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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
B Nussbaumer-Streit, I Klerings, G Wagner, T L Heise, A I Dobrescu, S Armijo-Olivo, J M Stratil, Emma Persad, S K Lhachimi, M G Van Noord, T Mittermayr, H Zeeb, L Hemkens, G 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 re-calculated meta-analyses. Cochrane authors determined whether the new evidence base would change conclusions...
June 1, 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
OBJECTIVE: 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, mixed) and outcome scale (agitation, psychosis, generic)...
May 18, 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
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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
Julie Bolvig, Carsten B Juhl, Isabelle Boutron, Peter Tugwell, Elizabeth A T Ghogomu, Jordi Pardo Pardo, Tamara Rader, George A Wells, Alain Mayhew, Lara Maxwell, Hans Lund, Henning Bliddal, Robin Christensen
OBJECTIVE: To evaluate the impact of bias-related study characteristics on treatment effects in osteoarthritis (OA) trials. STUDY DESIGN AND SETTING: Based on OA trials included in Cochrane reviews, the impact of study characteristics on treatment effect estimates was evaluated. Characteristics included items of the risk of bias (RoB) tool, trial size, single vs. multisite, and source of funding. Effect sizes (ESs) were calculated as standardized mean differences (SMDs)...
March 2018: Journal of Clinical Epidemiology
Hiraku Tsujimoto, Yasushi Tsujimoto, Yuki Kataoka
OBJECTIVE: PROSPERO, an international prospective register of systematic reviews, was launched in February 2011 to reduce publication bias of systematic reviews (SRs). A questionnaire survey of SR researchers conducted in 2005 indicated the existence of unpublished SRs and the potential influence of lack of funding as a reason for non-publication. Here, we investigated the publication status of registered SRs in the 1st year that PROSPERO launched and assessed the association between publication and the existence of funding or conflicts of interest (COIs)...
December 6, 2017: BMC Research Notes
Dario Tedesco, Mufiza Farid-Kapadia, Martin Offringa, Zulfiqar A Bhutta, Yvonne Maldonado, John P A Ioannidis, Despina G Contopoulos-Ioannidis
OBJECTIVES: Evaluate comparative harm rates from medical interventions in pediatric randomized clinical trials (RCTs) from more developed (MDCs) and less developed countries (LDCs). STUDY DESIGN AND SETTING: Meta-epidemiologic empirical evaluation of Cochrane Database of Systematic Reviews (June 2014) meta-analyses reporting clinically important harm-outcomes (severe adverse events [AEs], discontinuations due to AEs, any AE, and mortality) that included at least one pediatric RCT from MDCs and at least one from LDCs...
March 2018: Journal of Clinical Epidemiology
Jelena Savovic, Rebecca M Turner, David Mawdsley, Hayley E Jones, Rebecca Beynon, Julian P T Higgins, Jonathan A C Sterne
Flaws in the design of randomized trials may bias intervention effect estimates and increase between-trial heterogeneity. Empirical evidence suggests that these problems are greatest for subjectively assessed outcomes. For the Risk of Bias in Evidence Synthesis (ROBES) Study, we extracted risk-of-bias judgements (for sequence generation, allocation concealment, blinding, and incomplete data) from a large collection of meta-analyses published in the Cochrane Library (issue 4; April 2011). We categorized outcome measures as mortality, other objective outcome, or subjective outcome, and we estimated associations of bias judgements with intervention effect estimates using Bayesian hierarchical models...
May 1, 2018: American Journal of Epidemiology
Long Ge, Jin-Hui Tian, Ya-Nan Li, Jia-Xue Pan, Ge Li, Dang Wei, Xin Xing, Bei Pan, Yao-Long Chen, Fu-Jian Song, Ke-Hu Yang
OBJECTIVES: The aim of this study was to investigate the differences in main characteristics, reporting and methodological quality between prospectively registered and nonregistered systematic reviews. STUDY DESIGN AND SETTING: PubMed was searched to identify systematic reviews of randomized controlled trials published in 2015 in English. After title and abstract screening, potentially relevant reviews were divided into three groups: registered non-Cochrane reviews, Cochrane reviews, and nonregistered reviews...
January 2018: Journal of Clinical Epidemiology
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