Research on the development methodology for clinical practice guidelines for organic integration of traditional Chinese and Western medicine.

Integrated traditional Chinese medicine (TCM) and Western medicine (WM) is a new medical science grounded in the knowledge bases of both TCM and WM, which then forms a unique modern medical system in China. Integrated TCM and WM has a long history in China, and has made important achievements in the process of clinical diagnosis and treatment. However, the methodological defects in currently published clinical practice guidelines limit its development.

[Proposal of Living Evidence-based Guideline for Combination of Traditional Chinese and Western Medicine for Treatment of COVID-19].

In order to standardize the clinical diagnosis and treatment decision-making with traditional Chinese medicine for pa-tients of coronavirus disease 2019(COVID-19) and put the latest clinical study evidence into clinical practice, the international trust-worthy traditional Chinese medicine recommendations( TCM Recs) working group started the compilation of Living Evidence-based Guideline for Combination of Traditional Chinese and Western Medicine for Treatment of COVID-19 on the basis of the standards and re-quirements of WHO handbook, GRADE and RIGHT. This proposal mainly introduces the formulation methods and processes of the living guidelines in details, such as the composition of the working group, the collection and identification of clinical issues and out-comes, the production of the living systematic review and the consensus of recommendations. The guidelines will continue to monitor the clinical study evidences of TCM in the prevention and treatment of COVID-19, and conduct regular evidence updating, retrieval and screening.

[The prospective of minimal important difference and its application in clinical researches of Chinese medicine].

Minimal important difference (MID) is a concept in regards of efficacy evaluation in recent years. MID has its features and clinical significance. MID methods include anchor-based methods, distribution-based methods, expert consensus methods, literature analysis methods, and so on.

[Investigation on response of the patient-reported outcome scale of the main-symptoms of chronic obstructive pulmonary disease complicated with pulmonary heart disease].

Objective: To select appropriate descriptors for response of the patient-reported outcome (PRO) scale for the main symptoms of patients with chronic obstructive pulmonary disease (COPD) complicated with pulmonary heart disease.

Methods: A cross-sectional investigation was carried out. Five equidistant ordinal descriptive words in the PRO scale of main symptoms for COPD complicated with pulmonary heart disease were selected.

[Modern testing theory and its application in the field of health measurement].

This paper briefly introduces item response theory (IRT) as a typical representation of modern testing theory (MTT), and systematically reviews the processes and contents of the application of IRT in the area of health measurement, including, for example, item bank development, scale revision and computerized adaptive testing. The author presents the potential benefits and the notable problems during health measuring by IRT. Then, the author asserts the need for thorough assessment of feasibility when using the IRT in patient-reported outcome research.

[Establishment and implementation of evidence-based clinical pathway of Chinese medicine].

The purpose of establishing an evidence-based clinical pathway is to standardize the clinical practice, improve the quality of health care and cure patients' illness. Since the core of evidence-based medicine (EBM) lies in implementing the current best available evidence of clinical research to direct the decision making in clinical practice, evidence obtained from research should be kept to either in formulating a clinical practice guideline or establishing a clinical pathway. The EBM method for establishing clinical pathway was introduced in this paper, including setting up a compilation team, raising clinical relevant problems, searching and critically appraising available evidence, and incorporating them into the process of clinical pathway establishment, expecting to provide methodological guidance for establishing TCM clinical pathway in future.

[Key issues on the clinical pathway development: a view from Chinese medicine and integrative medicine].

Comparing with the Western medicine, the clinical pathway development of Chinese medicine (CM)/integrative medicine (IM), on one hand, should follow the basic principles of general clinical pathway; on the other and prior hand, it ought to coordinate with the rule of CM, and display sufficiently the advantages of CM based upon the evidences. Several key issues which may be encountered in the development and the relevant strategies were introduced in this paper.

[A study of scale response for Health Scale of Traditional Chinese Medicine].

Objective: To select appropriate descriptors for responses of the Health Scale of Traditional Chinese Medicine (HSTCM).

Methods: A cross-sectional investigation was carried out among 28 hospital staff members by using 151 scale descriptors. This investigation involved all the descriptors from the initial version of HSTCM.

[Pretest survey on the Chinese menopause rating scale].

Objective: To select the items from the Chinese menopause rating scale (CMRS) through pre-testing those people with menopausal syndromes.

Methods: 293 people were surveyed in Guangzhou in 2005, among which 196 people with menopausal syndromes and others without. Psychometrics methods were employed to develop the scale.

[Reliability and validity of Health Scale of Traditional Chinese Medicine].

Objective: To test the reliability and validity of Health Scale of Traditional Chinese Medicine (HSTCM) by means of questionnaires.

Methods: A cross-sectional survey was conducted at Liwan Community of Guangzhou, Old People's Home in Guangzhou and Outpatient Department of the Second Affiliated Hospital of Guangzhou University of Chinese Medicine. A total of 652 Chinese individuals (over 18 years old) were assessed with the 88-item version of HSTCM and World Health Organization Quality of Life Measure-Abbreviated Version (WHOQOL-BREF), which were randomly delivered to them.

[Establishment and initial evaluation of health scale of traditional Chinese medicine].

Viewing from some TCM concepts and basic characteristics of health, assimilating the operationalization concerning thinking and procedure of modern scientific research, the pilot form of Health Scale of TCM--initial health scale of TCM (iHSTCM) based upon TCM theory was developed. From November 2002 to January 2003, the domain, facets and items of HSTCM were finally established by analyzing the data from a survey of 652 persons in Guangzhou City using iHSTCM. In conclusion, the HSTCM has its theoretical ratio-nality and is applicable.

[Exploration on health concept of TCM and the operationalization of its measurement].

Viewing from the concept of health and several basic characteristics of health outlook of traditional Chinese medicine (TCM), assimilating the thinking and procedure of modern scientific research concerning operationalization, in this paper, the TCM concept of health and its measurement operationalization as well as their relevant things were expounded. And the frame, related domain, indexes and items of health assessment scale based upon TCM theory were tried to be established using opertionalization method.

[Exploration on establishment and application of soft index survey tools in TCM study].

This paper discussed the concept, categorizations, methods and basic principles for establishing of soft index survey tools (SIST) in clinical medicinal field, pointed out the relation between the connatural theoretical and practical mode of TCM and the establishment of SIST having TCM characteristics, and elaborated several key points which should be paid attention to in the establishment of SIST. It was pointed out that there was broad space for application of SIST in TCM study.

[Application of non-randomized study in the field of traditional Chinese medicine or integrated traditional Chinese and Western medicine].

Non-randomized studies (NRS) have gradually attracted people's attention in the field of clinical medicine. In this paper, the importance of NRS was emphasized on the viewpoints of the coherence of scientific research, the limitation of randomized control trials (RCTs), the immanent characteristics of TCM clinical practice and the actual requirement of complex intervention in clinical practice. And two main points in evaluation and implementation of NRS differed to those in RCTs were put forward, i.