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. The organic integration of TCM and WM is a deeper integration of TCM and WM. To realize the progression of "integration" to "organic integration", a targeted and standardized guideline development methodology is needed. Therefore, the purpose of this study is to establish a standardized development procedure for clinical practice guidelines for the organic integration of TCM and WM to promote the systematic integration of TCM and WM research results into clinical practice guidelines in order to achieve optimal results as the whole is greater than the sum of the parts.

[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. 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.

Pediatric Tui Na for acute diarrhea in children under 5 years old: A systematic review and meta-analysis of randomized clinical trials.

OBJECTIVE: To evaluate the benefits and harms of pediatric Tui Na as a non-pharmaceutical Chinese medicine therapy for acute diarrhea in children under 5 years of age. DESIGN: Systematic review and meta-analysis of randomized clinical trials. METHODS: We searched seven major English and Chinese databases from their inception to January 2018 for randomized clinical trials (RCTs) comparing pediatric Tui Na therapy with conventional medicine (montmorillonite/diosmectite or probiotics used alone or in combination). Two authors extracted data and assessed the Cochrane risk of bias, independently. The primary outcomes are clinical cure rate and diarrhea duration from admission to the cessation of diarrhea. 'Clinical cure' is defined as the frequency, timing and character of stool back to normal status, as well as disappearance of diarrhea symptoms. We present dichotomous data as risk ratio (RR), and continuous data as mean difference (MD) with their 95% confidence interval (CI). We used the Cochrane's Revman software (v.5.3) for data analysis. Trial sequential analysis (TSA) was applied to calculate the required sample size in a meta-analysis and detect the robustness of the results. The GRADEpro was used to generate a summary of finding table. RESULTS: Totally 26 RCTs were included, involving 2410 children with acute diarrhea. Most of the included trials had high or unclear risk of bias in terms of random sequence generation, blinding, and incomplete outcome reporting. The pooled results demonstrated that pediatric Tui Na was superior to montmorillonite after three-session treatment (RR 1.45, 95% CI 1.29-1.62, n = 772, 10 trials), and also superior to montmorillonite combined with probiotics after three-session treatment (RR 2.04, 95% CI 1.49-2.78, n = 533, 7 trials) and after six-session treatment (RR 1.52, 95% CI 1.34-1.73, n = 631, 5 trials) in improving clinical cure rate. Pediatric Tui Na significantly decreased the duration of acute diarrhea (hrs) (MD -0.40 h, 95% CI -15.31 to -5.48 h, n = 410, 6 trials) and daily stool frequency (MD -1.71times, 95% CI -2.37 to -1.04, n = 217, 3 trials, after three-session treatment). No adverse event related to pediatric Tui Na was reported in the included trials. The quality of evidence of included trials was generally moderate to low. TSA for cure rate demonstrated that the pooled data reached a sufficient power regarding both numbers of trials and participants. CONCLUSIONS: This review shows pediatric Tui Na appears to be effective and safe in improving clinical cure rate and shortening diarrhea duration in childhood aged less than five years of age with acute diarrhea. However, rigorously designed well-reported RCTs are warranted to confirm the findings.

[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. 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.

[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. There were 32 alternative words in the questionnaire. Thirty respondents were required to place each descriptive word on a 10-centimeter line according to where they considered each descriptive word should be placed. Then, the line was measured by ruler; average, standard deviation and median were calculated by excel software; the authors finally chose the five equidistant words which accurately reflect the degree of main symptoms. RESULTS: The five most appropriate descriptive words were selected; they were "never", "seldom", "half-partly sometimes", "very often" and "always". CONCLUSION: These selected decorated words are suitable for the PRO scale for patients with COPD complicated with pulmonary heart disease.

[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. Further research based on IRT and computerized adaptive testing in health measurement will be carried out in the field of medical care including traditional Chinese medicine and integrative medicine.

[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. Each response scale had five ordinal descriptors, including two anchors at extreme levels and three intermediates. The participants were invited to determine the two anchors of extreme levels, and then to place each descriptor on a 10-centimeter (0 to 10 cm) line according to where they considered the descriptor lay in relation to the two anchors. RESULTS: The selection of scale descriptors was based on comprehensive considerations regarding the median, average score and standard deviation of each descriptor. The main rule of selection was to choose the descriptor of extreme level anchor with a median value closer to 0 or 10, and the same for the selection of descriptors of the intermediates, which should possess a median value closer to 2.5 or 5 or 7.5. If two descriptors had similar median values, we compare the average score and/or the standard deviation of these descriptors and prefer to keep the one containing either an average score closer to anchor point or a less value of standard deviation. Furthermore, the codes of Chinese language were also considered. Four kinds of response scales including capacity, frequency, evaluation, and intensity with a total of 85 scale descriptors were selected. For HSTCM, a total of 8.24% (7/85) descriptors for 14.9% (7/47) items were revised based on the study results. CONCLUSION: The scale descriptors selected are suitable for HSTCM and the results can be referenced in developing similar health profile assessment.

[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. Some socioeconomic characteristics were registered. RESULTS: A test-retest reliability (15-day interval) was found among the 76 persons who completed the questionnaires by themselves. Intra-class correlation coefficient (ICC) was 0.93. Associated 95% confidence interval (CI) was 0.89-0.96. Split-half reliability was 0.79. Inter-investigator reliability (0.93) was also good, and the ICC of HSTCM was 0.90 (95%CI 0.67-0.97). The correlation between HSTCM and WHOQOL-BREF was -0.66. The correlations of HSTCM and questionnaire deliver order, investigator, interview date and interview time were 0.06, -0.12, -0.17 and 0.20 respectively. The correlation between HSTCM and self-rated health (0.46) was greater than that between HSTCM and chronic illness (0.28). Divided by individuals with or without chronic illness, area under the ROC (receiver operator characteristic) curve for HSTCM was 0.67 (95%CI 0.63-0.71). CONCLUSION: It indicates that the HSTCM is conceptually valid with satisfactory psychometric properties and forms a basis for further applications in clinical research of traditional or integrative medicine.

[Study on the reliability and validity of the Chinese Menopause Rating Scale (CMRS)].

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 WHOQOL-BREF, CMRS and MENQOL seemed good. The CMRS was able to discriminate between groups of people with or without menopausal syndrome and had 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.

[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. 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 appraisal item; c) two lie-test items. CONCLUSION: The Chinese menopausal syndrome scale we used seemed to possess good content validity, feasibility and intra-class reliability.

[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. It could be further applied in TCM clinical practice.

[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.