1.Discussion of the methodology and implementation steps for assessing the causality of adverse event
Hong FANG ; Shuo-Peng JIA ; Hai-Xue WANG ; Xiao-Jing PEI ; Min LIU ; An-Qi YU ; Ling-Yun ZHOU ; Fang-Fang SHI ; Shu-Jie LU ; Shu-Hang WANG ; Yue YU ; Dan-Dan CUI ; Yu TANG ; Ning LI ; Ze-Huai WEN
The Chinese Journal of Clinical Pharmacology 2024;40(2):299-304
The assessment of adverse drug events is an important basis for clinical safety evaluation and post-marketing risk control of drugs,and its causality assessment is gaining increasing attention.The existing methods for assessing the causal relationship between drugs and the occurrence of adverse reactions can be broadly classified into three categories:global introspective methods,standardized methods,and probabilistic methods.At present,there is no systematic introduction of the operational details of the various methods in the domestic literature.This paper compares representative causality assessment methods in terms of definition and concept,methodological steps,industry evaluation and advantages and disadvantages,clarifies the basic process of determining the causality of adverse drug reactions,and discusses how to further improve the adverse drug reaction monitoring and evaluation system,with a view to providing a reference for drug development and pharmacovigilance work in China.
2.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.
3.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.
4.Cognition and training needs of emergency response teamwork skills among nursing undergraduates: a qualitative study
Dan WEI ; Xinjuan WU ; Xiaojie WANG ; Jie CHEN ; Dongying ZHANG ; Meng ZHANG ; Jialu ZHANG ; Di SHI ; Hongbo LUO ; Hongyan LI ; Wei WANG ; Xiaoying LIANG ; Tianyi WANG ; Ning ZHANG ; Haixin BO
Chinese Journal of Modern Nursing 2024;30(33):4520-4525
Objective:To gain a deep understanding of the current cognition and training needs of nursing undergraduates regarding their emergency response teamwork skills, and to provide reference for the development of courses on emergency response teamwork among nursing undergraduates.Methods:From September to October 2023, purposive sampling was used to select 15 senior nursing undergraduates from Peking Union Medical College, Beijing University of Chinese Medicine, and Beijing City University as subjects for semi-structured interviews. Colazizzi 7-step analysis method was used to summarize and extract themes.Results:Three themes were extracted, including insufficient cognition and skill in emergency response, lack of emergency response teamwork cultivation, and the need for systematic and comprehensive training courses.Conclusions:Universities, hospitals, and other training institutions should work together to develop a systematic emergency response teamwork training course for nursing undergraduates, to cultivate the skills of nursing undergraduates and reserve talents for high-quality emergency response nursing teams.
5.Technical status and development trends of electronic tongue
Shu-ye QI ; Yue-zhong MAO ; Li-hua GENG ; Dao-xuan YANG ; Hui-dan TU ; Shang-chen YAO ; Shi-yi TIAN ; Bao-ming NING
Acta Pharmaceutica Sinica 2023;58(11):3165-3172
Electronic tongue is one kind of bionic detection technologies, which can objectively reflect the taste of drugs based on electrochemical principle. In this paper, the development histories of electronic tongue both of potential type and voltammetry type were introduced, including their detection principles and key innovation technologies. In order to comprehensively improve the understanding of electronic tongue, its technological progresses, such as the study of dedicated sensors or biosensors for specific tastes, and the development of miniaturized or hybrid devices, were also discussed in detail. And the challenges and countermeasures in the application of electronic tongue were analyzed to provide some suggestions for its further technology promotion.
6.Expert consensus on clinical practice in perioperative nursing for elderly patients with hip fracture (version 2023)
Mi SONG ; Dan KONG ; Yuan GAO ; Yaping CHEN ; Xiaohua CHEN ; Yi CUI ; Junqin DING ; Leling FENG ; Lili FENG ; Jinli GUO ; Yun HAN ; Jing HU ; Sanlian HU ; Tianwen HUANG ; Yu JIA ; Yan JIN ; Xiangyan KONG ; Haiyan LI ; Hui LI ; Lunlan LI ; Shuixia LI ; Hua LIN ; Juan LIU ; Xuemei LU ; Ning NING ; Lingli PENG ; Lingyun SHI ; Changli WAN ; Jie WANG ; Qi WANG ; Yi WANG ; Ruifeng XU ; Ying YING ; Ping ZHANG ; Shijun ZHANG ; Wenjuan ZHOU
Chinese Journal of Trauma 2023;39(3):214-222
Hip fracture is considered as the most severe osteoporotic fracture characterized by high disability and mortality in the elderly. Improved surgical techniques and multidisciplinary team play an active role in alleviating prognosis, which places higher demands on perioperative nursing. Dysfunction, complications, and secondary impact of anaesthesia and surgery add more difficulties to clinical nursing. Besides, there still lack clinical practices in perioperative nursing for elderly patients with hip fracture in China. In this context, led by the Orthopedic Nursing Committee of Chinese Nursing Association, the Expert consensus on clinical practice in perioperative nursing for elderly patients with hip fracture ( version 2023) is developed based on the evidence-based medicine. This consensus provides 11 recommendations on elderly patients with hip fracture from aspects of perioperative health education, condition monitoring and inspection, complication risk assessment and prevention, and rehabilitation, in order to provide guiding advices for clinical practice, improve the quality of nursing and ameliorate the prognosis of elderly patients with hip fracture.
7.Outcomes at discharge of preterm infants born <34 weeks' gestation.
Ning Xin LUO ; Si Yuan JIANG ; Yun CAO ; Shu Jun LI ; Jun Yan HAN ; Qi ZHOU ; Meng Meng LI ; Jin Zhen GUO ; Hong Yan LIU ; Zu Ming YANG ; Yong JI ; Bao Quan ZHANG ; Zhi Feng HUANG ; Jing YUAN ; Dan Dan PAN ; Jing Yun SHI ; Xue Feng HU ; Su LIN ; Qian ZHAO ; Chang Hong YAN ; Le WANG ; Qiu Fen WEI ; Qing KAN ; Jin Zhi GAO ; Cui Qing LIU ; Shan Yu JIANG ; Xiang Hong LIU ; Hui Qing SUN ; Juan DU ; Li HE
Chinese Journal of Pediatrics 2022;60(8):774-780
Objective: To investigate the incidence and trend of short-term outcomes among preterm infants born <34 weeks' gestation. Methods: A secondary analysis of data from the standardized database established by a multicenter cluster-randomized controlled study "reduction of infection in neonatal intensive care units (NICU) using the evidence-based practice for improving quality (REIN-EPIQ) study". This study was conducted in 25 tertiary NICU. A total of 27 192 infants with gestational age <34 weeks at birth and admitted to NICU within the first 7 days of life from May 2015 to April 2018 were enrolled. Infants with severe congenital malformation were excluded. Descriptive analyses were used to describe the mortality and major morbidities of preterm infants by gestational age groups and different admission year groups. Cochran-Armitage test and Jonckheere-Terpstra test were used to analyze the trend of incidences of mortality and morbidities in 3 study-years. Multiple Logistic regression model was constructed to analyze the differences of outcomes in 3 study-years adjusting for confounders. Results: A total of 27 192 preterm infants were enrolled with gestational age of (31.3±2.0) weeks at birth and weight of (1 617±415) g at birth. Overall, 9.5% (2 594/27 192) of infants were discharged against medical advice, and the overall mortality rate was 10.7% (2 907/27 192). Mortality for infants who received complete care was 4.7% (1 147/24 598), and mortality or any major morbidity was 26.2% (6 452/24 598). The incidences of moderate to severe bronchopulmonary dysplasia, sepsis, severe intraventricular hemorrhage or periventricular leukomalacia, proven necrotizing enterocolitis, and severe retinopathy of prematurity were 16.0% (4 342/27 192), 11.9% (3 225/27 192), 6.8% (1 641/24 206), 3.6% (939/25 762) and 1.5% (214/13 868), respectively. There was a decreasing of the overall mortality (P<0.001) during the 3 years. Also, the incidences for sepsis and severe retinopathy of prematurity both decreased (both P<0.001). However, there were no significant differences in the major morbidity in preterm infants who received complete care during the 3-year study period (P=0.230). After adjusting for confounders, infants admitted during the third study year showed significantly lower risk of overall mortality (adjust OR=0.62, 95%CI 0.55-0.69, P<0.001), mortality or major morbidity, moderate to severe bronchopulmonary dysplasia, sepsis and severe retinopathy of prematurity, compared to those admitted in the first study year (all P<0.05). Conclusions: From 2015 to 2018, the mortality and major morbidities among preterm infants in Chinese NICU decreased, but there is still space for further efforts. Further targeted quality improvement is needed to improve the overall outcome of preterm infants.
Bronchopulmonary Dysplasia/epidemiology*
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Gestational Age
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Humans
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Infant
;
Infant Mortality/trends*
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Infant, Newborn
;
Infant, Premature
;
Infant, Premature, Diseases/epidemiology*
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Patient Discharge
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Retinopathy of Prematurity/epidemiology*
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Sepsis/epidemiology*
8.Discussion on medication rules of constipation in Guide to Clinical Practice with Medical Records based on data mining
Chun LI ; Ning XIAO ; Liang YI ; Dan ZHAO ; Baozhu SHI ; Yan DONG
International Journal of Traditional Chinese Medicine 2022;44(2):201-205
Objective:To explore the medication rules of Ye Tianshi in the treatment of constipation from his clinical records. Methods:The drugs in the prescriptions of intestinal obstruction and stool closure were collected in Guide to Clinical Practice with Medical Records. Then the frequency of the prescriptions and the herbs for the treatment,as well as the herbal natures, flavors and meridian belongings were analyzed by Excel, SPSS 22.0 and SPSS Modeler software. Results:The main syndrome types of Ye's treatment of fecal occlusive disease were internal accumulation of dampness and heat, deficiency of kidney Yang, hyperactivity of fire due to yin deficiency, deficiency of liver and kidney Yin, and dysfunction of lung. The medicinal properties were mainly warm, cold and flat, and the tastes were mainly sweet, pungent and bitter, and the meridians mainly belonged to spleen and stomach, lung, liver, kidney and heart. Armeniacae Semen Amarum, Angelica sinensis, Poria, Semen Platycladi, Trichosanthes kirilowii Maxim, Semen Persicae were often used. The commonly used drug pairs, included Armeniacae Amarum Semen and Trichosanthes kirilowii Maxim, Armeniacae Amarum Semen and Radix Curcumae Aromaticae, Angelica sinensis and Semen Platycladi and so on. Conclusions:Ye Tianshi takes spleen and stomach as the center, pays attention to the important position of dampness pathogen in the pathogenic process, and pays attention to lung Qi purging, liver Qi drainage and bladder gasification. It provides new treatment ideas and methods, guiding future doctors.
9.Perinatal outcome of different approaches for second-trimester multifetal pregnancy reduction in women with dichorionic triamniotic triplet pregnancies
Xin ZHAO ; Yanlin HUANG ; Wei HE ; Ying XIONG ; Qian LIU ; Ning SHANG ; Dan CHEN ; Yiwei XIAO ; Lishuang SHI ; Huamei HUANG ; Jing WU
Chinese Journal of Perinatal Medicine 2021;24(4):254-260
Objective:To explore the effects of different approaches for second-trimester multifetal pregnancy reduction on pregnancy outcome in women with dichorionic triamniotic (DCTA) triplet.Methods:A retrospective study was performed on 51 women with DCTA triplet pregnancies who were referred to Guangdong Women and Children Hospital for second-trimester multifetal pregnancy reduction from January 2014 to January 2020. All participants were divided into either preventive group ( n=39) or treatment group ( n=12) according to the indication for multifetal pregnancy reduction, and they were further allocated to three subgroups based on different reduction methods, which were reduction to dichorionic twin by radiofrequency ablation (RFA) (RFA subgroup), reduction to monochorionic singleton (KCl-singleton subgroup) or monochorionic twin (KCl-twin subgroup) by cardiac injection of potassium chloride. Pregnancy loss rate, neonatal birth weight, gestational age at delivery, incidence of intrauterine death, and neonatal death were compared and analyzed between different groups using t-test, analysis of variance, Chi-square test, Fisher's exact test and Bonferroni correction. Results:(1) The mean gestational week at operation in the treatment group was significantly later than that in the preventive group [(18.5±3.1) vs (15.0±2.3) weeks, t=-4.209, P<0.001]. In the preventive group, the mean gestational week at operation in the RFA subgroup was later than the KCl-singleton and KCl-twin subgroup[(17.2±1.6) vs (13.8±1.5) and (12.7±1.0) weeks, t=6.630 and 3.875, respectively, both P<0.05]. (2) The postoperative pregnancy loss rate in the preventive group was decreased compared with the treatment group [10.3%(4/39) vs 5/12, Fisher's exact test, P<0.05], and the live birth ratio was increased [ 85.7%(48/56) vs 10/18, χ2=5.640, P=0.018]. No live birth infants with birth weight <1 500 g was reported in the KCl-singleton subgroup in preventive group, and the statistical significance was observed in the intra-group differences ( P<0.05) rather than the pairwise comparison differences in the preventive group. For the proportion of live births, there was a statistically significant difference in the intra-group comparison in the treatment group, which was higher in the RFA subgroup than that in the KCl-twin subgroup (6/6 vs 1/6, P=0.045). No significant difference was revealed among pregnancy loss rate, gestational weeks at delivery, the mean birth weight, premature delivery <32 gestational weeks, and full-term birth rate among three different approaches within the two groups. (3) No monochorionic twin complications or perinatal death occurred in any RFA or KCl-singleton subgroups in the two groups. In the KCl-twin subgroups including five cases with ten fetuses, including three live birth, four miscarriage, three intrauterine death occured, while no neonatal death was reported. One case with selective fetal uterine growth restriction in the preventive group delivered two live births, and one case with twin-to-twin transfusion syndrome in the treatment group had intrauterine death in one fetus and one survival neonate. Conclusions:The pregnancy outcome of multifetal pregnancy reduction to dichorionic diamniotic twins by RFA or reduction to singleton by cardiac injection of potassium chloride are comparative in women with DCTA triplet, regardless of whether it is a preventive or therapeutic reduction.
10.Current status of prevention and treatment of esophagogastric variceal bleeding in cirrhotic portal hypertension patients in Ningxia region: a multicenter study
Ronghua DING ; Yanmei HU ; Xiaoguo LI ; Chao SHI ; Jigang RUAN ; Jianping HU ; Jie XUAN ; Yang LI ; Ping WANG ; Yuzhen QI ; Fang PENG ; Hailong QI ; Wei YANG ; Qian SHEN ; Shuiping KU ; Ruichun SHI ; Xuejuan WEI ; Yanping ZHANG ; Yulin DING ; Peifang ZHANG ; Zhanbin HOU ; Xiaojuan ZHANG ; Yuanlan TIAN ; Guizhen WANG ; Ping ZHANG ; Yanxia QI ; Tianneng WANG ; Ying LI ; Ning KANG ; Dan XU ; Ruiling HE ; Chuan LIU ; Shengjuan HU ; Yang BO ; Xiaolong QI
Chinese Journal of Digestive Surgery 2021;20(10):1078-1084
Objective:To investigate the current status of prevention and treatment of esophagogastric variceal bleeding (EVB) in cirrhotic portal hypertension patients in Ningxia region.Methods:The retrospective and descriptive study was conducted. The clinical data of 820 cirrhotic portal hypertension patients who were admitted to 21 medical centers in Niangxia region from January 2018 to December 2020 were collected, including 85 cases in Ningxia Hui Autonomous Region People′s Hospital, 73 cases in the Fifth People′s Hospital of Ningxia Hui Autonomous Region, 59 cases in the Wuzhong People′s Hospital, 52 cases in the Qingtongxia People′s Hospital, 50 cases in the Guyuan People′s Hospital, 47 cases in the Yuanzhou District People′s Hospital of Guyuan City, 47 cases in the Yinchuan Second People′s Hospital, 40 cases in the General Hospital of Ningxia Medical University, 40 cases in the Tongxin People′s Hospital, 35 cases in the Yinchuan First People′s Hospital, 34 cases in the Third People′s Hospital of Ningxia Hui Autonomous Region, 32 cases in the Zhongwei People′s Hospital, 30 cases in the Lingwu People′s Hospital, 30 cases in the Wuzhong New District Hospital, 30 cases in the Yanchi People′s Hospital, 29 cases in the Ningxia Hui Autonomous Region Academy of Traditional Chinese Medicine, 28 cases in the Shizuishan Second People′s Hospital, 25 cases in the Shizuishan First People′s Hospital, 21 cases in the Haiyuan People′s Hospital, 20 cases in the Pengyang People′s Hospital, 13 cases in the Longde People′s Hospital. There were 538 males and 282 females, aged (56±13)years. Observation indicators: (1) clinical charac-teristics of cirrhotic portal hypertension patients; (2) overall prevention and treatment of EVB in cirrhotic portal hypertension patients; (3) prevention and treatment of EVB in cirrhotic portal hypertension patients from different grade hospitals. Measurement data with normal distribution were represented as Mean± SD. Count data were described as absolute numbers, and comparison between groups was analyzed using the chi-square test. Results:(1) Clinical characteristics of cirrhotic portal hypertension patients: of 820 cirrhotic portal hypertension patients, 271 cases were in compensated stage and 549 cases were in decompensated stage. Of the 271 cases in compensated stage, there were 183 maels and 88 females, aged (53±12)years. There were 185 Han people, 85 Hui people and 1 case of other ethic group. The etiological data of liver cirrhosis showed 211 cases of viral hepatitis B, 4 cases of alcoholic liver disease, 8 cases of viral hepatitis C, and 48 cases of other etiology. There were 235 cases of Child-Pugh grade A and 36 cases lack of data. Of the 549 cases in decompensated stage, there were 355 males and 194 females, aged (57±14) years. There were 373 Han people, 174 Hui people and 2 cases of other ethic group. The etiological data of liver cirrhosis showed 392 cases of viral hepatitis B, 33 cases of alcoholic liver disease, 10 cases of viral hepatitis C, and 114 cases of other etiology. There were 80 cases of Child-Pugh grade A, 289 cases of grade B, 170 cases of grade C and 10 cases lack of data. (2) Overall prevention and treatment of EVB in cirrhotic portal hypertension patients: of 271 patients in compensated stage, 38 cases received non-selective β-blocker (NSBB) therapy, 16 cases received endoscopic treatment, 6 cases received interventional therapy. Of 549 patients in decompensated stage, 68 cases received NSBB therapy, 46 cases received endoscopic treatment, 28 cases received interventional therapy. (3) Prevention and treatment of EVB in cirrhotic portal hypertension patients from different grade hospitals: of 271 patients in compensated stage, 181 cases came from tertiary hospitals, of which 28 cases received NSBB therapy, 15 cases received endoscopic treatment, 6 cases received interventional therapy. Ninety cases came from secondary hospitals, of which 10 cases received NSBB therapy, 1 cases received endoscopic treatment. There was no significant difference in NSBB for prevention of EVB between tertiary and secondary hospitals ( χ2=0.947, P>0.05), while there was a significant difference in endoscopic treatment for prevention of EVB between tertiary and secondary hospitals ( χ2=5.572, P<0.05). Of 549 patients in decompensated stage, 309 cases came from tertiary hospitals, of which 22 cases received NSBB therapy, 29 cases received endoscopic treatment, 22 cases received interventional therapy. Two hundreds and fourty cases came from secondary hospitals, of which 46 cases received NSBB therapy, 17 cases received endoscopic treatment, 6 cases received interven-tional therapy. There were significant differences in NSBB and interventional therapy for prevention of EVB between tertiary and secondary hospitals ( χ2=18.065, 5.956, P<0.05). Conclusions:The proportion of receiving EUB prevention in cirrhotic portal hypertension in Ningxia is relatively low. For patients with compensated liver cirrhosis, the proportion of NSBB therapy and endoscopic treatment in the secondary hospitals was lower than that in tertiary hospitals. For patients with decompensated liver cirrhosis, the proportion of interventional treatment in secondary hospitals is lower than that of tertiary hospitals, but the proportion of NSBB in secondary hospitals taking is higher than that of tertiary hospitals.

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