患者针刺期望量表的研制及其信效度检验

Acupuncture expectancy is one of the key influencing factors affecting clinical efficacy, but its evaluation currently lacks uniform and accepted criteria. The existing concept of acupuncture expectancy in clinical trials is not clear, and there are many problems in production, expression and property testing of these measurement tools. The development of the patient acupuncture expectancy scale should follow the principles and procedures of measurement, clarify the basic concepts, and test their property. Therefore, based on the previous research work, this study follows the basic principles and procedures of patient reporting outcome scale developed by the FDA, and identifies the concept and forms item tools of patient acupuncture expectancy scale through systematic reviews and patient cognitive interviews. The item pool is screened by the Delphi expert consensus method to form the first draft of the scale, and its reliability, validity and feasibility are also tested. After repeated revision tests, we plan to develop the patient acupuncture expectancy scale which is easy to understand and in line with the characteristics of Chinese language and culture and acupuncture treatment. Acupuncture expectancy scale will offer an objective and standardized measurement tool for the evaluation of patients’ expectancy, and meet the needs of high-quality acupuncture clinical trials, improve clinical efficacy, solve the key issue of patients’ expectancy in current acupuncture clinical research.

患者针刺期望是影响临床疗效的关键影响因素之一，但是其评价目前尚缺乏统一的、公认的评价标准。现有的临床研究中患者针刺期望的概念不明确，且测量工具在条目的产生、表达和性能测试等方面存在诸多问题。患者针刺期望量表的研制应遵循测量学的原则和流程，明确基本概念，并测试其性能。因此，本研究在前期研究工作的基础上，遵循FDA患者结局报告研制的基本原则和流程，通过系统评价和患者认知访谈明确患者针刺期望的概念，形成患者针刺期望量表的条目池，通过Delphi专家共识法进行条目筛选，形成量表初稿，并检验其信度、效度和可行性等，经过反复修改测试，研制出通俗易懂、符合我国语言文化特点和针刺诊疗特色的中国本土的患者针刺期望量表，为患者针刺期望供客观化、标准化的评价工具，以满足高质量针灸临床研究的需要，提高临床疗效，解决目前针灸临床研究中患者期望测量工具不规范、不严谨的关键问题。

患者针刺期望是影响临床疗效的关键影响因素之一，但是其评价目前尚缺乏统一的、公认的评价标准。现有的临床研究中患者针刺期望的概念不明确，且测量工具在条目的产生、表达和性能测试等方面存在诸多问题。患者针刺期望量表的研制应遵循测量学的原则和流程，明确基本概念，并测试其性能。. 本研究在前期研究工作的基础上，遵循FDA患者结局报告研制的基本原则和流程，通过系统评价和患者认知访谈明确患者针刺期望的理论内涵，形成患者针刺期望量表的条目池，接下来通过Delphi专家共识法对量表条目进行评分，进行条目筛选，形成量表初稿，并招募临床患者检验量表信度、效度和可行性等。经过反复修改测试，本量表共包含4个维度和11个条目，患者测试也表明其具有较好的信效度。. 本研究旨在研制通俗易懂、符合我国语言文化特点和针刺诊疗特色的中国本土的患者针刺期望量表，为患者针刺期望供客观化、标准化的评价工具，以满足高质量针灸临床研究的需要，提高临床疗效，解决目前针灸临床研究中患者期望测量工具不规范、不严谨的关键问题，后续将在针灸临床研究中进行推广。