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Background: Autism Spectrum Disorder (ASD) is characterized by impairments in social communication, limited repetitive behaviors, impaired language development, and interest or activity patterns, which include a group complex neurodevelopmental syndrome with diverse phenotypes that reveal considerable etiological and clinical heterogeneity and are also considered one of the most heritable disorders (over 90%). Genetic, epigenetic, and environmental factors play a role in the development of ASD.
Aim: This study was designed to investigate the extent of DNA damage in parents of autistic children by treating peripheral blood mononuclear cells (PBMCs) with bleomycin and hydrogen peroxide (H2O2).
Methods: Peripheral blood mononuclear cells (PBMCs) were isolated by the Ficoll method and treated with a specific concentration of bleomycin and H2O2 for 30 min and 5 min, respectively. Then, the degree of DNA damage was analyzed by the alkaline comet assay or single cell gel electrophoresis (SCGE), an effective way to measure DNA fragmentation in eukaryotic cells.
Results: Our findings revealed that there is a significant difference in the increase of DNA damage in parents with affected children compared to the control group, which can indicate the inability of the DNA molecule repair system. Furthermore, our study showed a significant association between fathers’ occupational difficulties (exposed to the influence of environmental factors), as well as family marriage, and suffering from ASD in offspring.
Conclusion: Our results suggested that the influence of environmental factors on parents of autistic children may affect the development of autistic disorder in their offspring. Subsequently, based on our results, investigating the effect of environmental factors on the amount of DNA damage in parents with affected children requires more studies.
Clio-Guide: Bibliotheken
(2023)
Das Kapitel definiert den Begriff Bibliothek, erläutert die wichtigsten Aufgaben und Dienstleistungen von Bibliotheken und stellt die wichtigsten Elemente des deutschen Bibliothekswesens vor. Darüber hinaus werden typologisch die wichtigsten Gattungen bibliothekarischer Informationsressourcen und -systeme darbestellt. Die behandelten Beispiele berücksichtigen insbesondere die Bedürfnisse von Forschung und Lehre in den historisch arbeitenden Fächern.
Appropriate data models are essential for the systematic collection, aggregation, and integration of health data and for subsequent analysis. However, recommendations for modeling health data are often not publicly available within specific projects. Therefore, the project Zukunftslabor Gesundheit investigates recommendations for modeling. Expert interviews with five experts were conducted and analyzed using qualitative content analysis. Based on the condensed categories “governance”, “modeling” and “standards”, the project team generated eight hypotheses for recommendations on health data modeling. In addition, relevant framework conditions such as different roles, international cooperation, education/training and political influence were identified. Although emerging from interviewing a small convenience sample of experts, the results help to plan more extensive data collections and to create recommendations for health data modeling.
Die verpflichtende Nachhaltigkeitsberichterstattung ist auf dem Weg das Nachhaltigkeitsreporting von Unternehmen zu verändern. Eine wachsende Zahl an Unternehmen muss immer häufiger Informationen offenlegen, die sie vormals bewusst nicht publizierten. Einige Unternehmen könnten dies als ein Hindernis sehen, andere erkennen darin womöglich eine Chance für die Unternehmenskommunikation. Indem sie über gesetzlichen Mindestanforderungen hinaus publizieren und sich damit für eine umfassendere und transparentere Berichterstattung entscheiden, könnten Unternehmen von Profilierungsmöglichkeiten und Wettbewerbsvorteile profitieren. Das Ziel dieser Arbeit ist die Frage zu beantworten, welche Determinanten die freiwillige Offenlegung von Informationen, die über die gesetzlichen Mindestanforderungen der nichtfinanziellen Erklärung (NfE) hinausgehen, beeinflussen. Um die Forschungsfrage zu beantworten, wurde eine quantitative Inhaltsanalyse von 200 nach dem § 289b Handelsgesetzbuch (HGB) berichtspflichtigen Unternehmen durchgeführt. Hierzu wurden die nichtfinanziellen Erklärungen und weitere nachhaltigkeitsbezogene Informationen auf ihrer Unternehmenswebsite analysiert. Zudem wurde ein Offenlegungsscore konzipiert, um den Grad der zusätzlichen freiwilligen Offenlegung zu messen. Anschließend wurde untersucht, inwieweit Einflussfaktoren eine über die gesetzlichen Mindestanforderungen hinausgehende Offenlegung erklären können. Die Ergebnisse zeigen einen signifikanten Zusammenhang zwischen den Determinanten Unternehmensgröße, Berichtshistorie, Vorstandsgröße sowie dem Anteil ausländischer Vorstandsmitglieder und dem Offenlegungsgrad von freiwilligen zusätzlichen nichtfinanziellen Informationen. Hingegen konnte kein signifikanter Zusammenhang zwischen dem Offenlegungsgrad und den Determinanten Branchenzugehörigkeit, Kapitalmarktorientierung und Frauenanteil im Vorstand beobachtet werden.
Social Scoring in China
(2023)
In den zurückliegenden Jahren hat eine Nachricht Schlagzeilen gemacht, die besonders in der westlichen Welt für Aufruhr gesorgt hat: Die Regierung der Volkrepublik China implementiere ein Sozialkreditsystem, das die Menschen in ihrem alltäglichen Verhalten bewerte und zu „Wohlverhalten" zwingen solle.
Diese Arbeit beschäftigt sich mit den Hintergründen des „Sozialkreditsystem", seiner Entstehung, Umsetzung und der Rezeption durch die chinesische Bevölkerung. Abschließend wird ein Vergleich mit ähnlichen Systemen in Deutschland versucht.
Economic and political/governmental infrastructural factors are major contributors to the economic development/growth of all sectors of a country, such as in the area of healthcare systems and clinical research, including the pharmaceutical industry. But what is the interaction between economic, and political/governmental infrastructural factors and the development of healthcare systems, especially, the performance of the pharmaceutical industry? Information from selected articles of a literature search of PubMed and by using Google Advanced Search led to the generation of five categories of infrastructural factors, and were filled with data from 41 African Countries using the World Health Organization data repository. Median changes over time were given and tested by Wilcoxon signed-rank test and Friedman test, respectively. Analysis of factors related to availability of healthcare facilities showed that physicians and pharmacies were significant increased, with insignificantly decreased number of hospital beds. Healthcare Financing by the Government showed notable differences. Private health spending decreased significantly unlike Gross National Income. Analysis of infrastructural factors showed that stable supply of electricity and the associated use of the Internet improved significantly. The low level of data on the expansion of paved road networks suggests less developed medical services in remote rural areas. Healthcare systems in African countries improved over the last two decades, but differences between the individual countries still prevail and some of the countries cannot yet offer an attractive sales market for the products of pharmaceutical companies.
Einfluss politischer Social-Media-Kommunikation auf journalistische Zeitungsberichterstattung
(2023)
Auswirkungen strategischer Social-Media-Kommunikation politischer Akteure auf Zeitungsartikel: Inwiefern Themenframes auf sozialen Netzwerken die deutsche Presse beeinflussen.
Wahlkämpfe sind ein ständiges Ringen um die Deutungshoheit über Themen in den Massenmedien zwischen politischen Parteien und Akteuren. Dabei wirkt sich die Art der Medienberichterstattung über den Wahlkampf auf die Meinungsbildung der Rezipient*innen aus und beeinflusst ihr Wahlverhalten. Diese Forschungsarbeit setzt einen anderen Blickwinkel auf die Wahlkampfberichterstattung und untersucht, wie politische Parteien im Wahlkampf Themen in sozialen Netzwerken darstellen (framen) und inwieweit diese Themenframes von Journalist*innen in Zeitungsartikel übernommen werden. Der SPD-Landesverband Niedersachsen veröffentlichte im gesamten Landtagswahlkampf eine sehr geringe Anzahl an Pressemitteilungen. Im Untersuchungszeitraum (08.09-06.10.2022), den letzten vier Wochen des Wahlkampfes, waren es drei Stück. Demnach liegt die Schlussfolgerung nahe, dass Pressemitteilungen kein relevantes Kommunikationsmittel im Wahlkampf (mehr) sind und Inhalte stattdessen über soziale Netzwerke kommuniziert werden.
Methodik
Das Forschungsthema wurde mithilfe einer Input-Output-Analyse bearbeitet. Im ersten Schritt wurde eine qualitative Input-Inhaltsanalyse der Social-Media-Kommunikation durchgeführt. Es wurden 52 Beiträge auf Twitter und Instagram auf ihre inhaltliche Gestaltung analysiert. Auf Grundlage dieser Ergebnisse wurde eine quantitative Output-Inhaltsanalyse durchgeführt. Darin wurden 427 Zeitungsartikel aus elf Tageszeitungen untersucht. Das Codebuch zur Output-Analyse zielte darauf ab, verwendeten Themen, Themenframes sowie Übernahmen von Originaltönen der Social-Media-Beiträge in Zeitungsartikeln zu ermitteln.
Ergebnisse
Journalist*innen übernehmen Inhalte aus Social-Media-Beiträgen (noch) zu einem geringen Anteil in Zeitungsartikel. Die Themenauswahl zwischen Social-Media-Beiträgen und Zeitungsartikeln war sehr ähnlich, die Frame-Übernahme fiel hingegen gering aus. Wenn Frames übernommen wurden, wurden sie überwiegend ohne Einordnung oder Kritik vermittelt. Inhalte und Originaltöne aus Social-Media Beiträgen des SPD-Landesverbands Niedersachsen übernahmen Journalist*innen im Großteil der Stichprobenartikel nicht. Insgesamt fiel auf, dass regionale Tageszeitungen häufiger SPD-Frames und Originaltöne aus Social-Media-Inhalten in ihre Berichterstattung übernahmen als überregionale Tageszeitungen. Im Hinblick auf Quellen in Zeitungsartikeln fiel auf, dass die SPD und dessen Akteure im Vergleich zu anderen Parteien und Parteiakteuren häufiger als Quelle verwendet wurden. Die Untersuchungsergebnisse lassen auf eine journalistisch unabhängige Arbeit und Artikelaufbereitung schließen. Für das Kommunikationsmanagement ist das jedoch möglicherweise eine Zeit des Umbruchs, weil eine Tendenz, zumindest in der politischen Kommunikation, zu beobachten ist: weg von klassischer Pressearbeit, hin zu sozialer Netzwerkkommunikation.
Soziale Medien ermöglichen es ihren Nutzern besondere Beziehungen untereinander aufzubauen und zu vertiefen. Manche User bauen dabei eine weitreichende Followerschaft auf, die sogenannten Influencer. Die vorliegende Arbeit untersucht die Beziehung von Followern zu Influencer, indem der aktuelle Forschungsstand zu (trans-)parasozialen Beziehungen sowie gefühlter Interkonnektivität herangezogen wird. Mithilfe einer Online-Befragung werden die Auswirkungen einer intensiven parasozialen Beziehung zu Influencern auf verschiedene Erwartungsdimensionen untersucht. Die Ergebnisse werden vor dem Hintergrund der Theorie diskutiert und mögliche Forschungslücken herausgestellt.
Monitoring of clinical trials is a fundamental process required by regulatory agencies. It assures the compliance of a center to the required regulations and the trial protocol. Traditionally, monitoring teams relied on extensive on-site visits and source data verification. However, this is costly, and the outcome is limited. Thus, central statistical monitoring (CSM) is an additional approach recently embraced by the International Council for Harmonisation (ICH) to detect problematic or erroneous data by using visualizations and statistical control measures. Existing implementations have been primarily focused on detecting inlier and outlier data. Other approaches include principal component analysis and distribution of the data. Here we focus on the utilization of comparisons of centers to the Grand mean for different model types and assumptions for common data types, such as binomial, ordinal, and continuous response variables. We implement the usage of multiple comparisons of single centers to the Grand mean of all centers. This approach is also available for various non-normal data types that are abundant in clinical trials. Further, using confidence intervals, an assessment of equivalence to the Grand mean can be applied. In a Monte Carlo simulation study, the applied statistical approaches have been investigated for their ability to control type I error and the assessment of their respective power for balanced and unbalanced designs which are common in registry data and clinical trials. Data from the German Multiple Sclerosis Registry (GMSR) including proportions of missing data, adverse events and disease severity scores were used to verify the results on Real-World-Data (RWD).
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.
Purpose
This study aims to determine the intention to use hospital report cards (HRCs) for hospital referral purposes in the presence or absence of patient-reported outcomes (PROs) as well as to explore the relevance of publicly available hospital performance information from the perspective of referring physicians.
Methods
We identified the most relevant information for hospital referral purposes based on a literature review and qualitative research. Primary survey data were collected (May–June 2021) on a sample of 591 referring orthopedists in Germany and analyzed using structural equation modeling. Participating orthopedists were recruited using a sequential mixed-mode strategy and randomly allocated to work with HRCs in the presence (intervention) or absence (control) of PROs.
Results
Overall, 420 orthopedists (mean age 53.48, SD 8.04) were included in the analysis. The presence of PROs on HRCs was not associated with an increased intention to use HRCs (p = 0.316). Performance expectancy was shown to be the most important determinant for using HRCs (path coefficient: 0.387, p < .001). However, referring physicians have doubts as to whether HRCs can help them. We identified “complication rate” and “the number of cases treated” as most important for the hospital referral decision making; PROs were rated slightly less important.
Conclusions
This study underpins the purpose of HRCs, namely to support referring physicians in searching for a hospital. Nevertheless, only a minority would support the use of HRCs for the next hospital search in its current form. We showed that presenting relevant information on HRCs did not increase their use intention.
Schattenbibliotheken sind Lösungen, die sich aus einem Literaturmangel in der Forschung ergeben haben. Urheberrechtlich geschützte Inhalte werden hier online jedem frei zur Verfügung gestellt. In der vorliegenden Arbeit wird versucht, das Wirken dieser Dokumentsammlungen einzuordnen. So wird die Entstehung von Schattenbibliotheken aufgezeigt, auf den rechtlichen Umgang mit diesen Plattform eingegangen, zwei Schattenbibliotheken beispielhaft näher betrachtet und deren Auswirkungen abgebildet, bevor die Arbeit mit einem persönlichen Fazit abschließt.
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.