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1.  Designing the CORONIS trial. Why a non-regular fractional factorial design? 
Trials  2013;14(Suppl 1):O57.
doi:10.1186/1745-6215-14-S1-O57
PMCID: PMC3981492
2.  Repeat prenatal corticosteroid prior to preterm birth: a systematic review and individual participant data meta-analysis for the PRECISE study group (prenatal repeat corticosteroid international IPD study group: assessing the effects using the best level of evidence) - study protocol 
Systematic Reviews  2012;1:12.
Background
The aim of this individual participant data (IPD) meta-analysis is to assess whether the effects of repeat prenatal corticosteroid treatment given to women at risk of preterm birth to benefit their babies are modified in a clinically meaningful way by factors related to the women or the trial protocol.
Methods/Design
The Prenatal Repeat Corticosteroid International IPD Study Group: assessing the effects using the best level of Evidence (PRECISE) Group will conduct an IPD meta-analysis. The PRECISE International Collaborative Group was formed in 2010 and data collection commenced in 2011. Eleven trials with up to 5,000 women and 6,000 infants are eligible for the PRECISE IPD meta-analysis. The primary study outcomes for the infants will be serious neonatal outcome (defined by the PRECISE International IPD Study Group as one of death (foetal, neonatal or infant); severe respiratory disease; severe intraventricular haemorrhage (grade 3 and 4); chronic lung disease; necrotising enterocolitis; serious retinopathy of prematurity; and cystic periventricular leukomalacia); use of respiratory support (defined as mechanical ventilation or continuous positive airways pressure or other respiratory support); and birth weight (Z-scores). For the children, the primary study outcomes will be death or any neurological disability (however defined by trialists at childhood follow up and may include developmental delay or intellectual impairment (developmental quotient or intelligence quotient more than one standard deviation below the mean), cerebral palsy (abnormality of tone with motor dysfunction), blindness (for example, corrected visual acuity worse than 6/60 in the better eye) or deafness (for example, hearing loss requiring amplification or worse)). For the women, the primary outcome will be maternal sepsis (defined as chorioamnionitis; pyrexia after trial entry requiring the use of antibiotics; puerperal sepsis; intrapartum fever requiring the use of antibiotics; or postnatal pyrexia).
Discussion
Data analyses are expected to commence in 2011 with results publicly available in 2012.
doi:10.1186/2046-4053-1-12
PMCID: PMC3351733  PMID: 22588009
3.  CESAR: conventional ventilatory support vs extracorporeal membrane oxygenation for severe adult respiratory failure 
Background
An estimated 350 adults develop severe, but potentially reversible respiratory failure in the UK annually. Current management uses intermittent positive pressure ventilation, but barotrauma, volutrauma and oxygen toxicity can prevent lung recovery. An alternative treatment, extracorporeal membrane oxygenation, uses cardio-pulmonary bypass technology to temporarily provide gas exchange, allowing ventilator settings to be reduced. While extracorporeal membrane oxygenation is proven to result in improved outcome when compared to conventional ventilation in neonates with severe respiratory failure, there is currently no good evidence from randomised controlled trials to compare these managements for important clinical outcomes in adults, although evidence from case series is promising.
Methods/Design
The aim of the randomised controlled trial of Conventional ventilatory support vs extracorporeal membrane oxygenation for severe adult respiratory failure (CESAR) is to assess whether, for patients with severe, but potentially reversible, respiratory failure, extracorporeal membrane oxygenation will increase the rate of survival without severe disability ('confined to bed' and 'unable to wash or dress') by six months post-randomisation, and be cost effective from the viewpoints of the NHS and society, compared to conventional ventilatory support. Following assent from a relative, adults (18–65 years) with severe, but potentially reversible, respiratory failure (Murray score ≥ 3.0 or hypercapnea with pH < 7.2) will be randomised for consideration of extracorporeal membrane oxygenation at Glenfield Hospital, Leicester or continuing conventional care in a centre providing a high standard of conventional treatment. The central randomisation service will minimise by type of conventional treatment centre, age, duration of high pressure ventilation, hypoxia/hypercapnea, diagnosis and number of organs failed, to ensure balance in key prognostic variables. Extracorporeal membrane oxygenation will not be available for patients meeting entry criteria outside the trial. 180 patients will be recruited to have 80% power to be able to detect a one third reduction in the primary outcome from 65% at 5% level of statistical significance (2-sided test). Secondary outcomes include patient morbidity and health status at 6 months.
Discussion
Analysis will be based on intention to treat. A concurrent economic evaluation will also be performed to compare the costs and outcomes of both treatments.
doi:10.1186/1472-6963-6-163
PMCID: PMC1766357  PMID: 17187683
4.  A randomised controlled trial investigating the effect of n-3 long-chain polyunsaturated fatty acid supplementation on cognitive and retinal function in cognitively healthy older people: the Older People And n-3 Long-chain polyunsaturated fatty acids (OPAL) study protocol [ISRCTN72331636] 
Nutrition Journal  2006;5:20.
The number of individuals with age-related cognitive impairment is rising dramatically in the UK and globally. There is considerable interest in the general hypothesis that improving the diet of older people may slow the progression of cognitive decline. To date, there has been little attention given to the possible protective role of n-3 long-chain polyunsaturated fatty acids (n-3 LCPs) most commonly found in oily fish, in age-related loss of cognitive function. The main research hypothesis of this study is that an increased dietary intake of n-3 LCPs will have a positive effect on cognitive performance in older people in the UK.
To test this hypothesis, a double-blind randomised placebo-controlled trial will be carried out among adults aged 70–79 years in which the intervention arm will receive daily capsules containing n-3 LCP (0.5 g/day docosahexaenoic acid and 0.2 g/day eicosapentaenoic acid) while the placebo arm will receive daily capsules containing olive oil. The main outcome variable assessed at 24 months will be cognitive performance and a second major outcome variable will be retinal function. Retinal function tests are included as the retina is a specifically differentiated neural tissue and therefore represents an accessible window into the functioning of the brain.
The overall purpose of this public-health research is to help define a simple and effective dietary intervention aimed at maintaining cognitive and retinal function in later life. This will be the first trial of its kind aiming to slow the decline of cognitive and retinal function in older people by increasing daily dietary intake of n-3 LCPs. The link between cognitive ability, visual function and quality of life among older people suggests that this novel line of research may have considerable public health importance.
doi:10.1186/1475-2891-5-20
PMCID: PMC1564406  PMID: 16945130
5.  One day survey by the Mental Health Act Commission of acute adult psychiatric inpatient wards in England and Wales 
BMJ : British Medical Journal  1998;317(7168):1279-1283.
Objectives
To provide (via the Mental Health Act Commission’s “national visit”) empirical evidence on ward occupancy levels, use of the Mental Health Act 1983, nurse staffing, and care of female patients on acute adult psychiatric wards.
Design
One day survey of a stratified random sample.
Settings
119/250 (47%) acute adult psychiatric inpatient units in England and Wales.
Subjects
End sample of 263 acute psychiatric inpatient wards.
Main outcome measures
Ward occupancy rates; number of patients detained under the Mental Health Act and proportion “absent without leave”; nurse staffing levels, skill mix, and vacancies; proportion of women with self contained, women-only facilities.
Results
Mean ward occupancy was 99% (95% confidence interval 97% to 102%). A ward mean of 30% (28% to 32%) of patients were detained under the Mental Health Act; of all detained patients, 1% (1% to 2%) were absent without leave. A ward mean of 0.3 (0.29 to 0.31) nurses were on duty per patient at the time of the visit. An estimated ward mean of 31% (30% to 32%) of nurse staffing may have been through casual contracts—higher in inner (48% (43% to 53%)) and outer London (45% (41% to 48%)). On 26% (21% to 32%) of wards, there were no nurses interacting with patients. A ward mean of 36% (30% to 41%) of female patients had self contained, women-only facilities.
Conclusions
Attention should focus on improving the quality of acute inpatient psychiatric care as well as of community care.
Key messagesLeave arrangements on adult psychiatric wards cause considerable difficulties in bed managementAn estimated third of nursing staff on duty are employed on a casual basisNurses spend much of their time engaged in intensive observation of a few patients, but a quarter of wards had no nurse interacting with patients at the time of the national visitOnly a third of female patients had the use of self contained, women-only areasPolicymaking, management, and training must be refocused to improve the quality of acute inpatient psychiatric care
PMCID: PMC28706  PMID: 9804713

Results 1-5 (5)