基于德尔菲法的中医药临床试验知情同意质量评价问卷的条目筛选

Item Selection for the Quality Evaluation of Informed Consent Questionnaire in Clinical Trials of Traditional Chinese Medicine Based on Delphi Method

目的运用德尔菲法对中医药临床试验知情同意质量评价问卷的领域及各领域备选条目开展相关专家调查,为制定一个有效、可靠、简便的问卷提供依据。方法应用已制定的专家咨询意见表,采用德尔菲法进行专家咨询,咨询结果从专家意见集中程度和协调程度两方面对量表条目进行统计分析。结果共进行2轮德尔菲法专家咨询,专家积极系数分别为87.5%、100%;第1轮权威系数在0.850~0.950之间,第2轮权威系数为0.883;专家对方案中绝大多数条目的评价的集中程度和协调程度较高。结论该研究参与德尔菲法的专家专业代表性强,权威程度、积极性高,集中程度和协调程度好。该调查应用德尔菲法形成的中医药临床试验知情同意质量评价问卷,能够为下一阶段的预调查和问卷考评提供比较可靠的依据。

Objective To conduct the investigation of expert survey on the field of the quality evaluation of informed consent questionnaire for clinical trials of traditional Chinese medicine(ICQ-TCM) and alternative items using Delphi method,so as to provide basis for formulating an effective,reliable,and simple questionnaire.Methods Using the established form of expert consultation, we carried out experts' consultation by means of the Delphi method. Statistical analysis of consultation results was performed according to the degree of concentration and coordination opinions of experts.Results Totally 2 rounds of Delphi expert investigations were conducted. The expert positive coefficients were 87.5% and 100% respectively. The expert authoritative coefficient of the first round was in the range of 0.850-0.950. In the second round of consultation,the authoritative coefficient was 0.883. All items met inclusion criteria,and most items were highly evaluated by experts in the degree of concentration and coordination opinions.Conclusion sThe experts participating in the study are representative, authoritative, active and coordinated. Therefore,the ICQ-TCM based on Delphi method can provide a reliable basis for the pre-survey and questionnaire evaluation in the next stage.