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Trial management: we need a cadre of high-class triallists to deliver the answers that patients need
Springer Science and Business Media LLC - Tập 20 Số 1 - 2019
Projection of participant recruitment to primary care research: a qualitative study
Springer Science and Business Media LLC - Tập 16 - Trang 1-13 - 2015
Recruitment to clinical trials remains a challenge, particularly in primary care
settings. Initial projections of participant recruitment need to be as accurate
as possible in order to avoid the financial, clinical and ethical costs of trial
extensions or failures. However, estimation of recruitment rates is challenging
and often poorly executed, if attempted at all. We used qualitative methods to...
The effect of bitter almond (Amygdalus communis L. var. Amara) gum as a functional food on metabolic profile, inflammatory markers, and mental health in type 2 diabetes women: a blinded randomized controlled trial protocol
Springer Science and Business Media LLC - Tập 24 - Trang 1-10 - 2023
Using functional foods in the prevention and treatment of type 2 diabetes
mellitus (T2DM) has increased across the world owing to their availability,
cultural acceptability, and lower side effects. The present study will aim to
examine the impact of bitter almond (Amygdalus communis L. var. Amara) gum as a
functional food on metabolic profile, inflammatory markers, and mental health in
women with ...
Cornerstone program for transition-age youth with serious mental illness: study protocol for a randomized controlled trial
Springer Science and Business Media LLC - Tập 17 - Trang 1-13 - 2016
Transition-age youth have elevated rates of mental disorders, and they often do
not receive services. This is a serious public health concern, as mental health
conditions persist into adulthood. Continuing to engage this population has been
a pervasive challenge for the mental health care system worldwide. Few mental
health interventions have been developed for transition-age youth, and even
fewer...
How informed is declared altruism in clinical trials? A qualitative interview study of patient decision-making about the QUEST trials (Quality of Life after Mastectomy and Breast Reconstruction)
Springer Science and Business Media LLC - Tập 17 - Trang 1-10 - 2016
Randomised controlled trials (RCTs) often fail to recruit sufficient
participants, despite altruism being cited as their motivation. Previous
investigations of factors influencing participation decisions have been
methodologically limited. This study evaluated how women weigh up different
motivations after initially expressing altruism, and explored their
understanding of a trial and its alternati...
Stopping guidelines for an effectiveness trial: what should the protocol specify?
Springer Science and Business Media LLC - Tập 17 - Trang 1-4 - 2016
Despite long-standing problems in decisions to stop clinical trials, stopping
guidelines are often vague or unspecified in the trial protocol. Clear,
well-conceived guidelines are especially important to assist the data monitoring
committees for effectiveness trials. To specify better stopping guidelines in
the protocol for such trials, the clinical investigators and trial statistician
should care...
Accounting for center in the Early External Cephalic Version trials: an empirical comparison of statistical methods to adjust for center in a multicenter trial with binary outcomes
Springer Science and Business Media LLC - Tập 15 - Trang 1-11 - 2014
Clustering of outcomes at centers involved in multicenter trials is a type of
center effect. The Consolidated Standards of Reporting Trials Statement
recommends that multicenter randomized controlled trials (RCTs) should account
for center effects in their analysis, however most do not. The Early External
Cephalic Version (EECV) trials published in 2003 and 2011 stratified by center
at randomizati...
Organising Support for Carers of Stroke Survivors (OSCARSS): study protocol for a cluster randomised controlled trial, including health economic analysis
Springer Science and Business Media LLC - Tập 20 - Trang 1-11 - 2019
Stroke often results in chronic disability, with partners and family members
taking on the role of informal caregiver. There is considerable uncertainty
regarding how best to identify and address carers’ needs. The Carer Support
Needs Assessment Tool (CSNAT) is a carer-led approach to individualised
assessment and support for caregiving that may be beneficial in palliative care
contexts. CSNAT inc...
Community and District Empowerment for Scale-up (CODES): a complex district-level management intervention to improve child survival in Uganda: study protocol for a randomized controlled trial
Springer Science and Business Media LLC - Tập 17 - Trang 1-8 - 2016
Innovative and sustainable strategies to strengthen districts and other
sub-national health systems and management are urgently required to reduce child
mortality. Although highly effective evidence-based and affordable child
survival interventions are well-known, at the district level, lack of data,
motivation, analytic and planning capacity often impedes prioritization and
management weaknesses ...
Power and sample size calculation for stepped-wedge designs with discrete outcomes
Springer Science and Business Media LLC - Tập 22 Số 1 - 2021
AbstractBackgroundStepped-wedge designs (SWD) are increasingly used to evaluate
the impact of changes to the process of care within health care systems.
However, to generate definitive evidence, a correct sample size calculation is
crucial to ensure such studies are properly powered. The seminal work of Hussey
and Hughes (Contemp Clin Trials 28(2):182–91, 2004) provides an analytical
formula for p...
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