[Show abstract][Hide abstract] ABSTRACT: 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’.
[Show abstract][Hide abstract] ABSTRACT: Randomized clinical trials that enroll patients in critical or emergency care (acute care) setting are challenging because of narrow time windows for recruitment and the inability of many patients to provide informed consent. To assess the extent that recruitment challenges lead to randomized clinical trial discontinuation, we compared the discontinuation of acute care and nonacute care randomized clinical trials.
Retrospective cohort of 894 randomized clinical trials approved by six institutional review boards in Switzerland, Germany, and Canada between 2000 and 2003.
Randomized clinical trials involving patients in an acute or nonacute care setting.
We recorded trial characteristics, self-reported trial discontinuation, and self-reported reasons for discontinuation from protocols, corresponding publications, institutional review board files, and a survey of investigators.
Of 894 randomized clinical trials, 64 (7%) were acute care randomized clinical trials (29 critical care and 35 emergency care). Compared with the 830 nonacute care randomized clinical trials, acute care randomized clinical trials were more frequently discontinued (28 of 64, 44% vs 221 of 830, 27%; p = 0.004). Slow recruitment was the most frequent reason for discontinuation, both in acute care (13 of 64, 20%) and in nonacute care randomized clinical trials (7 of 64, 11%). Logistic regression analyses suggested the acute care setting as an independent risk factor for randomized clinical trial discontinuation specifically as a result of slow recruitment (odds ratio, 4.00; 95% CI, 1.72-9.31) after adjusting for other established risk factors, including nonindustry sponsorship and small sample size.
Acute care randomized clinical trials are more vulnerable to premature discontinuation than nonacute care randomized clinical trials and have an approximately four-fold higher risk of discontinuation due to slow recruitment. These results highlight the need for strategies to reliably prevent and resolve slow patient recruitment in randomized clinical trials conducted in the critical and emergency care setting.
Full-text · Article · Oct 2015 · Critical care medicine
[Show abstract][Hide abstract] ABSTRACT: 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.
[Show abstract][Hide abstract] ABSTRACT: Objectives:
To investigate the frequency of interim analyses, stopping rules, and data safety and monitoring boards (DSMBs) in protocols of randomized controlled trials (RCTs); to examine these features across different reasons for trial discontinuation; and to identify discrepancies in reporting between protocols and publications.
Study design and setting:
We used data from a cohort of RCT protocols approved between 2000 and 2003 by six research ethics committees in Switzerland, Germany, and Canada.
Of 894 RCT protocols, 289 prespecified interim analyses (32.3%), 153 stopping rules (17.1%), and 257 DSMBs (28.7%). Overall, 249 of 894 RCTs (27.9%) were prematurely discontinued; mostly due to reasons such as poor recruitment, administrative reasons, or unexpected harm. Forty-six of 249 RCTs (18.4%) were discontinued due to early benefit or futility; of those, 37 (80.4%) were stopped outside a formal interim analysis or stopping rule. Of 515 published RCTs, there were discrepancies between protocols and publications for interim analyses (21.1%), stopping rules (14.4%), and DSMBs (19.6%).
Two-thirds of RCT protocols did not consider interim analyses, stopping rules, or DSMBs. Most RCTs discontinued for early benefit or futility were stopped without a prespecified mechanism. When assessing trial manuscripts, journals should require access to the protocol.
Full-text · Article · Jun 2015 · Journal of Clinical Epidemiology
[Show abstract][Hide abstract] ABSTRACT: 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.
[Show abstract][Hide abstract] ABSTRACT: The synthesis of published research in systematic reviews is essential when providing evidence to inform clinical and health policy decision-making. However, the validity of systematic reviews is threatened if journal publications represent a biased selection of all studies that have been conducted (dissemination bias). To investigate the extent of dissemination bias we conducted a systematic review that determined the proportion of studies published as peer-reviewed journal articles and investigated factors associated with full publication in cohorts of studies (i) approved by research ethics committees (RECs) or (ii) included in trial registries.
[Show abstract][Hide abstract] ABSTRACT: Hintergrund
Praktisch tätige Ärzte treffen täglich eine Vielzahl von medizinischen Entscheidungen. Diese basieren überwiegend auf dem in der Ausbildung Erlernten und persönlicher Erfahrung, sollen heutzutage jedoch auch Patientenpräferenzen und die wissenschaftliche Evidenz für den Nutzen einer Intervention berücksichtigen. Mit dem Ziel der bestmöglichen Versorgung von Patienten bilden diese drei Aspekte gleichgewichtet die Grundlage für das Konzept der evidenzbasierten Medizin (EbM). Ohne Verständnis der methodischen Hintergründe ist die Gefahr von Fehleinschätzungen der Evidenz jedoch hoch und kann Behandlungsfehler zur Konsequenz haben.
Im vorliegenden Beitrag werden das Konzept der systematischen Verzerrungen (Bias) und seine Bedeutung erläutert. Hierzu werden Ursachen, Auswirkungen und Methoden zur Minimierung von Bias dargestellt. Diese Inhalte sollen ein tieferes Verständnis vermitteln, um in der Praxis eine bessere Einschätzung von Studien und ihren Ergebnissen sowie die Umsetzung ihrer Empfehlungen zu erlauben.
Das Risk-of-Bias (RoB)-Tool der Cochrane Collaboration ist ein Instrument zur Bewertung des Verzerrungspotentials in kontrollierten Studien. Zu seinen Stärken zählen eine einfache Anwendung, kurze Bearbeitungszeit, hohe Transparenz der Beurteilung und eine leicht verständliche graphische Darstellung der Ergebnisse. Mit dieser Publikation wird die deutsche Fassung des RoB-Tool veröffentlicht. Sie soll die Anwendung des Instruments auch außerhalb von Expertenkreisen erleichtern und über die Einschätzung der Validität von Studienergebnissen zur Entscheidungsfindung bei medizinischen Fragestellungen beitragen.
[Show abstract][Hide abstract] ABSTRACT: Klinische Studien dienen dazu, die Wirksamkeit und Sicherheit medizinischer Maßnahmen zu evaluieren oder andere ungeklärte, z.B. diagnostische Fragestellungen zu untersuchen. Nicht jede klinische Studie wird jedoch optimal geplant, durchgeführt und ausgewertet und ist somit einem Risiko von systematischen Fehlern ausgesetzt, die die Studienergebnisse verfälschen können (Bias). Um diese Risiken zu reduzieren, sollten Studien nach bestimmten Qualitätskriterien durchgeführt werden. Um die methodische Qualität von Studien einzuschätzen, wurden Instrumente wie das Cochrane ‚Risk of Bias‘-Tool entwickelt.
No preview · Article · Oct 2014 · Zeitschrift für Evidenz Fortbildung und Qualität im Gesundheitswesen
[Show abstract][Hide abstract] ABSTRACT: Despite the fact that there are more than twenty thousand biomedical journals in the world, research into the work of editors and publication process in biomedical and health care journals is rare. In December 2012, the Esteve Foundation, a non-profit scientific institution that fosters progress in pharmacotherapy by means of scientific communication and discussion organized a discussion group of 7 editors and/or experts in peer review biomedical publishing. They presented findings of past editorial research, discussed the lack of competitive funding schemes and specialized journals for dissemination of editorial research, and reported on the great diversity of misconduct and conflict of interest policies, as well as adherence to reporting guidelines. Furthermore, they reported on the reluctance of editors to investigate allegations of misconduct or increase the level of data sharing in health research. In the end, they concluded that if editors are to remain gatekeepers of scientific knowledge they should reaffirm their focus on the integrity of the scientific record and completeness of the data they publish. Additionally, more research should be undertaken to understand why many journals are not adhering to editorial standards, and what obstacles editors face when engaging in editorial research.