Comparing the EQ-5D-5L and stroke impact scale 2.0 in stroke patients: an analysis of measurement properties.

BACKGROUND: Stroke has evolved to become a chronic disease and a major public health challenge. To adequately capture the full disease burden of stroke patients, the assessment of health-related quality of life (HRQoL) and thus the performance of respective measures is increasingly relevant. The aim of this analysis was to compare the measurement properties of two self-report instruments, the EQ-5D-5L and the Stroke Impact Scale 2.0. METHODS: The data used for the analysis was derived from a quasi-experimental case management study for mildly to moderately affected incident stroke and transient ischemic attack (TIA) patients aged ≥ 18 in Germany. Data was collected patient-individually at 3, 6 and 12 months after initial stroke. The EQ-5D-5L and SIS 2.0 were compared in terms of feasibility, ceiling and floor effects, responsiveness and known-groups validity (Kruskal-Wallis H and Wilcoxon rank-sum test). RESULTS: A response for all three follow-ups is available for n = 855 patients. The feasibility of the EQ-5D-5L is determined as good (completion rate: 96.4-96.6%, ≥ one item missing: 3.2 - 3.3%), whereas the SIS 2.0 is moderately feasible (overall completion rate: 44.9-46.1%, ≥ one item missing in domains: 4.7 - 28.7%). The SIS 2.0 shows substantial ceiling effects in comparable domains (physical function: 10.4 - 13%, others: 3.5-31.3%) which are mainly larger than ceiling effects in the EQ-5D-5L index (17.1-21.5%). In terms of responsiveness, the EQ-5D-5L shows small to moderate change while the SIS 2.0 presents with moderate to large responsiveness. The EQ-5D-5L index, mobility, usual activities and Visual Analogue Scale show known-groups validity (p < 0.05). Content-related domains of the SIS 2.0 show known-groups validity as well (p < 0.05). However, it is compromised in the emotion domain in both measures (p > 0.05). CONCLUSIONS: The EQ-5D-5L seems to be slightly more suitable for this cohort. Nonetheless, the results of both measures indicate limited suitability for TIA patients. Large-scale studies concerning responsiveness and known-groups validity are encouraged. TRIAL REGISTRATION: The study was registered in the German Clinical Trials Register, retrospective registration on 21.09.2022. REGISTRATION ID: DRKS00030297.

Markov-modulated marked Poisson processes for modeling disease dynamics based on medical claims data.

We explore Markov-modulated marked Poisson processes (MMMPPs) as a natural framework for modeling patients' disease dynamics over time based on medical claims data. In claims data, observations do not only occur at random points in time but are also informative, that is, driven by unobserved disease levels, as poor health conditions usually lead to more frequent interactions with the health care system. Therefore, we model the observation process as a Markov-modulated Poisson process, where the rate of health care interactions is governed by a continuous-time Markov chain. Its states serve as proxies for the patients' latent disease levels and further determine the distribution of additional data collected at each observation time, the so-called marks. Overall, MMMPPs jointly model observations and their informative time points by comprising two state-dependent processes: the observation process (corresponding to the event times) and the mark process (corresponding to event-specific information), which both depend on the underlying states. The approach is illustrated using claims data from patients diagnosed with chronic obstructive pulmonary disease by modeling their drug use and the interval lengths between consecutive physician consultations. The results indicate that MMMPPs are able to detect distinct patterns of health care utilization related to disease processes and reveal interindividual differences in the state-switching dynamics.

Influence of Self-Reported Health Impairments on German EQ-5D-5L Values.

OBJECTIVES: The German EQ-5D-5L value set is based on the average preferences of the general population. Nevertheless, in Germany, there is an ongoing debate about the appropriateness of using general population preferences and whether patient preferences should be used instead. Thus, this research aimed to determine the robustness of the German EQ-5D-5L valuation data for the general population compared with those with health impairments. METHODS: Subgroups were built on the self-reported quality of life, measured with the EQ-5D-5L. To identify which groups significantly influenced the value set, different regression models, including dummy variables for the subgroups, were tested while controlling for preference heterogeneity. Backward selection based on the Akaike information criterion led to significant subgroup dummies, which were analyzed in more detail. For each significant subgroup, the value set model was estimated separately. The models were then compared. Sociodemographics of the subgroups were considered. RESULTS: Three significant dummies were identified: state 11111, severity levels 5 to 7, and self-reported problems with pain/discomfort. The value sets for the 6 subgroups were compared with the national German value set, showing only marginal deviations. The mean absolute deviation ranged from 0.004 to 0.013. No different densities were identified for the decrements of the different value sets. CONCLUSIONS: People with self-reported health impairments do not have different EQ-5D-5L health state preferences compared with the German general population. Further research is needed to determine whether the presence of a chronic health condition has a larger influence on health state valuation than the general population.

An Innovative Telemedical Network to Improve Infectious Disease Management in Critically Ill Patients and Outpatients (TELnet@NRW): Stepped-Wedge Cluster Randomized Controlled Trial.

BACKGROUND: Evidence-based infectious disease and intensive care management is more relevant than ever. Medical expertise in the two disciplines is often geographically limited to university institutions. In addition, the interconnection between inpatient and outpatient care is often insufficient (eg, no shared electronic health record and no digital transfer of patient findings). OBJECTIVE: This study aims to establish and evaluate a telemedical inpatient-outpatient network based on expert teleconsultations to increase treatment quality in intensive care medicine and infectious diseases. METHODS: We performed a multicenter, stepped-wedge cluster randomized trial (February 2017 to January 2020) to establish a telemedicine inpatient-outpatient network among university hospitals, hospitals, and outpatient physicians in North Rhine-Westphalia, Germany. Patients aged ≥18 years in the intensive care unit or consulting with a physician in the outpatient setting were eligible. We provided expert knowledge from intensivists and infectious disease specialists through advanced training courses and expert teleconsultations with 24/7/365 availability on demand respectively once per week to enhance treatment quality. The primary outcome was adherence to the 10 Choosing Wisely recommendations for infectious disease management. Guideline adherence was analyzed using binary logistic regression models. RESULTS: Overall, 159,424 patients (10,585 inpatients and 148,839 outpatients) from 17 hospitals and 103 outpatient physicians were included. There was a significant increase in guideline adherence in the management of Staphylococcus aureus infections (odds ratio [OR] 4.00, 95% CI 1.83-9.20; P<.001) and in sepsis management in critically ill patients (OR 6.82, 95% CI 1.27-56.61; P=.04). There was a statistically nonsignificant decrease in sepsis-related mortality from 29% (19/66) in the control group to 23.8% (50/210) in the intervention group. Furthermore, the extension of treatment with prophylactic antibiotics after surgery was significantly less likely (OR 9.37, 95% CI 1.52-111.47; P=.04). Patients treated by outpatient physicians, who were regularly participating in expert teleconsultations, were also more likely to be treated according to guideline recommendations regarding antibiotic therapy for uncomplicated upper respiratory tract infections (OR 1.34, 95% CI 1.16-1.56; P<.001) and asymptomatic bacteriuria (OR 9.31, 95% CI 3.79-25.94; P<.001). For the other recommendations, we found no significant effects, or we had too few observations to generate models. The key limitations of our study include selection effects due to the applied on-site triage of patients as well as the limited possibilities to control for secular effects. CONCLUSIONS: Telemedicine facilitates a direct round-the-clock interaction over broad distances between intensivists or infectious disease experts and physicians who care for patients in hospitals without ready access to these experts. Expert teleconsultations increase guideline adherence and treatment quality in infectious disease and intensive care management, creating added value for critically ill patients. TRIAL REGISTRATION: ClinicalTrials.gov NCT03137589; https://clinicaltrials.gov/ct2/show/NCT03137589.

Secondary Prevention via Case Managers in Stroke Patients: A Cost-Effectiveness Analysis of Claims Data from German Statutory Health Insurance Providers.

Strokes remain a leading cause of death and disability worldwide. The STROKE OWL study evaluated a novel case management approach for patients with stroke (modified Rankin Scale 0-4) or transient ischemic attack (TIA) who received support across healthcare settings and secondary prevention training from case managers for one year. The primary aim of this quasi-experimental study was a reduction in stroke recurrence. Here, we report the results of a health economic analysis of the STROKE OWL study, conducted in accordance with CHEERS guidelines. The calculations were based on claims data of cooperating statutory health insurance companies. In addition to a regression analysis for cost comparison, the incremental cost-effectiveness ratio was determined, and a probabilistic sensitivity analysis was carried out. In total, 1167 patients per group were included in the analysis. The intervention group incurred 32.3% higher direct costs (p < 0.001) than the control group. With a difference of EUR 1384.78 (95% CI: [1.2384-1.4143], p < 0.0001) and a 5.32% increase in hazards for the intervention group (HR = 1.0532, 95% CI: [0.7869-1.4096], p = 0.7274) resulting in an ICER of EUR 260.30, we found that the case management intervention dominated in the total stroke population, even for an arbitrarily high willingness to pay. In the TIA subgroup, however, the intervention was cost-effective even for a low willingness to pay. Our results are limited by small samples for both TIA and severe stroke patients and by claims data heterogeneity for some cost components, which had to be excluded from the analysis. Future research should investigate the cost-effectiveness of case management interventions for both severe stroke and TIA populations using appropriate data.

Health economic evaluation of an electronic mindfulness-based intervention (eMBI) to improve maternal mental health during pregnancy - a randomized controlled trial (RCT).

BACKGROUND: Anxiety and depression are the most prevalent psychiatric diseases in the peripartum period. They can lead to relevant health consequences for mother and child as well as increased health care resource utilization (HCRU) and related costs. Due to the promising results of mindfulness-based interventions (MBI) and digital health applications in mental health, an electronic MBI on maternal mental health during pregnancy was implemented and assessed in terms of transferability to standard care in Germany. The present study focused the health economic outcomes of the randomized controlled trial (RCT). METHODS: The analysis, adopting a payer's and a societal perspective, included women of increased emotional distress at < 29 weeks of gestation. We applied inferential statistics (α = 0.05 significance level) to compare the intervention group (IG) and control group (CG) in terms of HCRU and costs. The analysis was primarily based on statutory health insurance claims data which covered the individual observational period of 40 weeks. RESULTS: Overall, 258 women (IG: 117, CG: 141) were included in the health economic analysis. The results on total health care costs from a payer's perspective indicated higher costs for the IGi compared to the CG (Exp(ß) = 1.096, 95% CI: 1.006-1.194, p = 0.037). However, the estimation was not significant after Bonferroni correction (p < 0.006). Even the analysis from a societal perspective as well as sensitivity analyses did not show significant results. CONCLUSIONS: In the present study, the eMBI did neither reduced nor significantly increased health care costs. Further research is needed to generate robust evidence on eMBIs for women suffering from peripartum depression and anxiety. TRIAL REGISTRATION: German Clinical Trials Register: DRKS00017210. Registered on 13 January 2020. Retrospectively registered.

Correction: Duevel et al. Secondary Prevention via Case Managers in Stroke Patients: A Cost-Effectiveness Analysis of Claims Data from German Statutory Health Insurance Providers. Healthcare 2024, 12, 1157.

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A case management intervention in stroke care: Evaluation of a quasi-experimental study.

BACKGROUND: Patients with initial stroke or transient ischemic attack (TIA) are at high risk for further strokes, death or cardiovascular events. Even the first-ever stroke is associated with a high chance of disability and need for assistance. The risk of long-term health care demands increases with each subsequent event. Although the inpatient sector already provides a high standard of care in Germany, it can be difficult to obtain cross-sectoral aftercare. Thus, the study investigated whether a structured case management program can avoid stroke recurrences. METHODS: The study was conducted with a quasi-experimental study design in three regions in North Rhine-Westphalia. Patients with first-ever stroke or TIA were eligible to participate. The intervention group was prospectively recruited and supported by a case manager during a one-year follow-up. Optimal Full Matching was used to generate a control group based on statutory claims data. The primary outcome was the stroke recurrence. Recurrence and mortality were analysed by using Cox regression; other secondary outcomes were examined with test-based procedures and with logistic regressions. Additionally, subgroup analyses were performed. RESULTS: From June 2018 to March 2020, 1,512 patients were enrolled in the intervention group. Claims data from 19,104 patients have been transmitted for establishing the control group. After the matching process, 1,167 patients of each group were included in the analysis. 70 recurrences (6.0%) occurred in the intervention group and 67 recurrences (5.7%) in the control group. With a hazard ratio of 1.06 (95% CI: [1.42-0.69]; p=0.69), no significant effect was found for the primary outcome. With regard to the secondary outcome mortality, 36 patients in the intervention group and 46 in the control group died (3.1% vs. 3.9%). Again, there was no significant effect (HR: 0.86; 95% CI: [0.58-1.28], p=0.46). DISCUSSION: Based on the present findings, the case management approach for stroke patients evaluated here was unable to demonstrate an improvement in health care. Potential effects of case management might not be adequately depicted in short observation periods. Thus, future studies should consider longer observation periods. CONCLUSION: A panel of experts should discuss whether the core approach of case management to support cost-intensive individual cases is contrary to a broad implementation with a one-size-fits-all intervention for stroke patients. In this case, further research should focus on more specific study populations.

A Case Management Approach in Stroke Care: A Mixed-Methods Acceptance Analysis from the Perspective of the Medical Profession.

PURPOSE OF STUDY: In terms of continuous and coordinated health care, cross-sectoral care structures are crucial. However, the German health care system is characterized by fragmentation of medical services and responsibilities. This fragmentation leads to multiple interfaces frequently causing loss of information, effectiveness, and quality. The concept of case management has the potential to improve cooperation between sectors and health care providers. Hence, a case management intervention for patients with stroke was evaluated with an acceptance analysis on the physicians' willingness to cooperate with stroke managers and their assessment of the potential of case management for the health care of patients with stroke. PRIMARY PRACTICE SETTINGS: Primary practice settings included physicians working in the hospital, rehabilitation, and outpatient sectors who had actual or potential contact with a stroke case manager within the project region of East Westphalia-Lippe. METHODOLOGY AND SAMPLE: The analysis was conducted using a mixed-methods approach. Expert interviews were conducted in 2020. Afterward a questionnaire was developed, which was then distributed to physicians in 2021. Both the interviews and the questionnaire included questions on conceptual knowledge and concrete expectations prior of the project, on experiences during the project and on recommendations and physicians' assessment of future organization in health care to classify and describe the acceptance. RESULTS: Nine interviews were conducted and 23 questionnaires were completed. Only slightly more than 50% of the physicians had prior knowledge of the case management approach. Overall, ambiguous results concerning the acceptance of case managers were revealed. Additional personal assistance for patients with stroke was seen as beneficial at the same time critical perspectives regarding further fragmentation of health care and overlapping of competences with existing professional groups or forms of health care were collected. General practitioners in particular were critical of the case management approach. IMPLICATIONS FOR CASE MANAGEMENT PRACTICE: From the physicians' point of view, at least two changes are necessary for the project approach to be integrated into standard care. First, the target group should be adapted according to the case management approach. Second, the delegation of tasks and responsibilities to case managers should be revised. The sectoral difference in the acceptance of case managers by physicians indicates that active cooperation and communication in everyday work has direct impact on the acceptance of a new occupational profession. Physician acceptance has a significant impact on the implementation of new treatment modalities and thus influences the overall quality of health care.

Population size and self-reported characteristics and sexual preferences of men-who-have-sex-with-men (MSM) in Germany based on social network data.

BACKGROUND: In the absence of detailed information about the population size and behaviour data of men-who-have-sex-with-men (MSM), the estimation of prevalence rates of sexually transmitted infections (STIs) and the design of public health interventions become difficult. The aim of the present study is to estimate the lower boundary of age-specific population sizes and retrieve self-reported information from this population. METHODS: We used publicly accessible data from a large online dating and social network website for MSM in Germany to retrieve data on the age and regional distribution of profiles. The profiles were also stratified by their information on the preferred position during anal intercourse, safer sex, and sexual identity. RESULTS: A total of 464,873 user profiles correspond to an average 15.2 profiles per 1,000 male inhabitants in Germany, varying between 7.6 and 45.6 across federal states. Although the information on the absolute numbers for different age groups is limited by the search engine, age-specific relative frequencies were found to increase from 12.9 in the age group of 18 to 20 year olds to 24.6 profiles per 1,000 male inhabitants in the 28 to 30 year olds. The data shows age-specific trends for safer sex with an increasing easiness of reporting "never" engaging in safer sex or stating that safer sex "needs discussion" with increasing age. Around one third of profile owners stated to be versatile with respect to the preferred position in anal intercourse. All other options ("only bottom", "more bottom", "only top", "more top") were preferred equally likely by roughly 10% of profile owners, respectively. CONCLUSIONS: Online social network or dating sites can provide some information about specific populations in the absence of other data sources. The presented results are the first to report age-specific rates of MSM per 1,000 male inhabitants in Germany and may be useful to estimate age-specific prevalence or incidence rates as well as to inform health promotion activities and modelling studies for MSM in Germany.

Classifying grey seal behaviour in relation to environmental variability and commercial fishing activity - a multivariate hidden Markov model.

Classifying movement behaviour of marine predators in relation to anthropogenic activity and environmental conditions is important to guide marine conservation. We studied the relationship between grey seal (Halichoerus grypus) behaviour and environmental variability in the southwestern Baltic Sea where seal-fishery conflicts are increasing. We used multiple environmental covariates and proximity to active fishing nets within a multivariate hidden Markov model (HMM) to quantify changes in movement behaviour of grey seals while at sea. Dive depth, dive duration, surface duration, horizontal displacement, and turning angle were used to identify travelling, resting and foraging states. The likelihood of seals foraging increased in deeper, colder, more saline waters, which are sites with increased primary productivity and possibly prey densities. Proximity to active fishing net also had a pronounced effect on state occupancy. The probability of seals foraging was highest <5 km from active fishing nets (51%) and decreased as distance to nets increased. However, seals used sites <5 km from active fishing nets only 3% of their time at sea highlighting an important temporal dimension in seal-fishery interactions. By coupling high-resolution oceanographic, fisheries, and grey seal movement data, our study provides a scientific basis for designing management strategies that satisfy ecological and socioeconomic demands on marine ecosystems.