Cost-Effectiveness of a Specialized Breathlessness Service Versus Usual Care for Patients With Advanced Diseases.

OBJECTIVES: The Munich Breathlessness Service (MBS) significantly improved control of breathlessness measured by the Chronic Respiratory Questionnaire (CRQ) Mastery in a randomized controlled fast track trial with waitlist group design spanning 8 weeks in Germany. This study aimed to assess the within-trial cost-effectiveness of MBS from a societal perspective. METHODS: Data included generic (5-level version of EQ-5D) health-related quality of life and disease-specific CRQ Mastery. Quality-adjusted life years (QALYs) were calculated based on 5-level version of EQ-5D utilities valued with German time trade-off. Direct medical costs and productivity loss were calculated based on standardized unit costs. Incremental cost-effectiveness ratios (ICER) and cost-effectiveness-acceptance curves were calculated using adjusted mean differences (AMD) in costs (gamma-distributed model) and both effect parameters (Gaussian-distributed model) and performing 1000 simultaneous bootstrap replications. Potential gender differences were investigated in stratified analyses. RESULTS: Between March 2014 and April 2019, 183 eligible patients were enrolled. MBS intervention demonstrated significantly better effects regarding generic (AMD of QALY gains of 0.004, 95% confidence interval [CI] 0.0003 to 0.008) and disease-specific health-related quality of life at nonsignificantly higher costs (AMD of €605 [95% CI -1109 to 2550]). At the end of the intervention, the ICER was €152 433/QALY (95% CI -453 545 to 1 625 903) and €1548/CRQ Mastery point (95% CI -3093 to 10 168). Intervention costs were on average €357 (SD = 132). Gender-specific analyses displayed dominance for MBS in males and higher effects coupled with significantly higher costs in females. CONCLUSIONS: Our results show a high ICER for MBS. Considering dominance for MBS in males, implementing MBS on approval within the German health care system should be considered.

Association of physical activity with utilization of long-term care in community-dwelling older adults in Germany: results from the population-based KORA-Age observational study.

BACKGROUND: Physical activity (PA) is a proven strategy to prevent chronic diseases and reduce falls. Furthermore, it improves or at least maintains performance of activities of daily living, and thus fosters an independent lifestyle in older adults. However, evidence on the association of PA with relevant subgroups, such as older adults with utilization of long-term care (LTC), is sparse. This knowledge would be essential for establishing effective, need-based strategies to minimize the burden on healthcare systems due to the increasing need for LTC in old age. METHODS: Data originate from the 2011/12 (t1) baseline assessment and 2016 (t2) follow-up of the population-based Cooperative Health Research in the Region of Augsburg (KORA-)Age study in southern Germany. In 4812 observations of individuals ≥65 years, the association between various types of PA (walking, exercise (i. e., subcategory of PA with the objective to improve or maintain one or more components of physical fitness), walking+exercise) and utilization of LTC (yes/no) was analyzed using generalized estimating equation logistic models. Corresponding models stratified by sex (females: 2499 observations; males: 2313 observations) examined sex-specific associations. Descriptive analyses assessed the proportion of individuals meeting the suggested minimum values in the German National Physical Activity Recommendations for older adults (GNPAR). RESULTS: All types of PA showed a statistically significant association with non-utilization of LTC in the entire cohort. "Walking+exercise" had the strongest association with non-utilization of LTC in the entire cohort (odds ratio (OR): 0.52, 95% confidence interval (CI): 0.39-0.70) and in males (OR: 0.41, CI: 0.26-0.65), whereas in females it was "exercise" (OR: 0.58; CI: 0.35-0.94). The proportion of individuals meeting the GNPAR was higher among those without utilization of LTC (32.7%) than among those with LTC (11.7%) and group differences were statistically significant (p ≤ 0.05). CONCLUSIONS: The GNPAR are rarely met by older adults. However, doing any type of PA is associated with non-utilization of LTC in community-dwelling older adults. Therefore, older adults should be encouraged to walk or exercise regularly. Furthermore, future PA programs should consider target-groups' particularities to reach individuals with the highest needs for support.

Effectiveness of a specialised breathlessness service for patients with advanced disease in Germany: a pragmatic fast-track randomised controlled trial (BreathEase).

BACKGROUND: The effectiveness of the Munich Breathlessness Service (MBS), integrating palliative care, respiratory medicine and physiotherapy, was tested in the BreathEase trial in patients with chronic breathlessness in advanced disease and their carers. METHODS: BreathEase was a single-blinded randomised controlled fast-track trial. The MBS was attended for 5-6 weeks; the control group started the MBS after 8 weeks of standard care. Randomisation was stratified by cancer and the presence of a carer. Primary outcomes were patients' mastery of breathlessness (Chronic Respiratory Disease Questionnaire (CRQ) Mastery), quality of life (CRQ QoL), symptom burden (Integrated Palliative care Outcome Scale (IPOS)) and carer burden (Zarit Burden Interview (ZBI)). Intention-to-treat (ITT) analyses were conducted with hierarchical testing. Effectiveness was investigated by linear regression on change scores, adjusting for baseline scores and stratification variables. Missing values were handled with multiple imputation. RESULTS: 92 patients were randomised to the intervention group and 91 patients were randomised to the control group. Before the follow-up assessment after 8 weeks (T1), 17 and five patients dropped out from the intervention and control groups, respectively. Significant improvements in CRQ Mastery of 0.367 (95% CI 0.065-0.669) and CRQ QoL of 0.226 (95% CI 0.012-0.440) score units at T1 in favour of the intervention group were seen in the ITT analyses (n=183), but not in IPOS. Exploratory testing showed nonsignificant improvements in ZBI. CONCLUSIONS: These findings demonstrate positive effects of the MBS in reducing burden caused by chronic breathlessness in advanced illness across a wide range of patients. Further evaluation in subgroups of patients and with a longitudinal perspective is needed.

[Validation of the FIMA Questionnaire for Health-Related Resource Use Against Medical Claims Data: The Role Played by Length of Recall Period]. / Validierung des FIMA-Fragebogens zur Inanspruchnahme von Versorgungsleistungen anhand von Routinedaten der Krankenversicherung: Welchen Einfluss hat der Erinnerungszeitraum?

AIM TO VALIDATE: the questionnaire on health-related resource use in an elderly population (FIMA). METHODS: Self-reported health care use of 1,552 participants was validated against medical claims data. Reliability was measured by intraclass correlation coefficient (ICC), sensitivity, specificity, and Cohen's Kappa. Linear regression models were used to investigate the association between validity and individual characteristics, health state, recall period (3, 6, or 12 months), or frequency of resource use. RESULTS: On average, participants were 74 years old; 95% rated the questionnaire as easy. The number of physician contacts was underestimated depending on recall period by 9 to 28% and the ICC was moderate (3/6/12 months, ICC 0.46/0.48/0.55), whereas contacts with physiotherapists were remembered quite well (ICC>0.75). Remembering the number of days in rehabilitation and hospital differed by recall periods (3/6/12 months); rehabilitation ICC=0.88/0.51/0.87; hospital ICC=0.69/0.88/0.66. Very good reliability of self-reported long-term care insurance benefits was found for all recall periods (Kappa>0.90) while agreement in self-reported medical aid was poor (Kappa<0.30); agreement in intake of medication was good (Kappa>0.40). The chance of agreement between self-reports and claims data significantly decreased with the number of contacts. Individuals with better health had a significantly higher chance of reporting contacts with physiotherapists accurately. CONCLUSION: The FIMA largely demonstrated good reliability. The FIMA is a coherent and valid instrument to collect health-related resource use in health economic studies in an elderly population.

How short is too short? A randomised controlled trial evaluating short-term existential behavioural therapy for informal caregivers of palliative patients.

BACKGROUND: Informal caregivers of palliative patients show higher levels of depression and distress compared with the general population. Fegg's (2013) existential behavioural therapy was shortened to two individual 1-h sessions (short-term existential behavioural therapy). AIM: Testing the effectiveness of sEBT on psychological symptoms of informal caregivers in comparison with active control. DESIGN: Randomised controlled trial. SETTING/PARTICIPANTS: Informal caregivers of palliative in-patients. METHODS: The primary outcome was depression; secondary outcomes were anxiety, subjective distress and minor mental disorders, positive and negative affect, satisfaction with life, quality of life and direct health care costs. General linear mixed models allow several measurements per participant and change over time. Reasons for declining the intervention were investigated by Rosenstock's Health Belief Model. RESULTS: Overall inclusion rate was 41.0%. Data of 157 caregivers were available (63.1% females; mean age: 54.6 years, standard deviation (SD): 14.1); 127 participants were included in the main analysis. Participation in sEBT or active control was not significantly associated with post-treatment depression. Outcomes showed prevailingly significant association with time of investigation. Self-efficacy, scepticism of benefit of the intervention, belief of better coping alone and support by family and friends were significant factors in declining participation in the randomised controlled trial. CONCLUSION: Inclusion rate was tripled compared with a previously evaluated longer EBT group intervention. By shortening the intervention, inclusion rate was traded for effectiveness and the intervention could not impact caregivers' psychological state. Early integration of sEBT and combination of individual and group setting and further study of the optimal length for caregiver interventions are suggested.

Brief telephone counselling is effective for caregivers who do not experience any major life events - caregiver-related outcomes of the German day-care study.

BACKGROUND: To date, there has been a dearth of scientifically tested, established intervention concepts focussed on supporting informal caregivers and embedded in routine health care structures. The aim of this study was to assess effects of a brief telephone intervention for caregivers of persons with cognitive impairment (PCIs) on caregivers' depressiveness and subjective burden. METHODS: A two-arm cluster-randomised controlled intervention study was carried out at 32 German day-care centres. During the six-month intervention period, informal caregivers in the intervention group (n = 205) received counselling in three phone calls focussed on stress reduction, development of self-management strategies, and how to deal with challenging behaviours. Both the control group (n = 154) and the intervention group were free to take part in any support programmes offered by the German Health Care System (TAU). Caregivers' subjective burden and depressiveness were measured with the Burden Scale for Family Caregivers - short version (BSFC-s) and the WHO-5 Well-Being Index (WHO-5). Outcomes were assessed by means of computer-assisted telephone interviews (CATIs) at baseline and at the end of the six-month intervention phase. Multiple regression analyses were used to show the influence of group allocation. RESULTS: After the intervention phase, group allocation was not found to significantly predict caregivers' subjective burden or depressiveness. The baseline scores (p < 0.001) were the only significant predictors of change in both outcomes. However, sensitivity analyses for caregivers who did not experience any events that they felt were major (in a negative or positive sense) during the six months (n = 271) showed that group allocation (p < 0.05) was a significant predictor of positive change in both outcomes (BSFC-s: Δ-1.3, [- 2.4, - 0.3], Cohen's d = 0.27; WHO-5: Δ1.5, [0.4, 2.7], Cohen's d = 0.26). Effect sizes were highest in the subgroup of caregivers of people with mild dementia (BSFC-s: Cohen's d = 0.43; WHO-5: Cohen's d = 0.42). CONCLUSIONS: A "low-dose" psychoeducative telephone intervention designed to empower caregivers is effective, especially in an early stage, if the overlap between the effect of the intervention and the effect of events that are experienced as major events in the caregiver's life is considered. TRIAL REGISTRATION: Identifier: ISRCTN16412551 (Registration date: 30 July 2014, registered retrospectively).

Determinants for utilization and transitions of long-term care in adults 65+ in Germany: results from the longitudinal KORA-Age study.

BACKGROUND: Societies around the world face the burden of an aging population with a high prevalence of chronic conditions. Thus, the demand for different types of long-term care will increase and change over time. The purpose of this exploratory study was to identify determinants for utilization and transitions of long-term care in adults older than 65 years by using Andersen's Behavioral Model of Health Services Use. METHODS: The study examined individuals older than 65 years between 2011/2012 (t1) and 2016 (t2) from the population-based Cooperative Health Research in the Region of Augsburg (KORA)-Age study from Southern Germany. Analyzed determinants consisted of predisposing (age, sex, education), enabling (living arrangement, income) and need (multimorbidity, disability) factors. Generalized estimating equation logistic models were used to identify determinants for utilization and types of long-term care. A logistic regression model examined determinants for transitions to long-term care over four years through a longitudinal analysis. RESULTS: We analyzed 810 individuals with a mean age of 78.4 years and 24.4% receiving long-term care at t1. The predisposing factors higher age and female sex, as well as the need factors higher multimorbidity and higher disability score, were determinants for both utilization and transitions of long-term care. Living alone, higher income and a higher disability score had a significant influence on the utilization of formal versus informal long-term care. CONCLUSION: Our results emphasize that both utilization and transitions of long-term care are influenced by a complex construct of predisposing, enabling and need factors. This knowledge is important to identify at-risk populations and helps policy-makers to anticipate future needs for long-term care. TRIAL REGISTRATION: Not applicable.

Determinants of adherence and effects on health-related quality of life after myocardial infarction: a prospective cohort study.

BACKGROUND: Adherence to recommendations and medication is deemed to be important for effectiveness of case management interventions. Thus, reasons for non-adherence and effects on health-related quality of life (HRQoL) should be fully understood. The objective of this research was to identify determinants of non-adherence to medication and recommendations, and to test whether increased adherence improved HRQoL in patients after myocardial infarction (MI) in a case management intervention. METHODS: Data were obtained from the intervention group of the KORINNA study, a randomized controlled trail of a nurse-led case management intervention with targeted recommendations in the elderly after MI in Germany. Reasons for non-adherence were described. Logistic mixed effects models and OLS (ordinary least squares) were used to analyze the effect of recommendations on the probability of adherence and the association between adherence and HRQoL. RESULTS: One hundred and twenty-seven patients with 965 contacts were included. Frequent reasons for non-adherence to medication and recommendations were "forgotten" (22%; 11%), "reluctant" (18%; 18%), "side effects" (38%; 7%), "the problem disappeared" (6%; 13%), and "barriers" (0%; 13%). The probability of adherence was lowest for disease and self-management (38%) and highest for visits to the doctor (61%). Only if patients diverging from prescribed medication because of side effects were also considered as adherent, 3-year medication adherence was associated with a significant gain of 0.34 quality-adjusted life years (QALYs). CONCLUSIONS: Most important determinants of non-adherence to medication were side effects, and to recommendations reluctance. Recommended improvements in disease and self-management were least likely adhered. Medication adherence was associated with HRQoL. TRIAL REGISTRATION: Current Controlled Trials ISRCTN02893746 , retrospectively registered, date assigned 27/03/2009.

The 3-Year Cost-Effectiveness of a Nurse-Based Case Management versus Usual Care for Elderly Patients with Myocardial Infarction: Results from the KORINNA Follow-Up Study.

OBJECTIVES: To assess the 3-year cost-effectiveness of a nurse-based case management intervention in elderly patients with myocardial infarction from a societal perspective. METHODS: The intervention consisted of one home visit and quarterly telephone calls in the first year, and semi-annual calls in the following 2 years. The primary effect measures were quality-adjusted life-years (QALYs), on the basis of the EuroQol five-dimensional questionnaire (EQ-5D-3L) and adjusted life-years from patients' self-rated health states according to the visual analogue scale (VAS-ALs). A linear regression model was used for adjusted life-years and a gamma model for costs. Estimation uncertainty was addressed by cost-effectiveness acceptability curves, which indicate the likelihood of cost-effectiveness for a given value of willingness to pay. The secondary objective was to examine EQ-5D-3L utility scores and VAS scores among survivors using linear mixed models. RESULTS: Primary outcomes regarding QALY gains (+0.0295; P = 0.76) and VAS-AL gains (+0.1332; P = 0.09) in the intervention group were not significant. The overall cost difference was -€2575 (P = 0.30). The probability of cost-effectiveness of the case management at a willingness-to-pay value of €0 per QALY was 84% in the case of QALYs and 81% in the case of VAS-ALs. Secondary outcomes concerning survivors' quality of life were significantly better in the intervention group (EQ-5D-3L utilities: +0.104, P = 0.005; VAS: +8.15, P = 0.001) after 3 years. CONCLUSIONS: The case management was cost-neutral and led to an important and significant improvement in health status among survivors. It was associated with higher QALYs and lower costs but the differences in costs and QALYs were not statistically significant.

Effectiveness of pulmonary rehabilitation for patients with asthma: study protocol of a randomized controlled trial (EPRA).

BACKGROUND: Asthma patients are enrolled in multimodal pulmonary rehabilitation (PR) programs. However, available data for the effectiveness of PR in asthma are sparse. Therefore, the primary aim of this randomized control trial (RCT) is to evaluate short-term (end of rehabilitation) and intermediate-term effectiveness (3 months after rehabilitation) of PR for patients with asthma regarding asthma control (primary outcome) and other outcomes. Secondly, moderator effects of gender, age, baseline asthma control, quality of life, and anxiety will be examined. Thirdly, a longitudinal follow-up study will explore the course of the outcomes over one year and the annual costs. METHODS: The EPRA study is a single-center randomized controlled waiting-list trial in the Bad Reichenhall Clinic. Inclusion criteria include a referral diagnosis for uncontrolled asthma, no cognitive impairment and no very severe co-morbidities that indicate significantly greater illness morbidity than asthma alone. In the intervention group (IG), participants will start PR within 4 weeks after randomization; participants of the control group (CG) will start PR 20 weeks after randomization. Data will be assessed at randomization (T0), after 4 weeks (T1; IG: begin of PR), 7 weeks (T2; IG: end of PR), and 20 weeks (T3, CG: begin of PR). The primary outcome is asthma control at T2/T3. Secondary outcomes are health-related quality of life, functional exercise capacity, dyspnea, anxiety, depression, subjective self-management skills, illness perceptions, sick leave and subjective work ability. Outcomes will be analyzed with analysis of covariance, including baseline values of the respective outcomes as covariates. Healthcare costs will be analyzed with a gamma model with a log-link. A longitudinal follow-up study will generate additional data at 3/6/9/12 months after PR for both IG and CG. Latent change models will be used to analyze the course of the primary and secondary outcomes. Annual cost differences before and after rehabilitation will be compared by paired t-test. DISCUSSION: This RCT will determine the effectiveness of a complex inpatient PR for asthma patients concerning asthma control. Furthermore, important medical and economic information regarding the effectiveness of PR as part of the long-term management of patients with uncontrolled asthma will be generated. TRIAL REGISTRATION: German Clinical Trials Register ( DRKS00007740 , May 15, 2015). Protocol version: 1.0 (December, 23, 2016).

The German day-care study: multicomponent non-drug therapy for people with cognitive impairment in day-care centres supplemented with caregiver counselling (DeTaMAKS) - study protocol of a cluster-randomised controlled trial.

BACKGROUND: It is the wish of both people with cognitive impairment and their informal caregivers for the impaired person to live at home for as long as possible. This is also in line with economic arguments about health. The existing structure of day-care services for the elderly can be used to achieve this. Due to the current lack of empirical evidence in this field, most day-care centres do not offer a scientifically evaluated, structured intervention, but instead offer a mixture of individual activities whose efficacy has not yet been established. Informal caregivers of people with dementia use day-care centres primarily to relieve themselves of their care tasks and as a support service. METHODS/DESIGN: The present study therefore investigates the effectiveness of a combination of a multicomponent activation therapy for people with mild cognitive impairment (MCI) or mild to moderate dementia at day-care centres and a brief telephone intervention for their informal caregivers. The study is conducted as a cluster-randomised intervention trial at 34 day-care centres in Germany with a 6-month treatment phase. The centres in the waitlist control group provide "care as usual". A power analysis indicated that 346 people should initially be included in the study. The primary endpoints of the study include the ability to perform activities of daily living (ADL) and cognitive capacities on the side of the day-care centre users and the subjectively perceived burden and well-being of the informal caregivers. The total duration of the study is 3 years, during which data are collected both by the psychometric testing of the people with cognitive impairment and by telephone interviews with informal caregivers. DISCUSSION: The project has three distinctive quality features. First, it is embedded in real care situations since the day-care services have already been established for this target group. Second, due to the large number of cases and the fact that the participating day-care centres are spread across the entire country, the results can be expected to be generalisable. Third, the interventions can be assumed to be implementable as they required only a one-day training event for the staff already working at the centres. TRIAL REGISTRATION: ISRCTN16412551 (Registration date: 30 July 2014, registered retrospectively).

New potential determinants of disability in aged persons with myocardial infarction: results from the KORINNA-study.

BACKGROUND: Elderly individuals with coronary heart disease are a population particularly burdened by disability. However, to date many predictors of disability established in general populations have not been considered in studies examining disability in elderly acute myocardial infarction (AMI) survivors. Our study explores factors associated with the ability to perform basic activities of daily living in elderly patients with AMI. METHODS: Baseline data from 333 AMI-survivors older than 64 years included within the randomized controlled KORINNA-study were utilized to examine disability assessed by the Stanford Health Assessment Questionare Disability Index (HAQ-DI). Numerous potential determinants including demographic characteristics, clinical parameters, co-morbidities, interventions, lifestyle, behavioral and personal factors were measured.Disability was defined as a HAQ-DI ≥ 0.5. After bi-variate testing the probability of disability was modeled with logistic regression. Missing covariate values were imputed using a Markov Chain Monte Carlo method. RESULTS: Disability was significantly more frequent in older individuals (Odds Ratio (OR): 1.10, 95% Confidence Interval (CI): 1.05-1.16), patients with deficient nutrition (OR: 3.38, 95% CI: 1.60-7.15), coronary artery bypass graft (CABG) (OR: 3.26, 95% CI: 1.29-8.25), hearing loss in both ears (OR: 2.85, 95% CI: 1.41-5.74), diabetes mellitus (OR: 2.56, 95% CI: 1.39-4.72), and heart failure (OR: 3.32, 95% CI: 1.79-6.16). It was reduced in patients with percutaneous transluminal coronary angioplasty (PTCA) (OR: 0.41, 95% CI: 0.21-0.80) and male sex (OR: 0.48, 95% CI: 0.27-0.85). CONCLUSIONS: Effects of nutrition, hearing loss, and diametrical effects of PTCA and CABG on disability were identified as relevant for examination of causality in longitudinal trials. TRIAL REGISTRATION: ISRCTN02893746.

Effects of a nurse-based case management compared to usual care among aged patients with myocardial infarction: results from the randomized controlled KORINNA study.

BACKGROUND: Transition from hospital to home is a critical period for older persons with acute myocardial infarction (AMI). Home-based secondary prevention programs led by nurses have been proposed to facilitate the patients' adjustment to AMI after discharge. The objective of this study was to evaluate the effects of a nurse-based case management for elderly patients discharged after an AMI from a tertiary care hospital. METHODS: In a single-centre randomized two-armed parallel group trial of patients aged 65 years and older hospitalized with an AMI between September 2008 and May 2010 in the Hospital of Augsburg, Germany, patients were randomly assigned to a case management or a control group receiving usual care. The case-management intervention consisted of a nurse-based follow-up for one year including home visits and telephone calls. Key elements of the intervention were to detect problems or risks and to give advice regarding a wide range of aspects of disease management (e.g. nutrition, medication). Primary study endpoint was time to first unplanned readmission or death. Block randomization per telephone call to a biostatistical center, where the randomization list was kept, was performed. Persons who assessed one-year outcomes and validated readmission data were blinded. Statistical analysis was based on the intention-to-treat approach and included Cox Proportional Hazards models. RESULTS: Three hundred forty patients were allocated to receive case-management (n=168) or usual care (n=172). The analysis is based on 329 patients (intervention group: n=161; control group: n=168). Of these, 62% were men, mean age was 75.4 years, and 47.1% had at least either diabetes or chronic heart failure as a major comorbidity. The mean follow-up time for the intervention group was 273.6 days, and for the control group it was 320.6 days. During one year, in the intervention group there were 57 first unplanned readmissions and 5 deaths, while the control group had 75 first unplanned readmissions and 3 deaths. With respect to the endpoint there was no significant effect of the case management program after one year (Hazard Ratio 1.01, 95% confidence interval 0.72-1.41). This was also the case among subgroups according to sex, diabetes, living alone, and comorbidities. CONCLUSIONS: A nurse-based management among elderly patients with AMI had no significant influence on the rate of first unplanned readmissions or death during a one-year follow-up. A possible long-term influence should be investigated by further studies. CLINICAL TRIAL REGISTRATION: ISRCTN02893746.

Empirical analysis shows reduced cost data collection may be an efficient method in economic clinical trials.

BACKGROUND: Data collection for economic evaluation alongside clinical trials is burdensome and cost-intensive. Limiting both the frequency of data collection and recall periods can solve the problem. As a consequence, gaps in survey periods arise and must be filled appropriately. The aims of our study are to assess the validity of incomplete cost data collection and define suitable resource categories. METHODS: In the randomised KORINNA study, cost data from 234 elderly patients were collected quarterly over a 1-year period. Different strategies for incomplete data collection were compared with complete data collection. The sample size calculation was modified in response to elasticity of variance. RESULTS: Resource categories suitable for incomplete data collection were physiotherapy, ambulatory clinic in hospital, medication, consultations, outpatient nursing service and paid household help. Cost estimation from complete and incomplete data collection showed no difference when omitting information from one quarter. When omitting information from two quarters, costs were underestimated by 3.9% to 4.6%.With respect to the observed increased standard deviation, a larger sample size would be required, increased by 3%. Nevertheless, more time was saved than extra time would be required for additional patients. CONCLUSION: Cost data can be collected efficiently by reducing the frequency of data collection. This can be achieved by incomplete data collection for shortened periods or complete data collection by extending recall windows. In our analysis, cost estimates per year for ambulatory healthcare and non-healthcare services in terms of three data collections was as valid and accurate as a four complete data collections. In contrast, data on hospitalisation, rehabilitation stays and care insurance benefits should be collected for the entire target period, using extended recall windows. When applying the method of incomplete data collection, sample size calculation has to be modified because of the increased standard deviation. This approach is suitable to enable economic evaluation with lower costs to both study participants and investigators. TRIAL REGISTRATION: The trial registration number is ISRCTN02893746.

Gender-linked determinants for utilization of long-term care in community-dwelling adults 65+ in Germany: Results from the population-based KORA-Age study.

BACKGROUND: The number of people using long-term care (LTC) is increasing steadily, hence, demand for adequate services is rising. The purpose of this exploratory study was to identify relevant gender-linked determinants for utilization of LTC in community-dwelling older adults. METHODS: We examined 4077 females (52.7%) and males ≥ 65 years old (range: 65-97 years) between 2011/12 (t1) and 2016 (t2). Data originated from the population-based Cooperative Health Research in the Region of Augsburg (KORA)-Age study in southern Germany. A descriptive analysis assessed the amount of LTC used. Cross-sectional generalized estimating equation logistic models identified determinants for utilization of (in)formal LTC. Determinants for transition to LTC between t1 and t2 were examined using a longitudinal logistic regression model. Potential determinants were chosen according to Andersen's Behavioral Model of Health Services Use. RESULTS: At t2, 820 (20.1%) were LTC users with 527 (64.3%) being female. The average amount of informal LTC was higher in males, whereas the amount of formal LTC was higher in females. In both genders, higher age, multimorbidity, and disability were associated with utilization of and transition to LTC. Living alone was significantly associated with utilization of LTC in both genders, but its effect was two times stronger in males. Thus, it is considered the essential gender-linked determinant. CONCLUSIONS: Gender-linked determinants must be considered when establishing demand-oriented policies. Future health programs should specifically target older individuals, especially males, living alone to improve their capabilities in activities of daily living to allow them to remain living longer and independently within community settings.

Nurse-based case management for aged patients with myocardial infarction: study protocol of a randomized controlled trial.

BACKGROUND: Aged patients with coronary heart disease (CHD) have a high prevalence of co-morbidity associated with poor quality of life, high health care costs, and increased risk for adverse outcomes. These patients are often lacking an optimal home care which may result in subsequent readmissions. However, a specific case management programme for elderly patients with myocardial infarction (MI) is not yet available. The objective of this trial is to examine the effectiveness of a nurse-based case management in patients aged 65 years and older discharged after treatment of an acute MI in hospital. The programme is expected to influence patient readmission, mortality and quality of life, and thus to reduce health care costs compared with usual care. In this paper the study protocol is described. METHODS/DESIGN: The KORINNA (Koronarinfarkt Nachbehandlung im Alter) study is designed as a single-center randomized two-armed parallel group trial. KORINNA is conducted in the framework of KORA (Cooperative Health Research in the Region of Augsburg). Patients assigned to the intervention group receive a nurse-based follow-up for one year including home visits and telephone calls. Key elements of the intervention are to detect problems or risks, to give advice regarding a broad range of aspects of disease management and to refer to the general practitioner, if necessary. The control group receives usual care. Twelve months after the index hospitalization all patients are re-assessed. The study has started in September 2008. According to sample size estimation a total number of 338 patients will be recruited. The primary endpoint of the study is time to first readmission to hospital or out of hospital death. Secondary endpoints are functional status, participation, quality of life, compliance, and cost-effectiveness of the intervention. For the economic evaluation cost data is retrospectively assessed by the patients. The incremental cost-effectiveness ratio (ICER) will be calculated. DISCUSSION: The KORINNA study will contribute to the evidence regarding the effectiveness of case management programmes in aged people with MI. The results can be an important basis for clinicians, administrators and health policy makers to decide on the provision of high-quality care to older patients with CHD.

Cost-effectiveness of a non-pharmacological treatment vs. "care as usual" in day care centers for community-dwelling older people with cognitive impairment: results from the German randomized controlled DeTaMAKS-trial.

BACKGROUND: Cognitive impairment in older adults causes a high economic and societal burden. This study assesses the cost-effectiveness of the multicomponent, non-pharmacological MAKS treatment vs. "care as usual" in German day care centers (DCCs) for community-dwelling people with mild cognitive impairment (MCI) or mild to moderate dementia over 6 months. METHODS: The analysis was conducted from the societal perspective alongside the cluster-randomized controlled, multicenter, prospective DeTaMAKS-trial with waitlist group design. Outcomes were Mini-Mental Status Examination (MMSE) and Erlangen Test of Activities of Daily Living in Persons with Mild Dementia or Mild Cognitive Impairment (ETAM) of 433 individuals in 32 DCCs. Incremental differences in MMSE and ETAM were calculated via a Gaussian-distributed and incremental cost difference via a Gamma-distributed Generalized Linear Model. Cost-effectiveness was assessed via cost-effectiveness planes and cost-effectiveness acceptability curves (CEAC). RESULTS: At 6 months, MMSE (adjusted mean difference = 0.92; 95% confidence interval (CI): 0.17 to 1.67; p = 0.02) and ETAM (adjusted mean difference = 1.00; CI: 0.14 to 1.85; p = 0.02) were significantly better in the intervention group. The adjusted cost difference was - €938.50 (CI: - 2733.65 to 763.13; p = 0.31). Given the CEAC, MAKS was cost-effective for 78.0% of MMSE and 77.4% for ETAM without a need for additional costs to payers. CONCLUSIONS: MAKS is a cost-effective treatment to stabilize the ability to perform activities of daily living and cognitive abilities of people with MCI or mild to moderate dementia in German DCCs. Thus, MAKS should be implemented in DCCs.

Non-Pharmacological Treatment in People With Cognitive Impairment.

BACKGROUND: A number of non-pharmacological methods are available to help elderly people with cognitive impairment. Unstructured and non-evidencebased interventions are commonly used. The multicomponent therapy MAKS (a German acronym for Motor, Activities of daily living, Cognitive, Social) has already been evaluated in nursing homes; in this study, we investigated its use in day care centers (DCCs). METHODS: A cluster-randomized, controlled, single-blinded trial involving a 6-month intervention phase was performed. 362 cognitively impaired persons in 32 DCCs took part in the trial. Multiple regression analyses were used to determine whether MAKS therapy led to any statistically significant and clinically relevant improvement over time (compared to membership in the control group) in these persons' cognitive abilities and activities of daily living (ADL) abilities, as assessed, respectively, with the Mini-Mental State Examination (MMSE) and the Erlangen Test of Activities of Daily Living in Persons with Mild Dementia or Mild Cognitive Impairment (ETAM). A primary per-protocol analysis was supplemented by an intention-to-treat analysis. Two secondary outcomes (social behavior and neuropsychiatric symptoms) were analyzed exploratively as well. Study registration: ISRCTN16412551. RESULTS: In the primary per-protocol analysis at 6 months, the intervention group had significantly better MMSE and ETAM scores than the control group (Cohen's d, 0.26 and 0.21, respectively; p = 0.012 for both). The same was found in the ITT analysis at 6 months (Cohen's d = 0.21, p = 0.033; and Cohen's d = 0.20, p = 0.019, respectively). Neuropsychiatric symptoms, one of the secondary outcomes, also evolved more favorably in the intervention group (Cohen's d = 0.23, p = 0.055). CONCLUSION: MAKS therapy is effective for persons with cognitive impairment ranging from mild cognitive impairment (MCI) to moderate dementia who live at home and regularly visit a day care center. The fact that 32 day care facilities from all over Germany participated in this study gives its findings high external validity.

Validity of self-reported hospital admissions in clinical trials depends on recall period length and individual characteristics.

RATIONALE, AIMS AND OBJECTIVES: We investigated the validity of self-reported admission data compared to administrative records in a clinical trial. METHOD: In the randomized KORINNA study (ISRCTN02893746), hospital admission data were collected in telephone interviews with 273 elderly patients quarterly over a 1-year period and thereafter annually over a 2-year period. Data were compared with administrative records and discharge letters. Mixed models were used to investigate if recall period and individual characteristics influence validity. RESULTS: Specificity (>99%) and sensitivity (94%) of self-reported data did not differ for different recall periods (3 months vs. 12 months). The differences between self-reported and registered inpatient days were not statistically significant. Having regard to all the admissions within the time period of last interview and dropping out, the bias was up to 40% underestimation. The chance of disagreement was significantly smaller [odds ratio (OR) of misremember an admission = 0.596, P = 0.049, confidence interval (CI) = 0.355 to 1.00; OR of misremember length of stay = 0.521, P = 0.002, CI = 0.344 to 0.789] for 3-month periods, but this was primarily driven by number of admissions within the recall period. Individuals with better health and longer stays had a significantly smaller chance of disagreement. CONCLUSIONS: The bias within one year was not influenced by applying various recall periods, although the probability of correctly self-reported single hospital admission was higher using a recall period of three months. It can be recommended that lengthened recall periods of 12 months are appropriate for gathering self-reported hospital admission data in elderly people with myocardial infarction.

Cost-effectiveness of nurse-based case management versus usual care for elderly patients with myocardial infarction: results from the KORINNA study.

OBJECTIVES: We assessed the cost-effectiveness of a case management intervention by trained nurses in elderly (≥65 years) patients with myocardial infarction from a societal perspective. METHODS: The intervention and observation period spanned 1 year and 329 participants were enrolled. The intervention consisted of at least one home visit and quarterly telephone calls. Data on resource use and quality of life were collected quarterly. The primary measurements of effect were quality-adjusted life years (QALYs), based on the EuroQol five-dimensional questionnaire (EQ-5D-3L) health utilities from the German time trade-off. The secondary measurements were EQ-5D-3L utility values and patients' self-rated health states according to the visual analogue scale (VAS) among survivors. To estimate mean differences, a linear regression model was used for QALYs and a gamma model for costs. Health states among the survivors were analysed using linear mixed models. To assess the impact of different health state valuation methods, VAS-adjusted life years were constructed. RESULTS: The mean difference in QALYs was small and not significant (-0.0163; CI -0.0681-0.0354, p value: 0.536, n = 297). Among survivors, EQ-5D-3L utilities showed significant improvements within 6 months in the intervention group (0.051; CI 0.0028-0.0989; p value: 0.0379, n = 280) but returned towards baseline levels by month 12. The mean improvement in self-rated health (VAS) within 1 year was significantly larger in the intervention group (+9.2, CI 4.665-13.766, p value: <0.0001, n = 266). The overall cost difference was -17.61 (CI - 2,601-2,615; p value: 0.9856, n = 297). The difference in VAS-adjusted life years was 0.0378 (CI -0.0040-0.0796, p value: 0.0759, n = 297). CONCLUSIONS: This study could not provide evidence to conclude that the case management intervention was an effective and cost-effective alternative to usual care within a time horizon of 1 year.