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[No abstract available]

Beschreibung: Die Ergebnisse aus systematischen Reviews sind eine wichtige Grundlage für evidenzbasierte Entscheidungen in der Gesundheitsversorgung und -politik und stoßen zunehmend auch auf das Interesse der breiten Öffentlichkeit. Cochrane bietet allen Interessierten, auch solchen [zum vollständigen Text gelangen Sie über die oben angegebene URL], Nützliche patientenrelevante Forschung; 21. Jahrestagung des Deutschen Netzwerks Evidenzbasierte Medizin

Background More than a quarter of randomized controlled trials (RCTs) are prematurely discontinued, mostly due to poor recruitment of patients. In this study, we systematically compared RCTs discontinued or revised for poor recruitment and completed RCTs with the same underlying research question to better understand the causes of poor recruitment, particularly related to methodological aspects and context-specific study settings. Methods We compared RCTs that were discontinued or revised for poor recruitment to RCTs that were completed as planned, matching in terms of population and intervention. Based on an existing sample of RCTs discontinued or revised due to poor recruitment, we identified matching RCTs through a literature search for systematic reviews that cited the discontinued or revised RCT and matching completed RCTs without poor recruitment. Based on extracted data, we explored differences in the design, conduct, and study settings between RCTs with and without poor recruitment, separately for each research question using semi-structured discussions. Results We identified 15 separate research questions with a total of 29 RCTs discontinued or revised for poor recruitment and 48 RCTs completed as planned. Prominent research areas in the sample were cancer and acute care. The mean number of RCTs with poor recruitment per research question was 1.9 ranging from 1 to 4 suggesting clusters of research questions or settings prone to recruitment problems. The reporting quality of the recruitment process in RCT publications was generally low. We found that RCTs with poor recruitment often had narrower eligibility criteria, were investigator- rather than industry-sponsored, were associated with a higher burden for patients and recruiters, sometimes used outdated control interventions, and were often launched later in time than RCTs without poor recruitment compromising uncertainty about tested interventions through emerging evidence. Whether a multi- or single-center setting was advantageous for patient recruitment seemed to depend on the research context. Conclusions Our study confirmed previously identified causes for poor recruitment, i.e., narrow eligibility criteria, investigator sponsorship, and a reduced motivation of patients and recruiters. Newly identified aspects were that researchers need to be aware of all other RCTs on a research question so that compromising effects on the recruitment can be minimized and that a larger number of centers is not always advantageous.

[No abstract available]

Zusammenfassung: Ein Großteil der biomedizinischen Forschung ist beobachtend, und die Qualität der veröffentlichten Berichte über diese Forschung ist oft unzureichend. Dies behindert die Beurteilung der Stärken und Schwächen einer Studie und ihrer Übertragbarkeit. Die Strengthening the Reporting of Observational Studies in Epidemiology (STROBE-) Initiative hat Empfehlungen entwickelt, was in einem akkuraten und vollständigen Bericht einer Beobachtungsstudie enthalten sein sollte. Die Empfehlungen wurden von uns so definiert, dass sie 3Hauptstudientypen abdecken: Kohorten-, Fallkontroll- und Querschnittsstudien. Im September 2004 veranstalteten wir einen zweitägigen Workshop mit Methodikern, Forschern und Herausgebern wissenschaftlicher Zeitschriften, um eine Checkliste zu entwerfen. Anschließend wurde der Entwurf bei mehreren Treffen der Koordinierungsgruppe und nach E-Mail-Diskussionen mit der erweiterten STROBE-Gruppe revidiert und dabei empirische Evidenz und methodologische Aspekte berücksichtigt. Das Ergebnis des Workshops und des anschließenden iterativen Prozesses aus Beratung und Revision war eine Checkliste von 22Punkten (STROBE-Statement), die sich auf die Bereiche Titel, Abstract, Einleitung, Methoden, Ergebnisse und Diskussion eines Artikels beziehen. 18 der Punkte sind relevant für alle 3Studiendesigns, während 4 der Punkte spezifisch für Kohorten-, Fallkontroll- und Querschnittsstudien sind. Ein ausführlicher Begleitartikel ("Explanation and Elaboration") wurde separat veröffentlicht und ist auf den Webseiten von "PLoS Medicine", "Annals of Internal Medicine" und "Epidemiology" frei zugänglich. Wir hoffen, dass das STROBE-Statement dazu beitragen kann, dass Beobachtungsstudien besser berichtet werden

I. Einführung und Relevanz des Themas: Systematische Reviews (SRs) sind eine wichtige Basis für evidenzbasierte Entscheidungen in der Gesundheitsversorgung und -politik. Die Erstellung und Publikation solcher SRs ist jedoch ressourcenaufwändig und langwierig, sodass Review-Inhalte teilweise[zum vollständigen Text gelangen Sie über die oben angegebene URL], Brücken bauen – von der Evidenz zum Patientenwohl; 19. Jahrestagung des Deutschen Netzwerks Evidenzbasierte Medizin

Zielsetzung: Ziel des Workshops ist die Vorstellung aktueller Aktivitäten zur Bereitstellung und Verbreitung von Cochrane-Evidenz in deutscher Sprache. Die vorgestellten Aktivitäten werden hinsichtlich der praktischen Aspekte, Qualitätssicherung und Verbreitung der Übersetzungen [zum vollständigen Text gelangen Sie über die oben angegebene URL], Klasse statt Masse – wider die wertlose Wissenschaft; 18. Jahrestagung des Deutschen Netzwerks Evidenzbasierte Medizin

Background: The Swiss National Science Foundation (SNSF), the main public funding body for research in Switzerland, promotes academic excellence through competitive selection of study proposals and rigorous evaluation of feasibility. Completion status and publication history of SNSF-supported studies[for full text, please go to the a.m. URL], Klasse statt Masse – wider die wertlose Wissenschaft; 18. Jahrestagung des Deutschen Netzwerks Evidenzbasierte Medizin

Routinely collected health data, obtained for administrative and clinical purposes without specific a priori research goals, are increasingly used for research. The rapid evolution and availability of these data have revealed issues not addressed by existing reporting guidelines, such as Strengthening the Reporting of Observational Studies in Epidemiology (STROBE). The REporting of studies Conducted using Observational Routinely collected health Data (RECORD) statement was created to fill these gaps. RECORD was created as an extension to the STROBE statement to address reporting items specific to observational studies using routinely collected health data. RECORD consists of a checklist of 13 items related to the title, abstract, introduction, methods, results, and discussion section of articles, and other information required for inclusion in such research reports. This document contains the checklist as well as explanatory and elaboration information to enhance the use of the checklist. Examples of good reporting for each RECORD checklist item are also included. This document, as well as the accompanying website and message board (http://www.record-statement.org), will improve the implementation and understanding of RECORD. By implementing RECORD, authors, journals editors, and peer reviewers can enhance transparency of research reporting.

OBJECTIVES: To study whether systematic reviewers apply procedures to counter-balance some common forms of research malpractice such as not publishing completed research, duplicate publications, or selective reporting of outcomes, and to see whether they identify and report misconduct. DESIGN: Cross-sectional analysis of systematic reviews and survey of their authors. PARTICIPANTS: 118 systematic reviews published in four journals (Ann Int Med, BMJ, JAMA, Lancet), and the Cochrane Library, in 2013. MAIN OUTCOMES AND MEASURES: Number (%) of reviews that applied procedures to reduce the impact of: (1) publication bias (through searching of unpublished trials), (2) selective outcome reporting (by contacting the authors of the original studies), (3) duplicate publications, (4) sponsors' and (5) authors' conflicts of interest, on the conclusions of the review, and (6) looked for ethical approval of the studies. Number (%) of reviewers who suspected misconduct are reported. The procedures applied were compared across journals. RESULTS: 80 (68%) reviewers confirmed their data. 59 (50%) reviews applied three or more procedures; 11 (9%) applied none. Unpublished trials were searched in 79 (66%) reviews. Authors of original studies were contacted in 73 (62%). Duplicate publications were searched in 81 (69%). 27 reviews (23%) reported sponsors of the included studies; 6 (5%) analysed their impact on the conclusions of the review. Five reviews (4%) looked at conflicts of interest of study authors; none of them analysed their impact. Three reviews (2.5%) looked at ethical approval of the studies. Seven reviews (6%) suspected misconduct; only 2 (2%) reported it explicitly. Procedures applied differed across the journals. CONCLUSIONS: Only half of the systematic reviews applied three or more of the six procedures examined. Sponsors, conflicts of interest of authors and ethical approval remain overlooked. Research misconduct is sometimes identified, but rarely reported. Guidance on when, and how, to report suspected misconduct is needed.

Objective: The aim of this study is to review highly cited articles that focus on non-publication of studies, and to develop a consistent and comprehensive approach to defining (non-) dissemination of research findings. Setting: We performed a scoping review of definitions of the term 'publication bias' in highly cited publications. Participants: Ideas and experiences of a core group of authors were collected in a draft document, which was complemented by the findings from our literature search. Interventions: The draft document including findings from the literature search was circulated to an international group of experts and revised until no additional ideas emerged and consensus was reached. Primary outcomes: We propose a new approach to the comprehensive conceptualisation of (non-) dissemination of research. Secondary outcomes: Our 'What, Who and Why?' approach includes issues that need to be considered when disseminating research findings (What?), the different players who should assume responsibility during the various stages of conducting a clinical trial and disseminating clinical trial documents (Who?), and motivations that might lead the various players to disseminate findings selectively, thereby introducing bias in the dissemination process (Why?). Conclusions: Our comprehensive framework of (non-) dissemination of research findings, based on the results of a scoping literature search and expert consensus will facilitate the development of future policies and guidelines regarding the multifaceted issue of selective publication, historically referred to as 'publication bias'.

Sie sehen eine 45-jährige Patientin mit einem bläulich-zyanotischen rechten Bein. Vor fünf Tagen habe ein Spannungsschmerz in der Wade begonnen und sich zunehmend in den Oberschenkel hochgezogen. Die rechte Wade misst im Umfang 4 cm mehr als die linke. Die Anamnese ergibt keine familiäre oder persönliche Vorgeschichte einer thromboembolischen Erkrankung. Die Patientin ist übergewichtig ( BMI 35 kg/m2) und nimmt seit einigen Jahren eine Östrogen-Progesteron-Kombination. Der Ultraschall zeigt eine Thrombose der tiefen Beinvenen, die bis in die äussere Beckenvene reicht.

Routinely collected health data, collected for administrative and clinical purposes, without specific a priori research questions, are increasingly used for observational, comparative effectiveness, health services research, and clinical trials. The rapid evolution and availability of routinely collected data for research has brought to light specific issues not addressed by existing reporting guidelines. The aim of the present project was to determine the priorities of stakeholders in order to guide the development of the REporting of studies Conducted using Observational Routinely-collected health Data (RECORD) statement. Two modified electronic Delphi surveys were sent to stakeholders. The first determined themes deemed important to include in the RECORD statement, and was analyzed using qualitative methods. The second determined quantitative prioritization of the themes based on categorization of manuscript headings. The surveys were followed by a meeting of RECORD working committee, and re-engagement with stakeholders via an online commentary period. The qualitative survey (76 responses of 123 surveys sent) generated 10 overarching themes and 13 themes derived from existing STROBE categories. Highest-rated overall items for inclusion were: Disease/exposure identification algorithms; Characteristics of the population included in databases; and Characteristics of the data. In the quantitative survey (71 responses of 135 sent), the importance assigned to each of the compiled themes varied depending on the manuscript section to which they were assigned. Following the working committee meeting, online ranking by stakeholders provided feedback and resulted in revision of the final checklist. The RECORD statement incorporated the suggestions provided by a large, diverse group of stakeholders to create a reporting checklist specific to observational research using routinely collected health data. Our findings point to unique aspects of studies conducted with routinely collected health data and the perceived need for better reporting of methodological issues.

Hintergrund und Fragestellung: Cochrane Reviews (CRs) beinhalten meist zwei Darstellungen des Bias-Risikos („risk of bias“, RoB) eingeschlossener Studien: ein horizontales Balkendiagramm aller Studien für jedes Bias-Kriterium (RoB Graph) und eine tabellarische Darstellung pro Kriterium[for full text, please go to the a.m. URL], EbM zwischen Best Practice und inflationärem Gebrauch; 16. Jahrestagung des Deutschen Netzwerks Evidenzbasierte Medizin

Zielsetzung: Viele Akteure im Gesundheitswesen und PatientInnen bevorzugen Informationen in ihrer eigenen Sprache und in Kurzformaten. Bisher sind viele evidenzbasierte Informationsquellen, z.B. systematische Reviews, englischsprachig. Dies führt dazu, dass im deutschsprachigen Raum relevante Inhalte,[for full text, please go to the a.m. URL], EbM zwischen Best Practice und inflationärem Gebrauch; 16. Jahrestagung des Deutschen Netzwerks Evidenzbasierte Medizin

Routinely collected health data, obtained for administrative and clinical purposes without specific a priori research goals, are increasingly used for research. The rapid evolution and availability of these data have revealed issues not addressed by existing reporting guidelines, such as Strengthening the Reporting of Observational Studies in Epidemiology (STROBE). The REporting of studies Conducted using Observational Routinely collected health Data (RECORD) statement was created to fill these gaps. RECORD was created as an extension to the STROBE statement to address reporting items specific to observational studies using routinely collected health data. RECORD consists of a checklist of 13 items related to the title, abstract, introduction, methods, results, and discussion section of articles, and other information required for inclusion in such research reports. This document contains the checklist and explanatory and elaboration information to enhance the use of the checklist. Examples of good reporting for each RECORD checklist item are also included herein. This document, as well as the accompanying website and message board (http://www.record-statement.org), will enhance the implementation and understanding of RECORD. Through implementation of RECORD, authors, journals editors, and peer reviewers can encourage transparency of research reporting.

Zielsetzung: Die Cochrane Public Health Group ist eine von insgesamt 53 Review Gruppen der Cochrane Collaboration und hat ihren Standort in der University of Melbourne, Melbourne School of Population and Global Health, Australien. Ihr Ziel ist die Unterstützung und Verbreitung von systematischen[for full text, please go to the a.m. URL], EbM zwischen Best Practice und inflationärem Gebrauch; 16. Jahrestagung des Deutschen Netzwerks Evidenzbasierte Medizin

Question clinique : Une patiente de 43 ans connue pour un lupus érythémateux disséminé et une néphropathie lupique stable et traitée par hydroxychloroquine et mycophénolate mofétil vous rapporte avoir eu contact il y a quatre jours avec un enfant atteint de la rougeole. Elle ne présente aucun symptôme et son dernier bilan vaccinal montre un taux d'anticorps contre la rougeole non protecteur. La patiente devrait-elle recevoir une immunisation active ou passive contre la rougeole? Contexte En Suisse : la couverture vaccinale contre la rougeole n'est pas assez importante pour empêcher sa diffusion. L'immunisation passive avec des immunoglobulines est destinée aux personnes non immunes exposées à la rougeole, recommandée en Suisse aux personnes à haut risque. Cette revue visait à évaluer l'efficacité et l'innocuité de l'injection intramusculaire ou de la perfusion intraveineuse d'immunoglobulines pour prévenir la rougeole chez les personnes susceptibles avant l'apparition des symptômes.

Much medical research is observational. The reporting of observational studies is often of insufficient quality. Poor reporting hampers the assessment of the strengths and weaknesses of a study and the generalisability of its results. Taking into account empirical evidence and theoretical considerations, a group of methodologists, researchers, and editors developed the Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) recommendations to improve the quality of reporting of observational studies. The STROBE Statement consists of a checklist of 22 items, which relate to the title, abstract, introduction, methods, results and discussion sections of articles. Eighteen items are common to cohort studies, case-control studies and cross-sectional studies and four are specific to each of the three study designs. The STROBE Statement provides guidance to authors about how to improve the reporting of observational studies and facilitates critical appraisal and interpretation of studies by reviewers, journal editors and readers. This explanatory and elaboration document is intended to enhance the use, understanding, and dissemination of the STROBE Statement. The meaning and rationale for each checklist item are presented. For each item, one or several published examples and, where possible, references to relevant empirical studies and methodological literature are provided. Examples of useful flow diagrams are also included. The STROBE Statement, this document, and the associated Web site (http://www.strobe-statement.org/) should be helpful resources to improve reporting of observational research., In this explanatory and elaboration document Mattias Egger and colleagues provide the meaning and rationale of each checklist item on the STROBE Statement.

Termin: Freitag, 16. März, 11:30 Uhr bis 13 Uhr Zielsetzung: Dieser Workshop soll einen Überblick über Inhalte, methodische Herausforderungen und Lösungsansätze bei der Erstellung, Berichterstattung und Evidenzsynthese im Bereich Public Health vermitteln, und einen [for full text, please go to the a.m. URL], Komplexe Interventionen – Entwicklung durch Austausch; 13. Jahrestagung des Deutschen Netzwerks Evidenzbasierte Medizin

Einleitung / Hintergrund: Einerseits ist die transparente und vollständige Berichterstattung von klinischen Studien in medizinischen Fachzeitschriften häufig durch eine vorgegebene Artikellänge begrenzt. Andererseits sind Patienten und Ärzte auf vollständige Studieninformationen[for full text, please go to the a.m. URL], 54. Jahrestagung der Deutschen Gesellschaft für Medizinische Informatik, Biometrie und Epidemiologie (gmds)

Much biomedical research is observational. The reporting of such research is often inadequate, which hampers the assessment of its strengths and weaknesses and of a study's generalizability. The Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) Initiative developed recommendations on what should be included in an accurate and complete report of an observational study. We defined the scope of the recommendations to cover 3 main study designs: cohort, case-control, and cross-sectional studies. We convened a 2-day workshop in September 2004, with methodologists, researchers, and journal editors, to draft a checklist of items. This list was subsequently revised during several meetings of the coordinating group and in e-mail discussions with the larger group of STROBE contributors, taking into account empirical evidence and methodological considerations. The workshop and the subsequent iterative process of consultation and revision resulted in a checklist of 22 items (the STROBE Statement) that relate to the title, abstract, introduction, methods, results, and discussion sections of articles. Eighteen items are common to all 3 study designs and 4 are specific for cohort, case-control, or cross-sectional studies. A detailed Explanation and Elaboration document is published separately and is freely available at www.annals.org and on the Web sites of PLoS Medicine and Epidemiology. We hope that the STROBE Statement will contribute to improving the quality of reporting of observational studies.