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Tim Mathes, Pauline Klaßen, Dawid Pieper
OBJECTIVE: The study aims to assess whether the results from registry-based randomized trials (RRCTs) systematically differ from the results of conventional randomized controlled trials (CRCTs). STUDY DESIGN: Meta-epidemiological study. We identified RRCTs (02/2016) and subsequent systematic reviews (SRs) that included one RRCT (04/2017). We calculated pooled odds ratios for RRCTs and CRCTs for mortality and other incidence measures (e.g., cardiovascular events)...
September 23, 2018: Journal of Clinical Epidemiology
Aviv Ladanie, Benjamin Speich, Florian Naudet, Arnav Agarwal, Tiago V Pereira, Francesco Sclafani, Juan Martin-Liberal, Thomas Schmid, Hannah Ewald, John P A Ioannidis, Heiner C Bucher, Benjamin Kasenda, Lars G Hemkens
BACKGROUND: The available evidence on the benefits and harms of novel drugs and therapeutic biologics at the time of approval is reported in publicly available documents provided by the US Food and Drug Administration (FDA). We aimed to create a comprehensive database providing the relevant information required to systematically analyze and assess this early evidence in meta-epidemiological research. METHODS: We designed a modular and flexible database of systematically collected data...
September 19, 2018: Trials
Perrine Janiaud, Ioana-Alinea Cristea, John P A Ioannidis
PURPOSE: To study the landscape of funding in intensive care research and assess whether the reported outcomes of industry-funded randomized controlled trials (RCTs) are more favorable. METHODS: We systematically assembled meta-analyses evaluating any type of intervention in the critical care setting and reporting the source of funding for each included RCT. Furthermore, when the intervention was a drug or biologic, we searched also the original RCT articles, when their funding information was unavailable in the meta-analysis...
August 27, 2018: Intensive Care Medicine
Agnes Dechartres, Ignacio Atal, Carolina Riveros, Joerg Meerpohl, Philippe Ravaud
Background: Evidence about the effect on meta-analysis results of including unpublished trials or those published in languages other than English is unclear or discordant. Purpose: To compare treatment effects between published and unpublished randomized controlled trials (RCTs) and between trials published in English and other languages using a meta-epidemiologic approach. Data Sources: Cochrane reviews published between March 2011 and January 2017 and trial references cited in the reviews...
August 21, 2018: Annals of Internal Medicine
Lauge Neimann Rasmussen, Paul Montgomery
BACKGROUND: Studies published in languages other than English are often neglected when research teams conduct systematic reviews. Literature on how to deal with non-English studies when conducting reviews have focused on the importance of including such studies, while less attention has been paid to the practical challenges of locating and assessing relevant non-English studies. We investigated the factors which might predict the inclusion of non-English studies in systematic reviews in the social sciences, to better understand how, when and why these are included/excluded...
August 23, 2018: Systematic Reviews
(no author information available yet)
No abstract text is available yet for this article.
August 17, 2018: BMJ: British Medical Journal
J W O'Sullivan, A Albasri, C Koshiaris, J K Aronson, C Heneghan, R Perera
OBJECTIVE: To determine the association between the quality of guidelines for diagnostic tests (both the quality and reporting and the quality of the evidence underpinning recommendations) and non-adherence. STUDY DESIGN AND SETTING: We conducted a meta-epidemiological study. We previously published a systematic review that quantified the percentage of test use that was non-adherent with guidelines. For the current study, we assessed these guidelines using the Appraisal of Guidelines for Research & Evaluation (AGREE) II tool...
July 5, 2018: Journal of Clinical Epidemiology
A Engelking, M Cavar, L Puljak
AIMS: New randomized clinical trials (RCTs) should be initiated if previous systematic reviews (SRs) indicate that new trials are needed. We analysed whether RCTs published in anaesthesiology journals mentioned previous SRs as a rationale for conducting trial and for discussing results. METHODS: This was a meta-epidemiological, descriptive cross-sectional study. We analysed RCTs published in the seven first-quartile anaesthesiology journals between 2014 and 2016...
July 5, 2018: European Journal of Pain: EJP
Barbara Nussbaumer-Streit, Irma Klerings, Gernot Wagner, Thomas L Heise, Andreea I Dobrescu, Susan Armijo-Olivo, Jan M Stratil, Emma Persad, Stefan K Lhachimi, Megan G Van Noord, Tarquin Mittermayr, Hajo Zeeb, Lars Hemkens, Gerald Gartlehner
OBJECTIVE: To assess the effects of abbreviated literature searches on evidence syntheses conclusions. STUDY DESIGN AND SETTING: We randomly selected 60 Cochrane reviews of clinical interventions and repeated literature searches using 14 abbreviated approaches (combinations of MEDLINE, Embase, CENTRAL with and without searches of reference lists). If abbreviated searches missed included studies, we recalculated meta-analyses. Cochrane authors determined whether the new evidence base would change conclusions...
October 2018: Journal of Clinical Epidemiology
Sophia Gratsia, Despina Koletsi, Padhraig S Fleming, Nikolaos Pandis
Background/objectives: To assess the prevalence of within-group comparisons from baseline to follow-up in published orthodontic articles and to identify potential associations between this statistical problem and a number of study characteristics. Materials/method: The most recent 24 issues of four leading orthodontic journals with highest impact factor (American Journal of Orthodontics and Dentofacial Orthopedics; AJODO, European Journal of Orthodontics; EJO, Angle Orthodontist; ANGLE, Orthodontics and Craniofacial Research; OCR) were electronically searched until December 31st 2017...
May 18, 2018: European Journal of Orthodontics
C H W Smeets, S U Zuidema, T A Hulshof, M Smalbrugge, D L Gerritsen, R T C M Koopmans, H J Luijendijk
OBJECTIVES: Postulating that efficacy of antipsychotics for agitation and psychosis in dementia is best estimated in trials among patients with these symptoms and with symptom-specific outcomes, we investigated whether clinically broader definitions affected the pooled efficacy. STUDY DESIGN AND SETTING: Trials were searched in multiple databases and categorized according to patient population (agitated, psychotic, and mixed) and outcome scale (agitation, psychosis, and generic)...
September 2018: Journal of Clinical Epidemiology
Victor M Lu, Kevin Phan, Julia X M Yin, Kerrie L McDonald
INTRODUCTION: There are many potential biomarkers in glioblastoma (GBM), and meta-analyses represent the highest level of evidence when inferring their prognostic significance. It is possible however, that inherent design properties of the studies included in these meta-analyses may affect the pooled hazard ratio (HR) of the meta-analyses. This meta-epidemiological study aims to investigate the potential bias of three study-level properties in meta-analyses of GBM biomarkers currently published in the literature...
May 16, 2018: Journal of Neuro-oncology
Spyridon N Papageorgiou, Guilherme M Xavier, Martyn T Cobourne, Theodore Eliades
OBJECTIVES: Clinical trial registration is widely recommended because it allows tracking of trials that helps ensure full and unbiased reporting of their results. The aim of the present overview was to provide empirical evidence on bias associated with trial registration via a meta-epidemiological approach. STUDY DESIGN AND SETTINGS: Six databases were searched in September 2017 for randomized clinical trials and systematic reviews thereof assessing the effects of orthodontic clinical interventions...
August 2018: Journal of Clinical Epidemiology
Perrine Janiaud, Faustine Glais, Guillaume Grenet, Audrey Lajoinie, Catherine Cornu, Behrouz Kassai-Koupai
The extrapolation of the benefit risk ratio from adults to children is performed during drug development and often implicitly used by many paediatricians when prescribing off-label drugs in children. This is due to the specific constraints of paediatric clinical research leading to a lack of safety and efficacy data in children. Extrapolation frameworks for drug development have been proposed by several regulatory agencies. Using a meta-epidemiological approach, we explored the similarities and differences of the benefit, the benefit risk ratio and the perceived placebo effect between adults and children from meta-analyses including randomized double-blinded placebo-controlled trials evaluating a drug intervention in an indication in adults and children with separate data for both populations...
April 2018: Thérapie
(no author information available yet)
No abstract text is available yet for this article.
April 2018: BMJ evidence-based medicine
Joshua D Wallach, Oriana Ciani, Alison M Pease, Gregg S Gonsalves, Harlan M Krumholz, Rod S Taylor, Joseph S Ross
BACKGROUND: The U.S. Food and Drug Administration (FDA) often approves new drugs based on trials that use surrogate markers for endpoints, which involve certain trade-offs and may risk making erroneous inferences about the medical product's actual clinical effect. This study aims to compare the treatment effects among pivotal trials supporting FDA approval of novel therapeutics based on surrogate markers of disease with those observed among postapproval trials for the same indication...
March 21, 2018: BMC Medicine
Juan Ruano, Francisco Gómez-García, Jesús Gay-Mimbrera, Macarena Aguilar-Luque, José Luis Fernández-Rueda, Jesús Fernández-Chaichio, Patricia Alcalde-Mellado, Pedro J Carmona-Fernandez, Juan Luis Sanz-Cabanillas, Isabel Viguera-Guerra, Francisco Franco-García, Manuel Cárdenas-Aranzana, José Luis Hernández Romero, Marcelino Gonzalez-Padilla, Beatriz Isla-Tejera, Antonio Velez Garcia-Nieto
BACKGROUND: Epidemiology and the reporting characteristics of systematic reviews (SRs) and meta-analyses (MAs) are well known. However, no study has analyzed the influence of protocol features on the probability that a study's results will be finally reported, thereby indirectly assessing the reporting bias of International Prospective Register of Systematic Reviews (PROSPERO) registration records. OBJECTIVE: The objective of this study is to explore which factors are associated with a higher probability that results derived from a non-Cochrane PROSPERO registration record for a systematic review will be finally reported as an original article in a scientific journal...
March 9, 2018: Systematic Reviews
Fares Alahdab, Wigdan Farah, Jehad Almasri, Patricia Barrionuevo, Feras Zaiem, Raed Benkhadra, Noor Asi, Mouaz Alsawas, Yifan Pang, Ahmed T Ahmed, Tamim Rajjo, Amrit Kanwar, Khalid Benkhadra, Zayd Razouki, M Hassan Murad, Zhen Wang
OBJECTIVE: To determine whether the early trials in chronic medical conditions demonstrate an effect size that is larger than that in subsequent trials. METHODS: We identified randomized controlled trials (RCTs) evaluating a drug or device in patients with chronic medical conditions through meta-analyses (MAs) published between January 1, 2007, and June 23, 2015, in the 10 general medical journals with highest impact factor. We estimated the prevalence of having the largest effect size or heterogeneity in the first 2 published trials...
March 2018: Mayo Clinic Proceedings
J C Trone, E Ollier, C Chapelle, L Bertoletti, M Cucherat, P Mismetti, N Magné, S Laporte
Background: Previous meta-analyses have shown paradoxical increased risk of bleeding and thrombotic events in patients receiving antiangiogenics (AA) that may be simply explained by the studies design included. By a meta-epidemiological approach, we aim to investigate the impact of double-blind (DB) and open-label study designs on the risks of bleeding, venous thrombotic events (VTE) and arterial thrombotic events (ATE) in cancer patients treated with AA. Materials and methods: We searched Medline, Cochrane, ClinicalTrials...
April 1, 2018: Annals of Oncology: Official Journal of the European Society for Medical Oncology
Ben Vandermeer, Ingeborg van der Tweel, Marijke C Jansen-van der Weide, Stephanie S Weinreich, Despina G Contopoulos-Ioannidis, Dirk Bassler, Ricardo M Fernandes, Lisa Askie, Haroon Saloojee, Paola Baiardi, Susan S Ellenberg, Johanna H van der Lee
BACKGROUND: We wished to compare the nuisance parameters of pediatric vs. adult randomized-trials (RCTs) and determine if the latter can be used in sample size computations of the former. METHODS: In this meta-epidemiologic empirical evaluation we examined meta-analyses from the Cochrane Database of Systematic-Reviews, with at least one pediatric-RCT and at least one adult-RCT. Within each meta-analysis of binary efficacy-outcomes, we calculated the pooled-control-group event-rate (CER) across separately all pediatric and adult-trials, using random-effect models and subsequently calculated the control-group event-rate risk-ratio (CER-RR) of the pooled-pediatric-CERs vs...
January 10, 2018: BMC Medical Research Methodology
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