1.Approach to CDISC SDTM Implementation for Clinical Trials Data Submission
Yanke AI ; Liyun HE ; Tiancai WEN ; Dongning WU ; Baoyan LIU
World Science and Technology-Modernization of Traditional Chinese Medicine 2015;(2):301-305
This study was aimed to discuss the ways of converting clinical data entered in the Case Report Form (CRF) to Study Data Tabulation Model (SDTM) database format in clinical research of traditional Chinese medicine (TCM). Currently, there were three approaches for implementing SDTM, which were the pure SDTM approach, submission-only approach and database-only approach. This article compared and analyzed advantages and disadvantages of three approaches and introduced experiences of the Clinical Evaluation Center of China Academy of Chinese Medical Sciences using database-only approach for SDTM implementation. The results showed that pure SDTM approach can maximally embrace SDTM standards. However, the current process and software system should be modified. Therefore, it was time-consuming and expensive. The submission-only approach was the most economic way in the application of SDTM standards. However, the data quality and traceability may not be guaranteed. The database-only approach built the study database based on the SDTM standard by writing transformed program before data entry while the data collection system was not SDTM-compatible. It was concluded that database-only approach for implementation SDTM was a suitable and practical way to TCM clinical research.
2.Cultural anthropology of traditional Chinese medicine
Xia WAN ; Jianping LIU ; Yanke AI ; Liuji LI
Journal of Integrative Medicine 2008;6(7):674-7
Biological, psychological and sociological model of medicine substantializes the old model lacking the social humane attributes. The new medical model makes people take medical anthropology into research and highly evaluate traditional medical system. Cultural anthropology of traditional Chinese medicine (TCM) is part of medical anthropology with three major characteristics: wide research scope, specificity, and integration. It has developed its own research methods, such as field investigation, comprehensive inspection and comparison study. Cultural anthropology provides an efficient research method for TCM, and its application would further develop TCM theory and form comprehensive evaluation on TCM effects.
3.Clinical outcome assessment and the effect measure
Hongwei ZHANG ; Jianping LIU ; Xia WAN ; Yanke AI
Journal of Integrative Medicine 2007;5(5):497-501
Effect of clinical intervention on human body is multistage and multifaceted, involving physiology, psychology, social function and the surrounding resources, etc. Therefore, the range of clinical outcome assessment includes patient, his or her family and care giver. The evaluation of clinical intervention mainly focuses on its effectiveness, safety and health economics. Effects of clinical interventions are measured by comparisons of the outcome of intervention and control groups. Different effect measures come from different comparisons.
4.Methods of selecting outcome variables for clinical intervention
Xia WAN ; Jianping LIU ; Hongwei ZHANG ; Yanke AI
Journal of Integrative Medicine 2007;5(1):11-4
Abstract: There are two stages for selecting the clinical intervention outcome variables. One is crude collection and the other is precise collection. The selection methods include brainstorming method, Delphi method, Gordon method, systematic review, systematic analysis method, mathematic model method and so on. Each method has some advantages or disadvantages. When selecting the clinical intervention outcome variables, researchers should make sure the research aim, the representative and the sensitivity of the variables, and select all kinds of recommended methods comprehensively, then decide which method should be used.
5.Quality Survey of Data Management of TCM Chronic Clinical Researches
Xiaoying LV ; Liyun HE ; Tiancai WEN ; Zhuolin ZHANG ; Yanke AI ; Baoyan LIU
Chinese Journal of Information on Traditional Chinese Medicine 2015;(4):1-3
Objective To study the scientificity and rationality in data management of the project of Chinese Chronic Disease Clinical Research System and its Achievements Application Mode;To provide evidence and reference for the improvement of follow-up work. Methods According to the relevant management regulations, guidelines, and other relevant documents of national and international clinical research data,“Questionnaire for Research Data Management Assessment of Chinese Chronic Disease Prevention” was designed. The questionnaires were used in 10 clinical topics during the on-site inspection survey, and 20 valid questionnaires were retrieved and analyzed statistically. Results 50-60 percentage of subjects in data management and statistics were performed by the third party;70 percentage of subjects were performed by their own central monitoring;50 percentage of the subjects adopted a cooperative manner with others to develop appropriate data management systems;7 centers had system and plan for data management;Data management was carried out;implementation degree of training, database, CRF tracing, and others 7 aspects was low. Conclusion Improving the quality of data management of TCM clinical research still needs to be perfected from many aspects, and quality mode of large-scale clinical trials should be improved.
6.Placebo Effect and the Design of Placebo Acupuncture in Clinical Trials
Yanhong ZHANG ; Yanke AI ; Jinhong YANG ; Weijuan GANG ; Xianghong JING ; Baoyan LIU
Journal of Traditional Chinese Medicine 2024;65(9):904-908
Clinical research is usually aimed at and guided by therapeutic efficacy. Clarifying the placebo effect and the nocebo effect from treatment outcomes is an important issue in clinical research. This paper reviews the meaning of the placebo effect, suggesting that factors that may produce the placebo effect in clinical practice include past experience associations, patient expectations, suggestion, and doctor-patient relationships. It also summarizes the characteristics of the nocebo effect, its influencing factors, and its impact on clinical prognosis. Combining the characteristics of traditional Chinese medicine, this paper explores the design of acupuncture clinical trials that can reflect the measurement of the placebo effect, attempting to provide a clearer interpretation of the placebo effect in the evaluation of acupuncture efficacy in traditional Chinese medicine. Taking primary insomnia as an example, a prospective randomized placebo-controlled trial is designed to observe and evaluate the relationship between the treatment effects of acupuncture and the placebo effect in different patients under the treatment of the same doctor. Group comparisons will help better distinguish clinical effects in different situations. The authors also attempt to explore the responsive population to the placebo effect and the effects of placebos in different populations.
7.The Development of Core Outcome Set for Premature Ovarian Insufficiency Treated with Traditional Chinese Medicine
Xue CAO ; Changhe YU ; Xiangran MENG ; Yuning QIN ; Yanke AI ; Jia LIU
Journal of Traditional Chinese Medicine 2024;65(13):1334-1339
ObjectiveTo construct the core outcome set (COS) for premature ovarian insufficiency (POI) treated with traditional chinese medicine (TCM), thereby standardizing the effect evaluation system of POI clinical researches. MethodsDatabases including PubMed, EMbase, Cochrane Library, Web of Science, CNKI, Wanfang, VIP, SinoMed from January 2017 to December 31, 2021, and Chinese Clinical Trials Registry (ChiCTR), ClinicalTrials.gov were searched to collect the outcomes used in clinical studies of POI. Supplemented with the patients preferred outcomes through semi-structured interviews, the outcome pool was then constructed. Finally through the Delphi survey and consensus conference, the COS for POI was obtained. ResultsA total of 554 clinical researches and 14 registered clinical research protocols were included. A semi-structured interview was conducted within 20 patients. A total of 77 outcomes were included in the pool after consolidation. After two rounds of Delphi surveys, 20 outcomes were initially included. The COS, which was finalized through expert consensus conference, consists of 8 outcomes in 3 domains, which were ovarian reserve function (follicle stimulating hormone, estradiol, anti-Mullerian hormone, sinus follicle count), menstruation-related indicators (menstrual symptoms condition) and fertility indicators (pregnancy rate, live birth rate and the numbers of retrieved oocytes). Through expert discussion, the corresponding measurement methods as well as the measurement time points of the COS were determined. ConclusionThis study formed COS for clinical studies of TCM in the treatment of POI, by practicing the general method of developing COS, and exploring the key points of developing COS with TCM features.