Introduction 1 2 3 4 5 6 8 9 10 22 23 24 25 26 27 28 practicality of using the EuroQol and HUI in a population with hearing complaints; construct validity of the EQ-5D UK tariff, EQ-5D Dutch tariff, HUI2 and HUI3; agreement between the EQ-5D UK tariff, EQ-5D Dutch tariff, HUI2 and HUI3; responsiveness of the EQ-5D UK tariff, EQ-5D Dutch tariff, HUI2 and HUI3 after hearing aid fitting; and the impact of on the ICER for hearing aid fitting. Methods The EQ-5D, HUI2 and HUI3 29 26 27 28 30 n 31 Study population and data collection 32 Practicality of the questionnaires Especially in an elderly population, an important aspect of a utility measure is the ease of completion. The practicality of using the EQ-5D and the HUI in a population with hearing complaints was therefore assessed by the completion rate, using a Wilcoxon Signed Ranks Test to test whether the completion rates were significantly different. Additionally we examined the item non-response. Construct validity 33 34 33 35 36 35 38 It was expected that persons with a BEPTA smaller than 35 dB would have a higher quality of life score than persons in the other four groups, because they are likely to experience less problems with hearing. It was also expected that non-applicants had a higher utility score than first time applicants, since the latter group is expected to experience more hearing complaints, resulting in fitting a hearing aid as a solution for their hearing problems.  U Agreement t 34 Responsiveness 39 t Impact on the ICER 5 40 41 Results Practicality n n n n P n n n P Construct validity n n n n 1 P Table 1 Comparison of mean scores, median scores and interquartile range (IR) at baseline according to different characteristics of the respondents    Age Sex BEPTA EQ-5D UK tariff EQ-5D Dutch tariff HUI2 HUI3 N Mean  % Male Mean  Mean Median (IR)  Mean Median (IR)  Mean Median (IR)  Mean Median (IR) Age <70 156 61.9 64% 37.4 0.86 0.94 (0.24)  0.88 0.95 (0.20) 0.78 0.79 (0.15) 0.64 0.65 (0.36)  ≥70 159 77.0 57% 47.1 0.81 0.80 (0.27) 0.84 0.84 (0.23) 0.76 0.80 (0.17) 0.58 0.59 (0.38)  P-value*      0.010  0.025  0.134  0.034 Sex Male 189 69.3 100% 43.4 0.85 0.88 (0.26) 0.87 0.90 (0.19) 0.77 0.80 (0.13) 0.61 0.62 (0.37)  Female 126 69.9 0% 40.5 0.81 0.80 (0.27) 0.83 0.84 (0.23) 0.76 0.78 (0.18) 0.61 0.63 (0.39) P-value*      0.019  0.012  0.575  0.965 Clinically distinctive groups BEPTA <35 dB 69 61.9 54% 21.3 0.84 0.81 (0.27) 0.86 0.84 (0.20) 0.80 0.80 (0.20) 0.70 0.66 (0.37) Non-applicants 46 74.2 59% 42.1 0.80 0.87 (0.27) 0.83 0.90 (0.23) 0.77 0.78 (0.15) 0.62 0.60 (0.41) First time applicants 108 71.2 62% 46.9 0.84 0.85 (0.27) 0.86 0.87 (0.23) 0.76 0.78 (0.16) 0.58 0.61 (0.28)  Re-applicants 65 69.6 66% 53.6 0.85 0.85 (0.27) 0.88 0.86 (0.20) 0.77 0.79 (0.17) 0.56 0.61 (0.41) P-value**      0.996  0.993  0.264  0.004 U ** Kruskal–Wallis test n n n n n P P P Agreement 2 3 Table 2 n Measure Minimum Maximum Median* Interquartile range Mean** Standard deviation EQ-5D UK tariff −0.25 1.00 0.85 0.27 0.83 0.21 EQ-5D Dutch tariff −0.03 1.00 0.86 0.19 0.86 0.18 HUI2 0.23 1.00 0.79 0.15 0.77 0.14 HUI3 −0.07 1.00 0.62 0.38 0.61 0.24 P t P Table 3 n Pairs of utility functions Kendall’s Tau* ICC (95% Confidence interval) EQ-5D UK tariff versus HUI2 r 0.51 (0.42–0.59) EQ-5D UK tariff versus HUI3 r 0.47 (0.38–0.55) EQ-5D UK versus Dutch tariff r 0.98 (0.97–0.98) HUI2 versus HUI3 r 0.74 (0.68–0.78) HUI2 versus EQ-5D Dutch tariff r 0.51 (0.42–0.59) HUI3 versus EQ-5D Dutch tariff r 0.44 (0.35–0.53) P 1 2 Fig. 1 Scatterplot of utility scores derived with EQ-5D UK tariff and HUI2  Fig. 2 Scatterplot of utility scores derived with EQ-5D UK tariff and HUI3  Responsiveness n 4 t P 3 3 3 Table 4 n Measure Mean Standard deviation Median Interquartile range Minimum Maximum a (95% CI) €/QALY EQ-5D UK tariff 0.01 0.13 0.00 0.04 −0.60 0.27 286,866 b EQ-5D Dutch tariff 0.00 0.12 0.00 0.04 −0.60 0.28 647,209 b HUI2 0.07* 0.13 0.08** 0.12 −0.50 0.40 25,337 (19,356–38,012) HUI3 0.12* 0.18 0.13** 0.22 −0.22 0.60 15,811 (11,664–24,654) t P ** P a  b  Fig. 3 Percentage of responses for each level of each attribute before (b) and after (a) hearingaid fitting for EQ-5D, HUI2 and HUI3  The mean change in utility score after hearing aid fitting, when measured with HUI2 and HUI3, was higher for first-time hearing aid applicants (0.08; 0.13) than for re-applicants (0.06; 0.10). This outcome was in line with our expectations, but is not significantly different. Impact on the ICER Mean costs of doing nothing were zero. The mean costs of hearing aid fitting were €1,877. The latter consisted of GP visits (€37), ENT visits (€295) and hearing aid(s) (€1545). All hearing aids were digital, and hearing aids were bilaterally fitted in 83% of the respondents. This resulted in mean one-year incremental costs of hearing aid fitting versus doing nothing of €1,877. The mean utility gain of 0.01 (sd 0.13), measured with the EQ-5D UK tariff, resulted in a ratio of €286,866 per QALY, with a 95% confidence interval of inferior (higher costs, lower utility) to €47,082/QALY. There was a 36% probability that hearing aid fitting was both more costly and less effective (inferior). The mean utility gain of 0.003, measured with the EQ-5D Dutch tariff, resulted in an ICER of €647,209 per QALY (95% confidence interval: inferior to €61,934/QALY). There was a 42% probability that hearing aid fitting was inferior. Applying the HUI2 and HUI3, the ICER was €25,337 per QALY (95% confidence interval: €38,012/QALY to €19,356/QALY) and €15,811 per QALY (95% confidence interval: €24,654/QALY to €11,664/QALY) respectively. For both measures there was no probability that hearing aid fitting was inferior. 42 4 5 Fig. 4 Incremental cost-effectiveness ratio for hearing aid fitting. Incremental costs (euro) are displayed at the vertical line, incremental effects (QALYs) on the horizontal line  Fig. 5 Cost-effectiveness acceptability curves of EQ-5D UK and Dutch tariff, HUI2 and HUI3  Conclusion and discussion 1 3 4 The results of this study in a relatively healthy population with hearing complaints provide insight in the differences between two widely used utility measures, the EQ-5D and the HUI system. Regarding practicality, both questionnaires had high completion rates, with the EQ-5D having a higher completion rate than the HUI. With the EQ-5D, differences were detected in utility by age and sex, indicating construct validity. The HUI3 detected differences by age, but not by sex. Differences between clinically distinctive groups were only detected by HUI3. However, the HUI3 did not confirm our expectation that non-applicants would have higher utility values than first-time applicants. An explanation for this may be that non-applicants had more health problems other than their hearing, as reflected in the ambulation and pain dimensions of the HUI3. Overall, HUI2 and HUI3 scores were lower than EQ-5D scores and agreement was moderate to poor. Although these measures intend to assess the same construct, namely health state utility, this result was expected as the instruments differ in their underlying assumptions about what constitutes health state utility. As to responsiveness, only HUI2 and HUI3 measured statistically significant improvement after hearing aid fitting, the EQ-5D UK and Dutch tariff both were not able to capture this effect. Half of the patients (53%) who were fitted with a hearing aid were lost to follow up, either because they had not finished their hearing aid fitting before the end of the study, or because they had their hearing aid fitted at a dispenser not participating in our study. As these patients did not differ from the follow-up group in baseline utility, hearing loss and age, we did not expect this low response rate to influence the results. The HUI2 and HUI3 change scores resulted in smaller ICERs for hearing aid fitting. Although they were only illustrative, the different ICERs found in the present study clearly show that the choice of a utility instrument in the economic evaluation of hearing aid fitting may heavily influence the cost-effectiveness outcome. 8 9 43 9 6 7 44 22 8 45 Three questions arise from the results of the present study: can differences be explained by differences in the measures, are the differences observed between the measures important, and what are the implications of the findings for utility measurement and cost-utility analysis in populations with hearing complaints? 46 3 4 15 22 5 5 27 5 43 12 11 13 19 21 24 5 12 47