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      Valuing health-related quality of life among the Indian population: a protocol for the Development of an EQ-5D Value set for India using an Extended design (DEVINE) Study

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          Abstract

          Introduction

          Quality-adjusted life year (QALY) has been recommended by the government as preferred outcome measure for Health Technology Assessment (HTA) in India. As country-specific health-related quality of life tariff values are essential for accurate measurement of QALYs, the government of India has commissioned the present study. The aim of this paper is to describe the methods for the Development of an EQ-5D Value set for India using an Extended design (DEVINE) Study. Additionally, this study aspires to establish if the design of 10-time trade-off (TTO) blocks is enough to generate valid value sets.

          Methods and analysis

          A cross-sectional survey using the EuroQol Group’s Valuation Technology (EQ-VT) will be undertaken in a sample of 2700 respondents selected from six different states of India using a multistage stratified random sampling technique. The participants will be interviewed using computer-assisted personal interviewing technique. The TTO valuation will be done using 10 composite TTO (c-TTO) tasks and 7 discrete choice experiment (DCE) tasks. Hybrid modelling approach using both c-TTO and DCE data to estimate the potential value set will be applied. Values of all 3125 health states will be predicted using both the conventional EQ-VT design of 10 blocks of 10 TTO tasks, and an extended design of 18 blocks of 10 TTO tasks. The potential added value of the eight additional blocks in overall validity will be tested. The study will deliver value set for India and assess the adequacy of existing 10-blocks design to be able to correctly predict the values of all 3125 health states.

          Ethics and dissemination

          The ethical approval has been obtained from Institutional Ethics Committee of PGIMER, Chandigarh, India. The anonymised EQ-5D-5L value set will be available for general use and in the HTAs commissioned by India’s central HTA Agency.

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          Most cited references34

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          A program of methodological research to arrive at the new international EQ-5D-5L valuation protocol.

          To describe the research that has been undertaken by the EuroQol Group to improve current methods for health state valuation, to summarize the results of an extensive international pilot program, and to outline the key elements of the five-level EuroQol five-dimensional (EQ-5D-5L) questionnaire valuation protocol, which is the culmination of that work.
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            German Value Set for the EQ-5D-5L

            Objectives The objective of this study was to develop a value set for EQ-5D-5L based on the societal preferences of the German population. As the first country to do so, the study design used the improved EQ-5D-5L valuation protocol 2.0 developed by the EuroQol Group, including a feedback module as internal validation and a quality control process that was missing in the first wave of EQ-5D-5L valuation studies. Methods A representative sample of the general German population (n = 1158) was interviewed using a composite time trade-off and a discrete choice experiment under close quality control. Econometric modeling was used to estimate values for all 3125 possible health states described by EQ-5D-5L. The value set was based on a hybrid model including all available information from the composite time trade-off and discrete choice experiment valuations without any exclusions due to data issues. Results The final German value set was constructed from a combination of a conditional logit model for the discrete choice experiment data and a censored at −1 Tobit model for the composite time trade-off data, correcting for heteroskedasticity. The value set had logically consistent parameter estimates (p < 0.001 for all coefficients). The predicted EQ-5D-5L index values ranged from −0.661 to 1. Conclusions This study provided values for the health states of the German version of EQ-5D-5L representing the preferences of the German population. The study successfully employed for the first time worldwide the improved protocol 2.0. The value set enables the use of the EQ-5D-5L instrument in economic evaluations and in clinical studies. Electronic supplementary material The online version of this article (10.1007/s40273-018-0615-8) contains supplementary material, which is available to authorized users.
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              Overview, Update, and Lessons Learned From the International EQ-5D-5L Valuation Work: Version 2 of the EQ-5D-5L Valuation Protocol

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                Author and article information

                Journal
                BMJ Open
                BMJ Open
                bmjopen
                bmjopen
                BMJ Open
                BMJ Publishing Group (BMA House, Tavistock Square, London, WC1H 9JR )
                2044-6055
                2020
                20 November 2020
                : 10
                : 11
                : e039517
                Affiliations
                [1 ] departmentDepartment of Community Medicine and School of Public Health , Postgraduate Institute of Medical Education and Research , Chandigarh, India
                [2 ] departmentDepartment of Preventive and Social Medicine , Jawaharlal Institute of Postgraduate Medical Education and Research , Puducherry, Tamil Nadu, India
                [3 ] Indian Institute of Public Health , Gandhinagar, Gujarat, India
                [4 ] departmentDepartment of Community Medicine and Family Medicine , All India Institute of Medical Sciences , Bhubaneswar, Odisha, India
                [5 ] departmentDepartment of Developmental Psychology , Universitas Padjadjaran , Jatinangor, West Jawa, Indonesia
                [6 ] departmentDepartment of Community Medicine , North Eastern Indira Gandhi Regional Institute of Health and Medical Sciences , Shillong, Meghalaya, India
                [7 ] Academy of Management Sciences , Lucknow, Uttar Pradesh, India
                [8 ] departmentDepartment of Health Research , Ministry of Health and Family Welfare, Government of India , New Delhi, India
                Author notes
                [Correspondence to ] Dr Shankar Prinja; shankarprinja@ 123456gmail.com
                Author information
                http://orcid.org/0000-0003-3787-2446
                http://orcid.org/0000-0001-7719-6986
                Article
                bmjopen-2020-039517
                10.1136/bmjopen-2020-039517
                7682473
                33444194
                82371e8d-2d27-44ef-9954-7a1d9840c4c6
                © Author(s) (or their employer(s)) 2020. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.

                This is an open access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited, appropriate credit is given, any changes made indicated, and the use is non-commercial. See:  http://creativecommons.org/licenses/by-nc/4.0/.

                History
                : 17 April 2020
                : 16 October 2020
                : 28 October 2020
                Funding
                Funded by: Department of Health Research, Ministry of Health & Family Welfare, Government of India;
                Award ID: F.NO.T.11011/02/2017-HR/3176774
                Categories
                Public Health
                1506
                1724
                Protocol
                Custom metadata
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                Medicine
                health economics,health policy,public health
                Medicine
                health economics, health policy, public health

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