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HELSEVEL-H-Gode og effektive helse-, omsorgs- og velferdstjenester

Improving valuation methods for the 15D instrument to estimate a value algorithm for use in Norwegian healthcare priority settings

Alternative title: null

Awarded: NOK 3.3 mill.

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Project Period:

2013 - 2019


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The aim of this project has been to gain knowledge that is useful for priority setting in health care. Quality-adjusted life years (QALYs) are used to assess the benefit of health care interventions across different types of patient groups, helping to decide whether or not to introduce new technologies. The QALY integrates health- related quality of life (HRQoL) over time, and as such is a measure that includes both increased survival and increased HRQoL from interventions. In clinical studies, for instance of a new drug, the QALYs accrued in a treatment arm is compared to QALYs accrued in the control arm. In such studies, HRQoL is typically measured at different points in time, using HRQoL questionnaires that ask about physical and mental issues, like e. g. pain, mobility or anxiety. Through large preference studies in the general population, an associated value algorithm is estimated; each way of filling out the questionnaire receives a specific HRQoL-value. This HRQoL-value, or weight, is integrated over time, resulting in QALYs. The reliance of priority setting on measuring and valuing HRQoL raises important questions. Using the 15D, a Nordic HRQoL questionnaire as a starting point, this project aimed to shed light over methods to improve existing methods to measure and value HRQoL . These questions were addressed in several studies within this project: We used a representative sample of more than 2000 Norwegians that responded to two generic HRQoL instruments, 15D and EQ5D, and the according valuation tasks: Visual analogue scale for 15D. Previously, there has been no Norwegian value algorithm for the 15D, and little is known about the properties of the instrument and the standard valuation procedure. The analyses have therefore focused on the valuation methods of 15D. A paper presenting the 15D data-collection and 15D-values using the original methods have been published. This paper includes a critical review of the original methods and proposes a new method for estimating 15D values. Further objectives were to compare the Norwegian and Finnish values using the original methods. Based on the discussions in this paper, an additional data collection was performed, allowing to estimate a Norwegian 15D value algorithm, with improved methods. A paper describing the new valuation task and presenting the Norwegian 15D values has been published. The tariff is expected to be of use for researchers in the health care sector in Norway, and for decision makers when making decisions about introducing new technologies. The objective the second study was two-fold: Firstly, to compare the inherent features of mobility-related items of six HRQoL measures (EQ-5D-5L, SF-36v2, HUI, QWB-SA, 15D, and AQoL-8D) and, secondly, to explore how these items were perceived by individuals living with spinal cord injuries (SCI). Mobility-related items are included in most generic health-related quality of life (HRQoL) instruments. However, the way in which respondents are asked to describe their physical functioning along these items differs substantially. Recent research has shown that individuals with spinal cord injury (SCI) have different overall perceptions towards the descriptive systems of HRQoL instruments. We performed a secondary analysis on data from a 2013 study from Vancouver, Canada. The original study explored the face validity and feasibility of the six HRQoL instruments by analyzing transcripts of three focus groups conducted with individuals living with SCI (n=15). An important finding from this study is that individuals who feel that they do not fit into any of the categories as described by the questionnaires will reframe the question to meaningful categories. To a certain extent, this means that respondents answer a different question than what the questionnaire actually asks. A paper presenting the findings of this study has been published.

Den nye 15D-tariffen er nyttig for forskningsprosjekt i helsesektoren i Norge der man ønsker å måle endring i helserelatert livskvalitet. Dette tillater å estimere QALYs basert på norske preferanser, og vil gi økt legitimitet til prioriteringsbeslutninger. Vi forventer at myndighetsorganer som er delaktige i prioriteringsbeslutninger, som Regionale helseforetak, Statens Legemiddelverk og Folkehelseinstituttet vil være brukere av 15D-tariffen. De vil ha nytte av den delen av forskningsprosjektet som har fokusert på metodeutfordringer, styrker og svakheter ved 15D. Hvordan instrumentene fungerer i praksis har konsekvenser for hvilke konkrete helsetiltak som blir prioritert. Legemiddelindustrien vil også være aktuelle brukere av verdisettet, ettersom det er industrien selv som gjennom studier skal vise effekt av nye medisiner før de blir godkjent. Et verdisett basert på norske preferanser kan gi forutsigbarhet i prosessen med å få refusjon for nye medisiner.

Norwegian health authorities recommend using quality-adjusted life years, i.e. health-related quality of life (HRQoL) integrated over time as a measure of health gain when assessing health interventions. HRQoL is estimated through multi-attribute utility instruments (MAUIs). Several MAUIs exist, however, no specific instrument has been recommended in a Norwegian priority setting context. The 15D instrument is a well-known MAUI, and has been listed as one among several potential standard MAUIs by both the Directorate of health and the Norwegian medicines agency. There exists no Norwegian valuation algorithm for the 15D, and little is known about the properties of the instrument and the standard valuation procedure. Researchers involved in this project hav e previously collected data that would allow estimating a 15D algorithm in the standard way. However, this procedure is hampered by serious methodological flaws. In this project, we would therefore like to 1- Explore these methodological problems and thei r consequences more closely and 2- Perform a minor data collection that together with the existing dataset would allow us to estimate a Norwegian value algorithm for the 15D in a methodologically consistent manner. The project would gain society primaril y in two ways: first, a Norwegian value algorithm for the 15D will be used by researchers, pharmaceutical industry, and the health-care sector. This in turn will improve the basis on which priority-decisions in the health sector are based. Second, the pro ject will increase Norwegian expertise on HRQoL-instruments. Improvements of valuation methods will also have international impact.

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HELSEVEL-H-Gode og effektive helse-, omsorgs- og velferdstjenester