Objective: To validate a patient-reported outcome (PRO) measure for patients with tension-type headache (TTH). Methods: Literature analysis, interview, and group discussion were performed to develop an initial TTH-PRO. Thereafter, the initial scale was pre-evaluation in a small range of patients with TTH, and the expert panel made necessary adjustments based on the content feedback. The clinical test was carried out by using the adjusted initial scale. Based on the test results, the items were screened by the method of classical test theory to form the final scale, and the performance evaluation indicators such as validity, reliability, and responsiveness of the final scale were tested. Results: The final formed TTH-PRO scale contained three domains, six dimensions, and 30 items. The split-half reliability, Cronbach's α coefficients, and construct validity of the scale were acceptable, as was feasibility. The responsiveness in the physiological domain was fair, but the overall responsiveness still needed further clinical validation. Conclusions:The TTH-PRO scale has been developed with extensive patient input and demonstrates evidence for reliability and validity. It is complementary to existing evaluation indicators of TTH, emphasizing the patient's experience. Further studies are needed to optimize its items and to verify its clinical applicability for population in more regions and countries.

中文翻译：

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紧张型头痛患者报告结果量表的开发和验证。

目的：验证对紧张型头痛 (TTH) 患者的患者报告结果 (PRO) 测量。方法：进行文献分析、访谈和小组讨论以开发初始 TTH-PRO。此后，最初的量表是对小范围的TTH患者进行预评估，专家组根据内容反馈进行必要的调整。临床试验采用调整后的初始量表进行。根据测试结果，采用经典测试理论的方法筛选出题目，形成最终量表，并对最终量表的效度、信度、反应性等绩效评价指标进行检验。结果：最终形成的 TTH-PRO 量表包含三个领域、六个维度和 30 个项目。分半信度，Cronbach α 系数，量表的结构效度和可行性是可以接受的。生理学领域的反应性尚可，但整体反应性仍需进一步临床验证。结论：TTH-PRO 量表是在广泛的患者输入下开发的，并证明了信度和效度的证据。它是对现有 TTH 评价指标的补充，强调患者的体验。需要进一步研究优化其项目，并验证其对更多地区和国家人群的临床适用性。TTH-PRO 量表是在大量患者输入的基础上开发的，并证明了可靠性和有效性的证据。它是对现有 TTH 评价指标的补充，强调患者的体验。需要进一步研究优化其项目，并验证其对更多地区和国家人群的临床适用性。TTH-PRO 量表是在大量患者输入的基础上开发的，并证明了可靠性和有效性的证据。它是对现有 TTH 评价指标的补充，强调患者的体验。需要进一步研究优化其项目，并验证其对更多地区和国家人群的临床适用性。