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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......
Evaluation of a home-based transcranial direct current stimulation (tDCS) treatment device for chronic pain: study protocol for a randomised controlled trial
Springer Science and Business Media LLC - Tập 16 - Trang 1-6 - 2015
Stimulation of the primary motor cortex (M1) has been shown to reduce the pain of neuropathy in multiple studies. There are several methods of stimulation both invasive and non-invasive. Recent work by this laboratory has seen that 40% of a sample of chronic neuropathic pain patients responded positively to non-invasive repetitive transcranial magnetic stimulation (rTMS) to the motor cortex with a......
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 ......
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