Oxygen uptake efficiency plateau is unaffected by fitness level - the NOODLE study.

BACKGROUND: Endurance athletes (EA) are an emerging population of focus for cardiovascular health. The oxygen uptake efficiency plateau (OUEP) is the levelling-off period of ratio between oxygen uptake (VO2) and ventilation (VE). In the cohort of EA, we externally validated prediction models for OUEP and derived with internal validation a new equation. METHODS: 140 EA underwent a medical assessment and maximal cycling cardiopulmonary exercise test. Participants were 55% male (N = 77, age = 21.4 ± 4.8 years, BMI = 22.6 ± 1.7 kg·m- 2, peak VO2 = 4.40 ± 0.64 L·min- 1) and 45% female (N = 63, age = 23.4 ± 4.3 years, BMI = 22.1 ± 1.6 kg·m- 2, peak VO2 = 3.21 ± 0.48 L·min- 1). OUEP was defined as the highest 90-second continuous value of the ratio between VO2 and VE. We used the multivariable stepwise linear regression to develop a new prediction equation for OUEP. RESULTS: OUEP was 44.2 ± 4.2 mL·L- 1 and 41.0 ± 4.8 mL·L- 1 for males and females, respectively. In external validation, OUEP was comparable to directly measured and did not differ significantly. The prediction error for males was - 0.42 mL·L- 1 (0.94%, p = 0.39), and for females was + 0.33 mL·L- 1 (0.81%, p = 0.59). The developed new prediction equation was: 61.37-0.12·height (in cm) + 5.08 (for males). The developed model outperformed the previous. However, the equation explained up to 12.9% of the variance (R = 0.377, R2 = 0.129, RMSE = 4.39 mL·L- 1). CONCLUSION: OUEP is a stable and transferable cardiorespiratory index. OUEP is minimally affected by fitness level and demographic factors. The predicted OUEP provided promising but limited accuracy among EA. The derived new model is tailored for EA. OUEP could be used to stratify the cardiorespiratory response to exercise and guide training.

Influence of voluntary isocapnic hyperpnoea on recovery after high-intensity exercise in elite short-track speedskaters - randomized controlled trial.

Respiratory muscle training plays a significant role in reducing blood lactate concentration (bLa) and attenuating negative physiological stress reactions. Therefore, we investigated if voluntary isocapnic hyperpnoea (VIH) performed after a maximum anaerobic effort influences bLa and perceived fatigue level in well-trained speedskaters. 39 elite short-track speedskaters participated in a trial with two parallel groups: experimental and control. All the participants performed the Wingate Anaerobic Test (WAnT). The experimental group performed a VIH-based recovery protocol 20 min after exercise, the control group used passive recovery only. Blood samples were taken 3 and 30 min after the WAnT to measure bLa. Fatigue was self-appraised on a 0-10 perceived rating-of-fatigue (ROF) scale 3 and 30 min after the WAnT. Noteworthy, but not statistically significant changes between the experimental and control groups were observed for changes in bLa (p = 0.101). However, statistically significant changes between the groups were found for ROF (p = 0.003, ηp2 = 0.211, ω2 = 0.106). Moreover, statistically significant interactions between post-exercise bLa clearance and VO2max (p = 0.028) and inspiratory muscle strength (p = 0.040) were observed. Our findings provided preliminary insight that VIH may be an efficient recovery protocol after anaerobic exercise performed by elite athletes. The association between VO2max and post-exercise bLa clearance indicates the vital role of aerobic fitness in repeated-efforts ability in short-track speedskaters. The study was registered at ClinicalTrials.gov as NCT05994092 on 15th August 2023.

Estimating excess mortality and economic burden of Clostridioides difficile infections and recurrences during 2015-2019: the RECUR Germany study.

BACKGROUND: Clostridioides difficile infections (CDIs) and recurrences (rCDIs) remain a major public health challenge due to substantial mortality and associated costs. This study aims to generate real-world evidence on the mortality and economic burden of CDI in Germany using claims data between 2015 and 2019. METHODS: A longitudinal and matched cohort study using retrospective data from Statutory Health Insurance (SHI) was conducted in Germany with the BKK database. Adults diagnosed with CDI in hospital and community settings between 2015 and 2018 were included in the study. Patients had a minimum follow-up of 12-months. All-cause mortality was described at 6-, 12-, and 24-months. Healthcare resource usage (HCRU) and associated costs were assessed at 12-months of follow-up. A cohort of non-CDI patients matched by demographic and clinical characteristics was used to assess excess mortality and incremental costs of HCRU. Up to three non-CDI patients were matched to each CDI patient. RESULTS: A total of 9,977 CDI patients were included in the longitudinal cohort. All-cause mortality was 32%, 39% and 48% at 6-, 12-, and 24-months, respectively, with minor variations by number of rCDIs. When comparing matched CDI (n = 5,618) and non-CDI patients (n = 16,845), CDI patients had an excess mortality of 2.17, 1.35, and 0.94 deaths per 100 patient-months, respectively. HCRU and associated costs were consistently higher in CDI patients compared to non-CDI patients and increased with recurrences. Total mean and median HCRU cost per patient during follow-up was €12,893.56 and €6,050 in CDI patients, respectively, with hospitalisations representing the highest proportion of costs. A total mean incremental cost per patient of €4,101 was estimated in CDI patients compared to non-CDI patients, increasing to €13,291 in patients with ≥ 3 rCDIs. CONCLUSIONS: In this real-world study conducted in Germany, CDI was associated with increased risk of death and substantial costs to health systems due to higher HCRU, especially hospitalisations. HCRU and associated costs were exacerbated by rCDIs.

Epidemiological and clinical burden of Clostridioides difficile infections and recurrences between 2015 - 2019: the RECUR Germany study.

BACKGROUND: This real-world study assessed the epidemiology and clinical complications of Clostridioides difficile infections (CDIs) and recurrences (rCDIs) in hospital and community settings in Germany from 2015 - 2019. METHODS: An observational retrospective cohort study was conducted among adult patients diagnosed with CDI in hospital and community settings using statutory health insurance claims data from the BKK database. A cross-sectional approach was used to estimate the annual incidence rate of CDI and rCDI episodes per 100,000 insurants. Patients' demographic and clinical characteristics were described at the time of first CDI episode. Kaplan-Meier method was used to estimate the time to rCDIs and time to complications (colonic perforation, colectomy, loop ileostomy, toxic megacolon, ulcerative colitis, peritonitis, and sepsis). A Cox model was used to assess the risk of developing complications, with the number of rCDIs as a time-dependent covariate. RESULTS: A total of 15,402 CDI episodes were recorded among 11,884 patients. The overall incidence of CDI episodes declined by 38% from 2015 to 2019. Most patients (77%) were aged ≥ 65 years. Around 19% of CDI patients experienced at least one rCDI. The median time between index CDI episode to a rCDI was 20 days. The most frequent complication within 12-months of follow-up after the index CDI episode was sepsis (7.57%), followed by colectomy (3.20%). The rate of complications increased with the number of rCDIs. The risk of any complication increased by 31% with each subsequent rCDI (adjusted hazard ratio [HR]: 1.31, 95% confidence interval: 1.17;1.46). CONCLUSIONS: CDI remains a public health concern in Germany despite a decline in the incidence over recent years. A substantial proportion of CDI patients experience rCDIs, which increase the risk of severe clinical complications. The results highlight an increasing need of improved therapeutic management of CDI, particularly efforts to prevent rCDI.

Is the Ventilatory Efficiency in Endurance Athletes Different?-Findings from the NOODLE Study.

Background: Ventilatory efficiency (VE/VCO2) is a strong predictor of cardiovascular diseases and defines individuals' responses to exercise. Its characteristics among endurance athletes (EA) remain understudied. In a cohort of EA, we aimed to (1) investigate the relationship between different methods of calculation of VE/VCO2 and (2) externally validate prediction equations for VE/VCO2. Methods: In total, 140 EA (55% males; age = 22.7 ± 4.6 yrs; BMI = 22.6 ± 1.7 kg·m-2; peak oxygen uptake = 3.86 ± 0.82 L·min-1) underwent an effort-limited cycling cardiopulmonary exercise test. VE/VCO2 was first calculated to ventilatory threshold (VE/VCO2-slope), as the lowest 30-s average (VE/VCO2-Nadir) and from whole exercises (VE/VCO2-Total). Twelve prediction equations for VE/VCO2-slope were externally validated. Results: VE/VCO2-slope was higher in females than males (27.7 ± 2.6 vs. 26.1 ± 2.0, p < 0.001). Measuring methods for VE/VCO2 differed significantly in males and females. VE/VCO2 increased in EA with age independently from its type or sex (ß = 0.066-0.127). Eleven equations underestimated VE/VCO2-slope (from -0.5 to -3.6). One equation overestimated VE/VCO2-slope (+0.2). Predicted and observed measurements differed significantly in nine models. Models explained a low amount of variance in the VE/VCO2-slope (R2 = 0.003-0.031). Conclusions: VE/VCO2-slope, VE/VCO2-Nadir, and VE/VCO2-Total were significantly different in EA. Prediction equations for the VE/VCO2-slope were inaccurate in EA. Physicians should be acknowledged to properly assess cardiorespiratory fitness in EA.

Renal Replacement Therapy in People With and Without Diabetes in Germany, 2010-2016: An Analysis of More Than 25 Million Inhabitants.

OBJECTIVE: Epidemiological studies have shown contradictory results regarding the time trend of end-stage renal disease (ESRD) in people with diabetes. This study aims to analyze the incidence of ESRD, defined as chronic renal replacement therapy (RRT), to investigate time trends among people with and without diabetes in Germany and to examine whether these patterns differ by age and sex. RESEARCH DESIGN AND METHODS: The data were sourced from nationwide data pooled from two German branches of statutory health insurances covering ∼25 million inhabitants. We estimated age- and sex-standardized incidence rates (IRs) for chronic RRT among people with and without diabetes in 2010-2016 and the corresponding relative risks. Time trends were analyzed using Poisson regression. RESULTS: We identified 73,638 people with a first chronic RRT (male 60.0%, diabetes 60.6%, mean age 71.3 years). The IR of chronic RRT among people with diabetes (114.1 per 100,000 person-years [95% CI 110.0-117.2]) was almost six times higher than among people without diabetes (19.6 [19.4-19.8]). A consistent decline in IR was observed among people with diabetes (3% annual reduction, P < 0.0001) for both sexes and all age classes. In contrast, no consistent change of IR was identified in people without diabetes. Only among women aged <40 years (P = 0.0003) and people aged ≥80 years (P < 0.0001) did this IR decrease significantly. CONCLUSIONS: Incidence of chronic RRT remained significantly higher among people with diabetes. The IR decreased significantly in people with diabetes independent of age and sex. Time trends were inconsistent in people without diabetes.

Do implantable loop recorders impact the survival of patients with recurrent unexplained syncope?

Aim: This study compares the outcomes of patients who receive an implantable loop recorder (ILR) for unexplained syncope to a control group without the diagnostic device in German claims data. Methods and materials: Patients with ILR were matched to a control group based on prior syncope events, age, gender and Charlson Comorbidity index (CCI). Survival, syncope hospitalizations, treatment and costs were compared. Results/conclusion: Four hundred and twelve ILR patients were matched with controls, mean age was 68, mean CCI was 2.7, 42% females. ILR patients lived on average 1.2 years longer than patients in the control group. Twenty-five percent of ILR patients received a therapeutic device compared with 5% in the control group. ILRs might help to diagnose and treat patients with positive impact on survival.

Time to Treatment Discontinuation in German Patients with Schizophrenia: Long-Acting Injectables versus Oral Antipsychotics.

BACKGROUND AND OBJECTIVE: Long-acting injectable antipsychotics (LAIs) are associated with better treatment adherence and persistence than oral antipsychotics (OAPs) in patients with schizophrenia. However, real-world evidence assessing the impact of treatment with LAIs in Germany is limited. To fill this gap, we compared antipsychotic medication adherence and risk of treatment discontinuation (TD) among schizophrenia patients newly initiated on LAI or who switched their OAP regimen (overall cohort; OC). METHODS: Claims data of German schizophrenia patients who initiated LAIs or switched their OAP during 2012-2016 (index date) were retrospectively analyzed. Treatment switch was defined as add-on medication to existing prescription or terminating the existing prescription and initiating another OAP. Adherence and time to treatment discontinuation (TTD) were estimated. Determinants of treatment discontinuation were analyzed using two Cox regression models. Model 1 controlled for age, sex, and Charlson Comorbidity Index (CCI); model 2 also included insurance status, and medication, visit, and psychiatric inpatient stay costs. Sensitivity analysis on patients who terminated existing prescriptions and initiated new OAPs (complete switch cohort; CSC) was performed. RESULTS: In OC (n = 2650), LAI users had better adherence (35.4% vs. 11.6%), persistence (no 60-day gap; 40.7% vs. 19.8%), and longer TTD (median [95% confidence interval (CI)] 216 [193-249] vs. 50 [46-56] days) than OAP users. OAP usage (hazard ratio [HR] 1.89, 95% CI 1.73-2.06; p < 0.001) and greater CCI (HR 1.04, 95% CI 1.00-1.07; p = 0.023) were associated with greater risk of TD in model 1. Model 2 showed similar results. LAI users in CSC also had better adherence, persistence, and longer TTD. In CSC too, OAP usage and greater CCI were associated with greater risk of TD in model 1, but only CCI was significant in model 2. Higher pre-index psychiatric inpatient costs were associated with lower risk of TD (HR 0.99, 95% CI 0.98-1.00; p = 0.014). LIMITATIONS: Inherent limitations of claims data and lack of control on OAP administration may have influenced the results. CONCLUSION: This real-world study associates LAIs with better medication adherence and lower antipsychotic discontinuation risk than OAPs.

Hospitalization Rates and Therapy Costs of German Schizophrenia Patients Who are Initiated on Long-Acting Injectable Medication: A Mirror-Image Study.

BACKGROUND: Long-acting injectable (LAI) antipsychotics can reduce relapse, hospitalization, and costs in patients with schizophrenia. However, real-world evidence assessing the impact of treatment with LAIs in Germany is limited. OBJECTIVE: To provide updated evidence on the impact of LAI initiation on hospitalization rates and therapy costs. METHODS: Using a mirror-image design, claims data of 850 German patients with schizophrenia who initiated treatment with LAIs during 2013-2015 was retrospectively analyzed. For the included patients, costs and resource utilization were compared for the 12 months before the index date (first initiation of LAI) and the 12 months after the index date. Annual treatment costs, hospitalization rates, ambulatory visits, sick leaves and medical aids were assessed. Two models were used to evaluate hospitalization and its costs. In model 1, hospitalization during the index date (first LAI prescription in 2013-2015) was allocated to the "pre-" time interval, while in model 2 it was neither attributed to the pre- nor to the post-index date. Regression analysis was performed to identify patients who benefited the most in terms of cost reduction from LAI initiation. RESULTS: Medication costs were significantly higher post-switching to LAI compared with pre-switching period (€3832 vs €799; p < 0.001). In model 1, number of hospitalizations, days hospitalized, and associated costs were significantly lower post-switching compared with pre-switching (2.3 vs 2.6; 59.2 vs 73.4; and €5355 vs €11,908, respectively; all p < 0.001). Similar results were obtained for costs in model 2 (€5355 vs €10,276; p < 0.001). Mean total costs reduced significantly from pre-switching to post-switching period in model 1 (€13,776 vs €10,418; p < 0.001). Patients with characteristics such as higher number of non-psychiatric and psychiatric inpatient stays during the pre-index period (all p < 0.05) benefited the most from cost reduction after LAI initiation. CONCLUSION: In this cohort of German patients with schizophrenia, treatment initiation with LAI resulted in reduced hospitalization rates and total costs.

Lower-extremity amputations in people with and without diabetes in Germany, 2008-2012 - an analysis of more than 30 million inhabitants.

BACKGROUND AND PURPOSE: Lower-extremity amputations (LEAs) in people with diabetes are associated with reduced quality of life and increased health care costs. Detailed knowledge on amputation rates (ARs) is of utmost importance for future health care and economics strategies. We conducted the present cohort study in order to estimate the incidences of LEA as well as relative and attributable risk due to diabetes and to investigate time trends for the period 2008-2012. METHODS: On the basis of the administrative data from three large branches of German statutory health insurers, covering ~34 million insured people nationwide (about 40% of the German population), we estimated age-sex-standardized AR (first amputation per year) in the populations with and without diabetes for any, major, and minor LEAs. Time trends were analyzed using Poisson regression. RESULTS: A total of 108,208 individuals (diabetes: 67.3%; mean age 72.6 years) had at least one amputation. Among people with diabetes, we observed a significant reduction in major and minor ARs during 2008-2012 from 81.2 (95% CI 77.5-84.9) to 58.4 (55.0-61.7), and from 206.1 (197.3-214.8) to 177.0 (169.7-184.4) per 100,000 person-years, respectively. Among people without diabetes, the major AR decreased significantly from 14.3 (13.9-14.8) to 11.6 ([11.2-12.0], 12.0), whereas the minor AR increased from 15.8 (15.3-16.3) to 17.0 (16.5-17.5) per 100,000 person-years. The relative risk (RR) comparing the diabetic with the nondiabetic populations decreased significantly for both major and minor LEAs (4% and 5% annual reduction, respectively). CONCLUSION: In this large nationwide population, we still found higher major and minor ARs among people with diabetes compared with those without diabetes. However, AR and RR of major and minor LEAs in the diabetic compared with the nondiabetic population decreased significantly during the study period, confirming a positive trend that has been observed in smaller and regional studies in recent years.