1.Guideline for the workflow of clinical comprehensive evaluation of drugs
Zhengxiang LI ; Rong DUAN ; Luwen SHI ; Jinhui TIAN ; Xiaocong ZUO ; Yu ZHANG ; Lingli ZHANG ; Junhua ZHANG ; Hualin ZHENG ; Rongsheng ZHAO ; Wudong GUO ; Liyan MIAO ; Suodi ZHAI
China Pharmacy 2025;36(19):2353-2365
OBJECTIVE To standardize the main processes and related technical links of the clinical comprehensive evaluation of drugs, and provide guidance and reference for improving the quality of comprehensive evaluation evidence and its transformation and application value. METHODS The construction of Guideline for the Workflow of Clinical Comprehensive Evaluation of Drugs was based on the standard guideline formulation method of the World Health Organization (WHO), strictly followed the latest definition of guidelines by the Institute of Medicine of the National Academy of Sciences of the United States, and conformed to the six major areas of the Guideline Research and Evaluation Tool Ⅱ. Delphi method was adopted to construct the research questions; research evidence was established by applying the research methods of evidence-based medicine. The evidence quality classification system of the Chinese Evidence-Based Medicine Center was adopted for evidence classification and evaluation. The recommendation strength was determined by the recommendation strength classification standard formulated by the Oxford University Evidence-Based Medicine Center, and the recommendation opinions were formed through the expert consensus method. RESULTS & CONCLUSIONS The Guideline for the Workflow of Clinical Comprehensive Evaluation of Drugs covers 4 major categories of research questions, including topic selection, evaluation implementation, evidence evaluation, and application and transformation of results. The formulation of this guideline has standardized the technical links of the entire process of clinical comprehensive evaluation of drugs, which can effectively guide the high-quality and high-efficient development of this work, enhance the standardized output and transformation application value of evaluation evidence, and provide high-quality evidence support for the scientific decision-making of health and the rationalization of clinical medication.
2.Development and validation of guardianship ability scale for guardians of patients with severe mental disorders: a study on reliability and validity
Xiaoling DUAN ; Zihua PAN ; Shaoling ZHONG ; Yanling LIANG ; Xiao TAN ; Liang ZHOU
Sichuan Mental Health 2024;37(6):549-556
BackgroundThe guardianship ability of guardians of patients with severe mental disorders plays an important role in supporting the patients' recovery and reintegration into society. It is necessary to develop a scientific tool since there is a lack of tools to quantitatively assess the guardianship ability. ObjectiveTo explore and develop an assessment scale for the guardianship ability of guardians of patients with severe mental disorders, so as to provide references for the construction of scientific and reasonable guardianship ability evaluation tools. MethodsA pool of scale items was constructed through a literature review and interviews, followed by two rounds of expert consultation with 15 specialists. 364 guardians of patients with severe mental disorders in Guangzhou were investigated. The scale items were screened and optimized using item analysis and exploratory factor analysis, and the structural validity of the scale was further verified through confirmatory factor analysis. The content validity of the scale was evaluated by item-level content validity index (I-CVI) the average scale-level content validity index (S-CVI/Ave). The reliability of the scale was tested by Cronbach's α coefficient and split-half reliability. ResultsThe guardianship ability scale for guardians of patients with severe mental disorders consists of 25 items, including three dimensions of guardianship willingness, guardianship knowledge and behavior and guardianship self-efficacy. The results of the item analysis showed that all items met the corresponding criteria and were retained. Validity test: the I-CVI ranged from 0.800 to 1.000, and the S-CVI/Ave was 0.964. Factor load of each item on the corresponding factors ranged from 0.596 to 0.976, and the model demonstrated good fit: chi-square degree of freedom ratio (χ2/df) was 2.444, Tucker-Lewis index (TLI) was 0.908, comparative goodness of fit index (CFI) was 0.917, standardized root mean square residual (SRMR) was 0.049, and root mean square residual (RMSEA) was 0.089. Reliability test showed that the total scale had a Cronbach's α coefficient of 0.966, and the split half reliability coefficient was 0.915. ConclusionThe guardianship ability scale for patients with severe mental disorders developed in this study has good reliability and validity, and has certain application value for the assessment of guardianship ability for patients with severe mental disorders. [Funded by Health Science and Technology Project of Guangzhou (number, 20221A011049)]
4.Effect of Botulinum Toxin Type A Injection Combined with Rehabilitation Functional Training on Upper Extremity Motor Function in Children with Spastic Hemiplegic Cerebral Palsy
Hua YAN ; Huijia ZHANG ; Weihong YANG ; Yimei WANG ; Chunguang GUO ; Jihong HU ; Pingqiu ZHOU ; Jinhua HE ; Hualin DUAN
Chinese Journal of Rehabilitation Theory and Practice 2012;18(2):172-175
Objective To observe the effect of Botulinum toxin type A (BTX-A) injection combined with rehabilitation functional training on upper extremity motor function in children with spastic hemiplegic cerebral palsy (CP). Methods 60 spastic hemiplegic CP children were treated with constraint-induced movement therapy (CIMT), physical therapy, electromyographic biofeedback stimulation therapy, occupational therapy, family-based training and so on after injected with BTX-A. The muscle tension of the hemiplegic upper extremity accessed by Modified Ashworth Scale (MAS), the wrist angle of active dorsiextention motion by orthrometer, fine movement quotient (FMQ) by Peabody developmental motor scale (PDMS-Ⅱ), and activities of daily living (ADL) were performed to evaluate the effects before and 3 months after treatment. Results These outcomes were improved significantly after treatment (P<0.001). Conclusion BTX-A injection combined with rehabilitation functional training could rapidly reduce spasticity of the upper extremity, increase the range of motion, improve motor function of upper extremity in children with spastic hemiplegic CP.
5.Effects of Neuromuscular Electric Stimulation on Salivation in Children with Cerebral Plasy
Hualin DUAN ; Huijia ZHANG ; Hua YAN ; Bin ZHANG ; Mingzhu LIU
Chinese Journal of Rehabilitation Theory and Practice 2010;16(5):453-454
ObjectiveTo investigate the effect of neuromuscular electrical stimulation (NMES) on salivated children with cerebral palsy. Methods43 salivated children with cerebral palsy were divided into NMES group (n=22) and control group (n=21). Both groups accepted the same routine treatment, while the NMES group was given the NMES in addition. All the children were evaluated before and 8 weeks after treatment with teacher drooling sizing (TDS). ResultsThe TDS of NMES group was significantly different with that of the control group (P<0.05) after treatment. ConclusionNMES can decrease the salivation in children with cerebral palsy, and promote their swallowing function.


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