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.

Health economic perspective on a community-based intervention for older people at risk of care dependency - results of a prospective quasi-experimental study.

This prospective, quasi-experimental study aims to compare healthcare resource utilization (HCRU) and costs of a multi-component care approach for older people in a community setting (intervention group (IG)) with usual care in a matched control group (CG) during a 21-month observation period. The reablement-oriented intervention included a geriatric assessment, a case and network management and digital supporting tools. Regression models were applied to determine intervention effects regarding hospitalization, total hospital length of stay (LOS), number of physician consultations, and healthcare costs using claims data. 872 subjects were included in the IG and 1,768 in the CG. The analyses showed that the intervention did not affect hospitalization (OR = 1.153; 95% CI: 0.971-1.369, p = .105). However, participating in the IG lead to a small but significant increase of physician contacts by a factor of 1.078 (Exp(ß) = 1.078; 95% CI: 1.011-1.149; p = .022). A non-significant mean difference in costs of €1,183 (95% CI: €-261.6 to €2,627.6, p = .108) per participant was identified. Further research is needed to generate robust evidence on the optimal design of care approaches for older people and the health economic implications of such interventions to improve care and resource allocation decision-making. Trial registration: The study was registered at the German Clinical Trials Register (DRKS00027866).

Effectiveness of a multi-component community-based care approach for older people at risk of care dependency - results of a prospective quasi-experimental study.

BACKGROUND: Due to demographic changes, the elderly population in western countries is constantly growing. As the risk of functional decline and multimorbidity increases with age, health care systems need to face the challenge of high demand for health care services and related costs. Therefore, innovative health care approaches and geriatric screenings are needed to provide individualised care. This study aims to expand the state of research by investigating the effectiveness of a multi-component care approach for the elderly in a German community setting. METHODS: A prospective, quasi-experimental study was initiated by statutory health insurance (SHI) companies. The innovative care approach includes a geriatric assessment, a case and network management as well as digital supporting tools and was implemented at the Center for Geriatrics and Gerontology (Albertinen Haus, Hamburg-Eimsbuettel). Participants of the intervention were compared to matched controls recruited in comparable urban areas. The primary outcome measure was the progression in long-term care grade during the period of observation (21 months), which was analysed on the basis of SHI claims data. Secondary endpoints were morbidity, mortality and self-reported health-related quality of life (HRQoL) measured by SF-36. RESULTS: Overall, 2,670 patients (intervention group (IG) n=873; control group (CG) n=1,797) were analysed. Logistic regression analysis showed no statistically significant difference in progression of long-term care grade between IG and CG (Odds Ratio (OR)=1.054; 95% confidence interval (CI) 0.856-1.296; p-value=0.616). Differentiated analyses indicated an initial effect, which might be attributable to the geriatric assessment. However, an adapted regression model resulted in a reversed but even non-significant effect (OR=0.945; 95% CI 0.757-1.177; p-value=0.619). While secondary analyses of long-term care grade, mortality and HRQoL did not show intervention effects, a statistically significant relative change of 0.865 (95% CI 0.780, 0.960; p-value=0.006) in morbidity indicated a potential benefit for the IG. CONCLUSIONS: The analyses did not reveal a significant effect of the community-based intervention on the primary outcome and thus we are not able to recommend a transfer into SHI standard care. Tendencies in secondary analyses need to be proved in further research. TRIAL REGISTRATION: German Clinical Trials Register, retrospective registration on February 01, 2022 ( DRKS00027866 ).

[Digital Health Applications: A Qualitative Study of Approaches to Improve Access to Statutory Health Insurance]. / Lösungsansätze für den Zugang digitaler Gesundheitsanwendungen zur Gesetzlichen Krankenversicherung: eine qualitative Studie.

BACKGROUND: There is a lack of integration of appropriate digital health applications (DiGA) into the first healthcare market in Germany. In order to enable a valid and reliable use of previously examined digital health products, their implementation into services of the statutory health insurance (SHI) is necessary. The aim of this study was the development of strategies to modify and improve access of DiGA to SHI reimbursement. The recently introduced Digitale-Versorgung-Gesetz (DVG) is an initial step in this direction. METHODS: Using a qualitative approach, focus group interviews were conducted with key stakeholders of existing access paths. Previously elaborated problem-solving approaches were discussed. The approaches ranged between adapting existing structures and implementing an original digital pathway. Subsequently, a comparison of the project results and legislative provision of the DVG was carried out. RESULTS: The proposed approaches were discussed heterogeneously and varied depending on the position of the participants. The implementation of an Advisory Council had a greater consensus than the introduction of a digital-specific pathway. Also individual measures like administrative support for generating the necessary evidence was considered as positive and beneficial. However, a deviation from the current evidence standards should be avoided. Furthermore, the legitimacy and time expenditure for the digital-specific pathway was called into doubt. CONCLUSIONS: In principle, a better focus on existing structures on digital health applications can be endorsed. For a short-term use of DiGA potentials, adaptions of existing structures are preferable. The DVG legislation, although conforming to the project results only to some degree, can be considered as a first step. An amendment, in particular from the viewpoint of diagnostic or therapeutic DiGA, appears to be necessary.

["Alternative study designs" for the evaluation of digital health applications - a real alternative?] / "Alternative Studiendesigns" zur Bewertung digitaler Gesundheitsanwendungen ­ eine echte Alternative?

INTRODUCTION: After the Digital Healthcare Act (Digitale-Versorgung-Gesetz, DVG) reformed digital health applications' (Digitale Gesundheitsanwendungen, DiGAs) access to German Statutory Health Insurance (SHI) reimbursement, the discussion concerning necessary evidence requirements has intensified. In the past, different "alternative study designs" have been proposed to replace randomized controlled trials (RCTs) in the DiGA efficacy and benefit assessments. The present paper examines the suitability of these alternative designs for informing SHI reimbursement decisions. METHODS: The four alternative study designs primarily discussed in the context of DiGA - "Continuous Evaluation of Evolving Behavioral Intervention Technologies" (CEEBIT), "Multiphase Optimization Strategy" (MOST), "Sequential Multiple Assignment Randomized Trial" (SMART) and "Micro-Randomized Trial" (MRT) - are characterized and compared on the basis of relevant primary and secondary sources. Subsequently, their suitability for effectiveness and benefit evaluation in the context of SHI reimbursement decisions is discussed. RESULTS: None of the study designs examined aims primarily at conclusively demonstrating efficacy and benefit. Three of the four designs (MOST, SMART, MRT) focus on the development and optimization of interventions. In order to reduce resource requirements, the approaches presented sometimes deviate considerably from the methodological approach in traditional RCTs. This is especially true for their applied statistical error tolerance and their underlying randomization logic. Three of the four concepts (MOST, SMART, MRT) therefore still require RCTs after the development phase in order to demonstrate the effectiveness and benefit of the optimized intervention. DISCUSSION: The methodological differences of the alternative study designs compared to classical RCTs are accompanied by serious potentials for bias and uncertainties with regard to the identified intervention effects. These may be acceptable in the context of intervention development, but do not appear to be appropriate for use in collective SHI reimbursement decisions. CONCLUSION: The alternative study designs presented cannot be regarded as a suitable RCT alternative for efficacy and benefit assessments. A pragmatic study design, which continues to meet high methodological standards, and better utilization of real-world data could, in the future, contribute to a compromise between the justified claims to sufficient certainty of results on the one hand and appropriate procedural effort on the other.

Effectiveness and cost-effectiveness of an electronic mindfulness-based intervention (eMBI) on maternal mental health during pregnancy: the mindmom study protocol for a randomized controlled clinical trial.

BACKGROUND: Mental disorders are common during the peripartum period and may have far-reaching consequences for both mother and child. Unfortunately, most antenatal care systems do not provide any structured screening for maternal mental health. As a consequence, mental illnesses are often overlooked and not treated adequately. If correctly diagnosed, cognitive behavioral therapy is currently the treatment of choice for mental illnesses. In addition, mindfulness-based interventions (MBIs) seem to represent a promising treatment option for anxiety and depression during the peripartum period. Considering the internet's increasing omnipresence, MBIs can also be offered electronically via a (tablet) computer or smartphone (electronically based MBI = eMBI). OBJECTIVE: The current study aims to examine the clinical effectiveness and cost-effectiveness of an eMBI (the mindmom application) developed by an interdisciplinary team of gynecologists, psychologists, and midwives, teaching pregnant women how to deal with stress, pregnancy-related anxiety, and depressive symptoms. The study sample consists of pregnant women in their third trimester who screened positive for emotional distress. The mindmom study is a bicentric prospective randomized controlled trial (RCT), which is currently conducted at the University women's hospitals of Heidelberg and Tübingen, Germany. METHODS: Within the scope of the routine prenatal care, pregnant women attending routine pregnancy care in Baden-Wuerttemberg, Germany, are invited to participate in a screening for mental distress based on the Edinburgh Postnatal Depression Scale (EPDS). Women with an EPDS screening result > 9 will be referred to one of the mindmom coordinating study centers and are offered counseling either face-to-face or via videotelephony. After an initial psychological counseling, women are invited to participate in an eMBI in their last pregnancy trimester. The study will enroll N = 280 study participants (N = 140 per group), who are randomized 1:1 into the intervention (IG) or control group (treatment as usual = TAU). All participants are requested to complete a total of 7 digital assessments (5 visits pre- and 2 follow-up visits postpartum), involving self-report questionnaires, sociodemographic and medical data, physiological measures, and morning cortisol profiles. The primary outcome will be depressive and anxiety symptoms, measured by the Edinburgh Postnatal Depression Scale, the State Trait Anxiety Questionnaire, and the Pregnancy-Related Anxiety Questionnaire. Secondary outcomes include mindfulness, satisfaction with birth, quality of life, fetal attachment, bonding, mode of delivery, and cost-effectiveness. DISCUSSION: This is the first German RCT to examine the (cost-)effectiveness of an eMBI on maternal mental health during pregnancy. If successful, the mindmom app represents a low-threshold and cost-effective help for psychologically distressed women during pregnancy, thereby reducing the negative impact on perinatal health outcome. TRIAL REGISTRATION: Deutsches Register Klinischer Studien, German Clinical Trials Register DRKS00017210 . Registered on 13 January 2020. Retrospectively registered.

Considering the societal perspective in economic evaluations: a systematic review in the case of depression.

BACKGROUND: Depressive disorders are associated with a high burden of disease. However, due to the burden posed by the disease on not only the sufferers, but also on their relatives, there is an ongoing debate about which costs to include and, hence, which perspective should be applied. Therefore, the aim of this paper was to examine whether the change between healthcare payer and societal perspective leads to different conclusions of cost-utility analyses in the case of depression. METHODS: A systematic literature search was conducted to identify economic evaluations of interventions in depression, launched on Medline and the Cost-Effectiveness Registry of the Tufts University using a ten-year time horizon (2008-2018). In a two-stepped screening process, cost-utility studies were selected by means of specified inclusion and exclusion criteria. Subsequently, relevant findings was extracted and, if not fully stated, calculated by the authors of this work. RESULTS: Overall, 53 articles with 92 complete economic evaluations, reporting costs from healthcare payer/provider and societal perspective, were identified. More precisely, 22 estimations (24%) changed their results regarding the cost-effectiveness quadrant when the societal perspective was included. Furthermore, 5% of the ICURs resulted in cost-effectiveness regarding the chosen threshold (2% of them became dominant) when societal costs were included. However, another four estimations (4%) showed the opposite result: these interventions were no longer cost-effective after the inclusion of societal costs. CONCLUSIONS: Summarising the disparities in results and applied methods, the results show that societal costs might alter the conclusions in cost-utility analyses. Hence, the relevance of the perspectives chosen should be taken into account when carrying out an economic evaluation. This systematic review demonstrates that the results of economic evaluations can be affected by different methods available for estimating non-healthcare costs.