Objective:To develop and demonstrate a comprehensive methodological framework for target trial emulation(TTE)implementation via post-laparoscopic septic shock fluid management as a clinical case study.Methods:We desig...Objective:To develop and demonstrate a comprehensive methodological framework for target trial emulation(TTE)implementation via post-laparoscopic septic shock fluid management as a clinical case study.Methods:We designed a simulated study of 10,000 patients in which colloid resuscitation was compared with crystalloid resuscitation.The framework incorporated precise eligibility criteria,standardized intervention protocols,and balanced treatment allocation with temporal anchoring.The primary analyses focused on 28-day mortality and were evaluated through survival analysis and comparative statistics.Results:The methodological framework successfully demonstrated the systematic implementation of TTE principles,providing reproducible protocols for eligibility determination,intervention standardization,and outcome assessment in observational studies.Conclusion:This work bridges the gap between TTE theory and practice by providing a detailed technical roadmap that enhances methodological transparency and reproducibility in comparative effectiveness research.展开更多
Objective To investigate the effectiveness of Xuanshen Yishen Decoction(XYD)in the treatment of hypertension.Methods Hospital electronic medical records from 2019–2023 were utilized to emulate a randomized pragmatic ...Objective To investigate the effectiveness of Xuanshen Yishen Decoction(XYD)in the treatment of hypertension.Methods Hospital electronic medical records from 2019–2023 were utilized to emulate a randomized pragmatic clinical trial.Hypertensive participants were eligible if they were aged≥40 years with baseline systolic blood pressure(BP)≥140 mm Hg.Patients treated with XYD plus antihypertensive regimen were assigned to the treatment group,whereas those who followed only antihypertensive regimen were assigned to the control group.The primary outcome assessed was the attainment rate of intensive BP control at discharge,with the secondary outcome focusing on the 6-month all-cause readmission rate.Results The study included 3,302 patients,comprising 2,943 individuals in the control group and 359 in the treatment group.Compared with the control group,a higher proportion in the treatment group achieved the target BP for intensive BP control[8.09%vs.17.5%;odds ratio(OR)=2.29,95%confidence interval(CI)=1.68 to 3.13;P<0.001],particularly in individuals with high homocysteine levels(OR=3.13;95%CI=1.72 to 5.71;P<0.001;P for interaction=0.041).Furthermore,the 6-month all-cause readmission rate in the treatment group was lower than in the control group(hazard ratio=0.58;95%CI=0.36 to 0.91;P=0.019),and the robustness of the results was confirmed by sensitivity analyse.Conclusions XYD could be a complementary therapy for intensive BP control.Our study offers real-world evidence and guides the choice of complementary and alternative therapies.(Registration No.ChiCTR2400086589)展开更多
Hyperuricemia is considered a modifiable risk factor for the development and progression of chronic kidney disease(CKD).There remains controversy over the effects of urate-lowering therapy(ULT)on kidney outcomes in pa...Hyperuricemia is considered a modifiable risk factor for the development and progression of chronic kidney disease(CKD).There remains controversy over the effects of urate-lowering therapy(ULT)on kidney outcomes in patients with CKD and hyperuricemia.We conducted a cohort study using a sequential target trial emulation framework to evaluate the composite kidney outcomes in patients with CKD and hyperuricemia initiating ULT versus supportive care alone(control).A total of 269,831 eligible person trials(56,936 unique persons)with CKD and hyperuricemia who had received supportive care were included from the China Renal Data System database.The primary outcome was a composite kidney outcome defined as a greater than 40%decline in the estimated GFR or end-stage kidney disease(ESKD).The 3-year cumulative incidence rates of the composite kidney outcomes were 19.69%and 23.22%in the ULT group and the control group,respectively,with a risk difference of−3.53%(95%CI,−5.25%to−1.94%).The estimated 3-year risk differences for ESKD,all-cause mortality,and cardiovascular mortality were−1.88%(−3.28%to−0.45%),−2.25%(−3.02%to−1.51%),and−0.69%(−1.33%to−0.05%),respectively,all of which favor the ULT group.The estimates from the subgroup and sensitivity analyses were consistent with those from the primary analysis.Thus,ULT is associated with a significantly lower risk of kidney disease progression and mortality in patients with stage 3 or higher CKD and hyperuricemia.Large randomized clinical trials with refined designs are needed to assess the effect of ULT in these patients.展开更多
基金Zhongheng Zhang received funding from the National Natural Science Foundation of China(82272180,82472243)the China National Key Research and Development Program(2023YFC3603104)+5 种基金the Huadong Medicine Joint Funds of the Zhejiang Provincial Natural Science Foundation of China(LHDMD24H150001)the China National Key Research and Development Program(2022YFC2504500)a collaborative scientific project co-established by the Science and Technology Department of the National Administration of Traditional Chinese Medicine and the Zhejiang Provincial Administration of Traditional Chinese Medicine(GZY-ZJKJ-24082)the General Health Science and Technology Program of Zhejiang Province(2024KY1099)Project of Zhejiang University Longquan Innovation Center(ZJDXLQCXZCJBGS2024016)Hongying Ni received funding from Jinhua Science and Technology Planning Project(2024-3-047).
文摘Objective:To develop and demonstrate a comprehensive methodological framework for target trial emulation(TTE)implementation via post-laparoscopic septic shock fluid management as a clinical case study.Methods:We designed a simulated study of 10,000 patients in which colloid resuscitation was compared with crystalloid resuscitation.The framework incorporated precise eligibility criteria,standardized intervention protocols,and balanced treatment allocation with temporal anchoring.The primary analyses focused on 28-day mortality and were evaluated through survival analysis and comparative statistics.Results:The methodological framework successfully demonstrated the systematic implementation of TTE principles,providing reproducible protocols for eligibility determination,intervention standardization,and outcome assessment in observational studies.Conclusion:This work bridges the gap between TTE theory and practice by providing a detailed technical roadmap that enhances methodological transparency and reproducibility in comparative effectiveness research.
基金Supported by State Administration of Traditional Chinese Medicine High-Level Chinese Medicine Key Discipline Construction Project(No.zyyzdxk-2023120)the Joint Scientific and Technological Projects of Department of Science and Technology,National Administration of Traditional Chinese Medicine(No.GZY-KJS-SD-2023-036)。
文摘Objective To investigate the effectiveness of Xuanshen Yishen Decoction(XYD)in the treatment of hypertension.Methods Hospital electronic medical records from 2019–2023 were utilized to emulate a randomized pragmatic clinical trial.Hypertensive participants were eligible if they were aged≥40 years with baseline systolic blood pressure(BP)≥140 mm Hg.Patients treated with XYD plus antihypertensive regimen were assigned to the treatment group,whereas those who followed only antihypertensive regimen were assigned to the control group.The primary outcome assessed was the attainment rate of intensive BP control at discharge,with the secondary outcome focusing on the 6-month all-cause readmission rate.Results The study included 3,302 patients,comprising 2,943 individuals in the control group and 359 in the treatment group.Compared with the control group,a higher proportion in the treatment group achieved the target BP for intensive BP control[8.09%vs.17.5%;odds ratio(OR)=2.29,95%confidence interval(CI)=1.68 to 3.13;P<0.001],particularly in individuals with high homocysteine levels(OR=3.13;95%CI=1.72 to 5.71;P<0.001;P for interaction=0.041).Furthermore,the 6-month all-cause readmission rate in the treatment group was lower than in the control group(hazard ratio=0.58;95%CI=0.36 to 0.91;P=0.019),and the robustness of the results was confirmed by sensitivity analyse.Conclusions XYD could be a complementary therapy for intensive BP control.Our study offers real-world evidence and guides the choice of complementary and alternative therapies.(Registration No.ChiCTR2400086589)
基金supported by grants 2021YFC2500200 and 2021YFC2500204(X.X.)from the National Key R&D Program of China2023B1111030004 to F.F.H.from the Key Technologies R&D Program of Guangdong Province+3 种基金2020B11170013 from Guangdong Provincial Clinical Research(F.F.H.)D18005 from the Program of Introducing Talents of Discipline to Universities(F.F.H.)82030022(F.F.H.)and 82330020(F.F.H.)from the National Natural Science Foundation of China2024A1515220155 from the Basic and Applied Basic Research Foundation of Guangdong Province(S.N.).
文摘Hyperuricemia is considered a modifiable risk factor for the development and progression of chronic kidney disease(CKD).There remains controversy over the effects of urate-lowering therapy(ULT)on kidney outcomes in patients with CKD and hyperuricemia.We conducted a cohort study using a sequential target trial emulation framework to evaluate the composite kidney outcomes in patients with CKD and hyperuricemia initiating ULT versus supportive care alone(control).A total of 269,831 eligible person trials(56,936 unique persons)with CKD and hyperuricemia who had received supportive care were included from the China Renal Data System database.The primary outcome was a composite kidney outcome defined as a greater than 40%decline in the estimated GFR or end-stage kidney disease(ESKD).The 3-year cumulative incidence rates of the composite kidney outcomes were 19.69%and 23.22%in the ULT group and the control group,respectively,with a risk difference of−3.53%(95%CI,−5.25%to−1.94%).The estimated 3-year risk differences for ESKD,all-cause mortality,and cardiovascular mortality were−1.88%(−3.28%to−0.45%),−2.25%(−3.02%to−1.51%),and−0.69%(−1.33%to−0.05%),respectively,all of which favor the ULT group.The estimates from the subgroup and sensitivity analyses were consistent with those from the primary analysis.Thus,ULT is associated with a significantly lower risk of kidney disease progression and mortality in patients with stage 3 or higher CKD and hyperuricemia.Large randomized clinical trials with refined designs are needed to assess the effect of ULT in these patients.
