Most previous studies concerning the validity of the EQ-5D-3L items refer to applications of only a single language version of the EQ-5D-3L in only one country. Therefore, there is little information concerning the extent to which the results can be generalised across different language versions and/or different countries. Here the validity of the EQ-5D-3L items is investigated for six different language versions in six different countries. Data came from 1341 type 2 diabetes patients (England: 289; Finland: 177; Germany: 255; Greece: 165; the Netherlands: 354; Spain: 101). The relationships of the five EQ-5D-3L items with seven different test variables (age, gender, education, previous stroke, problems with heart, problems with lower extremities, problems with eyes), were analysed for each combination of item and test variable. For each combination two logistic regression models with the dichotomised EQ-5D-3L item as dependent variable were computed. The first model contained the test variable and dummy coded countries as independent variables, the second model additionally the terms for the interaction between country and test variable. Statistically significant better fit of the second model was taken as evidence for country specific differences regarding the relationship. When such differences could be attributed mainly to one country the analyses were repeated without the data from this country. Validity was investigated with the remaining data using results of the first models. Due to lack of variation in the Spanish data only 31 of the originally intended 35 interaction tests could be performed. Only three of these yielded a significant result. In all three cases the Spanish data deviated most. Without the Spanish data only 1 of the 35 interaction tests yielded a significant result. With 3 exceptions, the tendency of reporting problems increased with age, female gender, lower education, previous stroke, heart problems, problems with lower extremities and problems with eyes for all EQ-5D-3L items. The results concerning the European Spanish version are ambiguous. However, the items of the English, Finnish, German, Greek and Dutch versions of the EQ-5D-3L relate in substantially the same way to the test variables. Mostly, these relationships indicate the items’ validity.

Background: Type 2 diabetes mellitus (T2DM) and coronary heart disease (CHD) are two chronic diseases that cause a tremendous burden. To reduce this burden, several programmes for optimising the care for these diseases have been developed. In Germany, so-called disease management programmes (DMPs), which combine components of Disease Management and the Chronic Care Model, are applied. These DMPs have proven effective. Nevertheless, there are opportunities for improvement. Current DMPs rarely address self-management of the disease, make no use of peer support, and provide no special assistance for persons with low health literacy and/or low patient activation. The study protocol presented here is for the evaluation of a programme that addresses these possible shortcomings and can be combined with current German DMPs for T2DM and CHD. This programme consists of four components: Meetings of peer support groups Personalised telephone-based health coaching for patients with low literacy and/or low patient activation Personalised patient feedback A browser-based web portal Methods: Study participants will be adults enrolled in a DMP for T2DM and/or CHD and living in North Rhine-Westphalia, a state of the Federal Republic of Germany. Study participants will be recruited with the assistance of their general practitioners by the end of June 2021. Evaluation will be performed as a pragmatic randomised controlled trial with one intervention group and one waiting control group. The intervention group will receive the intervention for 18 months. During this time, the waiting control group will continue with usual care and the usual measures of their DMPs. After 18 months, the waiting control group will also receive a shortened intervention. The primary outcome is number of hospital days. In addition, the effects on self-reported health-state, physical activity, nutrition, and eight different psychological variables will be investigated. Differences between values at month 18 and at the beginning will be compared to judge the effectiveness of the intervention. Discussion: If the intervention proves effective, it may be included into the DMPs for T2DM and CHD. Trial registration: The study was registered in the German Clinical Trials Registry (Deutsches Register Klinischer Studien (DRKS)) in early 2019 under the number 00020592. This registry has been affiliated with the WHO Clinical Trials Network (https://www.drks.de/drks_web/setLocale_EN.do) since 2008. It is based on the WHO template, but contains some additional categories for which information has to be given (https://www.drks.de/drks_web/navigate.do?navigationId=entryfields&messageDE=Beschreibung%20der%20Eingabefelder&messageEN=Description%20of%20entry%20fields ). A release and subsequent number assignment only take place when information for all categories has been given.

A short questionnaire which can be applied for assessing patient satisfaction in different contexts and different countries is to be developed. Six items addressing tangibles, reliability, responsiveness, assurance, empathy, and communication were analysed. The first five items stem from SERVQUAL (SERVice QUALity), the last stems from the discussion about SERVQUAL. The analyses were performed with data from 12 surveys conducted in six different countries (England, Finland, Germany, Greece, the Netherlands, Spain) covering two different conditions (type 2 diabetes, stroke). Sample sizes for included participants are 247 in England, 160 in Finland, 231 in Germany, 152 in Greece, 316 in the Netherlands and 96 in Spain for the diabetes surveys; and 101 in England, 139 in Finland, 107 in Germany, 58 in Greece, 185 in the Netherlands, and 92 in Spain for the stroke surveys. The items were tested by (1) bivariate correlations between the items and an item addressing ‘general satisfaction’, (2) multivariate regression analyses with ‘general satisfaction’ as criterion and the items as predictors, and (3) bivariate correlations between sum scores and ‘general satisfaction’. The correlations with ‘general satisfaction’ are 0.48 for tangibles, 0.56 for reliability, 0.58 for responsiveness, 0.47 for assurance, 0.53 for empathy, and 0.56 for communication. In the multivariate regression analysis, the regression coefficient for assurance is significantly negative while all other regression coefficients are significantly positive. In a multivariate regression analysis without the item ‘assurance’ all regression coefficients are positive. The correlation between the sum score and ‘general satisfaction’ is 0.608 for all six items and 0.618 for the finally remaining five items. The country specific results are similar. The five items which remain after removing ‘assurance’, i.e. the SERVQUAL-MOD-5, constitute a short patient satisfaction index which can usefully be applied for different medical conditions and in different countries.

The relationships between caregiver burden as measured with the Burden Scale for Family Caregivers–short form and 6 characteristics of caregivers caring for patients with dementia were investigated for caregivers from England (n = 36), Finland (n = 42), and Greece (n = 46) using survey data. In all 3 countries, caregiver burden increases with physical problems of the caregiver, emotional problems of the caregiver, and weekly hours of care. Hence, in all 3 countries, special support for informal care is required when these characteristics are at high levels. When the caregiver is a spouse or long-term partner of the person with dementia, lives in the same house as this person, or spends fewer than 20 h/wk for other duties than care, this is associated with less caregiver burden in England but with more caregiver burden in Greece. Accordingly, special support is required for Greek caregivers with these characteristics, but the opposite is true for English caregivers.