Quality appraisal of clinical practice guidelines addressing massage interventions using the AGREE II instrument.

OBJECTIVE: The purpose of this study was to systematically evaluate the methodological quality of massage-related clinical practice guidelines (CPGs)/consensus on massage using the Appraisal of Guidelines Research and Evaluation (AGREE II) instrument and to summarize the current status of recommendations in the CPGs. METHODS: The Chinese National Knowledge Infrastructure (CNKI), WanFang Data, China Science and Technology Journal Database (VIP), China Biology Medicine disc (CBM), PubMed, Embase, and guideline websites (such as the Chinese Medical Ace Base, the China Association of Chinese Medicine, the World Health Organization, Guideline International Network, National Institute for Health and Care Excellence, Scottish Intercollegiate Guidelines Network) were searched from inception to October 31, 2022. In addition, the reference lists of relevant studies were reviewed to identify domestic and overseas massage CPGs/consensus. The search terms adopted a combination of subject words and free words, mainly including traditional Chinese medicine, complementary therapies, Tuina, massage, manipulation, chiropractic/osteopathic, spinal, acupressure, guideline, and consensus. Two researchers independently completed the eligible records and extracted the data. Before the formal research, calibrations were performed twice on AGREE II, and all reviewers completed the pilot test three times until they understood and reached an agreement on the assessment items. Three researchers appraised the methodological quality of the included guidelines using the AGREE II instrument and calculated the overall intraclass correlation coefficient (ICC) of agreement. RESULTS: The evaluation results showed that among the 49 eligible CPGs/consensus, 4 (8.2%) CPGs/consensus were considered "recommended", 15 (30.6%) CPGs/consensus were considered "recommended with modifications", and 30 (61.2%) CPGs/consensus were considered "not recommended", while the consensus was considered "not recommended". Generally, the scores in the six domains of the guidelines were all higher than the consensus. Evaluation results for the overall quality of 36 CPGs showed that 4 (11%) were "good quality", 15 (42%) were "sufficient quality" and 17 (47%) were "lower quality". The AGREE II quality scores of domains ranged from 0.30 to 0.75 ([ICC = 0.993, 95% CI (0.992, 0.995)]). The domain of scope and purpose (domain 1), with a median score of 0.75 (0.52~0.91), performed best in the guidelines with AGREE II, and stakeholder involvement (domain 2) [median 0.39 (0.31~0.56)] and application (domain 5) [median 0.30 (0.17~0.47] obtained lower scores. The consensus score of domain 1 was better at 26.0 (21.6~44.8), followed by rigor of development (domain 3) with a score of 18.0 (10.0~28.9). A total of 119 massage-related recommendations were extracted from 49 guidelines/consensuses, including "in favor" (102, 85.7%), "against" (9, 7.6%), and "did not make recommendations" (8, 6.7%). CONCLUSION: The overall quality of the included guidelines was low, and most of the guidelines were not "recommended". In future guideline updates, the existing evidence should be used, the professional composition of members of the expert group should be enriched, and patients' values and preferences should be fully considered. It is necessary to clearly propose recognizable recommendations and strengthen the rigor and standardization of guideline formulation. Thus, clear standard guidelines can be formulated to better guide clinical practice.

Valid and Convenient Questionnaire Assessment of Chinese Body Constitution: Item Characteristics, Reliability, and Construct Validation.

Background: Body constitution is a fundamental concept in traditional Chinese medicine (TCM) for clinical diagnosis, treatment of illness, and community-based health promotion. Clinical assessment of patients' body constitutions, however, has never been easy and consistent, even by well-trained clinicians and TCM practitioners. Therefore, questionnaires such as the popular Constitution in Chinese Medicine Questionnaire (CCMQ) can be an appealing and convenient assessment alternative. The present research borrowed advanced methodologies for questionnaire development in psychology and other social sciences to examine the performance of the CCMQ in terms of (i) the strength of relations of each item with its designated constitution, (ii) the reliabilities of each constitution, and (iii) the overall 9-constitution structure. This research provided empirical evidence to support the use of the CCMQ and proposed directions for refinement in future revisions of the CCMQ or similar measures. Methods: A total of 1571 volunteers from three villages in southern China participated in the CCMQ survey. The item characteristics, reliabilities, interconstitution correlations, and confirmatory factor analysis of the 9-body-constitution structure were examined. Results: The results generally supported the appropriateness of the clinical observations (the questionnaire items) and the CCMQ 9-constitution classification structure. Nevertheless, some relatively weaker items, item pairs with similar meanings, and highly overlapping constitutions were identified for future CCMQ revisions. Conclusion: The CCMQ measured the 9 constitutions efficiently and with reasonably good reliability and construct validity. Given the various challenges to assessing TCM body constitutions even by experienced clinicians, the CCMQ provides an appealing alternative to measure the Chinese body constitutions of healthy participants in large-scale research or community health promotion programs. The present study also demonstrated how advanced methodologies in social sciences can help validate and refine the CCMQ and similar complementary medicine measures.

Chinese pediatric Tuina on children with acute diarrhea: a randomized sham-controlled trial.

BACKGROUND: Pediatric Tuina has been widely used in children with acute diarrhea in China. However, due to the lack of high-quality clinical evidence, the benefit of Tuina as a therapy is not clear. We aimed to assess the effect of pediatric Tuina compared with sham Tuina as an add-on therapy in addition to usual care for 0-6-year-old children with acute diarrhea. METHODS: Eighty-six participants aged 0-6 years with acute diarrhea were randomized to receive pediatric Tuina plus usual care (n = 43) or sham Tuina plus usual care (n = 43). The primary outcomes were days of diarrhea from baseline and times of diarrhea on day 3. Secondary outcomes included a global change rating (GCR) and the number of days when the stool characteristics returned to normal. Adverse events were assessed. RESULTS: Pediatric Tuina was associated with a reduction in times of diarrhea on day 3 compared with sham Tuina in both ITT (crude RR, 0.73 [95% CI, 0.59-0.91]) and PP analyses (crude RR, 0.66 [95% CI, 0.53-0.83]). However, the results were not significant when we adjusted for social demographic and clinical characteristics. No significant difference was found between groups in days of diarrhea, global change rating, or number of days when the stool characteristics returned to normal. CONCLUSIONS: In children aged 0-6 years with acute diarrhea, pediatric Tuina showed significant effects in terms of reducing times of diarrhea compared with sham Tuina. Studies with larger sample sizes and adjusted trial designs are warranted to further evaluate the effect of pediatric Tuina therapy. TRIAL REGISTRATION: Clinicaltrials.gov, Identifier: NCT03005821 , Data of registration: 2016-12-29.

Chinese pediatric Tuina on children with acute diarrhea: study protocol for a randomized sham-controlled trial.

BACKGROUND: Acute pediatric diarrhea is one of the most common causes of morbidity and mortality worldwide and seriously affects the health of children. Previous studies have shown that pediatric Tuina, a traditional Chinese medicine therapy, has potential therapeutic benefits for acute pediatric diarrhea. However, the evidence for its effectiveness is insufficient due to the lack of high-quality clinical studies. Our aim is to evaluate the efficacy of Chinese pediatric Tuina for children aged 0-6 years with acute diarrhea. METHODS/DESIGN: This study is a randomized, double-blind, sham-controlled trial. We will include 122 children with acute diarrhea from Dongguan Kanghua Hospital in Guangdong province, China. The patients will be allocated into either the pediatric Tuina group or the sham Tuina group in a 1:1 ratio. The treatment will last for 3 days followed by an 11-day follow-up period. Both groups will receive usual care. In addition, the experimental group will receive 15-25 min of Chinese pediatric Tuina, while the control group will receive 15-25 min of sham pediatric Tuina. Both groups will receive treatments once per day, for 3 consecutive days. Primary outcome measures are diarrhea days from baseline and diarrhea times on the third day. Secondary outcome measures are the global change rating and period of days when the stool character changes to normal. Safety assessments will be monitored during each visit. DISCUSSION: This clinical trial is designed to evaluate the efficacy of pediatric Tuina for children with acute diarrhea. We expect results to provide solid evidence and support for pediatric Tuina as an appropriate treatment for children with acute diarrhea. TRIAL REGISTRATION: ClinicalTrials.gov, NCT03005821. Registered on 29 December 2016.

[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.