背景:缺乏尿道下裂治疗的患者报告结局指标(PROM),大多数现有仪器是在没有患者输入的情况下开发的。
目的:本研究的目的是1)使用我们先前开发的尿道下裂杂志在青少年和年轻成人尿道下裂患者样本中进行概念启发,以及2)开发一种新的尿道下裂PROM。
方法:我们从2022年3月至6月在Facebook和Instagram上通过有针对性的广告招募了居住在美国的13-30岁英语男性,这些男性有自我报告的尿道下裂病史。使用Qualtrics筛选调查,使用自动欺诈检测和手动审核确定了不合格的受访者。向同意的参与者发送了电子尿道下裂杂志,其中包含简短的创造性写作练习和多项选择量表,以促进参与者对生殖器外观的反思。排尿,性功能,和社会心理健康。使用描述性统计对人口统计进行总结。以人为中心的设计研究人员将期刊的关键主题综合为:1)创建与尿道下裂相关的生活质量(QOL)域的亲和力图,以及2)涵盖每个域和子域的PROM项目草案。杂志参与者被要求完成一项调查,以1)对尿道下裂QOL域进行排名,子域,并为PROM起草项目,和2)探索他们对项目措辞的偏好。在一个小组虚拟采访中,泌尿科医生和尿道下裂患者审查并修订了PROM项目草案,并创建了最终的PROM。
结果:在完成的411项筛查调查中,391人不合格。将日志发送给20名符合条件的参与者。其中,12个完成的期刊:8个成年人;4个青少年(11个手术/1个非手术):66.7%白人,8.3%黑色,16.7%亚洲人,8.3%>1种族。食道位置远端占41.7%,近端为41.7%,未知/缺失16.7%。我们确定了四个尿道下裂相关的生活质量域和13个相应的子域(扩展摘要图),两个是新领域:1)关于病情/治疗和治疗决策舒适度的知识,和2)对与护理人员关系的影响,医疗提供者,和性伴侣。最终的PROM原型,创建了尿道下裂患者评估工具(PATH),涵盖参与者确定的所有QOL域。
结论:我们创建了一个简单的,简要介绍尿道下裂PROM,以筛选提供者在临床环境中需要解决的重要主题。限制包括小样本量和关于参与者的有限临床细节。
结论:我们的研究提供了尿道下裂PROM,可以在更大的样本中进行心理评估。
BACKGROUND: Patient-reported outcome measures (PROMs) for hypospadias care are lacking, and most existing instruments were developed without patient input.
OBJECTIVE: 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.
METHODS: 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.
RESULTS: 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.
CONCLUSIONS: 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.
CONCLUSIONS: Our study provides a hypospadias PROM that is ready for psychometric assessment in a larger sample.