This study outlines statistical methods and practical steps for designing and developing valid and reliable questionnaires in primary care. A series of studies on questionnaire development and scale design are reviewed and a standardized process for scale design in the primary care is developed. The process involves key and practical steps in the scale design process as well as statistical methods, which is illustrated with examples of previous relevant studies within the field. The suggested seven-step approach to developing a questionnaire in the primary care is: (1) defining the construction of measurement; (2) generating the pool of items; (3) selecting the scoring system and response format; (4) pre-testing (assessing content validity and face validity, etc.) ; (5) eliminating items by item analysis; (6) evaluating the scale initially, including evaluating the reliability and validity of the scale, and factor analysis or Rasch analysis; (7) re-evaluating the scale to re-examine the nature of the scale, including retesting reliability and constructing validity. In general, the studies on scale design should strictly follow the standardized steps of scale development, and the integrated use of Rasch model and factor analysis can make the measurements more objective.

本文概述了在初级卫生保健领域设计和开发有效、可靠问卷的统计学方法和实用步骤。回顾了一系列关于问卷编制和量表设计的研究，并制定了一套在初级卫生保健领域进行量表设计的标准化流程。该流程涉及量表设计过程中关键且实用的步骤及统计学方法，并结合以往该领域的相关研究案例加以说明。建议的初级卫生保健领域问卷的七步编制方法为：（1）定义测量的构念；（2）生成条目池；（3）选择评分系统和响应格式；（4）预测试（评估内容效度和表面效度等）；（5）通过项目分析剔除条目；（6）量表的初次评价，包括量表的信度和效度评价，以及因素分析或Rasch分析；（7）量表的再次评价，重新检验量表的性质，包括重测信度和结构效度。总的来说，量表设计类研究应严格按照量表编制的标准步骤，综合使用Rasch分析和因素分析的方法，这可以使量表的测量结果更加客观。