Reliability, Validity and Responsiveness of the EQ-5D-5L in Assessing and Valuing Health Status in Adolescents and Young Adults with Posttraumatic Stress Disorder: a Randomized Controlled Trail

To validate the EQ-5D-5L health-related quality of life (HrQoL) questionnaire in adolescents and young adults with posttraumatic stress disorder (PTSD) after sexual and/or physical abuse. We used data from a randomized controlled trial of 87 participants with PTSD aged 14-21 years. The discriminative ability was evaluated by comparing participants scores on the descriptive system of the EQ-5D-5L with general population scores. Furthermore, the discriminative ability between subgroups of participants with different disease severity levels was estimated. Correlations between the EQ-5D index and clinical parameters were used to measure construct validity. Test-retest reliability was measured by intraclass correlation coefficients (ICC) between baseline, posttreatment and 3-month follow-up scores of participants with stable symptoms. Finally, the responsiveness of the EQ-5D was calculated by mean differences, effect sizes and receiver operating characteristic (ROC) analyses for participants with improved symptoms. Participants reported significantly more problems on the dimensions "mobility", "usual activities", "pain/discomfort" and "anxiety/depression" than the general population. The EQ-5D-5L was able to discriminate between different disease severity levels. The EQ-5D index and clinical scales were significantly correlated with absolute values of correlation coefficients varying between 0.21 and 0.59. Furthermore, ICCs between 0.65 and 0.91 indicated good test-retest reliability for the EQ-5D index. The ICCs for the EQ-VAS between baseline and 3-month follow-up, and posttreatment and 3-month follow-up were statistically significant with 0.71 and 0.87, respectively, whereas the ICC between baseline and posttreatment was 0.08 and not statistically significant. Effect sizes to measure the responsiveness ranged between -0.008 and 0.40 for the EQ-5D index and - 0.32 and 0.40 for the EQ-VAS. Furthermore, the area under the curve in ROC analyses was between 0.40 and 0.64 for the EQ-5D index and 0.60 and 0.70 for the EQ-VAS. Discriminative ability, test-retest reliability and construct validity of the EQ-5D-5L were good, whereas the responsiveness was rather weak. Nevertheless, the EQ-5D-5L can be used to measure HrQoL in adolescents and young adults with PTSD. German Clinical Trials Register identifier: DRKS00004787; date of registration: 18th March 2013; https://www.drks.d

Health-Related Quality of Life and Costs of Posttraumatic Stress Disorder in Adolescents and Young Adults in Germany

Background Posttraumatic stress disorder (PTSD) is one of the psychopathological consequences of sexual and/or physical abuse. The economic burden is assumed to be high, whereas health-related quality of life and education is negatively affected. This study aims to determine health care costs, health-related quality of life, and educational interruption in adolescents and young adults with PTSD after sexual and/or physical abuse in Germany. Methods This analysis used data of 87 participants aged 14-21 years of a randomized controlled trial. Health care utilization, health-related quality of life (EQ-5D-5L), sick leave days, productivity, and delay or failure to achieve educational aims were assessed. Health care costs from a payer perspective were calculated using unit costs for the year 2014. Results Mean health care costs for a six-month period were 5,243euro (SE 868euro). In particular, costs of inpatient stays in psychiatric hospitals, general hospitals and rehabilitation as well as child welfare institutions were high. In addition, health-related quality of life was lower due to anxiety/depression, resulting in a mean EQ-5D index and EQ-VAS score of 0.70 and 61.0, respectively. Furthermore, participants reported on average 27 sick leave days, a productivity loss of 61%, and a delay in education attainment as well as having been unable to achieve educational aims. Conclusion PTSD in adolescents and young adults is associated with a high economic burden. Health-related quality of life was substantially reduced. Furthermore, delay and productivity losses in education were observed

Health Care Services Utilization and Health-Related Quality of Life of Syrian Refugees with Post-Traumatic Stress Symptoms in Germany (the Sanadak Trial)

Refugees who have fled from the ongoing civil war in Syria that arrived in Germany often develop post-traumatic stress symptoms (PTSS). The aim of this study was to determine health care services utilization (HCSU), health care costs and health-related quality of life (HrQoL) of Syrian refugees with mild to moderate PTSS without current treatment in Germany. The study was based on the baseline sample of a randomized controlled trial of a self-help app for Syrian refugees with PTSS (n = 133). HCSU and HrQoL based on the EQ-5D-5L and its visual analogue scale (EQ-VAS) were assessed with standardized interviews. Annual health care costs were calculated using extrapolated four-month HCSU and standardized unit costs. Associations between health care costs, HrQoL and PTSS severity were examined using generalized linear models. Overall, 85.0% of the sample utilized health care services within four months. The mean total annual health care costs were EUR 1920 per person. PTSS severity was not associated with health care costs. The EQ-5D-5L index score and the EQ-VAS score was 0.82 and 73.6, respectively. For Syrian refugees with higher PTSS severity, the EQ-5D-5L index score was lower (−0.17; p < 0.001). The HCSU and the resulting health care costs of Syrian refugees with mild to moderate PTSS without current treatment are low and those with a higher PTSS severity had a lower HrQoL

Valuing end-of-life care:translation and content validation of the ICECAP-SCM measure

Background: The evaluation of care strategies at the end of life is particularly important due to the globally increasing proportion of very old people in need of care. The ICECAP-Supportive Care Measure is a self-complete questionnaire developed in the UK to evaluate palliative and supportive care by measuring patient’s wellbeing in terms of ‘capability’. It is a new measure with high potential for broad and international use. The aims of this study were the translation of the ICECAP-Supportive Care Measure from English into German and the content validation of this version. Methods: A multi-step and team-based translation process based on the TRAPD model was performed. An expert survey was carried out to assess content validity. The expert panel (n = 20) consisted of four expert groups: representative seniors aged 65+, patients aged 65+ living in residential care, patients aged 65+ receiving end-of-life care, and professionals in end-of-life care. Results: The German version of the ICECAP-Supportive Care Measure showed an excellent content validity on both item- and scale-level. In addition, a high agreement regarding the length of the single items and the total length of the questionnaire as well as the number of answer categories was reached. Conclusions: The German ICECAP-SCM is a valid tool to assess the quality of life at the end of life that is suitable for use in different settings. The questionnaire may be utilized in multinational clinical and economic evaluations of end-of-life care

Traumatized Syrian Refugees with Ambiguous Loss: Predictors of Mental Distress

Refugees from war zones often have missing significant others. A loss without confirmation is described as an ambiguous loss. This physical absence with simultaneous mental persistence can be accompanied by economic, social or legal problems, boundary ambiguity (i.e., uncertainty about who belongs to the family system), and can have a negative impact on mental health. The aim of this study was to identify sociodemographic and loss-related predictors for prolonged grief, anxiety, depression, post-traumatic stress disorder (PTSD) and somatization in treatment-seeking Syrian refugees with post-traumatic stress symptoms in Germany experiencing ambiguous loss. For the present study, data were based on the treatment-seeking baseline sample of the “Sanadak” randomized-controlled trial, analyzing a subsample of 47 Syrian refugees with post-traumatic stress symptoms in Germany experiencing ambiguous loss. Sociodemographic and loss-related questions were applied, along with standardized instruments for symptoms of prolonged grief (ICG), anxiety (GAD-7), depression (PHQ-9), PTSD (PDS-5) and somatization (PHQ-15). Linear regression models were used to predict mental health outcomes. Having lost a close family member and higher boundary ambiguity showed a statistically significant association with higher severity in prolonged grief. The overall model for somatization reached statistical significance, while no predictor independently did. Boundary ambiguity showed a statistically significant positive association with depression, while the overall model showed no statistically significant associations. Boundary ambiguity and missing family members seemed to be important predictors for prolonged grief. These findings support the importance of reunification programs and suggest an inclusion of the topic into psychosocial support structures, e.g., including psychoeducational elements on boundary ambiguity in support groups for traumatized individuals and families experiencing ambiguous loss. Further research is needed for a more detailed understanding of the impact of ambiguous loss on refugee populations

Recruitment and Baseline Characteristics of Participants in the “Sanadak” Trial: A Self-Help App for Syrian Refugees with Post-traumatic Stress

Many Syrian refugees residing in Germany have been exposed to traumatizing events, while treatment options are scarce. Therefore, the self-help app “Sanadak” was developed to target post-traumatic stress in Syrian refugees. We aimed to inspect the recruitment and baseline characteristics of the participants in the trial, which is conducted to evaluate the app. Analyses were based on the recruitment sample (n = 170) and the trial sample (n = 133). Data were collected during structured face-to-face interviews in the Arabic language. Targeted outcomes included post-traumatic stress (primary; Post-traumatic Diagnostic Scale for DSM-5/PDS-5) and depressive symptoms, anxiety, resilience, among others (secondary). Recruited individuals were M = 32.8 (SD = 11.2, range = 18–65) years old; 38.8% were women. The average PDS-5 score was 23.6 (SD = 13.2) regarding trauma exposure, which was most frequently related to experiencing military- or combat-related events (32.9%). Moreover, 46.5% had major depression and 51.8% showed low resilience. Anxiety was present in 40.6% of the trial participants. Psychological distress was high in Syrian refugees residing in Germany, enrolled in a trial targeting post-traumatic stress. This underlines the need for intervention. Our results provide important figures on the mental health of a not well-studied population group in Germany

German tariffs for the ICECAP-Supportive Care Measure (ICECAP-SCM) for use in economic evaluations at the end of life

Objectives Economic evaluations often use preference-based value sets (tarifs) for health-related quality of life to quantify health efects. For wellbeing at the end of life, issues beyond health-related quality of life may be important. Therefore, the ICECAP Supportive Care Measure (ICECAP-SCM), based on the capability approach, was developed. A validated German ICECAP-SCM version was published recently. However, tarifs for the German ICECAP-SCM are not available. Therefore, the aim was to determine tarifs for the ICECAP-SCM based on preferences of the German general population. Methods An online sample of 2996 participants completed a best–worst scaling (BWS) and a discrete choice experiment (DCE). BWSs required participants to choose the best and worst statement within the same capability state, whereas DCEs required participants to trade-of between two capability states. First, BWS and DCE data were analyzed separately. Subsequently, combined data were analyzed using scale-adjusted conditional logit latent class models. Models were selected based on the stability of solutions and the Bayesian information criterion. Results The two latent class model was identifed to be optimal for the BWS, DCE, and combined data, and was used to derive tarifs for the ICECAP-SCM capability states. BWS data captured diferences in ICECAP-SCM scale levels, whereas DCE data additionally explained interactions between the seven ICECAP-SCM attributes. Discussion The German ICECAP-SCM tarifs can be used in addition to health-related quality of life to quantify efectiveness in economic evaluations. The tarifs based on BWS data were similar for Germany and the UK, whereas the tarifs based on combined data varied. We would recommend to use tarifs based on combined data in German evaluations. However, only results on BWS data are comparable between Germany and the UK, so that tarifs based on BWS data should be used when comparing results between Germany and the UK.Open Access funding enabled and organized by Projekt DEAL.. This research was funded by the Federal Ministry of Education and Research (Grand number 01GL1725B)

Mental Health Self-Stigma of Syrian Refugees With Posttraumatic Stress Symptoms: Investigating Sociodemographic and Psychopathological Correlates

Background: The high prevalence of mental disorders related to posttraumatic stress among Syrian refugees is often in contrast with their low utilization ofmental health care in the host countries. Mental health self-stigma, i.e., internalized stigma of having a mental disorder, could prevent individuals from seeking mental health care. Therefore, we aimed to provide evidence on different aspects of mental health self-stigmatization among adult Syrian refugees with posttraumatic stress symptoms residing in Germany. Moreover, we investigated associations with sociodemographic and psychopathological variables in order to identify those at higher risk of self-stigmatization. Material and Methods: Overall, 133 participants with mild to moderate posttraumatic stress symptoms were recruited in the metropolitan areas of Leipzig, Dresden and Halle, Germany, using a multimodal approach. Mental health self-stigma was assessed using the Self-Stigma of Mental Illness Scale – Short Form (SSMIS-SF), consisting of four subscales (Stereotype awareness, Stereotype agreement, Application to self, Harm to self-esteem), each scoring from 5 (low) to 45 (high) points. Linear regression analysis was used to test associations of sociodemographic and psychopathological variables with self-stigma subscales. Results: On average, self-stigma ratings ranged from 16.5 (SD = 6.6) points on Application to self to 28.3 (SD = 7.5) points on Stereotype awareness. Results showed higher scores on Application to self for individuals who were younger (t =2.65, p=0.009) and single (F = 5.70, p = 0.004). Regression analyses yielded statistically significant associations between having multiple comorbidities and a higher Application to self stigma ( = 0.18, p = 0.044), controlling for sociodemographic covariates. Discussion: Mental health self-stigma was increased among Syrian refugees in Germany. Correlates of increased self-stigma could inform efforts to improve access to mental health care among Syrian refugees with mental ill-health. Longitudinal studies following an intersectional approach by concurrently examining multiple forms of public and internalized stigma could provide helpful insights for developing tailored stigma reduction efforts in this context

Mapping the EQ-5D index by UPDRS and PDQ-8 in patients with Parkinson’s disease

Background: Clinical studies employ the Unified Parkinson’s Disease Rating Scale (UPDRS) to measure the severity of Parkinson’s disease. Evaluations often fail to consider the health-related quality of life (HrQoL) or apply disease-specific instruments. Health-economic studies normally use estimates of utilities to calculate quality-adjusted life years. We aimed to develop an estimation algorithm for EuroQol- 5 dimensions (EQ-5D)-based utilities from the clinical UPDRS or disease-specific HrQoL data in the absence of original utilities estimates. Methods: Linear and fractional polynomial regression analyses were performed with data from a study of Parkinson’s disease patients (n=138) to predict the EQ-5D index values from UPDRS and Parkinson’s disease questionnaire eight dimensions (PDQ-8) data. German and European weights were used to calculate the EQ-5D index. The models were compared by R2, the root mean square error (RMS), the Bayesian information criterion, and Pregibon’s link test. Three independent data sets validated the models. Results: The regression analyses resulted in a single best prediction model (R2: 0.713 and 0.684, RMS: 0.139 and 13.78 for indices with German and European weights, respectively) consisting of UPDRS subscores II, III, IVa-c as predictors. When the PDQ-8 items were utilised as independent variables, the model resulted in an R2 of 0.60 and 0.67. The independent data confirmed the prediction models. Conclusion: The best results were obtained from a model consisting of UPDRS subscores II, III, IVa-c. Although a good model fit was observed, primary EQ-5D data are always preferable. Further validation of the prediction algorithm within large, independent studies is necessary prior to its generalised use

Comparison of a group-delivered and individually delivered lifestyle-integrated functional exercise (LiFE) program in older persons: a randomized noninferiority trial

Background: The Lifestyle-Integrated Functional Exercise (LiFE) program is effective in improving strength, balance, and physical activity (PA) while simultaneously reducing falls in older people by incorporating exercise activities in recurring daily tasks. However, implementing the original LiFE program includes substantial resource requirements. Therefore, as part of the LiFE-is-LiFE project, a group format (gLiFE) of the LiFE program has been developed, which will be tested regarding its noninferiority to the individually delivered LiFE in terms of PA-adjusted fall incidence and overall cost-effectiveness. Methods: In a multi-centre, single-blinded noninferiority trial, an envisaged sample of N = 300 participants (&gt; 70 years; faller and/or confirmed falls risk; community-dwelling) will be randomized in either LiFE or gLiFE. Both groups will undergo the same strength and balance activities as well as PA promotion activities and habitualization strategies as described in the LiFE programme, however, based on different approaches of delivery: During the 6-month intervention phase, LiFE participants will receive seven home visits and two telephone calls; in gLiFE, the program will be delivered in seven group sessions and also two telephone calls. Main outcomes are a) fall incidence per PA and b) incremental cost-effectiveness ratio comparing costs and quality-adjusted life years between the two interventions. Secondary outcomes include PA behaviour, motor performance, health status, psychosocial status, program evaluation, and adherence. Measurements will be conducted at baseline, 6-month and 12-month follow-up; evaluation of intervention sessions and assessment of psychosocial variables related to execution and habitualization of LiFE activities will be made during the intervention period as well. Discussion: Compared to LiFE, we expect gLiFE to (a) reduce falls per PA by a similar rate; (b) be more cost-effective; (c) comparably enhance physical performance in terms of strength and balance as well as PA. By investigating the economic and societal benefit, this study will be of high practical relevance as noninferiority of gLiFE would facilitate large-scale implementation due to lower resource usage. This would result in better reach and increased accessibility, which is important for subjects with a history of falls and/or being at risk of falls. Trial registration ClinicalTrials.gov NCT03462654. Registered on March 12, 2018