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

Springer Science and Business Media LLC - Tập 4 - Trang 1-10 - 2019
Kavita Singh1,2, Mohammed K. Ali3, Raji Devarajan1,2, Roopa Shivashankar2, Dimple Kondal1,2, Vamadevan S. Ajay1,2, V. Usha Menon4, Premlata K. Varthakavi5, Vijay Viswanathan6, Mala Dharmalingam7, Ganapati Bantwal8, Rakesh Kumar Sahay9, Muhammad Qamar Masood10, Rajesh Khadgawat11, Ankush Desai12, Dorairaj Prabhakaran13,2,14, K. M. Venkat Narayan3, Victoria L. Phillips3, Nikhil Tandon11
1Public Health Foundation of India, Center of Excellence - Center for CArdio-metabolic Risk Reduction in South Asia, Gurgaon, India
2Centre for Chronic Disease Control, New Delhi, India
3Rollins School of Public Health, Emory University, Atlanta, USA
4Department of Endocrinology & Diabetes, Amrita Institute of Medical Sciences, Amrita Vishwa Vidyapeetham, Ponekkara P.O., Kochi, India
5Department of Endocrinology, TNM College & BYL Nair Charity Hospital, Mumbai, India
6MV Hospital for Diabetes & Diabetes Research Centre, Chennai, India
7Bangalore Endocrinology & Diabetes Research Centre, Bangalore, India
8Department of Endocrinology, St. John’s Medical College Hospital, Bangalore, India
9Department of Endocrinology, Osmania General Hospital, Hyderabad, India
10Department of Medicine, Section of Endocrinology and Diabetes, Aga Khan University, Karachi, Pakistan
11Department of Endocrinology & Metabolism, All India Institute of Medical Sciences, New Delhi, India
12Endocrine Unit, Department of Medicine, Goa Medical College, Bambolim, India
13Public Health Foundation of India, Gurgaon, India
14London School of Hygiene and Tropical Medicine, London, UK

Tóm tắt

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 multi-component quality improvement (QI) strategy for individuals with poorly-controlled type 2 diabetes in South Asia. 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. 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. ClinicalTrials.gov: NCT01212328 .

Tài liệu tham khảo

Bommer C, Heesemann E, Sagalova V, Manne-Goehler J, Atun R, Barnighausen T, Vollmer S. The global economic burden of diabetes in adults aged 20-79 years: a cost-of-illness study. Lancet Diabetes Endocrinol. 2017;5(6):423–30.

Basu S, Bendavid E, Sood N. Health and economic implications of National Treatment Coverage for cardiovascular disease in India: cost-effectiveness analysis. Circ Cardiovasc Qual Outcomes. 2015;8(6):541–51.

Deepa M, Anjana RM, Manjula D, Narayan KM, Mohan V. Convergence of prevalence rates of diabetes and cardiometabolic risk factors in middle and low income groups in urban India: 10-year follow-up of the Chennai urban population study. J Diabetes Sci Technol. 2011;5(4):918–27.

Decker SL, Kostova D, Kenney GM, Long SK. Health status, risk factors, and medical conditions among persons enrolled in Medicaid vs uninsured low-income adults potentially eligible for Medicaid under the affordable care act. JAMA. 2013;309(24):2579–86.

Shivashankar R, Kirk K, Kim WC, Rouse C, Tandon N, Narayan KM, Ali MK. Quality of diabetes care in low- and middle-income Asian and middle eastern countries (1993-2012): 20-year systematic review. Diabetes Res Clin Pract. 2015;107(2):203–23.

Tharkar S, Devarajan A, Kumpatla S, Viswanathan V. The socioeconomics of diabetes from a developing country: a population based cost of illness study. Diabetes Res Clin Pract. 2010;89(3):334–40.

Tharkar S, Satyavani K, Viswanathan V. Cost of medical care among type 2 diabetic patients with a co-morbid condition--hypertension in India. Diabetes Res Clin Pract. 2009;83(2):263–7.

Chin MH, Cook S, Jin L, Drum ML, Harrison JF, Koppert J, Thiel F, Harrand AG, Schaefer CT, Takashima HT, et al. Barriers to providing diabetes care in community health centers. Diabetes Care. 2001;24(2):268–74.

Sohal T, Sohal P, King-Shier KM, Khan NA. Barriers and facilitators for Type-2 diabetes Management in South Asians: a systematic review. PLoS One. 2015;10(9):e0136202.

Nam S, Chesla C, Stotts NA, Kroon L, Janson SL. Barriers to diabetes management: patient and provider factors. Diabetes Res Clin Pract. 2011;93(1):1–9.

Wangnoo SK, Maji D, Das AK, Rao PV, Moses A, Sethi B, Unnikrishnan AG, Kalra S, Balaji V, Bantwal G, et al. Barriers and solutions to diabetes management: an Indian perspective. Indian J Endocrinol Metab. 2013;17(4):594–601.

Ali MK, Singh K, Kondal D, Devarajan R, Patel SA, Shivashankar R, Ajay VS, Unnikrishnan AG, Menon VU, Varthakavi PK, et al. Effectiveness of a multicomponent quality improvement strategy to improve achievement of diabetes care goals: a randomized, controlled trial. Ann Intern Med. 2016;165(6):399–408.

Nuckols TK, Keeler E, Anderson LJ, Green J, Morton SC, Doyle BJ, Shetty K, Arifkhanova A, Booth M, Shanman R, et al. Economic evaluation of quality improvement interventions designed to improve glycemic control in diabetes: a systematic review and weighted regression analysis. Diabetes Care. 2018;41(5):985–93.

Singh K, Chandrasekaran AM, Bhaumik S, Chattopadhyay K, Gamage AU, Silva P, Roy A, Prabhakaran D, Tandon N. Cost-effectiveness of interventions to control cardiovascular diseases and diabetes mellitus in South Asia: a systematic review. BMJ Open. 2018;8(4):e017809.

Ramsey SD, Willke RJ, Glick H, Reed SD, Augustovski F, Jonsson B, Briggs A, Sullivan SD. Cost-effectiveness analysis alongside clinical trials II-an ISPOR good research practices task force report. Value Health. 2015;18(2):161–72.

Tan-Torres Edejer T, Baltussen R, Adam T, Hutubessy R, Acharya A, Evans DB, Murray CJL. WHO Guide to Cost-effectiveness analysis; 2003.

Sanders GD, Neumann PJ, Basu A, Brock DW, Feeny D, Krahn M, Kuntz KM, Meltzer DO, Owens DK, Prosser LA, et al. Recommendations for conduct, methodological practices, and reporting of cost-effectiveness analyses: second panel on cost-effectiveness in health and medicine. JAMA. 2016;316(10):1093–103.

Siegel JE, Weinstein MC, Russell LB, Gold MR. Recommendations for reporting cost-effectiveness analyses. Panel on cost-effectiveness in health and medicine. JAMA. 1996;276(16):1339–41.

The CARRS Trial Writing Group, Shah S, Singh K, Ali MK, Mohan V, Kadir MM, Unnikrishnan AG, Sahay RK, Varthakavi P, Dharmalingam M, et al. Improving diabetes care: multi-component cardiovascular disease risk reduction strategies for people with diabetes in South Asia--the CARRS multi-center translation trial. Diabetes Res Clin Pract. 2012;98(2):285–94.

Hayes AJ, Leal J, Gray AM, Holman RR, Clarke PM. UKPDS outcomes model 2: a new version of a model to simulate lifetime health outcomes of patients with type 2 diabetes mellitus using data from the 30 year United Kingdom prospective diabetes study: UKPDS 82. Diabetologia. 2013;56(9):1925–33.

Nabel EG, Braunwald E. A tale of coronary artery disease and myocardial infarction. N Engl J Med. 2012;366(1):54–63.

Krol M, Brouwer W. How to estimate productivity costs in economic evaluations. Pharmacoeconomics. 2014;32(4):335–44.

Nixon RM, Wonderling D, Grieve RD. Non-parametric methods for cost-effectiveness analysis: the central limit theorem and the bootstrap compared. Health Econ. 2010;19(3):316–33.

Fenwick E, Marshall DA, Levy AR, Nichol G. Using and interpreting cost-effectiveness acceptability curves: an example using data from a trial of management strategies for atrial fibrillation. BMC Health Serv Res. 2006;6:52.

Sonntag M, Konnopka A, Leichsenring F, Salzer S, Beutel ME, Herpertz S, Hiller W, Hoyer J, Joraschky P, Nolting B, et al. Reliability, validity and responsiveness of the EQ-5D in assessing and valuing health status in patients with social phobia. Health Qual Life Outcomes. 2013;11:215.

Horowitz E, Abadi-Korek I, Shani M, Shemer J. EQ-5D as a generic measure of health-related quality of life in Israel: reliability, validity and responsiveness. Isr Med Assoc J. 2010;12(12):715–20.

Yordanova S, Petkova V, Petrova G, Dimitrov M, Naseva E, Dimitrova M, Petkova E. Comparison of health-related quality-of-life measurement instruments in diabetic patients. Biotechnol Biotechnol Equip. 2014;28(4):769–74.

Simons CL, Rivero-Arias O, Yu LM, Simon J. Multiple imputation to deal with missing EQ-5D-3L data: should we impute individual domains or the actual index? Qual Life Res. 2015;24(4):805–15.

Faria R, Gomes M, Epstein D, White IR. A guide to handling missing data in cost-effectiveness analysis conducted within randomised controlled trials. Pharmacoeconomics. 2014;32(12):1157–70.

Briggs A, Clark T, Wolstenholme J, Clarke P. Missing... presumed at random: cost-analysis of incomplete data. Health Econ. 2003;12(5):377–92.

Schafer JL. Multiple imputation: a primer. Stat Methods Med Res. 1999;8(1):3–15.

Eddy DM, Hollingworth W, Caro JJ, Tsevat J, McDonald KM, Wong JB. Model transparency and validation: a report of the ISPOR-SMDM modeling good research practices task force--7. Value Health. 2012;15(6):843–50.

Godlee F. Publishing study protocols: making them visible will improve registration, reporting and recruitment. BMC News Views. 2001;2:4.

O'Sullivan AK, Thompson D, Drummond MF. Collection of health-economic data alongside clinical trials: is there a future for piggyback evaluations? Value Health. 2005;8(1):67–79.

Gaede P, Valentine WJ, Palmer AJ, Tucker DM, Lammert M, Parving HH, Pedersen O. Cost-effectiveness of intensified versus conventional multifactorial intervention in type 2 diabetes: results and projections from the Steno-2 study. Diabetes Care. 2008;31(8):1510–5.

Tao L, Wilson EC, Wareham NJ, Sandbaek A, Rutten GE, Lauritzen T, Khunti K, Davies MJ, Borch-Johnsen K, Griffin SJ, et al. Cost-effectiveness of intensive multifactorial treatment compared with routine care for individuals with screen-detected type 2 diabetes: analysis of the ADDITION-UK cluster-randomized controlled trial. Diabet Med. 2015;32(7):907–19.

Ramsey S, Willke R, Briggs A, Brown R, Buxton M, Chawla A, Cook J, Glick H, Liljas B, Petitti D, et al. Good research practices for cost-effectiveness analysis alongside clinical trials: the ISPOR RCT-CEA task force report. Value Health. 2005;8(5):521–33.

Johnston K, Buxton MJ, Jones DR, Fitzpatrick R. Assessing the costs of healthcare technologies in clinical trials. Health Technol Assess. 1999;3(6):1–76.

Davis S, Stevenson M, Tappenden P, Wailoo A. NICE DSU Technical support Document 15: cost-effectiveness modelling using patient level simulation; 2014.

Glick HA, Doshi JA, Sonnad SS, Polsky D. Economic evaluation in clinical trials. 2nd ed. Oxford: Oxford University Press; 2015.

Leggett LE, Khadaroo RG, Holroyd-Leduc J, Lorenzetti DL, Hanson H, Wagg A, Padwal R, Clement F. Measuring resource utilization: a systematic review of validated self-reported questionnaires. Medicine (Baltimore). 2016;95(10):e2759.

World Health Organization 2001. Macroeconomics and Health: Investing in Health for Economic Development. http://www1.worldbank.org/publicsector/pe/PEAMMarch2005/CMHReport.pdf. Accessed 21 Feb 2019.

Ali M, Siegel K, Chandrasekar E, Tandon N, Montoya P, et. al. “Diabetes: An Update on the Pandemic and Potential Solutions”. In: Disease Control Priorities (third edition): Volume 5, Cardiovascular, Respiratory, and Related Disorders, edited by D. Prabhakaran, S. Anand, T. Gaziano, J. Mbanya, Y. Wu, R. Nugent. Washington, DC: World Bank.

Thông tin
Thông tin xuất bản

Springer Science and Business Media LLC

Tập 4

1-10

Thông tin tác giả