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    ABSTRACT: Aim To investigate the informed consent experiences of women with human immunodeficiency virus (HIV) and childhood trauma involved in a neurocognitive and neuroimaging study. There is no previous research on the consent process for people with both HIV and childhood trauma, conditions that are syndemic in South Africa. Research on the consent process for each individual condition has shown that individuals with either of these conditions may be vulnerable research participants. This study aimed to investigate the opinions of the women involved in order to refine future consent processes and ensure that they are appropriate for this population. A qualitative semi-structured interview was conducted with women from Khayelitsha township in South Africa involved in a cohort study on neurocognitive and neuroimaging outcomes in HIV and childhood trauma, who agreed to participate in an interview immediately following their final study appointment. Findings Aspects most frequently commented upon by participants during the interview were community recruitment, incentives for participation, quality of information provided, and misunderstandings and unexpected events. The overarching finding was that of therapeutic misconception; participants expected, and highlighted as incentives for participation, health benefits that were not part of the study. A minority of participants reported discomfort from questions concerning their traumatic experiences. Despite this, the consent process was well received and there was good understanding of confidentiality issues and the voluntariness of participation. Full disclosure of true benefits from participation must be emphasised throughout the recruitment process. This is particularly important for participants with HIV who appear to participate because of perceived health incentives. Providing prior notification that questions about traumatic experiences will be asked may improve the experiences of participants. A generic but thoroughly conducted consent process is suitable in this population.
    Primary Health Care Research & Development 11/2013;
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    ABSTRACT: Hospital prealerting in acute stroke improves the timeliness of subsequent treatment, but little is known about the impact of prehospital assessments on in-hospital care. Examine the association between prehospital assessments and notification by emergency medical service staff on the subsequent acute stroke care pathway. This was a cohort study of linked patient medical records. Consenting patients with a diagnosis of stroke were recruited from two urban hospitals. Data from patient medical records were extracted and entered into a Cox regression analysis to investigate the association between time to CT request and recording of onset time, stroke recognition (using the Face Arm Speech Test (FAST)) and sending of a prealert message. 151 patients (aged 71±15 years) travelled to hospital via ambulance and were eligible for this analysis. Time of symptom onset was recorded in 61 (40%) cases, the FAST test was positive in 114 (75%) and a prealert message was sent in 65 (44%). Following adjustment for confounding, patients who had time of onset recorded (HR 0.73, 95% CI 0.52 to 1.03), were FAST-positive (HR 0.54, 95% CI 0.37 to 0.80) or were prealerted (HR 0.26, 95% CI 0.18 to 0.38), were more likely to receive a timely CT request in hospital. This study highlights the importance of hospital prealerting, accurate stroke recognition, and recording of onset time. Those not recognised with stroke in a prehospital setting appear to be excluded from the possibility of rapid treatment in hospital, even before they have been seen by a specialist.
    Emergency Medicine Journal 10/2013;
  • JAMA The Journal of the American Medical Association 09/2013; 310(12):1229-30.
  • Education for Primary Care 09/2013; 24(6):401-3.
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    ABSTRACT: Evidence suggests that a high proportion of perimenopausal and postmenopausal women experience vasomotor symptoms (hot flushes/night sweats) that can be severe and disruptive and which are the principal reason for seeking medical intervention. Hormone therapy (HT) is known to be an effective treatment for troublesome hot flushes/night sweats but research has raised questions about the safety of HT and there have been negative high profile media reports about its use. Consequently many women are seeking alternatives and exercise might be one such option but there is a lack of high quality evidence on its effectiveness. This RCT initially aims to investigate the feasibility/acceptability of two exercise interventions identified from our previous preference study in 165 women, and if found to be feasible/acceptable, continue to recruit sufficient women (n=261) to examine the effect of these interventions on hot flushes/night sweats and other outcomes relevant to menopausal women. We aim to recruit inactive perimenopausal and menopausal symptomatic women not using HT and randomise them to one of two exercise interventions or usual care for six months. We will assess outcomes at baseline and 6 and 12 months from randomisation. We hope this RCT will contribute towards increasing the evidence regarding the question of whether exercise is an effective treatment for vasomotor symptoms in women not taking HT.
    Maturitas 08/2013;
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    ABSTRACT: Subclinical thyroid disease is associated with abnormal cardiovascular haemodynamics and increased risk of heart failure. The burden of raised/low thyroid stimulating hormone (TSH) levels amongst South Asian (SA) and African-Caribbean (AC) minority groups in the UK is not well defined. Given that these groups are particularly susceptible to CVD, we hypothesised that STD would reflect abnormal cardiac function and heightened cardiovascular risk in these ethnic groups. We examined SA (n=1111, 56% male, mean age 57.6yrs) and AC (n=763, 44% male, mean age 59.2yrs) participants from a large heart failure screening study. Euthyroidism is defined as TSH (0.4 - 4.9 mlU/l), subclinical hypothyroidism is defined as a raised TSH with normal serum free thyroxine (FT4) concentrations (9-19 pmol/l). Subclinical hyperthyroidism is defined as a low TSH with both FT4 and free triiodothyronine (FT3) concentrations within range (2.6-5.7 pmol/l). Across ethnic groups, prevalence of subclinical hypothyroidism was 2.9% (95% CI 2.1-3.7), and of hyperthyroidism was 2.0% (1.4-2.7). Hyperthyroidism was more common amongst SA compared to AC (2.8% vs. 0.9%, P=0.017), while rates of subclinical hypothyroidism were similar. On multivariate analysis of variations in subclinical thyroid function, ethnicity was not independently significant. The prevalence of subclinical thyroid disorders amongst SA and AC minority groups in Britain reflects levels reported in other populations. The clinical cardiovascular significance of subclinical thyroid disease is unclear, and it does not appear to be ethnically specific.
    International journal of cardiology 08/2013;
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    ABSTRACT: Background: Guidelines for optimal exercise doses in people with multiple sclerosis (MS) have to be established. We need to ascertain the basic physiological and perceptual response and adaptation to different exercise doses in this clinical population. Aim: The aim of this paper was to explore the response during maximal and sub-maximal exercise in people with MS prior to and following two different twelve week exercise programmes. Design: Sub-analysis of per protocol exercise data of a two group, single blinded, randomised control trial. Setting: Multicentre (community leisure and rehabilitation centres). Population: Participants with MS assigned to a continuous (N.=12; mean±SE age=52.3±2.08; Barthel index median & range=19&13-20) or interval (N.=9; mean±SE age=49.3±3.5; Barthel index median & range=19&18-20) exercise programme. Methods: Cardiovascular, respiratory and perceptual exercise response and adaption was measured at maximal and sub-maximal levels of physical exercise prior to and following a twelve week exercise programme, delivered at different intensities. Results: Irrespective of the type of exercise programme followed, there was a significant increase in peak power (z=-1.98; P=0.05) and normalised oxygen uptake during unloaded cycling (z =-2.00; P=0.05). At discharge from the exercise programmes, the cardiovascular response to sub-maximal exercise had significantly changed (t(360) =-4.62; p<0.01). Conclusion: The response in people with MS at maximal and sub-maximal levels of physical exercise following a twelve week programme is analogous to non-diseased adults. Clinical Rehabilitation Impact: Cardiovascular adaptation in people with MS following a twelve week exercise programme suggests deconditioning rather than autonomic dysfunction caused by the disease.
    European journal of physical and rehabilitation medicine 07/2013;
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    ABSTRACT: CLINICAL QUESTION Is gradual smoking cessation associated with poorer success rates than abrupt cessation in smokers who want to quit? BOTTOM LINE Gradual reduction may not be associated with a clinically significant difference in smoking cessation rates compared with abrupt cessation.
    JAMA The Journal of the American Medical Association 07/2013; 310(1):91-92.
  • British Journal of General Practice 07/2013; 63(612):342-3.
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    ABSTRACT: This is an overview of the principles that underpin philosophy of science and how they may provide a framework for the diagnostic process. Although philosophy dates back to antiquity, it is only more recently that philosophers have begun to enunciate the scientific method. Since Aristotle formulated deduction, other modes of reasoning including induction, inference to best explanation, falsificationism, theory-laden observations and Bayesian inference have emerged. Thus, rather than representing a single overriding dogma, the scientific method is a toolkit of ideas and principles of reasoning. Here we demonstrate that the diagnostic process is an example of science in action and is therefore subject to the principles encompassed by the scientific method. Although a number of the different forms of reasoning are used readily by clinicians in practice, without a clear understanding of their pitfalls and the assumptions on which they are based, it leaves doctors open to diagnostic error. We conclude by providing a case example from the medico-legal literature in which diagnostic errors were made, to illustrate how applying the scientific method may mitigate the chance for diagnostic error.
    Family Practice 07/2013;
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