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.

Socioeconomic and risk-related drivers of compliance with measures to prevent SARS-CoV-2 infection: evidence from the Munich-based KoCo19 study.

OBJECTIVES: Although a growing share of the population in many countries has been vaccinated against the SARS-CoV-2 virus to different degrees, social distancing and hygienic non-pharmaceutical interventions still play a substantial role in containing the pandemic. The goal of this study was to investigate which factors are correlated with a higher compliance with these regulations in the context of a cohort study in the city of Munich, southern Germany, during the summer of 2020, i.e. after the first lockdown phase. METHODS: Using self-reported compliance with six regulations and personal hygiene rules (washing hands, avoiding touching face, wearing a mask, keeping distance, avoiding social gatherings, avoiding public spaces) we extracted two compliance factor scores, namely compliance with personal hygiene measures and compliance with social distancing regulations. Using linear and logistic regressions, we estimated the correlation of several socio-demographic and risk perception variables with both compliance scores. RESULTS: Risk aversion proved to be a consistent and significant driver of compliance across all compliance behaviors. Furthermore, being female, being retired and having a migration background were positively associated with compliance with personal hygiene regulations, whereas older age was related with a higher compliance with social distancing regulations. Generally, socioeconomic characteristics were not related with compliance, except for education, which was negatively related with compliance with personal hygiene measures. CONCLUSIONS: Our results suggest that for a targeted approach to improve compliance with measures to prevent SARS-CoV-2 infection, special attention should be given to younger, male and risk-prone individuals.

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.

Does uptake of specialty care affect HRQoL development in COPD patients beneficially? A difference-in-difference analysis linking claims and survey data.

BACKGROUND: There is an evidence gap on whether the choice of specialty care beneficially affects health-related quality of life (HRQoL) in patients with chronic obstructive pulmonary disease (COPD). This study analyzes how newly initiated pulmonologist care affects the generic and disease-specific HRQoL in COPD patients over a period of 1 year. METHODS: We linked claims data with data from two survey waves to investigate the longitudinal effect of specialty care on HRQoL using linear Difference-in-Difference models based on 1:3 propensity score matched data. Generic HRQoL was operationalized by EQ-5D-5L visual analog scale (VAS), and disease-specific HRQoL by COPD assessment test (CAT). Subgroup analyses examined COPD patients with low (GOLD AB) and high (GOLD CD) exacerbation risk. RESULTS: In contrast to routine care patients, pulmonologists' patients (n = 442) experienced no significant deterioration in HRQoL (VAS - 0.0, p = 0.9870; CAT + 0.5, p = 0.0804). Models unveiled a small comparative advantage of specialty care on HRQoL (mean change: CAT - 0.8, VAS + 2.9), which was especially pronounced for GOLD AB (CAT - 0.7; VAS + 3.1). CONCLUSION: The uptake of pulmonologist care had a statistically significant, but not clinically relevant, beneficial impact on the development of HRQoL by slowing down overall HRQoL deterioration within 1 year. Including specialty care more appropriately in COPD management, especially at lower disease stages (GOLD AB), could thus improve patients' health outcome.

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.

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 .

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.

Can Adherence to and Persistence with Inhaled Long-acting Bronchodilators Improve the Quality of Life in Patients with Chronic Obstructive Pulmonary Disease? Results from a German Disease Management Program.

BACKGROUND AND OBJECTIVE: Adherence to and persistence with inhaled long-acting bronchodilators (ILAB), is commonly considered to be a relevant driver of perceived health-related quality of life (HRQoL) in chronic obstructive pulmonary disease (COPD), but the topic is rarely studied with real-world data. Using survey and health insurance claims data, this study investigates the effect of adherence to and persistence with ILAB on EQ-5D-5L visual analog scale (VAS) in ILAB users who were enrolled in the German disease management programs (DMP) for COPD. METHODS: Included ILAB users were aged ≥ 18 years, continuously insured with AOK Bavaria and enrolled in the DMP for COPD. Adherence to ILAB [proportion of days covered (PDC); PDC ≥ 80%], and persistence (days of uninterrupted ILAB therapy) were assessed in the year preceding the study's HRQoL questionnaire. In a cross-sectional design we applied quasi-Poisson models with log link function and subgroup analyses. The robustness of results was analyzed with comprehensive sensitivity analyses. RESULTS: Patients with PDC ≥ 80% had 2.96% higher VAS scores than patients with lower PDCs. From all analyses, patients with GOLD stage III had the highest effects from PDC ≥ 80% (5.33% increased VAS). Patients without heart failure profited significantly more from PDC ≥ 80% (+ 4.34% vs - 2.88%) and from an additional persistent day (+ 0.01% vs - 0.01%) than patients with heart failure. CONCLUSIONS: Overall, ILAB users significantly profited from PDC ≥ 80%, but not from continuous PDC or persistent days. In secondary subgroup analyses, patients with GOLD stage III and patients without heart failure particularly profited from PDC ≥ 80%. Only patients without heart failure particularly profited from more persistent days. Because identified effects were small and often not robust, advancing adherence and persistence alone may not improve the German DMP for COPD substantially.

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.

Impact of Lung Function and Exacerbations on Health-Related Quality of Life in COPD Patients Within One Year: Real-World Analysis Based on Claims Data.

PURPOSE: Real-world evidence on the impact of forced expiratory volume in one second (FEV1) and exacerbations on health-related quality of life (HRQoL) in patients with chronic obstructive pulmonary disease (COPD) is sparse especially with regard to GOLD ABCD groups. This study investigates how changes in FEV1 and exacerbations affect generic and disease-specific HRQoL in COPD patients over one year. METHODS: Using German claims data and survey data, we classified 3016 COPD patients and analyzed their health status by GOLD groups AB and CD. HRQoL was measured with the disease-specific COPD assessment test (CAT) and the visual analog scale (VAS) from the generic Euro-Qol 5D-5L. We applied change score models to assess associations between changes in FEV1 (≥100 mL decrease/no change/≥100 mL increase) or the development of severe exacerbations with change in HRQoL. RESULTS: FEV1 decrease was associated with a significant but not minimal important difference (MID) deterioration in disease-specific HRQoL (mean change [95% CI]: CAT +0.74 [0.15 to 1.33]), while no significant change was observed in the generic VAS. Experiencing at least one severe exacerbation also had a significant impact on CAT deterioration (+1.58 [0.52 to 2.64]), but again not on VAS. Here, GOLD groups AB showed not only a statistically but also a clinically relevant MID deterioration in CAT (+2.1 [0.88 to 3.32]). These particular patient groups were further characterized by a higher probability of being male, having a higher mMRC and Charlson index, and a lower probability of having higher FEV1 or BMI values. CONCLUSION: FEV1 decline and the occurrence of ≥1 severe exacerbation are significantly associated with overall deterioration in disease-specific HRQoL. Preventing severe exacerbations particularly in patients without previous severe exacerbations (ABCD groups A and B) may help to stabilize the key patient-reported outcome HRQoL.

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.

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.