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Introduction
Atopic dermatitis (AD) is a common inflammatory skin disease. Many patients are initiating a systemic therapy, if the disease is not adequately controlled with topical treatment only. Currently, there is little real-world evidence on the AD-related medical care situation in Germany. This study analyzed patient characteristics, treatment patterns, healthcare resource utilization and costs associated with systemically treated AD for the German healthcare system.
Methods
In this descriptive, retrospective cohort study, aggregated anonymized German health claims data from the InGef research database were used. Within a representative sample of four million insured individuals, patients with AD and systemic drug therapy initiation (SDTI) in the index year 2017 were identified and included into the study cohort. Systemic drug therapy included dupilumab, systemic corticosteroids (SCS) and systemic immunosuppressants (SIS). Patients were observed for one year starting from the date of SDTI in 2017.
Results
9975 patients were included (57.8% female, mean age 39.6 years [SD 25.5]). In the one-year observation period, the most common systemic drug therapy was SCS (> 99.0%). Administrations of dupilumab (0.3%) or dispensations of SIS were rare (cyclosporine: 0.5%, azathioprine: 0.6%, methotrexate: 0.1%). Median treatment duration of SCS, cyclosporine and azathioprine was 27 days, 102 days, and 109 days, respectively. 2.8% of the patients received phototherapy; 41.6% used topical corticosteroids and/or topical calcineurin inhibitor. Average annual costs for medications amounted to € 1237 per patient. Outpatient services were used by 99.6% with associated mean annual costs of € 943; 25.4% had at least one hospitalization (mean annual costs: € 5836). 5.3% of adult patients received sickness benefits with associated mean annual costs of € 5026.
Conclusions
Despite unfavorable risk–benefit profile, this study demonstrated a common treatment with SCS, whereas other systemic drug therapy options were rarely used. Furthermore, the results suggest a substantial economic burden for patients with AD and SDTI.
Background
To perform a systematic review about the effect of using clinical pathways on length of stay (LOS), hospital costs and patient outcomes. To provide a framework for local healthcare organisations considering the effectiveness of clinical pathways as a patient management strategy.
Methods
As participants, we considered hospitalized children and adults of every age and indication whose treatment involved the management strategy "clinical pathways". We include only randomised controlled trials (RCT) and controlled clinical trials (CCT), not restricted by language or country of publication. Single measures of continuous and dichotomous study outcomes were extracted from each study. Separate analyses were done in order to compare effects of clinical pathways on length of stay (LOS), hospital costs and patient outcomes. A random effects meta-analysis was performed with untransformed and log transformed outcomes.
Results
In total 17 trials met inclusion criteria, representing 4,070 patients. The quality of the included studies was moderate and studies reporting economic data can be described by a very limited scope of evaluation. In general, the majority of studies reporting economic data (LOS and hospital costs) showed a positive impact. Out of 16 reporting effects on LOS, 12 found significant shortening. Furthermore, in a subgroup-analysis, clinical pathways for invasive procedures showed a stronger LOS reduction (weighted mean difference (WMD) -2.5 days versus -0.8 days)).
There was no evidence of differences in readmission to hospitals or in-hospital complications. The overall Odds Ratio (OR) for re-admission was 1.1 (95% CI: 0.57 to 2.08) and for in-hospital complications, the overall OR was 0.7 (95% CI: 0.49 to 1.0). Six studies examined costs, and four showed significantly lower costs for the pathway group. However, heterogeneity between studies reporting on LOS and cost effects was substantial.
Conclusion
As a result of the relatively small number of studies meeting inclusion criteria, this evidence base is not conclusive enough to provide a replicable framework for all pathway strategies. Considering the clinical areas for implementation, clinical pathways seem to be effective especially for invasive care. When implementing clinical pathways, the decision makers need to consider the benefits and costs under different circumstances (e.g. market forces).
Background:
The increase in food intolerances poses a burgeoning problem in our society. Food intolerances not only lead to physical impairment of the individual patient but also result in a high socio-economic burden due to factors such as the treatment required as well as absenteeism. The present study aimed to explore whether lactose intolerant (LI) patients exhibit more frequent comorbidities than non-LI patients.
Methods:
The study was conducted on a case-control basis and the results were determined using routine data analysis. Routine data from the IMS Disease Analyzer database were used for this purpose. A total of 6,758 data records were processed and analyzed.
Results:
There were significant correlations between LI and the incidence of osteoporosis, changes in mental status, and the presence of additional food intolerances. Comparing 3,379 LI vs. 3,379 non-LI patients, 34.5% vs. 17.7% (P<0.0001) suffered from abdominal pain; 30.6% vs. 17.2% (P<0.0001) from gastrointestinal infections; and 20.9% vs. 16.0% (P=0.0053) from depression. Adjusted odds ratios (OR) were the highest for fructose intolerance (n=229 LI vs. n=7 non-LI; OR 31.06; P<0.0001), irritable bowel syndrome (n=247 LI vs. n=44 non-LI; OR 5.23; P<0.0001), and bloating (n=351 LI vs. n=68 non-LI; OR 4.94; P<0.0001).
Conclusion:
The study confirms that LI should not be regarded as an isolated illness but considered a possible trigger for further diseases. Additional research is necessary to assert more precise statements.
Background:
Hereditary angioedema (HAE) is a rare genetic disease and characterized by clinical features such as paroxysmal, recurrent angioedema of the skin, the gastrointestinal tract, and the upper airways. Swelling of the skin occurs primarily in the face, extremities and genitals. Gastrointestinal attacks are accompanied by painful abdominal cramps, vomiting and diarrhea. Due to the low prevalence and the fact that HAE patients often present with rather unspecific symptoms such as abdominal cramps, the final diagnosis is often made after a long delay. The aim of this German-wide survey was to characterize the period between occurrence of first symptoms and final diagnosis regarding self-perceived health, symptom burden and false diagnoses for patients with HAE.
Results:
Overall, 81 patients with HAE were included and participated in the telephone-based survey. Of those, the majority reported their current health status as “good” (47.5%) or “very good” (13.8%), which was observed to be a clear improvement compared to the year before final diagnosis (“good” (16.3%), “very good” (11.3%)). Edema in the extremities (85.2%) and in the gastrointestinal tract (81.5%) were the most currently reported symptoms and occurred earlier than other reported symptoms (mean age at onset 18.1 and 17.8 years, respectively). Misdiagnoses were observed in 50.6% of participating HAE patients with appendicitis and allergy being the most frequently reported misdiagnoses (40.0 and 30.0% of those with misdiagnosis, respectively). Patients with misdiagnosis often received mistreatment (80.0%) with pharmaceuticals and surgical interventions as the most frequently carried out mistreatments (65.6 and 56.3% of those with mistreatment, respectively). The mean observed diagnostic delay was 18.1 years (median 15.0 years). The diagnostic delay was higher in older patients and index patients.
Conclusions:
This study showed that self-perceived status of health for patients is much better once the final correct diagnosis has been made and specific treatment was available. Further challenge in the future will still be to increase awareness for HAE especially in settings which are normally approached by patients at occurrence of first symptoms to assure early referral to specialists and therefore increase the likelihood of receiving an early diagnosis.
Aim:
To characterize palliative care patients, to estimate the incidence, prevalence, and 1-year all-cause mortality in patients in Germany who received palliative care treatment.
Subject and methods:
The study analyzed the InGef Research Database, which covers 4 million people insured in German statutory health insurance companies. Specific outpatient and inpatient reimbursement codes were used to capture cases with palliative conditions. The prevalence was ascertained for the year 2015. The incidence was calculated for patients without documented palliative care services in the year before the observation period. The Kaplan–Meier method was used to analyze the 1-year all-cause mortality.
Results:
The incidence rate of palliative conditions was 41.3 and 34.9 per 10,000 persons in women and men, respectively. The prevalence per 10,000 persons was 61.3 in women and 51.1 in men. The 1-year all-cause mortality among patients receiving their first palliative care treatment was 67.5%. Mortality was lower in patients receiving general outpatient palliative care treatment (AAPV; 60.8%) compared to patients receiving specialized outpatient palliative care treatment (SAPV; 86.1%) or inpatient palliative care treatment (90.6%). Within the first 30 days, mortality was particularly high (~43.0%).
Conclusions:
In Germany, more than 400,000 patients per year receive palliative care treatment, which is lower compared to estimates of the number of persons with a potential need for palliative care. This gap was observed particularly in younger to middle-aged individuals. The findings indicate a demand for methodologically sound studies to investigate the public health burden and to quantify the unmet need for palliative care in Germany.
Influence on persistence and adherence with oral bisphosphonates on fracture rates in osteoporosis
(2009)
Background and Aim:
Oral bisphosphonates have been shown to reduce the risk of fractures in patients with osteoporosis. It can be assumed that the clinical effectiveness of oral bisphosphonates depends on persistence with therapy.
Methods:
The influence of persistence with and adherence to oral bisphosphonates on fracture risk in a real-life setting was investigated. Data from 4451 patients with a defi ned index prescription of bisphosphonates were included. Fracture rates within 180, 360, and 720 days after index prescription were compared between persistent and non-persistent patients. In an extended Cox regression model applying multiple event analysis, the influence of adherence was analyzed. Persistence was defined as the duration of continuous therapy; adherence was measured in terms of the medication possession ratio (MPR).
Results:
In patients with a fracture before index prescription, fracture rates were reduced by 29% (p = 0.025) comparing persistent and non-persistent patients within 180 days after the index prescription and by 45% (p < 0.001) within 360 days. The extended Cox regression model showed that good adherence (MPR ≥ 0.8) reduced fracture risk by about 39% (HR 0.61, 95% CI 0.47–0.78; p < 0.01).
Conclusions:
In patients with osteoporosis-related fractures, good persistence and adherence to oral bisphosphonates reduced fracture risk significantly.
Background:
Huntington’s disease (HD) is a rare, genetic, neurodegenerative and ultimately fatal disease with no cure or progression-delaying treatment currently available. HD is characterized by a triad of cognitive, behavioural and motor symptoms. Evidence on epidemiology and management of HD is limited, especially for Germany. This study aims to estimate the incidence and prevalence of HD and analyze the current routine care based on German claims data.
Methods:
The source of data was a sample of the Institute for Applied Health Research Berlin (InGef) Research Database, comprising data of approximately four million insured persons from approximately 70 German statutory health insurances. The study was conducted in a retrospective cross-sectional design using 2015 and 2016 as a two-year observation period. At least two outpatient or inpatient ICD-10 codes for HD (ICD-10: G10) during the study period were required for case identification. Patients were considered incident if no HD diagnoses in the 4 years prior to the year of case identification were documented. Information on outpatient drug dispensations, medical aids and remedies were considered to describe the current treatment situation of HD patients.
Results:
A 2-year incidence of 1.8 per 100,000 persons (95%-Confidence interval (CI): 1.4–2.4) and a 2-year period prevalence of 9.3 per 100,000 persons (95%-CI: 8.3–10.4) was observed. The prevalence of HD increased with advancing age, peaking at 60–69 years (16.8 per 100,000 persons; 95%-CI: 13.4–21.0) and decreasing afterwards.
The most frequently observed comorbidities and disease-associated symptoms in HD patients were depression (42.9%), dementia (37.7%), urinary incontinence (32.5%), extrapyramidal and movement disorders (30.5%), dysphagia (28.6%) and disorders of the lipoprotein metabolism (28.2%).
The most common medications in HD patients were antipsychotics (66.9%), followed by antidepressants (45.1%). Anticonvulsants (16.6%), opioids (14.6%) and hypnotics (9.7%) were observed less frequently.
Physical therapy was the most often used medical aid in HD patients (46.4%). Nursing services and speech therapy were used by 27.9 and 22.7% of HD patients, respectively, whereas use of psychotherapy was rare (3.2%).
Conclusions:
Based on a representative sample, this study provides new insights into the epidemiology and routine care of HD patients in Germany, and thus, may serve as a starting point for further research.
Background:
Multiple Sclerosis (MS) is a chronic inflammatory, immune mediated disease of the central nervous system, with Relapsing Remitting MS (RRMS) being the most common type. Within the last years, the status of high disease activity (HDA) has become increasingly important for clinical decisions. Nevertheless, little is known about the incidence, the characteristics, and the current treatment of patients with RRMS and HDA in Germany. Therefore, this study aims to estimate the incidence of HDA in a German RRMS patient population, to characterize this population and to describe current drug treatment routines and further healthcare utilization of these patients.
Methods:
A claims data analyses has been conducted, using a sample of the InGef Research Database that comprises data of approximately four million insured persons from around 70 German statutory health insurances (SHI). The study was conducted in a retrospective cohort design, including the years 2012–2016. Identification of RRMS population based on ICD-10 code (ICD-10-GM: G35.1). For identification of HDA, criteria from other studies as well as expert opinions have been used. Information on incidence, characteristics and current treatment of patients with RRMS and HDA was considered.
Results:
The overall HDA incidence within the RRMS population was 8.5% for 2016. It was highest for the age group of 0–19 years (29.4% women, 33.3% men) and lowest for the age group of ≥ 50 years (4.3% women, 5.6% men). Mean age of patients with RRMS and incident HDA was 38.4 years (SD: 11.8) and women accounted for 67.8%.
Analyses of drug utilization showed that 82.4% received at least one disease-modifying drug (DMD) in 2016. A percentage of 49.8% of patients received drugs for relapse therapy. A share of 55% of RRMS patients with HDA had at least one hospitalization with a mean length of stay of 13.9 days (SD: 18.3 days) in 2016. The average number of outpatient physician contacts was 28.1 (SD: 14.0).
Conclusions:
This study based on representative Germany-wide claims data from the SHI showed a high incidence of HDA especially within the young RRMS population. Future research should consider HDA as an important criterion for the quality of care for MS patients.
Background and Objectives:
Drawing causal conclusions from real-world data (RWD) poses methodological challenges and risk of bias. We aimed to systematically assess the type and impact of potential biases that may occur when analyzing RWD using the case of progressive ovarian cancer.
Methods:
We retrospectively compared overall survival with and without second-line chemotherapy (LOT2) using electronic medical records. Potential biases were determined using directed acyclic graphs. We followed a stepwise analytic approach ranging from crude analysis and multivariable-adjusted Cox model up to a full causal analysis using a marginal structural Cox model with replicates emulating a reference randomized controlled trial (RCT). To assess biases, we compared effect estimates (hazard ratios [HRs]) of each approach to the
HR of the reference trial.
Results:
The reference trial showed an HR for second line vs. delayed therapy of 1.01 (95% confidence interval [95% CI]: 0.82e1.25). The corresponding HRs from the RWD analysis ranged from 0.51 for simple baseline adjustments to 1.41 (95% CI: 1.22e1.64) accounting for immortal time bias with time-varying covariates. Causal trial emulation yielded an HR of 1.12 (95% CI: 0.96e1.28).
Conclusion:
Our study, using ovarian cancer as an example, shows the importance of a thorough causal design and analysis if one is expecting RWD to emulate clinical trial results.
Background
Chronic obstructive pulmonary disease (COPD) causes significant morbidity and mortality worldwide. Estimation of incidence, prevalence and disease burden through routine insurance data is challenging because of under-diagnosis and under-treatment, particularly for early stage disease in health care systems where outpatient International Classification of Diseases (ICD) diagnoses are not collected. This poses the question of which criteria are commonly applied to identify COPD patients in claims datasets in the absence of ICD diagnoses, and which information can be used as a substitute. The aim of this systematic review is to summarize previously reported methodological approaches for the identification of COPD patients through routine data and to compile potential criteria for the identification of COPD patients if ICD codes are not available.
Methods
A systematic literature review was performed in Medline via PubMed and Google Scholar from January 2000 through October 2018, followed by a manual review of the included studies by at least two independent raters. Study characteristics and all identifying criteria used in the studies were systematically extracted from the publications, categorized, and compiled in evidence tables.
Results
In total, the systematic search yielded 151 publications. After title and abstract screening, 38 publications were included into the systematic assessment. In these studies, the most frequently used (22/38) criteria set to identify COPD patients included ICD codes, hospitalization, and ambulatory visits. Only four out of 38 studies used methods other than ICD coding. In a significant proportion of studies, the age range of the target population (33/38) and hospitalization (30/38) were provided. Ambulatory data were included in 24, physician claims in 22, and pharmaceutical data in 18 studies. Only five studies used spirometry, two used surgery and one used oxygen therapy.
Conclusions
A variety of different criteria is used for the identification of COPD from routine data. The most promising criteria set in data environments where ambulatory diagnosis codes are lacking is the consideration of additional illness-related information with special attention to pharmacotherapy data. Further health services research should focus on the application of more systematic internal and/or external validation approaches.
Aim
Musculoskeletal disorders are a major public health problem in most developed countries. As a main cause of chronic pain, they have resulted in an increasing prescription of opioids worldwide. With regard to the situation in Germany, this study aimed at estimating the prevalence of musculoskeletal diseases such as chronic low back pain (CLBP) and hip/knee osteoarthritis (OA) and at depicting the applied treatment patterns.
Subject and methods
German claims data from the InGef Research Database were analyzed over a 6-year period (2011–2016). The dataset contains over 4 million people, enrolled in German statutory health insurances. Inpatient and outpatient diagnoses were considered for case identification of hip/knee OA and CLBP. The World Health Organization (WHO) analgesic ladder was applied to categorize patients according to their pain management interventions. Information on demographics, comorbidities, and adjuvant medication was collected.
Results
In 2016, n = 2,693,481 individuals (50.5% female, 49.5% male) were assigned to the study population; 62.5% of them were aged 18–60 years. In 2016, n = 146,443 patients (5.4%) with CLBP and n = 307,256 patients (11.4%) with hip/knee OA were identified. Of those with pre-specified pain management interventions (CLBP: 66.3%; hip/knee OA: 65.1%), most patients received WHO I class drugs (CLBP: 73.6%; hip/knee OA: 68.7%) as the highest level.
Conclusion
This study provides indications that CLBP and hip/knee OA are common chronic pain conditions in Germany, which are often subjected to pharmacological pain management. Compared to non-opioid analgesic prescriptions of the WHO I class, the dispensation of WHO class II and III opioids was markedly lower, though present to a considerable extent.
Forschungsdatenzentrum Gesundheit – Vision für eine Weiterentwicklung aus Sicht der Forschung
(2023)
Das Forschungsdatenzentrum (FDZ) Gesundheit nach der Datentransparenzverordnung (DaTraV), angesiedelt am Bundesinstitut für Arzneimittel und Medizinprodukte (BfArM) wird Routinedaten der Gesetzlichen Krankenversicherung für die Forschung bereitstellen. Die Bereitstellung der Daten von knapp 90% der Bevölkerung in Deutschland dient dem übergeordneten Ziel, die gesundheitliche Versorgung im Hinblick auf Unter-, Über- und Fehlversorgung zu evaluieren und daraus Handlungsempfehlungen für eine evidenzbasierte Gesundheitsversorgung abzuleiten. Der gesetzliche Rahmen wird im Sozialgesetzbuch (§§ 303a-f SBG V) und zwei dazu gehörigen Verordnungen gesteckt, lässt jedoch hinreichend großen Spielraum für die Ausgestaltung auf der Organisations- und Arbeitsebene. Hier setzt das vorliegende Papier an. Aus Forscher*innensicht wurden zehn Statements für eine Weiterentwicklung formuliert, die das Potential eines Forschungsdatenzentrums aufzeigen und Ideen für die weitere zukunftsfähige Ausgestaltung und Entwicklung mit Bestandskraft darlegen.
Das Gesundheitsdatennutzungsgesetz – Potenzial für eine bessere Forschung und Gesundheitsversorgung
(2023)
Im Koalitionsvertrag der Ampel-Koalition wird für die laufende Legislaturperiode ein Gesundheitsdatennutzungsgesetz (GDNG) angekündigt. Dieses Gesetz soll „zu einer besseren wissenschaftlichen Nutzung in Einklang mit der DSGVO“ führen. Bekanntermaßen steht unser Gesundheitssystem vor großen Herausforderungen (Demografie, Digitalisierung, Fachkräftemangel, Klimakrise, regionale Unterschiede, etc.) und ist jetzt schon das teuerste in Europa bei mittelmäßiger Leistung. Diese Herausforderungen können effizienter und evidenzgeleitet bewältigt werden, wenn wie im geplanten GDNG angedacht, die Datenressourcen für die Evaluierung und Weiterentwicklung des Gesundheitssystems und der Gesundheitsversorgung optimal genutzt werden. In den folgenden Ausführungen werden aus Sicht von Versorgungsforscher*innen Voraussetzungen und Desiderata für eine optimale Ausgestaltung des Gesetzes formuliert. Das Papier wurde durch das Deutsche Netzwerk Versorgungsforschung (DNVF) und die Arbeitsgruppe Erhebung und Nutzung von Sekundärdaten (AGENS) der Deutschen Gesellschaft für Sozialmedizin und Prävention (DGSMP) und der Deutschen Gesellschaft für Epidemiologie (DGEpi) erstellt und wird von den unterzeichnenden Fachgesellschaften getragen. Das vorliegende Positionspapier und die hier aufgestellten Forderungen sind vor der Veröffentlichung und damit in Unkenntnis des Referentenentwurfs zum GDNG formuliert worden.