Proposal of Living Evidence-based Guideline for Combination of Traditional Chinese and Western Medicine for Treatment of COVID-19 / 中国中药杂志

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. When there is new study evidence, the steering committee will evaluate the possibility of the evidence to change clinical practice or previous recommendations, so as to decide whether the recommendations for the guidelines shall be implemented or upda-ted. The main criteria considered in the guideline updating are as follows:(1) There are new high-quality randomized controlled trial(RCT) evidences for TCM uninvolved in the previous edition of the guidelines;(2) as for the TCM involved in the guidelines, living sys-tematic review shows that new evidence may change the direction or strength of the existing recommendations. The specific implementation of the living evidence-based guidelines will take this proposal as the study basis and framework, in order to ensure the standardization of the formulation process and methods. This will be the first exploration of the methodology for living guidelines in the field of TCM.

The prospective of minimal important difference and its application in clinical researches of Chinese medicine / 中国中西医结合杂志

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. All these methods have their own advantages and disadvantages. In confirming MID, you'd better use them comprehensively according to the research objectives. The significance, range, and evaluation methods of MID in the clinical research of Chinese medicine were clarified. It is necessary to strengthen MID correlated researches and applications.

Establishment and implementation of evidence-based clinical pathway of Chinese medicine / 中国中西医结合杂志

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 / 中国中西医结合杂志

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.

Pretest survey on the Chinese menopause rating scale / 中华流行病学杂志

Objective To select the items from the Chinese menopause rating scale(CMRS)through pre-tcsting 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.The item pools were all round.Methods used would include:focus group discussion and interviews,subjective evaluation method and Delphi method,to preliminarily screen the items.Data on scales measured from 196 cases with and 97 subjects without menopausal syndromes during the menopausal period,were collected.Again,seven statistical methods were employed to select the items.Results The 40-items scale for menopausal syndrome was formed to include:a)three domains:somatic(18-items),psychological(14-items)and social(5-items);b)one general appraisaIitem:c)two lie-test iterns.Conclusion The Chinese menopausal syndrome scale we used seemed to possess good content validity.feasibility and intra-class reliability.

Study on the reliability and validity of the Chinese Menopause Rating Scale (CMRS) / 中华流行病学杂志

Objective To evaluate the feasibility,reliability,validity and responsiveness of a Chinese Menopause Rating Scale (CMRS).Methods Cross-sectional survey and convenience sampling were adopted. Participants:women with menopause syndrome and those in menopause but without menopause syndrome were recruited.All participants were asked to complete the CMRS,Kupperman Index,WHOQOL-BREF and MENQOL.The Self-control observation design was adopted when the responsiveness was evaluated.Patients were treated with TCM for weeks.MRSTCM was evaluated before and after the treatment.Results (1) Feasibility:3343 participants including 2320 patients and 1023 menopause women,were surveyed in 8 different settings.The recovery rate of CMRS was 100%,with a response rate as 99.7%.The completion of the CMRS took 10.30 minutes on average.(2)Reliability:Cronbach's alpha of CMRS,soma dimension,psychology dimension and community dimension of CMRS were 0.93,0.87,0.89 and 0.73 respectively,with the correlation coefficient of split half of the CMRS.Soma dimension,psychology dimension and community dimension were 0.92,0.89,0.86 and 0.73 respectively and the test-retest correlation coefficient of MRSTCM,the soma dimension,psychology dimension and community dimension were as 0.88,0.91,0.85 and 0.77 respectively.(3) Validity:CMRS was established on the basis of connotation of menopause syndrome,and a series of steps were adopted to modify the scale.CMRS was applicable for patients with menopause syndrome.CMRS seemed to have had good content-related validity.The result of exploratory factor analysis was accorded with the theory frame of CMRS by and large.The correlations between CMRS and KI,CMRS and WHOQOLBREF,CMRS and MENQOL seemed good.The CMRS was able to discriminate between groups of people with or without menopausal syndrome and bad good discriminative validity.(4) Responsibility:The CMRS was measured based on 174 patients with menopausal syndrome before and after the TCM therapy.Our result showed that the CMRS having the ability to measure the clinically important differences.Conclusion CMRS was suitable for outcome assessment of menopausal syndrome.This primary research proved that the CMRS had good feasibility,reliability,validity as well as responsiveness.

Exploration on health concept of TCM and the operationalization of its measurement / 中国中西医结合杂志

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.

Establishment and initial evaluation of health scale of traditional Chinese medicine / 中国中西医结合杂志

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. It could be further applied in TCM clinical practice.

Exploration on establishment and application of soft index survey tools in TCM study / 中国中西医结合杂志

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 / 中国中西医结合杂志

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.e. the first, the full-scale design of the study with the professional characteristics should be described very explicitly, especially the speciality of the objects, intervention elements and indexes for effectiveness evaluation, etc.; the second, the control of bias and evaluation of effectiveness, and their influence on conclusion induction should be fully taken into consideration. At the same time, the key step in improving the quality of NRS of TCM and integrative medicine was preliminary discussed in this paper.