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Purpose: To develop the Norwegian value set for the EQ-5D-5L based on interviews with a representative sample of the Norwegian adult population., Methods: Random and quota sampling were used to recruit the sample of adults (age> 18 years) representative of the Norwegian general population. Data collection followed EQ-VT 2.1 undertaken before and after the COVID-19 pandemic from November 2019 to December 2022, using PC-assisted and video conferencing interviews, respectively. Each respondent valued 10 health states using composite time trade-off (cTTO) and 7 health states using a discrete choice experiment (DCE). Different statistical models were assessed for logical consistency and predictive accuracy using cTTO and DCE data alone or in combination as hybrid models., Results: Of the 1,321 respondents, 1,237 met inclusion criteria. All statistical models demonstrated logical consistency. The weighted hybrid model combining both cTTOand DCE data was preferred and had the highest predictive accuracy. Predicted values ranged from -0.453 to 1, and the dimension of anxiety/depression was the most highly valued by respondents, followed by pain/discomfort, self-care, mobility, and usual activities. These findings are not dissimilar to those for most Western European countries, and regression coefficients are closest to those for other Scandinavian countries., Conclusion: This study provides the Norwegian value set for the EQ-5D-5L based on health state values obtained from members of the adult general population in Norway. This is an important contribution to economic evaluation and the broader application ofthe EQ-5D-5L in Norway including clinical and health services research, and quality measurement., Competing Interests: Declarations. Competing interests: James Shaw is an employee and shareholder in Bristol-Myers Squibb which financed the second data collection in this study. Kim Rand is an employee and shareholder in Maths in Health B.V. which received funding from Bristol-Myers Squibb for the second data collection. Kim Rand, Jim Shaw, and Knut Stavem are EuroQol members. The authors declare no other competing interests., (© 2024. The Author(s).)

Purpose: To undertake the first testing and comparison of measurement properties for the EuroQol EQ-5D-3L and 5L in patients with ankle problems., Methods: The cross-sectional postal survey of 959 patients aged ≥ 18 years, who underwent surgical treatment (ORIF) for unstable and closed ankle fractures in Eastern Norway. Both the EQ-5D-3L and 5L were included in a postal questionnaire in 2015, 3-6 years post surgery. Missing data, floor and ceiling effects, and response consistency were assessed. Tests of validity included comparisons with scores for the SF-36 and widely used ankle-specific instruments. The 5L version was assessed for test-retest reliability., Results: There were 567 (59%) respondents; 501 completed both versions and 182 (61%) the 5L retest questionnaire. The 5L outperformed the 3L in tests of data quality and classification efficiency. Correlations with scores for other instruments largely met expectations, those for the 5L being slightly higher. All 5L scores had acceptable levels of reliability. For the 5L index, the smallest detectable differences for group and individual comparisons were 0.02 and 0.20, respectively., Conclusion: The 5L outperformed the 3L in terms of data quality, number of health states assessed and tests of validity. The 5L is recommended in research and other applications following surgery for ankle fracture but further testing including responsiveness to change is recommended at clinically relevant follow-up periods., (© 2022. The Author(s).)

Background: The TTO task involves giving up life years, i.e. living a shorter life, to avoid an undesirable health state. Despite being a hypothetical task, some respondents take other life factors into account when completing the task. This study explored the effect of having children and/or a partner on TTO valuations of hypothetical EQ-5D-5L health states in a valuation study of the general population., Methods: The study used TTO data collected in a Norwegian EQ-5D-5L valuation study in 2019-2020, by one-to-one pc-assisted interviews following the EQ-VT protocol. We used regression modelling to determine the effect of significant others (having children or a partner) on disutility per health state from the TTO valuations., Results: 430 respondents were included [mean age 43.8 (SD 15.9) years, 58% female, 48% with children, 68% with a partner, 25% with neither children nor partner]. Having children and/or a partner was associated with lowered willingness to trade life years translating to higher elicited health state utilities (p < 0.01)., Conclusion: Having significant others, or the lack of having significant others, was associated with respondents' valuation of hypothetical health states using TTO, more so than traditional sampling variables such as age and sex. Inadequate representativeness in terms of having significant others could bias health state preference values in valuation studies., (© 2021. The Author(s).)

Purpose: Several guidelines for the use of patient-reported outcomes (PROs) in clinical studies have been published in the past decade. This review primarily aimed to compare the number and compliance with selected PRO-specific criteria for reporting of clinical studies in Europe using PROs published in 2008 and 2018. Secondarily, to describe the study designs, PRO instruments used, patient groups studied, and countries where the clinical studies were conducted., Methods: A literature search was conducted in MEDLINE to identify eligible publications. To assess the number of publications, all abstracts were screened for eligibility by pairs of reviewers. Compliance with PRO-specific criteria and other key characteristics was assessed in a random sample of 150 eligible full-text publications from each year. Randomized controlled trials (RCTs) were assessed according to the full CONSORT-PRO checklist., Results: The search identified 1692 publications in 2008 and 4290 in 2018. After screening of abstracts, 1240 from 2008 and 2869 from 2018 were clinical studies using PROs. By full-text review, the proportion of studies discussing PRO-specific limitations and implications was higher in 2018 than in 2008, but there were no differences in the other selected PRO-specific criteria. In 2018, a higher proportion of studies were longitudinal/cohort studies, included ≥ 300 patients, and used electronic administration of PRO than in 2008. The most common patient groups studied were those with cancer or diseases of the musculoskeletal system or connective tissue., Conclusion: The number of clinical studies from Europe using PROs was higher in 2018 than in 2008, but there was little difference in compliance with the PRO-specific criteria. The studies varied in terms of study design and PRO instruments used in both publication years., (© 2021. The Author(s).)

Purpose: To provide the first Norwegian EQ-5D-5L and EQ VAS population norms for the adult general population., Methods: Postal survey of a random sample of 12,790 Norwegians identified through the National Registry of the Norwegian Tax Administration. Norms, weighted for Norwegian general population characteristics, are shown for the five EQ-5D-5L dimensions, EQ-5D index, and EQ VAS scores for seven age categories, females, males, and education level., Results: There were 3200 (25.9%) respondents to 12,263 correctly addressed questionnaires. The EQ-5D-5L dimensions, EQ VAS, and background questions were completed by 3120 (24.6%) respondents. The mean age (SD) was 50.9 (21.7) and range was 18-97 years. The youngest age group of 18-29 years and oldest of 80 years and over had the highest (n = 691) and lowest (n = 239) number of respondents, respectively. Compared to the general population, the respondents comprised a greater number of females, younger and older ages, and had a higher education level. 32% of respondents reported no health problems on the EQ-5D-5L. From the youngest to oldest age groups, there was a general decline in health as assessed by the EQ-5D-5L. The exception was for anxiety/depression, where the youngest age groups had the poorest health. Apart from self-care, women reported poorer health than men, as assessed by the EQ-5D-5L; EQ VAS scores were similar for men and women. Higher levels of health (EQ-5D index, EQ VAS scores) were found with increasing levels of education., Conclusion: The population norms will improve interpretation of EQ-5D-5L and EQ VAS scores in Norwegian applications including clinical practice, clinical and health services research, and national quality registers where EQ-5D-5L is the most widely used patient-reported instrument., (© 2021. The Author(s).)

Purpose: The de facto standard method for valuing EQ-5D health states is the time trade-off (TTO), an iterative choice procedure. The TTO requires a starting point (SP), an initial offer of time in full health which is compared to a fixed offer of time in impaired health. From the SP, the time in full health is manipulated until preferential indifference. The SP is arbitrary, but may influence respondents, an effect known as anchoring bias. The aim of the study was to explore the potential anchoring effect and its magnitude in TTO experiments., Methods: A total of 1249 respondents valued 8 EQ-5D health states in a Web study. We used the lead time TTO (LT-TTO) which allows eliciting negative and positive values with a uniform method. Respondents were randomized to 11 different SPs. Anchoring bias was assessed using OLS regression with SP as the independent variable. In a secondary experiment, we compared two different SPs in the UK EQ-5D valuation study TTO protocol., Results: A 1-year increase in the SP, corresponding to an increase in TTO value of 0.1, resulted in 0.02 higher recorded LT-TTO value. SP had little impact on the relative distance and ordering of the eight health states. Results were similar to the secondary experiment., Conclusion: The anchoring effect may bias TTO values. In this Web-based valuation study, the observed anchoring effect was substantial. Further studies are needed to determine whether the effect is present in face-to-face experiments.

Purpose: Health state values are by convention anchored to 'perfect health' and 'death.' Attitudes toward death may consequently influence the valuations. We used attitudes toward euthanasia (ATE) as a sub-construct for attitudes toward death. We compared the influence on values elicited with time trade-off (TTO), lead-time TTO (LT-TTO) and visual analogue scale (VAS).Since the 'death' anchor is most explicit in TTO, we hypothesized that TTO values would be most influenced by ATE., Methods: Respondents valued eight EQ-5D health states with VAS, then TTO (n = 328) or LT-TTO (n = 484). We measured ATE on a scale from -2 (fully disagree) to 2 (fully agree) and used multiple linear regressions to predict VAS, TTO, and LT-TTO values by ATE, sex, age, and education., Results: A one-point increase on the ATE scale predicted a mean TTO value change of -.113 and LT-TTO change of -.072. Demographic variables, but not ATE, predicted VAS values., Conclusions: TTO appears to measure ATE in addition to preferences for health states. Different ways of incorporating death in the valuation may impact substantially on the resulting values. 'Death' is a metaphysically unknown concept, and implications of attitudes toward death should be investigated further to evaluate the appropriateness of using 'death' as an anchor.

Purpose: EQ-5D tariffs are typically based on general population valuations studies, but whether valuations of experienced health (EH) or hypothetical health (HH) are more appropriate is disputed. Previous comparisons of valuations of EH and HH have focused on absolute differences in dimension-specific regression coefficients. We examined differences in the relative importance attributed to the EQ-5D dimensions between EH and HH valuations of EQ-5D states in the United States., Methods: We used the regression model from the US EQ-5D valuation study on EH ratings from the 2000-2003 Medical Expenditure Panel Survey and on HH ratings from the US EQ-5D valuation study conducted in 2001. We then compared patterns in the relative magnitudes of coefficients that corresponded to the five dimensions., Results: In the HH model, self-care and pain/discomfort were the most important dimensions, while usual activities were the least important. In the EH model, usual activities were the most important dimension, while self-care was one of the least important., Discussion: The findings reveal considerable differences between stated preferences for HH and ratings of EH, particularly for self-care and usual activities. The findings accentuate the importance of the debate about which groups' values should be used in medical priority setting.

Objective: This article compares preference-based utilities from the multiattribute utility instrument 15D with those derived from the EQ-5D and the Short Form 36 (SF-6D) in patients with HIV/AIDS. In particular, we wanted to examine if the finer descriptive system of the 15D would result in better discriminative capacity or responsiveness., Methods: In a prospective observational study of 60 Norwegian patients with HIV/AIDS from two hospitals, the authors compared scores, assessed associations with disease staging systems, and assessed test-retest reliability and responsiveness of the instruments., Results: On average, the 15D gave higher utility scores than the other two measures, the mean utility scores were: 15D--0.86, SF-6D--0.73, and EQ-5D Index--0.77. Test-retest reliability was acceptable for all measures, with intraclass correlation coefficients between 0.78 and 0.94. The correlation between scores of the 3 scales was substantial (p = 0.74-0.80). There was no major difference in responsiveness between the measures., Conclusions: The different measures gave different utility values in this sample of patients with HIV/AIDS, although many of the measurement properties were similar. There was no evidence for better discriminative capacity or responsiveness for the 15D, than for the two other multiattribute measures.

The aim of this study was to validate the Norwegian version of the Seattle Angina Questionnaire (SAQ), a self-administered 19-item questionnaire designed to assess health-related quality of life in patients with chest pain or coronary artery disease. In 885 patients with prior myocardial infarction (MI), we abstracted clinical data from the patients' medical records. Two to three years after the MI, we mailed a self-administered questionnaire including the SAQ, the Short Form 36 (SF-36), and questions about current medication, to the 548 patients still alive. The response rate was 74%. Internal consistency reliability of the SAQ, assessed with Cronbach's alpha, ranged 0.75-0.92. Test-retest reliability, tested with an intraclass correlation coefficient, ranged 0.29-0.84. The pattern of association between similar and dissimilar scales of the SAQ and SF-36 mainly supported the construct validity of the SAQ. Four of the five SAQ scales discriminated between patients with different medication regimens as a proxy for severity of angina pectoris. We conclude that the Norwegian version of the SAQ showed acceptable reliability and cross-sectional validity following MI, with properties in line with the original US version.

The aim of this study was to validate the Norwegian version of a self-administered 30-item quality of life questionnaire designed to assess disorders of excessive sleepiness, the Functional Outcomes of Sleep Questionnaire (FOSQ). In total 226 patients previously evaluated for obstructive sleep apnea were included in the study. The patients received a postal questionnaire with the FOSQ, the Short Form 36 (SF-36) questionnaire, and a scale for assessment of excessive daytime sleepiness, the Epworth sleepiness scale (ESS). Among the 178 respondents, all five subscales of the FOSQ showed good internal consistency reliability (Cronbach's alpha = 0.84-0.93). Test-retest on average 18 days apart was satisfactory with intraclass correlation coefficients ranging from 0.61 to 0.86. The pattern of Spearman's rank correlation coefficients between FOSQ scales and related and unrelated scales SF-36 scales gave support to the construct validity of the FOSQ. In conclusion, the Norwegian translation of the FOSQ showed satisfactory internal consistency reliability, test-retest reliability and construct validity, in line with the original version.

The objective of the study was to assess the reliability and validity of the Dartmouth Primary Care Cooperative Information Project/World Organization of National Colleges, Academies, and Academic Associations of General Practice/Family Physicians (COOP/WONCA) questionnaire in outpatients with chronic obstructive pulmonary disease (COPD). The test-retest reliability of individual items of the COOP/WONCA questionnaire was assessed using a weighted kappa-statistic, and construct validity was assessed by correlating items of the COOP/WONCA with the EQ-5D health status measure. Discriminant validity was assessed by comparing scores for known groups, at the same time comparing the results with those of a lung-specific health status questionnaire. The individual items of the COOP/WONCA had test-retest reliabilities of 0.67-0.78 (weighted kappa). Spearman's rank correlations between COOP/WONCA single-item scores and corresponding EQ-5D ranged 0.45-0.72, which were generally higher than associations between non-corresponding items. Four of the five COOP/WONCA items did not discriminate between patient groups divided according to forced expiratory flow in 1 sec (FEV1) in percent of predicted and 6-min walking distance, while four of five items of the lung-specific questionnaire discriminated well between these groups. The COOP/WONCA chart system was reliable and showed properties supporting the construct validity of the measure. The items, however, did not discriminate well between known groups, indicating that this questionnaire is not very sensitive in patients with COPD. The reliability of the COOP/WONCA items was acceptable for use at group level, but lower than current recommendations for use in individual patients.

The objective of this study was to compare the health-related quality of life (HRQL) of patients with epilepsy with populations suffering from different chronic diseases, using the short form 36 (SF-36) health profile measure. The populations to be compared were adult patients drawn from hospital based registers, with confirmed epilepsy (n = 397), angina pectoris (n = 785), rheumatoid arthritis (n = 1,030), asthma (n = 117) and chronic obstructive pulmonary disease (COPD) (n = 221). Health-related quality of life scores were compared using analysis of covariance (ANCOVA) for predicting mean scores adjusted for age, gender, education and comorbidity. Patients with epilepsy on average scored highest on all scales, reflecting that in our sample the majority had well-controlled epilepsy. Our results indicate that the HRQL of a representative sample of patients with epilepsy is good, when compared with other chronic disorders, although reduced in several dimensions compared with a general reference population. Patients with rheumatoid arthritis (RA) and COPD scored lowest on the physical function scales, while rheumatoid arthritis patients reported most pain.

The objective of the study was to evaluate the reliability, validity and responsiveness of two generic multiattribute methods for measuring utility for health states: a 15-dimensional (15D) and a five-dimensional method (EuroQol and EQ-TTO). A self-administered questionnaire with both measures was used in 59 outpatients with chronic obstructive pulmonary disease and the findings compared with standard gamble (SG) and time trade-off (TTO) utilities, spirometry and arterial blood gases. Quality of life scores were smallest for EQ-TTO (median 0.73) and highest for SG and TTO (median 0.91 and 0.95 respectively), while 15D gave intermediate values (median 0.80). The test-retest reliability over 14 days was: 15D (p = 0.90) and EQ-TTO (p = 0.73), using Spearman's rank correlation. 15D was better than EQ-TTO at discriminating between groups of patients after reported global rating of change over 12 months (P = 0.004 versus P = 0.09), indicating that 15D was more responsive. The 15D instrument has many attractive properties when compared to the EQ-TTO method, including a better reliability and responsiveness. Validity depends on validation method. The findings in this study indicate that the different utility measures measure different aspects of health-related quality of life (HRQoL). Caution should be taken when choosing utility instruments in cost-utility studies, as this can strongly influence the results.