Quality of Life and Utility Values for Cost-Effectiveness Modeling in Japanese Patients with Type 2 Diabetes

Diabetes Therapy - Tập 11 - Trang 2931-2943 - 2020
Hitoshi Ishii1, Hiroshi Takamura2, Yuichi Nishioka1, Jakob Langer3, Michihisa Watanabe3, Hyunchung Ray Kim4, Bruce Crawford4
1Nara Medical University, Nara, Japan
2Takamura Internal Medicine Clinic, Tokyo, Japan
3Novo Nordisk Pharma Ltd., Tokyo, Japan
4Syneos Health, Tokyo, Japan

Tóm tắt

Reliable quality of life (QoL) measures and utility values are needed for patients with type 2 diabetes mellitus (T2DM) with a variety of comorbid conditions to help facilitate cost-effectiveness modeling. This study aimed to evaluate the Diabetes Treatment-Related Quality of Life (DTR-QOL) and EuroQol 5-dimension 5-level (EQ-5D-5L) questionnaires in patients with T2DM with and without diabetes complications and comorbidities in Japan. This was an observational survey study involving 1000 patients with T2DM, at least 20 years old, receiving treatment at Nara University Hospital or Takamura Internal Medicine Clinic in Japan. Patients completed the DTR-QOL and EQ-5D-5L questionnaires and clinicians completed an accompanying case report form. The DTR-QOL and EQ-5D-5L are scored on a scale of 0–100 and 0–1, with 100 and 1 representing the best possible scores, respectively. Out of 1000 recruited patients, 978 were included in the final analysis. Patients reported an average EQ-5D-5L value of 0.92 ± 0.11. Utility values corresponded to the degree of severity of health conditions while few differences were observed when stratified by the HbA1c 7% threshold, age, or BMI level, nor did the values correspond to the degree of clinical risk factors. Patients reported an average total DTR-QOL score of 79.26 ± 13.26. The DTR-QOL was sensitive to detect differences in patients with T2DM with a variety of complications and comorbidities, risk factors, and treatments. This is the largest study to report QOL values for patients with diabetes in Japan and the first to include a variety of comorbid diabetic conditions. These findings may be useful for cost-effectiveness modeling of patients with T2DM in Japan.

Tài liệu tham khảo

Ministry of Health Labour Welfare. National health and nutrition survey results. Japan 2017. https://www.mhlw.go.jp/stf/houdou/0000177189.html. Accessed 22 May 2019. National Institute of Diabetes and Digestive and Kidney Diseases. Preventing diabetes problems. USA 2019. https://www.niddk.nih.gov/health-information/diabetes/overview/preventing-problems. Accessed 27 May 2019. Holt RI, de Groot M, Golden SH. Diabetes and depression. Curr Diab Rep. 2014;14(6):014–0491. Ministry of Health Labour Welfare. 17th Chuo-shakai hokeniryou-kyougikai Cost-effectiveness Analysis subcommittee, Drug pricing subcommittee. Tokyo 2019. https://www.mhlw.go.jp/stf/shingi2/0000211220_00013.html. Accessed 17 July 2019. EuroQol. EuroQol—a new facility for the measurement of health-related quality of life. Health Policy. 1990;16(3):199–208. National Institute of Public Health. Guideline for preparing cost-effectiveness evaluation to the Central Social Insurance Medical Council. Core2 Health. 2019. https://c2h.niph.go.jp/tools/guideline/guideline_en.pdf. Accessed 22 July 2019. Swinburn P, Lloyd A, Boye KS, Edson-Heredia E, Bowman L, Janssen B. Development of a disease-specific version of the EQ-5D-5L for use in patients suffering from psoriasis: lessons learned from a feasibility study in the UK. Value Health. 2013;16(8):1156–62. Kind P, Lafata JE, Matuszewski K, Raisch D. The use of QALYs in clinical and patient decision-making: issues and prospects. Value Health. 2009;12(Suppl 1):S27–30. McGrath C, Rofail D, Gargon E, Abetz L. Using qualitative methods to inform the trade-off between content validity and consistency in utility assessment: the example of type 2 diabetes and Alzheimer’s disease. Health Qual Life Out. 2010;8:23. Ohsawa I, Ishida T, Oshida Y, Yamanouchi K, Sato Y. Subjective health values of individuals with diabetes in Japan: comparison of utility values with the SF-36 scores. Diabetes Res Clin Pract. 2003;62(1):9–16. Sakamaki H, Ikeda S, Ikegami N, et al. Measurement of HRQL using EQ-5D in patients with type 2 diabetes mellitus in Japan. Value Health. 2006;9(1):47–53. Takahara M, Katakami N, Shiraiwa T, et al. Evaluation of health utility values for diabetic complications, treatment regimens, glycemic control and other subjective symptoms in diabetic patients using the EQ-5D-5L. Acta Diabetol. 2019;56(3):309–19. Nair R, Kachan P. Outcome tools for diabetes-specific quality of life: study performed in a private family practice clinic. Can Fam Physician. 2017;63(6):e310–5. Ishii H. Development and psychometric validation of the Diabetes Therapy-Related QOL (DTR-QOL) questionnaire. J Med Econ. 2012;15(3):556–63. EuroQol. EQ-5D-5L about. The Netherlands 2019. https://euroqol.org/eq-5d-instruments/eq-5d-5l-about/. Accessed 17 Oct 2019. Ikeda S, Shiroiwa K, Igarashi A, et al. Developing a Japanese version of the EQ-5D-5L value set. Health Med Sci. 2015;64:47–55 (in Japanese). Clinicaltrials.gov. A double-blinded trial comparing the efficacy and safety of insulin degludec/liraglutide and insulin degludec both in combination with metformin in Japanese subjects with type 2 diabetes mellitus inadequately controlled with basal or pre-mix/combination insulin therapy and oral anti-diabetic drugs (DUAL™ II Japan). 2019. https://clinicaltrials.gov/ct2/show/NCT02911948?term=DUAL+II+Japan&rank=1. Accessed 28 Nov 2019. Crawford B, Takamura S, Nishioka Y, Langer J, Watanabe M, Kim H. Quality of life and utility values for cost-effectiveness modeling in Japanese patients with type 2 diabetes. Value Health. 2018;21:S139. Haneda M, Utsunomiya K, Koya D, et al. A new classification of diabetic nephropathy 2014: a report from joint committee on diabetic nephropathy. J Diabetes Investig. 2015;6(2):242–6. Shiroiwa T, Fukuda T, Ikeda S, et al. Japanese population norms for preference-based measures: EQ-5D-3L, EQ-5D-5L, and SF-6D. Qual Life Res. 2016;25(3):707–19. Beaudet A, Clegg J, Thuresson PO, Lloyd A, McEwan P. Review of utility values for economic modeling in type 2 diabetes. Value Health. 2014;17(4):462–70. Clarke P, Gray A, Holman R. Estimating utility values for health states of type 2 diabetic patients using the EQ-5D (UKPDS 62). Med Decis Mak. 2002;22(4):340–9. Fukuhara S, Lopes AA, Bragg-Gresham JL, et al. Health-related quality of life among dialysis patients on three continents: the Dialysis Outcomes and Practice Patterns Study. Kidney Int. 2003;64(5):1903–10. Japan Diabetes Society. Treatment guide for diabetes. Tokyo 2016. http://www.fa.kyorin.co.jp/jds/uploads/Treatment_Guide_for_Diabetes_2016-2017.pdf. Nicolucci A, Kovacs Burns K, Holt RI, et al. Diabetes Attitudes, Wishes and Needs second study (DAWN2™): cross-national benchmarking of diabetes-related psychosocial outcomes for people with diabetes [published correction appears in Diabet Med. 2013 Oct;30(10):1266]. Diabet Med. 2013;30(7):767–777.