1.Methodology for Developing Patient Guideline(1):The Concept of Patient Guideline
Lijiao YAN ; Ning LIANG ; Ziyu TIAN ; Nannan SHI ; Sihong YANG ; Yufang HAO ; Wei CHEN ; Xiaojia NI ; Yingfeng ZHOU ; Ruixiang WANG ; Zeyu YU ; Shuyu YANG ; Yujing ZHANG ; Ziteng HU ; Jianping LIU
Journal of Traditional Chinese Medicine 2024;65(20):2086-2091
Since the concept of patient versions of guidelines (PVGs) was introduced into China, several PVGs have been published in China, but we found that there is a big difference between the concept of PVG at home and abroad, and the reason for this difference has not been reasonably explained, which has led to ambiguity and even misapplication of the PVG concept by guideline developers. By analyzing the background and purpose of PVGs, and the understanding of the PVG concept by domestic scholars, we proposed the term patient guidelines (PGs). This refers to guidelines developed under the principles of evidence-based medicine, centered on health issues that concern patients, and based on the best available evidence, intended for patient use. Except for the general attribute of providing information or education, which is typical of common health education materials, PGs also provide recommendations and assist in decision-making, so PGs include both the patient versions of guidelines (PVG) as defined by the Guidelines International Network (GIN) and "patient-directed guidelines", i.e. clinical practice guidelines resulting from the adaptation or reformulation of recommendations through clinical practice guidelines.
2.Methodology for Developing Patient Guideline (2):Process and Methodology
Lijiao YAN ; Ning LIANG ; Nannan SHI ; Sihong YANG ; Ziyu TIAN ; Dan YANG ; Xiaojia NI ; Yufang HAO ; Wei CHEN ; Ruixiang WANG ; Yingfeng ZHOU ; Shibing LIANG ; Shuyu YANG ; Yujing ZHANG ; Ziteng HU ; Jianping LIU
Journal of Traditional Chinese Medicine 2024;65(21):2194-2198
At present, the process and methodology of patient guidelines (PGs) development varies greatly and lacks systematic and standardised guidance. In addition to the interviews with PG developers, we have sorted out the relevant methodology for the adaptation and development of existing clinical practice guideline recommendations and facilitated expert deliberations to achieve a consensus, so as to finally put forward a proposal for guidance on the process and methodology for the development of PGs. The development of PGs can be divided into the preparation stage, the construction stage, and the completion stage in general, but the specific steps vary according to the different modes of development of PGs. The development process of Model 1 is basically the same as the patient version of the guideline development process provided by the International Guidelines Network, i.e., team formation, screening of recommendations, guideline drafing, user testing and feedback, approval and dissemination. The developer should also first determine the need for and scope of translating the clinical practice guideline into a patient version during the preparation phase. Model 2 adds user experience and feedback to the conventional clinical practice guideline development process (forming a team, determining the scope of the PG, searching, evaluating and integrating evidence, forming recommendations, writing the guideline, and expert review). Based on the different models, we sort out the process and methods of PG development and introduce the specific methods of PG development, including how to identify the clinical problem and how to form recommendations based on the existing clinical practice guidelines, with a view to providing reference for guideline developers and related researchers.
3.Methodology for the Development of Clinical Practice Guidelines for Chinese Patent Medicine: 2.Establishment of Guideline Working Group and Management of Conflict of Interests
Yaxin CHEN ; Ning LIANG ; Lijiao YAN ; Ziteng HU ; Yujing ZHANG ; Fuqiang ZHANG ; Haili ZHANG ; Huizhen LI ; Yijiu YANG ; Jing GUO ; Nannan SHI ; Yanping WANG
Journal of Traditional Chinese Medicine 2024;65(1):50-54
This paper summarized the key points and methods in terms of the establishment of the guideline working group and the management of conflict of interests, trying to provide reference for the development of clinical practice guidelines for Chinese patent medicine (CPM). The establishment of the working group is the first important step for developing CPM guidelines. Considering the characteristics of the clinical practice guidelines for CPM, this study suggests that the three key elements of ‘multidisciplinarity’, ‘clinical relevance’ and ‘geographical representativeness’ should be put focus on when forming the working group. The guideline advisory committee, clinical expert group, evidence systematic evaluation group, secretary group and the external review group should be established. All group members should clarify the conflict of interest, and the process and management method of the conflict of interest should be clearly reported.
4.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.
5.Epidemiological characteristics of outbreaks of norovirus GII.17P17 acute gastroenteritis in China, 2022
Yanhui YANG ; Xiangyu KONG ; Qing ZHANG ; Lijiao CAO ; Shi CONG ; Jingxin LI ; Miao JIN ; Zhaojun DUAN
Chinese Journal of Experimental and Clinical Virology 2024;38(1):58-66
Objective:To analyze the epidemiological characteristics of norovirus (NoV) acute gastroenteritis (AGE) outbreaks caused by GII.17[P17] variant in China, 2022.Methods:Information and specimens of AGE outbreaks between January and December 2022 were collected. NoV RNA was detected in all specimens by real-time RT-PCR. The viral genome of the positive specimens were amplified, sequenced and analyzed.Results:Between January and December 2022, 360 AGE outbreaks were reported cumulatively, of which 266 outbreaks successfully obtained genotype results. GII.17 [P17] was one of the main genotypes and detected in 34 outbreaks (12.78%, 34/266), with the highest number of outbreaks detected in spring (6 outbreaks in March and 7 outbreaks in May), mainly in childcare facilities and primary schools (61.76%, 21/34). According to the result of NoV genotype analysis in different age groups, 14 strains of GII.17 [P17] in this study belonged to Cluster III b and SC III branch of Cluster III (Kawasaki308) in the capsid region and polymerase region, respectively, and both belonged to the same cluster as the variant strain (GZ41621 strain) that caused the NoV AGE outbreaks in China during the 2014/15 season. Compared to reference strains of Cluster I, Cluster II and Cluster III a, Cluster III b was provided with 22 amino acid mutations in VP1. The main amino acid changes in the subgroup of Cluster III b including the virus strains isolated in this study were at T294I and Q299R of antigen epitope A, an insertion mutation occurred at antigen epitope D, H353Q at the site I of the human histo-blood group antigen receptor binding site. The selection pressure analysis detected a large number of negative selection sites, indicating that negative selection plays an important role in the evolution of VP1 genes.Conclusions:GII.17 [P17] was one of the primary genotypes responsible for NoV diarrhea outbreaks in China in 2022. Phylogenetic analysis had revealed that it still belonged to the same cluster as the novel GII.17 [P17] variant (strain GZ41621) that caused NoV epidemics in China during the 2014/15 season, exhibiting minor amino acid variations at the potential epitope.
6.Combining vibroacoustic therapy with audio-visual feedback can improve the swallowing and the emotional state of survivors of a brainstem stroke
Li GAN ; Xin YANG ; Lijuan LI ; Lijiao MENG ; Yang YANG ; Youyang TANG ; Jun PANG ; Quan WEI
Chinese Journal of Physical Medicine and Rehabilitation 2023;45(5):414-417
Objective:To observe any effect of combining vibroacoustic therapy with audio-visual feedback on the swallowing and the emotional state of persons with a swallowing disorder after a brainstem stroke.Methods:Fifty brainstem stroke survivors with dysphagia were randomly divided into a control group and a combination group, each of 25. In addition to routine swallowing function training, the control group received additional direct feeding training, while the combination group was provided with vibroacoustic feeding training and swallowing stimulation from an animated audio-visual presentation. Before and after the treatment, the subjects′ swallowing function was quantified using the Standard Swallowing Assessment (SSA) scale and the Gugging swallowing screen (GUSS). The Positive and Negative Emotions Scale (PNAS) was used to quantify their emotional state.Results:After the treatment the average SSA scores of both groups had decreased significantly, while the average GUSS and PNAS scores had increased significantly. The average improvements in all three measures were significantly greater in the combination group than in the control group.Conclusion:In addition to routine swallowing function training, feeding training applying vibroacoustics and audio-visual stimulation can significantly improve the feeding function and emotional state of brainstem stroke survivors with dysphagia.
7.Clinical value of SLE-DAS in evaluating disease activity of systemic lupus erythematosus
Yang DONG ; Lijiao WANG ; Huixia CAO ; Lei YAN ; Zhu ZHANG ; Fengmin SHAO
Chinese Journal of Rheumatology 2023;27(2):91-95
Objective:To evaluate the diagnostic performance and clinical significance of SLE-DAS in the disease activity of SLE patients in China.Methods:The clinical data of 134 patients with SLE were collected. The disease activity was evaluated by SLE-DAS, SLEDAI-2000, BILAG-2004 and PGA scoring tools. Pearson test and Spearman test were used to analyze the correlation. The receiver operating characteristic curve (ROC curve) was used to evaluate SLE-DAS, and Kappa consistency test was adapted to assess the consistency of the two scoring methods.Results:One hundred and thirty-four patients with SLE, including 7 males and 127 females, aged 13-77 years, with an average of (35±13) years were included. Among them, renal involvement was 38.1%, skin mucosal involvement was 11.2%, musculoskeletal involvement was 8.2%, blood system involvement was 13.4%, heart and lung involvement was 2.2%, neuropsychiatric involvement was 1.5%, and multisystem involvement was 3.0%. SLE-DAS was positively correlated with CRP, ESR, anti-dsDNA antibody, urinary protein (24 h) level, SLEDAI-2000, BILAG-2004 and PGA ( r=0.25, 0.34, 0.47, 0.77, 0.93, 0.94, 0.95, P<0.01); SLE-DAS was negatively correlated with PLT, Hb, C3 and C4 ( r=-0.29, -0.43, -0.41, -0.32, P<0.01). When SLEDAI-2000>5 was used as a cut point for analyzing SLE-DAS, the results showed that the area under the curve (AUC) 95% CI of SLE-DAS was 0.961 (0.927,0.995), the Yoden index was 0.845. When the cut-off value was set up to 4.65( P<0.001), the sensitivity was 98.11%, the specificity was 86.42%, and the accuracy was 91.04%. Kappa consistency test showed that kappa value was 0.819( P<0.001). Conclusions:SLE-DAS can be used to evaluate the disease activity of SLE patients and can be used as the evidence to guide treatment plan in clinical practice.
8.Implementation effect of disaster medicine curriculum of traditional Chinese and Western medicine in the teaching of standardized training
Ming LEI ; Xiaofang YANG ; Lijiao YOU ; Huan GENG
Chinese Journal of Medical Education Research 2023;22(9):1386-1390
In order to improve the disaster response ability of resident physicians under standardized training, this study designed a disaster medicine curriculum of traditional Chinese and Western medicine with reference to domestic and foreign experience. The curriculum consisted of 8 modules with a total of 26 class hours. The definition and classification of disasters and the status of traditional Chinese medicine in disaster medicine were introduced. This study evaluated the teaching effect of disaster medicine curriculum of traditional Chinese and Western medicine carried out by the Emergency Trauma Center of the Seventh People's Hospital Affiliated to Shanghai University of Traditional Chinese Medicine in 84 resident physicians under standardized training. The results showed that the objective test scores of resident physicians under standardized training before and after the course were (45.00±2.51) and (76.25±2.76), respectively ( P<0.001). A questionnaire survey on the subjective understanding of knowledge related to disaster medicine of traditional Chinese and Western medicine was conducted among resident physicians under standardized training before and after the course. The results showed that the test scores before and after the course were (50.88±1.41) and (64.64±1.80), respectively ( P<0.001). This study showed that the theoretical knowledge, skills, and comprehensive ability of resident physicians under standardized training in disaster relief have been greatly improved through the disaster medicine-related curriculum, providing a reference for the establishment of disaster medical education-related curriculum of integrated traditional Chinese and Western medicine.
9.Clinical efficacy of angiotensin-receptor neprilysin inhibitors in the treatment of maintenance hemodialysis with heart failure
Changli SUN ; Yang DONG ; Lijiao WANG ; Xindi ZHAO ; Zhu ZHANG ; Fengmin SHAO
Chinese Journal of Nephrology 2022;38(1):15-22
Objective:To observe the clinical efficacy of angiotensin-receptor neprilysin inhibitors (ARNI) in the treatment of maintenance hemodialysis (MHD) with heart failure.Methods:The clinical data of heart failure patients who accepted MHD in Central China Fuwai Hospital were retrospectively collected. All patients accepted regular treatments of heart failure, and then the treatment group was treated with ARNI, while the control group was treated with valsartan. The treatment course was 6 months. The cardiac parameters: left ventricular ejection fraction (LVEF), left ventricular end-diastolic dimension (LVEDD), left ventricular end-systolic dimension (LVESD), pulmonary artery pressure, right ventricular end-diastolic dimension (RVED), right atrial end-diastolic dimension (RAED), N-terminal pro-B-type natriuretic peptide (NT-pro BNP), and serum potassium were collected and compared between the two groups. Multivariate ordered logistic regression analysis was adopted to analyze the influencing factors of treatment effect.Results:A total of 60 MHD patients with heart failure were enrolled with age of (53.92±11.88) years old, 37 males (61.7%), dialysis age of (27.83±12.92) months, and blood pressure of (154.22±15.27) mmHg/(85.43±12.31) mmHg. (1) There was no significant difference of the clinical data and cardiac parameters between the treatment group ( n=30) and the control group ( n=30) before treatment (all P>0.05); (2) After treatment of 6 months, the total effective rate [28/30(93.3%)] in the treatment group was significantly higher than that in the control group [20/30(66.7%)] and the rehospitalization rate [2/30(6.7%)] in the treatment group was significantly lower than that in the control group [10/30(33.3%)] (both P<0.05); (3) After treatment of 6 months, LVEF, LVEDD, LVESD, pulmonary artery pressure, RVED, RAED, NT-pro BNP, and blood pressure were all improved significantly compared with the baseline in both groups (all P<0.05) and there was no significant difference of serum potassium and body weight before and after treatment in the two groups (all P>0.05); (4) After treatment of 6 months, LVEF in the treatment group was higher than that in the control group and LVEDD, LVESD, pulmonary artery pressure, NT-pro BNP, and blood pressure in the treatment group were lower than those in the control group (all P<0.05). There was no significant difference of RVED, RAED, serum potassium and body weight between the two groups after treatment (all P>0.05); (5)The difference values before and after treatment of LVEF, LVEDD, LVESD, NT-pro BNP, body weight, systolic blood pressure, and diastolic blood pressure were different between the two groups (all P<0.05); (6)Therapy method ( β=-1.863, 95% CI -2.948-0.777, P=0.001) and residual urine ( β=-1.686, 95% CI -3.079- -0.293, P=0.018) were independent influencing factors of treatment effect (the treatment effect of ARNI was better than that of valsartan; the treatment effect of patients with normal urine volume was better than that of patients with oliguria and anuria). Conclusions:ARNI can effectively improve cardiac function in MHD patients with heart failure, inhibit ventricular remodeling, and improve disease prognosis.
10.Effect of umbilical therapy on ulcerative colitis: a systematic evaluation and Meta-analysis
Dan YANG ; Lijiao YAN ; Qiulu MAI ; Dou WANG ; Xiaoyan ZHANG ; Yufang HAO ; Hailing GUO ; Fang WANG
Chinese Journal of Modern Nursing 2022;28(1):32-41
Objective:To systematically evaluate the effect of umbilical therapy in adult ulcerative colitis.Methods:The clinical randomized controlled trials (RCT) related to the effect of umbilical therapy in ulcerative colitis in the Chinese and English databases were systematically searched, and their citations were traced. The search time limit was from the establishment of each database to December 30, 2020. Two researchers screened and evaluated the articles according to the inclusion and exclusion criteria, and extracted article information and data. RevMan5.3 was used for meta-analysis.Results:A total of 13 Chinese articles were included, with 898 patients. The results of meta-analysis showed that there was no statistically significant difference in the general symptom relief rate [ RR=0.70, 95% CI (0.12, 4.19), P=0.70]and effective rate [ RR=0.93, 95% CI (0.54, 1.59), P=0.86]between conventional therapy and umbilical therapy alone. Umbilical therapy combined with conventional therapy can improve the effective rate of treatment [ RR=1.26, 95% CI (1.18, 1.35), P<0.000 01], general symptom relief rate [ RR=1.94, 95% CI (1.44, 2.61), P<0.000 1], abdominal pain relief rate [ RR=1.90, 95% CI (1.42, 2.54), P<0.000 1], diarrhea relief rate [ RR=1.32, 95% CI (1.07, 1.64), P=0.01], remission rate of pus and blood stool [ RR=1.22, 95% CI (1.03, 1.44), P=0.02]and reduced disease activity [ MD=-1.79, 95% CI (-3.37, -0.21), P=0.03]. In terms of adverse reactions, the difference between the two groups was not statistically significant [ RR=0.33, 95% CI (0.08, 0.80), P=0.13]. Conclusions:The efficacy of umbilical therapy alone is equivalent to that of conventional therapy, but umbilical therapy combined with conventional therapy is more effective in improving the treatment effective rate, general symptom relief rate and clinical symptoms. Due to the limitation of the number and quality of the included studies, long-term follow-up, large sample and rigorous RCT studies are needed to prove it.

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