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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.
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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.
Subject(s)
Quality of Life , Refugees , Humans , Refugees/psychology , Refugees/statistics & numerical data , Germany , Quality of Life/psychology , Female , Male , Adult , Longitudinal Studies , Middle Aged , Young Adult , Adolescent , Health Status , Socioeconomic FactorsABSTRACT
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.
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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.
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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.
Subject(s)
Frail Elderly , Frailty , Independent Living , Patient Selection , Humans , Female , Male , Aged , Aged, 80 and over , Cross-Sectional Studies , Frailty/prevention & control , Home Care Services , Geriatric Assessment/methodsABSTRACT
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.
Subject(s)
Heart Failure , Palliative Care , Primary Health Care , Pulmonary Disease, Chronic Obstructive , Quality of Life , Humans , Palliative Care/methods , Male , Female , Aged , Germany , Pulmonary Disease, Chronic Obstructive/therapy , Pulmonary Disease, Chronic Obstructive/diagnosis , Aged, 80 and over , Heart Failure/therapy , Heart Failure/diagnosis , Dementia/therapy , Chronic Disease , Home Care Services , Patient Care Team , Time Factors , Interdisciplinary Communication , Delivery of Health Care, Integrated/organization & administrationABSTRACT
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 .
Subject(s)
Exercise , Life Style , Humans , Aged , Physical Therapy Modalities , Germany/epidemiology , Cost-Benefit AnalysisABSTRACT
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.
Subject(s)
Quality of Life , Humans , Linear Models , Germany/epidemiology , Socioeconomic Factors , RussiaABSTRACT
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.
Subject(s)
Inpatients , Patient Discharge , Humans , Aged , Aged, 80 and over , Treatment Outcome , Independent Living/psychology , Exercise Therapy/methods , Quality of Life , Randomized Controlled Trials as Topic , Multicenter Studies as TopicABSTRACT
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.
Subject(s)
Palliative Care , Quality of Life , Humans , Cost-Benefit Analysis , Chronic Disease , Referral and Consultation , Quality-Adjusted Life YearsABSTRACT
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.
Subject(s)
Cost-Effectiveness Analysis , Parkinson Disease , Humans , Parkinson Disease/drug therapy , State Medicine , Systematic Reviews as Topic , Cost-Benefit Analysis , Quality-Adjusted Life YearsABSTRACT
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 â¼20%. 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.
Subject(s)
Atrial Fibrillation , Heart Failure , Stroke , Humans , Atrial Fibrillation/diagnosis , Atrial Fibrillation/therapy , Atrial Fibrillation/complications , Cost-Benefit Analysis , Cost-Effectiveness Analysis , Heart Failure/diagnosis , Heart Failure/therapy , Heart Failure/complications , Stroke/complications , Quality-Adjusted Life YearsABSTRACT
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.
Subject(s)
Exercise , Life Style , Humans , Cost-Benefit Analysis , Exercise Therapy/adverse effects , Exercise Therapy/methodsABSTRACT
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.
Subject(s)
Quality of Life , Humans , Aged, 80 and over , Aged , Quality of Life/psychology , Reproducibility of Results , Surveys and Questionnaires , Psychometrics/methods , Cost-Benefit AnalysisABSTRACT
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.
Subject(s)
Language , Quality of Life , Humans , Psychometrics , Reproducibility of Results , Surveys and Questionnaires , Mood DisordersABSTRACT
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.
Subject(s)
Obsessive-Compulsive Disorder , Quality of Life , Adult , Humans , Reproducibility of Results , Personality Disorders , Surveys and Questionnaires , Anxiety , Germany , PsychometricsABSTRACT
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.
Subject(s)
Exercise , Life Style , Humans , Cost-Benefit Analysis , Exercise Therapy , Surveys and QuestionnairesABSTRACT
INTRODUCTION: Progressive chronic, non-malignant diseases (CNMD) like congestive heart failure (CHF), chronic obstructive pulmonary disease (COPD) and dementia are of growing relevance in primary care. Most of these patients suffer from severe symptoms, reduced quality of life and increased numbers of hospitalisations. Outpatient palliative care can help to reduce hospitalisation rate by up to 50%. Due to the complex medical conditions and prognostic uncertainty of the course of CNMD, early interprofessional care planning among general practitioners who provide general palliative care and specialist palliative home care (SPHC) teams seems mandatory. The KOPAL study (a concept for strenghtening interprofessional collaboration for patients with palliative care needs) will test the effectiveness of a SPHC nurse-patient consultation followed by an interprofessional telephone case conference. METHODS AND ANALYSIS: Multicentre two-arm cluster randomised controlled trial KOPAL with usual care as control arm. The study is located in Northern Germany and aims to recruit 616 patients in 56 GP practices (because of pandemic reasons reduced to 191 participants). Randomisation will take place on GP practice level immediately after inclusion (intervention group/control group). Allocation concealment is carried out on confirmation of participation. Patients diagnosed with CHF (New York Heart Association (NYHA) classification 3-4), COPD (Global Initiative for Chronic Obstructive Lung Disease (GOLD) stage classification 3-4, group D) or dementia GDS stage 4 or above). Primary outcome is a reduced hospital admission within 48 weeks after baseline, secondary outcomes include symptom burden, quality of life and health costs. The primary analysis will follow the intention-to-treat principle. Intervention will be evaluated after the observation period using qualitative methods. ETHICS AND DISSEMINATION: The responsible ethics committees of the cooperating centres approved the study. All steps of data collection, quality assurance and data analysis will continuously be monitored. The concept of KOPAL could serve as a blueprint for other regions and meet the challenges of geographical equity in end-of-life care. TRIAL REGISTRATION NUMBER: DRKS00017795; German Clinical Trials Register.
Subject(s)
Dementia , Heart Failure , Home Care Services , Pulmonary Disease, Chronic Obstructive , Chronic Disease , Heart Failure/therapy , Humans , Multicenter Studies as Topic , Palliative Care/methods , Pulmonary Disease, Chronic Obstructive/therapy , Quality of Life , Randomized Controlled Trials as Topic , Referral and Consultation , TelephoneABSTRACT
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.