[Decisions of the German Federal Joint Committee in situations with insufficient data : Decision-making options for new diagnostic and treatment methods].

Background: In accordance with legal requirements, the Federal Joint Committee (German: Gemeinsamer Bundesausschuss, G‑BA) decides based on the best available evidence which new diagnostic and treatment methods are reimbursed by statutory health insurance. If the benefit is proven with sufficient certainty, statutory health insurance providers pay for the new method, otherwise a trial study must be conducted.

Objectives: To present the G‑BA's decision-making options even in the case of insufficient evidence in the field of urology.

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.

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.

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.

[Health for refugees - the Bremen model].

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.

Decision-Making about Healthcare Related Tests and Diagnostic Strategies: User Testing of GRADE Evidence Tables.

Objective: To develop guidance on what information to include and how to present it in tables summarizing the evidence from systematic reviews of test accuracy following the Grading of Recommendations Assessment, Development and Evaluation (GRADE) approach.

Methods: To design and refine the evidence tables, we used an iterative process based on the analysis of data from four rounds of discussions, feedback and user testing. During the final round, we conducted one-on-one user testing with target end users.

When Choosing Wisely meets clinical practice guidelines.

The American Board of Internal Medicine (ABIM) Foundation launched the Choosing Wisely campaign in 2012 and until today convinced more than 50 US specialist societies to develop lists of interventions that may not improve people's health but are potentially harmful. We suggest combining these new efforts with the already existing efforts in clinical practice guideline development. Existing clinical practice guidelines facilitate a more participatory and evidence-based approach to the development of top 5 lists.

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.

Guideline group composition and group processes: article 3 in Integrating and coordinating efforts in COPD guideline development. An official ATS/ERS workshop report.

Background: Professional societies, like many other organizations around the world, have recognized the need to use more rigorous processes to ensure that health care recommendations are informed by the best available research evidence. This is the third of a series of 14 articles that were prepared to advise guideline developers in respiratory and other diseases on considerations for group compositions and group processes in guideline development, and how this can be effectively integrated in the context of respiratory disease guidelines on a national and international level.

Methods: We updated a review of the literature addressing group composition and group process, focusing on the following questions: 1.

A safety review and meta-analyses of bevacizumab and ranibizumab: off-label versus goldstandard.

Background: We set out a systemic review to evaluate whether off-label bevacizumab is as safe as licensed ranibizumab, and whether bevacizumab can be justifiably offered to patients as a treatment for age-related macular degeneration with robust evidence of no differential risk.

Methods And Findings: Medline, Embase and the Cochrane Library were searched with no limitations of language and year of publication. We included RCTs with a minimum follow-up of one year which investigated bevacizumab or ranibizumab in direct comparison or against any other control group (indirect comparison).

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.

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

Aim: To conduct a systematic review in order to compare adverse effects (AE) and the reporting of harm in randomised controlled trials (RCTs) and non-RCTs evaluating intravitreal ranibizumab and bevacizumab in age-related macular degeneration.

Methods: Medline, Embase and the Cochrane Library were searched with no limitations of language and year of publication. Studies which compared bevacizumab or ranibizumab as monotherapy with any other control group were included.

Reboxetine for acute treatment of major depression: systematic review and meta-analysis of published and unpublished placebo and selective serotonin reuptake inhibitor controlled trials.

Objectives: To assess the benefits and harms of reboxetine versus placebo or selective serotonin reuptake inhibitors (SSRIs) in the acute treatment of depression, and to measure the impact of potential publication bias in trials of reboxetine.

Design: Systematic review and meta-analysis including unpublished data.

Data Sources: Bibliographic databases (Medline, Embase, PsycINFO, BIOSIS, and Cochrane Library), clinical trial registries, trial results databases, and regulatory authority websites up until February 2009, as well as unpublished data from the manufacturer of reboxetine (Pfizer, Berlin).

[Evidence-based therapy of depression: S3 guidelines on unipolar depression].

Unipolar depressive disorders are among the most frequent reasons for utilizing the health care system. Although efficacious treatments are available and further advances have recently been made there is still a need for improving diagnostic and therapeutic procedures. Alignment of treatment on evidence-based treatment guidelines establishes an essential mainstay.

[Fraudulent studies, unpublished data and their effect on the development of guidelines and evidence-based recommendations].

Publication bias and scientific fraud are major threats to valid guidelines, especially guideline recommendations. Both topics have so far not been investigated systematically. It is assumed that guideline authors underestimate the potential influences on the validity of their recommendations.

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.

Grading quality of evidence and strength of recommendations in clinical practice guidelines. Part 1 of 3. An overview of the GRADE approach and grading quality of evidence about interventions.

The GRADE (Grades of Recommendation, Assessment, Development, and Evaluation) approach provides guidance to grading the quality of underlying evidence and the strength of recommendations in health care. The GRADE system's conceptual underpinnings allow for a detailed stepwise process that defines what role the quality of the available evidence plays in the development of health care recommendations. The merit of GRADE is not that it eliminates judgments or disagreements about evidence and recommendations, but rather that it makes them transparent.

[Randomised controlled trials (RCTs)].

Randomisation is regarded as an essential principle ensuring the internal validity of clinical trials. This is why randomised controlled trials (RCTs) lead every evidence hierarchy of therapeutic interventions. At the same time, there are controversies about the role of RCTs in health research.