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Rationale and protocol for estimating the economic value of a multicomponent quality improvement strategy for diabetes care in South Asia

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Global Health Research and Policy 2019年第1期4卷 333-342页

作者： Kavita Singh Mohammed KAli Raji Devarajan Roopa Shivashankar Dimple Kondal Vamadevan S.Ajay VUsha Menon Premlata KVarthakavi Vijay Viswanathan Mala Dharmalingam Ganapati Bantwal Rakesh Kumar Sahay Muhammad Qamar Masood Rajesh Khadgawat Ankush Desai Dorairaj Prabhakaran K.M.Venkat Narayan Victoria LPhillips Nikhil Tandon on behalf of the carrs trial group Public Health Foundation of India Center of Excellence-Center for CArdio-metabolic Risk Reduction in South Asia4th FloorPlot No.47Sector 44Institutional AreaGurgaonHaryana 122002India Rollins School of Public Health Emory University1518 Clifton RoadRm CNR 7041AtlantaGA 30322USA Department of Endocrinology&Diabetes Amrita Institute of Medical SciencesAmrita Vishwa VidyapeethamPonekkara P.O.KochiKerala 682041India Department of Endocrinology TNM College&BYL Nair Charity HospitalDr.A.L.Nair RoadMumbai CentralMumbaiMaharashtra 400008India MV Hospital for Diabetes&Diabetes Research Centre No 4West Madha Church StreetRoyapuramChennaiTamil Nadu 600013India Bangalore Endocrinology&Diabetes Research Centre #355th CrossMalleswaram CircleBangaloreKarnataka 560003India Department of Endocrinology St.John’s Medical College&HospitalSarjapur RoadKoramangalaBangaloreKarnataka 560034India Department of Endocrinology Osmania General Hospital2nd FloorGolden Jubilee BlockAfzalgunjHyderabadTelangana 500012India Department of Medicine Section of Endocrinology and DiabetesAga Khan UniversityStadium RoadKarachi 74800Pakistan Department of Endocrinology&Metabolism All India Institute of Medical SciencesBiotechnology Block3rd FloorAnsari NagarNew Delhi 110029India Endocrine Unit Department of MedicineGoa Medical CollegeBambolimGoa 403202India Public Health Foundation of India 4th FloorPlot No.47Sector 44Institutional AreaGurgaonHaryana 122002India Rollins School of Public Health Emory University1518 Clifton RoadRm CNR 7049AtlantaGA 30322USA Rollins School of Public Health Emory University1518 Clifton RoadAtlantaGA 30322USA Department of Endocrinology&Metabolism All India Institute of Medical SciencesBiotechnology Block3rd FloorRm#312Ansari NagarNew Delhi 110029India Centre for Chronic Disease Control C 1/52Second FloorSafdarjung Development AreaNew Delhi110016India London School of Hygiene and Tropical Medicine Keppel StBloomsburyLondon WC1E 7HTUK. 不详

Background:Economic dimensions of implementing quality improvement for diabetes care are understudied *** describe the economic evaluation protocol within a randomised controlled trial that tested a multicomponent quality improvement(QI)strategy for individuals with poorly-controlled type 2 diabetes in South ***/design:This economic evaluation of the Centre for Cardiometabolic Risk Reduction in South Asia(carrs)randomised trial involved 1146 people with poorly-controlled type 2 diabetes receiving care at 10 diverse diabetes clinics across India and *** economic evaluation comprises both a within-trial cost-effectiveness analysis(mean 2.5 years follow up)and a microsimulation model-based cost-utility analysis(life-time horizon).Effectiveness measures include multiple risk factor control(achieving HbA1ctrial *** measures include direct medical and non-medical costs relevant to outpatient care(consultation fee,medicines,laboratory tests,supplies,food,and escort/accompanying person costs,transport)and inpatient care(hospitalization,transport,and accompanying person costs)of the intervention compared to usual diabetes ***,healthcare system,and societal perspectives will be applied for *** cost and health effects will be discounted at 3%per year for within trial cost-effectiveness analysis over 2.5 years and decision modelling analysis over a lifetime *** will be reported as the incremental cost-effectiveness ratios(ICER)to achieve multiple risk factor control,avoid diabetes-related complications,or QALYs gained against varying levels of willingness to pay threshold *** analyses will be performed to assess uncertainties around ICER estimates by varying costs(95%CIs)across publ

关键词： Economic evaluation Diabetes care Multicomponent strategy Quality improvement South Asia

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甲异靛治疗慢性粒细胞白血病 Ⅲ 期临床观察

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中华血液学杂志 1997年第2期18卷 69-72页

作者： Cooperative Study group of Phase Ⅲ Clinical trial on Meisoindico,Tianjin 300020 甲异靛Ⅲ期临床试验协作组

目的：进一步考察甲异靛的疗效及副作用。方法：１９９４年３月～１９９５年７月中华医学会组织全国甲异靛治疗慢性粒细胞白血病（ＣＭＬ）Ⅲ期临床试验协作组，包括３６个省级以上医疗单位，有４０２例ＣＭＬ患者进入临床观察，可评价... 详细信息

目的：进一步考察甲异靛的疗效及副作用。方法：１９９４年３月～１９９５年７月中华医学会组织全国甲异靛治疗慢性粒细胞白血病（ＣＭＬ）Ⅲ期临床试验协作组，包括３６个省级以上医疗单位，有４０２例ＣＭＬ患者进入临床观察，可评价疗效的有３７４例。结果：单一用药，每日７５～１５０ｍｇ，总有效率为９０．１％，缓解率为８１．３％。初治患者疗效优于复治患者，缩脾效果好。获最佳疗效的时间平均为７３．３天。副作用主要为不同程度的骨、关节、肌肉的疼痛，消化道反应轻微，近期与长期观察无心、肝、肾功能的损害，所有患者均未发生骨髓抑制。结论：甲异靛是一种新型的治疗ＣＭＬ的药物。

关键词：慢性白血病甲异靛治疗

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Dual antiplatelet therapy may increase the risk of non-intracranial haemorrhage in patients with minor strokes: a subgroup analysis of the CHANCE trial

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Stroke & Vascular Neurology 2016年第2期1卷 29-36页

作者： David Wang Li Gui Yi Dong Hao Li Shujuan Li Huaguang Zheng Anxin Wang Xia Meng Li-Ping Liu Yi-Long Wang Guangyao Wang Jing Jing Zixiao Li Xing-Quan Zhao Yong-Jun Wang on behalf of the investigators for the CHANCE trial Illinois Neurological Institute Stroke Network Sisters of the Third Order of St.Francis Healthcare SystemUniversity of Illinois College of MedicinePeoriaIllinoisUSA Southwest Hospital Stroke Center Third Military University of Medical SciencesChongqingChina Department of Neurology Huashan HospitalFudan UniversityShanghaiChina China National Clinical Research Center for Neurological Diseases BeijingChina Chaoyang Hospital Neurology Department Capital Medical UniversityBeijingChina Department of Neurology Beijing Tiantan HospitalTiantan Clinical Trial and Research Center for StrokeCapital Medical UniversityBeijingChina Neurological Intensive Care Unit Beijing Tiantan HospitalCapital Medical UniversityBeijingChina Department of Neurology Beijing Tiantan HospitalVascular NeurologyCapital Medical UniversityBeijingChina 不详

Aim:The aim of this study was to explore the difference between haemorrhagic events among those patients on either aspirin or aspirin plus clopidogrel who were enrolled in the Clopidogrel in High-Risk Patients with Acute Non-disabling Ischemic Cerebrovascular Events(CHANCE)***:This was an ad hoc analysis of the CHANCE trial;data on all patients with any haemorrhagic event were reviewed and *** proportional hazards regression was used to determine factors association with any ***:In the CHANCE trial,there were a total of 101(2%)haemorrhagic events reported from 50 different *** clopidogrel–aspirin group had 60(2.3%)cases and the aspirin group had 41(1.6%,p=0.09).Moderate or severe haemorrhagic events occurred in 7 patients(0.3%)in the clopidogrel–aspirin group and in 8(0.3%)in the aspirin group(p=0.73).Of 36(0.7%)cases of intracranial haemorrhages,20(0.4%)were in the clopidogrel–aspirin group and 16(0.3%)in the aspirin *** group had 8(0.3%)cases of symptomatic haemorrhagic *** common haemorrhagic events included 24(0.5%)cases of skin bruises,13(0.3%)gastrointestinal haemorrhages,9(0.2%)gum haemorrhages and 8(0.2%)intraocular ***:There was no overall significant difference in haemorrhagic events(p=0.29),especially in the rate of intracranial haemorrhages between the 2 treatment ***,patients enrolled with minor strokes had an increased risk of haemorrhagic events regardless of treatment group,not seen in patients with high-risk transient ischaemic *** elderly,of male gender and with a history of aspirin or proton pump inhibitor usage were associated with increased risk of *** with higher body mass index had lower risk of haemorrhagic events.

关键词： patients intracranial analysis

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Shanghai expert consensus on clinical protocol for traditional Chinese medicine treatment of COVID-19 among the elderly population(second edition)

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Journal of Integrative Medicine 2022年第5期20卷 427-431页

作者： Xuan Chen Chou-ping Han Wei Zhang on behalf of Writing group of the Shanghai Expert Consensus on Clinical Protocol for Traditional Chinese Medicine Treatment of COVID-among the Elderly Population(Second Edition) Department of Respiratory and Critical Care Medicine Shuguang HospitalShanghai University of Traditional Chinese MedicineShanghai 201203China International Education College Shanghai University of Traditional Chinese MedicineShanghai 201203China Research Center for Traditional Chinese Medicine Shanghai Institute of Infectious Diseases and BiosecurityShuguang HospitalShanghai University of Traditional Chinese MedicineShanghai 201203China 不详

This document is the revised edition of the previously issued Shanghai Expert Consensus on Clinical Protocol for Traditional Chinese Medicine Treatment of COVID-19 among the Elderly *** on the clinical experience and the Protocol for Diagnosis and Treatment of COVID-19(trial 9th Edition),this revised edition provides treatment approaches and recommendations to proactively cope with Omicron variant and increase the therapeutic efficacy for coronavirus disease 2019 among the elderly population in Shanghai,China.

关键词： COVID-19 Aged Elderly population Expert consensus Traditional Chinese medicine Clinical treatment

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Results of the cancer screening feasibility study in China:a multicentered randomized controlled trial of lung and colorectal cancer screening

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Journal of the National Cancer Center 2021年第4期1卷 132-138页

作者： Jiang Li Ping Hu Jufang Shi Yaguang Fan Jiansong Ren Hongda Chen Ni Li Xianzhen Liao Yuqin Liu Lingbin Du Ning Wu Wei Tang Yueming Zhang Shuangmei Zou Paul Pinsky Philip Prorok Richard Fagerstrom Martina Taylor Barnett Kramer Min Dai Jie He on behalf of the China Cancer Screening trial Feasibility Study group National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital Chinese Academy of Medical Sciences and Peking Union Medical CollegeBeijingChina National Cancer Institute BethesdaUSA Tianjin Lung Cancer Institute Tianjin Medical University General HospitalTianjinChina Hunan Cancer Hospital ChangshaChina Gansu Cancer Hospital LanzhouChina Zhejiang Cancer Hospital HangzhouChina 不详

Background:To provide an understanding of important aspects of the participant recruitment and data collec-tion,become aware of any potential problems,and obtain necessary information in order to design a large-scale randomized controlled trial(RCT)for lung cancer and colorectal cancer(CRC)screening in ***:This feasibility study was a multicentered,open-label,pilot randomized trial.A total of 2696 participants who were at high risk of lung cancer were recruited from three screening centers and randomly allocated to arm 1(n=894),annual low-dose computed tomography(LDCT)plus a baseline colonoscopy;arm 2(n=902),biennial LDCT plus annual fecal immunochemical test(FIT)with OC-Sensor(OC-FIT);and arm 3(n=900),annual Insure-FIT plus Septin 9 blood *** on randomization,compliance,positivity rate,cancer case detection,and contamination with screening for lung cancer and CRC were ***:Participant characteristics were similar across study *** compliance rate of annual LDCT screening in arm 1 was 86.4%(95%CI:83.9%,88.5%)at baseline(T0),and 69.0%(95%CI:65.8%,72.0%)and 70.7%(95%CI:67.6%,73.7%)at the following two rounds(T1 and T2).The compliance rates of biennial LDCT screening in arm 2 were similar to those in arm 1 in the corresponding *** compliance rate was 55.5%(95%CI:52.2%,58.8%)for colonoscopy in arm 1,while the compliance rates of OC-FIT,Insure-FIT,and the Septin 9 test in arms 2 and 3 were all approximately 90%at T0,decreasing to 65%-80%at T1 and *** positivity rate,cancer case detection rate,and contamination rate of screening for lung cancer and CRC were also ***:In this pilot study,the feasibility of an RCT in China of lung cancer and CRC screening was demon-strated.

关键词： Screening Multicentered Randomized controlled trial Lung cancer Colorectal cancer

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Intensive blood pressure control on arterial stiffness among older patients with hypertension

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Chinese Medical Journal 2024年第9期137卷 1078-1087页

作者： Shuyuan Zhang Yixuan Zhong Shouling Wu Hailei Wu Jun Cai Weili Zhang On behalf of the STEP Study group National Clinical Research Center of Cardiovascular Diseases Fuwai HospitalNational Center for Cardiovascular DiseasesPeking Union Medical College&Chinese Academy of Medical SciencesBeijing 100037China Department of Cardiology State Key Laboratory of Complex Severe and Rare DiseasesPeking Union Medical College HospitalChinese Academy of Medical Sciences&Peking Union Medical CollegeBeijing 100730China State Key Laboratory of Cardiovascular Disease Fuwai HospitalNational Center for Cardiovascular DiseasesPeking Union Medical College&Chinese Academy of Medical SciencesBeijing 100037China Department of Cardiology Kailuan General HospitalTangshanHebei 063000China Central China Subcenter of National Center for Cardiovascular Diseases Henan Cardiovascular Disease CenterFuwai Central-China Cardiovascular HospitalCentral China Fuwai Hospital of Zhengzhou UniversityZhengzhouHenan 450046China 不详

Background:Arterial stiffening increases with age and blood pressure and is associated with cardiovascular disease(CVD),but the relationship between blood pressure lowering and arterial stiffening is still uncertain,especially in older *** study aimed to evaluate the effect of intensive blood pressure treatment on the progression of arterial stiffness and risk of CVD in older patients with ***:The Strategy of Blood Pressure Intervention in the Elderly Hypertensive Patients(STEP)trial was a multicenter,randomized,controlled trial performed at 42 clinical centers throughout China,and 8511 patients aged 60-80 years with essential hypertension were enrolled and randomly assigned to systolic blood pressure(SBP)target of 110 mmHg togroups were analyzed using a multivariate linear regression *** Cox proportional hazard regression model was used to evaluate the effect of intensive treatment on primary CVD ***:The changes in baPWV were 61.5 cm/s(95%confidence interval[CI]:49.8-73.2 cm/s)in the intensive treatment group and 98.4 cm/s(95%CI:86.7-110.1 cm/s)in the standard treatment group(Pgroups,*** a median follow-up period of 3.36 years,primary CVD outcomes occurred in 77(2.9%)patients in the intensive treatment group compared with 93(3.5%)in the standard treatment *** tre

关键词： Hypertension Arterial stiffness Cardiovascular disease Older people Blood pressure Pulse wave velocity

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瑞舒伐他汀治疗中国高胆固醇血症患者疗效和安全性的随机双盲多中心对照研究

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中华心血管病杂志 2007年第3期35卷 207-211页

作者： Rosuvastatin Registration Clinical trial group.Cardiovascular Institute and Fu Wai Hospital,Peking Union Medical College and Chinese Academy of Medical Science,Beijing 100037,China 瑞舒伐他汀中国注册临床研究协作组

目的评价瑞舒伐他汀治疗中国高胆固醇血症患者的疗效和安全性。方法采用随机、双盲、多中心研究。患者经6周筛选后符合 LDL-C≥4.14 mmol/L(160 mg/dl),<6.50 mmol/L(250 mg/dl)、TG<4.52 mmol/L(400 mg/dl)者以2:1随机接受瑞舒伐他汀10... 详细信息

目的评价瑞舒伐他汀治疗中国高胆固醇血症患者的疗效和安全性。方法采用随机、双盲、多中心研究。患者经6周筛选后符合 LDL-C≥4.14 mmol/L(160 mg/dl),<6.50 mmol/L(250 mg/dl)、TG<4.52 mmol/L(400 mg/dl)者以2:1随机接受瑞舒伐他汀10 mg/d 或阿托伐他汀10mg/d 治疗。12周后瑞舒伐他汀组 LDL-C 未达到 ATPⅢ治疗目标者,予瑞舒伐他汀20 mg 延续治疗8周。结果 304例进入随机治疗阶段,瑞舒伐他汀10 mg/d 组201例,阿托伐他汀10 mg/d 组103例。意向治疗人群290例,符合方案人群263例。瑞舒伐他汀组治疗12周后血 LDL-C 显著下降,下降幅度为45.6%,显著大于阿托伐他汀组的39.0%(P<0.001)。瑞舒伐他汀组患者 LDL-C 达标率也较阿托伐他汀组(78.0%比72.7%)有增高趋势,且在高危人群中优势更为明显(56.5%比35.0%),但差异未达到统计学意义。瑞舒伐他汀降低 TG(-22.8%)以及升高 HDL-C(+6.6%)和ApoA-1(+12.5%)的幅度与阿托伐他汀组差别无统计学意义(分别为-16.6%,+4.3%和+9.8%)。29例患者接受20 mg/d 瑞舒伐他汀延续治疗,22例完成治疗患者中10例(45.5%)LDL-C达标。研究中未发现药物相关的严重不良反应事件。结论本组研究显示瑞舒伐他汀10 mg 降低LDL-C 的疗效优于同等剂量的阿托伐他汀,治疗3个月安全性与之类似。

关键词：高胆固醇血症降血脂药治疗结果

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帕尼培南-倍他米隆治疗665例中重度肺部感染疗效与安全性

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中华内科杂志 2012年第7期51卷 547-550页

作者：无孙铁英帕尼培南-倍他米隆临床研究小组卫生部北京医院呼吸科 100730

目的评价帕尼培南-倍他米隆治疗中重度肺部感染的临床有效性与安全性。方法开放性、前瞻性、多中心临床研究。对621例中重度肺部感染患者[社区获得性肺炎（CAP）345例，医院获得性肺炎（HAP）230例，呼吸机相关性肺炎（VAP）46例]静脉... 详细信息

目的评价帕尼培南-倍他米隆治疗中重度肺部感染的临床有效性与安全性。方法开放性、前瞻性、多中心临床研究。对621例中重度肺部感染患者[社区获得性肺炎（CAP）345例，医院获得性肺炎（HAP）230例，呼吸机相关性肺炎（VAP）46例]静脉滴注帕尼培南-倍他米隆500mg，10（／6h，7～14d一个疗程，评估治疗结束时的临床疗效和细菌学疗效，记录观察期间出现的不良反应。结果帕尼培南-倍他米隆治疗中重度肺部感染的临床有效率为84．4％，其中CAP、HAP、VAP的临床有效率分别为91．9％、76．1％、69．6％，中度、重度肺部感染的临床有效率分别为87．5％和82．8％。细菌分离阳性率为54．8％，细菌学清除率为80．9％；对铜绿假单胞菌、肺炎克雷伯杆菌、大肠埃希菌、鲍曼不动杆菌的清除率分别为74．7％、95．6％、89．5％和50．9％。与药物相关的不良反应12例，发生率为1．8％，均为轻度，未予处理，停药后恢复正常。结论帕尼培南．倍他米隆治疗中重度肺部感染的疗效佳且不良反应发生率低。

关键词：帕尼培南-倍他米隆呼吸道感染治疗结果安全

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卡托普利对前壁与下壁心肌梗塞作用差异的临床试验

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中华心血管病杂志 1995年第3期23卷 165-169页

作者： (Chinese CEI-AMI Clinical trial Collaboration group)(Correspondence: Department of Hypertension, Fu Wai Hospital, CAMS, 100037 Beijing, China) 中国CEI-AMI临床研究协作组

报告中国转换酶抑制剂治疗急性心肌梗塞多中心随机双盲安慰剂对照临床试验的一部分，重点探讨卡托普利对前壁与下壁心肌梗塞作用的差异。选择急性心肌梗塞患者１２６３１例，随机分配到卡托普利治疗组或安慰剂对照组，口服卡托普利或安... 详细信息

报告中国转换酶抑制剂治疗急性心肌梗塞多中心随机双盲安慰剂对照临床试验的一部分，重点探讨卡托普利对前壁与下壁心肌梗塞作用的差异。选择急性心肌梗塞患者１２６３１例，随机分配到卡托普利治疗组或安慰剂对照组，口服卡托普利或安慰剂１２．５ｍｇ３次／ｄ，治疗４周。结果提示：前壁梗塞（ｎ＝６０５７）治疗组４周病死率（９．２％）明显低于对照组（１０．８％），减少死亡危险１５％（Ｐ＝０．０４），但下壁梗塞（ｎ＝３９９０）病死率治疗组（７．２％）与对照组（６．７％）差异无显著性（Ｐ＝０．５４）。发病６ｈ内入选前壁梗塞病死率治疗组（９．５％）显著低于对照组（１３．２％）（Ｐ＝０．００４），但下壁无此差异。非心动过缓（心率≥６０次／分）者总病死率治疗组（９．５％）明显低于对照组（１１．５％；Ｐ＝０．０４），在前壁尤为显著（治疗组８．６％；对照组１２．５％，Ｐ＝０．００１）。结果表明：卡托普利早期治疗前壁心肌梗塞是安全和有益的，但对下壁则无益。

关键词：卡托普利心肌梗塞死亡率药物疗法

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Association of fluid balance trajectories with clinical outcomes in patients with septic shock:A prospective multicenter cohort study

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Military Medical Research 2021年第3期8卷 395-404页

作者： Mei-Ping Wang Li Jiang Bo Zhu Bin Du Wen Li Yan He Xiu-Ming Xi China Critical Care Sepsis trial(CCCST)workgroup Department of Epidemiology and Health Statistics School of Public HealthCapital Medical UniversityNo.10XitoutiaoYou’anmenBeijingFengtai DistrictChina Department of Critical Care Medicine Fuxing HospitalCapital Medical UniversityNo.20Street FuxingmenwaiBeijingXicheng DistrictChina Department of Critical Care Medicine Xuanwu HospitalCapital Medical UniversityBeijing 100053China Medical Intensive Care Unit Peking Union Medical College HospitalPeking Union Medical College and Chinese Academy of Medical SciencesBeijing 100730China

Background:Septic shock has a high incidence and mortality rate in Intensive Care Units(ICUs).Earlier intravenous fluid resuscitation can significantly improve outcomes in septic patients but easily leads to fluid overload(FO),which is associated with poor clinical outcomes.A single point value of fluid cannot provide enough fluid *** aim of this study was to investigate the impact of fluid balance(FB)latent trajectories on clinical outcomes in septic ***:Patients were diagnosed with septic shock during the first 48 h,and sequential fluid data for the first 3 days of ICU admission were included.A group-based trajectory model(GBTM)which is designed to identify groups of individuals following similar developmental trajectories was used to identify latent subgroups of individuals following a similar progression of *** primary outcomes were hospital mortality,organ dysfunction,major adverse kidney events(MAKE)and severe respiratory adverse events(SRAE).We used multivariable Cox or logistic regression analysis to assess the association between FB trajectories and clinical ***:Nine hundred eighty-six patients met the inclusion criteria and were assigned to GBTM analysis,and three latent FB trajectories were detected.64(6.5%),841(85.3%),and 81(8.2%)patients were identified to have decreased,low,and high FB,*** with low FB,high FB was associated with increased hospital mortality[hazard ratio(HR)=1.63,95%CI 1.22–2.17],organ dysfunction[odds ratio(OR)=2.18,95%CI 1.22–3.42],MAKE(OR=1.80,95%CI 1.04–2.63)and SRAE(OR=2.33,95%CI 1.46–3.71),and decreasing FB was significantly associated with decreased MAKE(OR=0.46,95%CI 0.29–0.79)after adjustment for potential ***:Latent subgroups of septic patients followed a similar FB *** latent fluid trajectories were associated with clinical *** decreasing FB trajectory was associated with a decreased risk of hospital mortality and MAKE.

关键词： Septic shock Fluid overload group-based trajectory model Clinical outcomes

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