Biefang S, Richter U
Z Rheumatol. 1983 Nov-Dec;42(6):381-6.
In the course of the preparation of multicenter clinical trials involving patients suffering from rheumatic diseases, a self-administered questionnaire for the subjective assessment of health status was developed and tested; the pilot study included 186 patients at 14 hospitals. The questionnaire gathered data in the following areas: pain, complaints, psychological wellbeing, depression, anxiety, and functional status. Experts participating in our project thought these parameters to be relevant to the self-assessment of health status. Scales from the literature on psychometry and health indicators were chosen to assess the parameters. In the pilot study the usefulness and feasibility of the parameters and measurements were tested. A revised and shorter form of the original self-administered questionnaire was developed on the basis of the results of the pilot study, and this questionnaire was then recommended for use in clinical trials. The questionnaire is discussed in the light of the recent literature reporting on similar assessment methods for rheumatic patients.
在涉及风湿性疾病患者的多中心临床试验准备过程中，开发并测试了一份用于主观评估健康状况的自填式问卷；试点研究纳入了14家医院的186名患者。该问卷收集了以下方面的数据：疼痛、不适、心理健康、抑郁、焦虑和功能状态。参与我们项目的专家认为这些参数与健康状况的自我评估相关。选择了心理测量学和健康指标文献中的量表来评估这些参数。在试点研究中测试了这些参数和测量方法的实用性和可行性。根据试点研究结果，制定了原始自填式问卷的修订简化版，然后推荐该问卷用于临床试验。结合近期关于风湿性患者类似评估方法的文献对该问卷进行了讨论。
