Background:Economic dimensions of implementing quality improvement for diabetes care are understudied worldwide.We describe the economic evaluation protocol within a randomised controlled trial that tested a multicomp...Background:Economic dimensions of implementing quality improvement for diabetes care are understudied worldwide.We 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 Asia.Methods/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 Pakistan.The 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 HbA1c<7%and blood pressure<130/80 mmHg and/or LDL-cholesterol<100 mg/dl),and patient reported outcomes including quality adjusted life years(QALYs)measured by EQ-5D-3 L,hospitalizations,and diabetes related complications at the trial end.Cost 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 care.Patient,healthcare system,and societal perspectives will be applied for costing.Both 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 horizon.Outcomes 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 values.Sensitivity analyses will be performed to assess uncertainties around ICER estimates by varying costs(95%CIs)across public vs.private settings and using conservative estimates of effect size(95%CIs)for multiple risk factor control.Costs will be reported in US$2018.Discussion:We hypothesize that the additional upfront costs of delivering the intervention will be counterbalanced by improvements in clinical outcomes and patient-reported outcomes,thereby rendering this multi-component QI intervention cost-effective in resource constrained South Asian settings.Trial registration:ClinicalTrials.gov:NCT01212328.展开更多
基金funded in part by the National Heart,Lung,and Blood Institute,National Institutes of Health,U.SDepartment of Health and Human Services,under contract number HHSN268200900026C+3 种基金by UnitedHealth Group,Minneapolis,Minnesota.Several members of the research team at the Public Health Foundation of India and Emory University were supported by the Fogarty International Clinical Research Scholars and Fellows program through grant number 5R24TW007988 from the National Institutes of Health,Fogarty International Center through Vanderbilt University,Emory Global Health Institute,and D43 NCDs in India Training Program through award number 1D43HD05249 from the Eunice Kennedy Shriver National Institute of Child Health and Human Development and Fogarty International Centersupported by the Fogarty International Center,National Institutes of Health,under award number D43TW008332(ASCEND Research Network)supported by the National Institute of Mental Health supplemental grant under award number:R01MH100390-04S1development team:Mr.Prashant Tandon and Mr.Ajeet Kushwaha.The funding sources were not involved in the data collection,analysis,writing or interpretation of the manuscript or the decision to submit it for publication.
文摘Background:Economic dimensions of implementing quality improvement for diabetes care are understudied worldwide.We 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 Asia.Methods/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 Pakistan.The 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 HbA1c<7%and blood pressure<130/80 mmHg and/or LDL-cholesterol<100 mg/dl),and patient reported outcomes including quality adjusted life years(QALYs)measured by EQ-5D-3 L,hospitalizations,and diabetes related complications at the trial end.Cost 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 care.Patient,healthcare system,and societal perspectives will be applied for costing.Both 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 horizon.Outcomes 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 values.Sensitivity analyses will be performed to assess uncertainties around ICER estimates by varying costs(95%CIs)across public vs.private settings and using conservative estimates of effect size(95%CIs)for multiple risk factor control.Costs will be reported in US$2018.Discussion:We hypothesize that the additional upfront costs of delivering the intervention will be counterbalanced by improvements in clinical outcomes and patient-reported outcomes,thereby rendering this multi-component QI intervention cost-effective in resource constrained South Asian settings.Trial registration:ClinicalTrials.gov:NCT01212328.
