1.Development of the Scientific, Transparent and Applicable Rankings (STAR) tool for clinical practice guidelines.
Nan YANG ; Hui LIU ; Wei ZHAO ; Yang PAN ; Xiangzheng LYU ; Xiuyuan HAO ; Xiaoqing LIU ; Wen'an QI ; Tong CHEN ; Xiaoqin WANG ; Boheng ZHANG ; Weishe ZHANG ; Qiu LI ; Dong XU ; Xinghua GAO ; Yinghui JIN ; Feng SUN ; Wenbo MENG ; Guobao LI ; Qijun WU ; Ze CHEN ; Xu WANG ; Janne ESTILL ; Susan L NORRIS ; Liang DU ; Yaolong CHEN ; Junmin WEI
Chinese Medical Journal 2023;136(12):1430-1438
BACKGROUND:
This study aimed to develop a comprehensive instrument for evaluating and ranking clinical practice guidelines, named Scientific, Transparent and Applicable Rankings tool (STAR), and test its reliability, validity, and usability.
METHODS:
This study set up a multidisciplinary working group including guideline methodologists, statisticians, journal editors, clinicians, and other experts. Scoping review, Delphi methods, and hierarchical analysis were used to develop the STAR tool. We evaluated the instrument's intrinsic and interrater reliability, content and criterion validity, and usability.
RESULTS:
STAR contained 39 items grouped into 11 domains. The mean intrinsic reliability of the domains, indicated by Cronbach's α coefficient, was 0.588 (95% confidence interval [CI]: 0.414, 0.762). Interrater reliability as assessed with Cohen's kappa coefficient was 0.774 (95% CI: 0.740, 0.807) for methodological evaluators and 0.618 (95% CI: 0.587, 0.648) for clinical evaluators. The overall content validity index was 0.905. Pearson's r correlation for criterion validity was 0.885 (95% CI: 0.804, 0.932). The mean usability score of the items was 4.6 and the median time spent to evaluate each guideline was 20 min.
CONCLUSION
The instrument performed well in terms of reliability, validity, and efficiency, and can be used for comprehensively evaluating and ranking guidelines.
Reproducibility of Results
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Surveys and Questionnaires
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Practice Guidelines as Topic
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Humans
2.Venetoclax with low-dose cytarabine for patients with untreated acute myeloid leukemia ineligible for intensive chemotherapy: results from the Chinese cohort of a phase three randomized placebo-controlled trial
Yu HU ; Jie JIN ; Yu ZHANG ; Jianda HU ; Junmin LI ; Xudong WEI ; Sujun GAO ; Jiuhong ZHA ; Qi JIANG ; Jun WU ; Wellington MENDES ; H. Andrew WEI ; Jianxiang WANG
Chinese Journal of Hematology 2021;42(4):288-294
Objective:To investigate the safety and efficacy of venetoclax with low-dose cytarabine (LDAC) in Chinese patients with acute myeloid leukemia (AML) who are unable to tolerate intensive induction chemotherapy.Methods:Adults ≥ 18 years with newly diagnosed AML who were ineligible for intensive chemotherapy were enrolled in this international, randomized, double-blind, placebo-controlled trial. Globally, patients ( n=211) were randomized 2∶1 to either venetoclax with LDAC or placebo with LDAC in 28-d cycles, with LDAC on days 1-10. The primary endpoint was OS; the secondary endpoints included response rates, event-free survival, and adverse events. Results:A total of 15 Chinese patients were enrolled (venetoclax arm, n=9; placebo arm, n=6) . The median age was 72 years (range, 61-86) . For the primary analysis, the venetoclax arm provided a 38% reduction in death risk compared with the placebo[hazard ratio ( HR) , 0.62 (95% CI 0.12-3.07) ]. An unplanned analysis with an additional 6 months of follow-up demonstrated a median OS of 9.0 months for venetoclax compared with 4.1 months for placebo. The complete remission (CR) rates with CR with incomplete blood count recovery (CRi) were 3/9 (33%) and 0/6 (0%) , respectively. The most common non-hematologic adverse effects (venetoclax vs placebo) were hypokalemia[5/9 (56%) vs 4/6 (67%) ], vomiting[4/9 (44%) vs 3/6 (50%) ], constipation[2/9 (22%) vs 4/6 (67%) ], and hypoalbuminemia[1/9 (11%) vs 4/6 (67%) ]. Conclusion:Venetoclax with LDAC demonstrated meaningful efficacy and a manageable safety profile in Chinese patients consistent with the observations from the global VIALE-C population, making it an important treatment option for patients with newly diagnosed AML who are otherwise ineligible for intensive chemotherapy.
3. ECMO application of patients with Critical Corona Virus Disease 2019 and fulminant myocarditis
Xia SHI ; Fulan CEN ; Zhimin SU ; Gendong YANG ; Jinxiu LI ; Cheng FENG ; Ye CHEN ; Guoliang ZHANG ; Zhaoqin WANG ; Yingxia LIU ; Junmin WEN ; Hong GAO
Chinese Journal of Experimental and Clinical Virology 2020;34(0):E006-E006
Objective To evaluate the clinical experience of extracorporeal membrane oxygenation (ECMO) treatment on two cases of infection with the critical Corona Virus Disease 2019 (COVID-19) complicated by fulminant myocarditis (FM) . Methods This study selects two COVID-19 cases comorbid with fulminant myocarditis and had been treated with ECMO in Shenzhen Third People's Hospital from January 2020 to February 2020. We compare the index of inflammation, immunization, D-dimer and lactic acid before and after ECMO treatment in 24 and 96 hours, cardiopulmonary function before and after ECMO treatment in 24, 48, 72, 96 hours,. We also analyze the complications and clinical outcomes of the two cases during the ECMO treatment. Results Both patients were elderly obese men with chronic cardiopulmonary disease. Comparing the laboratory test results and imaging data of the two patients, the acute lung injury score, oxygenation index, albumin level, hypersensitive C-reactive protein, lactate and lactate dehydrogenase levels in 2 patients after ECMO treatment were improved as compared with those before ECMO treatment. Finally, case 1 died of multiple organ failure and his cardiac function continued to deteriorate, while, case 2 successfully withdrew and his cardiac function gradually improved. Conclusions For critical COVID-19 patients with fulminant myocarditis, ECMO treatment can improve pulmonary function in the short term, provide valuable time for rescuing COVID-19 patients with fulminant myocarditis.
4.A multicenter survey on changes in nutritional risk and malnutrition incidence of elderly patients in Chinese large hospitals during hospitalization
Jie PAN ; Hongyuan CUI ; Mingwei ZHU ; Wei CHEN ; Xin YANG ; Pianhong ZHANG ; Xiaoyu LIANG ; Jianqin SUN ; Yan SHI ; Hongyu ZHANG ; Yanyan GAO ; Sainan ZHU ; Junmin WEI
Chinese Journal of Clinical Nutrition 2019;27(2):65-69
Objective To investigate the change of the nutritional status of elderly patients in Chinese major hospitals dynamically with nutritional risk screening 2002 (NRS 2002) and subjective global assessment (SGA) during hospitalization.Methods A prospective,multi-center survey was conducted on over 65 years old patients who were admitted in departments of gastroenterology,respiratory medicine,general surgery,geriatrics,thoracic surgery,neurology,orthopedics and medical oncology of 9 large hospitals in China for 7-30 days between June 2014 and September 2014.On admission and within 24 hours after discharge,the clinical data were recorded,physical indices were measured,and laboratory examination were conducted.NRS 2002 and SGA were used to make an evaluation.The nutritional supports and clinical outcomes were also recorded and then the correlation between nutritional status and clinical outcomes were analyzed.Results A total of 2558 patients above 65 years old were included into the study.Compared with their status on admission,their grip strength,upper arm circumference and crural circumference were reduced significantly at discharge (P<0.05).The total protein,albumin and hemoglobin levels were significantly lower than those on admission (P<0.05).The incidence of nutritional risk (NRS 2002 score ≥ 3) and malnutrition (SGA B + C) on admission were lower than those at discharge (51.1% vs 53.0%,32.6% vs 35.6%).The hospitalization time and medical expenses were higher in patients with malnutrition on admission than in those with normal nutrition intakes.The nutritional status at discharge was negatively correlated with hospitalization time and medical expenses.61.3% patients having nutritional risk did not take nutritional support during the hospital stay,while utilization rate of parenteral nutrition was higher than that of enteral nutrition in patients receiving nutritional support (19.6% vs 11.9%).Conclusion Elderly patients have higher possibilities of facing nutritional risk or malnutrition on admission,these are associated with poor clinical outcomes and their nutritional status will not improve significantly at discharge.Therefore,the screening and evaluation of nutritional status in elderly patients during hospitalization should be conducted and their nutritional intervention should be standardized so as to improve the clinical outcomes.
5.Expression and significance of Gab2 in colorectal cancer tissues
Chenbo DING ; Jihong FENG ; Weina YU ; Shaoying GAO ; Lin XU ; Chao CHEN ; Junmin LUO
Chinese Journal of Immunology 2015;(2):160-162,168
Objective:To investigate the expression and significance of Gab 2 in colorectal cancer tissues .Methods:Immuno-histochemistry was used to detect the expression of Gab 2 in 78 cases of colorectal cancer tissues and 46 cases of the adjacent tissues and to analyze the association of Gab2 expression with the clinicopathologic features of colorectal cancer;The expression of Gab2 in samples from 10 cases of colorectal cancer tissues and matched adjacent nontumorous tissues was detected by Western blot .Results: The results of immunohistochemistry demonstrated that the Gab 2 protein positive expression rate in 78 cases of colorectal cancer was 53.85%;whereas was negative expression or weak in the adjacent tissues , showing a significant difference of comparison within this result (P<0.001) .The expression of Gab2 in colorectal cancer was related with TNM stage and lymph node metastasis (P<0.05) , but no relation with the size and differentiation of tumor (P>0.05) .Western blot showed that the Gab2 protein expression of colorectal cancer cases was significantly higher than that of matched adjacent nontumorous tissues ( P<0.05 ).Conclusion: Gab2 was overexpressed in colorectal cancer .Gab2 maybe play an important role in carcinogenesis and progression of colorectal carcinoma .
6.Clinical features and prognostic analysis of 75 primary myelofibrosis patients.
Qing YU ; Lan XU ; Xiaodong GAO ; Wenbin XU ; Hua YAN ; Wen WU ; Junmin LI ; Zhixiang SHEN
Chinese Journal of Hematology 2014;35(10):922-925
OBJECTIVETo investigate the clinical and hematological features and prognostic factors of primary myelofibrosis (PMF) patients in Shanghai and surrounding area of Shanghai, China.
METHODSThe clinical manifestations, laboratory parameters and survival were retrospectively analyzed in 75 PMF patients diagnosed from Jan, 1996 to Dec, 2013 in our hospital and were compared with those of Chinese subjects from Tianjin and foreign Caucasian patients, respectively. Comparison of categorical variables was performed by χ² test. Survival was estimated using the Kaplan- Meier method. Log- rank test was used to compare survival date. A Cox model was used for multivariate analyses.
RESULTSThe median age of the 75 patients was 56(19-81) years old. There were 51(68%) patients with HGB less than 100 g/L. The median value of HGB was 83 g/L. Similar with those from Tianjin, the patients in our study were significantly younger with higher proportion of severe anemia and lower platelet counts when compared with foreign Caucasian patients. Using IPSS and dynamic international prognostic scoring system (DIPSS) model, the survival curves of intermediate- 1, intermediate- 2 and high risk groups were significantly different. In univariate analyses, variables significantly correlated with poor prognosis were systemic symptoms, HGB<100 g/L, HGB<80 g/L, PLT ≤ 100 × 10⁹/L, WBC<10 × 10⁹/L and blood blasts ≥ 0.01. Multivariate analysis identified IPSS and HGB < 80 g/L as independent risk factors for survival.
CONCLUSIONChinese PMF patients may have characteristics of younger age at onset with more severe anemia. However, IPSS and DIPSS model are still suitable for Chinese patients to predict survival. To increase the weight of anemia severity may provide a better prognostic stratification for Chinese patients with PMF.
Adult ; Aged ; Aged, 80 and over ; China ; Humans ; Middle Aged ; Primary Myelofibrosis ; diagnosis ; Prognosis ; Retrospective Studies ; Risk Factors ; Young Adult
7.Clinical study of hepatic damage during perioperative period of liver resection for hepatic carcinoma in elderly patients
Donghui XIE ; Ge GAO ; Jian CHEN ; Junmin WEI
Chinese Journal of Geriatrics 2010;29(8):641-643
Objective To investigate the causes and preventive measures of hepatic failure during perioperative period of liver resection for primary hepatic carcinoma in the elderly patients, and to explore its diagnosis and treatment. Methods The 62 patients with primary hepatic carcinoma undergoing hepatectomy were analyzed retrospectively, and they were divided into two groups: elderly group (age≥60 years) and non-elderly group (age<60 years). The influencing factors for damage of hepatic function were analyzed using single variant and multivariate stepwise regression analysis in elderly and non-elderly group, pringle maneuver and non-pringle maneuver group, more (≥500 ml)and less (<500 ml) amount of bleeding group. Results The incidence of hepatic damage and mortality rate induced by hepatic failure were 32. 6% and 1.6% respectively after liver resection for primary hepatic carcinoma. Single variant analysis showed that pringle maneuver, intraoperative blood loss, blood transfusion and size of tumor were associated with postoperative hepatic function.Furthermore, multivariate stepwise regression analysis revealed that pringle maneuver was the independent risk factor associated with postoperative hepatic function (β = 0. 314, t= 2. 272, P <0. 05). Conclusions The postoperative hepatic damage is significantly correlated with pringle maneuver and intraoperative bleeding in liver resection for hepatocellular carcinoma in senile people.And improving operative techniques, shorting the time of pringle maneuver, decreasing intraoperative bleeding were the main preventive measures for hepatic damage after liver resection for primary hepatic carcinoma in the elderly patients.
8.Approved effect of hydrochloric-acid arotinolol on trembling symptom of patients with essential tremor: 30 cases analysis
Wenji ZHANG ; Xiangyu ZENG ; Xinde WANG ; Weiwei ZHANG ; Junmin GAO
Chinese Journal of Tissue Engineering Research 2006;10(8):168-169
BACKGROUND: Essential tremor is a kind of dyskinesia disease with a tendency to heredity. β-adnephrin receptor blocker is mainly used for treatment, but the dosage was great, patients could not persist in treatment. Hydrochloric-acid arotinolol, which characterizes by little side effect, is a β-receptor blocking agent combined with blocking effect of α receptor, and is an ideal drug to treat essential tremor in Japan.OBJECTIVE: To observe the reliability and curative effect of hydrochloric-acid arotinolol on essential tremor among Chinese people.DESIGN: Case analysis.SETTING: Neurological Departments of Beijing Hospital of Ministry of Public Health and General Hospital of Beijing Military Area Command of Chinese PLA.PARTICIPANTS: Totally 30 patients with essential tremor, 19 males and 11 females, aged from 21 to 74 years, with course of 1-40 years, average of (15.8±12.6) years, were selected from Neurological Departments of Beijing Hospital of Ministry of Public Health and General Hospital of Beijing Military Area Command of Chinese PLA from April 1999 to December 2000.METHODS: Tremor degree of upper limb, caput and lower limb, degree of dysfunction of hand, tremor degree of hand during writing and circling, and chief complaint of pain caused by tremor were scored before medication and 2, 4 and 6 weeks after medication. Scores were determined as 1 point, 2 points and 3 points according to mild, moderate and severe degree respectively. Evaluated criteria: ① Obviously effective: Differences were more than 7 points before and after treatment. ② Effective: Differences were 6.5-3 points before and after treatment. ③ A little effective: Differences were 3-1.5 points before and after treatment. ④ No changes: Differences were from 1 to -1 points before and after treatment. ⑤ Worse: Differences were less than -1.5 points before and after treatment. Meanwhile, blood pressure and heart rate of patients and side effect of drug were observed.MAIN OUTCOME MEASURES: ① Results of effective evaluation; ②Blood pressure and heart rate before and after treatment; ③ Adverse events and side effect.RESULTS: Totally 30 patients entered the final analysis. ① Among 30 patients with essential tremor, 6 had obvious effect, 11 had effect, 5 had a little effect, 7 had no effect, and 1 was worse. ② Average of blood pressure before treatment was (138.5±14.6)/(84.2±6.4) mm Hg (1 mm Hg=0.133 kPa), and was (130±10)/(79.7±6.3) mm Hg after 1 course. Average heart rate was (77.5±6.4) times/minute before treatment and (75±6.4) times/minute after treatment. The difference was not significant. ③ Among 30 patients, 4 had side effect at various degrees which was accounted for 13.4%; 1 had distress after medication, 1 had agrypnia, 2 had fullness in head and dizziness, and 1 gave up the treatment because of deteriorated tremor.CONCLUSION: Hydrochloric-acid arotinolol can improve tremor symptom of patients obviously and is an effective drug to treat essential tremor with convenient and safe medication.
9.Upregulation of B7 molecules expression by calcium ionorphore in K562 cells in vitro
Feng GAO ; Junmin CHEN ; Defu YE ; Shourong LIN
Chinese Journal of Immunology 2001;0(07):-
Objective:To investigate the effect of calcium ionorphore on B7 costimulatory molecules of chronic myeloid leukemia cells line K562.Methods:Well growing K562 cells were cultured in the medium containing calcium ionorphore(375 ng/ml),with K562 cells without CI treatment as control.The cells′ viability and number were calculated by Trypan Blue exclusion at 0,48 and 96 h.Before and after 96 h of cultured,B7-1 and B7-2 expression was assayed by flow cytometry.The proliferation of allogeneic human T cells was measured by MTT colorimetry.Results:B7 costimulatory molecules were abcent or lowly expressed on K562 cells.After 96 h of CI treatment,B7 costimulatory molecules of K562 cells were markedly upregulated and marked activation of allogeneic T cells occurred.No notable morphological change was found during the culture.K562 cells cultured in medium with CI grow slowly than that without CI.Conclusion:B7 costimulatory molecules expression on chronic myeloid leukemia cells line K562 surface was defective.These costimulatory molecules on K562 cells can be upregulated by calcium ionorphore.Calcium ionorphore may inhibit the growth of K562 cells.
10.Relationship of c-erbB2 overexpression with endocrine therapy and prognosis in patients with breast carcinoma
Peng GAO ; Gengyin ZHOU ; Junmin WEI ; Li LI ; Yiran CAI ; Miaoqing ZHAO ; Chengjun ZHOU
Chinese Journal of General Surgery 2001;0(10):-
Objective To investigate the relationship of c erbB2 with endocrine therapy and prognosis, to investigate the rapid and effective method to detect c erbB2 alteration in breast carcinoma(BC).Metheds Semi quantitative PCR was used to detect the amplification of c erbB2, and immunohistochemistry was used to detect the expression of protein of c erbB2. 58 cases of BC were followed up .Results There was significant relationship between c erbB2 protein overexpression and gene amplification(P

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