Introduction
Ageing of the populations and the increasing prevalence of chronic diseases in Europe poses significant burden on the health and social care systems [
1]. The economic evaluation of informal and social care interventions, as well as their contribution to societal welfare, have received increased attention in the past years [
2,
3]. In current health economic analyses and guidelines, the health-related quality of life (HRQoL) outcomes are used and recommended as golden standard. However, there is a growing interest in new emerging measures, which capture wider concept of well-being [
4].
ICECpop CAPability (ICECAP) measures have been developed to be used in economic evaluations to capture aspects of well-being beyond health and HRQoL. The ICECAP measures are based on Amartya Sen's capability approach which defines well-being in terms of an individual's ability and capability to ‘do’ certain things that are important in life [
5]. The ICECAP-A instrument has been developed for use among the general adult population (18 years and older) [
6], while the ICECAP-O instrument addresses important aspects of life of the older population (65 years and over) [
7]. Helter et al. identified 14 capability instruments, but only the ICECAP-A, ICECAP-O and the Adult Social Care Outcomes Toolkit (ASCOT) instruments reported both psychometric properties and valuation studies reflecting the preferences (utility) of the general public [
8]. The use of ICECAP instruments is evolving in economic evaluations. A recent systematic review by Proud et al. identified 22 studies where the ICECAP-O measure was applied in economic evaluations [
9]. On the regulatory level, the National Institute for Health and Care Excellence (NICE) recommends the use of ICECAP-O for measuring the impact of social care interventions, while in the Netherlands, ICECAP-O is recommended to be used for evaluations of long-term conditions [
10,
11].
Several studies assessed the validity of the ICECAP measures [
8,
9], however most of the literature focuses on the UK, where the measures were originally developed [
12‐
14], and on other English speaking countries, such as Australia [
15,
16] and Canada [
17,
18]. Other language versions of the ICECAP-O instrument have been developed and validated in Dutch [
19], German [
20], Spanish [
21] and Swedish [
22]. ICECAP-A has been validated in Chinese [
23] and in German [
11]. Nevertheless, no language versions have been available so far for the Central and Eastern European countries. Moreover, all ICECAP-A/-O studies (except an ICECAP-O study in Australia [
16]) involved either specific samples (e.g. patient groups or informal caregivers), or could achieve only partial representativeness in population-based samples due to online recruitment, relatively small sample size or higher response rates in specific groups [
13,
14,
24]. In European countries no population norms have been established that are based on a large sample, and can be considered representative along key demographic characteristics.
The primary aim of our study was, therefore, to develop the Hungarian versions of the ICECAP-A and ICECAP-O instruments, assess their construct validity, and test–retest their reliability among the Hungarian general population. Secondarily, we aimed to establish population normative data with both measures.
Methods
The survey
We designed and conducted a large population health survey in Hungary (year 2019) and developed the Hungarian version of the ICECAP-A and -O as part of this research. Computer-assisted personal interviews were conducted among the Hungarian adult general population (
N = 2023). The recruitment of the respondents and the interviews were carried out by a subcontractor (New Land Media Kft., Survey Company). Quotas were applied based on the number and composition of the population (National Central Statistical Office) to obtain a representative sample in terms of age, gender and residence [
25]. Ethical approval was obtained from the Hungarian Medical Research Council (no. 10058-3/2019/EKU). Respondents were informed that the participation in the survey was voluntary, the data would remain anonymous, impersonal and would be used solely for scientific purposes. Respondents needed to give their informed consent before the start of the survey.
In this paper our focus is on the ICECAP-A/-O results, but the survey covered five major modules: (1) socio-demographics (such as age, gender, education, marital status, employment status, household size, monthly net household income, place of residence) (2) health (3) well-being, happiness and satisfaction with life (4) major life events in the last 12 months and (5) experience with informal care either as a current caregiver (for the last 2 weeks) or recipient (in the past 3 months). A detailed definition of informal care was provided for the respondents. In brief, informal care was determined as a non-paid support or care, provided for family members or acquaintances in need of help due to health problems or ageing. The applied measurement tools introduced in the next sections were presented in the same order to each respondent. For the ICECAP-A, ICECAP-O and EQ-5D-5L questionnaires, we used self-completed paper based versions, and the data were recorded into the electronic database.
The instruments
The ICECAP-A and ICECAP-O and the development of their Hungarian versions
The ICECAP-A (for age group 18+) and ICECAP-O (for age group 65+) are preference-based measures of well-being capabilities, developed for use in economic evaluations [
6,
7,
12]. Both measures cover five domains of well-being. The ICECAP-A items are (1) Attachment (an ability to have love, friendship and support); (2) Stability (an ability to feel settled and secure); (3) Achievement (an ability to achieve and progress in life); (4) Enjoyment (an ability to experience enjoyment and pleasure) and (5) Autonomy (an ability to be independent). The ICECAP-O items are the following: (1) Attachment (love and friendship); (2) Security (thinking about the future without concern); (3) Role (doing things that make you feel valued); (4) Enjoyment (enjoyment and pleasure); (5) Control (independence). A 4-level response scale is applied for each item and respondents are asked to indicate the one that best describes their overall quality of life at the moment. Scores range from 0, which represents ‘no capability’ to 1, which represents ‘full capability’ based on the tariff sets for the instruments developed using best–worst scaling methods [
26,
27]. Tariffs are currently available only for the UK population, so we used those to calculate index scores. In this study, ICECAP-A scores were calculated for respondents below the age of 65 (< 65) and ICECAP-O scores for respondents (65+).
The Hungarian language versions of the ICECAP-A and ICECAP-O questionnaires were developed in accordance with available guidance on the topic [
28]. In brief, independent forward- and back-translations were undertaken. Differences were discussed among the investigators and they were reviewed by the copyright owner of the original English ICECAP measures. With the final versions, semi-structured interviews (
N = 10) were conducted with the aim to assess the comprehensiveness and the relevance of the content.
Minimum European Health Module (MEHM)
The MEHM health status measure consists of three general questions characterizing three different concepts of health: (1) self-perceived health in general (very good/good/fair/bad/very bad); (2) long-standing illness (3) long-standing activity limitations due to health problems measured via the Global Activity Limitation Indicator (GALI) (severely limited/limited but not severely/not limited at all) [
29].
The EQ-5D-5L
The EQ-5D-5L is a generic health status measure which distinguishes between five health domains, i.e. Mobility, Self-care, Usual activities, Pain/discomfort, Anxiety/depression [
30]. Respondents are asked to indicate the problem level (1—no, 2—slight, 3—moderate, 4—severe and 5—unable/extreme problems) that best describes their health ‘today’. Due to the lack of country-specific value set for Hungary [
31], we used the tariffs for England in our study (value range: − 0.285 to 1) to calculate EQ-5D-5L index score [
32]. In the second part of the questionnaire respondents are asked to value their health that day on a EQ VAS, a vertical 0–100 visual analogue scale (0—worst, 100—best health state the respondent can imagine).
World Health Organization-Five Well-Being Index (WHO-5)
The WHO-5 is a short self-reported measure of mental well-being [
33,
34]. It consists of five statements, which respondents rate in relation to the past 2 weeks on a 6-point Likert-scale (0—“at no time”; 5—“all of the time”) answer. The WHO-5 index is calculated by summing up the scores which is multiplied by 4 to give the final score between 0 and 100.
Happiness and satisfaction with life visual analogue scales (VAS)
We used 0–10 VAS to measure respondents’ current happiness and satisfaction with life (0—completely unhappy/not satisfied at all; 10—completely happy/completely satisfied).
The Satisfaction with Life Scale (SWLS)
The SWLS is a five-item instrument, designed to measure global cognitive judgments of satisfaction with one's life [
35,
36]. Respondents are asked to indicate their agreement with each of the five statements on a seven-point Likert-scale (1—“Strongly disagree”, 7—“Strongly agree”). The index is the summary of the scores, ranging from 5 to 35 with a score of 20 representing a neutral point on the scale (5–9: extremely dissatisfied; 31–35: extremely satisfied.)
Statistical analysis
The psychometric properties of the ICECAP-A and ICECAP-O instruments were evaluated in relation to socio-demographic characteristics, health status, major life events and health-related quality of life (EQ-5D-5L) as well as well-being measures (WHO-5, happiness and satisfaction VAS, SWLS).
We used the terminology from the COnsensus-based Standards for the selection of health status Measurement INstruments (COSMIN) taxonomy to describe validity while investigating psychometric properties of the instrument [
37]. We investigated internal consistency, construct validity (hypothesis testing, including convergent validity) and reliability (and test–retest reliability).
To assess the internal consistency, Cronbach’s alphas were calculated [
38]. Alpha ranges from 0 to 1 (0.7–0.8: acceptable, 0.8–0.9: good > 0.9: excellent internal consistency) [
39].
Construct validity was assessed via one-way subgroup comparisons and by multiple regression analysis. We investigated whether the ICECAP-A/ICECAP-O scores can differentiate between groups hypothesized to differ in their levels of the construct capability-well-being, i.e. among different socio-demographic characteristics, health status and major life events. Subgroup comparisons were carried out by one-way ANOVA tests, associations were also explored by OLS multiple regression analysis. Based on previous literature [
9,
11,
12,
14], we expected positive association with the following variables: being married/living with a partner, having higher income, being employed/having a paid job, living with others. A positive relationship was also expected between ICECAP-A/ICECAP-O scores and better health. On the other hand, we expected no association with gender, and no or negative association with age. We also investigated if capabilities differed by informal caregiving situation. Coast et al. found positive but not significant relationship [
12,
13].
To assess convergent validity, Pearson’s correlation coefficients were calculated between ICECAP-A/ ICECAP-O scores and related measures of health-related quality of life and well-being (EQ-5D-5L index, EQ VAS, WHO-5, happiness and satisfaction VAS, SWLS) and Spearman’s rho correlations between domains of these measures. Correlations were considered strong if the coefficient was over 0.5, moderate between 0.3 and 0.5 and weak under 0.3 [
40]. Based on previous literature we expected moderate / strong correlation with the EQ-5D-5L and SWLS measures [
11]. Positive association between ICECAP scores and WHO-5 scores were also assumed.
To assess the test–retest reliability of the ICECAP-O and ICECAP-A scores, 5% of the respondents were asked to participate in a follow up measurement right after the interview. For each questionnaire item, we calculated the percentage of agreement on each item. We calculated intra-class correlation coefficients (ICC), using a two-way mixed model of absolute agreement. The ICC can range from 0.00 (no stability/agreement) to 1.00 (perfect agreement). Based on Koo et al. [
41], agreement is considered poor for ICC values below 0.5, moderate between 0.50 and 0.749, good between 0.750 and 0.900 and excellent above 0.90.
In all types of analysis, a 5% significance level was applied. All analyses were undertaken using Stata version 13.
Discussion
The aim of the paper was to develop the Hungarian language version of the ICECAP-A and ICECAP-O instruments and assess their psychometric properties in relation to various health status, well-being and social support measures. Moreover, we aimed to provide population norms with both instruments to be used as reference scores in further clinical and public health studies. Overall, the Hungarian ICECAP-A/-O versions showed good psychometric properties. Main socio-demographic characteristics were not significant determinants of the ICECAP-O and only a few associations were observed with the ICECAP-A.
In terms of the construct validity of the Hungarian ICECAP-A and ICECAP-O, associations were in line with intuitive assumptions and previous literature findings [
9,
11,
12,
14]. Positive associations with marital status, employment, income, health and some major life events were confirmed by the subgroup analysis (and in multivariate regression analysis for the ICECAP-A), indicating good construct validity. Cronbach’s alpha of both ICECAP measures (0.86) indicated good internal consistency and these were very similar to what has been found by Linton et al. for the German version (0.83) and for the UK version (0.85) [
11].
With respect to convergent validity, we assessed correlations between ICECAP measures and other standard validated health status and well-being measures such as EQ-5D-5L, WHO-5 and SWLS. Before we discuss the findings, we have to highlight that even though most of these questionnaires focus on some aspects of health and well-being, only the ICECAP measures build on the concept of capability, while all the others rather address functioning. This important conceptual difference can partly explain possible (and to some extent expected) divergence between ICECAP and the other measures. In addition, these measures apply to slightly different time frames that might also induce some disparity.
Correlations between ICECAP-A/-O scores and EQ-5D-5L index scores were strong, and also with EQ VAS. On the domains’ level, correlations between EQ-5D-5L domains and Autonomy (independence) of ICECAP-A were found weak, whilst were moderate in case of Control (independence) of ICECAP-O. We assume that younger (and healthier) individuals consider primarily other aspects than health when they think of autonomy (e.g. financial independence, autonomy in decision making).
Although most of the validity studies used the EQ-5D measures when assessing convergent validity of the ICECAP instruments [
11,
14], only few of them are directly comparable to ours, as most of them used the three-response level (EQ-5D-3L) version [
15,
18,
42], and focused on specific conditions or patient population rather than the general population. Correlation coefficient found in our study between the ICECAP-A score and EQ-5D-5L index score (
r = 0.57), is very close to the ones found by Linton et al. for a German sample (
r = 0.62) and for a UK sample (
r = 0.61) of mixed populations of healthy individuals and patients [
11]. In our study, the Pearson correlation coefficient between the ICECAP-O and the EQ-5D-5L score was 0.65. Hackert et al. found a very similar (Spearman) correlation coefficient of 0.63 on the sample of UK general population of elderly [
24]. In both studies strongest correlations were observed between the Role item and the EQ-5D-5L domains, while lowest in the Attachment items and the EQ-5D-5L domains. Regarding ICECAP-O and EQ VAS scores, the corresponding coefficients were rather similar as well (0.58 vs 0.50).
With respect to the SWLS life-satisfaction measure, we found moderate/strong correlations between the ICECAP-A/O and SWLS scores, slightly lower than found in previous studies. Linton et al. reported stronger correlation between the SWLS and ICECAP-A scores (Germany: 0.66, the UK: 0.68) than between the EQ-5D-5L and ICECAP-A scores, indicating that ICECAP-A was more related to life satisfaction (SWLS) than to health-related quality of life. However, in our case, it was the opposite. Nevertheless, in both studies, correlation coefficients between SWLS and ICECAP-A domains were the lowest for the Autonomy domain. Regarding ICECAP-O, Hackert et al. reported a correlation coefficient of 0.72 between the ICECAP-O and SWLS scores [
24], while in our case it was slightly lower, 0.52.
According to our knowledge, this is the first study to assess the relationship between the WHO-5 mental well-being measure and the ICECAP-A/-O. Given that both are well-being measures, although with different approach, we expected strong association between these tools. Correlations between ICECAP-A/O scores and WHO-5 score were indeed strong (0.53 and 0.61, respectively), nonetheless their strength remained slightly under the level seen between the ICECAP-A/-O and the EQ-5D-5L health status index.
To assess test–retest reliability of the instruments, about 5% of the respondents were asked to fill in the ICECAP-A and -O questionnaires right after the interviews. So far, only two studies explored test–retest reliability of the ICECAP-A [
43,
44], and another two of the ICECAP-O instrument [
42,
45]. In these studies, the follow-up interview took place 1–2 weeks after the baseline interview, thus we expected and in fact found higher intra-class coefficients in our study indicating excellent agreement.
Multiple regression analysis revealed no significant associations between socio-demographic characteristics and ICECAP-O. For the ICECAP-A, only income and having a paid job showed significant positive associations, whilst living in Budapest resulted significantly worse ICECAP-A scores. In Australia, Couzner et al. found no strong relationship between ICECAP-O and socio-demographic status in age-group 65 and over, either [
16]. In our study, EQ-5D-5L health status was significant determinant of both ICECAP measures. Among the items of MEHM, only the self-perceived health status scale was proved to be significantly correlated with both ICECAP-A and -O (but the long-standing illness and GALI items were not). These results, on the one hand, enable estimates from one measure to another in the lack of observed data, nonetheless further research into exploring additional influencing factors of capabilities are suggested. On the other hand, our findings highlight and confirm previous studies regarding the remarkable difference between health status and well-being capabilities. We believe that it is time to consider the use of preference-based capability measures alongside the health status measures (e.g. MEHM) in international standardized and routinely collected population health statistics.
Some limitations of our study are worth mentioning. Because Hungarian tariffs for the ICECAP-A/-O and EQ-5D-5L were not available at the time of the study, the tariffs for the UK and England were used, respectively. These might differ from the preferences of the Hungarian general population. Also, the English tariff for the EQ-5D-5L has been recently criticized in the literature [
46]. Therefore, we analysed the correlations between these measures on the domains’ level as well which are independent from the national tariffs. Due to the cross-sectional nature of the study, we could not assess the responsiveness of the Hungarian ICECAP instruments to changes. Further prospective studies should be undertaken to tackle this issue. The time between the test and retest was short, therefore we cannot exclude some recall effects. This validation study has been carried out on a representative sample of the general population, which we think is one of the strengths of our research. Nevertheless, validity of the instruments should be tested also on patient populations for use in disease-specific studies.
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