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.

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 .

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.

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.

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.

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.

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.

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.

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.

Measurement properties of the EQ-5D in populations with a mean age of ≥ 75 years: a systematic review.

PURPOSE: Healthcare interventions for middle-old and oldest-old individuals are often (economically) evaluated using the EQ-5D to measure health-related quality of life (HrQoL). This requires sufficient measurement properties of the EQ-5D. Therefore, the current study aimed to systematically review studies assessing the measurement properties of the EQ-5D in this population. METHODS: The databases PubMed, Cochrane library, Web of Science, Embase, and EconLit were searched for studies providing empirical evidence of reliability, validity, and/or responsiveness of the EQ-5D-3L and EQ-5D-5L in samples with a mean age ≥ 75 years. Studies were selected by two independent reviewers, and the methodological quality was assessed using the COSMIN Risk of Bias checklist. Results were rated against updated criteria for good measurement properties (sufficient, insufficient, inconsistent, indeterminate). The evidence was summarized, and the quality of evidence was graded using a modified GRADE approach. RESULTS: For both EQ-5D versions, high-quality evidence for sufficient convergent validity was found. Known-groups validity was sufficient for the EQ-5D-5L (high-quality evidence), whereas the results were inconsistent for the EQ-5D-3L. Results regarding the reliability were inconsistent (EQ-5D-3L) or entirely lacking (EQ-5D-5L). Responsiveness based on correlations of change scores with instruments measuring related/similar constructs was insufficient for the EQ-5D-3L (high-quality evidence). For the EQ-5D-5L, the available evidence on responsiveness to change in (Hr)QoL instruments was limited. CONCLUSION: Since the responsiveness of the EQ-5D in a population of middle-old and oldest-old individuals was questionable, either using additional instruments or considering the use of an alternative, more comprehensive instrument of (Hr)QoL might be advisable, especially for economic evaluations.

Health-related quality of life of individuals sharing a household with persons with dementia.

INTRODUCTION: Previous research has found a negative effect of dementia on the health-related quality of life (HrQoL) of persons with dementia (PWD) and their primary informal caregivers. However, the impact of dementia on HrQoL of other individuals sharing a household with PWD has not been investigated to date. The current study therefore aimed to determine differences in the HrQoL between those sharing a household with PWD and those not living with PWD. In addition, factors related to the HrQoL of those sharing a household with PWD were evaluated. METHODS: The analyses were based on data from the German Socio-Economic Panel, using the SF-12 to measure HrQoL. Mixed-effects models were calculated to compare the HrQoL of those sharing a household with PWD and persons not living with PWD, as well as to determine factors related to the HrQoL of those sharing a household with PWD. Bootstrapping was used where residuals were not normally distributed. RESULTS: Mixed-effect models showed a significantly lower HrQoL among those sharing a household with PWD, compared to those not living with PWD. Number of diseases, number of persons in the household, marital status and educational level were significantly related to HrQoL among those sharing a household with PWD. DISCUSSION: The HrQoL of those sharing a household with PWD was reduced compared to persons not living with PWD. Further, those living with PWD in small households, or those with multi-morbidities had a lower HrQoL. Further research focusing on HrQoL in the social environment of PWD is needed.

Patient-centered placement matching of alcohol-dependent patients based on a standardized intake assessment: process evaluation within an exploratory randomized controlled trial.

BACKGROUND: In the implementation of placement matching guidelines, feasibility has been concerned in previous research. Objectives of this process evaluation were to investigate whether the patient-centered matching guidelines (PCPM) are consistently applied in referral decision-making from an inpatient qualified withdrawal program to a level of care in aftercare, which factors affect whether patients actually receive matched aftercare according to PCPM, and whether its use is feasible and accepted by clinic staff. METHODS: The study was conducted as process evaluation within an exploratory randomized controlled trial in four German psychiatric clinics offering a 7-to-21 day qualified withdrawal program for patients suffering from alcohol dependence, and with measurements taken during detoxification treatment and six months after the initial assessment. PCPM were used with patients in the intervention group by feeding back to them a recommendation for a level of care in aftercare that had been calculated from Measurements in the Addictions for Triage and Evaluation (MATE) and discussed with the staff on the treatment unit. As measurements, The MATE, the Client Socio-Demographic and Service Receipt Inventory-European Version, a documentation form, the Control Preference Scale, and the Motivation for Treatment Scale were administered. A workshop for the staff at the participating trial sites was conducted after data collection was finished. RESULTS: Among 250 patients participating in the study, 165 were interviewed at follow-up, and 125 had received aftercare. Although consistency in the application of PCPM was moderate to substantial within the qualified withdrawal program (Cohen's kappa ≥ .41), it was fair from discharge to follow-up. In multifactorial multinomial regression, the number of foregoing substance abuse treatments predicted whether patients received more likely undermatched (Odds Ratio=1.27; p=.018) or overmatched (Odds Ratio=0.78; p=.054) treatment. While the implementation process during the study was evaluated critically by the staff, they stated a potential of quality assurance, more transparency and patient-centeredness in the use of PCPM. CONCLUSIONS: While the use of PCPM has the potential to enhance the quality of referral decision making within treatment, it may not be sufficient to determine referral decisions for aftercare. TRIAL REGISTRATION: German Clinical Trials Register DRKS00005035 . Registered 03/06/2013.

A multifactorial interdisciplinary intervention to prevent functional and mobility decline for more participation in (pre-)frail community-dwelling older adults (PromeTheus): study protocol for a multicenter randomized controlled trial.

BACKGROUND: Age-related decline in physical capacity can lead to frailty, associated with an increased vulnerability to adverse health outcomes and greater healthcare utilization. In an aging population, effective strategies to prevent physical decline and frailty, and preserve independence are needed. Prevention programs for vulnerable community-dwelling older adults are, however, often not yet established and implemented in routine practice. Research on the feasibility, implementation, and (cost-)effectiveness of multifactorial, interdisciplinary intervention programs that take advantage of available services of healthcare providers is also limited. The main aim of this study is to evaluate the effectiveness of such an intervention program (PromeTheus) to prevent functional and mobility decline for more participation in community-dwelling (pre-)frail older adults. METHODS: The study is designed as a three-center, randomized controlled trial with a 12-month intervention period. Four hundred community-dwelling (pre-)frail (Clinical Frailty Scale score 4-6) older adults (≥70 years) will be randomized in a 1:1 ratio to the intervention group (IG) or the control group (CG). The IG will receive the PromeTheus program consisting of obligatory home-based physical exercises (Weight-bearing Exercise for Better Balance) accompanied by physiotherapists and facultative counseling services (person-environment-fit, coping with everyday life, nutrition, group-based activities) delivered via existing healthcare structures (e.g., social workers, nutritionists). The CG will receive usual care and a one-time counseling session on recommendations for physical activity and nutrition. Primary outcomes assessed at months 6 and 12 are the function component of the Late-Life Function and Disability Instrument and the University of Alabama at Birmingham Life-Space Assessment. Secondary outcomes are disability, physical capacity and activity, frailty, nutritional status, falls, fear of falling, health status, and psychosocial components. Process and economic evaluations are also conducted. Primary statistical analyses will be based on the intention-to-treat principle. DISCUSSION: Compared to usual care, the PromeTheus program is expected to result in higher function and mobility, greater independence and lower need for care, and more participation. As the PromeTheus program draws on existing German healthcare structures, its large-scale translation and delivery will be feasible, if evidence of (cost-)effectiveness and successful implementation can be demonstrated. TRIAL REGISTRATION: German Clinical Trials Register, . Registered on March 11, 2021.

Willingness to pay for a group and an individual version of the Lifestyle-integrated Functional Exercise program from a participant perspective.

BACKGROUND: Perceived benefits of intervention programs from a participant perspective can be examined by assessing their willingness to pay (WTP). Aiming to support decision-makers in their decision to implement a fall prevention program, this study examined (1) the WTP for a group-based and an individually delivered fall prevention program, (2) which factors influence WTP, and (3) whether the WTP exceeds the intervention costs. METHODS: WTP was elicited using Payment Cards from 237 individuals who participated in a randomized non-inferiority trial (LiFE-is-LiFE) comparing a group version of the Lifestyle-integrated Functional Exercise program (gLiFE) with the individually delivered version (LiFE). Linear regression models were used to examine factors associated with WTP. The net benefit for (g)LiFE was calculated as the difference between WTP and intervention costs, assuming different scenarios of intervention costs (varying group sizes of gLiFE) and hypothetical subsidy levels by a payer (€0, €50, or €75). RESULTS: The mean WTP was €196 (95% CI [172, 221]) for gLiFE and €228 (95% CI [204, 251]) for LiFE. In the linear regression model, WTP was significantly associated with delivery format (-€32, 95% CI [- 65, - 0.2], for gLiFE) and net household income (+ 68€, 95% CI [23, 113], for ≥€3000 compared to <€2000). The net benefit for gLiFE was positive in most cases. Due to higher intervention costs of LiFE compared to gLiFE (€298 vs. €113), the net benefit for LiFE was negative for the majority of the sample, even at a subsidy of €75. CONCLUSION: The results provide insight into how valuable the interventions are perceived by the participants and thereby may be used by decision-makers as complement to cost-effectiveness analyses. WTP for both programs was generally high, probably indicating that participants perceived the intervention as quite valuable. However, further research is needed on the WTP and net benefit of fall prevention programs, as results relied on the specific context of the LiFE-is-LiFE trial.

Lifestyle-integrated functional exercise to prevent falls and promote physical activity: Results from the LiFE-is-LiFE randomized non-inferiority trial.

BACKGROUND: The 'Lifestyle-integrated Functional Exercise' (LiFE) program successfully reduced risk of falling via improvements in balance and strength, additionally increasing physical activity (PA) in older adults. Generally being delivered in an individual one-to-one format, downsides of LiFE are considerable human resources and costs which hamper large scale implementability. To address this, a group format (gLiFE) was developed and analyzed for its non-inferiority compared to LiFE in reducing activity-adjusted fall incidence and intervention costs. In addition, PA and further secondary outcomes were evaluated. METHODS: Older adults (70 + years) at risk of falling were included in this multi-center, single-blinded, randomized non-inferiority trial. Balance and strength activities and means to enhance PA were delivered in seven intervention sessions, either in a group (gLiFE) or individually at the participant's home (LiFE), followed by two "booster" phone calls. Negative binomial regression was used to analyze non-inferiority of gLiFE compared to LiFE at 6-month follow-up; interventions costs were compared descriptively; secondary outcomes were analyzed using generalized linear models. Analyses were carried out per protocol and intention-to-treat. RESULTS: Three hundred nine persons were randomized into gLiFE (n = 153) and LiFE (n = 156). Non-inferiority of the incidence rate ratio of gLiFE was inconclusive after 6 months according to per protocol (mean = 1.27; 95% CI: 0.80; 2.03) and intention-to-treat analysis (mean = 1.18; 95% CI: 0.75; 1.84). Intervention costs were lower for gLiFE compared to LiFE (-€121 under study conditions; -€212€ under "real world" assumption). Falls were reduced between baseline and follow-up in both groups (gLiFE: -37%; LiFE: -55%); increases in PA were significantly higher in gLiFE (+ 880 steps; 95% CI 252; 1,509). Differences in other secondary outcomes were insignificant. CONCLUSIONS: Although non-inferiority of gLiFE was inconclusive, gLiFE constitutes a less costly alternative to LiFE and it comes with a significantly larger enhancement of daily PA. The fact that no significant differences were found in any secondary outcome underlines that gLiFE addresses functional outcomes to a comparable degree as LiFE. Advantages of both formats should be evaluated in the light of individual needs and preferences before recommending either format. TRIAL REGISTRATION: The study was preregistered under clinicaltrials.gov (identifier: NCT03462654 ) on March 12th 2018.

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.

[Recovering Quality of Life: German Translation of a Questionnaire to assess the Quality of Life of People with Mental Disorders]. / Recovering Quality of Life: Deutsche Übersetzung eines Fragebogens zur Erfassung der gesundheitsbezogenen Lebensqualität von Menschen mit psychischen Erkrankungen.

AIM OF THE STUDY: The aim of this study was to translate the self-reported questionnaire "Recovering Quality of Life (ReQoL)" to measure the health-related quality of life of people with mental disorders into German. METHODS: The questionnaire was translated into German independently by 2 qualified translators. Discrepancies in meaning and terminology were checked by reviewing a back translation against the original English version. The German translation of the questionnaire was pretested in 5 patients with mental disorders. RESULTS: The translation of several English phrasings of the questionnaire into German was difficult, mainly due to lingual and cultural differences. By expert discussion of the translation and the pretest in patients with mental disorders, appropriate phrasings were found. CONCLUSION: A German version of the self-reported ReQoL questionnaire is available to measure the health-related quality of life of people with mental disorders.

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.de.

Mediating factors on the association between fear of falling and health-related quality of life in community-dwelling German older people: a cross-sectional study.

BACKGROUND: Previous research has shown that not only falls, but also fear of falling (FoF) influences health-related quality of life (HrQoL) negatively. The EQ-5D (consisting of an index and a visual analogue scale [EQ-VAS]) is a frequently used instrument to determine HrQoL in clinical studies and economic evaluations, but no previous study compared the association between FoF and the EQ-5D index with the association between FoF and the EQ-VAS. Moreover, factors that influence the association between FoF and HrQoL are rarely examined. Thus, this study aimed to examine the association between FoF and HrQoL and to examine factors that mediate the association. METHODS: FoF (Short Falls Efficacy Scale International) and HrQoL (EQ-5D descriptive system, EQ-5D index, and EQ-VAS) were assessed in a sample of community-dwelling older persons (≥70 years) participating in the baseline assessment of a randomized controlled trial (N = 309). Linear and logistic regression analyses were performed, adjusting for sociodemographic variables, frequency of falls, number of chronic conditions, functional mobility (Timed up-and-go test), and subjective functional capacity (LLFDI function and disability scales). Multiple regression models were used to test the mediating effects. RESULTS: Moderate or high FoF was prevalent in 66% of the sample. After adjusting for covariates, FoF was negatively associated with the EQ-5D index, but not with the descriptive system or the EQ-VAS. Subjective functional capacity partly mediated the association between FoF and the EQ-5D index and completely mediated the association between FoF and the EQ-VAS. CONCLUSION: FoF was negatively associated with the EQ-5D index. As subjective functional capacity mediated the association between FoF and HrQoL, future interventions should account for subjective functional capacity in their design.