Risk stratification by pre-operative cardiopulmonary exercise testing improves outcomes following elective abdominal aortic aneurysm surgery : a cohort study

Background: In 2009, the NHS evidence adoption center and National Institute for Health and Care Excellence (NICE) published a review of the use of endovascular aneurysm repair (EVAR) of abdominal aortic aneurysms (AAAs). They recommended the development of a risk-assessment tool to help identify AAA patients with greater or lesser risk of operative mortality and to contribute to mortality prediction. A low anaerobic threshold (AT), which is a reliable, objective measure of pre-operative cardiorespiratory fitness, as determined by pre-operative cardiopulmonary exercise testing (CPET) is associated with poor surgical outcomes for major abdominal surgery. We aimed to assess the impact of a CPET-based risk-stratification strategy upon perioperative mortality, length of stay and non-operative costs for elective (open and endovascular) infra-renal AAA patients. Methods: A retrospective cohort study was undertaken. Pre-operative CPET-based selection for elective surgical intervention was introduced in 2007. An anonymized cohort of 230 consecutive infra-renal AAA patients (2007 to 2011) was studied. A historical control group of 128 consecutive infra-renal AAA patients (2003 to 2007) was identified for comparison. Comparative analysis of demographic and outcome data for CPET-pass (AT ≥ 11 ml/kg/min), CPET-fail (AT < 11 ml/kg/min) and CPET-submaximal (no AT generated) subgroups with control subjects was performed. Primary outcomes included 30-day mortality, survival and length of stay (LOS); secondary outcomes were non-operative inpatient costs. Results: Of 230 subjects, 188 underwent CPET: CPET-pass n = 131, CPET-fail n = 35 and CPET-submaximal n = 22. When compared to the controls, CPET-pass patients exhibited reduced median total LOS (10 vs 13 days for open surgery, n = 74, P < 0.01 and 4 vs 6 days for EVAR, n = 29, P < 0.05), intensive therapy unit requirement (3 vs 4 days for open repair only, P < 0.001), non-operative costs (£5,387 vs £9,634 for open repair, P < 0.001) and perioperative mortality (2.7% vs 12.6% (odds ratio: 0.19) for open repair only, P < 0.05). CPET-stratified (open/endovascular) patients exhibited a mid-term survival benefit (P < 0.05). Conclusion: In this retrospective cohort study, a pre-operative AT > 11 ml/kg/min was associated with reduced perioperative mortality (open cases only), LOS, survival and inpatient costs (open and endovascular repair) for elective infra-renal AAA surgery

Individualised pelvic floor muscle training in women with pelvic organ prolapse: a multicentre randomised controlled trial

&lt;br&gt;Background: Pelvic organ prolapse is common and is strongly associated with childbirth and increasing age. Women with prolapsed are often advised to do pelvic floor muscle exercises, but supporting evidence is limited. Our aim was to establish if one-to-one individualised pelvic floor muscle training (PFMT) is effective in reducing prolapse symptoms.&lt;/br&gt; &lt;br&gt;Methods: A parallel‐group multicentre randomised controlled trial (ISRCTN35911035) in female outpatients with newly-diagnosed, symptomatic stage I, II or III prolapse, comparing five PFMT appointments over 16 weeks (n=225) versus a lifestyle advice leaflet (n=222). Treatment allocation was by remote computer allocation using minimisation. Our primary endpoint was participants’ self-report of prolapsed symptoms at 12 months. Group assignment was masked from outcome assessors. We compared outcomes between trial groups in an intention-to-treat analysis. The cost of PFMT and savings on subsequent treatments were calculated to estimate cost-effectiveness.&lt;/br&gt; &lt;br&gt;Findings: Compared to the control group, the intervention group reported fewer prolapse symptoms at 12 months (mean difference between groups in change score 1.52, 95% CI [0.46, 2.59], p=0.0053); reported their prolapse to be “better” more often (57.2% versus 44.7%, difference 12.6%, 95% CI [1.1%, 24.1%], p=0.0336); and had an increased but non-significant odds of having less severe stage of prolapse at their 6-month clinical examination, (OR 1.47, 95% CI [0.97, 2.27], p=0.07). The control group had a greater uptake of other prolapse treatment (49.6% versus 24.1%, difference 25.5%, 95% CI [14.5%, 36.0%], p &#60;0.0001). Findings were robust to missing data. The net cost of the 25 intervention was £131.61 per woman and the cost per one-point reduction in the symptom score was £86.59, 95% CI [£50.81, £286.11]. &lt;/br&gt

Which medical technology and/or local treatment is most conducive, as of 2012, to pressure sore debridement ? Developing French guidelines for clinical practice

AbstractIntroductionImplementation of a curative strategy at the debridement stage associates systemic therapy with local therapy.ObjectivesTo determine which medical devices and technology other than support surfaces and what kinds of drugs to use in order to cleanse a pressure ulcer in 2012.MethodA systematic review of the literature querying the databases PASCAL Biomed, Cochrane Library and PubMed from 2000 to 2010 along with a compendium of prevailing professional practices.ResultsPressure sore debridement is based on local care and on the use of alginates, hydrogels and hydrocolloids.DiscussionThe analyzed articles do not take into account any specific stage of pressure ulcer debridement. Data that might favor some kinds of dressings show a low level of evidence. Were it possible to decide on the dressing to be used for a given indication, professionals would be better able to orient and narrow down their choices.ConclusionUse of alginates and hydrogels in pressure ulcer debridement is of real interest. According to expert opinion, other dressings (irrigo-absorbents, for instance) seem promising, but have yet to receive adequate scientific validation

Village-Integrated Eye Worker trial (VIEW): rationale and design of a cluster-randomised trial to prevent corneal ulcers in resource-limited settings.

IntroductionCorneal opacity is a leading cause of blindness worldwide. In resource-limited settings, untreated traumatic corneal abrasions may result in infection and ultimately, opacity. Although antimicrobial treatment of corneal ulcers may successfully cure infections, the scarring that accompanies the resolution of infection can still result in visual impairment. Prevention may be the optimal approach for reducing corneal blindness. Studies have employed community health workers to provide prompt administration of antimicrobials after corneal abrasions to prevent infections, but these studies were not designed to determine the effectiveness of such a programme.Methods and analysisThe Village-Integrated Eye Worker trial (VIEW) is a cluster-randomised trial designed to assess the effectiveness of a community health worker intervention to prevent corneal ulcers. Twenty-four Village Development Committees (VDCs) in Nepal were randomised to receive a corneal ulcer prevention programme or to no intervention. Female Community Health Volunteers (FCHVs) in intervention VDCs are trained to diagnose corneal abrasions, provide antimicrobials and to refer participants when needed. An annual census is conducted over 3 years in all study VDCs to assess the incidence of corneal ulceration via corneal photography (primary outcome). Masked outcome assessors grade corneal photographs to determine the presence or absence of incident corneal opacities. The primary analysis is negative binomial regression to compare the incidence of corneal ulceration by study arm.Ethics and disseminationThe University of California San Francisco Committee on Human Research, Nepal Netra Jyoti Sangh and the Nepal Health Research Council have given ethical approval for the trial. The results of this trial will be presented at local and international meetings and submitted to peer-reviewed journals for publication.Trial registration numberNCT01969786; Pre-results

Liraglutide and Cardiovascular Outcomes in Type 2 Diabetes

Background The cardiovascular effect of liraglutide, a glucagon-like peptide 1 analogue, when added to standard care in patients with type 2 diabetes, remains unknown. Methods In this double-blind trial, we randomly assigned patients with type 2 diabetes and high cardiovascular risk to receive liraglutide or placebo. The primary composite outcome in the time-to-event analysis was the first occurrence of death from cardiovascular causes, nonfatal myocardial infarction, or nonfatal stroke. The primary hypothesis was that liraglutide would be noninferior to placebo with regard to the primary outcome, with a margin of 1.30 for the upper boundary of the 95% confidence interval of the hazard ratio. No adjustments for multiplicity were performed for the prespecified exploratory outcomes. Results A total of 9340 patients underwent randomization. The median follow-up was 3.8 years. The primary outcome occurred in significantly fewer patients in the liraglutide group (608 of 4668 patients [13.0%]) than in the placebo group (694 of 4672 [14.9%]) (hazard ratio, 0.87; 95% confidence interval [CI], 0.78 to 0.97; P<0.001 for noninferiority; P=0.01 for superiority). Fewer patients died from cardiovascular causes in the liraglutide group (219 patients [4.7%]) than in the placebo group (278 [6.0%]) (hazard ratio, 0.78; 95% CI, 0.66 to 0.93; P=0.007). The rate of death from any cause was lower in the liraglutide group (381 patients [8.2%]) than in the placebo group (447 [9.6%]) (hazard ratio, 0.85; 95% CI, 0.74 to 0.97; P=0.02). The rates of nonfatal myocardial infarction, nonfatal stroke, and hospitalization for heart failure were nonsignificantly lower in the liraglutide group than in the placebo group. The most common adverse events leading to the discontinuation of liraglutide were gastrointestinal events. The incidence of pancreatitis was nonsignificantly lower in the liraglutide group than in the placebo group. Conclusions In the time-to-event analysis, the rate of the first occurrence of death from cardiovascular causes, nonfatal myocardial infarction, or nonfatal stroke among patients with type 2 diabetes mellitus was lower with liraglutide than with placebo. (Funded by Novo Nordisk and the National Institutes of Health; LEADER ClinicalTrials.gov number, NCT01179048 .)

GALA: an international multicentre randomised trial comparing general anaesthesia versus local anaesthesia for carotid surgery

Background: Patients who have severe narrowing at or near the origin of the internal carotid artery as a result of atherosclerosis have a high risk of ischaemic stroke ipsilateral to the arterial lesion. Previous trials have shown that carotid endarterectomy improves long-term outcomes, particularly when performed soon after a prior transient ischaemic attack or mild ischaemic stroke. However, complications may occur during or soon after surgery, the most serious of which is stroke, which can be fatal. It has been suggested that performing the operation under local anaesthesia, rather than general anaesthesia, may be safer. Therefore, a prospective, randomised trial of local versus general anaesthesia for carotid endarterectomy was proposed to determine whether type of anaesthesia influences peri-operative morbidity and mortality, quality of life and longer term outcome in terms of stroke-free survival. Methods/design: A two-arm, parallel group, multicentre randomised controlled trial with a recruitment target of 5000 patients. For entry into the study, in the opinion of the responsible clinician, the patient requiring an endarterectomy must be suitable for either local or general anaesthesia, and have no clear indication for either type. All patients with symptomatic or asymptomatic internal carotid stenosis for whom open surgery is advised are eligible. There is no upper age limit. Exclusion criteria are: no informed consent; definite preference for local or general anaesthetic by the clinician or patient; patient unlikely to be able to co-operate with awake testing during local anaesthesia; patient requiring simultaneous bilateral carotid endarterectomy; carotid endarterectomy combined with another operation such as coronary bypass surgery; and, the patient has been randomised into the trial previously. Patients are randomised to local or general anaesthesia by the central trial office. The primary outcome is the proportion of patients alive, stroke free ( including retinal infarction) and without myocardial infarction 30 days post-surgery. Secondary outcomes include the proportion of patients alive and stroke free at one year; health related quality of life at 30 days; surgical adverse events, re-operation and re-admission rates; the relative cost of the two methods of anaesthesia; length of stay and intensive and high dependency bed occupancy

EXPLORING BIOGRAPHIES: THE EDUCATIONAL JOURNEY TOWARDS BECOMING INCLUSIVE EDUCATORS OF CHILDREN WITH DISABILITIES

The current study explored the formative processes of twelve student teachers constructing role understandings in the context of their experiences and interactions with people with disabilities. In particular, it examined the participants’ changing notions of self-as-teacher and their unfolding perceptions of an inclusive educator’s role in teaching children with disabilities. The research aimed to investigate personal and professional forms of knowledge linked with the prior subjective life experiences of the student teachers and those arising from their interactions in situated learning experiences in community settings. The contextual framework of the study focused on the development of the student teachers’ unique understandings and awareness of people with disabilities through processes of biographical situated learning. The investigation examined participants’ voluntary out-ofcourse experiences with people with disabilities across three community settings for the ways in which these experiences facilitated the participants’ emerging role understandings. These settings included respite experiences in families’ homes of young children with disabilities receiving early intervention, an after-school recreational program for primary and secondary aged children and adolescents with disabilities, and an independent living centre providing post-school options and activities for adults with disabilities. ii Two groups participated in the current study, each consisted of six student teachers in the Bachelor of Education Course at the Bathurst campus of Charles Sturt University. Group One participants were in the second year compulsory inclusive education subject and Group Two participants were in the third year elective early intervention subject. The investigation examines the nature of reflexive and reflective processes of the student teachers from subjective, conflict realities in an attempt to link community experiences with real-life issues affecting inclusive educational practices. The voluntary community experiences engaged the research participants in multi-faceted interactions with people with disabilities, providing thought-provoking contexts for their reflections on observations, responses and reactions to situations, such as critical incidents. The participants engaged in reflexive and reflective processes in records made in learning journals and in semi-structured interviews conducted throughout the investigation. Results were analysed from a constructivist research paradigm to investigate their emerging role understandings. Prior to this study there had been few practical components in the compulsory undergraduate inclusive education subject which meant that previously student teachers gained theoretical knowledge without the opportunity to apply their learning. Many student teachers had expressed their feelings of anxiety and uneasiness about what they should do and say to a person with a disability. Thus, the community experiences were selected in order to give a specific context for student teachers’ learning and to provide participants with expanded opportunities to consider their professional identity, social awareness and acceptance of people with disabilities. iii An analysis of the data demonstrated the centrality of reflection within a situated teaching and learning framework. Understandings of prior experiences and motivation were shown to interact with the outcomes of the community experiences through an on-going process of reflection and reflexivity. This reconstructing process encouraged learners to reflect on past, present and projected future experiences and reframe actions from multiple perspectives as a way of exploring alternatives within broader contexts. The data reveal the participants’ engagement in the community experiences facilitated their awareness of wider socio-cultural educational issues, while focusing their attention on more appropriate inclusive teaching and learning strategies. The reflective inquiry process of identifying diverse issues led participants to consider other possible alternatives to current community practices for better ways to support their changing perspectives on ideal inclusive classroom practices. The dialogic nature of participants’ on-going deliberations contributed to the construction of their deeper understandings of an inclusive educator’s role. The findings of the study identified external environmental and internal personal factors as contributing biographical influences which shaped the student teachers’ emerging role understandings. The results emphasised the value of contextual influences in promoting desirable personal and professional qualities in student teachers. Importantly, situated learning enhanced participants’ unique interpretations of their prospective roles. As a result of analysing their insights from interactions in community contexts, the student teachers had increased their personal and professional understandings of individuals with disabilities and broadened their perceptions of their roles as inclusive educators. Thus, the study found that encouraging a biographical reflexive and reflective orientation in participants was conducive iv to facilitating changes in their understandings. Overall, the outcomes had benefits for student teachers and teacher educators in finding innovative ways for integrating biographical perspectives into situated teaching and learning approaches. The study showed that contextual influences facilitated deeper understanding of role identity and produced new ideas about the nature of reflexivity and reflection in guiding student teachers’ learning. (Note: Appendices not included in digital version of thesis

Impact of Diabetes and Its Treatment on Cognitive Function Among Adolescents Who Participated in the Diabetes Control and Complications Trial

OBJECTIVE—The purpose of this study was to evaluate whether severe hypoglycemia or intensive therapy affects cognitive performance over time in a subgroup of patients who were aged 13–19 years at entry in the Diabetes Control and Complications Trial (DCCT)