761 research outputs found
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Methodological considerations for neonatal trials involving multiples: lessons from the bracelet study (bereavement and randomised controlled trials)
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Feeding back the results of trials to the families of participants who have died: methodological considerations from the bracelet study (bereavement and randomised controlled trials)
Should involvement in a trial be discussed at a bereavement follow up visit? Views of clinicians and bereaved parents from the bracelet study (bereavement and randomised controlled trials)
Evaluating the cost-effectiveness of existing needle and syringe programmes in preventing hepatitis C transmission in people who inject drugs
AIM: To evaluate the cost-effectiveness of needle and syringe programmes (NSPs) compared with no NSPs on hepatitis C virus (HCV) transmission in the United Kingdom. DESIGN: Cost-effectiveness analysis from a National Health Service (NHS)/health-provider perspective, utilizing a dynamic transmission model of HCV infection and disease progression, calibrated using city-specific surveillance and survey data, and primary data collection on NSP costs. The effectiveness of NSPs preventing HCV acquisition was based on empirical evidence. SETTING AND PARTICIPANTS: UK settings with different chronic HCV prevalence among people who inject drugs (PWID): Dundee (26%), Walsall (18%) and Bristol (45%) INTERVENTIONS: Current NSP provision is compared with a counterfactual scenario where NSPs are removed for 10 years and then returned to existing levels with effects collected for 40 years. MEASUREMENTS: HCV infections and cost per quality-adjusted life year (QALY) gained through NSPs over 50 years. FINDINGS: Compared with a willingness-to-pay threshold of £20 000 per QALY gained, NSPs were highly cost-effective over a time-horizon of 50 years and decreased the number of HCV incident infections. The mean incremental cost-effectiveness ratio was cost-saving in Dundee and Bristol, and £596 per QALY gained in Walsall, with 78, 46 and 40% of simulations being cost-saving in each city, respectively, with differences driven by coverage of NSP and HCV prevalence (lowest in Walsall). More than 90% of simulations were cost-effective at the willingness-to-pay threshold. Results were robust to sensitivity analyses, including varying the time-horizon, HCV treatment cost and numbers of HCV treatments per year. CONCLUSIONS: Needle and syringe programmes are a highly effective low-cost intervention to reduce hepatitis C virus transmission, and in some settings they are cost-saving. Needle and syringe programmes are likely to remain cost-effective irrespective of changes in hepatitis C virus treatment cost and scale-up
The BRACELET Study: surveys of mortality in UK neonatal and paediatric intensive care trials.
BACKGROUND: The subject of death and bereavement in the context of randomised controlled trials in neonatal or paediatric intensive care is under-researched. The objectives of this phase of the Bereavement and RAndomised ControlLEd Trials (BRACELET) Study were to determine trial activity in UK neonatal and paediatric intensive care (2002-06); numbers of deaths before hospital discharge; and variation in mortality across intensive care units and trials and to determine whether bereavement support policies were available within trials. These are essential prerequisites to considering the implications of future policies and practice subsequent to bereavement following a child's enrollment in a trial. METHODS: The units survey involved neonatal units providing level 2 or 3 care, and paediatric units providing level II care or above; the trials survey involved trials where allocation was randomized and interventions were delivered to intensive care patients, or to parents but designed to affect patient outcomes. RESULTS: Information was available from 191/220 (87%) neonatal units (149 level 2 or 3 care); and 28/32 (88%) paediatric units. 90/177 (51%) eligible responding units participated in one or more trial (76 neonatal, 14 paediatric) and 54 neonatal units and 6 paediatric units witnessed at least one death. 50 trials were identified (36 neonatal, 14 paediatric). 3,137 babies were enrolled in neonatal trials, 210 children in paediatric trials. Deaths ranged 0-278 (median [IQR interquartile range] 2 [1, 14.5]) per neonatal trial, 0-4 (median [IQR] 1 [0, 2.5]) per paediatric trial. 534 (16%) participants died post-enrollment: 522 (17%) in neonatal trials, 12 (6%) in paediatric trials. Trial participants ranged 1-236 (median [IQR] 21.5 [8, 39.8]) per neonatal unit, 1-53 (median [IQR] 11.5 [2.3, 33.8]) per paediatric unit. Deaths ranged 0-37 (median [IQR] 3.5 [0.3, 8.8]) per neonatal unit, 0-7 (median [IQR] 0.5 [0, 1.8]) per paediatric unit. Three trials had a formal policy for responding to bereavement. CONCLUSIONS: A substantial number of deaths after trial enrollment were identified, distributed over many trials and units. Few trial teams had responses to bereavement in place. Those with the largest numbers of deaths might be best placed to collaborate in developing and assessing responses to bereavement.RIGHTS : This article is licensed under the BioMed Central licence at http://www.biomedcentral.com/about/license which is similar to the 'Creative Commons Attribution Licence'. In brief you may : copy, distribute, and display the work; make derivative works; or make commercial use of the work - under the following conditions: the original author must be given credit; for any reuse or distribution, it must be made clear to others what the license terms of this work are
Major epidemiological changes in sudden infant death syndrome : a 20-year population-based study in the UK
Background
Results of case-control studies in the past 5 years suggest that the epidemiology of sudden infant death syndrome (SIDS) has changed since the 1991 UK Back to Sleep campaign. The campaign's advice that parents put babies on their back to sleep led to a fall in death rates. We used a longitudinal dataset to assess these potential changes.
Methods
Population-based data from home visits have been collected for 369 consecutive unexpected infant deaths (300 SIDS and 69 explained deaths) in Avon over 20 years (1984—2003). Data obtained between 1993 and 1996 from 1300 controls with a chosen “reference” sleep before interview have been used for comparison.
Findings
Over the past 20 years, the proportion of children who died from SIDS while co-sleeping with their parents, has risen from 12% to 50% (p<0·0001), but the actual number of SIDS deaths in the parental bed has halved (p=0·01). The proportion seems to have increased partly because the Back to Sleep campaign led to fewer deaths in infants sleeping alone—rather than because of a rise in deaths of infants who bed-shared, and partly because of an increase in the number of deaths in infants sleeping with their parents on a sofa. The proportion of deaths in families from deprived socioeconomic backgrounds has risen from 47% to 74% (p=0·003), the prevalence of maternal smoking during pregnancy from 57% to 86% (p=0·0004), and the proportion of pre-term infants from 12% to 34% (p=0·0001). Although many SIDS infants come from large families, first-born infants are now the largest group. The age of infants who bed-share is significantly smaller than that before the campaign, and fewer are breastfed.
Interpretation
Factors that contribute to SIDS have changed in their importance over the past 20 years. Although the reasons for the rise in deaths when a parent sleeps with their infant on a sofa are still unclear, we strongly recommend that parents avoid this sleeping environment. Most SIDS deaths now occur in deprived families. To better understand contributory factors and plan preventive measures we need control data from similarly deprived families, and particularly, infant sleep environments
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“You have to keep your nerve on a DMC.” Challenges for data monitoring committees in neonatal intensive care trials: qualitative accounts from the bracelet study
"You have to keep your nerve on a DMC." Challenges for Data Monitoring Committees in neonatal intensive care trials: Qualitative accounts from the BRACELET Study.
BACKGROUND: Data Monitoring Committees (DMCs) are essential to the good conduct of many trials. Typically they comprise a small expert group which monitors safety, efficacy, progress and early outcome data as trials recruit. DMCs can recommend protocol revisions and early stopping of a trial. As DMC meetings usually consider unblinded interim data confidentially, their deliberations are seldom exposed to research scrutiny. Although there have been some case studies from trials from mixed specialties which offer insights into some of the common issues faced by DMCs, we have, however, little empirical information about the challenges faced within specific clinical settings. METHODS: In-depth interviews with participants in the BRACELET Study on death and bereavement in neonatal intensive care trials produced qualitative accounts of experiences and views of a subgroup of 18 DMC members. These interviews explored views of DMC members in relation to the clinical context of neonatal intensive care and the conduct of neonatal intensive care trials. RESULTS: Interviewees felt that an understanding of both the neonatal intensive care setting and population was crucial in a DMC. They considered the neonatal intensive care research population especially vulnerable, and that outcomes that included both death and severe disability raised particular challenges rarely faced in other settings. In exploring these key outcomes they were mindful of the need to meet high scientific standards and the needs of babies in the trials and their families. DMC members discussed particular difficulties around the composite outcome of death and severe disability, especially when mortality data were available long before data on longer term disability. While statistical stopping guidance is helpful, DMC members described decisions about stopping, revising or continuing a trial being informed by a wider set of considerations and discussions than a pre-set p value. These included potentially competing needs of current trial participants and future patients, and reflections on the nature of benefit and harm. Given their cognisance of the potential impact and consequences of the decisions made by DMCs in this setting of life, death, and disability, interviewees commonly used the imagery of bravery, and described DMCs either holding or losing their nerve. CONCLUSIONS: DMCs for trials in other fields may also face difficult ethical trade-offs in monitoring composite outcomes. The experience from this sample of DMC members suggest that for neonatal intensive care trials there are some very specific challenges seldom faced elsewhere. The vulnerability of the population, and the different timescales for essential data becoming available to inform decisions, presented particular challenges. We suggest that it is important to consider the challenges raised in other settings to better understand the complex work of these committees and to prepare future generations of DMC members
The development of a dementia awareness training package in the Thames Valley region: an evidence based approach
Introduction: Health Education England’s (2014) mandate stipulated that 250,000 healthcare staff required Tier 1 level dementia awareness training. In response, Health Education Thames Valley in the UK commissioned the Dementia Academic Action Group. This consortium, of University of Bedfordshire, Oxford Brookes University, University of Northampton and University of West London, reviewed dementia awareness training, identifying gaps, best practice and barriers to accessing training. This work led to the development of a training model for delivery to health & social care sectors.Method: A scoping review was undertaken to achieve a comprehensive understanding of the range of dementia awareness training currently being delivered. A mixed method approach was employed, consisting of a literature review; review of Tier 1 dementia awareness educational resources (59 training documents); stakeholder interviews (n=32); carer focus groups (n=2) and online staff survey (n=74).Results: The literature and scoping reviews and stakeholder interviews found a wide range of training available. Stakeholders reported this variety made it challenging to confidently identify training which met staff and organisational needs. The review of dementia training identified that most resources included information on signs/symptoms, types/causes, supporting people with dementia and person centred care. Information on policy, legislation and end of life care were less evident. The literature review identified ethnic diversity, learning disability and young onset dementia as gaps in training provision. The stakeholder, staff and carer findings highlighted theneed for greater information on: developing personal communication strategies; information about dementia and how to develop activities to support positive engagement. Finally, staff and stakeholders considered benefits of different training delivery styles, reporting a preference for a blended learning approach, stating this was more suited to developing dementia knowledge and skills, as opposed to a solely online format.Conclusion: Based on the findings, it was identified that there is an apparent need to develop a standard training package, which should be person centred, support enhanced communication approaches and increase understanding of coping with a diagnosis of dementia. This could prove attractive to the health & social care workforce in the Thames Valley Region, across the UK, and to the international arena
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