Michael Kulig

Gemeinsame Bundesausschuss (G-BA) · Medical Consultancy Department

Introduction: The Federal Joint Committee (G-BA) is the highest decision-making body of the self-governing health care system in Germany [1]. Aside numerous responsibilities the G-BA performs an (additional) benefit assessment (see § 35a SGB V) for all newly approved drugs including drugs treating rare diseases (so-called orphan drugs [OD]). The e...

Hintergrund Der Gemeinsame Bundesausschuss (G-BA) führt für alle neu zugelassenen Arzneimittel eine (Zusatz)Nutzenbewertung durch (vgl. § 35a SGB V). Für Arzneimittel zur Behandlung seltener Erkrankungen (sogenannte Orphan Drugs [OD]) gelten einige Sonderregeln. Methodik Anhand öffentlich zugänglicher Dokumente auf der Homepage des G-BA sowie der F...

Dissemination bias occurs when only some results emerging from clinical research reach their intended audience in the knowledge translation process. Given that coverage decisions increasingly rely on evidence, it is important to explore the types of evidence considered. This paper aimed to examine the evidence base used by regulatory institutions i...

Background: Coverage decisions determining the benefit baskets of health systems have been increasingly relying on evidence regarding patient benefit and costs. Relevant structures, methodologies, and processes have especially been established for pharmaceuticals but approaches differ. The objective of this work was thus to identify institutions i...

Dissemination bias in clinical research severely impedes informed decision-making not only for healthcare professionals and patients, but also for funders, research ethics committees, regulatory bodies and other stakeholder groups that make health-related decisions. Decisions based on incomplete and biased evidence cannot only harm people, but may...

GRADE suggests that examination of 95% confidence intervals (CIs) provides the optimal primary approach to decisions regarding imprecision. For practice guidelines, rating down the quality of evidence (i.e., confidence in estimates of effect) is required when clinical action would differ if the upper versus the lower boundary of the CI represented...

Studies with individual data. (DOCX)

Search strategyused in MEDLINE via Ovid. (DOCX)

Patients with metastatic rhabdomyosarcoma (RMS) have a poor prognosis. The aim of this systematic review is to investigate whether high-dose chemotherapy (HDCT) followed by autologous hematopoietic stem cell transplantation (HSCT) in patients with metastatic RMS has additional benefit or harm compared to standard chemotherapy. Systematic literature...

Soft tissue sarcomas (STS) are a highly heterogeneous group of rare malignant solid tumors. Non-rhabdomyosarcoma soft tissue sarcomas (NRSTS) comprise all STS except rhabdomyosarcoma. In patients with advanced local or metastatic disease, autologous hematopoietic stem cell transplantation (HSCT) applied after high-dose chemotherapy (HDCT) is a plan...

e20527 Background: Patients with advanced RMS have a poor outcome. Treating these patients with HDCT followed by autologous HSCT is regarded experimental. The aim of this study was to evaluate the results from controlled trials. Methods: We systematically searched MEDLINE, EMBASE, and CENTRAL from inception to May 2009 without limits on study type...

Background/Objectives: The role of high dose chemotherapy followed by autologous stem cell transplantation (ASCT) for women with breast cancer is still a controversial issue. To-date, several randomized controlled trials (RCTs) have been completed, and for some trials follow-up data of more than 5 years are available. The aim of the current project...

Introduction: The Finnish prevention policy as well as the Finnish preventative interventions are widely recognized as a model for other countries. This qualitative interview study has the objective of shedding light on the political, organizational and scientific framework of their success. Methods: In 2008, qualitative interviews with twelve expe...

The true prevalence and risk factors of food allergies in children are not known because estimates were based predominantly on subjective assessments and skin or serum tests of allergic sensitization to food. The diagnostic gold standard, a double-blind placebo-controlled food provocation test, was not performed consistently to confirm suspected al...

The role of passive smoking for allergies and asthma in children above the age of 3 years remains unclear and possible interactive effects with parental allergies have not been formally evaluated in long-term studies. To examine the interaction of passive smoking and an allergic predisposition regarding allergic sensitization, allergic airway sympt...

Der medizinische Nutzen wird entsprechend den Vorgaben des §35b des SGB V anhand patientenbezogener Endpunkte bewertet. Die zentralen Nutzendimensionen sind hierbei Mortalität, Morbidität, Lebensqualität. Dies darf nicht zwangsläufig mit Wirksamkeitsbewertungen gleichgesetzt werden. Eine signifikante Veränderung eines Blutwertes oder eine detaillie...

Respiratory infections are the most frequent health problem in childhood. There is little precise information on how many respiratory illness episodes can be expected in a normal child. This study was designed to create reference values for the frequency of respiratory infections as recordable by history. Respiratory illnesses were recorded in a pr...

It is unclear which exposures may cause or modify the adverse effect of rapid weight gain on fat mass development in term children whose birth weight is appropriate-for-gestational age (AGA). To determine which intrauterine or postnatal exposures increase the risk of or modify the effect of rapid weight gain on body fat percentage (BF%) and body ma...

All European countries are facing common challenges for delivering appropriate, evidence-based care to patients with cancer. Despite tangible improvements in diagnosis and treatment, marked differences in cancer survival exist throughout Europe. The reliable translation of new research evidence into consistent patient-oriented strategies is a key e...

Some studies have suggested that supplementation of food with lactobacilli may prevent or improve atopic dermatitis in children. This study was designed to investigate the therapeutic effect of Lactobacillus rhamnosus GG (LGG) as a food supplement in infants suffering from atopic dermatitis. Infants aged 3-12 months suffering from mild-to-moderate...

The purpose of the study was to investigate whether the duration of sensitization to food allergens during early childhood is related to later development of IgE mediated hypersensitivity to inhalant allergens and of allergic rhinitis and asthma in 5-year-old children and whether long-lasting food-sensitization may be used to predict subsequent all...

The availability of comprehensive, up-to-date epidemiologic data would improve the understanding of the disease burden and clinical consequences of rotavirus gastroenteritis (RVGE) in Europe. During the 2004-2005 season, a prospective, multicenter, observational study was conducted in children <5 years of age in primary care, emergency department,...

The Global Allergy and Asthma European Network (GA2LEN) is a consortium of 26 leading European research centres committed to establish a European research area of excellence in the field of allergy and asthma. One of the GA2LEN work packages was designed to identify and compare the existing European birth cohort studies on asthma and atopic disease...

Gastro-oesophageal reflux disease can be associated with extra-oesophageal reflux disease such as chronic cough or laryngeal symptoms. The aim of this study was to analyse the clinical course of extra-oesophageal reflux disease in a large population with gastro-oesophageal reflux disease and extra-oesophageal reflux disease under routine clinical c...

Gastro-oesophageal reflux disease (GERD) is a common and frequently chronic condition that causes considerable costs. To estimate the economic burden caused by patients with erosive and non-erosive reflux disease, and Barrett's oesophagus. The Progression of Gastro-oesophageal Reflux Disease study includes a total of 6,215 patients. At baseline, pa...

The reasons for the rise in asthma and allergies remain unclear. To identify risk or protective factors, it is essential to carry out longitudinal epidemiological studies, preferably birth cohort studies. In Europe, several birth cohort studies on asthma and atopic diseases have been initiated over the last two decades. One of the work packages wit...

Proton pump inhibitor therapy has been reported to reduce proliferative changes of the oesophagus significantly in gastro-oesophageal reflux disease (GERD). To assess the histological effects of esomeprazole treatment on the oesophagus. Data were derived from a subgroup of patients participating in the proGERD study, who had either erosive reflux d...

To study the association of gastro-esophageal reflux disease (GERD) with the absence from work and to estimate the extent of loss in gross domestic product due to inability to work. Analysis was based on the prospectively gathered data of a large European cohort study involving 6 215 symptomatic GERD patients (ProGERD). Among these patients, 2 871...

Double-blind, placebo-controlled food challenges are time-consuming, expensive and not without risk to patients. Therefore, an in vitro test that could accurately diagnose food allergy would be of great value. To evaluate the utility of the ratio of specific immunoglobulin E (IgE)/total IgE compared with specific IgE (sIgE) alone in predicting symp...

The American Journal of Gastroenterology is published by Nature Publishing Group (NPG) on behalf of the American College of Gastroenterology (ACG). Ranked the #1 clinical journal covering gastroenterology and hepatology*, The American Journal of Gastroenterology (AJG) provides practical and professional support for clinicians dealing with the gastr...

Mortality rates from ischaemic heart disease have consistently been higher in East compared to West Germany both prior to and since reunification. Coronary care is inversely related to mortality from ischaemic heart disease. The objective of the present study was, therefore, to compare cardiovascular medication in East and West German patients foll...

Background: Prenatal and postnatal environmental tobacco smoke exposure (ETSE) is regarded as one of the most important risk factors for developing non-allergic and allergic respiratory diseases in early childhood. The goals of the study are to describe the extent of ETSE and to define the determinants of childhood exposure. Methods: Annual data on...

We describe the validation of a German-language version of the Reflux Disease Questionnaire in what is the first validation study of this patient questionnaire for a non-English speaking population. Gastro-oesophageal reflux disease is one of the most common diseases in primary care and has a significant negative impact on patients' quality of life...

Previous reports of a circadian variation of angina pectoris were based primarily on selected patients of clinical studies. The present ESCVA Study (European Survey on Circadian Variation of Angina Pectoris) was designed to determine the timing of angina pectoris attacks in outpatients, the association of wake time and possible external triggers wi...

Specific immunotherapy (SIT) and treatment with anti-immunoglobulin (Ig)E antibody are complementary approaches to treat allergic rhinoconjunctivitis, which may be used for single or combined treatment. A randomized, double-blind, placebo-controlled trial was conducted to compare the efficacy of single and combined treatment with SIT and anti-IgE (...

Gastroesophageal reflux disease can be divided into three categories: nonerosive GERD (NERD), erosive GERD (ERD), and Barrett's esophagus. A shift among these categories rarely occurs. The aim of the present study was to elucidate potential patient-associated risk factors associated with ERD. A total of 6,215 patients with troublesome heartburn wer...

We describe the design and report the first results of the Progression of Gastroesophageal Reflux Disease (ProGERD) study, to our knowledge the largest prospective study of GERD patients. Patients were recruited at 1,253 centers in Germany, Austria, and Switzerland. Following an assessment of medical history, all patients were endoscoped and receiv...

The aim of the present study was to assess change in health-related quality of life (HRQoL) after cardiac rehabilitation in the usual care setting, and to determine predictors for change. In the Post Infarction Care Study, 2441 patients were consecutively included at admission to 18 inpatient cardiac rehabilitation centres following coronary events...

RationaleEffect of in utero tobacco (IUT) and environmental tobacco smoke (ETS) exposure on the development of allergic sensitization and airway disorders during the first 10 years of life.

There are still ongoing controversies as to which histological parameters allow the diagnosis of gastroesophageal reflux disease (GERD). The aim of the present analysis was to relate histological changes of the esophageal squamous epithelium to different severities of GERD. Data were obtained from patients participating in the ProGERD study, who ha...

Return to work in patients after cardiac rehabilitation Objectives: The objectives of the present study were to determine prospectively return to work and its predictors in patients after cardiac rehabilitation. Methods: Patients were enrolled at admission to inpatient cardiac rehabilitation centres (n = 18). Primary indications for admission were...

To determine the impact of gastro-oesophageal reflux disease (GERD) on the quality of life, to assess changes in the quality of life during treatment with esomeprazole and to define factors that can predict these changes. Patients with GERD (n=6215) were included in a prospective cohort study (ProGERD). All patients underwent endoscopy and received...

Gastro-oesophageal reflux disease (GERD) can be associated with a variety of extra-oesophageal disorders (EED) such as chronic cough, asthma, laryngeal disorder or chest pain. The aim of the study was to estimate and compare the prevalence of EED in a population with symptomatic GERD presenting as either erosive reflux disease (ERD) or non-erosive...

Guidelines (GLs) for the management of heart failure (HF) are of great importance in order to define and disseminate therapeutic recommendations based on scientific evidence. The aim was to analyse and to compare the methodological quality of HF GLs as well as to evaluate the consistency of therapeutic recommendations. Eleven international GLs for...

Background Guidelines (GLs) for the management of heart failure (HF) are of great importance in order to define and disseminate therapeutic recommendations based on scientific evidence. The aim was to analyse and to compare the methodological quality of HF GLs as well as to evaluate the consistency of therapeutic recommendations. Methods Eleven in...

The symptoms of gastroesophageal reflux disease (GERD), particularly heartburn and acid regurgitation, are experienced by a large and growing number of persons worldwide. The prevalence of GERD has increased 10-fold in the past 30 years. Antacids, histamine2-receptor antagonists, and proton pump inhibitors are the most commonly used therapies for t...

After the unification in 1990 two different health and political systems merged in Germany. Our aim was to analyze trends in mortality from cerebrovascular diseases in the formerly divided western and eastern parts of Germany since the unification. Trends in mortality were determined by analyzing age-adjusted vital statistics data obtained from the...

The objectives of the present study were to determine prospectively return to work and its predictors in patients after cardiac rehabilitation. Patients were enrolled at admission to inpatient cardiac rehabilitation centres (n = 18). Primary indications for admission were myocardial infarction, coronary artery bypass grafting or percutaneous transl...

Die evidenzbasierte Medizin (EBM) soll für den Patienten die wirksamste und nebenwirkungsärmste Diagnostik und Therapie bereitstellen. Die Bevorzugung der Ratio und der bewusste Verzicht auf unreflektierte Intuition bei der Entscheidungsfìndung dienen als Basis. Der Suche nach dem besten vorhandenen medizinischen Wissen folgen strukturiert und nach...

Return to work in patients after cardiac rehabilitation Objectives: The objectives of the present study were to determine prospectively return to work and its predictors in patients after cardiac rehabilitation. Methods: Patients were enrolled at admission to inpatient cardiac rehabilitation centres (n = 18). Primary indications for admission were...

Berlin, Humboldt-Univ., Habil.-Schr., 2002 (Nicht für den Austausch).

Birth cohort studies offer the opportunity to study average risks, rates and occurrence times of disease longitudinally from birth. The effect of genetic and environmental factors and their interactions can be studied. Furthermore, quantity and duration of exposure to environmental agents can be evaluated prospectively. However, prospective birth c...

Epidemiological surveys have indicated that there has been a notable increase in the prevalence of both asthma and other allergic symptoms in children and young adults. Since it seems unlikely that genetic factors would contribute to the rising trend, environmental factors might play a major part in the development of childhood asthma. In a prospec...

Several birth cohort studies have been initiated during the past two decades to study environmental and genetic risk factors for atopic dermatitis, asthma and allergic rhinitis. This article summarizes results from the German Multicentre Allergy Study (MAS), which has followed children (initially 1,314) from birth (in 1990) to the present time. The...

To compare the effectiveness of Helicobacter pylori eradication in curing peptic ulcer disease in trials involving both gastric ulcer and duodenal ulcer. Twenty-four relevant randomized controlled trials and randomized comparative trials met the predefined selection criteria. Only proton pump inhibitor-based eradication trials were considered for t...

Background: The study aimed to assess the effect of pre- and postnatal tobacco smoke exposure on specific sensitization to food allergens and inhalant allergens during the first 3 years of life. Methods: A total of 342 children of a prospective and observational birth cohort study on atopy (MAS) were included on the basis of a complete follow-up of...

Bacille Calmette-Guérin (BCG) is a strong T helper 1 incentive and, thus, may contribute to a decreased risk of T helper 2-dependent atopic disease. To investigate the natural course of specific immunoglobulin E (IgE) responses and atopic disease in BCG-vaccinated and nonvaccinated children. Seven hundred seventy-four children from a prospectively...

Systematic data are sparse on clinical outcome after acute coronary disease followed by cardiac rehabilitation therapy. Therefore, our objective was to determine the long-term development of cardiac risk factors, recurrent clinical events, and cardiac medication in patients undergoing routine in hospital cardiac rehabilitation therapy. In the prosp...

Against the background of the controversial discussion about an increase in allergic rhinitis in recent years, intraindividual longitudinal data is lacking for IgE-mediated seasonal allergic rhinitis (SAR). Little is known about the development of SAR in terms of prevalence and incidence rates from birth to school age. In a prospective birth cohort...

Mobile emergency care units provide immediate benefit for patients with acute cardiovascular disease, but the subsequent prognosis of this patient population is unclear. We, therefore, aimed to determine whether the long-term survival of patients with acute cardiovascular syndromes requiring emergency medical care differs from controls of the gener...

A positive atopic family history has proved to be one important risk factor for the development of atopic diseases in offspring. However, many epidemiologists are concerned about the accuracy and reliability of data because responses to questionnaires can be biased for many reasons. The study investigated whether responses of parents questioned abo...

Background: A positive atopic family history has proved to be one important risk factor for the development of atopic diseases in offspring. However, many epidemiologists are concerned about the accuracy and reliability of data because responses to questionnaires can be biased for many reasons.Objective: The study investigated whether responses of...

Specific IgE antibody responses to alimentary and environmental allergens are one of the hallmarks of atopic diseases. The knowledge of the time course of allergic sensitization during early life may facilitate measures for preventive interventions. In a prospective birth cohort study (the Multicenter Allergy Study [MAS]) we investigated annual inc...

of our study was to investigate the effect of pre- and postnatal passive tobacco smoke exposure on the incidence of allergic sensitization. Specific sensitization to food, outdoor and indoor allergens was determined in 342 children at the age of 1, 2 and 3 years. Parents were asked about their smoking habit at the birth of their children, at 18 mon...

Total serum IgE percentiles were derived for a population-based sample of 4082 white children from Germany by weighted analysis of measurements from the Multicenter Allergy Study cohort. The children of a prospective birth cohort were selected from a complete 1-year sample of newborns in 6 obstetric departments in 1990. Total IgE was determined at...

Aim of our study was to investigate the effect of preand postnatal passive tobacco smoke exposure on the incidence of allergic sensitization. Patients and methods Specific sensitization to food, outdoor and indoor allergens was determined in 342 children at the age of 1, 2 and 3 years. Parents were asked about their smoking habit at the birth of th...

Objective: To exanine links between environmental tobacco smoke (ETS)-exposure and urnary cotinine excretion during the first five years of life. Design: Prospective birth cohiort study Patients: 307 children from the Genran Multicenter Atopy Study (MAS-90) Measurements and results: ETS-exposure was investigated by questionnaires about the parental...

The study aimed to assess the effect of pre- and postnatal tobacco smoke exposure on specific sensitization to food allergens and inhalant allergens during the first 3 years of life. A total of 342 children of a prospective and observational birth cohort study on atopy (MAS) were included on the basis of a complete follow-up of specific IgE measure...

A family history of atopy is a poor predictor of sensitization to inhalant allergens and allergic disease during childhood. We recently identified early sensitization to food allergens, especially hen's egg, as a valuable predictor of subsequent sensitization to inhalant allergens. (1) Whether prediction will be improved by in vitro allergy tests a...

A family history of atopy is a poor predictor of sensitization to inhalant allergens and allergic disease during childhood. We recently identified early sensitization to food allergens, especially hen's egg, as a valuable predictor of subsequent sensitization to inhalant allergens. (1) Whether prediction will be improved by in vitro allergy tests a...

The purpose of the study was to investigate whether the duration of sensitization to food allergens during early childhood is related to later development of IgE mediated hypersensitivity to inhalant allergens and of allergic rhinitis and asthma in 5-year-old children and whether long-lasting food-sensitization may be used to predict subsequent all...

The aim of the study was to investigate possible associations between the time course of early sensitization to latex and various life style factors. Of the 398 children from a prospective birth cohort study, 20 (5%) showed specific serum IgE to latex at the age of 5 years. Sensitization started beyond the first year of life and 19 out of 20 sensit...

Background: The purpose of the study was to investigate the influence of environmental allergen exposure on allergic sensitization in infancy and early childhood. Methods: A cohort of 1314 newborns was recruited and followed up prospectively at the ages 12, 24, and 36 months. The levels of major mite (Der p 1 and Der f 1) and cat (Fel d 1) aller...

Specific predictors for atopic sensitization in early infancy are prerequisites for preventive intervention studies. To identify predictors of allergic sensitization to common aeroallergens in infancy, 1314 children in five German cities were followed up from birth (1990) to the age of 3 years. Blood samples were taken from cord blood and at follow...

A number of epidemiological studies indicate that the prevalance of allergic airway diseases has been increasing over recent decades, especially in western industrialised countries, for reasons which are not yet completely understood (1, 2, 3). Changes in life style or an increase in indoor allergen exposure due to higher indoor temperature and hum...

In order to investigate, whether atopic and nonatopic children show differences in their specific IgE and IgG4 immune responses to tetanus (T) and diphtheria (D) antigens, we studied 538 children who had been followed from birth on and from whom records had been kept of all immunizations. The prevalence of eczema and asthma was registered at regula...