Department of Urology, Tulane University Health Sciences Center, New Orleans, Louisiana 70112, 70112, USA.
J Urol. 2013 Aug;190(2):627-34. doi: 10.1016/j.juro.2013.01.090. Epub 2013 Jan 31.
We validated the Peyronie's Disease Questionnaire (http://www.auxilium.com/PDQ), a 15-question self-reported survey that measures the impact and severity of Peyronie's disease symptoms in 3 domains, including 1) psychological and physical symptoms, 2) penile pain and 3) symptom bother.
We used baseline data from 2 phase 3 clinical trials (334 and 345 patients, respectively) of collagenase clostridium histolyticum treatment for Peyronie's disease associated penile curvature and bother. Collected data included PDQ domain scores, International Index of Erectile Function scores, objective penile curvature measures and patient reported Peyronie's disease symptom severity. Psychometric analyses included confirmatory factor analysis, inter-item reliability, and tests of convergent and discriminant validity, all related to the overall construct validity of the scale.
Confirmatory factor analysis supported the conceptual framework of the PDQ with 3 confirmed subdomains. Each scale showed good consistency, ie internal reliability (each Cronbach α >0.70). Convergent and discriminant validity were noted in the pattern of associations between PDQ domains and other Peyronie's disease measures. PDQ domain scores significantly differed between patients with vs without erectile dysfunction and between patients with vs without Peyronie's disease related symptom distress, further supporting PDQ construct validity.
This study confirms the conceptual framework, factor structure, and convergent and discriminant validity of the PDQ psychological and physical symptoms, penile pain, and symptom bother domains. Used in conjunction with objective penile curvature measurements, the PDQ can serve as a valuable diagnostic tool or outcome measure to assess treatment related improvements in Peyronie's disease symptoms.
我们对 Peyronie 病问卷(http://www.auxilium.com/PDQ)进行了验证,这是一个 15 个问题的自我报告调查,用于评估 3 个领域中 Peyronie 病症状的影响和严重程度,包括 1)心理和身体症状,2)阴茎疼痛和 3)症状困扰。
我们使用了 2 项 3 期临床试验(分别为 334 例和 345 例患者)的基线数据,这些患者接受了胶原酶组织溶菌素治疗与 Peyronie 病相关的阴茎弯曲和困扰。收集的数据包括 PDQ 域评分、国际勃起功能指数评分、客观阴茎弯曲测量和患者报告的 Peyronie 病症状严重程度。心理计量学分析包括验证性因子分析、项目间信度和收敛性及判别有效性检验,这些分析均与量表的整体结构有效性有关。
验证性因子分析支持 PDQ 的概念框架,具有 3 个确认的子域。每个量表都表现出良好的一致性,即内部一致性(每个 Cronbach α>0.70)。在 PDQ 域与其他 Peyronie 病测量之间的关联模式中观察到了收敛性和判别有效性。PDQ 域评分在有或无勃起功能障碍的患者之间以及有或无 Peyronie 病相关症状困扰的患者之间存在显著差异,进一步支持了 PDQ 的结构有效性。
本研究证实了 PDQ 心理和身体症状、阴茎疼痛和症状困扰域的概念框架、因子结构以及收敛性和判别有效性。与客观阴茎弯曲测量相结合,PDQ 可作为评估治疗相关改善 Peyronie 病症状的有价值的诊断工具或结局测量工具。