Development of Patient Self-Reported Core Outcome Set in Community Studies on Heat-Sensitive Moxibustion for Primary Hypertension
10.13288/j.11-2166/r.2025.01.007
- VernacularTitle:热敏灸治疗原发性高血压社区研究患者自我报告核心指标集的初步构建
- Author:
Jianyu YOU
1
;
Shuqing LI
2
;
Guihua DENG
1
;
Xu ZHOU
2
Author Information
1. School of Acupuncture，Moxibustion and Tuina，Jiangxi University of Traditional Chinese Medicine，Nanchang，330004
2. Evidence-based Medicine Research Centre，Jiangxi University of Traditional Chinese Medicine
- Publication Type:Journal Article
- Keywords:
heat-sensitive moxibustion;
primary hypertension;
patient self-reported;
core outcome set;
effectiveness evaluation
- From:
Journal of Traditional Chinese Medicine
2025;66(1):34-41
- CountryChina
- Language:Chinese
-
Abstract:
ObjectiveTo establish the self-reported core outcome set （COS） for patients with an example of a community study on heat-sensitive moxibustion for primary hypertension （PH）， to provide a reference for the selection of effectiveness evaluation indicators in community study on heat-sensitive moxibustion. MethodsA systematic literature search was conducted to collect outcomes used in randomized controlled trials and systematic review of heat-sensitive moxibustion for PH （Jan 2021）， and additional outcomes were added through patient and expert questionnaires （Feb 2021） to create a pool of outcome entries. A multidisciplinary expert Delphi survey was conducted to screen outcomes applicable to patient self-reporting （Apr 2021）， and the importance of outcome indicators was rated on a 5-Point Likert Scale. Finally， patient self-reported COS was determined through a consensus conference （June 2021）. ResultsA pool of patient self-reported indicators in the community study of heat-sensitive moxibustion treatment for PH was generated by standardizing and combining the outcome indicators based on the results of the literature search and the questionnaire survey， which consisted of totally 100 measurement tools or contents， excluding 51 indicators or measurement tools required measurement by specialized physicians or hospital equipment， and 49 items were retained to enter the initial list of indicator entries. For the first round of Delphi survey， the mean score for expert familiarity was 0.819， the mean score for basis of judgment was 0.710， and the expert authority coefficient was 0.765， with a total of 21 indicator measurement tools or contents deleted （significance score ≤ 75 or coefficient of variation ＞ 0.25）， 28 retained， and 3 new expert-added indicator entries added. In the second round of Delphi survey， the average score for expert familiarity was 0.859， the average score for basis for judgment was 0.763， and the expert authority coefficient was 0.811， with a total of 11 indicator measurement tools or contents deleted and 20 retained involving 5 domains. Following an expert consensus meeting， 8 outcome indicators were finalized for inclusion in the patient self-reported COS， including 6 indicators of effectiveness evaluation such as quality-of-life scores， blood pressure， traditional Chinese medicine symptom scores， cost-benefit， cardiovascular and cerebrovascular events， and adverse reactions/events， and 2 indicators of factors influencing effectiveness such as sensation of heat-sensitive moxibustion， and adherence. ConclusionIn this study， we initially established a criteria for evaluating the effectiveness in the community study on heat-sensitive moxibustion by constructing patient self-reported COS in the community study on heat-sensitive moxibustion for PH， which can provide a scientific research paradigm for the subsequent development of the community study on heat-sensitive moxibustion.
