Evolution of gastro-oesophageal reflux disease over 5 years under routine medical care--the ProGERD study.

BACKGROUND: The evolution of gastro-oesophageal reflux disease (GERD) under current management options remains uncertain. AIM: To examine whether, depending on the initial presentation, non-erosive (NERD) and erosive reflux disease (ERD) without Barrett's oesophagus will progress to more severe disease under current routine care following the resolution of the initial condition. METHODS: Patients with the primary symptom of heartburn were included at baseline, and stratified into non-erosive (NERD) and erosive reflux disease (ERD), LA grades A-D (Los Angeles classification). After a 2- to 8-week course with esomeprazole therapy to achieve endoscopic healing in ERD and symptom relief in NERD, patients were treated routinely at the discretion of their physician. We report oesophagitis status and the presence of endoscopic and confirmed Barrett's oesophagus after 5 years. RESULTS: A total of 6215 patients were enrolled in the study of whom 2721 patients completed the 5-year follow-up. Progression, regression and stability of GERD severity were followed from baseline to 5 years. Only a few patients with NERD and mild/moderate ERD progressed to severe forms of ERD and even Barrett's oesophagus. Most patients remained stable or showed improvement in their oesophagitis; 5.9% of the NERD patients, 12.1% of LA grade A/B patients and 19.7% of LA grade C/D patients in whom no Barrett's oesophagus was recorded at baseline progressed to endoscopic or confirmed Barrett's oesophagus at 5 years. CONCLUSION: Most GERD patients remain stable or improve over a 5-year observation period under current routine clinical care.

[Nursing concepts for patients with dementia. Systematic review]. / Pflegerische Betreuungskonzepte bei Patienten mit Demenz. Ein systematischer Review.

BACKGROUND: Today there are approximately one million people with dementia in Germany. Because most forms of dementia cannot be cured the focus of treatment is to provide adequate care, aiming at the maintenance of cognitive functioning, the ability to perform everyday tasks and quality of life. Important approaches for dementia care are multisensory stimulation, validation, reality orientation and reminiscence therapy. However, the efficacy of these approaches is unclear. METHODS: A systematic review of the literature was performed. We included randomised controlled trials with at least 30 participants on the efficacy of multi-sensory stimulation, validation, reality orientation and reminiscence therapy for dementia. No restrictions were defined with regard to the endpoints under investigation. RESULTS: A total of 14 studies with 1,513 patients could be included of which 5 studies assessed reminiscence therapy, 4 multi-sensory stimulation, 3 validation and 2 reality orientation. The studies analysed cognitive functioning, behavioural outcomes, psychological symptoms and quality of life. Most studies did not find significant differences between the intervention and the control group. CONCLUSION: The studies conducted to date provide only little evidence for the efficacy of the approaches for dementia care considered in this review. However, only few methodologically robust studies could be identified for this review which highlights the need for more interventional studies.

Clinical course of laryngo-respiratory symptoms in gastro-oesophageal reflux disease during routine care--a 5-year follow-up.

BACKGROUND: Gastro-oesophageal reflux disease (GERD) can be associated with laryngo-respiratory symptoms (LRS) such as chronic cough, asthma or laryngeal symptoms. AIM: To analyse the long-term clinical course of LRS in a large population with GERD and LRS. METHODS: ProGERD is a prospective multicentre cohort study of 6215 adult out-patients with GERD. At baseline, the prevalence of LRS was assessed. Initial standardized treatment was esomeprazole for up to 8 weeks. After 5 years of follow-up, patients were interviewed for LRS and a multivariate analysis was performed with resolved vs. persistent symptoms for chronic cough, asthma and laryngeal symptoms. RESULTS: In all, 2886 patients (46.4%) were available for analysis at baseline and at 5 years. The prevalence of chronic cough and laryngeal disorders had decreased while the prevalence of asthma had increased. Resolution of LRS was independent of clinical reflux characteristics or PPI medication. CONCLUSIONS: In a large population with GERD, only few patients reported persistent LRS over 5 years. Resolution of LRS was independent of the stage of GERD and PPI treatment. Accordingly, data on the direction of causality between GERD and LRS are lacking and the strength of the association between the two must remain controversial.

Health-related quality of life in patients with gastro-oesophageal reflux disease under routine care: 5-year follow-up results of the ProGERD study.

BACKGROUND: Gastro-oesophageal reflux disease (GERD) is a common disorder associated with substantial reductions in health-related quality of life (HRQL). AIM: To describe patterns of change in HRQL during 5 years of follow-up in a large population of GERD patients. METHODS: In 2000, a total of 6215 GERD patients were enrolled in the Progression of GERD (ProGERD) study. During follow-up, patients received any medication considered necessary. HRQL was assessed yearly with the Short-Form 36 and the Quality of Life in Reflux and Dyspepsia (QOLRAD) questionnaires. Associations between patient characteristics and changes in HRQL were analysed using multiple logistic regression models. RESULTS: After 5 years, data on HRQL were available for 4597 (74%) patients. Both generic and disease-specific HRQL improved after baseline and remained well above baseline levels in the following years. A clinically relevant decrease in QOLRAD scores was reported by 3-5% of patients. According to our multivariate analysis, a decrease in HRQL was associated with a higher reflux symptom load and the presence of night-time heartburn. CONCLUSIONS: Only a small minority of the ProGERD population reported a clinically relevant decrease in HRQL, which was associated most strongly with nocturnal heartburn.

Serum gastrin and pepsinogens do not correlate with the different grades of severity of gastro-oesophageal reflux disease: a matched case-control study.

BACKGROUND: Gastrin and pepsinogens reflect the functional state of the gastric mucosa. AIM: To evaluate whether serum gastrin and pepsinogens correlate with the different grades of severity of gastro-oesophageal reflux disease (GERD). METHODS: In all, 388 patients with heartburn not taking any form of acid suppressive therapy were matched-controlled for age and gender and sub-classified into four groups: group 1 non-erosive reflux disease (NERD); group 2, erosive reflux disease (ERD) Los Angeles (LA) A and B, group 3, ERD LA C and D; group 4 Barrett's oesophagus (BO). Fasting serum was analysed for gastrin 17, pepsinogen I, pepsinogen II und Helicobacter pylori using specific EIA tests (GastroPanel; Biohit, Plc). STATISTICS: Kruskal-Wallis test and analysis of variance. RESULTS: There was a significant difference among the four groups with respect for pepsinogen I, but not for pepsinogen II, the pepsinogen I pepsinogen II ratio, H. pylori serology and gastrin levels. Pepsinogen I was the lowest in NERD and the highest in BO (median 91.6, mean +/- standard deviation 106.2 +/- 51.6 vs. median 114.7, mean +/- standard deviation 130.4 +/- 70.6; P = 0.046). Pepsinogen I levels were higher in H. pylori positive subjects. After adjusting for H. pylori status, the differences in pepsinogen I across patient groups were no longer statistically significant (P = 0.298). CONCLUSIONS: Serum gastrin and pepsinogen I and II do not correlate with the different grades of severity of GERD. The non-invasive GastroPanel is not useful for the differentiation of the various forms of GERD.

[The small difference in medicine. A survey on the acceptance of gender-related aspects in medicine]. / Der kleine Unterschied in der Medizin. Eine Befragung zur Akzeptanz von Geschlechtsaspekten.

INTRODUCTION: Gender medicine investigates sex-related differences in morbidity and mortality. The consideration of relevant sex-specific factors should lead to an improvement in prevention, diagnosis and therapy. The goal of this survey was to obtain a picture of the current status and the future potential of gender medicine from the perspective of clinicians. METHODS: A questionnaire on gender medicine in education, diagnosis, therapy and research was sent to all professors as well as a random sample of assistant medical directors specializing in gynaecology, cardiology and neurology at German university hospitals. RESULTS: The response rate was 55% (N = 136). The present importance of gender medicine in Germany was rated by 83% of the respondents as low, and 62% said that gender medicine should be a required subject during medical studies. Through more consideration of gender-specific aspects, 72% expect a more exact diagnosis, 80% more specific treatment, 77% the avoidance of secondary complications, 64% a reduction of mortality and 73% the reduction of consequential costs. DISCUSSION: The current importance of gender medicine is assessed as rather low. The vast majority of the doctors expect clear improvements in patient medical care when the connection between gender and health are given more consideration.

Long-term treatment of patients with gastro-oesophageal reflux disease in routine care - results from the ProGERD study.

BACKGROUND: Gastro-oesophageal reflux disease (GERD) is a common condition frequently requiring long-term pharmacological treatment. AIM: To describe the long-term pattern of GERD medication use in GERD patients receiving routine care. METHODS: Patients were recruited as part of the ongoing ProGERD study, a 10-year-cohort study including 6215 patients at baseline. GERD medication and symptoms were assessed with patient questionnaires. During follow-up, medical treatment was prescribed by participating primary care physicians. Associations between patient characteristics and medication were analysed by logistic regression. RESULTS: The percentage of patients who reported using any GERD medication remained constant from year 1 to year 4 (74%, 74%, 73% and 71%). Of patients who reported using GERD medication, the majority were taking proton pump inhibitors (PPI) (79%, 84%, 85%, and 87%). Continuous PPI intake was the predominant prescription pattern (53%, 49%, 56% and 56%), followed by on-demand treatment (26%, 35%, 29% and 29%). Continuous PPI intake was strongly associated with the presence of erosive GERD. CONCLUSION: Three-quarters of the GERD population in our study reported long-term treatment with a PPI. Continuous PPI intake was the predominant treatment pattern, and the proportion of patients taking a PPI on a continuous basis remained constant over time.

[Demands of private gastroenterologists for collaborative treatment concepts with clinics. Results of a Germany-wide survey]. / Welche Anforderungen stellen niedergelassene Gastroenterologen an integrierte Versorgungskonzepte mit Kliniken? Ergebnisse einer deutschlandweiten Umfrage.

BACKGROUND: New demands and possibilities of collaboration between hospitals and private practices in Germany have appeared, now that the way has been opened legally. A poll was conducted to analyse the current status of collaboration between outpatient gastroenterologists and hospital surgical departments and to identify possible future collaborations. MATERIALS AND METHODS: One thousand twenty-six private practices specialising in endoscopy were found by contacting the Association of Statutory Health Insurance Physicians and additional internet research. Of these, 50% were randomly selected (513 private practices) and contacted by mail with anonymous questionnaires about cooperation with their clinical partners. Two hundred three (39.6%) practices responded, of which 200 could be analysed. RESULTS: Of all practices reached, 75% considered the cooperation with clinics very valuable or even exceptional. Still, almost half (46%) suggested necessary improvements in these collaborations. Around a third of all contacted colleagues were already involved in projects following integrated care models. In about 80% of all participants, the main interest in integrated models was specified to be common therapy planning. CONCLUSION: The data analysis of this study shows a substantial interest of private-practice gastroenterologists in close collaboration with hospitals. It is now up to the hospitals to open contracts with their medical outpatient partners.

Health-related quality of life in patients with pancreatic cancer.

BACKGROUND: Pancreatic cancer is an aggressive cancer with low survival time, with health-related quality of life (HRQoL) being of major importance. The aim of our study was to assess both generic and disease-specific HRQoL in patients with pancreatic cancer. METHODS: Patients with pancreatic cancer were consecutively included at admission to hospital. HRQoL was determined with the disease-specific European Organization for Research and Treatment of Cancer (EORTC) and generic EuroQoL (EQ-5D) health status instruments. Scores of patients were compared to those of norm populations. The association of symptoms with overall HRQoL was analysed using linear regression. RESULTS: A total of 45 patients with pancreatic cancer were included. The mean age was 64 years, 53% were females. Of all patients, 44% had metastases at the time of admission. HRQoL was significantly impaired for most EORTC and EQ-5D scales in comparison to norm populations. Symptoms of fatigue (-0.34 regression coefficient; 95% CI -0.63, -0.11) and pain (-0.21; 95% CI -0.39, -0.02) were significantly associated with impaired overall HRQoL. CONCLUSIONS: HRQoL was severely impaired in patients with pancreatic cancer. Symptom control and palliative care appear to be of particular importance.

Prevalence and sociodemographics of reflux symptoms in Germany--results from a national survey.

BACKGROUND: Although gastro-oesophageal reflux disease is a common gastrointestinal disorder, the prevalence rates differ depending on the population studied. AIM: To determine the prevalence of reflux symptoms in the German adult population and any associations with age, gender or socio-economic status. METHODS: A total of 7124 subjects were interviewed as part of the German National Health Interview and Examination Survey, which is a representative sample of the general adult population. The prevalence of mild, moderate or severe heartburn or regurgitation was calculated. Logistic regression models were developed to determine the relationship between reflux symptoms and sociodemographic factors such as age, gender and socio-economic status. RESULTS: The overall prevalence of moderate and severe reflux symptoms was 14% and 4%, respectively. The prevalence increased with age and was highest in the age group 60-69 years with 25% of these subjects reporting moderate or severe reflux symptoms. Being male, it increased the risk of mild, but not of moderate or severe symptoms. Lower socio-economic status was associated with moderate or severe symptoms. CONCLUSIONS: Because of their high prevalence, reflux symptoms are of major public health importance.

Lifestyle factors and symptoms of gastro-oesophageal reflux -- a population-based study.

BACKGROUND: Although the symptoms of gastro-oesophageal reflux disease are common in the general adult population, the aetiology of gastro-oesophageal reflux disease is still largely unknown. Lifestyle factors such as diet, body mass index, and smoking have been frequently suggested as possible risk factors. AIM: In the present study, we investigated the relationship between various lifestyle factors and gastro-oesophageal reflux disease symptoms. METHODS: A total of 7124 subjects were interviewed as part of the German National Health Interview and Examination Survey, a representative sample of the general adult population. We examined a variety of possible risk factors, including age, gender, body mass index, smoking, alcohol consumption, sports and different foods. To investigate the association between lifestyle and symptoms, we used a multiple logistic regression model, including various gastro-oesophageal reflux disease patient characteristics. RESULTS: We found an association among those with reflux symptoms who were overweight and obese (odds ratio: 1.8, 95% confidence interval: 1.5-2.2; odds ratio: 2.6, 95% confidence interval: 2.2-3.2), respectively. Further risk factors included smoking and the frequent consumption of spirits, sweets, or white bread. Physical activity and the consumption of fruits seemed to have some protective effect. CONCLUSIONS: Lifestyle factors -- in particular overweight, obesity and smoking -- were associated with increased reflux symptoms.

Cost-of-disease analysis in patients with gastro-oesophageal reflux disease and Barrett's mucosa.

BACKGROUND: Gastro-oesophageal reflux disease (GERD) is a common and frequently chronic condition that causes considerable costs. AIM: To estimate the economic burden caused by patients with erosive and non-erosive reflux disease, and Barrett's oesophagus. METHODS: The Progression of Gastro-oesophageal Reflux Disease study includes a total of 6,215 patients. At baseline, patients were categorized as non-erosive reflux disease, erosive reflux disease, or Barrett's oesophagus according to endoscopic findings alone or as confirmed by histology. Direct and indirect disease-related costs were calculated based on 5,273 patients with complete information in the second year of the study. RESULTS: A total of 73% of the Progression of Gastro-oesophageal Reflux Disease patients had taken GERD medication, 61% had visited a doctor, and 2% had been hospitalized because of GERD during the previous 12 months. Of all employed persons, 6% reported days off work because of GERD. This health resource utilization caused direct costs of 342+/-864 (mean+/-s.d.) and indirect costs of 40+/-473 per patient and year. Total costs for patients with Barrett's oesophagus or erosive reflux disease were higher than those for patients with non-erosive reflux disease. CONCLUSION: Patients with GERD frequently need long-term medication and doctor care. The disorder is associated with a considerable health economic burden to society.

Long-term clinical course of extra-oesophageal manifestations in patients with gastro-oesophageal reflux disease. A prospective follow-up analysis based on the ProGERD study.

BACKGROUND: 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 care. METHODS: ProGERD is a prospective multicentre cohort study of 6215 outpatients with gastro-oesophageal reflux disease. At baseline all patients underwent endoscopies and were interviewed for extra-oesophageal reflux disease. Initial standardised treatment was esomeprazole for up to 8 weeks. After 2 years of follow-up, reflux symptoms and the prevalence of extra-oesophageal reflux disease were assessed. A multivariate analysis was performed with resolved versus persistent symptoms for chronic cough and laryngeal symptoms as dependent predictors. Independent variables were gender, age, body mass index (BMI), alcohol consumption, cigarette smoking, gastro-oesophageal reflux disease classification, history of gastro-oesophageal reflux disease in the family, duration of gastro-oesophageal reflux disease and proton pump inhibitors medication. RESULTS: Four thousand four hundred and four patients (71%) were available for analysis at 2 years, including 570 and 454 patients who had chronic cough and laryngeal disorders at baseline, respectively. In 63% and 74% of the patients, chronic cough and laryngeal disorders had resolved. Patients with persistent respiratory symptoms in year 2 had significantly more reflux symptoms. Further clinically relevant associations were smoking and non-steroidal anti-inflammatory drugs use. According to the multivariate analysis, classification of gastro-oesophageal reflux disease, proton pump inhibitors medication or duration of gastro-oesophageal reflux disease were not associated with the resolution of cough or laryngeal symptoms. CONCLUSION: In most patients with gastro-oesophageal reflux disease and extra-oesophageal reflux disease, respiratory symptoms resolve during long-term routine care. A high reflux symptom load was associated with the persistence of respiratory disorders.

The predictive value of the skin prick test weal size for the outcome of oral food challenges.

BACKGROUND: The skin prick test (SPT) is regarded as an important diagnostic measure in the diagnostic work-up of food allergy. Objective To evaluate the diagnostic capacity of the SPT in predicting the outcome of oral food challenges, and to determine decision points for the weal size and the skin index (SI) that could render double-blind, placebo-controlled food challenges unnecessary. METHODS: In 385 children (median age 22 months), 735 controlled oral challenges were performed with cow's milk (CM), hen's egg (HE), wheat and soy. Three hundred and thirty-six of 385 (87%) children suffered from atopic dermatitis. SPT was performed in all children. Diagnostic capacity, receiver-operator characteristics (ROC) curves and predictive decision points were calculated for the mean weal size and the calculated SI. RESULTS: Three hundred and twelve of 735 (43%) oral food challenges were assessed to be positive. Calculation of 95% and 99% predicted probabilities using logistic regression revealed predictive decision points of 13.0 and 17.8 mm for HE, and 12.5 and 17.3 mm for CM, respectively. However, using the SI, the corresponding cut-off levels were 2.6 and 3.7, respectively, for HE, and 2.7 and 3.7 for CM. For wheat, 95% and 99% decision points of 2.2 and 3.0 were found in children below 1 year of age. CONCLUSION: Predictive decision points for a positive outcome of food challenges can be calculated for HE and CM using weal size and SI. They may help to avoid oral food challenges.

Utility of the ratio of food-specific IgE/total IgE in predicting symptomatic food allergy in children.

BACKGROUND: 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. OBJECTIVE: To evaluate the utility of the ratio of specific immunoglobulin E (IgE)/total IgE compared with specific IgE (sIgE) alone in predicting symptomatic food allergy. METHODS: We retrospectively analysed 992 controlled oral food challenges performed in 501 children (median age 13 months). The ratio of sIgE/total IgE was calculated and tested for correlation with the outcome of food challenges. Receiver operator characteristics (ROC)-curves were performed; predicted probabilities and predictive decision points were calculated. RESULTS: A significant correlation was found between the ratio and the outcome of food challenges for cow's milk (CM), hen's egg (HE), and wheat, but not for soy. The ROC and predicted probability curves as well as sensitivity and specificity of the decision points of the ratio were similar to those of sIgE levels for CM, HE and wheat. CONCLUSION: In view of the greater effort needed to determine the ratio, without benefit compared with the sIgE alone, the calculation of the ratio of sIgE/total IgE for diagnosing symptomatic food allergy offers no advantage for CM, HE, wheat or soy. For the majority of cases controlled oral food challenges still remain the method of choice.

The predictive value of specific immunoglobulin E levels in serum for the outcome of oral food challenges.

BACKGROUND: Specific serum IgE is considered as one of the important diagnostic measures in the diagnostic work-up of food allergy. OBJECTIVE: To evaluate the role of specific serum IgE in predicting the outcome of oral food challenges, and to determine threshold concentrations of specific serum IgE that could render double-blind, placebo-controlled food challenges unnecessary. METHODS: In 501 children (median age 13 months), 992 controlled oral challenges were performed with cow's milk (CM), hen's egg (HE), wheat and soy. 440/501 (88%) children suffered from atopic dermatitis. For all children, specific IgE concentrations in serum were determined. Sensitivity, specificity, positive and negative predictive values, receiver operator characteristics-curves as well as predictive decision points were calculated. RESULTS: Four hundred and forty-five out of 992 oral food challenges with allergens were assessed as positive. Sensitivity of specific serum IgE was 97% for HE, 83% for CM, 69% for soy, and 79% for wheat. Specificity was 51% for HE, 53% for CM, 50% for soy, and 38% for wheat. Calculating 90%, 95% and 99% predicted probabilities using logistic regression revealed predictive decision points of 6.3, 12.6, and 59.2 kU/L for HE, respectively. Subdividing our children in those of below or above 1 year of age resulted in a markedly different predicted probability for HE. For CM, only the 90% predicted probability (88.8 kU/L) could be calculated. No decision points could be determined for CM, wheat and soy. CONCLUSION: In general, specific serum IgE levels showed a correlation with the outcome of positive oral food challenges for CM and HE. Meaningful predictive decision points can be calculated for HE, which may help to avoid oral food challenges in some cases. However, data need to be ascertained for each allergen separately. Furthermore, the age of the patient population under investigation must also be taken into account.

Validation of the Reflux Disease Questionnaire for a German population.

OBJECTIVE: 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. There is no gold standard for diagnosing gastro-oesophageal reflux disease, however, so the valid assessment of symptoms is especially important. DESIGN AND METHODS: A total of 5689 patients (92%) completed the questionnaire both before treatment and after 2 weeks. The results were tested for validity and reliability. Predictive validity was tested in a pilot study of 100 patients. Convergent validity was examined using the Quality of Life in Reflux and Dyspepsia Questionnaire for the assessment of disease-specific quality of life and the McMaster Overall Treatment Evaluation for the assessment of therapeutic success. RESULTS: Principal component analysis suggested a three-factor solution with the subscores heartburn, regurgitation, and dyspepsia. The internal consistencies of the subscores were between 0.84 and 0.86. Item difficulty ranged from 0.33 to 0.53, and corrected item-total correlation from 0.66 to 0.72. Effect sizes were between 0.8 and 1.0. CONCLUSION: The German version of the questionnaire has good psychometric properties and is responsive to changes in health. Thus, we conclude that the German Reflux Disease Questionnaire is suitable for the assessment of heartburn, regurgitation, and treatment response, both in primary care settings and clinical studies.

Risk factors of gastroesophageal reflux disease: methodology and first epidemiological results of the ProGERD study.

OBJECTIVE: 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. STUDY DESIGN AND SETTING: Patients were recruited at 1,253 centers in Germany, Austria, and Switzerland. Following an assessment of medical history, all patients were endoscoped and received esomeprazole for 2 to 8 weeks before entering the 5-year observational phase. RESULTS: A total of 6,215 patients (53% male, age 54+/-14) were included. Of these patients, 46% reported at least daily symptoms, 15% were unable to work at least once during the prior year, and 71% had visited a physician due to reflux symptoms. Barrett's esophagus (BE) was found in 11% of our GERD patients. In polychotomous regression analysis, the main factors related to the occurrence of the three GERD subgroups (nonerosive, erosive disease, and BE) were age, gender, duration of GERD, body mass index (BMI), smoking, and previous PPI use. Factors associated with longer disease duration were increasing age, male gender, BMI, increasing symptom severity, presence of erosive GERD or BE, positive family history, and smoking. CONCLUSION: The findings indicate that GERD is a great burden for patients, and has significant socioeconomic implications. The long-term follow-up period with further endoscopic and histologic evaluations, will help further our understanding of the natural course of the disease.