Girman C J, Hartmaier S, Thiboutot D, Johnson J, Barber B, DeMuro-Mercon C, Waldstreicher J
Department of Epidemiology, Merck Research Laboratories, West Point, PA 19486, USA.
Qual Life Res. 1996 Oct;5(5):481-90. doi: 10.1007/BF00540020.
Although psychosocial aspects of skin diseases are well known, disease-specific questionnaires validated for use in clinical trials are not available to assess the impact of facial acne on health-related quality of life or to evaluate therapeutic change. Development of such an instrument was undertaken and included item generation, reduction and pilot-testing phases. By interviewing acne subjects and dermatologists and literature review, 168 possible items were identified. Next, 165 acne subjects identified which items affected them and rated importance on a 5-point scale. Reduction to a brief questionnaire was performed by evaluating patient-perceived importance and factor analysis; four domains were identified (self-perception, role-emotional, role-social, acne symptoms). After pilot-testing for comprehension in acne subjects, further revisions were made to improve clarity and applicability. The resulting instrument takes 10 minutes to complete, and consists of 24 questions assessing how acne affected certain aspects of patients' lives during the past week on a 7-point scale. Thus, an instrument with excellent content validity was developed to assess health-related quality of life in patients with facial acne, and is comprised of statistically meaningful items of importance to patients. Other measurement characteristics are being assessed in a recently initiated study to evaluate test-retest reliability and responsiveness to therapy.
尽管皮肤病的社会心理方面广为人知，但目前尚无经过验证可用于临床试验的特定疾病问卷，以评估面部痤疮对健康相关生活质量的影响或评估治疗变化。因此开展了这样一种工具的开发工作，包括项目生成、缩减和预测试阶段。通过对面部痤疮患者和皮肤科医生进行访谈以及文献回顾，确定了168个可能的项目。接下来，165名痤疮患者指出哪些项目对他们有影响，并按5分制对重要性进行评分。通过评估患者感知的重要性和因素分析，将项目缩减为一份简短的问卷；确定了四个领域（自我认知、角色情感、角色社会、痤疮症状）。在对痤疮患者进行理解预测试后，又进行了进一步修订，以提高清晰度和适用性。最终形成的工具需要10分钟完成，由24个问题组成，这些问题以7分制评估痤疮在过去一周对患者生活某些方面的影响。因此，开发了一种具有出色内容效度的工具，用于评估面部痤疮患者的健康相关生活质量，该工具由对患者具有统计学意义的重要项目组成。在最近启动的一项研究中，正在评估该工具的其他测量特性，以评估重测信度和对治疗的反应性。
