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Privacy and confidentiality in pragmatic clinical trials [PDF]

open access: yesClinical Trials, 2015
With pragmatic clinical trials, an opportunity exists to answer important questions about the relative risks, burdens, and benefits of therapeutic interventions. However, concerns about protecting the privacy of this information are significant and must be balanced with the imperative to learn from the data gathered in routine clinical practice ...
Deven, McGraw   +5 more
openaire   +2 more sources

Study within a trial of electronic versus paper-based Patient-Reported oUtcomes CollEction (SPRUCE): study protocol for a partially randomised patient preference study

open access: yesBMJ Open, 2023
Introduction Patient-reported outcomes (PRO) are currently collected from trial participants using paper questionnaires by the Clinical Trials and Statistics Unit at The Institute of Cancer Research (ICR-CTSU).
Rebecca Lewis   +11 more
doaj   +1 more source

Reducing the environmental impact of trials: a comparison of the carbon footprint of the CRASH-1 and CRASH-2 clinical trials. [PDF]

open access: yes, 2011
BACKGROUND: All sectors of the economy, including the health research sector, must reduce their carbon emissions. The UK National Institute for Health Research has recently prepared guidelines on how to minimize the carbon footprint of research.
Subaiya, Saleena   +8 more
core   +2 more sources

Clinical- and cost-effectiveness of a technology-supported and solution-focused intervention (DIALOG+) in treatment of patients with chronic depression—study protocol for a multi-site, cluster randomised controlled trial [TACK]

open access: yesTrials, 2022
Background Many with an acute depressive disorder go on to develop chronic depression, despite ongoing care. There are few specifically designed interventions to treat chronic depression.
Philip McNamee   +13 more
doaj   +1 more source

Managing clinical trials. [PDF]

open access: yes, 2010
Managing clinical trials, of whatever size and complexity, requires efficient trial management. Trials fail because tried and tested systems handed down through apprenticeships have not been documented, evaluated or published to guide new trialists ...
Barbara Farrell   +11 more
core   +2 more sources

Double-blind randomised controlled trial of percutaneous tibial nerve stimulation versus sham electrical stimulation in the treatment of faecal incontinence: CONtrol of Faecal Incontinence using Distal NeuromodulaTion (the CONFIDeNT trial)

open access: yesHealth Technology Assessment, 2015
Background: Faecal incontinence (FI) is a common condition which is often under-reported. It is distressing for those suffering from it, impacting heavily on their quality of life.
Emma J Horrocks   +7 more
doaj   +1 more source

Pragmatic clinical trials

open access: yesComplementary Therapies in Medicine, 2004
Both pragmatic and explanatory randomised controlled trials have a useful role to play in the evaluation of health care interventions. In this descriptive article, the key steps in conducting a pragmatic trial are described. The strengths and limitations of pragmatic trials are also discussed.
openaire   +2 more sources

The added value of ordinal analysis in clinical trials: an example in traumatic brain injury. [PDF]

open access: yes, 2011
INTRODUCTION: In clinical trials, ordinal outcome measures are often dichotomized into two categories. In traumatic brain injury (TBI) the 5-point Glasgow outcome scale (GOS) is collapsed into unfavourable versus favourable outcome.
Perel, P   +37 more
core   +2 more sources

Stepped-wedge randomised trial of laparoscopic ventral mesh rectopexy in adults with chronic constipation: study protocol for a randomized controlled trial

open access: yesTrials, 2018
Background Laparoscopic ventral mesh rectopexy (LVMR) is an established treatment for external full-thickness rectal prolapse. However, its clinical efficacy in patients with internal prolapse is uncertain due to the lack of high-quality evidence ...
Ugo Grossi   +12 more
doaj   +1 more source

"Targeted" Consent for Pragmatic Clinical Trials [PDF]

open access: yesJournal of General Internal Medicine, 2015
Research on interventions within the standard of care has enormous potential, yet it also raises several ethical and regulatory challenges. Perhaps the most important is determining what consent process is needed for these "pragmatic" clinical trials. Some argue that pragmatic clinical trials need to obtain in-depth research consent.
openaire   +2 more sources

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