Publications by authors named "Ursula Marschall"

50 Publications

Optimization of sepsis therapy based on patient-specific digital precision diagnostics using next generation sequencing (DigiSep-Trial)-study protocol for a randomized, controlled, interventional, open-label, multicenter trial.

Trials 2021 Oct 18;22(1):714. Epub 2021 Oct 18.

Department of Anesthesiology and Intensive Care Medicine, Essen University Hospital, University Duisburg-Essen, Hufelandstr. 55, 45147, Essen, Germany.

Background: Sepsis is triggered by an infection and represents one of the greatest challenges of modern intensive care medicine. With regard to a targeted antimicrobial treatment strategy, the earliest possible pathogen detection is of crucial importance. Until now, culture-based detection methods represent the diagnostic gold standard, although they are characterized by numerous limitations. Culture-independent molecular diagnostic procedures represent a promising alternative. In particular, the plasmatic detection of circulating, cell-free DNA by next-generation sequencing (NGS) has shown to be suitable for identifying disease-causing pathogens in patients with bloodstream infections.

Methods: The DigiSep-Trial is a randomized, controlled, interventional, open-label, multicenter trial characterizing the effect of the combination of NGS-based digital precision diagnostics with standard-of-care microbiological analyses compared to solely standard-of-care microbiological analyses in the clinical picture of sepsis/septic shock. Additional anti-infective expert consultations are provided for both study groups. In 410 patients (n = 205 per arm) with sepsis/septic shock, the study examines whether the so-called DOOR-RADAR (Desirability of Outcome Ranking/Response Adjusted for Duration of Antibiotic Risk) score (representing a combined endpoint including the criteria (1) intensive/intermediate care unit length of stay, (2) consumption of antibiotics, (3) mortality, and (4) acute kidney injury (AKI)) can be improved by an additional NGS-based diagnostic concept. We also aim to investigate the cost-effectiveness of this new diagnostic procedure. It is postulated that intensive/intermediate care unit length of stay, mortality rate, incidence of AKI, the duration of antimicrobial therapy as well as the costs caused by complications and outpatient aftercare can be reduced. Moreover, a significant improvement in patient's quality of life is expected.

Discussion: The authors´ previous work suggests that NGS-based diagnostics have a higher specificity and sensitivity compared to standard-of-care microbiological analyses for detecting bloodstream infections. In combination with the here presented DigiSep-Trial, this work provides the optimal basis to establish a new NGS-driven concept as part of the national standard based on the best possible evidence.

Trial Registrations: DRKS-ID DRKS00022782 . Registered on August 25, 2020 ClinicalTrials.gov NCT04571801 . Registered October 1, 2020.
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http://dx.doi.org/10.1186/s13063-021-05667-xDOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8522064PMC
October 2021

Maternal and neonatal complications in women with congenital heart disease: a nationwide analysis.

Eur Heart J 2021 Oct 12. Epub 2021 Oct 12.

Department of Cardiology III, Adult Congenital and Valvular Heart Disease, University Hospital Muenster, Albert-Schweitzer-Campus 1, 48149 Münster, Germany.

Aims: The aim of this study was to provide population-based data on maternal and neonatal complications and outcome in the pregnancies of women with congenital heart disease (CHD).

Methods And Results: Based on administrative data from one of the largest German Health Insurance Companies (BARMER GEK, ∼9 million members representative for Germany), all pregnancies in women with CHD between 2005 and 2018 were analysed. In addition, an age-matched non-CHD control group was included for comparison and the association between adult CHD (ACHD) and maternal or neonatal outcomes investigated. Overall, 7512 pregnancies occurred in 4015 women with CHD. The matched non-CHD control group included 6502 women with 11 225 pregnancies. Caesarean deliveries were more common in CHD patients (40.5% vs. 31.5% in the control group; P < 0.001). There was no excess mortality. Although the maternal complication rate was low in absolute terms, women with CHD had a significantly higher rate of stroke, heart failure and cardiac arrhythmias during pregnancy (P < 0.001 for all). Neonatal mortality was low but also significantly higher in the ACHD group (0.83% vs. 0.22%; P = 0.001) and neonates to CHD mothers had low/extremely low birth weight or extreme immaturity (<0.001) or required resuscitation and mechanical ventilation more often compared to non-CHD offspring (P < 0.001 for both). On multivariate logistic regression maternal defect complexity, arterial hypertension, heart failure, prior fertility treatment, and anticoagulation with vitamin K antagonists emerged as significant predictors of adverse neonatal outcome (P < 0.05 for all). Recurrence of CHD was 6.1 times higher in infants to ACHD mothers compared to controls (P < 0.0001).

Conclusions: This population-based study illustrates a reassuringly low maternal mortality rate in a highly developed healthcare system. Nevertheless, maternal morbidity and neonatal morbidity/mortality were significantly increased in women with ACHD and their offspring compared to non-ACHD controls highlighting the need of specialized care and pre-pregnancy counselling.
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http://dx.doi.org/10.1093/eurheartj/ehab571DOI Listing
October 2021

Correction to: Impact of the COVID-19 pandemic on appendicitis treatment in Germany-a population-based analysis.

Langenbecks Arch Surg 2021 Oct 11. Epub 2021 Oct 11.

Department of General, Visceral, Transplantation, Vascular and Pediatric Surgery, University Hospital, University of Wuerzburg, Oberduerrbacherstr. 6, 97080, Wuerzburg, Germany.

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http://dx.doi.org/10.1007/s00423-021-02343-1DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8502629PMC
October 2021

Increased Pulmonary Embolism Incidence and Mortality in Patients Subsequently Diagnosed with COVID-19: An Analysis of Health Insurance Claims Data.

Eur J Vasc Endovasc Surg 2021 Sep 6. Epub 2021 Sep 6.

Department of Vascular Medicine, Research Group GermanVasc, University Medical Centre Hamburg-Eppendorf, Hamburg, Germany. Electronic address:

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http://dx.doi.org/10.1016/j.ejvs.2021.08.027DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8418913PMC
September 2021

Effectiveness of a Psychosocial Aftercare Program for Youth Aged 8 to 17 Years With Severe Chronic Pain: A Randomized Clinical Trial.

JAMA Netw Open 2021 Sep 1;4(9):e2127024. Epub 2021 Sep 1.

German Paediatric Pain Centre, Children's and Adolescents' Hospital, Datteln, Germany.

Importance: Severe chronic pediatric pain causes individual suffering and significantly affects social functioning and psychological well-being. For children with high pain severity, intensive interdisciplinary pain treatment (IIPT) is a well-established treatment. However, across specialized centers, it is not sufficient for all patients.

Objective: To evaluate the effectiveness of a psychosocial aftercare (PAC) program for pediatric patients with severe chronic pain followed up for 6 months after discharge from IIPT.

Design, Setting, And Participants: This multicenter randomized clinical trial with 4 assessment points (pre-IIPT, immediately post-IIPT, 3 months, and 6 months) was conducted at 3 pediatric specialized tertiary care pain centers in Germany between September 11, 2018, and March 31, 2020. Included patients were aged 8 to 17 with a severe chronic pain condition who had been admitted for IIPT. Data were analyzed from June 8 to September 4, 2020.

Interventions: Patients and their families were randomly assigned to 1 of 2 study groups at inpatient IIPT admission. Both groups received standardized 3- to 4-week IIPT. After IIPT discharge, the intervention group received PAC and the control group received usual care. PAC involved ongoing contact with a social worker for as long as the family requested the support, up to a maximum of 6 months.

Main Outcomes And Measures: The primary outcome measure was pain at 6 months, measured using the Chronic Pain Grading (CPG), an instrument based on an algorithm indicating severity of the chronic pain disorder. Secondary outcomes included other pain-related and emotional parameters.

Results: A total of 419 patients were randomized (mean [SD] age, 14.3 [2.1] years; 303 [72.3%] girls; 116 [27.7%] boys), with 218 assigned to usual care and 201 assigned to PAC. At baseline in both groups, the median (IQR) CPG was 3 (2-4). Superiority of PAC compared with usual care was demonstrated at 6 months (median [IQR] CPG: usual care, 2 [2-3]; PAC, 1 [1-2]; r = 0.30; 95% CI, 0.17-0.41). Additionally, PAC significantly improved emotional parameters (eg, significant time × group interaction: b = -8.84; P < .001).

Conclusions And Relevance: This randomized clinical trial found that PAC improved pain-related and emotional parameters during the intervention 6 months after discharge from IIPT. Future research is needed to investigate the intervention's long-term effects.

Trial Registration: German Clinical Trials Register ID: DRKS00015230.
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http://dx.doi.org/10.1001/jamanetworkopen.2021.27024DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8477265PMC
September 2021

Comorbidity and healthcare utilisation in persons with incident systemic lupus erythematosus followed for 3 years after diagnosis: analysis of a claims data cohort.

Lupus Sci Med 2021 08;8(1)

Epidemiology Unit, German Rheumatism Research Centre, Berlin, Germany.

Objective: To analyse comorbidity and healthcare utilisation in individuals with SLE.

Methods: A cohort of individuals with incident SLE diagnosis in 2016 were investigated using claims data from a German statutory health insurance fund. Concomitant diagnoses, medical prescriptions, hospitalisation and sick leave were analysed in the year prior to diagnosis and during a 3-year follow-up in comparison with age-matched and sex-matched controls (1) without autoimmune diseases and (2) with incident diabetes mellitus. Sensitivity analyses were performed excluding cases with additional autoimmune diagnoses and without prescription of antimalarials.

Results: Among 571 individuals with SLE, hypertension (48%), depression (30%), hyperlipidaemia (25%), osteoarthritis (25%) and osteoporosis (20%) were the most frequent comorbidities in 2016. Cerebrovascular disease was documented in 9.6%. The number of drugs (mean 9.6, ∆+6.2), hospitalisation (40%, ∆+27%) and days on sick leave (median 46 days, ∆+27 days) increased significantly in the first year with SLE diagnosis. Individuals with SLE were more frequently hospitalised and had more medications compared with both control groups (all p<0.001). The increase in comorbidity diagnoses was low in controls without autoimmune diseases, while controls with diabetes showed a more pronounced increase in cardiovascular risk factors, but less in osteoporosis and cerebrovascular disease. Sensitivity analyses showed comparable results.

Conclusion: Comorbidities are frequently detected at the time of diagnosis of SLE. High numbers of drug prescriptions and hospitalisation following SLE diagnosis reflect the comprehensive disease burden. The comparison with incident diabetes shows that differences with controls without autoimmune disease are overestimated by detection bias.
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http://dx.doi.org/10.1136/lupus-2021-000526DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8388287PMC
August 2021

Treatment Patterns and Resource Utilization of Pregnant Women with Inflammatory Rheumatic Diseases or Psoriasis in Germany: A Claims Database Analysis.

Rheumatol Ther 2021 Aug 24. Epub 2021 Aug 24.

PMV Research Group, Faculty of Medicine and University Hospital Cologne, University of Cologne, Herderstraße 52, D-50931, Cologne, Germany.

Background: Uncontrolled inflammatory disease activity can impact pregnancy outcomes and the health of the mother and child. This retrospective claims database analysis assessed treatment patterns before, during, and after pregnancy among women with inflammatory rheumatic disease (IRD; axial spondyloarthritis [axSpA], psoriatic arthritis [PsA], and rheumatoid arthritis [RA]) or psoriasis (PSO) in Germany.

Methods: Data were extracted from the BARMER sickness fund (2013-2017). Pregnant women (18-45 years) with documented IRD or PSO diagnoses were compared with age-matched controls from the same database for the analysis of patient characteristics, healthcare resource utilization, and pharmacological treatment during pregnancy. Reported measures included the proportion of women with pharmacological prescriptions or hospitalization/new prescription of corticosteroids or biologics in the 180 days before pregnancy, during pregnancy, and 180 days after delivery. Pre-specified prescription categories (such as disease-specific drugs [not including biologics]) were identified by anatomical therapeutic chemical classification codes. Extrapolated values to the German statutory health insurance population are reported.

Results: Overall, 2702 pregnant women with IRD (axSpA: 1063; PsA: 660; RA: 979) and 6527 with PSO were identified. The proportion of women with IRD receiving prescriptions for disease-specific drugs reduced during pregnancy and remained stable after delivery (before: 15.0%; during: 9.0%; after: 9.7%). The proportion of women with PSO receiving prescriptions for disease-specific drugs was low (before: 0.6%; during: 0.3%; after: 0.1%). The proportion of women with hospitalization/new prescription of corticosteroids or biologics decreased during pregnancy, compared with pre-pregnancy, and increased after delivery in women with IRD (before: 9.0%; during: 5.1%; after: 11.1%) and PSO (before: 3.5%; during: 1.9%; after: 2.7%).

Conclusions: A reduction in pharmacological treatment during pregnancy was observed for women with IRD in Germany. Many women with IRD did not return to pre-pregnancy treatments after delivery, despite signs of disease exacerbation, such as hospitalization and initiation of treatment with corticosteroids/biologics, in this period.
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http://dx.doi.org/10.1007/s40744-021-00347-3DOI Listing
August 2021

Sex Disparities in Long-Term Mortality after Paclitaxel Exposure in Patients with Peripheral Artery Disease: A Nationwide Claims-Based Cohort Study.

J Clin Med 2021 Jul 2;10(13). Epub 2021 Jul 2.

Research Group GermanVasc, Department of Vascular Medicine, University Medical Center Hamburg-Eppendorf, 20246 Hamburg, Germany.

Background: Randomized controlled trials have reported excess mortality in patients treated with paclitaxel-coated devices versus uncoated devices, while observational studies have reported the opposite. This study aims to determine the underlying factors and cohort differences that may explain these opposite results, with specific focus on sex differences in treatment and outcomes.

Methods: Multicenter health insurance claims data from a large insurance fund, BARMER, were studied. A homogeneous sample of patients with an index of endovascular revascularization for symptomatic peripheral arterial occlusive disease between 2013 and 2017 was included. Adjusted logistic regression and Cox regression models were used to determine the factors predicting allocation to paclitaxel-coated devices and sex-specific 5-year all-cause mortality, respectively.

Results: In total, 13,204 patients (54% females, mean age 74 ± 11 years) were followed for a median of 3.5 years. Females were older (77 vs. 71 years), and had less frequent coronary artery disease (23% vs. 33%), dyslipidemia (44% vs. 50%), and diabetes (29% vs. 41%), as well as being less likely to have a history of smoking (10% vs. 15%) compared with males. Mortality differences were mostly attributable to the female subgroup who were revascularized above the knee (hazard ratio, HR 0.78, 95% CI: 0.64-0.95), while no statistically significant differences were observed in males.

Conclusions: This study found that females treated above the knee benefited from paclitaxel-coated devices, while no differences were found in males. Ongoing and future registries and trials should take sex disparities into account.
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http://dx.doi.org/10.3390/jcm10132978DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8268810PMC
July 2021

Impact of specialized electrophysiological care on the outcome of catheter ablation for supraventricular tachycardias in adults with congenital heart disease: Independent risk factors and gender aspects.

Heart Rhythm 2021 Jul 13. Epub 2021 Jul 13.

Department of Cardiology III, Adult Congenital and Valvular Heart Disease, University Hospital Münster, Münster, Germany.

Background: Limited data exist on the impact of gender and specialized care on the requirement of repeat treatment of supraventricular tachycardia (SVT) in adult patients with congenital heart disease (ACHDs).

Objective: The study aimed to assess independent predictors of a combined end point of re-catheter ablation (CA) or cardioversion at 3 years of follow-up, including the impact of gender and specialized ACHD care.

Methods: All ACHDs registered in a database of one of the largest German health insurers (≈9.2 million members) who underwent CA for SVT were analyzed.

Results: Of 38,892 ACHDs 16 years or older, 485 (49.5% women; median age 58.4 years; interquartile range 42.1-70.8 years) underwent CA for SVT. Over 3-year follow-up, the number of yearly CA procedures increased significantly, particularly for atrial fibrillation (+195%) and atrial flutter (+108%). Moderate to severe complexity heart disease (odds ratio [OR] 1.66; P = .01), advanced age (OR 1.85 per year; P = .02), chronic kidney disease (OR 1.70; P = .01), and atrial fibrillation (OR 2.02; P = .002) emerged as independent predictors of retreatment. Retreatment was significantly less often performed if primary CA was carried out at a specialized CHD center (P = .009) in patients with moderate to severe complexity heart disease. Women treated in specialist centers had a 1.6-fold reduced risk of undergoing retreatment (P = .01).

Conclusion: CA for SVT is increasingly performed in ACHDs, especially for atrial flutter and atrial fibrillation. Patients with moderate and severe complexity congenital heart defects and female ACHDs benefit from upfront referral to specialized CHD centers for CA. Centralization of care for ACHD arrhythmias should thus be advocated.
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http://dx.doi.org/10.1016/j.hrthm.2021.07.009DOI Listing
July 2021

Lack of specialist care is associated with increased morbidity and mortality in adult congenital heart disease: a population-based study.

Eur Heart J 2021 Jul 16. Epub 2021 Jul 16.

Department of Cardiology III-Adult Congenital and Valvular Heart Disease, University Hospital Muenster, Albert-Schweitzer Campus 1, Building A1, Münster 48149, Germany.

Aims: The aim of this study was to provide population-based data on the healthcare provision for adults with congenital heart disease (ACHD) and the impact of cardiology care on morbidity and mortality in this vulnerable population.

Methods And Results: Based on administrative data from one of the largest German Health Insurance Companies, all insured ACHD patients (<70 years of age) were included. Patients were stratified into those followed exclusively by primary care physicians (PCPs) and those with additional cardiology follow-up between 2014 and 2016. Associations between level of care and outcome were assessed by multivariable/propensity score Cox analyses. Overall, 24 139 patients (median age 43 years, 54.8% female) were included. Of these, only 49.7% had cardiology follow-up during the 3-year period, with 49.2% of patients only being cared for by PCPs and 1.1% having no contact with either. After comprehensive multivariable and propensity score adjustment, ACHD patients under cardiology follow-up had a significantly lower risk of death [hazard ratio (HR) 0.81, 95% confidence interval (CI) 0.67-0.98; P = 0.03) or major events (HR 0.85, 95% CI 0.78-0.92; P < 0.001) compared to those only followed by PCPs. At 3-year follow-up, the absolute risk difference for mortality was 0.9% higher in ACHD patients with moderate/severe complexity lesions cared by PCPs compared to those under cardiology follow-up.

Conclusion: Cardiology care compared with primary care is associated with superior survival and lower rates of major complications in ACHD. It is alarming that even in a high resource setting with well-established specialist ACHD care approximately 50% of contemporary ACHD patients are still not linked to regular cardiac care. Almost all patients had at least one contact with a PCP during the study period, suggesting that opportunities to refer patients to cardiac specialists were missed at PCP level. More efforts are required to alert PCPs and patients to appropriate ACHD care.
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http://dx.doi.org/10.1093/eurheartj/ehab422DOI Listing
July 2021

Effectiveness of two types of palliative home care in cancer and non-cancer patients: A retrospective population-based study using claims data.

Palliat Med 2021 06;35(6):1158-1169

Institute of General Practice and Family Medicine, Jena University Hospital, Jena, Germany.

Background: Comparative effectiveness of different types of palliative homecare is sparsely researched internationally-despite its potential to inform necessary decisions in palliative care infrastructure development. In Germany, specialized palliative homecare delivered by multi-professional teams has increased in recent years and factors beyond medical need seem to drive its involvement and affect the application of primary palliative care, delivered by general practitioners who are supported by nursing services.

Aim: To compare effectiveness of primary palliative care and specialized palliative homecare in reducing potentially aggressive interventions at the end-of-life in cancer and non-cancer.

Design: Retrospective population-based study with claims data from 95,962 deceased adults in Germany in 2016 using multivariable regression analyses.

Settings/participants: Patients having received primary palliative care or specialized palliative homecare (alone or in addition to primary palliative care), for at least 14 days before death, differentiating between cancer and non-cancer patients.

Results: Rates of potentially aggressive interventions in most indicators were higher in primary palliative care than in specialized palliative homecare ( < 0.01), in both cancer and non-cancer patients: death in hospital (odds ratio (OR) 4.541), hospital care (OR 2.720), intensive care treatment (OR 6.749), chemotherapy (OR 2.173), and application of a percutaneous endoscopic gastrostomy (OR 4.476), but not for parenteral nutrition (OR 0.477).

Conclusion: Specialized palliative homecare is more strongly associated with reduction of potentially aggressive interventions than primary palliative care in the last days of life. Future research should identify elements of specialized palliative homecare applicable for more effective primary palliative care, too. German Clinical Trials Register (DRKS00014730).
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http://dx.doi.org/10.1177/02692163211013666DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8189010PMC
June 2021

Instruments to measure outcomes of post-intensive care syndrome in outpatient care settings - Results of an expert consensus and feasibility field test.

J Intensive Care Soc 2021 May 14;22(2):159-174. Epub 2020 May 14.

Department of Anesthesiology and Operative Intensive Care Medicine (CCM, CVK), Charité - Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin, Humboldt-Universität zu Berlin, and Berlin Institute of Health, Berlin, Germany.

Background: There is no consensus on the instruments for diagnosis of post-intensive care syndrome (PICS). We present a proposal for a set of outcome measurement instruments of PICS in outpatient care.

Methods: We conducted a three-round, semi-structured consensus-seeking process with medical experts, followed each by exploratory feasibility investigations with intensive care unit survivors (n = 5; n = 5; n = 7). Fourteen participants from nine stakeholder groups participated in the first and second consensus meeting. In the third consensus meeting, a core group of six clinical researchers refined the final outcome measurement instrument set proposal.

Results: We suggest an outcome measurement instrument set used in a two-step process. First step: Screening with brief tests covering PICS domains of (1) mental health (Patient Health Questionnaire-4 (PHQ-4)), (2) cognition (MiniCog, Animal Naming), (3) physical function (Timed Up-and-Go (TUG), handgrip strength), and (4) health-related quality of life (HRQoL) (EQ-5D-5L). Single items measure subjective health before and after the intensive care unit stay. If patients report new or worsened health problems after intensive care unit discharge and show relevant impairment in at least one of the screening tests, a second extended assessment follows: (1) Mental health (Patient Health Questionnaire-8 (PHQ-8), Generalized Anxiety Disorder Scale-7 (GAD-7), Impact of Event Scale - revised (IES-R)); (2) cognition (Repeatable Battery for the Assessment of Neuropsychological Status (RBANS), Trail Making Test (TMT) A and B); (3) physical function (2-Minute Walk Test (2-MWT), handgrip strength, Short Physical Performance Battery (SPPB)); and (4) HRQoL (EQ-5D-5L, 12-Item WHO Disability Assessment Schedule (WHODAS 2.0)).

Conclusions: We propose an outcome measurement instrument set used in a two-step measurement of PICS, combining performance-based and patient-reported outcome measures. First-step screening is brief, free-of-charge, and easily applicable by health care professionals across different sectors. If indicated, specialized healthcare providers can perform the extended, second-step assessment. Usage of the first-step screening of our suggested outcome measurement instrument set in outpatient clinics with subsequent transfer to specialists is recommended for all intensive care unit survivors. This may increase awareness and reduce the burden of PICS.

Trial Registration: This study was registered at ClinicalTrials.gov (Identifier: NCT04175236; first posted 22 November 2019).
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http://dx.doi.org/10.1177/1751143720923597DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8120565PMC
May 2021

Prevalence of COVID-19 Risk Factors and Risks of Severe Acute Respiratory Disease are Markedly Higher in Patients with Symptomatic Peripheral Arterial Occlusive Disease.

Eur J Vasc Endovasc Surg 2021 05 5;61(5):859-860. Epub 2021 Mar 5.

Department of Vascular Medicine, Research Group GermanVasc, University Medical Centre Hamburg-Eppendorf, Hamburg, Germany. Electronic address:

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http://dx.doi.org/10.1016/j.ejvs.2021.02.055DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7934833PMC
May 2021

A health insurance claims analysis on the effect of female sex on long-term outcomes after peripheral endovascular interventions for symptomatic peripheral arterial occlusive disease.

J Vasc Surg 2021 09 27;74(3):780-787.e7. Epub 2021 Feb 27.

Department of Vascular Medicine, Research Group GermanVasc, University Heart and Vascular Center Hamburg, University Medical Center Hamburg-Eppendorf, Hamburg, Germany. Electronic address:

Objective: Several reports have addressed sex disparities in peripheral arterial occlusive disease (PAOD) treatment with inconclusive or even conflicting results. However, most previous studies have neither been sufficiently stratified nor used matching or weighting methods to address severe confounding. In the present study, we aimed to determine the disparities between sexes after percutaneous endovascular revascularization (ER) for symptomatic PAOD.

Methods: Health insurance claims data from the second-largest insurance fund in Germany, BARMER, were used. A large cohort of patients who had undergone index percutaneous ER of symptomatic PAOD from January 1, 2010 to December 31, 2018 were included in the present study. The study cohort was stratified by the presence of intermittent claudication, ischemic rest pain, and wound healing disorders. Propensity score matching was used to adjust for confounding through differences in age, treated vessel region, comorbidities, and pharmacologic treatment. Sex-related differences regarding cardiovascular event-free survival, amputation-free survival, and overall survival within 5 years of surgery were determined using Kaplan-Meier time-to-event curves, log-rank test, and Cox regression analysis.

Results: In the present study, 50,051 patients (47.2% women) were identified and used to compose a matched cohort of 35,232 patients. Among all strata, female patients exhibited lower mortality (hazard ratio [HR], 0.69-0.90), fewer amputations or death (HR, 0.70-0.89), and fewer cardiovascular events or death (HR, 0.78-0.91). The association between female sex and improved long-term outcomes was most pronounced for the patients with intermittent claudication.

Conclusions: In the present propensity score-matched analysis of health insurance claims, we observed superior cardiovascular event-free survival, amputation-free survival, and overall survival during 5 years of follow-up after percutaneous ER in women with symptomatic PAOD. Future studies should address sex disparities in the open surgical treatment of PAOD to illuminate whether the conflicting data from previous reports might have resulted from insufficient stratification of the studies.
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http://dx.doi.org/10.1016/j.jvs.2021.01.066DOI Listing
September 2021

Impact of the COVID-19 pandemic on appendicitis treatment in Germany-a population-based analysis.

Langenbecks Arch Surg 2021 Mar 9;406(2):377-383. Epub 2021 Jan 9.

Department of General, Visceral, Transplantation, Vascular and Pediatric Surgery, University Hospital, University of Wuerzburg, Oberduerrbacherstr. 6, 97080, Wuerzburg, Germany.

Purpose: Acute appendicitis is one of the most common reasons for emergency medical consultation. While simple appendicitis can be treated with antibiotics or surgery, complex appendicitis including gangrene, abscess, and perforation requires appendectomy. During the COVID-19 pandemic in early 2020, an overall drop in emergency room consultations was observed. We therefore aimed to investigate the incidence and treatment strategies of acute appendicitis during that period.

Methods: Data of insurance holders with the ICD code for "acute appendicitis" or OPS procedure of appendectomy of a major health insurance company in Germany were analyzed retrospectively. Groups were built, containing of the means of March-June of 2017, 2018, and 2019, defined as "pre-COVID group" with the "COVID group," defined as data from March to June of 2020. Data was analyzed by age, sex, comorbidities, length of hospital stay, diagnoses, and treatment. Data of the COVID group was analyzed for simultaneous COVID-19 infection.

Results: During the COVID-19 pandemic of early 2020, an overall reduction by 12.9% of patients presenting with acute appendicitis was noticeable. These results were mainly due to decreased rates of uncomplicated appendicitis, while complicated appendicitis was scarcely affected. Especially in the group of females < 40 years, a drastic reduction was visible. Rates of extended surgery did not change. Likewise, the complication rate like appendix stump leakage or need for re-operation did not differ. In March 2020, 4.8% of acute appendicitis patients had concomitant COVID-19 infection.

Conclusion: In line with the overall drop of emergency room visits during the COVID-19 pandemic of spring 2020 in Germany, a significantly lowered number of patients with uncomplicated appendicitis were noticeable, whereas complicated appendicitis did not differ. Also, treatment and complication rate of acute appendicitis did not change. These findings might be a hint that acute appendicitis is not a progressing disease but caused by different entities for uncomplicated and complicated appendicitis and therefore another clue that uncomplicated appendicitis can be treated with antibiotics or observation. Nevertheless provided data does not cover outpatient treatment; therefore, no statement observation or antibiotics in outpatients can be made.
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http://dx.doi.org/10.1007/s00423-021-02081-4DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7794073PMC
March 2021

Study protocol for a prospective, double-blinded, observational study investigating the diagnostic accuracy of an app-based diagnostic health care application in an emergency room setting: the eRadaR trial.

BMJ Open 2021 01 8;11(1):e041396. Epub 2021 Jan 8.

Hospital of the Goethe University Frankfurt Surgery Centre, Frankfurt am Main, Hessen, Germany.

Introduction: Occurrence of inaccurate or delayed diagnoses is a significant concern in patient care, particularly in emergency medicine, where decision making is often constrained by high throughput and inaccurate admission diagnoses. Artificial intelligence-based diagnostic decision support system have been developed to enhance clinical performance by suggesting differential diagnoses to a given case, based on an integrated medical knowledge base and machine learning techniques. The purpose of the study is to evaluate the diagnostic accuracy of Ada, an app-based diagnostic tool and the impact on patient outcome.

Methods And Analysis: The eRadaR trial is a prospective, double-blinded study with patients presenting to the emergency room (ER) with abdominal pain. At initial contact in the ER, a structured interview will be performed using the Ada-App and both, patients and attending physicians, will be blinded to the proposed diagnosis lists until trial completion. Throughout the study, clinical data relating to diagnostic findings and types of therapy will be obtained and the follow-up until day 90 will comprise occurrence of complications and overall survival of patients. The primary efficacy of the trial is defined by the percentage of correct diagnoses suggested by Ada compared with the final discharge diagnosis. Further, accuracy and timing of diagnosis will be compared with decision making of classical doctor-patient interaction. Secondary objectives are complications, length of hospital stay and overall survival.

Ethics And Dissemination: Ethical approval was received by the independent ethics committee (IEC) of the Goethe-University Frankfurt on 9 April 2020 including the patient information material and informed consent form. All protocol amendments must be reported to and adapted by the IEC. The results from this study will be submitted to peer-reviewed journals and reported at suitable national and international meetings.

Trial Registration Number: DRKS00019098.
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http://dx.doi.org/10.1136/bmjopen-2020-041396DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7798704PMC
January 2021

Sex Disparities in Long Term Outcomes After Open Surgery for Chronic Limb Threatening Ischaemia: A Propensity Score Matched Analysis of Health Insurance Claims.

Eur J Vasc Endovasc Surg 2021 03 15;61(3):423-429. Epub 2020 Dec 15.

Department of Vascular Medicine, Research Group GermanVasc, University Heart and Vascular Centre Hamburg, University Medical Centre Hamburg-Eppendorf, Hamburg, Germany. Electronic address:

Objective: Several studies suggest a disadvantage for women in peri-operative morbidity and mortality after open surgery in peripheral arterial occlusive disease. In addition to their heterogeneity regarding design and analysed cohorts, long term data are mostly missing. This study aimed to determine sex disparities in outcomes after open revascularisation in chronic limb threatening ischaemia (CLTI).

Methods: Using health insurance claims data of the second largest insurance fund in Germany, BARMER, a large cohort of patients was sampled consecutively for analysis including index open surgical revascularisations of CLTI performed between 1 January 2010, and 31 December 2018. Propensity score matching was used to adjust for confounding. Sex related differences regarding overall survival, amputation free survival (AFS), and cardiovascular event free survival (CVEFS) during the five years after surgery were determined using Kaplan-Meier time to event curves, log rank test, logistic, and Cox regression.

Results: Among 9 526 patients (49.5% women) in the entire cohort, 6 502 patients were matched. Before matching, women were older at presentation (78.0 vs. 71.8 years, p < .001) and suffered more often from multiple comorbidities (van Walraven score > 9, 55.5% vs. 50.6%, p < .001). During the hospital stay, there were 692 (7.3%) deaths, while 4 631 deaths (48.6%) occurred during the follow up. In the matched cohort, the median follow up was 746 days for women and 871 days for men. In the matched analyses, female sex was significantly associated with better overall survival (hazard ratio, HR, 0.80, log rank p < .001), AFS (HR 0.81, log rank p < .0001), and CVEFS (HR 0.84, log rank p < .001) five years after the index treatment.

Conclusion: In this largest propensity score matched analysis of health insurance claims to date from Germany, evidence was found for better long term outcomes in women after open surgical revascularisations for chronic limb threatening ischaemia. Future guidelines and studies should address the impact of sex on patient selection practice and outcomes to determine the underlying reasons for existing disparities.
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http://dx.doi.org/10.1016/j.ejvs.2020.11.006DOI Listing
March 2021

Editor's Choice - The GermanVasc Score: A Pragmatic Risk Score Predicts Five Year Amputation Free Survival in Patients with Peripheral Arterial Occlusive Disease.

Eur J Vasc Endovasc Surg 2021 02 15;61(2):248-256. Epub 2020 Dec 15.

Department of Vascular Medicine, Research Group GermanVasc, University Medical Centre Hamburg-Eppendorf, Hamburg, Germany. Electronic address:

Objective: Patients with peripheral arterial occlusive disease (PAOD) face an increased risk of both lower limb amputation and death. To date, it has been challenging to predict the long term outcomes for PAOD. The aim was to develop a risk score to predict worse five year amputation free survival (AFS).

Methods: In this retrospective analysis of claims data, symptomatic PAOD patients were split into training and validation sets. Variables in the model were patient age and sex, Elixhauser comorbidities, and the 190 most common secondary diagnoses. Penalised Cox regression (least absolute shrinkage and selection operator [LASSO]) with tenfold cross validation for variable selection was performed and patients were categorised into five risk groups using the ten most important variables. All analyses were stratified by intermittent claudication (IC) and chronic limb threatening ischaemia (CLTI).

Results: In total, 87 293 patients with PAOD (female 45.3%, mean age 71.4 ± 11.1 years) were included in the analysis. The most important variable predicting worse five year AFS was patient age >80 years. The GermanVasc score exhibited good predictive accuracy both for IC (c statistic = 0.70, 95% confidence interval [CI] 0.69-0.71) and CLTI (c statistic = 0.69, 95% CI 0.68-0.70) with adequate calibration due largely to alignment of observed and expected risk. Depending on the cumulative point score, the five year risk of amputation or death ranged from 9% (low risk) to 48% (high risk) for IC, and from 25% to 88% for CLTI.

Conclusion: The GermanVasc score predicts worse five year AFS stratified for inpatients suffering from IC and CLTI, with good predictive accuracy. By separating low from high risk patients, the GermanVasc score may support patient centred consent.
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http://dx.doi.org/10.1016/j.ejvs.2020.11.013DOI Listing
February 2021

Use of guideline-recommended drug therapy in patients undergoing percutaneous coronary intervention for stable coronary heart disease in Germany: a multilevel analysis of nationwide routine data.

BMJ Open 2020 12 13;10(12):e042886. Epub 2020 Dec 13.

Chair of Health Economics, Technical University Munich, Munich, Germany.

Objectives: To determine the prescription of guideline recommended drug therapy in patients with stable coronary heart disease (sCHD) prior to percutaneous coronary intervention (PCI) in Germany and to examine the role of patient characteristics and features of regional healthcare supply in a multilevel model.

Design: Secondary data analysis of factors associated with the prescription of guideline recommended drug therapy using a multilevel model to analyse regional-level effects, over and above the effects of patient-level demographic and health status.

Setting: Office-based prescriptions in the year prior to the invasive procedure.

Participants: A linked nationwide dataset from Germany's three largest statutory health insurance funds of all patients receiving PCI in the year 2016.

Main Outcome Measures: Patients' odds of receiving optimal medical therapy and symptom-oriented therapy within 1 year prior to PCI.

Results: 68.6% of patients received at least one lipid-lowering drug and one symptom-oriented therapy prior to PCI. 43.6% received at least two agents to control their symptoms. Patients who received treatment in accordance with the recommendations had a greater number of diagnosed risk factors, a more severe history of cardiac disease and used a higher volume of ambulatory office-based physician services. The prescriptions prevalence for the symptom-oriented therapies differed significantly between eastern and western Germany, with a higher prevalence in the eastern districts.

Conclusions: Guidelines can only provide decision-making corridors, and the applicability of recommendations must always be assessed on a case by case basis. Nevertheless, our analysis indicates that the prevalence of prescriptions in routine practice is subject to substantial variation and that conservative therapy options are not fully exhausted prior to PCI. This suggests that there might be room for improvement in the care of patients with sCHD.
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http://dx.doi.org/10.1136/bmjopen-2020-042886DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7737102PMC
December 2020

The impact of extra-musculoskeletal manifestations on disease activity, functional status, and treatment patterns in patients with axial spondyloarthritis: results from a nationwide population-based study.

Ther Adv Musculoskelet Dis 2020 21;12:1759720X20972610. Epub 2020 Nov 21.

Epidemiology Unit, German Rheumatism Research Centre, Berlin, Germany.

Objective: The aim of this study was to investigate the association of extra-musculoskeletal manifestations (EMMs) with disease activity, functional status, and treatment patterns in a large population-based cohort of patients with axial spondyloarthritis (axSpA).

Methods: A stratified random sample of patients with axSpA, drawn from health insurance data, received a survey on disease-related characteristics including history (ever presence) of the following EMMs: inflammatory bowel disease (IBD), psoriasis (PSO), and anterior uveitis (AU). Survey data were linked to health insurance data, gathering additional information on current occurrence (within one year) of EMMs and drug prescriptions. Separate multivariable linear regression models were calculated to determine the association of EMMs with disease activity (Bath Ankylosing Spondylitis Disease Activity Index), and functional status (Bath Ankylosing Spondylitis Functional Index) after adjustment for relevant parameters, including treatment.

Results: A total of 1729 patients with axSpA were included in the analyses (response: 47%; mean age: 56 years; 46% female) of whom 6% (9%) had current (ever) IBD, 10% (15%) had current (ever) PSO, and 9% (27%) had current (ever) AU. Ever presence of IBD and history of PSO were significantly associated with higher level of disease activity. Ever presence of PSO was also associated with higher level of functional impairment, whereas current AU was significantly associated with lower disease activity. Patients with current IBD or PSO received more frequently biological and conventional synthetic disease-modifying anti-rheumatic drugs as well as systemic steroids. AU was associated with a higher use of conventional synthetic disease-modifying anti-rheumatic drugs only.

Conclusion: Disease activity is higher in patients with axSpA with history of IBD or history of PSO. Functional impairment is also higher in patients with axSpA with history of PSO. The presence of different EMMs was associated with different treatment patterns in axSpA.
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http://dx.doi.org/10.1177/1759720X20972610DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7682214PMC
November 2020

[Palliative care at the end of life in Germany : Utilization and regional distribution].

Bundesgesundheitsblatt Gesundheitsforschung Gesundheitsschutz 2020 Dec 13;63(12):1502-1510. Epub 2020 Nov 13.

Institut für Allgemeinmedizin, Universitätsklinikum Jena, Bachstr. 18, 07743, Jena, Deutschland.

Background: Palliative care supply increased in Germany in recent years. But how many people use which forms of palliative care and how does this differ between regions?

Method: Retrospective cohort study with claims data from insured persons who died in 2016: Based on services billed at least once in the last six months of life, we determined the use of primary palliative care (PPC), specialized palliative homecare (SPHC), as well as inpatient palliative and hospice care, using regional billing codes for PPC and SPHC services for the first time.

Results: Of the 95,962 deceased in the study population, 32.7% received palliative care nationwide, with variations from 26.4% in Bremen to 40.8% in Bavaria. PPC services were billed at 24.4% (16.9% in Brandenburg to 34.1% in Bavaria). SPHC services received 13.1% (6.3% in Rhineland-Palatinate to 18.9% in Brandenburg and 22.9% in Westphalia-Lippe with different SPHC practices). Inpatient palliative care was received by 8.1% (6.7% in Schleswig-Holstein/Hesse to 13.0% in Thuringia); 3.3% (1.6% in Bremen to 5.6% in Berlin) with hospice services.

Conclusion: SPHC is used more frequently than previously reported, while PPC is declining. Utilization seems to be based less on objective needs than on region-specific framework conditions. Besides needs criteria, further development of palliative care should be oriented more towards outcomes and relevant framework conditions.
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http://dx.doi.org/10.1007/s00103-020-03240-6DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7686196PMC
December 2020

Current use and safety of novel oral anticoagulants in adults with congenital heart disease: results of a nationwide analysis including more than 44 000 patients.

Eur Heart J 2020 11;41(43):4168-4177

Department of Cardiology III-Adult Congenital and Valvular Heart Disease, University Hospital Muenster, Albert Schweitzer Campus 1, A1, 48149 Muenster, Germany.

Aims: To evaluate the use of novel oral anticoagulants (NOACs) compared with vitamin K antagonists (VKAs) in adult congenital heart disease (ACHD) and assess outcome in a nationwide analysis.

Methods And Results: Using data from one of Germany's largest Health Insurers, all ACHD patients treated with VKAs or NOACs were identified and changes in prescription patterns were assessed. Furthermore, the association between anticoagulation regimen and complications including mortality was studied. Between 2005 and 2018, the use of oral anticoagulants in ACHD increased from 6.3% to 12.4%. Since NOACs became available their utilization increased constantly, accounting for 45% of prescribed anticoagulants in ACHD in 2018. Adult congenital heart disease patients on NOACs had higher thromboembolic (3.8% vs. 2.8%), MACE (7.8% vs. 6.0%), bleeding rates (11.7% vs. 9.0%), and all-cause mortality (4.0% vs. 2.8%; all P < 0.05) after 1 year of therapy compared with VKAs. After comprehensive adjustment for patient characteristics, NOACs were still associated with increased risk of MACE (hazard rate-HR 1.22; 95% CI 1.09-1.36) and increased all-cause mortality (HR 1.43; 95% CI 1.24-1.65; both P < 0.001), but also bleeding (HR 1.16; 95% CI 1.04-1.29; P = 0.007) during long-term follow-up.

Conclusion: Despite the lack of prospective studies in ACHD, NOACs are increasingly replacing VKAs and now account for almost half of all oral anticoagulant prescriptions. Particularly, NOACs were associated with excess long-term risk of MACE, and mortality in this nationwide analysis, emphasizing the need for prospective studies before solid recommendations for their use in ACHD can be provided.
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http://dx.doi.org/10.1093/eurheartj/ehaa844DOI Listing
November 2020

Long-Term Effectiveness and Safety of Initiating Statin Therapy After Index Revascularization In Patients With Peripheral Arterial Occlusive Disease.

J Am Heart Assoc 2020 11 13;9(22):e018338. Epub 2020 Nov 13.

Department of Vascular Medicine Research Group GermanVasc University Medical Center Hamburg-Eppendorf Hamburg Germany.

Background An increasing number of patients with a peripheral arterial occlusive disease were put on statins during the past years. This study assessed whether statin therapy was effective and safe for these new users. Methods and Results Using health insurance claims data from Germany's second-largest insurance fund, BARMER, we identified patients with peripheral arterial occlusive disease who had index revascularization between 2008 and 2018 without prior statin therapy. We compared patients with and without statin therapy in addition to antithrombotics during the first quarter after discharge (new users versus nonusers). Outcomes were all-cause mortality, cardiovascular events, and incident major amputation for effectiveness and incident diabetes mellitus and incident myopathy for safety. Propensity score matching was used to balance the study groups. All analyses were stratified into patients with chronic limb-threatening ischemia and intermittent claudication. A total of 22 208 patients (mean age 71.1 years and 50.3% women) were included in the study. In 10 922 matched patients, statin initiation was associated with lower all-cause mortality (chronic limb-threatening ischemia: hazard ratio [HR], 0.75 [95% CI, 0.68-0.84]; intermittent claudication: HR, 0.80 [95% CI, 0.70-0.92]), lower risk of major amputation in patients with chronic limb-threatening ischemia (HR, 0.73; 95% CI, 0.58-0.93) and lower risk of cardiovascular events (hazard ratio, 0.80; 95% CI, 0.70-0.92) in patients with intermittent claudication during 5 years of follow-up. Safety outcomes did not differ among the study groups. Conclusions Initiating statin therapy in patients with peripheral arterial occlusive disease after index revascularization is efficient and safe with an effect size comparable to earlier studies. Awareness campaigns for evidence-based optimal pharmacological treatment among patients are recommended.
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http://dx.doi.org/10.1161/JAHA.120.018338DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7763713PMC
November 2020

Mortality and morbidity in patients with congenital heart disease hospitalised for viral pneumonia.

Heart 2020 Oct 27. Epub 2020 Oct 27.

Adult Congenital and Valvular Heart Disease Center, Department of Cardiology and Angiology, University Hospital Muenster, Muenster, Germany.

Objectives: Data on the clinical outcome of patients with congenital heart disease (CHD) affected by severe viral pneumonia are limited. We analysed morbidity and mortality of viral pneumonia and evaluated the association between medical conditions, medication, vaccination and outcome specifically in patients with CHD requiring hospitalisation for viral pneumonia.

Methods: Based on data from one of Germany's largest health insurers, all cases of viral pneumonia requiring hospital admission (2005-2018) were studied. Mortality, and composites of death, transplantation, mechanical circulatory support, ventilation or extracorporeal lung support served as endpoints.

Results: Overall, 26 262 viral pneumonia cases occurred in 24 980 patients. Of these, 1180 cases occurred in patients with CHD. Compared with patients without CHD, mortality rate was elevated in patients with CHD. As a group, patients with CHD aged 20-59 years even exceeded mortality rates in patients without CHD aged >60 years. No mortality was observed in patients with CHD with simple defects <60 years of age without associated cardiovascular risk factors. On multivariable logistic regression analysis, age, CHD complexity, chromosomal anomalies, cardiac medication, use of immunosuppressants and absence of vaccination for influenza emerged as risk factors of adverse outcome.

Conclusions: We present timely data on morbidity and mortality of severe viral pneumonia requiring hospital admission in patients with CHD. Need for mechanical ventilation and risk of death in CHD increase early in life, reaching a level equivalent to non-CHD individuals >60 years of age. Our data suggest that except for patients with isolated simple defects, patients with CHD should be considered higher-risk individuals when faced with severe viral pneumonia.
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http://dx.doi.org/10.1136/heartjnl-2020-317706DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8223651PMC
October 2020

Challenges in the Transition from In-Patient to Out-Patient Treatment in Depression.

Dtsch Arztebl Int 2020 Jul;117(27-28):472-479

Oberberg Parkklinik Wiesbaden Schlangenbad, Wiesbaden, Germany.

Background: Few data are available on the characteristics of inpatient treatment and subsequent outpatient treatment for depression in Germany. In this study, we aimed to characterize the inpatient and outpatient treatment phases, to determine the rates of readmission and mortality, and to identify risk factors.

Methods: We carried out a descriptive statistical analysis of routine administrative data from a large health-insurance carrier (BARMER). All insurees aged 18 to 65 who were treated in 2015 as inpatients on a psychiatry and psychotherapy service or on a psychosomatic medicine and psychotherapy service with a main diagnosis of depression were included in the analysis. Risk factors for readmission and death were determined with the aid of mixed logistic regression.

Results: Of the 22 893 patients whose data were analyzed, 78% had been hospitalized on a psychiatry and psychotherapy service and 22% on a psychosomatic medicine and psychotherapy service. The median length of hospital stay was 42 days. Follow-up care in the outpatient setting failed to conform with the recommendations of the pertinent guidelines in 92% of the patients with a main diagnosis of severe depression during hospitalization, and in 50% of those with moderate depression. 21% of the patients were readmitted within a year. The mortality at one year was 961 per 100 000 individuals (adjusted for the age and sex structure of the German population), or 3.4 times the mortality of the population at large. In the regression model, more treatment units during hospitalization and subsequent treatment with psychotherapy were associated with a lower probability of readmission, while longer hospitalization with subsequent pharmacotherapy or psychotherapy was associated with lower mortality.

Conclusion: The recommendations of the national (German) S3 guidelines for the further care of patients who have been hospitalized for depression are inadequately implemented at present in the sectored structures of in- and outpatient care in the German health care system. This patient group has marked excess mortality.
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http://dx.doi.org/10.3238/arztebl.2020.0472DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7575898PMC
July 2020

Comorbidity and health care utilisation in persons with Sjögren's syndrome: a claims data analysis.

Clin Exp Rheumatol 2020 Jul-Aug;38 Suppl 126(4):78-84. Epub 2020 Sep 18.

German Rheumatism Research Centre, Epidemiology Unit, Berlin, Germany.

Objectives: To capture comorbidity and medication of persons with Sjögren's syndrome (SS) in a population-based cohort in comparison to matched controls.

Methods: Individuals with an outpatient diagnosis of M35.0 (ICD-10) in ≥2 quarters of a year or an inpatient diagnosis of M35.0 were identified in a German statutory health insurance fund covering 7.2 million people. Persons in rheumatologic care were grouped by incident or prevalent diagnosis and by co-existing autoimmune disease (sSS) or primary (p)SS and compared to age- and sex-matched controls regarding comorbidity (ICD-10), medical prescriptions, hospitalisation and inability to work in the previous year.

Results: In 2018, 7,283 persons (0.10%) had incident and 54,273 persons (0.75%) prevalent SS diagnosis, and 5,961 (11%) were in rheumatologic care. Of these (90% female, mean age 66 years), 3,457 (58%) had further autoimmune disease (sSS), mostly rheumatoid arthritis (80%) and systemic lupus erythematosus (13%). Compared to controls, frequent comorbid conditions in SS were hypertension (controls: 52%, pSS: 55%, sSS: 63%), osteoarthritis (22%/40%/47%), osteoporosis (10%/26%/38%) and depression (21%/34%/36%). Systemic antirheumatic drugs were prescribed in 31% (pSS) and 66% (sSS) while < 5% received topical therapies. Glucocorticoids (8%/34%/59%), NSAIDs (28%/41%/45%), opioids (8%/15%/21%), analgesics (19%/30%/36%) and antidepressants (14%/21%/21%) were frequently prescribed. Compared to controls, hospitalisation (21%/32%/39%) and inability to work in persons <65 years (41%/48%/44%, median days 17/24/30) were more frequent in pSS and sSS than in controls.

Conclusions: SS claims diagnosis is associated with substantial comorbidity and frequent prescription of anti-inflammatory drugs, analgesics and antidepressants. The individual and societal burden of SS shows that, in addition to effective treatment strategies, intensive attention to comorbidities is important in this disease.
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October 2020

Enhanced Recovery after Intensive Care (ERIC): study protocol for a German stepped wedge cluster randomised controlled trial to evaluate the effectiveness of a critical care telehealth program on process quality and functional outcomes.

BMJ Open 2020 09 25;10(9):e036096. Epub 2020 Sep 25.

Department of Anesthesiology and Operative Intensive Care Medicine, Charité-Universitätsmedizin Berlin, Berlin, Germany

Introduction: Survival after critical illness has noticeably improved over the last decades due to advances in critical care medicine. Besides, there is an increasing number of elderly patients with chronic diseases being treated in the intensive care unit (ICU). More than half of the survivors of critical illness suffer from medium-term or long-term cognitive, psychological and/or physical impairments after ICU discharge, which is recognised as post-intensive care syndrome (PICS). There are evidence-based and consensus-based quality indicators (QIs) in intensive care medicine, which have a positive influence on patients' long-term outcomes if adhered to.

Methods And Analysis: The protocol of a multicentre, pragmatic, stepped wedge cluster randomised controlled, quality improvement trial is presented. During 3 predefined steps, 12 academic hospitals in Berlin and Brandenburg, Germany, are randomly selected to move in a one-way crossover from the control to the intervention condition. After a multifactorial training programme on QIs and clinical outcomes for site personnel, ICUs will receive an adapted, interprofessional protocol for a complex telehealth intervention comprising of daily telemedical rounds at ICU. The targeted sample size is 1431 patients. The primary objective of this trial is to evaluate the effectiveness of the intervention on the adherence to eight QIs daily measured during the patient's ICU stay, compared with standard of care. Furthermore, the impact on long-term recovery such as PICS-related, patient-centred outcomes including health-related quality of life, mental health, clinical assessments of cognition and physical function, all-cause mortality and cost-effectiveness 3 and 6 months after ICU discharge will be evaluated.

Ethics And Dissemination: This protocol was approved by the ethics committee of the Charité-Universitätsmedizin, Berlin, Germany (EA1/006/18). The results will be published in a peer-reviewed scientific journal and presented at international conferences. Study findings will also be disseminated via the website (www.eric-projekt.net).

Trial Registration Number: ClinicalTrials.gov Registry (NCT03671447).
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http://dx.doi.org/10.1136/bmjopen-2019-036096DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7520839PMC
September 2020

[Evaluation of an early interdisciplinary multimodal assessment for patients with pain : Protocol of a randomized controlled study (PAIN2020)].

Schmerz 2021 Aug;35(4):251-264

Deutsche Schmerzgesellschaft e. V., Alt-Moabit 101b, 10559, Berlin, Deutschland.

Health care provision for patients with pain and risk factors for chronicity is still insufficient and characterized in particular by over-, under- and misuse of existing approaches. The PAIN2020 project is funded by the German Federal Ministry of Health Care (Innovationsfonds 01NVF17049) and aims to improve health care delivery for this group of patients by implementing an early ambulatory diagnostic approach by a pain specialist, resulting in an improvement in pain and restored or maintained function. A randomized clinical trial in 31 facilities Germany-wide will identify eligible patients and guide them into early specialized pain diagnostics. The interventional arm provides an interdisciplinary multimodal assessment, delivered by pain medicine specialists, physiotherapists and clinical psychologists. The control arm contains a single assessment by a pain specialist. Patients and caregivers receive detailed recommendations for evidence-based interventions tailored to the needs of the individual patient. Two evaluation approaches will be merged. The first requires a net sample size of 3840 patients, assessed (admission) and followed-up (3 and 6 months) by clinical data (German Pain Questionnaire, additional scales) and analyzed by a multi-level approach. In a second evaluation arm the clinical data of the included patients will be supplemented by secondary data from a statutory health insurance (BARMER) and compared to a sample of policyholders not addressed by the study. Data analyses will be performed by an external evaluation institute. The project started in April 2018.
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http://dx.doi.org/10.1007/s00482-020-00497-3DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8302527PMC
August 2021

The prevalence and impact of comorbidities on patients with axial spondyloarthritis: results from a nationwide population-based study.

Arthritis Res Ther 2020 09 10;22(1):210. Epub 2020 Sep 10.

Epidemiology Unit, German Rheumatism Research Centre, Charitéplatz 1, 10117, Berlin, Germany.

Background: In contrast to other chronic rheumatic musculoskeletal diseases such as rheumatoid arthritis, comorbidities in axial spondyloarthritis (axSpA) and their impact on disease outcomes are less well studied. The aim of this study was to investigate the prevalence of comorbidities and their association with disease activity and functional impairment in a large population-based cohort of patients with axSpA.

Methods: A random sample of patients with axSpA, stratified by age and sex, was drawn from health insurance data. Patients in the sample received a survey on demographic, socioeconomic, and disease-related parameters. Comorbidities were defined using the Elixhauser coding algorithms excluding rheumatoid arthritis/collagen vascular diseases and including osteoporosis and fibromyalgia, resulting in a set of 32 comorbidities. The prevalence of comorbidities in the axSpA patients and their pharmacological treatment were examined. Multivariable linear regression models were calculated to determine the association of comorbidities with disease activity and functional status.

Results: A total of 1776 axSpA patients were included in the analyses (response, 47%; mean age, 56 years; 46% female). The most prevalent comorbidities were hypertension, depression, and chronic pulmonary disorders. The number of comorbidities was significantly associated with both the BASDAI and BASFI: β (95% CI) = 0.17 (0.09-0.24) and 0.24 (0.15-0.32), respectively. When analysed separately, hypertension, depression, and chronic pulmonary disease were comorbidities with a significant and independent association with BASFI, while for BASDAI, such an association was found for depression and chronic pulmonary disease only.

Conclusions: Comorbidities are common in axSpA patients and are associated with higher disease activity and higher levels of functional impairment. Higher disease activity and higher levels of functional impairment might be indicators of severe disease resulting in the development of comorbidities.
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http://dx.doi.org/10.1186/s13075-020-02301-0DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7488243PMC
September 2020
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