构建中医领域病例-对照研究技术规范:基于Delphi法的第1次调查

First consultation of developing the methodological guideline for case-control study in traditional Chinese medicine based on Delphi method

关键词:  中医药  病例-对照研究  Delphi法  专家咨询  方法学规范

Key words:  traditional Chinese medicine  case-control study  Delphi method  expert consultation  methodological guideline

摘要:

[目的] 通过专家咨询的方式对调查问题条目进行第1轮评估,经分析讨论后形成第2轮调查问题条目。[方法] 采用国际上通用的德尔菲(Delphi)法,以专家咨询的形式进行第1轮咨询调查,对调查问题条目进行重要性评估,并对相关条目提出归纳意见和建议,最后根据专家咨询的结果确定需要纳入的条目,为第2轮咨询调查提供草案。[结果] 根据系统查阅文献的结果,结合观察性研究的STROBE规范以及国际上其他相关方法学技术规范制订的过程,最终制订出45条调查问题条目,以此进行专家调查。调查结果显示专家积极系数为81.8%。专家意见的集中程度指标一致,提示专家意见集中程度较好。条目变异系数(CV)均<0.3,提示专家意见协调程度较好。条目平均分≥4分的有36条,3分≤平均分<4分的有9条。其中关于证候和体质时点的确定以及选择新发病例方面是质疑较多的条目。[结论] 最后确定纳入第1轮意见征询的条目36条、可能纳入的条目9条。其结果提示,中医药领域的病例-对照研究有其自身的特殊性,尤其是证候、体质方面,需要针对性的方法学指导。

Abstract:

[Objective] To evaluate the items by consulting experts, and then form the second round items to be questioned for developing the methodological guideline. [Methods] We evaluated the importance of items by using the general international Delphi method, and adopted the way of expert consultation for the first round consultation. Meanwhile, the experts could raise their opinions and suggestions about the items. Finally, confirming the included items according to the results of expert consultation and providing the draft for the second round consultation. [Results] According to the results of systematic literature search, complying with the STROBE guideline of observational studies and other procedures of methodological guidelines, we formulated the questionnaire including 45 items. The recovery rate of the questionnaire (specialist active coefficient) was 81.8%. The concentration indexes, including mean, mode and sum scores calculated from experts' opinion were consistency, which indicated a good degree of concentration among experts' opinion. All coefficient of variation (CV) were < 0.3, suggesting coordination degree of experts was better. The results showed that mean scores of 36 items were greater than or equal to 4 points,and 9 items were greater than or equal to 3 points and less than 4 points. The identification about time point of traditional Chinese medicine (TCM) syndrome and constitution classification in TCM were questioned more. [Conclusion] The 36 items were included in the second round survey,and 9 items had the possibility to be included. It showed that there were some particularity in case-control studies for TCM, especially TCM syndrome and constitution classification fields.