Reasons for non-recruitment of eligible patients to a randomised controlled trial of secondary prevention after intracerebral haemorrhage: Observational study
Author(s): Maxwell A.E.; Al-Shahi Salman R.; MacLeod M.J.; Joyson A.; Johnson S.; Ramadan H.; Bellfield R.; Byrne A.; McGhee C.; Rudd A.; Price F.; Vasileiadis E.; Holden M.; Hewitt J.; Carpenter M.; Needle A.; Valentine S.; Patel F.; Harrington F.; Mudd P.; Emsley H.; Gregary B.; Kane I.; Muir K.; Tiwari D.; Owusu-Agyei P.; Temple N.; Sekaran L.; Ragab S.; England T.; Hedstrom A.; Jones P.; Jones S.; Doherty M.; McCarron M.O.; Cohen D.L.; Tysoe S.
Source: Trials; Apr 2017; vol. 18 (no. 1)
Publication Date: Apr 2017
Publication Type(s): Article
Available in full text at Trials - from BioMed Central
Abstract:Background: Recruitment to randomised prevention trials is challenging, not least for intracerebral haemorrhage (ICH) associated with antithrombotic drug use. We investigated reasons for not recruiting apparently eligible patients at hospital sites that keep screening logs in the ongoing REstart or STop Antithrombotics Randomised Trial (RESTART), which seeks to determine whether to start antiplatelet drugs after ICH. Method: By the end of May 2015, 158 participants had been recruited at 108 active sites in RESTART. The trial coordinating centre invited all sites that kept screening logs to submit screening log data, followed by one reminder. We checked the integrity of data, focused on the completeness of data about potentially eligible patients and categorised the reasons they were not randomised. Results: Of 108 active sites, 39 (36%) provided usable screening log data over a median of ten (interquartile range = 5-13) months of recruitment per site. During this time, sites screened 633 potentially eligible patients and randomised 53 (8%) of them. The main reasons why 580 patients were not randomised were: 43 (7%) patients started anticoagulation, 51 (9%) patients declined, 148 (26%) patients' stroke physicians were not uncertain about using antiplatelet drugs, 162 (28%) patients were too unwell and 176 (30%) patients were not randomised due to other reasons. Conclusion: RESTART recruited ~8% of eligible patients. If more physicians were uncertain about the therapeutic dilemma that RESTART is addressing, RESTART could have recruited up to four times as many participants. The trial coordinating centre continues to engage with physicians about their uncertainty. Trial registration: EU Clinical Trials, EudraCT 2012-003190-26. Registered on 3 July 2012.Copyright © 2017 The Author(s).
Tolterodine ER reduced increased bladder wall thickness in women with overactive bladder. A randomized, placebo-controlled, double-blind, parallel group study
Author(s): Bray R.; Khullar V.; Cartwright R.; Cardozo L.; Hill S.; Guan Z.
Source: Neurourology and Urodynamics; 2017
Publication Date: 2017
Publication Type(s): Article In Press
Available in full text at Neurourology and Urodynamics - from John Wiley and Sons
Abstract:AIMS: We evaluated the effect of Tolterodine extended release (TER) versus placebo on bladder wall thickness (BWT) using transvaginal ultrasound in women with overactive bladder (OAB). MATERIALS AND METHODS: We recruited 79 women with symptoms of OAB with a mean age of 47 years who had a BWT of at least 5mm and a post-micturition volume of less than 50mL at screening. Subjects received TER 4mg or placebo once daily for the first 12 weeks of the study. For the subsequent 12 weeks, all subjects received TER 4mg once daily. BWT was measured at screening, weeks 12 and 24. Subjects recorded number of micturitions, incontinence episodes and urgency episodes, and volume voided per micturition at regular intervals during the study. RESULTS: Treatment with TER for 12 weeks produced a statistically significant decrease from baseline in BWT (mean [SD]=0.9 [1.4] mm; P<0.05) that was not evident following treatment with placebo (0.2 [1.6] mm; P=0.54). However, the treatment difference did not reach statistical significance (LS Mean=-0.4; 95%CI: -1.2, 0.3; P=0.25). After 12 weeks of treatment, subjects who had taken TER showed an improvement in each bladder diary variable compared to placebo-treated subjects. CONCLUSIONS: TER may have a direct effect on BWT in women with OAB. Larger studies are warranted to further investigate the effect of behavioral interventions and antimuscarinics, such as TER, on BWT in women with OAB and increased BWT.Copyright © 2017 Wiley Periodicals, Inc.
Author(s): Hajibandeh S.
Source: Western Journal of Emergency Medicine; Apr 2017; vol. 18 (no. 3); p. 331-332
Publication Date: Apr 2017
Publication Type(s): Letter
Available in full text at Western Journal of Emergency Medicine - from National Library of Medicine
Author(s): Kew K.M.; Carr R.; Crossingham I.
Source: Cochrane Database of Systematic Reviews; Apr 2017; vol. 2017 (no. 4)
Publication Date: Apr 2017
Publication Type(s): Review
Abstract:Background: Adolescents with asthma are at high risk of poor adherence with treatment. This may be compounded by activities that worsen asthma, in particular smoking. Additional support above and beyond routine care has the potential to encourage good self-management. We wanted to find out whether sessions led by their peers or by lay leaders help to reduce these risks and improve asthma outcomes among adolescents. Objectives: To assess the safety and efficacy of lay-led and peer support interventions for adolescents with asthma. Search methods: We identified trials from the Cochrane Airways Trials Register, which contains reports of randomised trials obtained from multiple electronic and handsearched sources, and we searched trial registries and reference lists of primary studies. We conducted the most recent searches on 25 November 2016. Selection criteria: Eligible studies randomised adolescents with asthma to an intervention led by lay people or peers or to a control. We included parallel randomised controlled trials with individual or cluster designs. We included studies reported as full text, those published as abstract only and unpublished data. Data collection and analysis: Two review authors screened the searches, extracted numerical data and study characteristics and assessed each included study for risk of bias. Primary outcomes were asthma-related quality of life and exacerbations requiring at least a course of oral steroids. We graded the analyses and presented evidence in a 'Summary of findings' table. We analysed dichotomous data as odds ratios, and continuous data as mean differences (MD) or standardised mean differences, all with a random-effects model. We assessed clinical, methodological and statistical heterogeneity when performing meta-analyses, and we described skewed data narratively. Main results: Five studies including a total of 1146 participants met the inclusion criteria for this review. As ever with systematic reviews of complex interventions, studies varied by design (cluster and individually randomised), duration (2.5 to 9 months), setting (school, day camp, primary care) and intervention content. Most risk of bias concerns were related to blinding and incomplete reporting, which limited the meta-analyses that could be performed. Studies generally controlled well for selection and attrition biases. All participants were between 11 and 17 years of age. Asthma diagnosis and severity varied, as did smoking prevalence. Three studies used the Triple A programme; one of these studies tested the addition of a smoke-free pledge; another delivered peer support group sessions and mp3 messaging to encourage adherence; and the third compared a peer-led asthma day camp with an equivalent camp led by healthcare practitioners. We had low confidence in all findings owing to risk of bias, inconsistency and imprecision. Results from an analysis of asthma-related quality of life based on the prespecified random-effects model were imprecise and showed no differences (MD 0.40, 95% confidence interval (CI) -0.02 to 0.81); a sensitivity analysis based on a fixed-effect model and a responder analysis suggested small benefit may be derived for this outcome. Most other results were summarised narratively and did not show an important benefit of the intervention; studies provided no analysable data on asthma exacerbations or unscheduled visits (data were skewed), and one study measuring adherence reported a drop in both groups. Effects on asthma control favoured the intervention but findings were not statistically significant. Results from two studies with high levels of baseline smoking showed some promise for self-efficacy to stop smoking, but overall nicotine dependence and smoking-related knowledge were not significantly better in the intervention group. Investigators did not report adverse events. Authors' conclusions: Although weak evidence suggests that lay-led and peer support interventions could lead to a small improvement in asthma-related quality of life for adolescents, benefits for asthma control, exacerbations and medication adherence remain unproven. Current evidence is insufficient to reveal whether routine use of lay-led or peer support programmes is beneficial for adolescents receiving asthma care. Ongoing and future research may help to identify target populations for lay-led and peer support interventions, along with attributes that constitute a successful programme.Copyright © 2017 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
Author(s): Hiam L.; McKee M.; Dorling D.; Harrison D.
Source: Journal of the Royal Society of Medicine; Apr 2017; vol. 110 (no. 4); p. 153-162
Publication Date: Apr 2017
Publication Type(s): Article
Available in full text at Journal of the Royal Society of Medicine - from National Library of Medicine
Abstract:Objectives To understand why mortality increased in England and Wales in 2015. Design Iterative demographic analysis. Setting England and Wales Participants Population of England and Wales. Main outcome measures Causes and ages at death contributing to life expectancy changes between 2013 and 2015. Results The long-term decline in age-standardised mortality in England and Wales was reversed in 2011. Although there was a small fall in mortality rates between 2013 and 2014, in 2015 we then saw one of the largest increases in deaths in the post-war period. Nonetheless, mortality in 2015 was higher than in any year since 2008. A small decline in life expectancy at birth between 2013 and 2015 was not significant but declines in life expectancy at ages over 60 were. The largest contributors to the observed changes in life expectancy were in those aged over 85 years, with dementias making the greatest contributions in both sexes. However, changes in coding practices and diagnosis of dementia demands caution in interpreting this finding. Conclusions The long-term decline in mortality in England and Wales has reversed, with approximately 30,000 extra deaths compared to what would be expected if the average age-specific death rates in 2006-2014 had continued. These excess deaths are largely in the older population, who are most dependent on health and social care. The major contributor, based on reported causes of death, was dementia but caution was advised in this interpretation. The role of the health and social care system is explored in an accompanying paper.
The prevalence of self-reported lower limb and foot health problems experienced by participants with systemic lupus erythematosus: Results of a UK national survey
Author(s): Cherry, L; Alcacer-Pitarch, B; Hopkinson, N; Teh, L S; Vital, E M; Edwards, C J; Blake, A; Williams, A E
Source: Lupus; Apr 2017; vol. 26 (no. 4); p. 410-416
Publication Type(s): Journal Article
Available in full text at Lupus
Abstract:Objective The main aim of this survey was to determine the frequency of self-reported lower limb or foot and ankle complications experienced by participants with systemic lupus erythematosus (SLE). A secondary aim was to determine the frequency of treatments that have been received or that participants with SLE may like to receive if offered. Method A quantitative, cross-sectional, self-reported survey design was utilized. The developed survey was checked for face and content validity prior to patient partner cognitive debriefing in order to ensure usability, understanding of the process of completion and of the questions posed. The full protocol for survey development has been published previously. Results This is the first comprehensive national UK survey of lower limb and foot health problems reported by participants with SLE. A high prevalence of vascular, dermatological and musculoskeletal complications was reported by survey respondents. Additionally, whilst the relative prevalence of sensory loss was low, a quarter of people reported having had a fall related to changes in foot sensation demonstrating a previously unknown rate and cause of falls. Conclusion Complications related to vascular, dermatological and musculoskeletal health are identified as particularly prevalent in participants with SLE. Further, there is a suggestion that the provision of interventions to maintain lower limb health is highly varied and lacks national standardization, despite there being a strong indication of participant reported need. The findings of this work can be used to inform care guideline development in addition to identifying areas for future research.
Management of sulfonylurea-treated monogenic diabetes in pregnancy: Implications of placental glibenclamide transfer
Author(s): Shepherd M.; Brook A.J.; Chakera A.J.; Hattersley A.T.
Source: Diabetic Medicine; 2017
Available in full text at Diabetic Medicine - from John Wiley and Sons
Abstract:The optimum treatment for HNF1A/HNF4A maturity-onset diabetes of the young and ATP-sensitive potassium (KATP) channel neonatal diabetes, outside pregnancy, is sulfonylureas, but there is little evidence regarding the most appropriate treatment during pregnancy. Glibenclamide has been widely used in the treatment of gestational diabetes, but recent data have established that glibenclamide crosses the placenta and increases risk of macrosomia and neonatal hypoglycaemia. This raises questions about its use in pregnancy. We review the available evidence and make recommendations for the management of monogenic diabetes in pregnancy. Due to the risk of stimulating increased insulin secretion in utero, we recommend that in women with HNF1A/ HNF4A maturity-onset diabetes of the young, those with good glycaemic control who are on a sulfonylurea per conception either transfer to insulin before conception (at the risk of a short-term deterioration of glycaemic control) or continue with sulfonylurea (glibenclamide) treatment in the first trimester and transfer to insulin in the second trimester. Early delivery is needed if the fetus inherits an HNF4A mutation from either parent because increased insulin secretion results in ~800-g weight gain in utero, and prolonged severe neonatal hypoglycaemia can occur post-delivery. If the fetus inherits a KATP neonatal diabetes mutation from their mother they have greatly reduced insulin secretion in utero that reduces fetal growth by ~900 g. Treating the mother with glibenclamide in the third trimester treats the affected fetus in utero, normalising fetal growth, but is not desirable, especially in the high doses used in this condition, if the fetus is unaffected. Prospective studies of pregnancy in monogenic diabetes are needed.Copyright © 2017 Diabetes UK.
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