Associations of preoperative anemia and postoperative hemoglobin values with hospital costs in total knee arthroplasty (TKA).

BACKGROUND: Total knee arthroplasty are among the most frequently conducted surgeries, due to an aging society. Since hospital costs are subsequently rising, adequate preparation of patients and reimbursement becomes more and more important. Recent literature revealed anemia as a risk factor for enhanced length of stay (LOS) and complications. This study analyzed whether preoperative hemoglobin (Hb) and postoperative Hb were associated with total hospital costs and general ward costs. METHODS: The study comprised 367 patients from a single high-volume hospital in Germany. Hospital costs were calculated with standardized cost accounting methods. Generalized linear models were applied to account for confounders, such as age, comorbidities, body mass index, insurance status, health-related quality of life, implant types, incision-suture-time and tranexamic acid. RESULTS: Preoperative anemic women had 426 Euros higher general ward costs (p < 0.01), due to increased LOS. For men, 1 g/dl less Hb loss between the preoperative value and the value before discharge reduced total costs by 292 Euros (p < 0.001) and 161 Euros fewer general ward costs (p < 0.001). Total hospital costs were reduced by 144 Euros with 1 g/dl higher Hb on day 2 postoperatively for women (p < 0.01). CONCLUSION: Preoperative anemia was associated with increased general ward costs for women and Hb loss with decreasing total hospital costs for men and women. Cost containment, especially reduced utilization of the general ward, may be feasible with the correction of anemia for women. Postoperative Hb values may be a factor for adjustments of reimbursement systems. LEVEL OF EVIDENCE: Retrospective cohort study, III.

The impact of the COVID-19 pandemic on processes, resource use and cost in palliative care.

BACKGROUND: The COVID-19 pandemic impacts on working routines and workload of palliative care (PC) teams but information is lacking how resource use and associated hospital costs for PC changed at patient-level during the pandemic. We aim to describe differences in patient characteristics, care processes and resource use in specialist PC (PC unit and PC advisory team) in a university hospital before and during the first pandemic year. METHODS: Retrospective, cross-sectional study using routine data of all patients cared for in a PC unit and a PC advisory team during 10-12/2019 and 10-12/2020. Data included patient characteristics (age, sex, cancer/non-cancer, symptom/problem burden using Integrated Palliative Care Outcome Scale (IPOS)), information on care episode, and labour time calculated in care minutes. Cost calculation with combined top-down bottom-up approach with hospital's cost data from 2019. Descriptive statistics and comparisons between groups using parametric and non-parametric tests. RESULTS: Inclusion of 55/76 patient episodes in 2019/2020 from the PC unit and 135/120 episodes from the PC advisory team, respectively. IPOS scores were lower in 2020 (PCU: 2.0 points; PC advisory team: 3.0 points). The number of completed assessments differed considerably between years (PCU: episode beginning 30.9%/54.0% in 2019/2020; PC advisory team: 47.4%/40.0%). Care episodes were by one day shorter in 2020 in the PC advisory team. Only slight non-significant differences were observed regarding total minutes/day and patient (PCU: 150.0/141.1 min., PC advisory team: 54.2/66.9 min.). Staff minutes showed a significant decrease in minutes spent in direct contact with relatives (PCU: 13.9/7.3 min/day in 2019/2020, PC advisory team: 5.0/3.5 min/day). Costs per patient/day decreased significantly in 2020 compared to 2019 on the PCU (1075 Euro/944 Euro for 2019/2020) and increased significantly for the PC advisory team (161 Euro/200 Euro for 2019/2020). Overhead costs accounted for more than two thirds of total costs. Direct patient cost differed only slightly (PCU: 134.7 Euro/131.1 Euro in 2019/2020, PC advisory team: 54.4 Euro/57.3 Euro). CONCLUSIONS: The pandemic partially impacted on daily work routines, especially on time spent with relatives and palliative care problem assessments. Care processes and quality of care might vary and have different outcomes during a crisis such as the COVID-19 pandemic. Direct costs per patient/day were comparable, regardless of the pandemic.

An accelerated access pathway for innovative high-risk medical devices under the new European Union Medical Devices and health technology assessment regulations? Analysis and recommendations.

INTRODUCTION: The new European Union (EU) Regulations for medical devices (MDs) and health technology assessment (HTA) are welcome developments that should increase the quality of clinical evidence for MDs and reduce fragmentation in the EU market access process. To fully exploit anticipated benefits, their respective assessment processes should be closely coordinated, particularly for promising, highly innovative MDs. Accelerated approval is worth exploring for certain categories of high-risk MDs to keep the EU regulatory process competitive compared to accelerated MD approval programs elsewhere (e.g. US). AREAS COVERED: Problems observed in worldwide accelerated drug and MD regulatory approval programs are reviewed, including greater uncertainty in premarket clinical evidence generation and lack of oversight for post approval evidence requirements. Implications for MD approval, HTA and coverage are explored. EXPERT OPINION: Through analysis of two decades of drug and MD accelerated approval programs worldwide, recommendations for an Accelerated Access Pathway for select innovative, high-risk MDs are proposed to fit the EU context, leverage the two new regulations, increase opportunities for Expert Panels to provide timely advice regarding manufacturers' evidence generation plans along the MD lifecycle (pre, postmarket), and safely speed patient access while promoting increased collaboration among Member States on coverage decisions.

Cost-Effectiveness of SAPIEN 3 Transcatheter Aortic Valve Implantation Versus Surgical Aortic Valve Replacement in German Severe Aortic Stenosis Patients at Low Surgical Mortality Risk.

INTRODUCTION: In the randomized PARTNER 3 trial, transcatheter aortic valve implantation (TAVI) with the SAPIEN 3 device significantly reduced a composite of all-cause death, stroke, and rehospitalization, compared with surgical aortic valve replacement (SAVR), in patients with severe symptomatic aortic stenosis and low risk of surgical mortality. Furthermore, TAVI has been shown to be cost-effective in low-risk patients, compared with SAVR, in a number of countries. This study aimed to determine the cost-effectiveness of TAVI with SAPIEN 3 versus SAVR in Germany. METHODS: A previously published two-stage Markov-based model that captured clinical outcomes from the PARTNER 3 trial was adapted for the German context using the German Statutory Health Insurance perspective. The model had a lifetime horizon. The cost-utility analysis estimated changes in direct healthcare costs as well as survival and health-related quality of life using TAVI with SAPIEN 3 compared with SAVR. RESULTS: TAVI with SAPIEN 3 increased quality-adjusted life years (QALYs) by + 0.72 at an increased cost of €8664 per patient. The incremental cost-effectiveness/QALY ratio was €12,037, which fell below that of other cardiovascular interventions in use in Germany. The cost-effectiveness of TAVI over SAVR remained robust across multiple challenging scenarios and was driven by lower longer-term management costs compared with SAVR. CONCLUSIONS: TAVI with SAPIEN 3 appears to be a clinically meaningful, cost-effective treatment option over SAVR for patients with severe symptomatic aortic stenosis and low risk for surgical mortality in Germany. CLINICAL TRIAL REGISTRATION NUMBER: www. CLINICALTRIALS: gov identifier: NCT02675114.

Healthcare resource utilization and costs of cardiovascular events in patients with atherosclerotic cardiovascular disease in Germany - results of a claims database study.

OBJECTIVES: We assessed healthcare resource utilization (HCRU) and costs of cardiovascular (CV) events in patients with a history of atherosclerotic cardiovascular disease (ASCVD) in Germany. METHODS: We conducted a retrospective matched case-control study based on German claims data from 1 January 2012 to 31 December 2017 using the "Institute for Applied Health Research Berlin" (InGef) Research Database. Cases who had a myocardial infarction (MI), stroke and angina pectoris identified by ICD-10-GM codes between 1 January 2014 and 31 December 2016 were matched to event-free controls by an exact matching approach without replacement at a ratio of 1:2. Costs and HCRU were assessed in individual 1-year follow-up periods after the index event for the overall cohort and subgroups of MI cases and stroke cases. RESULTS: The overall cohort consisted of a total of 14,169 cases with a CV index event matched to 28,338 controls. The mean age of the overall cohort was 73.3 years, 34.1% of the patients were female, 3,717 (26.2%) had an MI, and 3,752 (26.5%) had stroke. Following the index events, 12.2% of cases in the overall cohort, 12.6% of MI cases, and 8.7% of stroke cases experienced a recurrent CV event. CV cases had on average 1.7 more all-cause hospitalizations (p <0.001) and 6.1 more outpatient visits (p <0.001) during the 1-year follow-up period than did controls. In the MI and stroke subgroups, cases had on average 1.8 and 1.6 more all-cause hospitalizations and 7.0 and 4.0 more outpatient visits, respectively (differences were statistically significant). Compared to controls, cases incurred on average higher total healthcare costs: by €11,898 for overall cases, by €16,349 for MI, and by €14,360 in stroke cases (overall: p <0.001; MI: p <0.001; stroke: p <0.001). CONCLUSION: CV events in ASCVD patients pose a considerable clinical burden on patients and cause significant costs for the German statutory healthcare system.

Costs of Pharmacological and Non-Pharmacological Interventions in Interstitial Lung Disease Management in Germany.

INTRODUCTION: Interstitial lung diseases (ILDs) are associated with a high economic burden, yet prospective data of the German healthcare system are sparse. OBJECTIVE: We assessed average ILD-related costs of pharmacological and non-pharmacological (hospitalizations, outpatient, rehabilitation, physiotherapy, and medical aids) interventions in ILD. METHODS: We used data from the multicenter, observational, prospective Exploring Clinical and Epidemiological Characteristics of Interstitial Lung Diseases registry to evaluate adjusted per capita costs and cost drivers for ILD-related healthcare costs over 4 years, using generalized estimating equation regression models. RESULTS: Idiopathic pulmonary fibrosis (IPF) had the highest annual pharmacological costs >EUR 21,000, followed by connective tissue disease-associated ILD (CTD-ILD) averaging EUR 6,000. Other idiopathic interstitial pneumonias and hypersensitivity pneumonitis averaged below EUR 2,400 and sarcoidosis below EUR 400. There were no significant differences in pharmacological costs over time. Trends in non-pharmacological costs were statistically significant. At year 1, CTD-ILD had the highest costs (EUR 7,700), while sarcoidosis had the lowest (EUR 2,547). By year 4, these declined to EUR 3,218 and EUR 232, respectively. Regarding cost drivers, the ILD subtype had the greatest impact with 75 times higher pharmacological costs in IPF and 4 times higher non-pharmacological costs in CTD-ILD, compared to the reference. Pulmonary hypertension (PH) and gastroesophageal reflux disease (GERD) triggered higher pharmacological costs, and higher values of forced vital capacity % predicted were associated with lower pharmacological and non-pharmacological costs. CONCLUSION: Stabilizing lung function and reducing the impact of PH and GERD are crucial in reducing the economic burden of ILD. There is an urgent need for effective treatment options, especially in CTD-ILD.

Preoperative patients' health decrease moderately, while hospital costs increase for hip and knee replacement due to the first COVID-19 lockdown in Germany.

PURPOSE: The purpose of this study was a comparison between osteoarthritis patients with primary hip and knee replacements before, during and after the first COVID-19 lockdown in Germany. Patients' preoperative health status is assumed to decrease, owing to delayed surgeries. Costs for patients with osteoarthritis were assumed to increase, for example, due to higher prices for protective equipment. Hence, a comparison of patients treated before, during and after the first lockdown is conducted. METHODS: In total, 852 patients with primary hip or knee replacement were included from one hospital in Germany. Preoperative health status was measured with the WOMAC Score and the EQ-5D-5L. Hospital unit costs were calculated using a standardised cost calculation. Kruskal-Wallis tests and Chi-squared tests were applied for the statistical analyses. RESULTS: The mean of the preoperative WOMAC Score was slightly higher (p < 0.01) for patients before the first lockdown, compared with patients afterwards. Means of the EQ-5D-5L were not significantly different regarding the lockdown status (NS). Length of stay was significantly reduced by approximately 1 day (p < 0.001). Total inpatient hospital unit costs per patient and per day were significantly higher for patients during and after the first lockdown (p < 0.001). CONCLUSION: Preoperative health, measured with the WOMAC Score, worsened slightly for patients after the first lockdown compared with patients undergoing surgery before COVID-19. Preoperative health, measured using the EQ-5D-5L, was unaffected. Inpatient hospital unit costs increased significantly with the COVID-19 pandemic. LEVEL OF EVIDENCE: Retrospective cohort study, III.

Inequality and heterogeneity in health-related quality of life: findings based on a large sample of cross-sectional EQ-5D-5L data from the Swedish general population.

PURPOSE: This study aimed to investigate inequality and heterogeneity in health-related quality of life (HRQoL) and to provide EQ-5D-5L population reference data for Sweden. METHODS: Based on a large Swedish population-based survey, 25,867 respondents aged 30‒104 years, HRQoL is described by sex, age, education, income, economic activity, health-related behaviours, self-reported diseases and conditions. Results are presented by EQ-5D-5L dimensions, respondents rating of their overall health on the EQ visual analogue scale (EQ VAS), VAS index value and TTO (time trade-off) index value allowing for calculation of quality-adjusted life years (QALYs). Ordinary Least Squares and multivariable logistic regression analyses were used to study inequalities in observed EQ VAS score between socioeconomic groups and the likelihood to report problems on the dimensions, respectively, adjusted for confounders. RESULTS: In total, 896 different health states were reported; 24.1% did not report any problems. Most problems were reported with pain/discomfort. Women reported worse HRQoL than men, and health deteriorated with age. The strongest association between diseases and conditions and EQ VAS score was seen for depression and mental health problems. There was a socioeconomic gradient in HRQoL; adjusting for health-related behaviours, diseases and conditions slightly reduced the differences between educational groups and income groups, but socioeconomic inequalities largely remained. CONCLUSION: EQ-5D-5L population reference (norms) data are now available for Sweden, including socioeconomic differentials. Results may be used for comparisons with disease-specific populations and in health economic evaluations. The observed socioeconomic inequality in HRQoL should be of great importance for policy makers concerned with equity aspects.

Effect of BMI on health care expenditures stratified by COPD GOLD severity grades: Results from the LQ-DMP study.

Chronic Obstructive Pulmonary Disease (COPD) is characterized by persistent respiratory symptoms and airflow limitation, which is progressive and not fully reversible. In patients with COPD, body mass index (BMI) is an important parameter associated with health outcomes, e.g. mortality and health-related quality of life. However, so far no study evaluated the association of BMI and health care expenditures across different COPD severity grades. We used claims data and documentation data of a Disease Management Program (DMP) from a statutory health insurance fund (AOK Bayern). Patients were excluded if they had less than 4 observations in the 8 years observational period. Generalized additive mixed models with smooth functions were used to evaluate the association between BMI and health care expenditures, stratified by severity of COPD, indicated by GOLD grades 1-4. We included 30,682 patients with overall 188,725 observations. In GOLD grades 1-3 we found an u-shaped relation of BMI and expenditures, where patients with a BMI of 30 or slightly above had the lowest and underweight and obese patients had the highest health care expenditures. Contrarily, in GOLD grade 4 we found an almost linear decline of health care expenditures with increasing BMI. In terms of expenditures, the often reported obesity paradox in patients with COPD was clearly reflected in GOLD grade 4, while in all other severity grades underweight as well as severely obese patients caused the highest health care expenditures. Reduction of obesity may thus reduce health care expenditures in GOLD grades 1-3.

Lifecycle evidence requirements for high-risk implantable medical devices: a European perspective.

INTRODUCTION: The new European Union (EU) Regulations on medical devices and on in vitro diagnostics provide manufacturers and Notified Bodies with new tools to improve pre-market and post-market clinical evidence generation especially for high-risk products but fail to indicate what type of clinical evidence is appropriate at each stage of the whole lifecycle of medical devices. In this paper we address: i) the appropriate level and timing of clinical evidence throughout the lifecycle of high-risk implantable medical devices; and ii) how the clinical evidence generation ecosystem could be adapted to optimize patient access. AREAS COVERED: The European regulatory and health technology assessment (HTA) contexts are reviewed, in relation to the lifecycle of high-risk medical devices and clinical evidence generation recommended by international network or endorsed by regulatory and HTA agencies in different jurisdictions. EXPERT OPINION: Four stages are relevant for clinical evidence generation: i) pre-clinical, pre-market; ii) clinical, pre-market; iii) diffusion, post-market; and iv) obsolescence & replacement, post-market. Each stage has its own evaluation needs and specific studies are recommended to generate the appropriate evidence. Effective lifecycle planning requires anticipation of what evidence will be needed at each stage.

Predictive ability of the American Society of Anaesthesiologists physical status classification system on health-related quality of life of patients after total hip replacement: comparisons across eight EQ-5D-3L value sets.

BACKGROUND: American Society of Anaesthesiologists (ASA) physical status classification system and its association with postoperative outcomes has been studied in different diseases. However, there is a paucity of studies on the relationship between ASA class and postoperative health-related quality of life (HRQoL) outcomes following total hip replacement (THR). The aim of this study was to assess the discriminative abilities of EQ-5D-3L value sets from Sweden, Germany, Denmark and the United Kingdom in relation to ASA classes and these value sets' abilities to show the predictive performance of ASA classes on HRQoL among THR patients in Sweden. METHODS: A longitudinal study was conducted using data of patients in the Swedish Hip Arthroplasty Register who underwent THR between 2008 and 2016. We included 69,290 pre- and 1-year postoperative records and 21,305 6-year postoperative records. The study examined three experience-based EQ-5D-3L value sets (the Swedish VAS and TTO and the German VAS) and five hypothetical value sets (TTO from Germany and VAS and TTO value sets from Denmark and the UK each). Using linear models, the abilities of the value sets to discriminate among ASA classes and to show the predictive performance of ASA classes on HRQoL score were assessed. RESULTS: All value sets differentiated among ASA classes and showed the predictive effect of ASA classes on HRQoL. ASA classes were found to predict HRQoL consistently for all value sets investigated, with small variations in prediction error among the models. CONCLUSION: ASA classes of patients undergoing THR predicted HRQoL scores significantly and consistently, indicating their importance in tailoring care for patients.

Experience-Based Swedish TTO and VAS Value Sets for EQ-5D-5L Health States.

BACKGROUND AND OBJECTIVE: Although value sets for the five-level version of the generic health-related quality-of-life instrument EQ-5D are emerging, there is still no value set available in the literature based on time trade-off valuations made by individuals experiencing the valued health states. The aim of this study was to estimate experience-based value sets for the EQ-5D-5L for Sweden using time trade-off and visual analogue scale valuation methods. METHODS: In a large, cross-sectional, population-based, self-administered postal health survey, the EQ-5D-5L descriptive system, EQ visual analogue scale and a time trade-off question were included. Time trade-off and visual analogue scale valuations of the respondent's current health status were used in statistical modelling to estimate a single-index value of health for each of the 3125 health states. Ordinary least-squares and generalised linear models were estimated with the main effect within each of the five dimensions represented by 20 dummy variables reflecting the additional decrement in value for levels 2-5 when the severity increases by one level sequentially beginning from having no problem. Interaction variables representing the occurrence of severity levels in at least one of the dimensions were tested: severity level 2 or worse (N2); severity level 3 or worse (N3); severity level 4 or worse (N4); severity level 5 (N5). RESULTS: A total of 896 health states (28.7% of the 3125 possible EQ-5D-5L health states) were reported by the 25,867 respondents. Visual analogue scale (n = 23,899) and time trade-off (n = 13,381) responders reported valuations of their currently experienced health state. The preferred regression models used ordinary least-squares estimation for both time trade-off and visual analogue scale values and showed consistency in all coefficients after combining certain levels. Levels 4 and 5 for the dimensions of mobility, self-care and usual activities were combined in the time trade-off model. Including the interaction variable N5, indicating severity level 5 in at least one of the five dimensions, made it possible to distinguish between the two worst severity levels where no other dimension is at level 5 as this coefficient is applied only once. In the visual analogue scale regression model, levels 4 and 5 of the mobility dimension were combined. The interaction variables N2-N4 were included, indicating that each of these terms reflect a statistically significant decrement in visual analogue scale value if any of the dimensions is at severity level 2, 3 or 4, respectively. CONCLUSIONS: Time trade-off and visual analogue scale value sets for the EQ-5D-5L are now available for Sweden. The time trade-off value set is the first such value set based on experience-based time trade-off valuation. For decision makers with a preference for experience-based valuations of health states from a representative population-based sample, the reported value sets may be considered fit for purpose to support resource allocation decision as well as evaluating population health and healthcare performance.

Patients with coronary artery disease after acute myocardial infarction: effects of continuous enrollment in a structured Disease Management Program on adherence to guideline-recommended medication, health care expenditures, and survival.

OBJECTIVE: Acute myocardial infarction (AMI) carries increased risk of mortality and excess costs. Disease Management Programs (DMPs) providing guideline-recommended care for chronic diseases seem an intuitively appealing way to enhance health outcomes for patients with chronic conditions such as AMI. The aim of the study is to compare adherence to guideline-recommended medication, health care expenditures and survival of patients enrolled and not enrolled in the German DMP for coronary artery disease (CAD) after an AMI from the perspective of a third-party payer over a follow-up period of 3 years. METHODS: The study is based on routinely collected data from a regional statutory health insurance fund (n = 15,360). A propensity score matching with caliper method was conducted. Afterwards guideline-recommended medication, health care expenditures, and survival between patients enrolled and not enrolled in the DMP were compared with generalized linear and Cox proportional hazard models. RESULTS: The propensity score matching resulted in 3870 pairs of AMI patients previously and continuously enrolled and not enrolled in the DMP. In the 3-year follow-up period the proportion of days covered rates for ACE-inhibitors (60.95% vs. 58.92%), anti-platelet agents (74.20% vs. 70.66%), statins (54.18% vs. 52.13%), and ß-blockers (61.95% vs. 52.64%) were higher in the DMP group. Besides that, DMP participants induced lower health care expenditures per day (€58.24 vs. €72.72) and had a significantly lower risk of death (HR: 0.757). CONCLUSION: Previous and continuous enrollment in the DMP CAD for patients after AMI is a promising strategy as it enhances guideline-recommended medication, reduces health care expenditures and the risk of death.

Impact of interventions to reduce overnutrition on healthcare costs related to obesity and type 2 diabetes: a systematic review.

CONTEXT: In recent decades, obesity and type 2 diabetes mellitus (T2DM) have both become global epidemics associated with substantial healthcare needs and costs. OBJECTIVE: The aim of this review was to critically assess nutritional interventions for their impact on healthcare costs to community-dwelling individuals regarding T2DM or obesity or both, specifically using CHEERS (Consolidated Health Economic Evaluation Reporting Standards) criteria to assess the economic components of the evidence. DATA SOURCES: Searches were executed in Embase, EconLit, AgEcon, PubMed, and Web of Science databases. STUDY SELECTION: Studies were included if they had a nutritional perspective, reported an economic evaluation that included healthcare costs, and focused on obesity or T2DM or both. Studies were excluded if they examined clinical nutritional preparations, dietary supplements, industrially modified dietary components, micronutrient deficiencies, or undernutrition; if they did not report the isolated impact of nutrition in complex or lifestyle interventions; or if they were conducted in animals or attempted to transfer findings from animals to humans. DATA EXTRACTION: A systematic review was performed according to PRISMA guidelines. Using predefined search terms, 21 studies evaluating food habit interventions or taxation of unhealthy foods and beverages were extracted and evaluated using CHEERS criteria. RESULTS: Overall, these studies showed that nutrition interventions and taxation approaches could lead to cost savings and improved health outcomes when compared with current practice. All of the included studies used external sources and economic modeling or risk estimations with population-attributable risks to calculate economic outcomes. CONCLUSIONS: Most evidence supported taxation approaches. The effect of nutritional interventions has not been adequately assessed. Controlled studies to directly measure economic impacts are warranted.

Direct and indirect costs of COPD progression and its comorbidities in a structured disease management program: results from the LQ-DMP study.

BACKGROUND: Evidence on the economic impact of chronic obstructive pulmonary disease (COPD) for third-party payers and society based on large real world datasets are still scarce. Therefore, the aim of this study was to estimate the economic impact of COPD severity and its comorbidities, stratified by GOLD grade, on direct and indirect costs for an unselected population enrolled in the structured German Disease Management Program (DMP) for COPD. METHODS: All individuals enrolled in the DMP COPD were included in the analysis. Patients were only excluded if they were not insured or not enrolled in the DMP COPD the complete year before the last DMP documentation (at physician visit), had a missing forced expiratory volume in 1 s (FEV1) measurement or other missing values in covariates. The final dataset included 39,307 patients in GOLD grade 1 to 4. We used multiple generalized linear models to analyze the association of COPD severity with direct and indirect costs, while adjusting for sex, age, income, smoking status, body mass index, and comorbidities. RESULTS: More severe COPD was significantly associated with higher healthcare utilization, work absence, and premature retirement. Adjusted annual costs for GOLD grade 1 to 4 amounted to €3809 [€3691-€3935], €4284 [€4176-€4394], €5548 [€5328-€5774], and €8309 [€7583-9065] for direct costs, and €11,784 [€11,257-€12,318], €12,985 [€12,531-13,443], €15,805 [€15,034-€16,584], and €19,402 [€17,853-€21,017] for indirect costs. Comorbidities had significant additional effects on direct and indirect costs with factors ranging from 1.19 (arthritis) to 1.51 (myocardial infarction) in direct and from 1.16 (myocardial infarction) to 1.27 (cancer) in indirect costs. CONCLUSION: The findings indicate that more severe GOLD grades in an unselected COPD population enrolled in a structured DMP are associated with tremendous additional direct and indirect costs, with comorbidities significantly increase costs. In direct cost category hospitalization and in indirect cost category premature retirement were the main cost driver. From a societal perspective prevention and interventions focusing on disease control, and slowing down disease progression and strengthening the ability to work would be beneficial in order to realize cost savings in COPD.

Are health risk attitude and general risk attitude associated with healthcare utilization, costs and working ability? Results from the German KORA FF4 cohort study.

BACKGROUND: Risk attitudes influence decisions made under uncertainty. This paper investigates the association of risk attitudes with the utilization of preventive and general healthcare services, work absence and resulting costs to explore their contribution to the heterogeneity in utilization. METHODS: Data of 1823 individuals (56.5 ± 9.5 years), participating in the German KORA FF4 population-based cohort study (2013/2014) were analyzed. Individuals' general and health risk attitude were measured as willingness to take risk (WTTR) on 11-point scales. Utilization of preventive and medical services and work absence was assessed and annual costs were calculated from a societal perspective. Generalized linear models with log-link function (logistic, negative-binomial and gamma regression) adjusted for age, sex, and height were used to analyze the association of WTTR with the utilizations and costs. RESULTS: Higher WTTR was significantly associated with lower healthcare utilization (physician visits, physical therapy, and medication intake), work absence days and indirect costs. Regarding preventive services, an overall negative correlation between WTTR and utilization was examined but this observation remained non-significant except for the outcome medical check-up. Here, higher WTTR was significantly associated with a lower probability of participation. For all associations mentioned, Odds Ratios ranged between 0.90 and 0.79, with p < 0.05. Comparing the two risk attitudes (general and regarding health) we obtained similar results regarding the directions of associations. CONCLUSIONS: We conclude that variations in risk attitudes contribute to the heterogeneity of healthcare utilization. Thus, knowledge of their associations with utilization might help to better understand individual decision-making - especially in case of participation in preventive services.

Which Reimbursement System Fits Inpatient Palliative Care? A Qualitative Interview Study on Clinicians' and Financing Experts' Experiences and Views.

Context: Internationally, a variety of reimbursement systems exists for palliative care (PC). In Germany, PC units (PCUs) may choose between per-diem rates and diagnosis-related groups (DRGs). Both systems are controversially discussed. Objectives: To explore the experiences and views of German PCU clinicians and experts for PCU financing regarding per-diem rates and DRGs as reimbursement systems with a focus on (1) cost coverage, (2) strengths and weaknesses of both financing systems, and (3) options for further development of funding PCUs. Design: Qualitative semistructured interviews with PCU clinicians and experts for PCU financing, analyzed by thematic analysis using the Framework approach. Setting/Subjects/Measurements: Ten clinicians and 13 experts for financing were interviewed June-October 2015 on both reimbursement systems for PCU. Results: Interviewees had divergent experiences with both reimbursement systems regarding cost coverage. A described strength of per-diem rates was the perceived possibility of individual care without direct financial pressure. The nationwide variation of per-diem rates and the lack of quality standards were named as weaknesses. DRGs were criticized for incentives perceived as perverse and inadequate representation of PC-specific procedures. However, the quality standards for PCUs required within the German DRG system were described as important strength. Suggestions for improvement of the funding system pointed toward a combination of per-diem rates with a grading according to disease severity/complexity of care. Conclusions: Expert opinions suggest that neither current DRGs nor per-diem rates are ideal for funding of PCUs. Suggested improvements regarding adequate funding of PCUs resemble and supplement international developments.

Understanding complexity - the palliative care situation as a complex adaptive system.

BACKGROUND: The concept of complexity is used in palliative care (PC) to describe the nature of patients' situations and the extent of resulting needs and care demands. However, the term or concept is not clearly defined and operationalised with respect to its particular application in PC. As a complex problem, a care situation in PC is characterized by reciprocal, nonlinear relations and uncertainties. Dealing with complex problems necessitates problem-solving methods tailored to specific situations. The theory of complex adaptive systems (CAS) provides a framework for locating problems and solutions. This study aims to describe criteria contributing to complexity of PC situations from the professionals' view and to develop a conceptual framework to improve understanding of the concept of "complexity" and related elements of a PC situation by locating the complex problem "PC situation" in a CAS. METHODS: Qualitative interview study with 42 semi-structured expert (clinical/economical/political) interviews. Data was analysed using the framework method. The thematic framework was developed inductively. Categories were reviewed, subsumed and connected considering CAS theory. RESULTS: The CAS of a PC situation consists of three subsystems: patient, social system, and team. Agents in the "system patient" are allocated to further subsystems on patient level: physical, psycho-spiritual, and socio-cultural. The "social system" and the "system team" are composed of social agents, who affect the CAS as carriers of characteristics, roles, and relationships. Environmental factors interact with the care situation from outside the system. Agents within subsystems and subsystems themselves interact on all hierarchical system levels and shape the system behaviour of a PC situation. CONCLUSIONS: This paper provides a conceptual framework and comprehensive understanding of complexity in PC. The systemic view can help to understand and shape situations and dynamics of individual care situations; on higher hierarchical level, it can support an understanding and framework for the development of care structures and concepts. The framework provides a foundation for the development of a model to differentiate PC situations by complexity of patients and care needs. To enable an operationalisation and classification of complexity, relevant outcome measures mirroring the identified system elements should be identified and implemented in clinical practice.

A pilot study on patient-related costs and factors associated with the cost of specialist palliative care in the hospital: first steps towards a patient classification system in Germany.

BACKGROUND: Specialist palliative care in the hospital addresses a heterogeneous patient population with complex care needs. In Germany, palliative care patients are classified based on their primary diagnosis to determine reimbursement despite findings that other factors describe patient needs better. To facilitate adequate resource allocation in this setting, in Australia and in the UK important steps have been undertaken towards identifying drivers of palliative care resource use and classifying patients accordingly. We aimed to pioneer patient classification based on determinants of resource use relevant to specialist palliative care in Germany first, by calculating the patient-level cost of specialist palliative care from the hospital's perspective, based on the recorded resource use and, subsequently, by analysing influencing factors. METHODS: Cross-sectional study of consecutive patients who had an episode of specialist palliative care in Munich University Hospital between 20 June and 4 August, 2016. To accurately reflect personnel intensity of specialist palliative care, aside from administrative data, we recorded actual use of all involved health professionals' labour time at patient level. Factors influencing episode costs were assessed using generalized linear regression and LASSO variable selection. RESULTS: The study included 144 patients. Mean costs of specialist palliative care per palliative care unit episode were 6542€ (median: 5789€, SE: 715€) and 823€ (median: 702€, SE: 31€) per consultation episode. Based on multivariate models that considered both variables recorded at beginning and at the end of episode, we identified factors explaining episode cost including phase of illness, Karnofsky performance score, and type of discharge. CONCLUSIONS: This study is an important step towards patient classification in specialist palliative care in Germany as it provides a feasible patient-level costing method and identifies possible starting points for classification. Application to a larger sample will allow for meaningful classification of palliative patients.