Search results for "Clinical study design"
showing 10 items of 33 documents
Quantifying and addressing the prevalence and bias of study designs in the environmental and social sciences
2020
Building trust in science and evidence-based decision-making depends heavily on the credibility of studies and their findings. Researchers employ many different study designs that vary in their risk of bias to evaluate the true effect of interventions or impacts. Here, we empirically quantify, on a large scale, the prevalence of different study designs and the magnitude of bias in their estimates. Randomised designs and controlled observational designs with pre-intervention sampling were used by just 23% of intervention studies in biodiversity conservation, and 36% of intervention studies in social science. We demonstrate, through pairwise within-study comparisons across 49 environmental da…
Improving scientific rigour in conservation evaluations and a plea deal for transparency on potential biases
2020
Abstract The delivery of rigorous and unbiased evidence on the effects of interventions lay at the heart of the scientific method. Here we examine scientific papers evaluating agri‐environment schemes, the principal instrument to mitigate farmland biodiversity declines worldwide. Despite previous warnings about rudimentary study designs in this field, we found that the majority of studies published between 2008 and 2017 still lack robust study designs to strictly evaluate intervention effects. Potential sources of bias that arise from the correlative nature are rarely mentioned, and results are still promoted by using a causal language. This lack of robust study designs likely results from …
Standardising clinical outcomes measures for adult clinical trials in Fabry disease: A global Delphi consensus.
2021
International audience; Background: Recent years have witnessed a considerable increase in clinical trials of new investigational agents for Fabry disease (FD). Several trials investigating different agents are currently in progress; however, lack of standardisation results in challenges to interpretation and comparison. To facilitate the standardisation of investigational programs, we have developed a common framework for future clinical trials in FD.Methods and findings: A broad consensus regarding clinical outcomes and ways to measure them was obtained via the Delphi methodology. 35 FD clinical experts from 4 continents, representing 3389 FD patients, participated in 3 rounds of Delphi p…
The dietary inflammatory index and human health: an umbrella review of meta-analyses of observational studies
2021
Numerous observational studies have investigated the role of the Dietary Inflammatory Index (DII®) in chronic disease risk. The aims of this umbrella review and integrated meta-analyses were to systematically synthesize the observational evidence reporting on the associations between the DII and health outcomes based on meta-analyses, and to assess the quality and strength of the evidence for each associated outcome. This umbrella review with integrated meta-analyses investigated the association between the DII and a range of health outcomes based on meta-analyses of observational data. A credibility assessment was conducted for each outcome using the following criteria: Statistical heterog…
The person-oriented approach to burnout : A systematic review
2016
The variable-oriented approach has dominated empirical burnout research, but during the last 10 years a person-oriented approach to burnout has also become common. The aim of this systematic literature review was to identify, categorize and evaluate the empirical research to date that has adopted a person-oriented approach to burnout. The results of these studies were then compared with those generated by variable-oriented burnout research. An electronic search of seven databases was conducted in spring 2015. Initially 470 publications were identified, 24 of which met the selection criteria. The reviewed articles were categorized into three groups based on their research target(s): (1) intr…
Validity of a questionnaire developed to measure the impact of a high‐fidelity simulation intervention: A feasibility study
2019
To evaluate the validity and responsiveness of a questionnaire developed to measure the impact of a high-fidelity simulation intervention.A pre- and postintervention design.In August 2017, 107 participants completed a questionnaire measuring knowledge and perceived self-confidence pre- and postintervention. Validity of the questionnaire was determined by expert reviews, individual interviews and estimates of the changes in knowledge and perceived self-confidence. The changes were estimated by the differences between paired proportions of participants. The responsiveness of the ordered categorical item scores on self-confidence was evaluated by the measure of systematic group change and indi…
Immediate loading implants: Review of the critical aspects
2018
Purpose. Modern dentistry have witnessed, a rapid and continuing evolution. Concerning the implant-rehabilitation protocols, they have beenEdizioniredefined in order to satisfy patientâs increasing expectations in terms of comfort, aesthetic and shorter treatment period. The purpose of this review is to explore the concept of implant immediate loading and the indications for clinical practice. All the critical aspects that could influence the outcomes of this treatment will also be considered. Materials and methods. Three protocols for implant load timing have been classified: immediate loading implants (ILI); early loading implants (ELI); and conventional loading implants (CLI). Two subc…
Fallzahlplanung bei ophthalmologischen Studien*
2000
An essential aspect in the cooperation of clinic and biometry consists in designing of studies, e.g. during the preparation of grant applications or for review by official drug surveillance institutions. A central aspect in study planning is the design-adequate and well-documented prediction of sample size, which should be recommended for any intended study. Based on several examples for sample size planning in study designs, which are of common relevance for ophthalmology, guidelines are derived to enable clinical researchers to perform sample size planning on their own. The latter can be based on the various available software packages for sample size prediction.
Biases in study design, implementation, and data analysis that distort the appraisal of clinical benefit and ESMO-Magnitude of Clinical Benefit Scale…
2021
BACKGROUND: The European Society for Medical Oncology-Magnitude of Clinical Benefit Scale (ESMO-MCBS) is a validated, widely used tool developed to score the clinical benefit from cancer medicines reported in clinical trials. ESMO-MCBS scores assume valid research methodologies and quality trial implementation. Studies incorporating flawed design, implementation, or data analysis may generate outcomes that exaggerate true benefit and are not generalisable. Failure to either indicate or penalise studies with bias undermines the intention and diminishes the integrity of ESMO-MCBS scores. This review aimed to evaluate the adequacy of the ESMO-MCBS to address bias generated by flawed design, im…
Technology-Supported Guidance Models Stimulating the Development of Critical Thinking in Clinical Practice: Protocol for a Mixed Methods Systematic R…
2020
BackgroundCritical thinking is an essential skill that nursing students need to develop. Technological tools have opened new avenues for technology-supported guidance models, but the challenges and facilitators of such guidance models, as well as how they stimulate the development of critical thinking, remain unclear.ObjectiveWe developed a protocol for a mixed methods systematic review to investigate the use of technology-supported guidance models that stimulate the development of critical thinking in nursing education clinical practice.MethodsA convergent integrated design following the Joanna Briggs Institute Manual for Evidence Synthesis will be employed. A pair of authors will select t…