Medical App Treatment of Non-Specific Low Back Pain in the 12-month Cluster-Randomized Controlled Trial Rise-uP: Where Clinical Superiority Meets Cost Savings.

Purpose: Non-specific low back pain (NLBP) exerts a profound impact on global health and economics. In the era of Web 3.0, digital therapeutics offer the potential to improve NLBP management. The Rise-uP trial introduces a digitally anchored, general practitioner (GP)-focused back pain management approach with the Kaia back pain app as the key intervention. Here, we present the 12-months evaluation of the Rise-uP trial including clinical and economic outcomes, patient satisfaction and behavioral tracking analysis. Methods: The cluster-randomized controlled study (registration number: DRKS00015048) enrolled 1237 patients, with 930 receiving treatment according to the Rise-uP approach and 307 subjected to standard of care treatment. Assessments of pain, psychological state, functional capacity, and well-being (patient-reported outcome measures; PROMs) were collected at baseline, and at 3-, 6-, and 12-months follow-up intervals. Health insurance partners AOK, DAK, and BARMER provided individual healthcare cost data. An artificial intelligence (AI)-driven behavioral tracking analysis identified distinct app usage clusters that presented all with about the same clinical outcome. Patient satisfaction (patient-reported experience measures; PREMs) was captured at the end of the trial. Results: Intention-to-treat (ITT) analysis demonstrated that the Rise-uP group experienced significantly greater pain reduction at 12 months compared to the control group (IG: -46% vs CG: -24%; p < 0.001) with only the Rise-uP group achieving a pain reduction that was clinically meaningful. Improvements in all other PROMs were notably superior in patients of the Rise-uP group. The AI analysis of app usage discerned four usage clusters. Short- to long-term usage, all produced about the same level of pain reduction. Cost-effectiveness analysis indicated a substantial economic benefit for Rise-uP. Conclusion: The Rise-uP approach with a medical multimodal back pain app as the central element of digital treatment demonstrates both, clinical and economic superiority compared to standard of care in the management of NLBP.

Design and implementation of ParkinsonAKTIV: an interventional study to evaluate the effectiveness of a novel online platform to guide quickcard-based treatment decisions.

INTRODUCTION: Patients with Parkinson's Disease (PD) require an all-encompassing and individualized care including pharmacological as well as non-pharmacological treatment approaches, such as physical therapy, occupational therapy and speech and swallowing therapy. ParkinsonAKTIV is an innovative, multidisciplinary, and comprehensive approach to guide this non-pharmacological PD treatment in northwestern Germany. Its online communication platform called JamesAKTIV has been developed to enhance and standardize PD healthcare professionals' communication. The implementation of ParkinsonAKTIV and JamesAKTIV is accompanied through a detailed process evaluation and to gather evidence on the impact on patient-related outcomes, such as health-related quality of life and healthcare costs for people with PD through an effectiveness evaluation. METHODS: The study design contains two parts: (1) first, a quantitative effectiveness evaluation is conducted utilizing a prospective quasi-experimental approach with a control group which examines PD patient's health-related quality of life and physician-assessed PD patient's health status (Unified Parkinson Disease Rating Scale). Moreover, a health economic evaluation of the ParkinsonAKTIV intervention is conducted using patient-reported outcomes and cost data as well as routine data from a statutory health insurance. (2) Second, a mixed-methods process evaluation among healthcare professionals, which examines the feasibility and potential barriers and facilitators of ParkinsonAKTIV for routine care, is performed. Quantitative results from a social network analysis and a survey among healthcare professionals will be triangulated with data from qualitative stakeholder interviews and focus group discussions. PERSPECTIVE: Findings are expected to provide evidence of an increase in quality of life of patients with PD, less severe PD symptoms, and a better ability to participate in activities of daily living. ParkinsonAKTIV has the potential of increasing PD patients' quality of care through sufficient and more tailored prescription of non-pharmacological therapies. It is anticipated that ParkinsonAKTIV will improve communication among health professionals. Results from the ParkinsonAKTIV study will provide first practice-oriented evidence and a roadmap for implementation of an online tool for a comprehensive, multidisciplinary care PD network for patients and their caregivers in routine care in Germany. Trial registration ClinicalTrials.gov: registration number NCT05251298 (retrospectively registered: https://clinicaltrials.gov/ct2/show/record/NCT05251298 ).

[10 Years Accountable Care Organizations in the USA: Impulses for Health Care Reform in Germany?] / 10 Jahre Accounable Care Organizations in den USA: Impulse für Reformen in Deutschland?

GOAL OF THE STUDY: An intent of the Patient Protection and Affordable Care Acts (ACA), also know as Obama Care, was to slow the expenditure growth in the public Medicare-System by shifting the accountability for health care outcomes and costs to the provider. For this purpose, provider were allowed to form networks, which would then take accountability for a defined population - Accountable Care Organizations (ACOs). Ten years after the introduction of ACOs, this paper looks at the impact of ACOs both on quality of care and costs of care to assess if ACOs can be a model of care delivery for Germany. METHODS: In a mixed-method approach, a rapid review was conducted in Health System Evidence and PubMed. This was supported with further papers identified using the snowballing-technique. After screening the abstracts, we included articles containing information on cost- and/or quality impact of US-Medicare-ACOs. The findings of the rapid review were challenged with 16 ACO-experts and stakeholder in the USA. RESULTS: In total, we included 60 publications which incorporated 6 reports that were either conducted directly by governmental institutions or ordered by them, along with 3 previous reviews. Among these, 31 contained information on costs of care, 18 contained information on quality of care and 11 had information on both aspects. The publications show that ACOs reduced costs of of care. Cost reductions were achieved compared to historic costs, to populations not cared for in ACOs, and counterfactuals. Quality of care stayed the same or improved. CONCLUSION: ACOs contributed to slowing the cost growth in US Medicare without compromising quality of care. Thus, a transferal of this model of care to Germany should be considered. However, various policies have led to ACOs failing to unleash their full potential. Against this background, and against the background of stark differences between US Medicare and the German health care system, a critical reflection of the necessary policies underlying ACOs-like structures in Germany, needs to be undertaken.

[Primary Healthcare Provision and Introduction of New Models of Care in Hard to Serve Regions: A Population Survey]. / Hausärztliche Versorgungssituation und Einführung neuer Versorgungsformen in schwer zu versorgenden Regionen: Eine Befragung der Bevölkerung.

OBJECTIVE OF THE STUDY: One of the central challenges in health policy is to ensure nationwide provision of primary healthcare services. However, it is not clear how the general public rates the current primary healthcare provision in their region. Furthermore, there is very little information on whether people are willing to make use of new models of care that could contribute to ensuring a nationwide provision of healthcare services. Thus, the objective of this study was to analyse the general public's ratings of the local primary healthcare provision as well as their acceptance of selected new models of care. Furthermore, potential differences in the ratings of the population between hard to serve regions and normal regions will be analysed. METHODOLOGY: Focus group discussions and a literature review were conducted in order to develop a questionnaire to elicit the expectations of the population concerning the local provision of primary healthcare as well as their acceptance of new models of care. A postal questionnaire was sent to a random sample of 2,000 persons in 8 regions in Lower Saxony. RESULTS: The adjusted response rate of the postal survey was 51% (n=996). 97% of respondents saw a general practitioner regularly, with 5.4 visits per year on average. Patients could reach the practice in 13 min on average. Respondents predominantly rated the current healthcare provision as being good. However, the majority of respondents expected the local primary healthcare provision to deteriorate in the future. New models of care most preferred by the respondents were the delegation of medical tasks to non-medical professionals and mobility-oriented models. On the other hand, the provision of healthcare via telemedicine was rejected. DISCUSSION: According to the results of this study, respondents believe that new models of care can play an important role in ensuring the nationwide provision of healthcare services. Introducing, at an early stage, those new models of care that people accept could contribute to ensuring a sustainable provision of primary healthcare services. Furthermore, the introduction of these new models of care could reduce the public's concerns regarding a worsening provision of primary healthcare services in their regions. Additionally, pilot projects with those new models of care that are rather rejected might increase acceptance with these models of care if they prove to be successful.

Potential savings in the treatment pathway of liver transplantation: an inter-sectorial analysis of cost-rising factors.

INTRODUCTION: Identification of cost-driving factors in patients undergoing liver transplantation is essential to target reallocation of resources and potential savings. AIM: The aim of this study is to identify main cost-driving factors in liver transplantation from the perspective of the Statutory Health Insurance. METHODS: Variables were analyzed with multivariable logistic regression to determine their influence on high cost cases (fourth quartile) in the outpatient, inpatient and rehabilitative healthcare sectors as well as for medications. RESULTS: Significant cost-driving factors for the inpatient sector of care were a high labMELD-score (OR 1.042), subsequent re-transplantations (OR 7.159) and patient mortality (OR 3.555). Expenditures for rehabilitative care were significantly higher in patients with a lower adjusted Charlson comorbidity index (OR 0.601). The indication of viral cirrhosis and hepatocellular carcinoma resulted in significantly higher costs for medications (OR 21.618 and 7.429). For all sectors of care and medications each waiting day had a significant impact on high treatment costs (OR 1.001). Overall, cost-driving factors resulted in higher median treatment costs of 211,435 €. CONCLUSIONS: Treatment costs in liver transplantation were significantly influenced by identified factors. Long pre-transplant waiting times that increase overall treatment costs need to be alleviated by a substantial increase in donor organs to enable transplantation with lower labMELD-scores. Disease management programs, the implementation of a case management for vulnerable patients, medication plans and patient tracking in a transplant registry may enable cost savings, e.g., by the avoidance of otherwise necessary re-transplants or incorrect medication.

Decision modelling for economic evaluation of liver transplantation.

As the gap between a shortage of organs and the immense demand for liver grafts persists, every available donor liver needs to be optimized for utility, urgency and equity. To overcome this challenge, decision modelling might allow us to gather evidence from previous studies as well as compare the costs and consequences of alternative options. For public health policy and clinical intervention assessment, it is a potentially powerful tool. The most commonly used types of decision analytical models include decision trees, the Markov model, microsimulation, discrete event simulation and the system dynamic model. Analytic models could support decision makers in the field of liver transplantation when facing specific problems by synthesizing evidence, comprising all relevant options, generalizing results to other contexts, extending the time horizon and exploring the uncertainty. For modeling studies of economic evaluation for transplantation, understanding the current nature of the disease is crucial, as well as the selection of appropriate modelling techniques. The quality and availability of data is another key element for the selection and development of decision analytical models. In addition, good practice guidelines should be complied, which is important for standardization and comparability between economic outputs.

"Market withdrawals" of medicines in Germany after AMNOG: a comparison of HTA ratings and clinical guideline recommendations.

BACKGROUND: According to the AMNOG act, the German Federal Joint Committee (G-BA) determines the additional benefit of new medicines as a basis for subsequent price negotiations. Pharmaceutical companies may withdraw their medications from the market at any time during the process. This analysis aims to compare recommendations in clinical guidelines and HTA appraisals of medicines that were withdrawn from the German market since the introduction of AMNOG in 2011. METHODS: Medications withdrawn from the German market between January 2011 and June 2016 following benefit assessment were categorized as opt-outs (max. 2 weeks after start of price negotiations) or supply terminations (during or after further price negotiations). Related guidelines were systematically analyzed. For all withdrawals, therapeutic area, additional benefit rating and recommendation status in relevant clinical guidelines were assessed. RESULTS: Among 139 medications, 10 opt-outs and 12 supply terminations were identified. Twenty-one out of 22 withdrawn medicines (95%) received 'no additional benefit' appraisal by the G-BA (average 'no additional benefit' rating for all AMNOG products: 47%). Of the 22 medicines, 15 (68%) were recommended by at least one guideline at the time of benefit assessment and 18 (82%) on 1 June 2016. Heterogeneity among guidelines was high. Acceptance of clinical trial endpoints was different between G-BA appraisals and clinical guidelines. CONCLUSION: Our analysis revealed considerable differences across clinical guidelines as well as between clinical guidelines and HTA appraisals of the medicines that were withdrawn from the German market. Better alignment of the clinical perspective and close collaboration between all involved parties is required to achieve and maintain optimization of patient care.

Evaluation of published assessment tools for comorbidity in liver transplantation: a systematic review protocol.

INTRODUCTION: Liver transplantation is considered the best therapy option for end-stage liver disease. Different factors including recipient comorbidity at time of transplantation are supposed to have substantial impact on outcomes. Although several studies have focused on comorbidity assessment indices for liver transplant recipients, there is no systematic review available on the methodological details and prognostic accuracy of these instruments. The aim of this study is to systematically review recipient comorbidity assessment indices in the context of liver transplantation. METHODS AND ANALYSIS: PubMed, Embase, Web of Science and PsyINFO databases will be searched. Studies describing, using or evaluating specific assessment tools to predict the effect of comorbidity on clinical outcomes after liver transplantation will be included. The selection will be conducted independently by two reviewers. The study characteristics and methodological information on published comorbidity assessment tools will be extracted into a predefined structural table. This approach will be deployed to systematically extract information on the validity, reliability and practical feasibility of investigated comorbidity assessment tools for comparative evaluation. Narrative information synthesis will be conducted, and additional meta-analytical comparison will be performed, if appropriate. ETHICS AND DISSEMINATION: All data are collected from published literature. Thus, formal ethics review for the research is not required. The findings of this systematic review will be published in a peer-reviewed journal and presented at relevant conferences. The results of this systematic review will be highly relevant for further research on prognostic models, clinical decision making and optimisation of donor organ allocation. PROSPERO REGISTRATION NUMBER: CRD42017074609.

Effect of Crossover in Oncology Clinical Trials on Evidence Levels in Early Benefit Assessment in Germany.

BACKGROUND: In oncology clinical trials, crossover is used frequently but may lead to uncertainties regarding treatment effects. OBJECTIVE: To investigate the handling of evidence from crossover trials by the European Medicines Agency (EMA) and the German Federal Joint Committee (G-BA). METHODS: For oncology medicines with early benefit assessments before January 2015, presence of crossover, clinical data, EMA requests for additional data, and G-BA benefit ratings/evidence levels were analyzed from manufacturers' dossiers, G-BA appraisals, European Public Assessment Reports, and original publications. RESULTS: Eleven of 21 benefit assessments included crossover trials. Significant intergroup differences (P < 0.05) in overall survival (OS) were noted in 7 of 11 trials with and 7 of 10 without crossover. For 6 of 11 medicines with crossover, these were demonstrated before crossover. Treatment effects generally worsened with increasing proportions of crossover. The EMA requested additional data more frequently if crossover was performed, particularly if no OS data were available before crossover. The G-BA granted a considerable benefit to 73% of medicines with crossover and 40% of those without. Evidence levels were intermediate for 50% and 75%, respectively. None of the medicines received the highest evidence level. CONCLUSIONS: In G-BA appraisals, oncology medicines with crossover received better additional benefit ratings, but were assigned lower evidence levels, than those without. The five medicines with crossover after progression were assigned lower evidence levels than the six medicines with crossover after demonstration of superior OS, indicating that the way in which crossover is implemented may be one factor influencing the assignment of evidence levels by the G-BA.

Contract Design: Financial Options and Risk.

INTRODUCTION: Integrated care systems as well as accountable care organisations (ACOs) in the US and similar concepts in other countries are advocated as an effective method of improving the performance of healthcare systems. These systems outline a payment and care delivery model that intends to tie provider reimbursements to predefined quality metrics. By this the total costs of care shall be reduced. When designing healthcare options contractors are faced with a variety of financial options. The costs of market utilisation are highly relevant for the conception of healthcare contracts; furthermore contract-specific investments are an obstacle to the efficient operation of ACOs. METHODS: A comprehensive literature review on methods of designing contracts in Integrated Care was conducted. This article is the second in a row of three that are all published in this issue and contribute to a specific issue in designing healthcare contracts. The first dealt with the organisation of contracts and information asymmetries, while part 3 concludes with the question of risk management and evaluation. The specific research question of this second article focusses on the financial options and reimbursement schemes that are available to define healthcare contracts. RESULTS: A healthcare contract is a relational contract, which determines the level of reimbursement, the scope of services and the quality between service providers and payers, taking account of the risks relating to population and performance. A relational contract is an agreement based upon assumption of a longer timeframe. A major obstacle to the practical implementation of healthcare contracts is the prognosis of the inflows and outflows due to the actuarial risks of the insured population. Financing conditions and reimbursement arrangements that are based on a prospectively determined fixed price, have a significant drawback: it is very difficult to take the differences in health status and the utilisation of distinct insured clientele (panel) into account. DISCUSSION AND CONCLUSION: The first two articles of this series on contract design have shown that complete contracts in healthcare are unrealistic. Healthcare reimbursement contracts are incomplete contracts with a high degree of uncertainty. In incomplete contracts specific contractual regulations are not made for any eventuality. For this reason it is important that the parties agree on the prevention of endogenous risks (asymmetric information after the conclusion of the contract) and on the procedure in the case of unforeseen circumstances (the risks of random, parameter risk and change risks to the healthcare program).

[Assessing the benefits of digital health solutions in the societal reimbursement context]. / Nutzenbewertung von digitalen Gesundheitsprodukten (Digital Health) im gesellschaftlichen Erstattungskontext.

For a number of reasons, achieving reimbursability for digital health products has so far proven difficult. Demonstrating the benefits of the technology is the main hurdle in this context. The generally accepted evaluation processes, especially parallel group comparisons in randomized controlled trials (RCTs) for (clinical) benefit assessment, are primarily intended to deal with questions of (added) medical benefit. In contrast to drugs or classical medical devices, users of digital health solutions often profit from gaining autonomy, increased awareness and mindfulness, better transparency in the provision of care, and improved comfort, although there are also digital solutions with an interventional character targeting clinical outcomes (e. g. for indications such as anorexia, depression). Commonly accepted methods for evaluating (clinical) benefits primarily rely on medical outcomes, such as morbidity and mortality, but do not adequately consider additional benefits unique to digital health. The challenge is therefore to develop evaluation designs that respect the particularities of digital health without reducing the validity of the evaluations (especially with respect to safety). There is an increasing need for concepts that include both continuous feedback loops for adapting and improving an application while at the same time generate sufficient evidence for complex benefit assessments. This approach may help improve risk benefit ratio assessments of digital health when it comes to implementing digital innovations in healthcare.

Which strategies might improve local primary healthcare in Germany? An explorative study from a local government point of view.

BACKGROUND: Facing rising inequities and poorer accessibility of physicians in rural areas, new healthcare delivery structures are being considered to support local healthcare in German communities. To better understand perspectives on and attitudes towards different supplementary models, we examined attitudes among local politicians in the German federal state of Lower Saxony towards the suitability of supplementary care models. METHODS: As part of a cross-sectional study, we surveyed local politicians in Lower Saxony at the local authority and district levels (n = 449) by mail questionnaire. We asked for an assessment of four potential supplementary healthcare models at the local level: the use of trained medical assistants, patients' buses, mobile physicians' offices, and telemedicine. RESULTS: The response rate was 71.0% for mayors (n = 292) and 81.6% (n = 31) for county administrators. In summary, 72.4% of respondents supported the use of trained medical assistants, 48.9% voted for patients' buses, 22.0% for mobile physicians' offices, and 13.9% for telemedicine. Except for telemedicine, the politicians' approval of the supplementary models in rural areas was higher than in urban areas. The assessment regarding the suitability of each model was not significantly connected with indicators of a positively or negatively assessed local healthcare situation. The analyses showed that the use of trained medical assistants was associated with the positive effects of division of labor and potential to relieve physicians. In contrast, there was skepticism about technical support via telemedicine, mostly due to concerns about its unsuitability for elderly people and the potential lower quality of healthcare delivery. CONCLUSION: Local politicians widely accept the use of trained medical assistants, whereas the applicability of technical solutions such as telemedicine is perceived with skepticism. Therefore, the knowledge gap between evidence for and prejudices against telemedicine needs to be addressed more effectively. Reasons for the assessments of the presented models are more likely traceable to personal views than to assessments of the actual estimated local primary care situation.

High resource utilization in liver transplantation-how strongly differ costs between the care sectors and what are the main cost drivers?: a retrospective study.

To control treatment pathways of transplant patients across healthcare sectors, a profound knowledge of the underlying cost structure is necessary. The aim of this study was to analyze the resource utilization of patients undergoing liver transplantation. Data on resource utilization for 182 liver-transplanted patients was investigated retrospectively. The observational period started with the entry on the waiting list and ended up to 3 years after transplantation. Median treatment cost was 144 424€. During waiting time, median costs amounted to 9466€; 72% of costs were attributed to inpatient care, 3% to outpatient care, and 26% to pharmaceuticals. During the first year after transplantation, median costs of 105 566€ were calculated; 83% were allocated for inpatient and 1% outpatient care, 14% for drugs, and 1% for rehabilitative care. During follow-up after the first year of transplantation, median costs amounted to 20 115€; 75% of these were caused by pharmaceuticals, 21% by inpatient, 4% by outpatient, and <1% by rehabilitative services. Subgroup analyses (e.g., for labMELD scores) were done. Costs incurred by inpatient care and pharmaceuticals are the dominating cost factors. These findings encourage a debate on challenges and improvements for cost-efficient clinical management between different healthcare sectors.

Inconsistent approaches of the G-BA regarding acceptance of primary study endpoints as being relevant to patients - an analysis of three disease areas: oncological, metabolic, and infectious diseases.

BACKGROUND: Previous evaluations of oncological medicines in the German early benefit assessment (EBA) procedure have demonstrated inconsistent acceptance of endpoints by regulatory authorities and the Federal Joint Committee (G-BA). Accepted standard endpoints for regulatory purposes are frequently not considered as patient-relevant in the German EBA system. In this study the acceptance of clinically acknowledged primary endpoints (PEPs) from regulatory trials in EBAs conducted by the G-BA was evaluated across three therapeutic areas. METHODS: Medicines for oncological, metabolic and infectious diseases with EBAs finalised before 25 January 2016 were evaluated. Respective manufacturer's dossiers, regulatory assessments, G-BA appraisals and oral hearing minutes were reviewed, and PEPs were examined to determine whether they were considered relevant to patients by the G-BA. Furthermore, the acceptance of symptomatic vs asymptomatic PEPs was also analysed. RESULTS: A total of 65 EBAs were evaluated. Mortality PEPs were widely accepted as patient-relevant but were only used in a minority of EBAs and exclusively in oncological diseases. Morbidity PEPs constituted around 72 % of assessed PEPs, but were excluded from the EBA in over half of the corresponding assessments as they were not considered patient-relevant. Symptomatic endpoints were largely deemed patient-relevant, whereas acceptance of asymptomatic endpoints varied between therapeutic areas. CONCLUSIONS: This evaluation identified inconsistencies in patient relevance of morbidity-related PEPs as well as in acceptance of asymptomatic endpoints by the G-BA in all three disease areas examined. Better harmonisation between the regulatory authorities and the G-BA is still required after 5 years of AMNOG health technology assessment in Germany.

Would German physicians opt for pay-for-performance programs? A willingness-to-accept experiment in a large general practitioners' sample.

BACKGROUND: Implementing pay-for-performance (P4P) programs is a non-trivial task. As evaluation studies showed, P4P programs often failed to improve performance quality. A crucial element for the successful implementation of P4P is to gain acceptance with health care providers. OBJECTIVES: The aim of our study was to determine, if (and at what bonus rate) German general practitioners (GPs) would participate in a P4P program. We further examined differences between respondents who would participate in a P4P program (participants) versus respondents who would not participate (non-participants). METHODS: A mail survey was conducted among 2493 general practitioners (GPs) in Lower Saxony (with a response rate of 36.2%). The questionnaire addressed attitudes toward P4P and included a willingness to accept experiment concerning P4P implementation. RESULTS: The participation rate increased from 28% (at a bonus of 2.5%) to 50% (at a bonus of 20%). Participants showed better performance in target achievement and expected higher gains from P4P than non-participants. Major attitude differences were found in assessing feasibility of P4P, incentivizing performance and unintended consequences. The crucial factor for (not) accepting P4P might be the sense of (un)fairness of P4P. CONCLUSION: To convince GPs to participate in P4P, better evidence for the effectiveness of P4P is required. To address the concerns of GPs, future endeavors should be directed to tailoring P4P programs. Finally, program implementation must be well communicated and thoroughly discussed with health care providers.

Analysing predictors for future high-cost patients using German SHI data to identify starting points for prevention.

BACKGROUND: Demographic change influences not only the terms of health care, but also its financing. Hence, prevention is becoming a more important key to facing upcoming challenges. Aim of this study was to identify predictors for future high-cost patients and derive implications for potential starting points for prevention. METHODS: Claims data from a German statutory health insurance agency were used. High-cost patients were defined as the 10% most expensive persons to insure in 2011. The predictors stemmed from the previous year. Logistic regression with stepwise forward selection for 10 sex- and age-specific subgroups was performed. Model fit was assessed by Nagelkerke's R-squared value. RESULTS: Model fit values indicated well-suited models that yielded better results among younger age-groups. Identified predictors can be summarized as different sets of variables that mostly pertain to diseases. Some are rather broad and include different disorders, like the set of mental/behavioural disorders including depression and schizophrenia; other sets of variables are more homogenous, such as metabolic diseases, with diabetes mellitus (DM) being the dominant member of every subgroup. CONCLUSION: Because diabetes was a significant predictor for future high-cost patients in all analysed subgroups, it should be considered as a potential starting point for prevention. The disease is specific enough to allow for the implementation of effective prevention strategies, and it is possible to intervene, even in patients already affected by DM. Furthermore, the monetary savings potential is probably high because the long-term complications of DM are expensive to treat and affect a large part of the population.

[The influence of framework conditions for integrated care programs on their potential of evaluation]. / Wie beeinflussen die Rahmenbedingungen integrierter Versorgungsprogramme die Möglichkeiten der Evaluation?

AIM AND METHODS: A common justification of the failure to perform scientific evaluations of integrated care programs (in accordance with Sect. 140 SGB V) is the high level of expenditure which is strongly influenced by the conditions of the particular program. Two practical examples will be used to outline frameworks of integrated care programs that may create obstacles to evaluation. If possible, appropriate solutions that may help to avoid or at least reduce these obstacles will be presented. RESULTS: In many programs target groups and program objectives are inaccurately defined. Especially disease-specific programs bear the risk of having too small a sample size to exclude random effects. Only a few integrated care programs include evaluations that have been proactively planned from the outdet. CONCLUSION: In particular, early planning of evaluations plays an important role in avoiding distortions of results and additional expenses. It may also have a positive influence on all other frameworks.