Measuring health-related quality of life in the general population and Roma communities in Romania: study protocol for two cross-sectional studies

Abstract

IntroductionThe importance of health-related quality of life (HRQoL) is increasing and many healthcare authorities recommend the use of measures that account for both mortality and morbidity. This study will determine, for the first time in Romania, value sets for EuroQoL-five-dimensions-3-level (EQ-5D-3L) and EQ-5D-5L questionnaires and their population norms (study 1). It will also compare the HRQoL (measured with EQ-5D-5L) of Roma communities in Romania with that of the general population (study 2).Methods and analysisCross-sectional studies of face-to-face interviews conducted in representative samples of the Romanian general population and Romanian Roma communities. 1614 non-institutionalised adults older than 18 years will be interviewed using a computer-assisted interview for study 1. Participants will complete EQ-5D-3L and 5L, 13 composite time trade-off tasks (cTTO), 7 discrete choice experiment questions (DCE) and sociodemographic questions. For study 2, 606 non-institutionalised self-identified Roma people older than 18 years will be interviewed using a pencil-and-paper interview. Participants will complete EQ-5D-5L and the same sociodemographic questions as for study 1. The 3L value set will be estimated using econometric models and the cTTO data. cTTO and DCE data will be used for the 5L value set. Population norms will be reported by age and gender. The ORs for reporting different levels of problems and the most common health states in the population will be estimated. For study 2, t-tests and analysis of variance will be used to explore differences between groups in HRQoL and for each EQ-5D.Ethics and disseminationEthics approval was given by the National Bioethics Committee of Medicines and Medical Devices Romania and Newcastle University’s Research Ethics Committee. Results will be published in peer-reviewed journals, presented at scientific conferences and on the project’s website. The EQ-5D-5L anonymised datasets will be deposited in a centralised repository. Two public workshops with local authorities, physicians and patients’ associations will be held.

Quality of life in people living with HIV in Romania and Spain

“…Using a value set from a different country may bias the utility score given the health and social differences between both countries. A Romanian value set is forthcoming, and the distribution of the EQ-5D domains presented are based on the data collected for this study [ 36 ].…”

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

“…Interviews are flagged as non-compliant if the explanations for the two wheelchair example exercises last for less than 3 min, if the WTD element is not shown in the examples, if the duration of the 10 real c-TTO tasks is less than 5 min, or if the value given to the worst health state (health state '55555', which is always the worst state presented to every respondent) is not the lowest and at least 0.5 higher than that of the state with the lowest value. [35][36][37] As a part of quality control, interviewers' effect will also be assessed in addition to the protocol compliance. The presence of interviewers' effect in the data will be assessed by indicators like distribution of TTO responses with respect to different health states for each interviewer, presence of clustering the TTO responses, health states given a value of '0' in the TTO tasks, health states given value of 'less than 0' in the TTO tasks and proportion of non-traders (individuals who refuse to give up any amount of time in the TTO, thus giving all health states the value of 1) in the respondents.…”

Estimating an EQ-5D-3L Value Set for Romania Using Time Trade-Off

“…The sample size needed for national representativeness was estimated at 1794 with a maximum error of ±3% for a confidence level of 95% and including a 10% nonresponse rate [ 38 ]. The sample size needed for an EQ-5D-3L valuation study is 300 people [ 16 ].…”