Search results for "Trials"
showing 10 items of 966 documents
Rationale, study design, and analysis plan of the Alveolar Recruitment for ARDS Trial (ART): study protocol for a randomized controlled trial.
2012
Abstract Background Acute respiratory distress syndrome (ARDS) is associated with high in-hospital mortality. Alveolar recruitment followed by ventilation at optimal titrated PEEP may reduce ventilator-induced lung injury and improve oxygenation in patients with ARDS, but the effects on mortality and other clinical outcomes remain unknown. This article reports the rationale, study design, and analysis plan of the Alveolar Recruitment for ARDS Trial (ART). Methods/Design ART is a pragmatic, multicenter, randomized (concealed), controlled trial, which aims to determine if maximum stepwise alveolar recruitment associated with PEEP titration is able to increase 28-day survival in patients with …
Planning and Analysis of Trials Using a Stepped Wedge Design: Part 26 of a Series on Evaluation of Scientific Publications
2019
Background The stepped-wedge design (SWD) of clinical trials has become very popular in recent years, particularly in health services research. Typically, study participants are randomly allotted in clusters to the different treatment options. Methods The basic principles of the stepped wedge design and related statistical techniques are described here on the basis of pertinent publications retrieved by a selective search in PubMed and in the CIS statistical literature database. Results In a typical SWD trial, the intervention is begun at a time point that varies from cluster to cluster. Until this time point is reached, all participants in the cluster belong to the control arm of the trial…
Cluster-Randomized Studies.
2018
Background Cluster-randomized trials (CRT) are needed to compare interventions that are allocated to entire groups of subjects, rather than to individuals. Publications about CRT have become steadily more common over the past decade. Readers of such publications should be able to categorize and interpret the findings of CRT correctly while considering the methodological requirements applicable to this type of study. Methods This review is based on a selection of pertinent literature and on the authors' expertise. CRT-specific methodological aspects of the planning, performance, and interpretation of studies are discussed. Results Readers of publications on CRT should check whether due consi…
Rare Cancers Europe (RCE) methodological recommendations for clinical studies in rare cancers: A European consensus position paper
2015
While they account for one-fifth of new cancer cases, rare cancers are difficult to study. A higher than average degree of uncertainty should be accommodated for clinical as well as for population-based decision making. Rules of rational decision making in conditions of uncertainty should be rigorously followed and would need widely informative clinical trials. In principle, any piece of new evidence would need to be exploited in rare cancers. Methodologies to explicitly weigh and combine all the available evidence should be refined, and the Bayesian logic can be instrumental to this end. Likewise, Bayesian-design trials may help optimize the low number of patients liable to be enrolled in …
Pre-training inter-rater reliability of clinical instruments in an international psychosis research project.
2021
International audience
Comparing motivational, self-regulatory and habitual processes in a computer-tailored physical activity intervention in hospital employees - protocol…
2017
Abstract Background Most people do not engage in sufficient physical activity to confer health benefits and to reduce risk of chronic disease. Healthcare professionals frequently provide guidance on physical activity, but often do not meet guideline levels of physical activity themselves. The main objective of this study is to develop and test the efficacy of a tailored intervention to increase healthcare professionals’ physical activity participation and quality of life, and to reduce work-related stress and absenteeism. This is the first study to compare the additive effects of three forms of a tailored intervention using different techniques from behavioural theory, which differ accordin…
Quality assessment of randomized controlled trial abstracts on drug therapy of periodontal disease from the abstracts published in dental Science Cit…
2020
Background Randomized controlled trials (RCTs) provide the highest level of evidence and are likely to influence clinical decision-making. This study evaluated the reporting quality of RCT abstracts on drug therapy of periodontal disease and assessed the associated factors. Material and Methods The Pubmed database was searched for periodontal RCTs published in Science Citation Indexed (SCI) dental journals from 2010/01/01 to 2019/07/17. Information was extracted from the abstracts according to a modified Consolidated Standards of Reporting Trials (CONSORT) guideline checklist. The data was analyzed using descriptive statistical analysis and the statistical associations were examined using t…
Methodological aspects of clinical trials in tinnitus: a proposal for an international standard
2012
Abstract: Chronic tinnitus is a common condition with a high burden of disease. While many different treatments are used in clinical practice, the evidence for the efficacy of these treatments is low and the variance of treatment response between individuals is high. This is most likely due to the great heterogeneity of tinnitus with respect to clinical features as well as underlying pathophysiological mechanisms. There is a clear need to find effective treatment options in tinnitus, however, clinical trials differ substantially with respect to methodological quality and design. Consequently, the conclusions that can be derived from these studies are limited and jeopardize comparison betwee…
Future Research in Graves' Orbitopathy: From Priority Setting to Trial Design Through Patient and Public Involvement
2015
Graves' orbitopathy (GO) is a disfiguring autoimmune condition, which can sometimes cause blindness (1). The disease has profound effects on quality of life (2), psychological health (3), and socioeconomic status (4). Progress in understanding and treating this disease has been slow. However, recent advances include delineation of plausible immunological mechanisms (5), development of an animal model (6), and publication of randomized studies defining the role and limitations of intravenous steroids (7), rituximab (8,9), and selenium (10). Yet, some of this knowledge remains to be translated into improvement in clinical care. Access of patients to specialist treatments is patchy and seems t…
Valorización de residuos con cromo del sector galvánico para su utilización como licor curtiente
2008
El presente trabajo desarrolla la metodología necesaria para el acondicionamiento y valorización de los baños agotados de Cr (VI), provenientes de la industria galvánica, para su utilización como licor curtiente en el sector de curtición.