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 primary patella resurfacing on health-related quality of life outcomes and return to sport in total knee arthroplasty (TKA).

INTRODUCTION: Primary patella resurfacing (PPR) in primary total knee arthroplasty (TKA) is a topic without clear clinical evidence. Using Patient Reported Outcome Measurements (PROM), previous work found TKA patients without PPR to have more pain postoperatively, but little is known whether this may impede patients from returning to their usual leisure sport. This observational study aimed at evaluating the treatment effect of PPR, with PROMs and return to sport (RTS). MATERIALS AND METHODS: 156 primary TKA patients were retrospectively included from August 2019 to November 2020, from a single hospital in Germany. PROMs were measured with the Western Ontario McMaster University Osteoarthritis Index (WOMAC) and the EuroQoL Visual Analog Scale (EQ-VAS), preoperatively and 1 year postoperatively. Leisure sport with three levels of intensity (never, sometimes, regular) were requested. The treatment effect of PPR was evaluated with a difference-in-difference (DiD) approach, with several confounders. RESULTS: Descriptively, the mean WOMAC total score and the mean WOMAC pain score were postoperatively better with PPR, ( - 4.8 points, - 1.1 points), then without PPR. The mean improvements of the WOMAC total score were better with PPR ( - 7.8 points). Mean improvements for the WOMAC pain score were also better with PPR ( - 1.2 points). Mean EQ-VAS were postoperatively similar, and the mean improvements were better with PPR (3.4 points). Rate of RTS was 93% for patients with PPR and 95% for patients without PPR. The DiD revealed minor differences in PROMs and RTS, not to result in statistically significant treatment effects. CONCLUSIONS: There was no treatment effect for TKA with PPR, regarding PROMs and RTS, and descriptive differences were below published thresholds for clinical relevance. Rate of RTS was high for all patients, regardless of PPR. For the two endpoint categories, there was no measurable advantage of TKA with PPR over TKA without PPR.

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.

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.

COMPANION: development of a patient-centred complexity and casemix classification for adult palliative care patients based on needs and resource use - a protocol for a cross-sectional multi-centre study.

BACKGROUND: A casemix classification based on patients' needs can serve to better describe the patient group in palliative care and thus help to develop adequate future care structures and enable national benchmarking and quality control. However, in Germany, there is no such an evidence-based system to differentiate the complexity of patients' needs in palliative care. Therefore, the study aims to develop a patient-oriented, nationally applicable complexity and casemix classification for adult palliative care patients in Germany. METHODS: COMPANION is a mixed-methods study with data derived from three subprojects. Subproject 1: Prospective, cross-sectional multi-centre study collecting data on patients' needs which reflect the complexity of the respective patient situation, as well as data on resources that are required to meet these needs in specialist palliative care units, palliative care advisory teams, and specialist palliative home care. Subproject 2: Qualitative study including the development of a literature-based preliminary list of characteristics, expert interviews, and a focus group to develop a taxonomy for specialist palliative care models. Subproject 3: Multi-centre costing study based on resource data from subproject 1 and data of study centres. Data and results from the three subprojects will inform each other and form the basis for the development of the casemix classification. Ultimately, the casemix classification will be developed by applying Classification and Regression Tree (CART) analyses using patient and complexity data from subproject 1 and patient-related cost data from subproject 3. DISCUSSION: This is the first multi-centre costing study that integrates the structure and process characteristics of different palliative care settings in Germany with individual patient care. The mixed methods design and variety of included data allow for the development of a casemix classification that reflect on the complexity of the research subject. The consecutive inclusion of all patients cared for in participating study centres within the time of data collection allows for a comprehensive description of palliative care patients and their needs. A limiting factor is that data will be collected at least partly during the COVID-19 pandemic and potential impact of the pandemic on health care and the research topic cannot be excluded. TRIAL REGISTRATION: German Register for Clinical Studies trial registration number: DRKS00020517 .

Concordance among Swedish, German, Danish, and UK EQ-5D-3L Value Sets: Analyses of Patient-Reported Outcomes in the Swedish Hip Arthroplasty Register.

Background: Application of different value sets to health-related quality of life (HRQoL) measured with the EQ-5D-3L may lead to different results due to differences in methods, perspectives, and countries used. Focusing on concordance, this study aimed at understanding the implications of applying EQ-5D-3L value sets from Sweden, Germany, Denmark, and the UK to evaluate HRQoL of patients undergoing total hip replacement (THR) in Sweden before and after surgery. Methods: We performed a longitudinal study of patients in the Swedish Hip Arthroplasty Register from preoperative stage to 1-year follow-up (n = 73,523) using data collected from 2008 to 2016. Eight EQ-5D-3L value sets from the four countries were compared based on a valuation method (visual analogue scale (VAS) or time trade-off (TTO)), perspective (experience-based or hypothetical), and country. Concordance among the value sets with patient-reported EQ VAS score was also assessed. Longitudinal changes in EQ-5D-3L index over the 1-year follow-up were compared across value sets by method, perspective, and country. Results: Value sets based on the same method and perspective showed higher concordance in EQ-5D-3L index at both measurement time points than other comparisons. In the comparisons by perspective, VAS value sets showed higher concordance than TTO value sets. The Swedish VAS and the Danish TTO value sets showed the highest levels of concordance with patient-reported EQ VAS scores. Generally, value sets based on the same method and perspective had the smallest mean differences between changes in EQ-5D-3L indices from preoperative to 1-year postoperative follow-up. Conclusion: Among THR patients value sets based on the same method and perspective, a direct transfer of results across countries could be meaningful. In cases of differences in methods and perspectives among value sets, transfer of value sets across settings would have to consider conversion through crosswalk.

Long-term weight gain in obese COPD patients participating in a disease management program: a risk factor for reduced health-related quality of life.

BACKGROUND: Little is known about how long-term weight gain affects the health perception of COPD patients. OBJECTIVES: The aim is to evaluate the long-term association of BMI change and health-related quality of life (HRQoL) in obese COPD patients. METHODS: Claims and survey data from a COPD disease management program were used to match two groups of COPD patients with BMI ≥ 30 who have differing weight trajectories over a 5-year timespan via propensity score and genetic matching. EQ-5D-5L, including visual analog scale (VAS) and COPD Assessment Test (CAT), were used as outcomes of interest. Sociodemographic and disease-based variables were matched. RESULTS: Out of 1202 obese COPD patients, 126 with a weight increase of four or more BMI points were matched separately with 252 (propensity score matching) and 197 (genetic matching) control subjects who had relatively stable BMI. For the EQ-5D-5L, patients with BMI increase reported significantly worse health perception for VAS and all descriptive dimensions except pain/discomfort. For the CAT, especially the perception of ability to complete daily activities and overall energy results were significantly worse. VAS differences reach the range of minimal important differences. Stopping smoking and already being in obesity class II were the most influential risk factors for BMI increase. CONCLUSION: Obese COPD patients who gain four or more BMI points over 5 years report significantly lower results in different dimensions of generic and disease-specific HRQoL than their peers with stable BMI. To improve real-world outcomes, tracking and preventing specific BMI trajectories could constitute a clinically relevant aspect of managing COPD patients.

The relationship between body mass index and health-related quality of life in COPD: real-world evidence based on claims and survey data.

BACKGROUND: Body mass index (BMI) is an important parameter associated with mortality and health-related quality of life (HRQoL) in chronic obstructive pulmonary disease (COPD). However, informed guidance on stratified weight recommendations for COPD is still lacking. This study aims to determine the association between BMI and HRQoL across different severity grades of COPD to support patient management. METHODS: We use conjunct analysis of claims and survey data based on a German COPD disease management program from 2016 to 2017. The EQ-5D-5L visual analog scale (VAS) and COPD Assessment Test (CAT) are used to measure generic and disease-specific HRQoL. Generalized additive models with smooth functions are implemented to evaluate the relationship between BMI and HRQoL, stratified by COPD severity. RESULTS: 11,577 patients were included in this study. Mean age was 69.4 years and 59% of patients were male. In GOLD grades 1-3, patients with BMI of around 25 had the best generic and disease-specific HRQoL, whereas in GOLD grade 4, obese patients had the best HRQoL using both instruments when controlled for several variables including smoking status, income, COPD severity, comorbidities, emphysema, corticosteroid use, and days spent in hospital. CONCLUSION: This real-world analysis shows the non-linear relationship between BMI and HRQoL in COPD. HRQoL of obese patients with mild to severe COPD might improve following weight reduction. For very severe COPD, a negative association of obesity and HRQoL could not be confirmed. The results hint at the need to stratify COPD patients by disease stage for optimal BMI management.

Patient characteristics and valuation changes impact quality of life and satisfaction in total knee arthroplasty - results from a German prospective cohort study.

BACKGROUND: Evaluation of variations in pre- and postoperative patient reported outcomes (PRO) and the association between preoperative patient characteristics and health and satisfaction outcomes after total knee arthroplasty (TKA) may support shared decision-making in Germany. Since previous research on TKA health outcomes indicated valuation differences in longitudinal data, experienced-based population weights were used for the first time as an external valuation system to measure discrepancies between patient and average population valuation of HRQoL. METHODS: Baseline data (n = 203) included sociodemographic and clinical characteristics and PROs, measured by the EQ-5D-3 L and WOMAC. Six-month follow-up data (n = 161) included medical changes since hospital discharge, PROs and satisfaction. A multivariate linear regression analysis was performed to evaluate the relationship between preoperative patient characteristics and PRO scores. Patient acceptable symptom state (PASS) was calculated to provide a satisfaction threshold. Patient-reported health-related quality of life (HRQoL) valuations were compared with average experienced-based population values to detect changes in valuation. RESULTS: One hundred thirty-seven subjects met inclusion criteria. All PRO measures improved significantly. Preoperative WOMAC and EQ-5D VAS, housing situation, marital status, age and asthma were found to be predictors of postoperative outcomes. 73% of study participants valued their preoperative HRQoL higher than the general population valuation, indicating response shift. Preoperatively, patient-reported EQ-5D VAS was substantially higher than average experienced-based population values. Postoperatively, this difference declined sharply. Approximately 61% of the patients reported satisfactory postoperative health, being mainly satisfied with results if postoperative WOMAC was ≥82.49 (change ≥20.25) and postoperative EQ-5D VAS was ≥75 (change ≥6). CONCLUSION: On average, patients benefited from TKA. Preoperative WOMAC and EQ-5D VAS were predictors of postoperative outcomes after TKA. Particularly patients with high absolute preoperative PRO scores were more likely to remain unsatisfied. Therefore, outcome prediction can contribute to shared-decision making. Using general population valuations as a reference, this study underlined a discrepancy between population and patient valuation of HRQoL before, but not after surgery, thus indicating a potential temporary response shift before surgery.

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.

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.

Psychometric properties and minimal important differences of SF-36 in Idiopathic Pulmonary Fibrosis.

BACKGROUND: Idiopathic pulmonary fibrosis (IPF) is a rare disease with a median survival of 3-5 years after diagnosis with limited treatment options. The aim of this study is to assess the psychometric characteristics of the Short Form 36 Health Status Questionnaire (SF-36) in IPF and to provide disease specific minimally important differences (MID). METHODS: Data source was the European IPF Registry (eurIPFreg). The psychometric properties of the SF-36 version 2 were evaluated based on objective clinical measures as well as subjective perception. We analysed acceptance, feasibility, discrimination ability, construct and criterion validity, responsiveness and test-retest-reliability. MIDs were estimated via distribution and anchor-based approaches. RESULTS: The study population included 258 individuals (73.3% male; mean age 67.3 years, SD 10.7). Of them 75.2% (194 individuals) had no missing item. The distribution of several items was skewed, although floor effect was acceptable. Physical component score (PCS) correlated significantly and moderately with several anchors, whereas the correlations of mental component score (MCS) and anchors were only small. The tests showed mainly significant lower HRQL in individuals with long-term oxygen therapy. Analyses in stable individuals did not show significant changes of HRQL except for one dimension and anchor. Individuals with relevant changes of the health status based on the anchors had significant changes in all SF-36 dimensions and summary scales except for the dimension PAIN. PCS and MCS had mean MIDs of five and six, respectively. Mean MIDs of the dimensions ranged from seven to 21. CONCLUSION: It seems that the SF-36 is a valid instrument to measure HRQL in IPF and so can be used in RCTs or individual monitoring of disease. Nevertheless, the additional evaluation of longitudinal aspects and MIDs can be recommended to further analyse these factors. Our findings have a great potential impact on the evaluation of IPF patients. TRIAL REGISTRATION: The eurIPFreg and eurIPFbank are listed in https://clinicaltrials.gov ( NCT02951416 ).

Predicting patient-reported outcomes following hip and knee replacement surgery using supervised machine learning.

BACKGROUND: Machine-learning classifiers mostly offer good predictive performance and are increasingly used to support shared decision-making in clinical practice. Focusing on performance and practicability, this study evaluates prediction of patient-reported outcomes (PROs) by eight supervised classifiers including a linear model, following hip and knee replacement surgery. METHODS: NHS PRO data (130,945 observations) from April 2015 to April 2017 were used to train and test eight classifiers to predict binary postoperative improvement based on minimal important differences. Area under the receiver operating characteristic, J-statistic and several other metrics were calculated. The dependent outcomes were generic and disease-specific improvement based on the EQ-5D-3L visual analogue scale (VAS) as well as the Oxford Hip and Knee Score (Q score). RESULTS: The area under the receiver operating characteristic of the best training models was around 0.87 (VAS) and 0.78 (Q score) for hip replacement, while it was around 0.86 (VAS) and 0.70 (Q score) for knee replacement surgery. Extreme gradient boosting, random forests, multistep elastic net and linear model provided the highest overall J-statistics. Based on variable importance, the most important predictors for post-operative outcomes were preoperative VAS, Q score and single Q score dimensions. Sensitivity analysis for hip replacement VAS evaluated the influence of minimal important difference, patient selection criteria as well as additional data years. Together with a small benchmark of the NHS prediction model, robustness of our results was confirmed. CONCLUSIONS: Supervised machine-learning implementations, like extreme gradient boosting, can provide better performance than linear models and should be considered, when high predictive performance is needed. Preoperative VAS, Q score and specific dimensions like limping are the most important predictors for postoperative hip and knee PROMs.

Costs and effects of intra-operative fluorescence molecular imaging - A model-based, early assessment.

INTRODUCTION: Successful breast conserving cancer surgeries come along with tumor free resection margins and account for cosmetic outcome. Positive margins increase the likelihood of tumor recurrence. Intra-operative fluorescence molecular imaging (IFMI) aims to focus surgery on malignant tissue thus substantially lowering the presence of positive margins as compared with standard techniques of breast conservation (ST). A goal of this paper is to assess the incremental number of surgeries and costs of IFMI vs. ST. METHODS: We developed a decision analytical model and applied it for an early evaluation approach. Given uncertainty we considered that IFMI might reduce the proportion of positive margins found by ST from all to none and this proportion is assumed to be reduced to 10% for the base case. Inputs included data from the literature and a range of effect estimates. For the costs of IFMI, respective cost components were added to those of ST. RESULTS: The base case reduction lowered number of surgeries (mean [95% confidence interval]) by 0.22 [0.15; 0.30] and changed costs (mean [95% confidence interval]) by €-663 [€-1,584; €50]. A tornado diagram identified the Diagnosis Related Group (DRG) costs, the proportion of positive margins of ST, the staff time saving factor and the duration of frozen section analysis (FSA) as important determinants of this cost. CONCLUSIONS: These early results indicate that IFMI may be more effective than ST and through the reduction of positive margins it is possible to save follow-up surgeries-indicating further health risk-and to save costs through this margin reduction and the avoidance of FSA.

Redefining diagnosis-related groups (DRGs) for palliative care - a cross-sectional study in two German centres.

BACKGROUND: Hospital costs and cost drivers in palliative care are poorly analysed. It remains unknown whether current German Diagnosis-Related Groups, mainly relying on main diagnosis or procedure, reproduce costs adequately. The aim of this study was therefore to analyse costs and reimbursement for inpatient palliative care and to identify relevant cost drivers. METHODS: Two-center, standardised micro-costing approach with patient-level cost calculations and analysis of the reimbursement situation for patients receiving palliative care at two German hospitals (7/2012-12/2013). Data were analysed for the total group receiving hospital care covering, but not exclusively, palliative care (group A) and the subgroup receiving palliative care only (group B). Patient and care characteristics predictive of inpatient costs of palliative care were derived by generalised linear models and investigated by classification and regression tree analysis. RESULTS: Between 7/2012 and 12/2013, 2151 patients received care in the two hospitals including, but not exclusively, on the PCUs (group A). In 2013, 784 patients received care on the two PCUs only (group B). Mean total costs per case were € 7392 (SD 7897) (group A) and € 5763 (SD 3664) (group B), mean total reimbursement per case € 5155 (SD 6347) (group A) and € 4278 (SD 2194) (group B). For group A/B on the ward, 58%/67% of the overall costs and 48%/53%, 65%/82% and 64%/72% of costs for nursing, physicians and infrastructure were reimbursed, respectively. Main diagnosis did not significantly influence costs. However, duration of palliative care and total length of stay were (related to the cost calculation method) identified as significant cost drivers. CONCLUSIONS: Related to the cost calculation method, total length of stay and duration of palliative care were identified as significant cost drivers. In contrast, main diagnosis did not reflect costs. In addition, results show that reimbursement within the German Diagnosis-Related Groups system does not reproduce the costs adequately, but causes a financing gap for inpatient palliative care.

Estimates of costs for modelling return on investment from smoking cessation interventions.

BACKGROUND AND AIMS: Modelling return on investment (ROI) from smoking cessation interventions requires estimates of their costs and benefits. This paper describes a standardized method developed to source both economic costs of tobacco smoking and costs of implementing cessation interventions for a Europe-wide ROI model [European study on Quantifying Utility of Investment in Protection from Tobacco model (EQUIPTMOD)]. DESIGN: Focused search of administrative and published data. A standardized checklist was developed in order to ensure consistency in methods of data collection. SETTING AND PARTICIPANTS: Adult population (15+ years) in Hungary, Netherlands, Germany, Spain and England. For passive smoking-related costs, child population (0-15 years) was also included. MEASUREMENTS: Costs of treating smoking-attributable diseases; productivity losses due to smoking-attributable absenteeism; and costs of implementing smoking cessation interventions. FINDINGS: Annual costs (per case) of treating smoking attributable lung cancer were between €5074 (Hungary) and €52 106 (Germany); coronary heart disease between €1521 (Spain) and €3955 (Netherlands); chronic obstructive pulmonary disease between €1280 (England) and €4199 (Spain); stroke between €1829 (Hungary) and €14 880 (Netherlands). Costs (per recipient) of smoking cessation medications were estimated to be: for standard duration of varenicline between €225 (England) and €465 (Hungary); for bupropion between €25 (Hungary) and €220 (Germany). Costs (per recipient) of providing behavioural support were also wide-ranging: one-to-one behavioural support between €34 (Hungary) and €474 (Netherlands); and group-based behavioural support between €12 (Hungary) and €257 (Germany). The costs (per recipient) of delivering brief physician advice were: €24 (England); €9 (Germany); €4 (Hungary); €33 (Netherlands); and €27 (Spain). CONCLUSIONS: Costs of treating smoking-attributable diseases as well as the costs of implementing smoking cessation interventions vary substantially across Hungary, Netherlands, Germany, Spain and England. Estimates for the costs of these diseases and interventions can contribute to return on investment estimates in support of national or regional policy decisions.

Cost-effectiveness of alternative smoking cessation scenarios in Spain: results from the EQUIPTMOD.

AIMS: To assess the cost-effectiveness of alternative smoking cessation scenarios from the perspective of the Spanish National Health Service (NHS). DESIGN: We used the European study on Quantifying Utility of Investment in Protection from Tobacco model (EQUIPTMOD), a Markov-based state transition economic model, to estimate the return on investment (ROI) of: (a) the current provision of smoking cessation services (brief physician advice and printed self-helped material + smoking ban and tobacco duty at current levels); and (b) four alternative scenarios to complement the current provision: coverage of proactive telephone calls; nicotine replacement therapy (mono and combo) [prescription nicotine replacement therapy (Rx NRT)]; varenicline (standard duration); or bupropion. A rate of 3% was used to discount life-time costs and benefits. SETTING: Spain. PARTICIPANTS: Adult smoking population (16+ years). MEASUREMENTS: Health-care costs associated with treatment of smoking attributable diseases (lung cancer, coronary heart disease, chronic obstructive pulmonary infection and stroke); intervention costs; quality-adjusted life years (QALYs). Costs and outcomes were summarized using various ROI estimates. FINDINGS: The cost of implementing the current provision of smoking cessation services is approximately €61 million in the current year. This translates to 18 quitters per 1000 smokers and a life-time benefit-cost ratio of 5, compared with no such provision. All alternative scenarios were dominant (cost-saving: less expensive to run and generated more QALYs) from the life-time perspective, compared with the current provision. The life-time benefit-cost ratios were: 1.87 (proactive telephone calls); 1.17 (Rx NRT); 2.40 (varenicline-standard duration); and bupropion (2.18). The results remained robust in the sensitivity analysis. CONCLUSIONS: According to the EQUIPTMOD modelling tool it would be cost-effective for the Spanish authorities to expand the reach of existing GP brief interventions for smoking cessation, provide pro-active telephone support, and reimburse smoking cessation medication to smokers trying to stop. Such policies would more than pay for themselves in the long run.

Understanding perceived availability and importance of tobacco control interventions to inform European adoption of a UK economic model: a cross-sectional study.

BACKGROUND: The evidence on the extent to which stakeholders in different European countries agree with availability and importance of tobacco-control interventions is limited. This study assessed and compared stakeholders' views from five European countries and compared the perceived ranking of interventions with evidence-based ranking using cost-effectiveness data. METHODS: An interview survey (face-to-face, by phone or Skype) was conducted between April and July 2014 with five categories of stakeholders - decision makers, service purchasers, service providers, evidence generators and health promotion advocates - from Germany, Hungary, the Netherlands, Spain, and the United Kingdom. A list of potential stakeholders drawn from the research team's contacts and snowballing served as the sampling frame. An email invitation was sent to all stakeholders in this list and recruitment was based on positive replies. Respondents were asked to rate availability and importance of 30 tobacco control interventions. Kappa coefficients assessed agreement of stakeholders' views. A mean importance score for each intervention was used to rank the interventions. This ranking was compared with the ranking based on cost-effectiveness data from a published review. RESULTS: Ninety-three stakeholders (55.7% response rate) completed the survey: 18.3% were from Germany, 17.2% from Hungary, 30.1% from the Netherlands, 19.4% from Spain, and 15.1% from the UK. Of those, 31.2% were decision makers, 26.9% evidence generators, 19.4% service providers, 15.1% health-promotion advocates, and 7.5% purchasers of services/pharmaceutical products. Smoking restrictions in public areas were rated as the most important intervention (mean score = 1.89). The agreement on availability of interventions between the stakeholders was very low (kappa = 0.098; 95% CI = [0.085, 0.111] but the agreement on the importance of the interventions was fair (kappa = 0.239; 95% CI = [0.208, 0.253]). A correlation was found between availability and importance rankings for stage-based interventions. The importance ranking was not statistically concordant with the ranking based on published cost-effectiveness data (Kendall rank correlation coefficient = 0.40; p-value = 0.11; 95% CI = [- 0.09, 0.89]). CONCLUSIONS: The intrinsic differences in stakeholder views must be addressed while transferring economic evidence Europe-wide. Strong engagement with stakeholders, focussing on better communication, has a potential to mitigate this challenge.