatment and comfort with treatment decision, and 2) impact on relationships with caregivers, medical providers, and sexual partners. A final PROM prototype, the Patient Assessment Tool for Hypospadias (PATH) was created, covering all QOL domains identified by participants.
We created a simple, brief hypospadias PROM to screen for salient topics to be addressed by providers in the clinical setting. Limitations include the small sample size and limited clinical details about participants.
Our study provides a hypospadias PROM that is ready for psychometric assessment in a larger sample.
简介/背景：针对尿道下裂治疗的患者报告结局测量（PROM）工具尚不完善，并且大多数现有的工具都是在没有患者参与的情况下开发的。
本研究的目的是 1）在一组青少年和年轻成年尿道下裂患者中使用我们之前开发的尿道下裂期刊进行概念挖掘，2）开发一种新的尿道下裂 PROM。
我们通过 Facebook 和 Instagram 上的定向广告招募了年龄在 13 至 30 岁之间、居住在美国、自述有尿道下裂病史的英语男性。使用 Qualtrics 筛选调查，通过自动欺诈检测和手动审查来识别不合格的受访者。同意参加的参与者会收到一份电子尿道下裂期刊，其中包含简短的创意写作练习和多项选择量表，以方便参与者反思生殖器外观、排尿、性功能和心理社会幸福感。使用描述性统计数据总结人口统计学特征。以人为中心的设计研究人员综合了期刊的主要主题，1）创建一个与尿道下裂相关的生活质量（QOL）领域的亲和图，以及 2）为涵盖每个领域和子领域的 PROM 起草项目。期刊参与者被要求完成一项调查，1）对尿道下裂 QOL 领域、子领域和 PROM 的草案项目进行排名，以及 2）探索他们对项目措辞的偏好。在一个小型的虚拟小组访谈中，一名泌尿科医生和一名尿道下裂患者审查并修改了 PROM 草案项目，并创建了最终的 PROM。
在完成的 411 份筛选调查中，391 份不合格。期刊寄给了 20 名合格的参与者。其中 12 人完成了期刊：8 名成年人；4 名青少年（1 名手术/1 名非手术）：66.7%为白人，8.3%为黑人，16.7%为亚洲人，8.3%为多种族。尿道口位置为远端的占 41.7%，近端的占 41.7%，未知/缺失的占 16.7%。我们确定了四个与尿道下裂相关的生活质量领域和 13 个相应的子领域（扩展摘要图），其中两个是新领域：1）对病情/治疗的了解和对治疗决策的舒适度，以及 2）对与照顾者、医疗提供者和性伴侣关系的影响。最后创建了一个尿道下裂患者评估工具（PATH）原型，涵盖了参与者确定的所有 QOL 领域。
我们创建了一个简单、简短的尿道下裂 PROM，以筛查提供者在临床环境中需要解决的重要问题。限制包括样本量小和参与者的临床细节有限。
我们的研究提供了一种尿道下裂 PROM，可以在更大的样本中进行心理测量评估。
