Garbe, Edeltraut

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Garbe, Edeltraut

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Garbe, Edeltraut

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Methodische Aspekte bei der Durchführung von Arzneimittelsicherheits- und Utilisationsstudien basierend auf Routinedaten der gesetzlichen Krankenversicherung
(2016-05-04)
Jobski, Kathrin
;
Zeeb, Hajo
;
Hoffmann, Falk
;
Garbe, Edeltraut
At the time of approval, the safety and utilization of drugs in routine clinical practice cannot be fully assessed. Therefore, active post-marketing surveillance including the determination of the safety but also the utilization of the drugs as part of risk management plans is required by regulatory agencies. Pharmacoepidemiological studies based on claims data from statutory health insurance (SHI) providers are increasingly used to address these questions. These studies require a comprehensive knowledge of the healthcare system including reimbursement policies as well as specifics of the data source. Based on several safety and utilization studies using claims data, this thesis discusses methodological aspects relevant to conducting these studies. Considering regulations of the German health care system, the assessment of exposure, outcomes, and confounders as well as the determination of potential indications are described. Further, this thesis discusses approaches for addressing confounders which either cannot be measured in databases or if, only inadequately. Since even large electronic healthcare databases may not provide a sufficient sample size to examine rare outcomes or rare exposures, multinational database studies including databases with different structures are conducted. This thesis characterizes challenges arising from the analysis of these different databases. Pharmacoepidemiological studies based on SHI claims data are an important instrument to assess the safety and utilization of drugs following approval. The development of pharmacoepidemiology is characterized by the implementation of suitable data sources as well as the development of methodological instruments. This thesis depicts the current status and outlines future challenges.
Dissertation
381 308
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Clinical epidemiology of vaccines and vaccine-preventable diseases using administrative healthcare data
(2018-08-09)
Thöne, Kathrin
;
Haug, Ulrike
;
Zeeb, Hajo
;
Garbe, Edeltraut
For centuries, infectious diseases have been among the top 10 leading causes of death. In 2015, they accounted for about 11% of 56.4 million deaths worldwide indicating a global public health relevance. Vaccines provide an opportunity to eliminate or even eradicate infectious diseases. In order to maximize the benefit of vaccines while minimizing their risks, it is important to investigate infectious disease etiology as well as to continuously monitor and evaluate direct vaccination effects as well as indirect vaccination effects through herd immunity. Since vaccines are usually administered to healthy people to prevent infectious diseases, the monitoring of the safety of vaccines is of high importance. For their evaluation, there is usually no trade-off between risk of disease and risk of its treatment as is usually the case for the treatment of severe diseases. Vaccine safety is also essential for the acceptance of vaccines in the population and thus for high vaccine uptake to enable herd immunity. Epidemiological observational studies are a powerful tool to investigate the burden of vaccine-preventable diseases, direct and indirect vaccination effects as well as the safety of vaccines in a real-world setting, meaning they provide important data as they includea often in contrast to randomized controlled trialsa older or immunocompromised people as well as children or pregnant women, which are most often the target population groups for vaccinations. Administrative data are a valuable data source for epidemiological observational studies and are increasingly used for studies on vaccines and vaccine-preventable diseases. However, a comprehensive knowledge of the healthcare system itself, including reimbursement policies, but also of the data source and the containing information depth is required. This thesis investigates different aspects of vaccines and vaccine-preventable diseases. Thus, in a first study, the burden of the vaccine-preventable disease of herpes zoster (HZ) and its complications is investigated and in a separate study, the risk of stroke complication after HZ infection. Vaccine uptake of the human papillomavirus (HPV) vaccine at the population level as well as its indirect impact after vaccine recommendation is assessed. Furthermore, this thesis discusses the nested case-control design with respect to its potential use for direct effectiveness and safety studies of vaccines. Relevant methodological challenges when using different observational study designs based on administrative healthcare data as well as methods to control confounding or to reduce bias are elucidated and discussed. Finally, this thesis gives outlook on potential challenges of future studies on vaccines and vaccine-preventable diseases, especially with regard to newly developed therapeutic vaccines for chronic diseases.
Dissertation
488 476
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Routinedatenbasierte Untersuchungen zum Off-Label-Use in der ambulanten Versorgung
(2013-11-01)
Dörks, Michael
;
Hoffmann, Falk
;
Zeeb, Hajo
;
Garbe, Edeltraut
In many medical disciplines, particularly in paediatrics, psychiatry and oncology, drugs are often prescribed off-label. An off-label use is defined as the practice of prescribing drugs outside the terms of the product license, especially prescribed for an unapproved indication or age group. One problem is the impact of off-label use on drug safety in terms of adverse drug reactions associated with these drugs. In Germany, only limited data investigating the extent of off-label use in ambulatory care exist. Over the years, the use of secondary data from large administrative healthcare databases for pharmacoepidemiological and health service research increased. Drug utilisation studies based on these population-based data are valuable to explore patterns of drug use including off-label use. This thesis investigates the ambulatory off-label use of antidepressant and antiepileptic drugs in paediatric patients and the ambulatory off-label use of lenalidomide in oncology patients based on claims data of statutory health insurances. Drug utilisation studies to evaluate off-label use are closing a gap in the ascertainment of drug safety after approval. As physician's prescription behaviour is not influenced, claims data of statutory health insurances are an important data source to study off-label use, particularly in patients that are often underrepresented in clinical trials.
Dissertation
370 182
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Die ambulante Antibiotikatherapie : Methoden der Anwendungsforschung und Strategien der Förderung rationaler Verordnungsmuster
(2017-10-09)
Holstiege, Jakob
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Zeeb, Hajo
;
Hoffmann, Falk
;
Garbe, Edeltraut
The rise of antibiotic resistance is widely acknowledged to be an increasing threat to global public health. Promoting rational antibiotic prescribing patterns is one important approach to counter this development. Comprehensive analysis of patterns of antibiotic utilization and its quality in routine care is a perquisite to the design of effective tailored interventions to promote rational and judicious antibiotic prescribing. Automated health care databases facilitate the analysis of antibiotic utilization in outpatient care in large populations and can be used for international comparison of prescribing habits. In the German health care setting administrative databases of statutory health insurance companies (SHIs) capture all outpatient dispensations of prescription drugs and allow for the population-based and detailed analysis of antibiotic use in primary care. This doctoral thesis is based onone study on paediatric antibiotic use in German primary care and two studies comparing outpatient prescribing of systemic antibiotics to children and adolescents in the age group 0-18 years between Denmark, Italy, Germany, the Netherlands and the UK. These publications are complemented by a systematic review on the effectiveness of computer-aided clinical decision support systems in strengthening rational outpatient antibiotic prescribing. Here the aim is to (1) to further explore the significance of the published results in the light of the current state of research and (2) to amplify the discussion of important methodological issues and limitations. This comprises a critical review of the strengths and weaknesses of administrative data of German SHIs and comparable European databases as a basis for population-based studies of outpatient antibiotic utilization and cross-national comparison between European countries. In addition, an overview of the current state of knowledge regarding interventions to foster rational and judicious outpatient antibiotic prescribing is given and specific methodological challenges of the synthesis of evidence in this field are discussed. By allowing detailed cross-national comparisons of age- and gender-specific measures of antibiotic use, administrative data from German SHIs and similar European health care databases close an important gap in the surveillance of outpatient patterns of antibiotic use and the assessment of prescribing quality. Additional research is warranted to assess the validity of disease-specific measures of use based on German SHIs data. In recent years outpatient antibiotic use decreased in Germany, most remarkably in the paediatric setting. Nevertheless, further room for improvement exists. In particular, this concerns relatively high prescribing of broad spectrum agents as first line treatment of seasonal respiratory infections. Notably higher prescribing in contrast to other European countries such as the Netherlands, Denmark, Sweden or the UK can be seen for chinolones, cephalosporines (2nd and 3rd generation) and new macrolides. So far, a large number of international studies has been published aiming to improve quality of outpatient antibiotic prescription, mostly showing marginal to moderate intervention effects. Nevertheless, a selection of recently published studies consistently shows favourable effectiveness for some types of intervention, including the use of specific point-of-care tests.
Dissertation
379 450
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Versorgungsepidemiologische Analysen kardiovaskulärer Erkrankungen auf Basis von Routinedaten der gesetzlichen Krankenkassen
(2015-09-11)
Ohlmeier, Christoph
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Zeeb, Hajo
;
Hoffmann, Falk
;
Garbe, Edeltraut
Routine data of statutory health insurance providers (SHI) are increasingly used in health services research. The size, the longitudinal character of the data, the largely unselected populations as well as the possibility to evaluate routine care render SHI routine data an attractive data source for health services research. Since the data is generated for reimbursement processes, SHI routine data is limited with regard to the range and depth of information. Furthermore, the validity of the data for research purposes often is unclear. The aim of this thesis is to discuss the methodological challenges regarding the use of SHI routine data in health services research arising from the limitations inherent in the data and to further outline approaches to overcome these limitations. One of the biggest challenges regarding the use of SHI routine data in health services research is the fact that information on disease severity which may represent a confounder in analytical health services research is largely lacking. In this context, advantages and disadvantages of different propensity score methods regarding their potential for confounder control are discussed in the thesis. A further challenge is related to the fact that studies are often based on data from a single or few SHIs. Since insurants covered by the various SHIs differ with regard to sociodemographic characteristics which, in turn, can be related to the morbidity risk or the probability of receiving certain health services, the external validity of study results might be limited. Concerning this matter, weighting approaches to account for these differences are discussed. To evaluate the validity of SHI routine data with an external gold standard or to enrich SHI routine data with external data due to the limited range of information, a patient-individual record linkage with another data source is required. However, such a record linkage often cannot be realized, since processing person-identifying information requires meeting very high standards of data protection. In this thesis, methods allowing a record linkage of SHI routine data with another data source based on person-identifying information are discussed. Finally, there is an outlook regarding the availability of SHI routine data for research purposes.
Dissertation
637 284
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Klinisch-epidemiologische Forschung anhand von Daten der gesetzlichen Krankenkassen - Grenzen und Möglichkeiten
(2013-10-22)
Kraut, Astrid Angela
;
Hoffmann, Falk
;
Zeeb, Hajo
;
Garbe, Edeltraut
This dissertation discusses potential and limitation of routine data of statutory health insurances for clinical-epidemiological research exemplified by five studies conducted for two different diseases (attention deficit-/hyperactivity disorder and anogenital warts). The included studies examine the burden of disease, prevalence of comorbidities, drug treatment patterns and the effectiveness of a prophylactic vaccine in the general population. The database used for these studies was the German Pharmacoepidemiological Research Database (GePaRD), which contains records of more than 14 million people from all regions of Germany. The GePaRD contains information of in- and outpatient medical services and of medications that are reimbursed by health insurance companies. For the estimation of the burden of diseases, regional variation of disease and the examination of the effectiveness of a vaccine in the general population routine data of statutory health insurances can be a very valuable data source. For research questions for which the severity of the disease, social status and lifestyle factors are important this data are not or only of limited use.
Dissertation
592 184
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Over-the-counter (OTC) drug regulation and the epidemiology of OTC drug use in Germany
(2019-02-08)
Barrenberg, Eva
;
Hoffmann, Falk
;
Zeeb, Hajo
;
Garbe, Edeltraut
Introduction: Public health practice must ensure efficient access to effective and safe pharmaceuticals, while protecting the population from health risks related to the inappropriate use of pharmaceuticals. Background: About half of all packs sold in German pharmacies are over-the counter (OTC) drugs; their use and regulation is thus a subject of high relevance to public health. At the same time, OTC drugs receive rather limited attention in the drug regulatory and pharmacological literature, and little empirical evidence is available about OTC drug consumption and risk perceptions. Scope: The present thesis is based on four individual research papers that cover perceptions of and behaviours regarding OTC drugs among German adults, reasons for unsuccessful applications for changes to drug trade statuses, pharmacological perspectives on prescription-only (Rx)-to-OTC switches and the prevalence and predictors of OTC drugs use. Methods: This research draws on mixed methods, including an online survey, qualitative content analysis of policy and legislative documents and epidemiological analysis of data from the first phase of the German Health Interview and Examination Survey for Adults. Results: Among the adult population living in Germany, a seven-day OTC drug use prevalence of 40.2% was found. Female gender, older age, self-reported reduced health status and multimorbidity were significant predictors of OTC drug use. There were seven Rx-to-OTC switches between 2006 and 2015, but not all of these decisions were fully in line with the recommendations of the EU guideline on changing drug trade statuses. Further, unsuccessful applications for Rx-to-OTC switches, OTC-to-Rx switches and other changes trade Status were not infrequent. At the expert level, the most important reasons for rejected applications were drug safety concerns and insufficient data. At the policy level, negative decisions were mainly made because of legal restrictions. It was also found that risk perception of OTC drugs greatly depends on the route of administration and whether the product is plant-based or not. Moreover, consumers do not always read all details in the package leaflet. Conclusions: This thesis constitutes the first measure of OTC drug use in a representative sample of the adult population living in Germany. With a seven-day prevalence of 40.2%, OTC drug use is significant. While applications for changes in drug trade status and their fate are transparent, the reasons for negative recommendations are far less traceable. The findings of this thesis have led to the identification of several opportunities to improve OTC drug regulation. Detailed justifications for negative decisions on applications to changing drug trade statuses should be provided. Data that are already available a for instance, from large epidemiological studies a could be used to inform decision-making on potential changes to drug trade statuses. Such studies should make a distinction between self-medication and OTC drug use; they should also collect information on the doses and durations of OTC drug use. In addition, past changes to trade statuses should be evaluated so that lessons learned can inform future decision-making. Elaboration of a set of criteria concerning the risks and benefits of OTC availability is also recommended to increase evidence-based OTC drug regulation.
Dissertation
803 1844
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Opportunities and Pitfalls in Drug Safety Studies after Marketing Approval An Evaluation with a Focus on Older Patients
(2016-07-08)
Schmedt, Niklas
;
Hoffmann, Falk
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Zeeb, Hajo
;
Garbe, Edeltraut
In the next decades, the number of older people will rise substantially in Germany. Likewise, drug treatment and polypharmacy will also augment due to the high prevalence of multimorbidity in this subpopulation. Since older people are often excluded from randomized controlled trials prior to drug approval, pharmacoepidemiological safety studies (PSS) based on spontaneous reporting systems and electronic healthcare databases often represent the only opportunity to investigate the safety of drugs in this population. However, these studies have specific methodological challenges related to the clinical characteristics of older patients and the nature of the data sources. Thus, the overall aim of this thesis is to (1) critically assess methodological challenges of PSS based on spontaneous reporting systems and electronic healthcare databases with a focus on older patients and (2) to define further areas of research to enhance their quality. In this context, disproportionality analyses based on spontaneous reports, cohort studies, nested case control studies, and case only designs are introduced as study designs for PSS. Confounding (e.g., by frailty), outcome and exposure misclassification as well as time related biases in PSS are illustrated as selected methodological challenges. These challenges are then discussed in the context of my research articles with a focus on older people, and opportunities to address these challenges are presented. More specifically, the role of spontaneous reporting systems in the detection of adverse drug reactions in older people is critically assessed. Afterwards, drug utilization studies as well as the application of high dimensional propensity score methods and case only designs are discussed as options to overcome the specific problem of confounding by indication and unmeasured confounding in PSS among older people. Further, a detailed review of the patienta s profile is recommended to increase the specificity of the outcome case algorithms in administrative claims databases. Moreover, it is highlighted that sensitivity analyses in drug utilization and safety studies are particularly important in the case of a as neededa treatment among older patients and if information on the prescribed daily dose is missing. Finally, it is highlighted how time related biases can be prevented in cohort and nested case control studies using a time dependent analysis and risk set sampling, respectively. In the conclusion, future research perspectives with regard to PSS in older patients are pointed out as, for instance, the use of semi automated drug safety monitoring based on electronic healthcare databases, the availability of additional medical information in the context of the German a e healtha legislation or the need for external validation studies to study the impact of outcome and drug exposure misclassification.
Dissertation
544 345

Garbe, Edeltraut

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