Kubin M, Trudeau E, Gondek K, Seignobos E, Fugl-Meyer A R
Bayer AG, Pharma Research Center, 42096 Wuppertal, Germany.
Eur Urol. 2004 Dec;46(6):768-74; discussion 774-5. doi: 10.1016/j.eururo.2004.08.001.
To describe the early development of a pluri-language self-report questionnaire to assess male patients and their female partners' satisfaction with drug treatment for erectile dysfunction (ED).
This first development phase proceeded in several parts. Item generation followed literature review, hypothesized characteristics of the drug and in-depth interviews with patients and their partners. Perceptions and feelings related to ED and patients' expectations of treatment were explored. Items were generated simultaneously in 5 languages (American English, Canadian French, English, French and German). Content and face validity were empirically assessed by interviews with a few patients and partners in each country. Conceptual equivalence between languages was ascertained.
The final content domains included satisfaction with: sexual spontaneity, quality of erection, quality of ejaculation, sexual pleasure, orgasm, confidence, reliability of treatment, side effects, convenience, overall satisfaction, conformity to treatment expectations and intent to continue use of drug. Cognitive debriefing with patients and partners found few issues with comprehension, however some words were considered problematic. The simultaneous development for the different languages allowed adaptation of the content at this stage and ensured consistency of all language versions. The final questionnaire consisted of 4 modules: unmedicated patient, medicated patient, unmedicated partner, and medicated partner modules. The questionnaire was then linguistically validated into 15 additional languages for further psychometric validation.
The Treatment Satisfaction Scale (TSS) is a multi-facetted measure of patients' and partners' satisfaction with their sexual life relating to erectile dysfunction and intended for prospective use. Its simultaneous development for a variety of countries and languages has fostered true item equivalence across language versions. However, further work is needed to validate the TSS psychometrically, including identification of domains, test responsiveness and determination of appropriate scoring prior to its clinical use.
描述一种多语言自填式问卷的早期开发过程，该问卷用于评估男性患者及其女性伴侣对勃起功能障碍（ED）药物治疗的满意度。
这一初始开发阶段分为几个部分。通过文献综述、药物的假设特征以及对患者及其伴侣的深入访谈来生成条目。探讨了与勃起功能障碍相关的认知和感受以及患者的治疗期望。条目同时用5种语言（美国英语、加拿大法语、英语、法语和德语）生成。通过对每个国家的一些患者和伴侣进行访谈，对内容效度和表面效度进行实证评估。确定了不同语言之间的概念等效性。
最终的内容领域包括对以下方面的满意度：性自发性、勃起质量、射精质量、性快感、性高潮、信心、治疗可靠性、副作用、便利性、总体满意度、符合治疗期望程度以及继续使用药物的意愿。对患者和伴侣进行的认知汇报发现理解方面几乎没有问题，不过有些词汇被认为存在问题。不同语言的同步开发使得在此阶段能够对内容进行调整，并确保所有语言版本的一致性。最终问卷由4个模块组成：未用药患者模块、用药患者模块、未用药伴侣模块和用药伴侣模块。然后，该问卷经过语言验证，增加了15种语言版本，以便进行进一步的心理测量学验证。
治疗满意度量表（TSS）是一种多方面衡量患者及其伴侣对与勃起功能障碍相关的性生活满意度的工具，旨在用于前瞻性研究。它针对多个国家和多种语言同时开发，促进了不同语言版本间条目的真正等效性。然而，在临床使用前，还需要进一步开展工作对TSS进行心理测量学验证，包括确定领域、测试反应性以及确定合适的评分方法。
