Department of Urology, Memorial Sloan Kettering Cancer Center, New York, NY, USA.
Department of Urology, Memorial Sloan Kettering Cancer Center, New York, NY, USA; Division of Urology, Department of Surgery, University of Alberta, Edmonton, Alberta, Canada.
J Sex Med. 2021 Sep;18(9):1641-1651. doi: 10.1016/j.jsxm.2021.06.020. Epub 2021 Aug 7.
BACKGROUND: No validated English language patient-reported outcome (PRO) currently exists that assesses satisfaction with inflatable penile prosthesis (IPP). Satisfaction data have been largely based primarily on surgeon assessment of patients or using questionnaires that have not been designed for this purpose. AIM: To develop an English-language validated PRO that assesses patient satisfaction after IPP surgery. METHODS: Initially, a literature review and discussions with experts defined domains important to IPP satisfaction (pain, appearance, function, overall satisfaction). The initial 35-item Satisfaction Survey for Inflatable Penile Implant (SSIPI) was developed. Cognitive interviews were then performed with IPP patients (n = 12) to gain feedback on the SSIPI domains and items. These data were used to modify SSIPI with the addition of 2 questions for a final item number of 37. Patients from 4 centers, who were between 6 months and 5 years after IPP, were administered the questionnaire through RedCap. Reliability statistics and content analysis were used to winnow questions to yield the final 16-item version of the SSIPI. Internal consistency was assessed via Cronbach's alpha and item-total correlation. Test-retest reliability was assessed via intraclass correlation coefficients using baseline and 2-week data. For convergent validity, the Erectile Dysfunction Inventory of Treatment Satisfaction and the Self-Esteem and Relationship (SEAR) questionnaire were used. For discriminant validity, the International Prostate Symptom Score (IPSS) was used. Confirmatory factor analysis was used to assess the factor structure of the SSIPI. OUTCOMES: Internal consistency, test-retest reliability, convergent and discriminant validity, and confirmatory factor analysis were assessed. RESULTS: 118 men were surveyed. Mean age was 66.8 ± 9.5 years. The 16-item SSIPI showed high internal consistency with an overall Cronbach's Alpha of 0.97 (domains 0.85-0.89). Item-total correlations for individual items to subscales ranged from 0.60 to 0.91. The overall test-retest reliability was 0.94 (domains 0.87-0.93). Erectile Dysfunction Inventory of Treatment Satisfaction and Self-Esteem and Relationship had correlations of 0.84 overall (domains 0.57-0.79) and 0.47 overall (domains 0.34-0.44), respectively. International Prostate Symptom Score (discriminant validity) had correlations of -0.29 overall (domains -0.17 to -0.31). CLINICAL IMPLICATIONS: SSIPI is the first English-language validated IPP satisfaction PRO. This will enable clinicians to collect satisfaction data in a standardized way. STRENGTHS AND LIMITATIONS: As strengths we have used a rigorous psychometric process and have no industry sponsorship. Limitations include small numbers of specific subpopulations. CONCLUSION: The SSIPI has demonstrated robust psychometric properties. Salter CA, Bach PV, Jenkins L, et al. Development and Validation of the Satisfaction Survey for Inflatable Penile Implant (SSIPI). J Sex Med 2021;18:1641-1651.
背景:目前尚不存在经过验证的英文患者报告结局(PRO)评估可充气阴茎假体(IPP)满意度。满意度数据主要基于医生对患者的评估或使用并非为此目的设计的问卷。
目的:开发一种经过验证的评估 IPP 手术后患者满意度的英文 PRO。
方法:最初,通过文献回顾和与专家讨论,确定了与 IPP 满意度相关的重要领域(疼痛、外观、功能、总体满意度)。最初的 35 项可充气阴茎植入物满意度调查(SSIPI)由此产生。然后对 12 名 IPP 患者进行认知访谈,以获取有关 SSIPI 领域和项目的反馈。这些数据用于修改 SSIPI,增加了 2 个问题,最终项目数量为 37 个。来自 4 个中心的、IPP 后 6 个月至 5 年的患者通过 RedCap 完成了问卷。使用可靠性统计和内容分析来筛选问题,得出最终的 16 项 SSIPI 版本。通过 Cronbach's alpha 和项目总分相关性评估内部一致性。使用基线和 2 周的数据评估测试-重测信度,通过组内相关系数进行评估。为了评估收敛效度,使用了治疗满意度勃起功能障碍问卷和自尊与关系(SEAR)问卷。为了评估判别效度,使用了国际前列腺症状评分(IPSS)。使用验证性因子分析评估 SSIPI 的因子结构。
结果:对 118 名男性进行了调查。平均年龄为 66.8±9.5 岁。16 项 SSIPI 显示出较高的内部一致性,总体 Cronbach's Alpha 为 0.97(领域为 0.85-0.89)。各个项目与子量表的总分相关性范围为 0.60 至 0.91。总体测试-重测可靠性为 0.94(领域为 0.87-0.93)。治疗满意度勃起功能障碍问卷和自尊与关系的总体相关性分别为 0.84(领域为 0.57-0.79)和 0.47(领域为 0.34-0.44)。国际前列腺症状评分(判别效度)的总体相关性为-0.29(领域为-0.17 至-0.31)。
结论:SSIPI 是第一个经过验证的 IPP 满意度的英文 PRO。这将使临床医生能够以标准化的方式收集满意度数据。
优势和局限性:我们的优势在于使用了严格的心理计量学过程,且没有行业赞助。局限性包括特定亚人群数量较少。
结论:SSIPI 具有良好的心理计量学特性。
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