Association between physical activity and costs in very mild to moderately frail community-dwelling older adults: a cross-sectional study.

BACKGROUND: Physical activity (PA) plays a vital role in maintaining the functional ability that enables well-being in older age (healthy aging), potentially also saving costs for the healthcare system and society. The aim of this study was to examine the association between PA and healthcare and societal costs in a sample of very mild to moderately frail older adults. METHODS: This cross-sectional study is a secondary analysis using baseline data from the PromeTheus randomized-controlled trial, which included 385 very mild to moderately frail community-dwelling older adults (70 + years) from Germany. Participants self-reported their health-related resource use in the previous 6 months (FIMA questionnaire), which was monetarily valued using standardized unit costs. PA was also self-reported using the German Physical Activity Questionnaire for middle-aged and older adults (German-PAQ-50+) and categorized as 'insufficient'/'sufficient' or 'insufficient'/'moderate'/'high' in accordance with the World Health Organization guidelines for PA. Mean and median healthcare costs (including outpatient, inpatient, rehabilitation, formal care, and medication costs) and societal costs (healthcare costs plus informal care costs) for different PA groups were estimated using generalized linear models and quantile regression, with sociodemographic variables and physical capacity (Short Physical Performance Battery) as covariates. RESULTS: Of the sample, 24% were classified as insufficiently, 23% as moderately, and 54% as highly active. Sufficient PA, especially high PA, was associated with lower costs in the 6 months prior to data collection compared to insufficient PA (-€6,237, 95% CI [-10,656; -1,817] and -€8,333, 95% CI [-12,183; -4,483], respectively). The cost difference between PA intensity groups was largely driven by differences in informal care costs and decreased substantially when physical capacity was accounted for in the analyses; e.g., the mean difference in societal costs between sufficient and insufficient PA decreased from -€7,615 (95% CI [-11,404; -3,825]) to -€4,532 (95% CI [-7,930; -1,133]). CONCLUSION: Promoting PA throughout the lifespan as a means of promoting healthy aging and reducing dependency in old age could potentially provide economic benefits and help to mitigate the economic consequences of an aging population with increasing health and long-term care needs. Future longitudinal studies should attempt to disentangle the mediating and confounding role of physical capacity and health status in the association between PA and costs.

Implementation of a multimodal home-based rehabilitation intervention after discharge from inpatient geriatric rehabilitation (GeRas): an early qualitative process evaluation.

BACKGROUND: Geriatric rehabilitation aims at increasing physical and social activity and maintaining the functional reserve of older people. However, the continuity of geriatric rehabilitation in the outpatient setting is limited due to a lack of structured aftercare programs. In order to overcome this, a three-month multimodal home-based intervention program (GeRas) was implemented. The aim of this early qualitative process evaluation was to assess GeRas in terms of perceived reach, effectiveness/efficacy, adoption/uptake, implementation, and maintenance/sustainability (Domains within the RE-AIM Framework) from the perspective of patients who received the intervention and healthcare providers who were involved in the delivery of the intervention. METHODS: In a qualitative process evaluation, 13 healthcare providers and 10 patients were interviewed throughout the beginning of the implementation period of GeRas to capture early experiences using a semi-structured interview guide. The interview guide and qualitative content analysis was guided by the RE-AIM Framework. RESULTS: The GeRas program was perceived to be largely well implemented and beneficial by healthcare providers and patients. According to healthcare providers, GeRas showed more advantages compared to usual care. Additionally, outcome expectations were mainly met (Domain 1: Effectiveness). However, the implementation of the intervention delivered via the eHealth system was perceived as challenging (Domain 2: Adoption). Nevertheless, the outpatient physical exercise, the outpatient counselling, and the continuous care after discharge improved perceived well-being regardless of the intervention type (Domain 3: Implementation). To facilitate the continued use of GeRas, technical requirements should be created to increase user-friendliness and to motivate patients to continue the training in the long term (Domain 4: Maintenance). CONCLUSION: Although initial experiences with the implementation and effectiveness of GeRas were positive in general, organisational and technical issues need to be resolved to enhance sustainable and successful implementation of the GeRas program. TRIAL REGISTRATION: German Clinical Trials Register (DRKS00029559). Registered 5/10/2022.

Flight-related determinants of healthcare services utilization of asylum seekers and refugees in Germany: a study based on the German Socio-Economic Panel.

The aim of this study was to analyze the associations between healthcare services utilization and flight-related characteristics of asylum seekers and refugees in Germany. The 2020 wave of the German Socio-Economic Panel's Survey of Refugees was used to compile a sample of asylum seekers and refugees (n = 3134). Healthcare services utilization was measured using the self-reported number of visits to primary care physicians and hospitalization. Only the feeling of being welcome and worries about not being able to stay in Germany were identified as potential flight-related determinants of healthcare services utilization.

Flight-related determinants of health-related quality of life of asylum seekers and refugees in Germany: a longitudinal study based on the German Socio-Economic Panel (SOEP).

BACKGROUND: Germany played a key role as receiving country during the so-called refugee and displacement crisis with about 5 million asylum seekers arriving in the EU between 2014 and 2020. It is well known that asylum seekers and refugees (ASRs) have a high burden of disease and are particularly prone to mental disorders such as trauma, stress-related and affective disorders. Not much is known about the determinants of health-related quality of life (HrQoL) among ASRs, especially in the context of the flight. Therefore, the aim of this study was to analyze the associations between flight-related characteristics and HrQoL of ASRs in Germany. METHODS: The sample of this study was based on five consecutive waves of the Survey of Refugees samples of the German Socio-Economic Panel (n = 8015; 14,314 observations). Mental and physical HrQoL was measured using the mental (MCS) and physical (PCS) component summary scores of the SF-12v2. Associations between flight-related characteristics and HrQoL were examined using multilevel mixed-effects linear regressions. RESULTS: The different countries of birth were associated with varying MCS and PCS scores. The MCS and PCS scores were lower among ASRs with an economic situation below average in their countries of origin. Persecution, discrimination, and poor living conditions as reasons for leaving the county were associated with lower MCS scores. ASRs who were dissatisfied with their own living situation and who were discriminated often due to their origin had both lower MCS and PCS scores. Not feeling welcome in Germany and missing people from one's country of origin were both associated with lower MCS scores. No worries about not being able to stay in Germany or not being able to return to one's country of origin were both associated with higher MCS scores. CONCLUSIONS: The economic situation in the country of origin and the presence of persecution, discrimination, and/or poor living conditions as reason for flight may be pre-flight-related determinants of HrQoL of ASRs in Germany. Possible post-flight-related determinants can be the residence status, the satisfaction with one's living situation, discrimination due to one's origin and a feeling of missing people from one's country of origin. With regard to those determinants, the clarity about the residence status, reducing racial discrimination and the mourning of flight-related circumstances must be ensured.

Migration-related determinants of health-care service utilization among persons with a direct migration background in Germany: an exploratory study based on the German Socio-Economic Panel (SOEP).

BACKGROUND: It is known that the health-care service utilization in primary care of persons with a direct migration background is lower compared to non-migrants. However, potential migration-related determinants of health-care service utilization are not known. Therefore, this study aimed to analyze the associations between health-care service utilization and migration-related characteristics of persons with a direct migration background in Germany. METHODS: The migration samples (M1 and M2) of the German Socio-Economic Panel (SOEP) were used as the sample for this study. Associations between the number of visits to primary care physicians in the previous three months and migration-related characteristics were examined using generalized linear models. Associations between the hospitalization within one year and migration-related characteristics were examined using logit models. RESULTS: The mean number of visits to primary care physicians was about 2, and 8% of persons were hospitalized. Being born in a country other than Russia was associated with a higher number of visits to primary care physicians (+ 26% to + 34%). Both, a very strong connectedness with the country of birth and very good oral German language skills were associated with higher number of visits to primary care physicians (both + 13%) compared to no connectedness and fairly bad oral German language skills. CONCLUSION: Only the country of birth, connectedness with the country of birth and oral German language skills may be migration-related determinants of health-care service utilization with regard to the number of visits to primary care physicians by persons with a direct migration background in Germany. With regard to hospitalization, no potential migration-related determinants of health-care service utilization could be identified.

Cost-effectiveness of endovascular thrombectomy for acute ischemic stroke with established large infarct in Germany: a decision tree and Markov model.

BACKGROUND: Recent studies, including the TENSION trial, support the use of endovascular thrombectomy (EVT) in acute ischemic stroke with large infarct (Alberta Stroke Program Early Computed Tomography Score (ASPECTS) 3-5). OBJECTIVE: To evaluate the cost-effectiveness of EVT compared with best medical care (BMC) alone in this population from a German healthcare payer perspective. METHODS: A short-term decision tree and a long-term Markov model (lifetime horizon) were used to compare healthcare costs and quality-adjusted life years (QALYs) between EVT and BMC. The effectiveness of EVT was reflected by the 90-day modified Rankin Scale (mRS) outcome from the TENSION trial. QALYs were based on published mRS-specific health utilities (EQ-5D-3L indices). Long-term healthcare costs were calculated based on insurance data. Costs (reported in 2022 euros) and QALYs were discounted by 3% annually. Cost-effectiveness was assessed using incremental cost-effectiveness ratios (ICERs). Deterministic and probabilistic sensitivity analyses were performed to account for parameter uncertainties. RESULTS: Compared with BMC, EVT yielded higher lifetime incremental costs (€24 257) and effects (1.41 QALYs), resulting in an ICER of €17 158/QALY. The results were robust to parameter variation in sensitivity analyses (eg, 95% probability of cost-effectiveness was achieved at a willingness to pay of >€22 000/QALY). Subgroup analyses indicated that EVT was cost-effective for all ASPECTS subgroups. CONCLUSIONS: EVT for acute ischemic stroke with established large infarct is likely to be cost-effective compared with BMC, assuming that an additional investment of €17 158/QALY is deemed acceptable by the healthcare payer.

Costs associated with insufficient physical activity in Germany: cross-sectional results from the baseline examination of the German national cohort (NAKO).

BACKGROUND: Insufficient physical activity (PA) is a leading risk factor for non-communicable diseases posing a significant economic burden to healthcare systems and societies. The study aimed to examine the differences in healthcare and indirect costs between sufficient and insufficient PA and the cost differences between PA intensity groups. METHODS: The cross-sectional analysis was based on data from 157,648 participants in the baseline examination of the German National Cohort (NAKO) study. Healthcare and indirect costs were calculated based on self-reported information on health-related resource use and productivity losses. PA in the domains leisure, transport, and work was assessed by the Global Physical Activity Questionnaire and categorized into sufficient/insufficient and intensity levels (very low/low/medium/high) based on PA recommendations of the World Health Organization. Two-part models adjusted for relevant covariates were used to estimate mean costs for PA groups. RESULTS AND CONCLUSION: Insufficiently active people had higher average annual healthcare costs (Δ €188, 95% CI [64, 311]) and healthcare plus indirect costs (Δ €482, 95% CI [262, 702]) compared to sufficiently active people. The difference was especially evident in the population aged 60 + years and when considering only leisure PA. An inverse association was observed between leisure PA and costs, whereas a direct association was found between PA at work and costs. Adjusting for the number of comorbidities reduced the differences between activity groups, but the trend persisted. The association between PA and costs differed in direction between PA domains. Future research may provide further insight into the temporal relationship between PA and costs.

Prevention at home in older persons with (pre-)frailty: analysis of participants' recruitment and characteristics of the randomized controlled PromeTheus trial.

BACKGROUND: The "PromeTheus" trial is evaluating a home-based, multifactorial, interdisciplinary prevention program for community-dwelling (pre-)frail older adults. These individuals often suffer from reduced participation, which can complicate the recruitment and enrollment in a clinical trial. AIMS: The aim of this study was to evaluate different recruitment strategies and differences in participant characteristics in relation to these strategies. METHODS: This cross-sectional study used baseline data from the randomized-controlled PromeTheus trial, in which community-dwelling (pre-)frail older persons (Clinical Frailty Scale [CFS] 4-6 pt., ≥ 70 years) were recruited via general practitioners ("GP recruitment") or flyers, newspaper articles, and personalized letters ("direct recruitment"). Differences in the sociodemographic, clinical, physical, functional, mobility-related, psychological and social characteristics were analyzed in relation to the recruitment strategy. RESULTS: A total of 385 participants (mean age = 81.2, SD 5.9 years; women: n = 283, 73.5%) were enrolled, of which 60 (16%) were recruited by GPs and 325 (84%) through direct recruitment. Participants recruited via GPs had significantly higher subjective frailty levels (CFS), were more often physically frail (Fried Frailty Phenotype), and showed lower physical capacity (Short Physical Performance Battery), participation (disability component of the short version of the Late-Life Function and Disability Instrument), and life-space mobility (Life-Space Assessment) compared to those recruited via the direct approach (p = 0.002-0.026). Costs per randomized participant were 94€ for the GP recruitment strategy and €213 for the direct recruitment strategy. CONCLUSION: Different strategies may be required to successfully recruit (pre-)frail home-living older adults into preventive programs. Direct recruitment strategies, in which potential participants are directly informed about the prevention program, seem to be more promising than GP recruitment but may result in enrolment of persons with less functional impairment and higher recruitment costs. TRIAL REGISTRATION: German Clinical Trials Register, DRKS00024638. Registered on March 11, 2021.

Evaluating palliative care case conferences in primary care for patients with advanced non-malignant chronic conditions: a cluster-randomised controlled trial (KOPAL).

BACKGROUND: Patients with congestive heart failure (CHF), chronic obstructive pulmonary disease (COPD) and dementia are underrepresented in specialist palliative home care (SPHC). However, the complexity of their conditions requires collaboration between general practitioners (GPs) and SPHC teams and timely integration into SPHC to effectively meet their needs. OBJECTIVE: To facilitate joint palliative care planning and the timely transfer of patients with advanced chronic non-malignant conditions to SPHC. METHODS: A two-arm, unblinded, cluster-randomised controlled trial. 49 GP practices in northern Germany were randomised using web-based block randomisation. We included patients with advanced CHF, COPD and/or dementia. The KOPAL intervention consisted of a SPHC nurse-patient consultation followed by an interprofessional telephone case conference between SPHC team and GP. The primary outcome was the number of hospital admissions 48 weeks after baseline. Secondary analyses examined the effects on health-related quality of life and self-rated health status, as measured by the EuroQol 5D scale. RESULTS: A total of 172 patients were included in the analyses. 80.4% of GP practices had worked with SHPC before, most of them exclusively for cancer patients. At baseline, patients reported a mean EQ-VAS of 48.4, a mean quality of life index (EQ-5D-5L) of 0.63 and an average of 0.80 hospital admissions in the previous year. The intervention did not significantly reduce hospital admissions (incidence rate ratio = 0.79, 95%CI: [0.49, 1.26], P = 0.31) or the number of days spent in hospital (incidence rate ratio = 0.65, 95%CI: [0.28, 1.49], P = 0.29). There was also no significant effect on quality of life (∆ = -0.02, 95%CI: [-0.09, 0.05], P = 0.53) or self-rated health (∆ = -2.48, 95%CI: [-9.95, 4.99], P = 0.51). CONCLUSIONS: The study did not show the hypothesised effect on hospitalisations and health-related quality of life. Future research should focus on refining this approach, with particular emphasis on optimising the timing of case conferences and implementing discussed changes to treatment plans, to improve collaboration between GPs and SPHC teams.

Migration-related determinants of health-related quality of life of persons with direct migration background in Germany: a study based on the German Socio-Economic Panel.

Introduction: Persons with a direct migration background made up a share of around 17% of the total German population in the year 2020. Not much is known about migration-related determinants of health-related quality of life (HrQoL) of persons with direct migration background. This study aimed to analyze the associations between HrQoL, sociodemographic, and migration-related characteristics of persons with direct migration background in Germany. Methods: The sample of this study was based on four waves (2014, 2016, 2018, and 2020) of the migration samples (M1 and M2) of the German Socio-Economic Panel (SOEP). The SF-12 was used to measure HrQoL using its mental (MCS) and physical (PCS) component summary scores. Missing information was replaced by multiple imputation by chained equations with predictive mean matching. Associations between HrQoL and sociodemographic and migration-related characteristics were examined using multilevel mixed-effects linear regressions. Results: The mean MCS and PCS scores of persons with direct migration background(n = 4,124) were 51.81 and 51.57, respectively. Being born in Russia was associated statistically significantly with a lower PCS score compared with non-east European and American/Oceanic countries. A longer period since migration to Germany was negatively associated with both MCS and PCS scores (both with p < 0.01). A steady relationship before migration was associated with a higher MCS score (+0.69, p = 0.017). Not feeling German and experiencing disadvantages due to origin were negatively associated with the MCS (both with p < 0.001). The oral ability in the German language was positively associated with the PCS score (p < 0.05). Conclusion: The time since migration to Germany, and the relationship status before migration may be determinants of HrQoL of persons with a direct migration background. Furthermore, connectedness with Germany, disadvantages due to origin and oral ability in the German language, representative of integration in Germany, can be potential determinants of HrQoL. Thus, integration of persons with migration background is crucial for their mental and physical HrQoL.

Budget impact analysis of a Lifestyle-integrated Functional Exercise (LiFE) program for older people in Germany: a Markov model based on data from the LiFE-is-LiFE trial.

BACKGROUND: Fall prevention is important for healthy ageing, but the economic impact of fall prevention are scarcely investigated. A recent cost-effectiveness analysis compared a group-delivered Lifestyle-integrated Functional Exercise Program (gLiFE) with an individually-delivered program (LiFE) in community-dwelling people (aged ≥ 70 years) at risk of falling. In addition, the current study aimed to analyze the budget impact of LiFE and gLiFE, compared with standard care in Germany. METHODS: A Markov model was developed to reflect falls and associated care needs for community-dwelling persons over 5 years. The intervention effects of LiFE and gLiFE were shown to be equivalent in a non-inferiority trial, although the costs differed. Outpatient, inpatient, and intervention costs were assessed from a payer's perspective. The effect of parameter uncertainty was assessed in sensitivity analyses. RESULTS: The budget impact due to intervention costs was €510 million for LiFE and €186 million for gLiFE. Over five years, health care expenditures were €35,008 million for those receiving standard care, €35,416 million for those receiving LiFE, and €35,091 million for persons receiving gLiFE. Thereby, LiFE and gLiFE could prevent 2700 deaths and 648,000 falls over 5 years. Parameter uncertainties in the risk of falling, uptake of an intervention offer, and in the intervention effects had a major influence; thus cost savings for LiFE and gLiFE compared with standard care could be achieved for individuals with a high risk of falling. CONCLUSIONS: The results revealed that cost savings for LiFE and gLiFE compared with standard care could only be achieved for individuals at high risk of falling, with gLiFE being superior to LiFE. Future research should consider benefits and aspects of fall prevention beyond falls (e.g., physical activity, social aspects, and personal preferences of participants). TRIAL REGISTRATION: The study was preregistered under underclinicaltrials.gov (identifier: NCT03462654) on 12th March 2018; https://clinicaltrials.gov/ct2/show/NCT03462654 .

Multimodal home-based rehabilitation intervention after discharge from inpatient geriatric rehabilitation (GeRas): study protocol for a multicenter randomized controlled trial.

BACKGROUND: Geriatric rehabilitation aims to maintain the functional reserves of older adults in order to optimize social participation and prevent disability. After discharge from inpatient geriatric rehabilitation, patients are at high risk for decreased physical capacity, increased vulnerability, and limitations in mobility. As a result, ageing in place becomes uncertain for a plethora of patients after discharge from geriatric rehabilitation and effective strategies to prevent physical decline are required. Collaboration between different health-care providers is essential to improve continuity of care after discharge from inpatient geriatric rehabilitation. The aim of this study is to evaluate the effectiveness of a multi-professional home-based intervention program (GeRas) to improve functional capacity and social participation in older persons after discharge from inpatient geriatric rehabilitation. METHODS: The study is a multicenter, three-arm, randomized controlled trial with a three-month intervention period. Two hundred and seventy community-dwelling older people receiving inpatient geriatric rehabilitation will be randomized with a 1:1:1 ratio to one of the parallel intervention groups (conventional IG or tablet IG) or the control group (CG). The participants of both IGs will receive a home-based physical exercise program supervised by physical therapists, a nutritional recommendation by a physician, and social counseling by social workers of the health insurance company. The collaboration between the health-care providers and management of participants will be realized within a cloud environment based on a telemedicine platform and supported by multi-professional case conferences. The CG will receive usual care, two short handouts on general health-related topics, and facultative lifestyle counseling with general recommendations for a healthy diet and active ageing. The primary outcomes will be the physical capacity measured by the Short Physical Performance Battery and social participation assessed by the modified Reintegration to Normal Living Index, three months after discharge. DISCUSSION: The GeRas program is designed to improve the collaboration between health-care providers in the transition from inpatient geriatric rehabilitation to outpatient settings. Compared to usual care, it is expected to improve physical capacity and participation in geriatric patients after discharge from inpatient geriatric rehabilitation. TRIAL REGISTRATION: German Clinical Trials Register (DRKS00029559). Registered on October 05, 2022.

Cost-effectiveness of a specialist palliative care nurse-patient consultation followed by an interprofessional case conference for patients with non-oncological palliative care needs: results of the KOPAL trial.

BACKGROUND: Worldwide, progressive chronic, non-malignant diseases are highly prevalent. Especially with increasing age, they are characterised by high hospitalisation rates and high healthcare costs. Improved interprofessional collaboration between general practitioners (GPs) and specialist palliative home care (SPHC) teams might reduce hospitalisation while improving symptoms and quality of life, or preventing them from deterioration. The aim of this study was to examine the cost-effectiveness of a newly developed intervention in patients with advanced chronic, non-malignant diseases consisting of a structured palliative care nurse-patient consultation followed by an interprofessional telephone case conference. METHODS: The analysis was based on data from 172 participants of the KOPAL multi-centre, cluster randomised controlled trial. Patients with advanced congestive heart failure (CHF), chronic obstructive pulmonary disease (COPD), or dementia were randomised into intervention group (IG) and control group (CG, usual care). Cost-effectiveness was examined over 48 weeks from a societal and healthcare payer's perspective. Effects were quantified as quality-adjusted life years (QALYs, EQ-5D-5L). Incremental cost-effectiveness ratios were calculated and cost-effectiveness acceptability curves were constructed. RESULTS: Baseline imbalances in costs and effects could be observed between IG and CG. After adjusting for these imbalances and compared to the CG, mean costs in the IG were non-significantly higher from a societal and lower from a payer's perspective. On the effect side, the IG had marginally lower mean QALYs. The results were characterized by high statistical uncertainty, indicated by large confidence intervals for the cost and effect differences between groups and probabilities of cost-effectiveness between 18% and 65%, depending on the perspective and willingness-to-pay. CONCLUSIONS: Based on the results of this study, the cost-effectiveness of the KOPAL intervention was uncertain. The results highlighted (methodological) challenges of economic evaluations in patients with chronic, non-malignant diseases related to sample size, heterogeneity of participants, and the way the intervention effectiveness is typically captured in economic evaluations.

Modelling the Cost Effectiveness of Treatments for Parkinson's Disease: An Updated Methodological Review.

OBJECTIVE: This article systematically reviewed the methodological quality of modelling approaches for economic evaluations of the treatment of motor symptoms in Parkinson's disease in studies published after 2010. METHODS: A systematic literature search was undertaken using PubMed, EconLit, the Cochrane Database of Systematic Reviews, National Health Service Economic Evaluation Database and Health Technology Assessment databases of the UK National Health Service Centre for Review and Dissemination (March 2010 to July 2022). Quality was assessed using a checklist from the German Scientific Working Group. RESULTS: A total of 20 studies were evaluated, with the majority based on Markov models (n = 18). Studies assessed the cost effectiveness of medical (n = 12) or surgical (n = 8) treatment, and included costs from a payer or healthcare provider's perspective (n = 17). Furthermore, all studies included quality-adjusted life-years as an effect measure. In the quality assessment of the literature, a mean score of 42.1 points (out of 56 points) on the checklist of the German Scientific Working Group was achieved. Seventeen studies concluded the intervention under study was (likely) cost effective. No intervention was classified as cost ineffective. CONCLUSIONS: The quality of economic evaluation models in Parkinson's disease has improved in terms of calculating cost and transition parameters, as well as carrying out probabilistic sensitivity analyses, compared with the published literature of previous systematic reviews up to 2010. However, there is still potential for further development in terms of the integration of non-motor complications and treatment changes, the transparent presentation of parameter estimates, as well as conducting sensitivity analyses and validations to support the interpretation of results.

Cost-effectiveness of early rhythm control vs. usual care in atrial fibrillation care: an analysis based on data from the EAST-AFNET 4 trial.

AIMS: The randomized, controlled EAST-AFNET 4 trial showed that early rhythm control (ERC) reduces the rate of a composite primary outcome (cardiovascular death, stroke, or hospitalization for worsening heart failure or acute coronary syndrome) by ∼20%. The current study examined the cost-effectiveness of ERC compared to usual care. METHODS AND RESULTS: This within-trial cost-effectiveness analysis was based on data from the German subsample of the EAST-AFNET 4 trial (n = 1664/2789 patients). Over a 6-year time horizon and from a healthcare payer's perspective, ERC was compared to usual care regarding costs (hospitalization and medication) and effects (time to primary outcome; years survived). Incremental cost-effectiveness ratios (ICERs) were calculated. Cost-effectiveness acceptability curves were constructed to visualize uncertainty. Early rhythm control was associated with higher costs [+€1924, 95% CI (-€399, €4246)], resulting in ICERs of €10 638 per additional year without a primary outcome and €22 536 per life year gained. The probability of ERC being cost-effective compared to usual care was ≥95% or ≥80% at a willingness-to-pay value of ≥€55 000 per additional year without a primary outcome or life year gained, respectively. CONCLUSION: From a German healthcare payer's perspective, health benefits of ERC may come at reasonable costs as indicated by the ICER point estimates. Taking statistical uncertainty into account, cost-effectiveness of ERC is highly probable at a willingness-to-pay value of ≥€55 000 per additional life year or year without a primary outcome. Future studies examining the cost-effectiveness of ERC in other countries, subgroups with higher benefit from rhythm control therapy, or cost-effectiveness of different modes of ERC are warranted.

Comparison of falls and cost-effectiveness of the group versus individually delivered Lifestyle-integrated Functional Exercise (LiFE) program: final results from the LiFE-is-LiFE non-inferiority trial.

BACKGROUND: the individually delivered Lifestyle-integrated Functional Exercise (LiFE) was shown to improve physical activity (PA) and reduce fall incidence, however being rather resource-consuming due to one-to-one delivery. A potentially less resource-intensive group format (gLiFE) was developed and compared against the original program, considering higher risk of falling due to possible PA enhancement. OBJECTIVE: to investigate non-inferiority in terms of PA-adjusted fall risk and cost-effectiveness of gLiFE at 12-month follow-up. DESIGN: single-blinded, randomised, multi-centre non-inferiority trial. SETTING: community. SUBJECTS: in total, 309 adults aged 70+ years at risk of or with history of falling; n = 153 in gLiFE, n = 156 in LiFE. METHODS: LiFE was delivered one-to-one at the participants' homes, gLiFE in a group. PA-adjusted fall risk was analysed using negative binomial regression to compare incidence rate ratios (IRR). Cost-effectiveness was presented by incremental cost-effectiveness ratios and cost-effectiveness acceptability curves, considering quality-adjusted life years, PA and falls as effect measures. Secondary analyses included PA (steps/day) and fall outcomes. RESULTS: non-inferiority was inconclusive (IRR 0.96; 95% confidence interval, CI 0.67; 1.37); intervention costs were lower for gLiFE, but cost-effectiveness was uncertain. gLiFE participants significantly increased PA (+1,090 steps/day; 95% CI 345 and 1.835) versus insignificant increase in LiFE (+569, 95% CI -31; 1,168). Number of falls and fallers were reduced in both formats. CONCLUSION: non-inferiority of gLiFE compared with LiFE was inconclusive after 12 months. Increases in PA were clinically relevant in both groups, although nearly twice as high in gLiFE. Despite lower intervention costs of gLiFE, it was not clearly superior in terms of cost-effectiveness.

Psychometric evaluation of the German version of the Recovering Quality of Life (ReQoL) measures in patients with affective disorders.

BACKGROUND: The generic self-reported Recovering Quality of Life (ReQoL) measures were developed for measuring recovery-focused health-related quality of life (HrQoL) in persons with mental health conditions. The aim of this study was to assess the psychometric properties of the German version of the ReQoL measures in patients with affective disorders in Germany. METHODS: Data from a patient sub-sample in a randomized controlled trial have been used (N = 393). The internal consistency and the test-retest reliability of the ReQoL measures were assessed using Cronbach's Alpha and the intra-class correlation coefficient (ICC). The concurrent validity and the known-group validity of the ReQoL measures were assessed using Pearson's Correlation coefficient and Cohen's d. The responsiveness was assessed using Glass' Δ and the standardized response mean (SRM). RESULTS: The reliability among the items of the ReQoL-20 was overall excellent. The ICC of the ReQoL-20 was r = 0.70, indicating moderate test-retest reliability. The concurrent validity of the ReQoL-20 with the clinical measure PHQ-9 was strong with a correlation coefficient of r = - 0.76. The known-group validity of the ReQoL-20 using PHQ-9 cut-off points was large with an effect size of d = 1.63. The ReQoL measures were sensitive to treatment response and remission of symptoms measured by the PHQ-9 with large effect sizes/SRM. DISCUSSION: The psychometric properties of the ReQoL measures for the assessment of patients with affective disorders were overall good. With the ReQoL, valid and reliable measures for the assessment of recovery-focused HrQoL for persons with affective disorders are available in German language.

Validation of the Recovering Quality of Life (ReQoL) questionnaires for patients with anxiety, obsessive-compulsive, stress-related, somatoform and personality disorders in Germany.

The health-related quality of life (HrQoL) and the recovery process of persons with mental health conditions can be assessed with the Recovering Quality of Life questionnaires (ReQoL-20 and ReQoL-10). The aim of this study was to assess the psychometric properties of the German version of the ReQoL measures in patients with anxiety, obsessive-compulsive, stress-related, and somatoform disorders and in patients with disorders of adult personality and behavior. This study was based on a sub-sample of patients that were included in a randomized controlled trial evaluating an evidence-based, stepped and coordinated care service model for mental disorders (RECOVER). The internal consistency was assessed using Cronbach's Alpha and the test-retest reliability was assessed by the intra-class correlation coefficient (ICC). Concurrent validity was assessed by Pearson's Correlation Coefficient and the known-group validity was assessed using the Cohen's d. The internal consistency of the ReQoL-20 and ReQoL-10 was excellent and good with Cronbach's alpha of α = 0.91 and α = 0.83 for all items. The test-retest reliability of the ReQoL measures was moderate with ICC of r = 0.72 to 0.74. The concurrent validity of the ReQoL measures with the Global Severity Index was overall high with a correlation coefficient of r = -0.70. In conclusion, for patients with anxiety, obsessive-compulsive, stress-related, somatoform and personality disorders, the German version of the ReQoL measures is valid and reliable for the assessment of HrQoL and the recovery process.