Technical recommendation for pragmatic randomized controlled trial of heat-sensitive moxibustion in community (Ⅰ): randomization with consideration of patient preference.
10.13703/j.0255-2930.20210512-k0004
- Author:
Xu ZHOU
1
;
Ze-Huai WEN
2
;
Ling LI
3
;
Jian-Ping LIU
4
;
Yi-Huang GU
5
;
Xin-Feng GUO
6
;
Xing LIAO
7
;
Wei-Feng ZHU
1
;
Shu-Qing LI
1
;
Xin SUN
3
Author Information
1. Evidence-Based Medicine Research Centre, Jiangxi University of CM, Nanchang 330004, China.
2. Key Unit of Methodology in Clinical Research, Guangdong Provincial Hospital of TCM.
3. Chinese Evidence-Based Medicine Centre, West China Hospital, Sichuan University, Chengdu 610041.
4. Centre for Evidence-Based Medicine, Beijing University of CM.
5. Acupuncture-Moxibustion and Tuina College, Nanjing University of Chinese Medicine.
6. Second Affiliated Hospital of Guangzhou University of CM.
7. Office of Evidence-based Medicine, Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medical Sciences.
- Publication Type:Randomized Controlled Trial
- Keywords:
community;
heat-sensitive moxibustion;
patient preference;
pragmatic randomized controlled trial (pRCT);
randomization
- MeSH:
Hot Temperature;
Humans;
Moxibustion;
Patient Preference;
Random Allocation;
Reproducibility of Results
- From:
Chinese Acupuncture & Moxibustion
2022;42(1):85-90
- CountryChina
- Language:Chinese
-
Abstract:
Heat-sensitive moxibustion is the appropriate technique of the external treatment in traditional Chinese medicine and it is widely used in community because of its "easy learning, simple operation and clear curative effect". Pragmatic randomized controlled trial is a main intervention design in the real world study, which provides a high-level evidence for the effectiveness assessment of heat-sensitive moxibustion in community management. Focusing on the key links of randomization, e.g. block randomization, stratified randomization, cluster randomization, sample size allocation, allocation concealment and blinding, the paper elaborates the advantages, disadvantages and technical details of two-stage randomization with consideration of patient preference in pragmatic randomized controlled trials of heat-sensitive moxibustion in community. It facilitates improving the quality of evidence, reproducibility and methodological homogeneity among different trials.
