1.Methodological Consideration on Combination Model of TCM Clinical Practice Guidelines and Real-world Study
Guozhen ZHAO ; Huizhen LI ; Ning LIANG ; Haili ZHANG ; Bin LIU ; Qianzi CHE ; Feng ZHOU ; He LI ; Xiaowen CHEN ; Long YE ; Jiahao LIN ; Xingyu ZONG ; Dingyi WANG ; Nannan SHI ; Yanping WANG
Chinese Journal of Experimental Traditional Medical Formulae 2024;30(22):87-93
The clinical practice guidelines of traditional Chinese medicine (TCM) have problems such as limited clinical application and unclear implementation effects, which may be related to the lack of clinical practice evidence. To provide reliable and precise evidence for clinical practice, this article proposes a model of combining TCM guidelines with real-world study, which includes 4 steps. Firstly, during the implementation process of the guidelines, a high-quality research database is established. Secondly, the recommendations in the guidelines are evaluated based on the established database in multiple dimensions, including applicability, effectiveness, safety, and cost-effectiveness, and thus their effectiveness in practical applications can be determined. Thirdly, based on the established database, core prescriptions are identified, and the targeted populations and medication plans are determined. That is, the best treatment regimen is established based on the analysis of abundant clinical data regarding the effects of different medication frequencies, dosages, and duration on efficacy. Fourthly, the guidelines are updated according to the real-world evidence. The research based on this model can provide real-world evidence for ancient and empirical prescriptions, improving their application in clinical practice. Moreover, this model can reduce research costs and improve research efficiency. When applying this model, researchers need to pay attention to the quality of real-world evidence, ensuring that it can truly reflect the situation in clinical practice. In addition, importance should be attached to the clinical application of guideline recommendations, ensuring that doctors can conduct standardized diagnosis and treatment according to the guidelines. Finally, full-process participation of multidisciplinary experts is encouraged to ensure the comprehensiveness and scientificity of the study. In conclusion, the application of this model will contribute to the development of TCM guidelines responsive to the needs of clinical practice and achieve the goal of promoting the homogenization of TCM clinical diagnosis and treatment.
2.Methods and Challenges for Identifying and Controlling Confounding Factors in Traditional Chinese Medicine Observational Studies
Guozhen ZHAO ; Ziheng GAO ; Chen ZHAO ; Huizhen LI ; Ning LIANG ; Bin LIU ; Qianzi CHE ; Haili ZHANG ; Yixiang LI ; Feng ZHOU ; He LI ; Bo LI ; Nannan SHI
Chinese Journal of Experimental Traditional Medical Formulae 2024;30(22):120-126
As a supplement to randomized controlled trials, observational studies can provide evidence for the effectiveness of traditional Chinese medicine (TCM) treatment measures. They can also study influencing factors of diseases, etiology, and prognosis. However, there is a confounding effect due to the lack of randomization, which seriously affects the causal inference between the study factors and the outcome, resulting in confounding bias. Therefore, identifying and controlling confounding factors are key issues to be addressed in TCM observational studies. According to the causal network and the characteristics of TCM theory, confounding factors can be categorized into measured and unmeasured confounding factors. In addition, attention must be paid to identifying confounding factors and intermediate variables, as well as the interaction between confounding factors and study factors. For methods of controlling confounding factors, measured confounding factors can be controlled by stratification, multifactor analysis, propensity scores, and disease risk scores. Unmeasured and unknown confounding factors can be corrected using instrumental variable methods, difference-in-difference methods, and correction for underlying event rate ratios. Correcting and controlling confounding factors can ensure a balance between groups, and confounding bias can be reduced. In addition, methods such as sensitivity analysis and determination of interactions make the control of confounding factors more comprehensive. Due to the unique characteristics of TCM, observational studies of TCM face unique challenges in identifying and controlling confounding factors, including the ever-changing TCM treatment measures received by patients, the often-overlooked confounding effects in the four diagnostic information of TCM, and the lack of objective criteria for TCM evidence-based diagnosis. Some scholars have already conducted innovative explorations to address these issues, providing a methodological basis for conducting higher-quality TCM observational studies, so as to obtain more rigorous real-world evidence of TCM and gradually develop quality evaluation criteria for OS that are consistent with the characteristics of TCM.
3.Methodology for Developing Patient Guideline (3):Reporting Frameworks and Presentation
Lijiao YAN ; Ning LIANG ; Haili ZHANG ; Nannan SHI ; Ziyu TIAN ; Ruixiang WANG ; Xiaojia NI ; Yufang HAO ; Wei CHEN ; Yingfeng ZHOU ; Dan YANG ; Shuyu YANG ; Yujing ZHANG ; Ziteng HU ; Jianping LIU
Journal of Traditional Chinese Medicine 2024;65(22):2304-2309
Standardized reporting is a crucial factor affecting the use of patient guidelines (PGs), particularly in the reporting and presentation of recommendations. This paper introduced the current status of PG reporting, including the research on PG content and presentation formats, and provided comprehensive recommendations for PG reporting from aspects such as overall framework, recommendations, presentation format, and readability. First, the presentation of PG recommendations should include clearly defined clinical questions, recommendations and their rationale, and guidance on how patients should implement the interventions; for specific content in the PG, such as level of evidence, level of recommendation, it is recommended to explain in text the reasons for giving different levels of recommendation, i.e., to present the logic behind giving the level of recommendation to the patient; additional information needed in the recommendation framework should be supplemented by tracing references or authoritative textbooks and literature that support the recommendations. Subsequently, the PG text should be written based on the Reporting Checklist for Public Versions of Guidelines (RIGHT-PVG) reporting framework. Finally, to enhance readability and comprehension, it is recommended to refer to the Patient Education Materials Assessment Tool (PEMAT) for translating PG content. To enhance the readability of PGs, it is suggested to present the PG content in a persona-lized and layered manner.
4.Key Techniques and Methodological Considerations for Formation of Traditional Chinese Medicine Syndrome Classification Standards
Guozhen ZHAO ; Xingyu ZONG ; Xueyao ZHAO ; Huizhen LI ; Feng ZHOU ; Xuanling ZENG ; Jiahao LIN ; Ning LIANG ; Haili ZHANG ; Qianzi CHE ; Bin LIU ; Nannan SHI
Chinese Journal of Experimental Traditional Medical Formulae 2024;30(24):257-261
The classification of traditional Chinese medicine (TCM) syndromes is one of the core technical elements in the industry standard of Specification of Diagnosis and Therapeutic Effect Evaluation of Diseases and Syndromes in TCM. In the past,when clinical standards for TCM were formulated,the determination of TCM syndrome classification relied heavily on textbooks and expert experience,lacking systematic research. This approach thus failed to reflect the advancement and scientificity of the standards,thereby affecting their implementation and application. This article reviewed the presentation forms and technical methods of TCM syndrome classification,including the two-tier syndrome classification model with primary and secondary symptoms,as well as the application of modern literature research,ancient literature research,Delphi method,in-depth expert interviews,consensus conferences,and real-world research. When syndrome classification standards are developed,it is necessary to build upon modern literature research,adopt a mixed approach combining qualitative research and quantitative analysis results,and reach expert consensus through consensus conferences. Through systematic research,the scientificity,applicability,and coordination of TCM syndrome classification standards can be enhanced,providing guidance for the standardization of TCM.
5.Clinical characteristics, treatment strategy, and clinical outcomes in type 2 intestinal failure
Xiaolong GE ; Weilin QI ; Wei LIU ; Haili XU ; Linna YE ; Qian CAO ; Ning LI ; Wei ZHOU
Chinese Journal of Gastrointestinal Surgery 2024;27(9):966-969
Objective:To evaluate the characteristics, clinical management and clinical outcomes of type 2 intestinal failure (IF).Methods:A descriptive case-control study was carried out. The inclusion criteria were as follows: (1) the diagnosis of IF was performed according to the European Society for Parenteral and Enteral Nutrition (ESPEN) consensus statement. (2) using a requirement for parenteral nutrition (PN) of 28 days or more as surrogate marker. (3) a multidisciplinary team (MDT) included surgeons, nutritionist, pharmacist, stoma therapists, and critical care physicians. (4) complete laboratory data. Patients with type 1 and type 3 IF and those who do not cooperate with follow-up. All the data of 67 type II IF were collected from the database in Sir Run Run Shaw Hospital from Jan 2016 to Dec 2023. The pathophysiology, clinical management, and outcomes of type II IF were analyzed.Results:A total of 67 type II IF were included. The median age was 54 (15-83) with 43 males and 24 females. The body mass index was (17.5±3.8) kg/m 2, the incidence of malnutrition was 67.2% (45/67), the incidence of sarcopenia was 74.6% (50/67), the median number of previous surgeries was 2.0 (1-13), and the median duration time of PN was 2.1 (1-12) months. The underlying disease of type 2 IF included 36 Crohn`s disease, 2 ulcerative colitis, 3 radiation enteritis, 2 intestinal Behcet's disease, 4 mesenteric infarction, 1 aggressive fibromatosis, 5 abdominal cocoon syndrome, 5 gastrointestinal perforation, 1 hernia, 4 intestinal dysmotility, and 4 other reasons (gastrointestinal tumor, trauma, and non-Hodgkin's lymphoma). According to the pathophysiology of IF, there were 33 intestinal fistula, 12 intestinal dysmotility, 6 mechanical obstruction, 13 short bowel syndrome, and 3 extensive small bowel mucosal disease. After treatment with MDT, 67 patients with type 2 IF received nutritional support therapy for intestinal rehabilitation treatment, of which 36 patients recovered with oral diet or enteral nutrition, 31 patients underwent reconstructive surgery after intestinal rehabilitation treatment failure. The median duration time of reconstructive surgery was 2.7 (1-9) months. 24 patients recovered intestinal autonomy after surgery, with 7 deaths, including 6 deaths due to abdominal infections and 1 case of intestinal dysmotility with abiotrophy and liver failure. Conclusion:Standardized multidisciplinary treatment plays an important role in type II intestinal failure, and it promotes patients with intestinal failure regain enteral autonomy.
6.Clinical characteristics, treatment strategy, and clinical outcomes in type 2 intestinal failure
Xiaolong GE ; Weilin QI ; Wei LIU ; Haili XU ; Linna YE ; Qian CAO ; Ning LI ; Wei ZHOU
Chinese Journal of Gastrointestinal Surgery 2024;27(9):966-969
Objective:To evaluate the characteristics, clinical management and clinical outcomes of type 2 intestinal failure (IF).Methods:A descriptive case-control study was carried out. The inclusion criteria were as follows: (1) the diagnosis of IF was performed according to the European Society for Parenteral and Enteral Nutrition (ESPEN) consensus statement. (2) using a requirement for parenteral nutrition (PN) of 28 days or more as surrogate marker. (3) a multidisciplinary team (MDT) included surgeons, nutritionist, pharmacist, stoma therapists, and critical care physicians. (4) complete laboratory data. Patients with type 1 and type 3 IF and those who do not cooperate with follow-up. All the data of 67 type II IF were collected from the database in Sir Run Run Shaw Hospital from Jan 2016 to Dec 2023. The pathophysiology, clinical management, and outcomes of type II IF were analyzed.Results:A total of 67 type II IF were included. The median age was 54 (15-83) with 43 males and 24 females. The body mass index was (17.5±3.8) kg/m 2, the incidence of malnutrition was 67.2% (45/67), the incidence of sarcopenia was 74.6% (50/67), the median number of previous surgeries was 2.0 (1-13), and the median duration time of PN was 2.1 (1-12) months. The underlying disease of type 2 IF included 36 Crohn`s disease, 2 ulcerative colitis, 3 radiation enteritis, 2 intestinal Behcet's disease, 4 mesenteric infarction, 1 aggressive fibromatosis, 5 abdominal cocoon syndrome, 5 gastrointestinal perforation, 1 hernia, 4 intestinal dysmotility, and 4 other reasons (gastrointestinal tumor, trauma, and non-Hodgkin's lymphoma). According to the pathophysiology of IF, there were 33 intestinal fistula, 12 intestinal dysmotility, 6 mechanical obstruction, 13 short bowel syndrome, and 3 extensive small bowel mucosal disease. After treatment with MDT, 67 patients with type 2 IF received nutritional support therapy for intestinal rehabilitation treatment, of which 36 patients recovered with oral diet or enteral nutrition, 31 patients underwent reconstructive surgery after intestinal rehabilitation treatment failure. The median duration time of reconstructive surgery was 2.7 (1-9) months. 24 patients recovered intestinal autonomy after surgery, with 7 deaths, including 6 deaths due to abdominal infections and 1 case of intestinal dysmotility with abiotrophy and liver failure. Conclusion:Standardized multidisciplinary treatment plays an important role in type II intestinal failure, and it promotes patients with intestinal failure regain enteral autonomy.
7.Application of multidisciplinary family empowerment mode in home care for patients after percutaneous endoscopic gastrostomy
Yu LI ; Zhicheng HUANG ; Haili FANG ; Jing YANG ; Caixia MOU ; Lijuan WANG ; Yanjiang LIU ; Xiuling ZHOU
Journal of Interventional Radiology 2024;33(11):1234-1238
Objective To discuss the effect of multidisciplinary family empowerment mode in home care for patients after receiving percutaneous endoscopic gastrostomy(PEG).Methods A total of 86 patients,who received initial PEG at the Jilin Provincial Cancer Hospital of China from January 2021 to July 2023,were selected for this study.The patients were randomly divided into observation group.The patients of the control group received routine nursing guidance for gastrostomy,while the patients of the observation group received multidisciplinary family empowerment nursing mode.The self-care ability[using self-care ability scale of the elderly(SASE)score],health behavior ability[using self-rating scale of health behavior ability(SRAHP)score],incidence of complications,and healing time of complications were compared between the two groups.Results In the observation group the SASE[(129.48±5.48)points vs.(73.05±12.04)points]and the SRAHP[(80.14±1.00)points vs.(70.25±7.92)points]were significantly higher than those in the control group(all P<0.05),the incidence of complications was lower than that in the control group,and the healing time of complications was shorter than that in the control group.Conclusion The implementation of multidisciplinary family empowerment nursing mode can improve the self-care ability and health behavior ability of patients after receiving PEG,reduce postoperative complications,as well as shorten the healing time of complications,therefore,this nursing mode is suitable for home patients after receiving PEG.
8.Conceptual analysis of clown care
Haili FANG ; Xiuling ZHOU ; Anqi HU ; Xin FANG
Chinese Journal of Modern Nursing 2023;29(35):4881-4886
Objective:To clarify the connotation of clown care by conceptual analysis of clown care, so as to provide references for clinical nursing work.Methods:Literature related to clown care was searched in PubMed, EBSCO, Embase, CNKI, Wanfang Database and VIP, and the search period was from the establishment of the databases until August 31, 2022. Based on the inclusion and exclusion criteria, literature was screened. The Rodgers evolutionary concept analysis method was adopted to analyze the relevant contents of clown care from aspects of development history, definition and evolution, conceptual attributes, typical cases, antecedents, consequences and identification of related concepts.Results:A total of 463 articles were retrieved, and 94 were finally included, including 8 Chinese articles and 86 English articles. At present, there was no unified and comprehensive definition of clown care. It included 5 conceptual attributes, such as support relationship, individuation, interaction, flexibility and empowerment. The antecedents included demographic, clown, and social factors, and the consequences mainly included the effect on the patient's health status, negative emotions of medical staff, clown care skills and creativity.Conclusions:Clarifying the concept of clown care can provide clear conceptual support for the research on clown care, and provide references for the construction of scientific clown care program.
9.Research progress on the questionnaire related to persistent postural-perceptual dizziness.
Min ZHAO ; Ganggang CHEN ; Ling ZHANG ; Jie YANG ; Jiaxing WU ; Liyuan ZHOU ; Ying LI ; Haili ZHANG
Journal of Clinical Otorhinolaryngology Head and Neck Surgery 2023;37(5):398-402
Persistent postural-perceptual dizziness(PPPD) is the most common chronic vestibular disease, the clinical manifestation is dizziness, unstable and non-rotational dizziness for three months or more. And the symptom is exacerbated by upright posture, active or passive movement, and complex visual stimuli. In addition, PPPD is a functional disease, so routine vestibular function tests and imaging tests are often negative. According to the diagnostic criteria established by the Barany Association, the diagnosis of PPPD often relies on history. This article provides a review of PPPD-related questionnaires.
Humans
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Dizziness/diagnosis*
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Vertigo/diagnosis*
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Vestibular Diseases/diagnosis*
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Surveys and Questionnaires
10.Correlation study on mesenteric fat and disease behavior in patients of Crohn's disease
Xiaolong GE ; Rongpan BAI ; Weilin QI ; Wei LIU ; Yan WU ; Haili XU ; Lingna YE ; Qian CAO ; Wei ZHOU
Chinese Journal of General Surgery 2023;38(7):521-525
Objective:To analyze the relationship between mesenteric fat or creeping fat and bowel stricture or penetrating disease of Crohn's disease (CD).Methods:Clinical data of 101 CD patients undergoing bowel surgery at Department of General Surgery in our hospital between Mar 2021 and Dec 2021 were retrospectively analyzed. The characteristics of mesenteric fat, creeping fat, luminal cross-section diameter, and the intestinal stricture index were analyzed. The Spearman correlation analysis was used to evaluate the correlation between disease behavior and mesenteric fat score or creeping fat score.Results:Totally 101 CD patients were enrolled, with 68 stricturing diseases and 33 penetrating diseases. CD patients with stricturing diseases had higher score of mesenteric disease activity index (4.6±1.9 vs. 3.7±2.0, t=2.212, P=0.029) and creeping fat index (4.2±2.0 vs. 2.9±1.6, t=3.154, P=0.002) than those in patients with penetrating diseases. The mesenteric fat and creeping fat score positively correlated with the intestinal stricture index, C-reactive protein, and fecal calprotectin, and negatively correlated with minimum luminal cross-section diameter. Conclusion:The higher score of mesenteric fat and creeping fat were observed in CD patients with stricturing disease, which were associated with intestinal stricture index and inflammation status.

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