Hospitalisation patterns in interstitial lung diseases: data from the EXCITING-ILD registry.

BACKGROUND: Interstitial lung diseases (ILD) comprise a heterogeneous group of mainly chronic lung diseases with more than 200 entities and relevant differences in disease course and prognosis. Little data is available on hospitalisation patterns in ILD. METHODS: The EXCITING-ILD (Exploring Clinical and Epidemiological Characteristics of Interstitial Lung Diseases) registry was analysed for hospitalisations. Reasons for hospitalisation were classified as all cause, ILD-related and respiratory hospitalisations, and patients were analysed for frequency of hospitalisations, time to first non-elective hospitalisation, mortality and progression-free survival. Additionally, the risk for hospitalisation according to GAP index and ILD subtype was calculated by Cox proportional-hazard models as well as influencing factors on prediction of hospitalisation by logistic regression with forward selection. RESULTS: In total, 601 patients were included. 1210 hospitalisations were recorded during the 6 months prior to registry inclusion until the last study visit. 800 (66.1%) were ILD-related, 59.3% of admissions were registered in the first year after inclusion. Mortality was associated with all cause, ILD-related and respiratory-related hospitalisation. Risk factors for hospitalisation were advanced disease (GAP Index stages II and III) and CTD (connective tissue disease)-ILDs. All cause hospitalisations were associated with pulmonary hypertension (OR 2.53, p = 0.005). ILD-related hospitalisations were associated with unclassifiable ILD and concomitant emphysema (OR = 2.133, p = 0.001) as well as with other granulomatous ILDs and a positive smoking status (OR = 3.082, p = 0.005). CONCLUSION: Our results represent a crucial contribution in understanding predisposing factors for hospitalisation in ILD and its major impact on mortality. Further studies to characterize the most vulnerable patient group as well as approaches to prevent hospitalisations are warranted.

Disease trajectories in interstitial lung diseases - data from the EXCITING-ILD registry.

BACKGROUND: Interstitial lung diseases (ILD) comprise a heterogeneous group of mainly chronic lung diseases with different disease trajectories. Progression (PF-ILD) occurs in up to 50% of patients and is associated with increased mortality. METHODS: The EXCITING-ILD (Exploring Clinical and Epidemiological Characteristics of Interstitial Lung Diseases) registry was analysed for disease trajectories in different ILD. The course of disease was classified as significant (absolute forced vital capacity FVC decline > 10%) or moderate progression (FVC decline 5-10%), stable disease (FVC decline or increase < 5%) or improvement (FVC increase ≥ 5%) during time in registry. A second definition for PF-ILD included absolute decline in FVC % predicted ≥ 10% within 24 months or ≥ 1 respiratory-related hospitalisation. Risk factors for progression were determined by Cox proportional-hazard models and by logistic regression with forward selection. Kaplan-Meier curves were utilised to estimate survival time and time to progression. RESULTS: Within the EXCITING-ILD registry 28.5% of the patients died (n = 171), mainly due to ILD (n = 71, 41.5%). Median survival time from date of diagnosis on was 15.5 years (range 0.1 to 34.4 years). From 601 included patients, progression was detected in 50.6% of the patients (n = 304) with shortest median time to progression in idiopathic NSIP (iNSIP; median 14.6 months) and idiopathic pulmonary fibrosis (IPF; median 18.9 months). Reasons for the determination as PF-ILD were mainly deterioration in lung function (PFT; 57.8%) and respiratory hospitalisations (40.6%). In multivariate analyses reduced baseline FVC together with age were significant predictors for progression (OR = 1.00, p < 0.001). Higher GAP indices were a significant risk factor for a shorter survival time (GAP stage III vs. I HR = 9.06, p < 0.001). A significant shorter survival time was found in IPF compared to sarcoidosis (HR = 0.04, p < 0.001), CTD-ILD (HR = 0.33, p < 0.001), and HP (HR = 0.30, p < 0.001). Patients with at least one reported ILD exacerbation as a reason for hospitalisation had a median survival time of 7.3 years (range 0.1 to 34.4 years) compared to 19.6 years (range 0.3 to 19.6 years) in patients without exacerbations (HR = 0.39, p < 0.001). CONCLUSION: Disease progression is common in all ILD and associated with increased mortality. Most important risk factors for progression are impaired baseline forced vital capacity and higher age, as well as acute exacerbations and respiratory hospitalisations for mortality. Early detection of progression remains challenging, further clinical criteria in addition to PFT might be helpful.

Cannabis use, health problems, and criminal offences in Germany: national and state-level trends between 2009 and 2021.

The German federal government plans to decriminalise cannabis. The impact of this policy on use prevalence, cannabis-related health and legal problems cannot be fully anticipated and should be viewed in context with current trends. We used routine data on (a) cannabis use (population-based surveys), (b) cannabis-related diagnoses (ICD-10 code F12) in outpatient medical settings and (c) minor law offences (registered violations against the narcotics law for possessing small amounts) to analyse age and sex-specific trends by federal state between 2009 and 2021. To enable comparisons across time and federal state besides crude prevalence rates, age-standardised rates were calculated. Between 2009 and 2021, the age-standardised prevalence of cannabis use (5.7-10.6%), rate of diagnoses (1.1-3.7 per 1,000), and legal offences (1.8-3.1 per 1,000) increased, with the largest increase noted for cannabis-related diagnoses. Relatively, increases were most pronounced for older users (40-to-59-year-olds: use and offences; 35-to-44-year-olds: cannabis-related diagnoses) and rather stagnant for minors. Cannabis use and health problems appear to be more pronounced in Northern and city states, while no clear geographic trend was observed for law offences. Cannabis-related outpatient treatment demand has risen more steeply than use prevalence suggesting an increasing challenge for the health care system. Despite rising rates for documented offences, the long-term implications of law violations on social and occupational life are poorly understood but may be considered for evaluations of the proposed law changes.

Cannabis-related treatment demand at the eve of German cannabis legalization - a 20-years trend analysis.

Post-2000, the prevalence of cannabis consumption has been rising internationally. This paper investigates whether cannabis-related treatment demand in German outpatient addiction care facilities (OACFs) has been following this trend. Treatment demand related to cannabis use disorder (CUD) for the period 2001 to 2021 was investigated using data from the nation-wide standardized German Addiction Care Statistical Service. Analyses covered all and first-time treatment admissions, demographics, and treatment outcomes. We identified years with significant changes in slope or direction of trends through joinpoint regression. Trends within the CUD client population were contrasted with trends among the entire OACF client population. CUD is the second-most common cause for OACF admissions in Germany. Between 2001 and 2021, the share of CUD-related cases among total OACF caseload increased from 7.1 to 19.9%, whereby the share of first-time treatment admissions declined from 79.6 to 55.6%. The share of CUD client population > 35 years almost tripled from 6.0 to 17.4%, that of female client population rose from 15.6 to 18.1%. From 2001 to 2007, the share of CUD-related treatments completed with improved symptomatology increased from 54.7 to 65.6%, followed by a marginal decline. CUD-related treatment demand is growing in Germany's OACFs, involving a client population that is increasingly older and more experienced with the addiction care system. As current intervention programmes mainly target adolescents and young adults who have been consuming cannabis only for a short time, adapting service offers to the changing client profiles appears paramount to improve treatment effectiveness.

Development of Gambling Behaviour and Its Relationship with Perceived Social Support: A Longitudinal Study of Young Adult Male Gamblers.

Young adult men who gamble frequently face an elevated risk of developing gambling-related problems. So far, little is known about how changing levels of perceived social support interact with the course of gambling behaviour and gambling-related problems in this population. Using data from a prospective single-arm cohort study (Munich Leisure Time Study), we applied hierarchical linear models to investigate the longitudinal association of changes in perceived emotional and social support (hereafter PESS; operationalized as ENRICHD Social Support Instrument score) with gambling intensity, gambling frequency, and fulfilled criteria for gambling disorder. Pooling data from three time points (baseline, 12-month and 24-month follow-ups) to assess two 1-year intervals, these models disentangle the associations of (a) "level of PESS" (cross-sectional, between participants) and (b) "changes in individual PESS" (longitudinally, within-participants). Among the 169 study participants, higher levels of PESS were associated with fewer gambling-related problems (- 0.12 criteria met; p = 0.014). Furthermore, increasing individual PESS was associated with lower gambling frequency (- 0.25 gambling days; p = 0.060) and intensity (- 0.11 gambling hours; p = 0.006), and fewer gambling-related problems (- 0.19 problems; p < 0.001). The results suggest a mitigating influence of PESS on gambling behaviour and gambling-related problems. Increasing individual PESS appears more decisive for this pathway than high initial levels of PESS. Treatment and prevention strategies that activate and reinforce beneficial social resources in people with gambling-related problems are recommended and promising.

Cost-Effectiveness of a Specialized Breathlessness Service Versus Usual Care for Patients With Advanced Diseases.

OBJECTIVES: The Munich Breathlessness Service (MBS) significantly improved control of breathlessness measured by the Chronic Respiratory Questionnaire (CRQ) Mastery in a randomized controlled fast track trial with waitlist group design spanning 8 weeks in Germany. This study aimed to assess the within-trial cost-effectiveness of MBS from a societal perspective. METHODS: Data included generic (5-level version of EQ-5D) health-related quality of life and disease-specific CRQ Mastery. Quality-adjusted life years (QALYs) were calculated based on 5-level version of EQ-5D utilities valued with German time trade-off. Direct medical costs and productivity loss were calculated based on standardized unit costs. Incremental cost-effectiveness ratios (ICER) and cost-effectiveness-acceptance curves were calculated using adjusted mean differences (AMD) in costs (gamma-distributed model) and both effect parameters (Gaussian-distributed model) and performing 1000 simultaneous bootstrap replications. Potential gender differences were investigated in stratified analyses. RESULTS: Between March 2014 and April 2019, 183 eligible patients were enrolled. MBS intervention demonstrated significantly better effects regarding generic (AMD of QALY gains of 0.004, 95% confidence interval [CI] 0.0003 to 0.008) and disease-specific health-related quality of life at nonsignificantly higher costs (AMD of €605 [95% CI -1109 to 2550]). At the end of the intervention, the ICER was €152 433/QALY (95% CI -453 545 to 1 625 903) and €1548/CRQ Mastery point (95% CI -3093 to 10 168). Intervention costs were on average €357 (SD = 132). Gender-specific analyses displayed dominance for MBS in males and higher effects coupled with significantly higher costs in females. CONCLUSIONS: Our results show a high ICER for MBS. Considering dominance for MBS in males, implementing MBS on approval within the German health care system should be considered.

Alcoholic Beverage Preference in Germany: An Age-Period-Cohort Analysis of Trends 1995-2018.

AIMS: Germany is experiencing a decline in alcohol consumption but not for every alcoholic beverage type. Given the differential health impacts of alcoholic beverage type, it is important to understand the drivers of these trends. We investigated: (a) temporal trends in beverage preference and (b) the effects of age, period and cohort on these trends. METHODS: Data came from nine waves (1995-2018; ntotal = 75,550) of the German Epidemiological Survey of Substance Abuse, a nationally representative household survey of individuals aged 18-59 years. The quantity of beer, wine, spirits and mixed drinks drank in the last 30 days was transformed into grammes of ethanol, and the beverage type preference was estimated as the proportion of total ethanol consumption. Fractional multinomial logit regression was applied to analyse the age, period and cohort effects on temporal trends of beverage preference by sex. RESULTS: The preference for spirits and mixed drinks decreased with increasing age, while the preference for wine increased with no age effect on beer. There was a general decrease in the preference for beer and an increase in the preference for wine among both sexes, with an additional increase in the preference for spirits in males. CONCLUSION: Trends in beverage preference were more related to individual ageing and changes in the whole population than to cohorts. With the continued reduction in alcohol consumption, the decreasing preference for beer and the growing preference for wine suggest a positive development. Trends of an increasing preference for spirits in males are of concern.

'We are not the ones to blame'. Gamblers' and providers' appraisal of self-exclusion in Germany.

BACKGROUND: Given low utilization by individuals experiencing gambling problems the potential of self-exclusion (SE) might be not fully exploited in Germany. This paper aims to gain insight into different actors' perceptions and reflections on the problems and difficulties in the process of self-exclusion to delineate which specific attitudes hamper a successful implementation of SE. METHODS: 13 individual and four group interviews with individuals experiencing gambling problems and governmental or commercial gambling providers were examined. A Grounded Theory Approach was used to portray the opinions of these different actors on existing regulations of SE and to delineate potentially diverging interests between the distinct groups. RESULTS: The interviewees agreed on the usefulness of SE and consented that it is important to early recognize individuals experiencing gambling problems. They also considered the present practice insufficient but for different reasons. Individuals experiencing gambling problems and providers particularly disagreed on addressing individuals experiencing gambling problems. While individuals experiencing gambling problems stated that they had hardly ever been approached, providers argued that help offers were mostly rejected. Especially commercial providers also regarded insufficient German language skills and rapid fluctuation of guests as strong barriers to approaching individuals experiencing gambling problems. Interviewees from governmental venues furthermore suspected that commercial providers took addressing individuals experiencing gambling problems less seriously. CONCLUSION: Our results emphasize the dilemma of conflicting interests in both individuals experiencing gambling problems and providers. Rather than acting against the economic interests of employers, venue staff blame individuals experiencing gambling problems for lack of problem recognition. Conversely, individuals experiencing gambling problems blame the providers for not offering help. To address individuals experiencing gambling problems appropriate staff training is required, and SE regulations need to be controlled by an independent body rather than by the providers themselves.

Healthcare resource utilisation and medical costs for children with interstitial lung diseases (chILD) in Europe.

BACKGROUND: No data on healthcare utilisation and associated costs for the many rare entities of children's interstitial lung diseases (chILD) exist. This paper portrays healthcare utilisation structures among individuals with chILD, provides a pan-European estimate of a 3-month interval per-capita costs and delineates crucial cost drivers. METHODS: Based on longitudinal healthcare resource utilisation pattern of 445 children included in the Kids Lung Register diagnosed with chILD across 10 European countries, we delineated direct medical and non-medical costs of care per 3-month interval. Country-specific utilisation patterns were assessed with a children-tailored modification of the validated FIMA questionnaire and valued by German unit costs. Costs of care and their drivers were subsequently identified via gamma-distributed generalised linear regression models. RESULTS: During the 3 months prior to inclusion into the registry (baseline), the rate of hospital admissions and inpatient days was high. Unadjusted direct medical per capita costs (€19 818) exceeded indirect (€1 907) and direct non-medical costs (€1 125) by far. Country-specific total costs ranged from €8 713 in Italy to €28 788 in Poland. Highest expenses were caused by the disease categories 'diffuse parenchymal lung disease (DPLD)-diffuse developmental disorders' (€45 536) and 'DPLD-unclear in the non-neonate' (€47 011). During a follow-up time of up to 5 years, direct medical costs dropped, whereas indirect costs and non-medical costs remained stable. CONCLUSIONS: This is the first prospective, longitudinal study analysing healthcare resource utilisation and costs for chILD across different European countries. Our results indicate that chILD is associated with high utilisation of healthcare services, placing a substantial economic burden on health systems.

Comparing outcomes of ILD patients managed in specialised versus non-specialised centres.

BACKGROUND: Early appropriate diagnosis and treatment of interstitial lung diseases (ILD) is crucial to slow disease progression and improve survival. Yet it is unknown whether initial management in an expert centre is associated with improved outcomes. Therefore, we assessed mortality, hospitalisations and health care costs of ILD patients initially diagnosed and managed in specialised ILD centres versus non-specialised centres and explored differences in pharmaceutical treatment patterns. METHODS: An epidemiological claims data analysis was performed, including patients with different ILD subtypes in Germany between 2013 and 2018. Classification of specialised centres was based on the number of ILD patients managed and procedures performed, as defined by the European Network on Rare Lung Diseases. Inverse probability of treatment weighting was used to adjust for covariates. Mortality and hospitalisations were examined via weighted Cox models, cost differences by weighted gamma regression models and differences in treatment patterns with weighted logistic regressions. RESULTS: We compared 2022 patients managed in seven specialised ILD centres with 28,771 patients managed in 1156 non-specialised centres. Specialised ILD centre management was associated with lower mortality (HR: 0.87, 95% CI 0.78; 0.96), lower all-cause hospitalisation (HR: 0.93, 95% CI 0.87; 0.98) and higher respiratory-related costs (€669, 95% CI €219; €1156). Although risk of respiratory-related hospitalisations (HR: 1.00, 95% CI 0.92; 1.10) and overall costs (€- 872, 95% CI €- 75; €1817) did not differ significantly, differences in treatment patterns were observed. CONCLUSION: Initial management in specialised ILD centres is associated with improved mortality and lower all-cause hospitalisations, potentially due to more differentiated diagnostic approaches linked with more appropriate ILD subtype-adjusted therapy.

Epidemiology, healthcare utilization, and related costs among patients with IPF: results from a German claims database analysis.

BACKGROUND: Idiopathic pulmonary fibrosis (IPF) is a progressive form of fibrosing interstitial pneumonia with poor survival. This study provides insight into the epidemiology, cost, and disease course of IPF in Germany. METHODS: A cohort of incident patients with IPF (n = 1737) was identified from German claims data (2014-2019). Incidence and prevalence rates were calculated and adjusted for age differences compared with the overall German population. All-cause and IPF-related healthcare resource utilization as well as associated costs were evaluated per observed person-year (PY) following the initial IPF diagnosis. Finally, Kaplan-Meier analyses were performed to assess time from initial diagnosis to disease deterioration (using three proxy measures: non-elective hospitalization, IPF-related hospitalization, long-term oxygen therapy [LTOT]); antifibrotic therapy initiation; and all-cause death. RESULTS: The cumulative incidence of IPF was estimated at 10.7 per 100,000 individuals in 2016, 10.9 in 2017, 10.5 in 2018, and 9.6 in 2019. The point prevalence rates per 100,000 individuals for the respective years were 21.7, 23.5, 24.1, and 24.1. On average, ≥ 14 physician visits and nearly two hospitalizations per PY were observed after the initial IPF diagnosis. Of total all-cause direct costs (€15,721/PY), 55.7% (€8754/PY) were due to hospitalizations and 29.1% (€4572/PY) were due to medication. Medication accounted for 49.4% (€1470/PY) and hospitalizations for 34.8% (€1034/PY) of total IPF-related direct costs (€2973/PY). Within 2 years of the initial IPF diagnosis (23.6 months), 25% of patients died. Within 5 years of diagnosis, 53.1% of patients had initiated LTOT; only 11.6% were treated with antifibrotic agents. The median time from the initial diagnosis to the first non-elective hospitalization was 5.5 months. CONCLUSION: The incidence and prevalence of IPF in Germany are at the higher end of the range reported in the literature. The main driver for all-cause cost was hospitalization. IPF-related costs were mainly driven by medication, with antifibrotic agents accounting for around one-third of the total medication costs even if not frequently prescribed. Most patients with IPF do not receive pharmacological treatment, highlighting the existing unmet medical need for effective and well-tolerated therapies.

Association of physical activity with utilization of long-term care in community-dwelling older adults in Germany: results from the population-based KORA-Age observational study.

BACKGROUND: Physical activity (PA) is a proven strategy to prevent chronic diseases and reduce falls. Furthermore, it improves or at least maintains performance of activities of daily living, and thus fosters an independent lifestyle in older adults. However, evidence on the association of PA with relevant subgroups, such as older adults with utilization of long-term care (LTC), is sparse. This knowledge would be essential for establishing effective, need-based strategies to minimize the burden on healthcare systems due to the increasing need for LTC in old age. METHODS: Data originate from the 2011/12 (t1) baseline assessment and 2016 (t2) follow-up of the population-based Cooperative Health Research in the Region of Augsburg (KORA-)Age study in southern Germany. In 4812 observations of individuals ≥65 years, the association between various types of PA (walking, exercise (i. e., subcategory of PA with the objective to improve or maintain one or more components of physical fitness), walking+exercise) and utilization of LTC (yes/no) was analyzed using generalized estimating equation logistic models. Corresponding models stratified by sex (females: 2499 observations; males: 2313 observations) examined sex-specific associations. Descriptive analyses assessed the proportion of individuals meeting the suggested minimum values in the German National Physical Activity Recommendations for older adults (GNPAR). RESULTS: All types of PA showed a statistically significant association with non-utilization of LTC in the entire cohort. "Walking+exercise" had the strongest association with non-utilization of LTC in the entire cohort (odds ratio (OR): 0.52, 95% confidence interval (CI): 0.39-0.70) and in males (OR: 0.41, CI: 0.26-0.65), whereas in females it was "exercise" (OR: 0.58; CI: 0.35-0.94). The proportion of individuals meeting the GNPAR was higher among those without utilization of LTC (32.7%) than among those with LTC (11.7%) and group differences were statistically significant (p ≤ 0.05). CONCLUSIONS: The GNPAR are rarely met by older adults. However, doing any type of PA is associated with non-utilization of LTC in community-dwelling older adults. Therefore, older adults should be encouraged to walk or exercise regularly. Furthermore, future PA programs should consider target-groups' particularities to reach individuals with the highest needs for support.

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.

Age, period, and cohort effects on trends in outpatient addiction care utilization in the general Berlin population from 2008 to 2016.

BACKGROUND: The aim of this study was to decompose independent effects of age, period, and cohort on trends in outpatient addiction care utilization resulting from alcohol (AUD) and illicit substances use disorders (ISUD). Decomposing trends in addiction care utilization into their independent effects by age, period, and cohort may lead to a better understanding of utilization patterns. METHODS: Individuals seeking help in Berlin outpatient addiction care facilities between 2008 and 2016 with an age range of 18-81 years for AUD (n = 46,706) and 18-70 years for ISUD (n = 51,113) were standardized to the general Berlin population using data from the German Federal Statistical Office. Classification of utilization as AUD- (F10) or ISUD-related (F11, F12, F14, F15, F16, F18, F19) help-seeking was based on primary diagnoses according to the International Statistical Classification of Diseases and Related Health Problems. Age was measured in years and period as year of data collection. Cohort was defined as the mathematical difference between period and age. Age, period, and cohort analyses were conducted using the intrinsic estimator model on AUD- and ISUD-related outpatient addiction care utilization. RESULTS: Age effects on AUD-related utilization were highest in 18- to 19-year-old and in 39- to 59-year-old individuals. ISUD-related utilization declined almost continuously with increasing age. Period effects on AUD- and ISUD-related utilization were small. AUD-related utilization was highest in cohorts born from 1951 to 1986. ISUD-related utilization increased in cohorts born between 1954 and 1973 where utilization peaked, followed by a decline of the same order. CONCLUSIONS: Age and cohort effects were the strongest drivers of trends in AUD- and ISUD-related outpatient addiction care utilization. Onset of help-seeking in earlier phases of AUD development should be enhanced as well as help-seeking for AUD and ISUD in general. The highest cohort-related rates in the baby boomer and following cohorts for AUD and ISUD underline an increased demand for addiction care.

Effectiveness of a specialised breathlessness service for patients with advanced disease in Germany: a pragmatic fast-track randomised controlled trial (BreathEase).

BACKGROUND: The effectiveness of the Munich Breathlessness Service (MBS), integrating palliative care, respiratory medicine and physiotherapy, was tested in the BreathEase trial in patients with chronic breathlessness in advanced disease and their carers. METHODS: BreathEase was a single-blinded randomised controlled fast-track trial. The MBS was attended for 5-6 weeks; the control group started the MBS after 8 weeks of standard care. Randomisation was stratified by cancer and the presence of a carer. Primary outcomes were patients' mastery of breathlessness (Chronic Respiratory Disease Questionnaire (CRQ) Mastery), quality of life (CRQ QoL), symptom burden (Integrated Palliative care Outcome Scale (IPOS)) and carer burden (Zarit Burden Interview (ZBI)). Intention-to-treat (ITT) analyses were conducted with hierarchical testing. Effectiveness was investigated by linear regression on change scores, adjusting for baseline scores and stratification variables. Missing values were handled with multiple imputation. RESULTS: 92 patients were randomised to the intervention group and 91 patients were randomised to the control group. Before the follow-up assessment after 8 weeks (T1), 17 and five patients dropped out from the intervention and control groups, respectively. Significant improvements in CRQ Mastery of 0.367 (95% CI 0.065-0.669) and CRQ QoL of 0.226 (95% CI 0.012-0.440) score units at T1 in favour of the intervention group were seen in the ITT analyses (n=183), but not in IPOS. Exploratory testing showed nonsignificant improvements in ZBI. CONCLUSIONS: These findings demonstrate positive effects of the MBS in reducing burden caused by chronic breathlessness in advanced illness across a wide range of patients. Further evaluation in subgroups of patients and with a longitudinal perspective is needed.

Pirfenidone vs. nintedanib in patients with idiopathic pulmonary fibrosis: a retrospective cohort study.

BACKGROUND: Two antifibrotic drugs, pirfenidone and nintedanib, are licensed for the treatment of patients with idiopathic pulmonary fibrosis (IPF). However, there is neither evidence from prospective data nor a guideline recommendation, which drug should be preferred over the other. This study aimed to compare pirfenidone and nintedanib-treated patients regarding all-cause mortality, all-cause and respiratory-related hospitalizations, and overall as well as respiratory-related health care costs borne by the Statutory Health Insurance (SHI). METHODS: A retrospective cohort study with SHI data was performed, including IPF patients treated either with pirfenidone or nintedanib. Stabilized inverse probability of treatment weighting (IPTW) based on propensity scores was applied to adjust for observed covariates. Weighted Cox models were estimated to analyze mortality and hospitalization. Weighted cost differences with bootstrapped 95% confidence intervals (CI) were applied for cost analysis. RESULTS: We compared 840 patients treated with pirfenidone and 713 patients treated with nintedanib. Both groups were similar regarding two-year all-cause mortality (HR: 0.90 95% CI: 0.76; 1.07), one-year all cause (HR: 1.09, 95% CI: 0.95; 1.25) and respiratory-related hospitalization (HR: 0.89, 95% CI: 0.72; 1.08). No significant differences were observed regarding total (€- 807, 95% CI: €- 2977; €1220) and respiratory-related (€- 1282, 95% CI: €- 3423; €534) costs. CONCLUSION: Our analyses suggest that the patient-related outcomes mortality, hospitalization, and costs do not differ between the two currently available antifibrotic drugs pirfenidone and nintedanib. Hence, the decision on treatment with pirfenidone versus treatment with nintedanib ought to be made case-by-case taking clinical characteristics, comorbidities, comedications, individual risk of side effects, and patients' preferences into account.

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.

Cost drivers in the pharmacological treatment of interstitial lung disease.

INTRODUCTION: Treatments of interstitial lung diseases (ILDs) mainly focus on disease stabilization and relief of symptoms by managing inflammation or suppressing fibrosis by (in part costly) drugs. To highlight economic burden of drug treatment in different ILD-subtypes we assessed cost trends and therewith-associated drivers. METHODS: Using data from the German, observational HILDA study we estimated adjusted mean medication costs over 36-month intervals using one- and two-part Generalized Estimating Equation (GEE) regression models with a gamma distribution and log link. Next, we determined factors associated with costs. RESULTS: In Idiopathic pulmonary fibrosis (IPF) mean per capita medication costs increased from €1442 before to €11,000€ at the end of study. In non-IPF subtypes, the increase took place at much lower level. Mean per capita ILD-specific medication costs at the end of the study ranged between €487 (other ILD) and €9142 (IPF). At baseline, higher FVC %predicted values were associated with lower medication costs in IPF (-9%) and sarcoidosis (-1%). During follow up higher comorbidity burden escalated costs in progressive fibrosing ILD (PF-ILD) (+52%), sarcoidosis (+60%) and other ILDs (+24%). The effect of disease duration was not uniform, with cost savings in PF-ILD (-8%) and sarcoidosis (-6%), but increased spending in IPF (+11%). CONCLUSION: Pharmacological management of ILD, in particular of IPF imposes a substantial economic burden on the healthcare system. Strategies to reduce comorbidity burden and early treatment may reduce the impact of ILDs on the healthcare system.

Cost-Effectiveness of Pulmonary Rehabilitation in Patients With Bronchial Asthma: An Analysis of the EPRA Randomized Controlled Trial.

OBJECTIVES: At 3 months after the intervention, this study evaluates the cost-effectiveness of a 3-week inpatient pulmonary rehabilitation (PR) in patients with asthma compared with usual care alongside the single-center randomized controlled trial-Effectiveness of Pulmonary Rehabilitation in Patients With Asthma. METHODS: Adopting a societal perspective, direct medical costs and productivity loss were assessed using the Questionnaire for Health-Related Resource Use-Lung, a modification of the FIM in an Elderly Population. The effect side was operationalized as minimal important differences (MIDs) of the Asthma Control Test (ACT) and the Asthma Quality of Life Questionnaire (AQLQ) and through quality-adjusted life-years (QALYs) gained. Adjusted mean differences in costs (gamma-distributed model) and each effect parameter (Gaussian-distributed model) were simultaneously calculated within 1000 bootstrap replications to determine incremental cost-effectiveness ratios (ICERs) and to subsequently delineate cost-effectiveness acceptability curves. RESULTS: PR caused mean costs per capita of €3544. Three months after PR, we observed higher mean costs (Δ€3673; 95% confidence interval (CI) €2854-€4783) and improved mean effects (ACT Δ1.59 MIDs, 95% CI 1.37-1.81; AQLQ Δ1.76 MIDs, 95% CI 1.46-2.08; QALYs gained Δ0.01, 95% CI 0.01-0.02) in the intervention group. The ICER was €2278 (95% CI €1653-€3181) per ACT-MID, €1983 (95% CI €1430-€2830) per AQLQ-MID, and €312 401 (95% CI €209 206-€504 562) per QALY gained. CONCLUSIONS: Contrasting of PR expenditures with ICERs suggests that the intervention, which achieves clinically relevant changes in asthma-relevant parameters, has a high probability to be already cost-effective in the short term. However, in terms of QALYs, extended follow-up periods are likely required to comprehensively judge the added value of a one-time initial investment in PR.

Is bouldering-psychotherapy a cost-effective way to treat depression when compared to group cognitive behavioral therapy - results from a randomized controlled trial.

BACKGROUND: Bouldering-Psychotherapy (BPT) has proven to effectively reduce depressive symptoms, but evidence on its cost-effectiveness is lacking. Corresponding information is paramount to support health policy decision making on a potential implementation of BPT in routine care. METHODS: Using data from the German KuS trial BPT was compared with group Cognitive Behavioral Therapy (CBT). Severity of depression symptoms at end of the intervention was operationalized via Montgomery-Asberg Depression Rating Scale (MADRS) and Patient Health Questionnaire (PHQ-9). Adopting a societal perspective, direct medical costs and productivity loss were calculated based on standardized unit costs. To determine incremental cost-effectiveness ratios (ICER) and cost-effectiveness-acceptance curves (CEAC), adjusted mean differences (AMD) in costs (gamma-distributed model) and both effect parameters (Gaussian-distributed model) were obtained from 1000 simultaneous bootstrap replications. RESULTS: BPT was related to improved effects (AMDs: MADRS -2.58; PHQ-9: - 1.35) at higher costs (AMD: +€ 754). No AMD was significant. ICERs amounted to €288 per MADRS-point and €550 per PHQ-9-point. For both effect parameters about 20% of bootstrap replications indicated dominance of BPT, and about 75% larger effects at higher costs. At hypothetical willingness to pay (WTP) thresholds of €241 (MADRS) and €615 (PHQ-9) per unit of change BPT had a 50% probability of being cost-effective. CONCLUSION: BPT is a promising alternate treatment strategy which - in absence of established WTP thresholds for improving symptoms of depression - cannot unambiguously be claimed cost-effective. Further studies defining subgroups that particularly benefit from BPT appear paramount to delineate recommendations for an efficient prospective roll-out to routine care.