Application of clinical value assessment of treatment protocols in guideline development: taking the WFAS Clinical Practice Guideline of Acupuncture and Moxibustion for Migraine as an example. / 治疗方案临床价值评估在指南制定中的应用.

To enhance the clinical applicability of guidelines and provide more effective guidance for clinical practice, a clinical value assessment was conducted during the development of the World Federation of Acupuncture-Moxibustion Societies (WFAS) Clinical Practice Guideline of Acupuncture and Moxibustion for Migraine, which involved the evaluation of 59 acupuncture and moxibustion treatment protocols from randomized controlled trials (RCTs). This article introduced the methodology, content and results of the clinical value assessment of RCT-based acupuncture and moxibustion treatment protocols, which involved the integration of historical and contemporary medical evidence and expert consensus. It served as a methodological reference for the future development of acupuncture and moxibustion clinical practice guidelines.

[Study on key outcome indexes in treatment of migraine with acupuncture and moxibustion].

OBJECTIVE: To identify the key outcome indexes in treatment of migraine with acupuncture and moxibustion. METHODS: Using literature research, questionnaire survey and consensus conference, the key outcome indexes in treatment of migraine with acupuncture and moxibustion were screened and prioritized. RESULTS: The critical outcome indexes for the treatment in attack stage of migraine included 6 effectiveness outcome indexes (headache intensity, headache duration, headache relieve time, effectiveness and level of headache relief within 2 h, headache-related quality of life, level of headache relief within 24 h) and 1 safety outcome index (incidence of serious adverse reactions). The critical outcome indexes for prophylactic treatment included 6 effectiveness outcome indexes (headache day, headache frequency, headache intensity, effective rate, headache-related quality of life, health-related quality of life) and 1 safety outcome index (incidence of serious adverse reactions). CONCLUSION: In terms of the attack stage treatment and prophylactic treatment with acupuncture and moxibustion, the outcome indexes are different, among which, those can directly reflect the conditions of migraine should be optioned in priority. To assess the effectiveness of attack stage, the headache intensity is preferred, using the visual analogue scale (VAS) score, and the preferred time is 2 hours after treatment. Regarding the effectiveness of prophylactic treatment, the headache day, headache frequency and headache intensity should be firstly considered in the assessment, in which, the preferred time for assessment is 12 weeks into treatment, while, the best time for follow-up should be 12 weeks after treatment completion. When the quality of life is considered, the migraine-specific quality of life questionnaire (MSQ) is the top option. For either the attack stage treatment or the prophylactic treatment, the high attention should be laid on the outcome indexes for safety and medical economics evaluation.

Pharmacokinetics and Safety of Single-Dose Amphotericin B Colloidal Dispersion in Healthy Chinese Subjects and Population Pharmacokinetic/Pharmacodynamic Analysis to Inform Clinical Efficacy in Invasive Infections Caused by Candida albicans.

PURPOSE: Amphotericin B colloidal dispersion (ABCD) is a less toxic formulation of amphotericin B for the treatment of invasive fungal infections. The pharmacokinetic (PK) profile and safety of a generic ABCD were investigated after a single dose (0.5 to 1.5 mg/kg) administered as an intravenous infusion in 30 healthy Chinese subjects. METHODS: PK data from healthy Chinese male subjects were applied for developing a population PK model to predict the PK profiles of standard doses (3 or 4 mg/kg) in patients. A 5000-time Monte Carlo simulation of AUC0-24/MIC target was implemented to determine the probability of target attainment (PTA) and cumulative fraction of response (CFR) under standard doses. FINDINGS: The PK profiles of intravenous administration of ABCD were best described by a 3-compartmental model with a time-varying clearance and a dose-dependent volume of distribution in the peripheral compartment. PK/pharmacodynamic (PK/PD) analysis revealed that 3 or 4 mg/kg ABCD once a day resulted in favorable CRF (>98%) with 2-log reduction of Candida albicans. A high PTA (>90%) was achieved at MIC ≤2 mg/L for the dosing regimen of ABCD 3 mg/kg and 4 mg/kg for MIC ≤4 mg/L. IMPLICATIONS: PK/PD analysis indicated that a favorable efficacy of ABCD could be reached at a dose of 3 or 4 mg/kg once daily for 14 to 28 days to treat invasive fungal infections caused by C albicans. ClinicalTrials.gov identifier: NCT03577509.

Assessment of coronary artery abnormalities and variability of Z-score calculation in the acute episode of Kawasaki disease-A retrospective study from China.

BACKGROUND: Accurate classification of coronary artery abnormalities (CAAs) is essential for clinical decision-making and long-term management in Kawasaki disease (KD) patients. To date, there are several echocardiographic criteria of CAA assessment. MATERIALS AND METHODS: The Japanese Ministry of Health (JMH) criteria and the Z-score criteria from 2004 American Heart Association guidelines were adopted and their detective efficacies for CAAs were compared in 251 Chinese patients with KD Z scores were calculated by 6 published methods. RESULTS: According to the JMH criteria, 19 (7.57%) KD patients were classified as CAAs during the acute KD episode. However, the detective number of CAAs was highest and had a 0.68-fold increase by the Dallaire et al method with a Z-score cut point of ≥2.5 as compared with the JMH criteria; in contrast, more than 78.95% of patients with CAAs identified by the JMH criteria had a coronary artery Z score ≥2.5. All 6 different Z-score methods had satisfactory accuracies with a range from 93.23% to 97.61% in screening CAAs. For the 19 patients with CAAs identified by the JMH criteria, their Z scores presented the widest variation calculated by the McCrindle et al method. CONCLUSIONS: The JMH criteria underestimate the prevalence of CAAs as compared with the Z-score criteria. Quantitative assessment of coronary artery luminal dimensions, normalized as Z scores adjusted for body surface, should be recommended. The larger coronary artery luminal dimensions vary, the more heterogeneous Z scores calculated by different methods have.

Item response modeling: a psychometric assessment of the children's fruit, vegetable, water, and physical activity self-efficacy scales among Chinese children.

BACKGROUND: This study aimed to evaluate the psychometric properties of four self-efficacy scales (i.e., self-efficacy for fruit (FSE), vegetable (VSE), and water (WSE) intakes, and physical activity (PASE)) and to investigate their differences in item functioning across sex, age, and body weight status groups using item response modeling (IRM) and differential item functioning (DIF). METHODS: Four self-efficacy scales were administrated to 763 Hong Kong Chinese children (55.2% boys) aged 8-13 years. Classical test theory (CTT) was used to examine the reliability and factorial validity of scales. IRM was conducted and DIF analyses were performed to assess the characteristics of item parameter estimates on the basis of children's sex, age and body weight status. RESULTS: All self-efficacy scales demonstrated adequate to excellent internal consistency reliability (Cronbach's α: 0.79-0.91). One FSE misfit item and one PASE misfit item were detected. Small DIF were found for all the scale items across children's age groups. Items with medium to large DIF were detected in different sex and body weight status groups, which will require modification. A Wright map revealed that items covered the range of the distribution of participants' self-efficacy for each scale except VSE. CONCLUSIONS: Several self-efficacy scales' items functioned differently by children's sex and body weight status. Additional research is required to modify the four self-efficacy scales to minimize these moderating influences for application.

Story Immersion May Be Effective in Promoting Diet and Physical Activity in Chinese Children.

OBJECTIVE: To evaluate the effect of playing a health video game embedded with story immersion, Escape from Diab (Diab), on children's diet and physical activity (PA) and to explore whether children immersed in Diab had greater positive outcomes. DESIGN: Two groups, nonrandomized; 3 outcome assessments: at baseline, immediately after the game (post 1), and 8-10 weeks after the game (post 2). PARTICIPANTS: A total of 179 Chinese children aged 8-12 years. INTERVENTION: The treatment group played Diab; the control group received no intervention. MAIN OUTCOME MEASURES: Motivation; self-efficacy; preference for fruit, vegetables, water, and PA; as well as PA behavior. ANALYSIS: Adjusted changes to post 1 and post 2 by ANCOVA controlling for demographic and baseline variables. RESULTS: Children who played Diab had increased intrinsic motivation for fruit and water, self-efficacy for PA, and self-reported PA scores at post 1 (all P < .05). Children with higher immersion scores (above the median) had increased intrinsic motivation for fruit and water, and autonomous and controlled motivation for PA at post 1 (all P < .05). However, these were not significant at post 2. CONCLUSIONS AND IMPLICATIONS: Diab provides a promising innovative medium for promoting Chinese children's psychological correlates of diet and PA and PA behavior. However, its maintenance of effectiveness needs to be enhanced and mechanisms of change need to be investigated more thoroughly.