[Health for refugees - the Bremen model]. / Gesundheit für Flüchtlinge - das Bremer Modell.

The Bremen model recognizes that refugee health care has to go beyond merely checking for the prevalence of contagious diseases. Elementary health care offered in the reception centre and transitory facilities is based on voluntary acceptance by the refugees. At the same time, legal requirements for the medical reception of refugees are observed. In addition, doctors performing the initial medical examination are enabled to cover acute care on the spot. During the preliminary phase of immigration refugees are allowed to see a doctor in their facility repeatedly. After a certain time, they are provided with a health card permitting limited access to regular care outside of their facility. The current rise of refugee numbers affects the situation of Bremen health care for adult as well as juvenile refugees. In spite of the increase, health care standards are maintained by means of the health card. From 2011 to 2014, "Factors influencing health status and contact with health services" averaged 29.6 % in the health check data. Diseases of the respiratory system (18.1 %) and "symptoms, signs and abnormal findings not elsewhere classified" (16.9 %) ranked second and third, respectively. Diseases of the digestive system (6.1 %) of the musculoskeletal system (6 %) and of the skin and subcutaneous tissue (3.6 %) followed. Infectious diseases such as HIV infections, hepatitis or tuberculosis were seldom.

Comparison of high-resolution X-ray and micro-CT for experimental evaluation of intracranial stent prototypes: quality evaluation beyond CE mark.

INTRODUCTION: As digital mammography and micro-computed tomography (CT) have been used for evaluation of stents deployed in experimental animal models, we compared the two methods regarding their sensitivity to detect abnormalities in three prototypes of intracranial stents. METHODS: Three different prototypes of intracranial stents (n = 84) were implanted in various animal models. Explanted stents were examined using digital mammography and micro-CT. The images were compared with respect to maintenance of material and form and the stents were compared to one another. Histological analysis was performed as well. RESULTS: In the open-cell stents, expansion of the stent cells was detected in the majority of cases (57.1 %) using micro-CT and less frequently using mammography (42.3 %). The closed-cell stent revealed kink stenoses in mammography as well as in micro-CT (3/7, 42.9 %). Detailed reconstructions of micro-CT images showed high-grade kink stenoses of the flow-diverter stent in two extremely curved vessels. Strut breaks were observed more frequently using micro-CT (6/84, 7.1 %) than by mammography (4/84, 4.8 %). Histology confirmed all changes of stent architecture. CONCLUSION: Significant changes of stent architecture can be observed and assessed even in the two-dimensional mammographic images. The use of micro-CT is recommended to detect subtle changes like single strut breaks and for three-dimensional information.

Accuracy of diagnostic antibody tests for coeliac disease in children: summary of an evidence report.

OBJECTIVE: The aim of this study was to summarise the evidence from 2004 to September 2009 on the performance of laboratory-based serological and point of care (POC) tests for diagnosing coeliac disease (CD) in children using histology as reference standard. PATIENTS AND METHODS: We searched MEDLINE and EMBASE for studies reporting on children for tests based on IgA and IgG anti-gliadin (AGA), endomysial (EmA), anti-transglutaminase-2 (TG2), and anti-deamidated gliadin peptides (DGP) antibodies or POC tests. For inclusion, histological analysis of duodenal biopsies and sensitivity and specificity for index tests had to be reported. Data were pooled and summary measures calculated for sensitivity, specificity, positive and negative likelihood ratios ("LR+", "LR-"), and diagnostic odds ratios (DOR). In case of elevated statistical heterogeneity, studies reaching 90% sensitivity or specificity were reported. RESULTS: A total of 2510 articles were reviewed; 16 entered meta-analysis, reporting on 3110 patients (1876 with CD, 1234 without CD). For IgA-EmA, sensitivity was ≥90% in 7/11 studies and pooled specificity 98.2%. For IgA-anti-TG2, 11/15 studies yielded sensitivities ≥90% and 13/15 specificities ≥90%. For IgA-DGP, sensitivity ranged between 80.7% and 95.1% (specificity 86.3%-93.1%); for IgG-DGP between 80.1% and 98.6% (specificity 86.0-96.9%). IgA-EmA had the highest pooled DOR (554) and LR+ (31.8) for a laboratory test, followed by IgA-anti-TG2, IgG-DGP, IgA-DGP and IgA-AGA. POC tests showed a pooled sensitivity of 96.4% for IgA-TG2 (specificity 97.7%). CONCLUSIONS: IgA-EmA and IgA-anti-TG2 tests appear highly accurate to diagnose CD. IgG-anti-DGP tests may help in excluding CD. IgA-AGA and IgA-DGP tests show inferior accuracy. POC tests may achieve high accuracy in the hands of experienced readers, but IgA-anti-TG2/EmA were superior.

Intravitreal bevacizumab (Avastin) vs. ranibizumab (Lucentis) for the treatment of age-related macular degeneration: a systematic review.

PURPOSE OF REVIEW: We conducted a systematic review to evaluate whether the existing evidence justifies the intravitreal use of bevacizumab in comparison to ranibizumab in age-related macular degeneration. RECENT FINDINGS: Compared with photodynamic therapy, bevacizumab shows a relative improvement in visual acuity that is of similar size as in the comparison of ranibizumab with photodynamic therapy (relative improvement from 30 to 35%). However, this finding is based on one randomized controlled trial including less than 50 patients treated with bevacizumab. Also, nothing is known about long-term (>12 months) improvements in visual acuity and optimal treatment intervals for bevacizumab.Regarding safety, the published literature indicates that ocular and systemic adverse effects are less frequent under bevacizumab than ranibizumab treatment. But the validity of this finding is strongly limited by inadequate reporting, an unsystematic evaluation of adverse effects and short follow-up times in studies evaluating bevacizumab. SUMMARY: Given the lack of controlled data, the widespread off-label use of bevacizumab is not justified in clinical practice. On the other hand, a major challenge in the management of patients who require repeated antivascular endothelial growth factor injections is the high cost of ranibizumab. This dilemma underlines the need for head-to-head studies comparing both vascular endothelial growth factor antibodies, or, at least, well conducted randomized controlled trials evaluating intravitreal bevacizumab.

[From evidence to recommendation influence of consensus processes on grades of recommendation-'against consensus'?]. / Von der Evidenz zur Empfehlung Einfluss von Konsensprozessen auf Empfeh- lungsgrade-"kontra Konsens"?

Guidelines are not only sources of condensed evidence. They also contain graded recommendations that have been agreed upon in consensus procedures. Frequently there are discrepancies between the results of the critical appraisal of the evidence expressed in levels of evidence and the strength of the resulting recommendations. Unfortunately, the reasons for these discrepancies remain largely obscure and guideline users are therefore unable to comprehend this so-called 'upgrading' or 'downgrading', respectively. A consensus process consisting of several stages and a more detailed documentation could be a possible remedy. The present contribution is based on a lecture held at the 7th Annual Meeting of the DNEbM (German Network for Evidence-based Medicine) in Bochum in March 2006.

[A guide to the critical reflection of health services research studies]. / Studien zur Versorgungsforschung. Eine Hilfe zur kritischen Rezeption.

Proponents of evidence-based medicine have developed a framework for the critical appraisal of clinical studies. Though this framework is generally accepted, a universal standard for health services research is not yet available. While clinical research evaluates the efficacy and effectiveness of medical interventions, the remit of health services research is to investigate the actual delivery of care in a given health care system. Here, we propose six criteria for the critical appraisal of work published in the field of health services research: the research question, the validity of the study design, the indicators used, the data source, the audience being addressed and the interests behind a study should all be considered when discussing health services research studies. Ideally, health services research should be an integral part of research efforts including basic as well as clinical research.

[Method report 2007 of the Programme for National Disease Management Guidelines--background and content]. / Der Methodenreport 2007 des Nationalen Programms für VersorgungsLeitlinien - Hintergrund und Inhalt.

The Programme for National Disease Management Guidelines (German DM-CPG Programme) was established in 2002 by the German Medical Association (umbrella organisation of the German Chambers of Physicians) and joined by the Association of the Scientific Medical Societies (AWMF)--umbrella organisation of more than 150 professional societies--and by the National Association of Statutory Health Insurance Physicians (NASHIP) in 2003. The programme provides a conceptual basis for disease management, focussing on high priority healthcare topics and aiming at the implementation of best practice recommendations for prevention, acute care, rehabilitation and chronic care. It is organised by the German Agency for Quality in Medicine, a founding member of the Guidelines International Network G-I-N. The main objective of the German DM-CPG Programme is to establish consensus among the medical professions on evidence-based key recommendations covering all sectors of healthcare provision and facilitating the coordination of care for the individual patient through time and across interfaces. Within the last year DM-CPGs have been published for asthma, COPD, type 2 diabetes and coronary heart disease. In addition, experts from national patient self-help groups have been developing patient guidance based upon the recommendations for healthcare providers. The article describes background, methods and tools of the DM-CPG programme using the DM-CPG Method Report 2007.

[The German program for disease management guidelines--implementation with pathways and quality management]. / Nationale VersorgungsLeitlinien--Nutzung im Qualitätsmanagement unter besonderer Berücksichtigung von Klinischen Behandlungspfaden und Regionalen Leitlinien.

In Germany, physicians enrolled in disease management programs are legally obliged to follow evidence-based clinical practice guidelines. That is why a Program for National Disease Management Guidelines (German DM-CPG Program) was established in 2002 aiming at implementation of best-practice evidence-based recommendations for nationwide as well as regional disease management programs. Against this background the article reviews programs, methods and tools for implementing DM-CPGs via clinical pathways as well as regional guidelines for outpatient care. Special reference is given to the institutionalized program of adapting DM-CPGs for regional use by primary-care physicians in the State of Hesse.

[The German Program for Disease Management Guidelines: COPD Guideline 2006. Short review]. / Die Nationale VersorgungsLeitlinie COPD: Ein zusammenfassender Bericht.

In Germany, the first national consensus on evidence-based recommendations for COPD prevention and disease management was reached in spring 2006. After a development period of 9 months, the National Disease Management Guideline COPD was finalized by nominal group process under the authorship of the scientific societies for pneumology (DGP and Atemwegsliga), general internal medicine (DGIM), family medicine (DEGAM), and the Drug Commission of the German Medical Association (AKDAE). The recommendations' main sources are the NICE COPD Guideline 2004, the GOLD Recommendations as well as existing German guidelines and reviews of recent scientific evidence. The article gives an overview on authors, sources, and key recommendations of the German National Disease Management Guideline COPD 2006 (www.copd.versorgungsleitlinien.de).

[The German Program for Disease Management Guidelines Type 2 Diabetes - Diabetic Foot Guideline 2006. Short review]. / Die Nationale VersorgungsLeitlinie Typ-2-Diabetes - Fusskomplikationen. Ein zusammenfassender Bericht.

In Germany, the first national consensus between 14 medical scientific associations on evidence-based recommendations for prevention and therapy of foot problems in type 2 diabetes was reached in fall 2006. The recommendations' main sources are the NICE Guideline 2003 on foot problems in type 2 diabetes, as well as existing German guidelines and reviews of recent scientific evidence. The article gives an overview on authors, sources, and key recommendations of the German National Disease Management Guideline Type 2 Diabetes - Diabetic Foot 2006 (www.diabetes.versorgungsleitlinien.de).

[The German program for disease management guidelines: type 2 diabetes--diabetic retinopathy/maculopathy guideline 2006. Short review]. / Die Nationale VersorgungsLeitlinie Typ-2-Diabetes--Netzhautkomplikationen. Ein zusammenfassender Bericht.

In Germany, the first national consensus between six medical scientific associations on evidence-based recommendations for prevention and therapy of retinopathy/maculopathy in type 2 diabetes was reached in fall 2006. The recommendations' main sources are the NICE Retinopathy Guideline 2002, and existing German guidelines and reviews of recent scientific evidence. The article gives an overview on authors, sources, and key recommendations of the German National Disease Management Guideline Type 2 Diabetes-Retinopathy/Maculopathy 2006 (www.diabetes.versorgungsleitlinien.de).

Decision making about healthcare-related tests and diagnostic test strategies. Paper 2: a review of methodological and practical challenges.

OBJECTIVES: In this first of a series of five articles, we provide an overview of how and why healthcare-related tests and diagnostic strategies are currently applied. We also describe how our findings can be integrated with existing frameworks for making decisions that guide the use of healthcare-related tests and diagnostic strategies. STUDY DESIGN AND SETTING: We searched MEDLINE, references of identified articles, chapters in relevant textbooks, and identified articles citing classic literature on this topic. RESULTS: We provide updated frameworks for the potential roles and applications of tests with suggested definitions and practical examples. We also discuss study designs that are commonly used to assess tests' performance and the effects of tests on people's health. These designs include diagnostic randomized controlled trials and retrospective validation. We describe the utility of these and other currently suggested designs, which questions they can answer and which ones they cannot. In addition, we summarize the challenges unique to decision-making resulting from the use of tests. CONCLUSION: This overview highlights current challenges in the application of tests in decision-making in healthcare, provides clarifications, and informs the proposed solutions.

Decision making about healthcare-related tests and diagnostic test strategies. Paper 4: International guidelines show variability in their approaches.

OBJECTIVES: The objective of the study was to describe and compare current practices in developing guidelines about the use of healthcare-related tests and diagnostic strategies (HCTDS). STUDY DESIGN AND SETTING: We sampled 37 public health and clinical practice guidelines about HCTDS from various sources without language restrictions. RESULTS: Detailed descriptions of the systems used to assess the quality of evidence and develop recommendations were challenging to find within guidelines. We observed much variability among and within organizations with respect to how they develop recommendations about HCTDS. Twenty-four percent of the guidelines did not consider health benefits and harms but based decisions solely on test accuracy. We did not identify guidelines that described the main potential care pathways involving tests for a healthcare problem. In addition, we did not identify guidelines that systematically assessed, described, and referenced the evidence that linked test accuracy and patient-important outcomes. CONCLUSION: There is considerable variability among the processes used and factors considered in developing recommendations about the use of tests. This variability may be the cause for the disagreement we observed in recommendations about testing for the same condition.

Decision making about healthcare-related tests and diagnostic test strategies. Paper 3: a systematic review shows limitations in most tools designed to assess quality and develop recommendations.

OBJECTIVES: The objective of this study was to identify and describe critical appraisal tools designed for assessing the quality of evidence (QoE) and/or strength of recommendations (SoRs) related to health care-related tests and diagnostic strategies (HCTDSs). STUDY DESIGN AND SETTING: We conducted a systematic review to identify tools applied in guidelines, methodological articles, and systematic reviews to assess HCTDS. RESULTS: We screened 5,534 titles and abstracts, 1,004 full-text articles, and abstracted data from 330 references. We identified 29 tools and 14 modifications of existing tools for assessing QoE and SoR. Twenty-three out of 29 tools acknowledge the importance of assessing the QoE and SoR separately, but in 8, the SoR is based solely on QoE. When making decisions about the use of tests, patient values and preferences and impact on resource utilization were considered in 6 and 8 tools, respectively. There is also confusion about the terminology that describes the various factors that influence the QoE and SoR. CONCLUSION: Although at least one approach includes all relevant criteria for assessing QoE and determining SoR, more detailed guidance about how to operationalize these assessments and make related judgments will be beneficial. There is a need for a better description of the framework for using evidence to make decisions and develop recommendations about HCTDS.

[The German Disease Management Guideline Asthma: methods and development process]. / Nationale VersorgungsLeitlinie Asthma: Methodik und Entwicklungsprozess.

The German National Program for Disease Management Guidelines, which is being operated under the auspices of the German Medical Association (GMA), the Association of the Scientific Medical Societies (AWMF) and the National Association of Statutory Health Insurance Physicians (NASHIP), provides a conceptual basis for the disease management of prioritized healthcare aspects. The main objective of the program is to establish consensus of the medical professions on key recommendations covering all sectors of healthcare provision and facilitating the coordination of care for the individual patient through time and across interfaces. Within the scope of this program, the Scientific Medical Societies concerned with the prevention, diagnosis, treatment and rehabilitation of asthma in children, adolescents and adults have reached consensus on the core contents for a National Disease Management Guideline for Asthma. This consensus was reached by applying formal techniques and on the basis of the adaptation of recommendations from existing guidelines with high quality standards in methodology and reporting, and information from evidence reports.

[Consumer involvement in the Disease Management Guideline for Asthma--a background report]. / Patientenbeteiligung an der NVL Asthma--ein Werkstattbericht.

In the past clinical guidelines were mainly developed by experts and in everyday clinical practice almost exclusively used by clinical experts, while issues that were relevant from the patients' (consumers') point of view tended to be neglected. But then, the majority of patient information has not been perceptibly connected to clinical guidelines. Connecting the development of clinical guidelines with the development of patient information publications would make good sense for both products, though. On the one hand, evidence-based treatment guidelines could be made available to the actual target group of the clinical care process--i.e. the patients or consumers--and on the other hand, patient experiences and competencies (social evidence) might inform the production of guidelines. Such a procedure demands the cooperation of clinical experts and patients. So far there are no generally accepted methods in Germany for the practical implementation of consumer involvement on both the organizational and content level with the aim of involving patients in the development process of guidelines as well as the production of the respective patient information versions. Such a methodology shall be established as part of the National Program for Disease Management Guidelines. For the first time in this program, patient involvement is being exercised within the scope of the National Disease Management Guideline for Asthma (NDM Asthma). Here, patients are involved in the NDM development process by providing the opportunity to comment on the consented guideline draft and to participate in the translation of the NDM Asthma into a patient version. The present paper is a background report describing the current state of work and indicating consequences for some future developments.

[The German Program for Disease Management Guidelines: CHD Guideline 2006. Short review]. / Die Nationale VersorgungsLeitlinie KHK 2006: Ein zusammenfassender Bericht.

In Germany, the first national consensus on evidence-based recommendations for disease management in patients with chronic coronary heart disease was reached in summer 2006. After a development period of 4 years, the National Disease Management Guideline Chronic Coronary Heart Disease was finalized by nominal group process under the authorship of the scientific associations for cardiac rehabilitation (DGPR), cardiac surgery (DGTHG), cardiology (DGK), general internal medicine (DGIM), family medicine (DEGAM), and the Drug Commission of the German Medical Association (AKDAE). The recommendations' main sources are the ACC/AHA guidelines 2002 updates as well as existing German guidelines and reviews of recent scientific evidence. The article gives an overview on authors, sources, and key recommendations of the German National Disease Management Guideline Chronic Coronary Heart Disease 2006 (www.khk.versorgungsleitlinie.de).

[The German program for disease management guidelines. Background, methods, and development process]. / Nationale Versorgungsleitlinien von BAK, AWMF und KBV : Hintergrund, Methodik und Instrumente.

The Program for National Disease Management Guidelines (German DM-CPG Program) was established in 2002 by the German Medical Association (umbrella organization of the German Chambers of Physicians) and joined by the Association of the Scientific Medical Societies (AWMF; umbrella organization of more than 150 professional societies) and by the National Association of Statutory Health Insurance Physicians (NASHIP) in 2003. The program provides a conceptual basis for disease management, focusing on high-priority health-care topics and aiming at the implementation of best practice recommendations for prevention, acute care, rehabilitation and chronic care. It is organized by the German Agency for Quality in Medicine, a founding member of the Guidelines International Network (G-I-N). The main objective of the German DM-CPG Program is to establish consensus of the medical professions on evidence-based key recommendations covering all sectors of health-care provision and facilitating the coordination of care for the individual patient through time and across interfaces. Within the last year, DM-CPGs have been published for asthma, chronic obstructive pulmonary disease, type 2 diabetes, and coronary heart disease. In addition, experts from national patient self-help groups have been developing patient guidance based upon the recommendations for health-care providers. The article describes background, methods, and tools of the DM-CPG Program, and is the first of a publication series dealing with innovative recommendations and aspects of the program.

[Clinical practice guidelines in Germany, 1994 to 2004. From guideline methodology towards guideline implementation]. / Medizinische Leitlinien in Deutschland, 1994 bis 2004. Von der Leitlinienmethodik zur Leitlinienimplementierung.

The role of clinical practice guidelines (CPG) as a tool for continuous medical education (CME), and quality management in health care is now widely accepted in Germany. Since the 90ies, the physicians' professional associations as well as health care authorities and parliament have been introducing several incentives and regulations in order to promote the use of evidence based CPG. In the past German CPG agencies have been focussing their work on developing and optimising methodological CPG standards. Future CPG activities should address much more other key factors for the success of CPGs, such as medical relevance, practicability, effective dissemination, and implementation. The article describes the process of guideline adaptation by regional physician audit groups as a tool for CPG implementation.