Background The generic and preference-based instrument EQ-5D is available in a five-response levels version (EQ-5D-5L). A value set for the EQ-5D-5L based on a representative sample of the German population has recently been developed. The aim of this study was to estimate normative values of the EQ-5D-5L index for Germany, and to examine associations between the EQ-5D-5L and selected sociodemographic factors. Methods The analysis was based on a representative sample (n = 4998) of the German general adult population in 2014. Participants had to rate their health-related quality of life on the EQ-5D-5L descriptive system as well as on a visual analogue scale (EQ-VAS). Normative values of the EQ-5D-5L index were estimated for selected sociodemographic characteristics. For the examination of associations between EQ-5D-5L index scores and selected sociodemographic factors, multivariate regression analyses were used. ResultsThe mean EQ-5D-5L index score of the total sample was 0.88 (SD 0.18), corresponding to an overall mean EQ-VAS score of 71.59 (SD 21.36). Female gender and increasing age were associated with a lower EQ-5D-5L index score (p < 0.001). Higher education, full-time employment and private health insurance were associated with a higher EQ-5D-5L index score (p < 0.001). ConclusionThis was the first study to estimate normative values of the EQ-5D-5L index for Germany based on a representative sample. The German normative values of the EQ-5D-5L are comparable to those reported for other countries. However, the mean EQ-5D-5L index score of the total sample was worse than those of the samples of studies from other countries.

Background Syrian refugees residing in Germany often develop posttraumatic stress as a result of the Syrian civil war, their escape, and postmigration stressors. At the same time, there is a lack of adequate treatment options. The smartphone-based app Sanadak was developed to provide cognitive behavioral therapy–based self-help in the Arabic language for Syrian refugees with posttraumatic stress. Objective The aim of this study was to evaluate the effectiveness and cost-effectiveness of the app. Methods In a randomized controlled trial, eligible individuals were randomly allocated to the intervention group (IG; app use) or control group (CG; psychoeducational reading material). Data were collected during structured face-to-face interviews at 3 assessments (preintervention/baseline, postintervention/after 4 weeks, follow-up/after 4 months). Using adjusted mixed-effects linear regression models, changes in posttraumatic stress and secondary outcomes were investigated as intention-to-treat (ITT) and per-protocol (PP) analysis. Cost-effectiveness was evaluated based on adjusted mean total costs, quality-adjusted life years (QALYs), and cost-effectiveness acceptability curves using the net benefit approach. Results Of 170 screened individuals (aged 18 to 65 years), 133 were eligible and randomized to the IG (n=65) and CG (n=68). Although there was a pre-post reduction in posttraumatic stress, ITT showed no significant differences between the IG and CG after 4 weeks (Posttraumatic Diagnostic Scale for DSM-5, Diff –0.90, 95% CI –0.24 to 0.47; P=.52) and after 4 months (Diff –0.39, 95% CI –3.24 to 2.46; P=.79). The same was true for PP. Regarding secondary outcomes, ITT indicated a treatment effect for self-stigma: after 4 weeks (Self-Stigma of Mental Illness Scale/SSMIS–stereotype agreement: d=0.86, 95% CI 0.46 to 1.25; stereotype application: d=0.60, 95% CI 0.22 to 0.99) and after 4 months (d=0.52, 95% CI 0.12 to 0.92; d=0.50, 95% CI 0.10 to 0.90), the IG showed significantly lower values in self-stigma than the CG. ITT showed no significant group differences in total costs and QALYs. The probability of cost-effectiveness was 81% for a willingness-to-pay of €0 per additional QALY but decreased with increasing willingness-to-pay. Conclusions Sanadak was not more effective in reducing mild to moderate posttraumatic stress in Syrian refugees than the control condition nor was it likely to be cost-effective. Therefore, Sanadak is not suitable as a standalone treatment. However, as the app usability was very good, no harms detected, and stigma significantly reduced, Sanadak has potential as a bridging aid within a stepped and collaborative care approach. Trial Registration German Clinical Trials Register DRKS00013782; https://www.drks.de/drks_web/navigate.do?navigationId=trial.HTML&TRIAL_ID=DRKS00013782 International Registered Report Identifier (IRRID) RR2-10.1186/s12888-019-2110-y

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