291 results on '"Murtagh M"'
Search Results
152. Scattering of 7-GeV Muons in Nuclei
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May, M., primary, Aslanides, E., additional, Lederman, L. M., additional, Limon, P., additional, Rapp, P., additional, Entenberg, A., additional, Jöstlein, H., additional, Kim, I. J., additional, Königsman, K., additional, Kostoulas, I. G., additional, Melissinos, A. C., additional, Gittleson, H., additional, Kirk, T., additional, Murtagh, M., additional, Tannenbaum, M. J., additional, Sculli, J., additional, White, T., additional, and Yamanouchi, T., additional
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- 1975
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153. Your TV Times.
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Murtagh, M., Laird, Ian, Harrison, Mandy, Lowther, Pat, Jackson, L. M., Trangmar, Jennifer, and Baker, Sandra
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- 2017
154. Systematic review of mass media interventions designed to improve public recognition of stroke symptoms, emergency response and early treatment
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Ford Gary A, White Martin, Murtagh Madeleine J, Rodgers Helen, Lecouturier Jan, and Thomson Richard G
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Public aspects of medicine ,RA1-1270 - Abstract
Abstract Background Mass media interventions have been implemented to improve emergency response to stroke given the emergence of effective acute treatments, but their impact is unclear. Methods Systematic review of mass media interventions aimed at improving emergency response to stroke, with narrative synthesis and review of intervention development. Results Ten studies were included (six targeted the public, four both public and professionals) published between 1992 and 2010. Only three were controlled before and after studies, and only one had reported how the intervention was developed. Campaigns aimed only at the public reported significant increase in awareness of symptoms/signs, but little impact on awareness of need for emergency response. Of the two controlled before and after studies, one reported no impact on those over 65 years, the age group at increased risk of stroke and most likely to witness a stroke, and the other found a significant increase in awareness of two or more warning signs of stroke in the same group post-intervention. One campaign targeted at public and professionals did not reduce time to presentation at hospital to within two hours, but increased and sustained thrombolysis rates. This suggests the campaign had a primary impact on professionals and improved the way that services for stroke were organised. Conclusions Campaigns aimed at the public may raise awareness of symptoms/signs of stroke, but have limited impact on behaviour. Campaigns aimed at both public and professionals may have more impact on professionals than the public. New campaigns should follow the principles of good design and be robustly evaluated.
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- 2010
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155. Response to symptoms of stroke in the UK: a systematic review
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White Martin, Ford Gary A, Thomson Richard G, Murtagh Madeleine J, Lecouturier Jan, Eccles Martin, and Rodgers Helen
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Public aspects of medicine ,RA1-1270 - Abstract
Abstract Background The English National Stroke Strategy suggests that there is a need to improve the response of patients and witnesses to the symptoms of acute stroke to increase rapid access to specialist care. We wished to review the evidence base regarding the knowledge, attitudes and behaviours of stroke patients, witnesses and the public to the symptoms of stroke and the need for an urgent response at the onset of symptoms. Methods We conducted a systematic review of UK articles reporting empirical research on a) awareness of and response to the symptoms of acute stroke or TIA, and b) beliefs and attitudes about diagnosis, early treatment and consequences of acute stroke or TIA. Nine electronic databases were searched using a robust search strategy. Citations and abstracts were screened independently by two reviewers. Data were extracted by two researchers independently using agreed criteria. Results 11 studies out of 7144 citations met the inclusion criteria. Methods of data collection included: postal survey (n = 2); interview survey (n = 6); review of hospital documentation (n = 2) and qualitative interviews (n = 1). Limited data reveal a good level of knowledge of the two commonest stroke symptoms (unilateral weakness and speech disturbance), and of the need for an emergency response among the general public and at risk patients. Despite this, less than half of patients recognised they had suffered a stroke. Symptom recognition did not reduce time to presentation. For the majority, the first point of contact for medical assistance was a general practitioner. Conclusions There is an assumption that, in the UK, public knowledge of the symptoms of stroke and of the need for an emergency response is lacking, but there is little published research to support this. Public awareness raising campaigns to improve response to the symptoms of stroke therefore may not produce an increase in desired behaviours. Further research is needed to understand why people who experience or witness stroke symptoms frequently do not call emergency services.
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- 2010
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156. 'Obesity' and 'Clinical Obesity' Men's understandings of obesity and its relation to the risk of diabetes: A qualitative study
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Unwin Nigel C, Hayes Louise, Weaver Nicola F, and Murtagh Madeleine J
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Public aspects of medicine ,RA1-1270 - Abstract
Abstract Background The 2007 Wanless report highlights the ever increasing problem of obesity and the consequent health problems. Obesity is a significant cause of diabetes. An increasing evidence base suggests that in terms of reducing diabetes and CVD risk, it is better to be "fit and fat" than unfit and of normal weight. There has been very little previous research into the understandings that men in the general population hold about the issues of weight, exercise and health; we therefore undertook this study in order to inform the process of health promotion and diabetes prevention in this group. Methods A qualitative study in North East England General Practice using a purposive sample of men aged 25 and 45 years (selection process designed to include 'normal', 'overweight' and 'obese' men). One to one audio-recorded semi structured interviews focused on: overweight and obesity, diet, physical activity and diabetes. Transcripts were initially analysed using framework analysis. Emerging themes interlinked. Results The men in this study (n = 17) understand the word obesity differently from the clinical definition; "obesity" was used as a description of those with fat in a central distribution, and understandings of the term commonly take into account fitness as well as weight. Men in their late 30s and early 40s described becoming more aware of health issues. Knowledge of what constitutes a 'healthy lifestyle' was generally good, but men described difficulty acting upon this knowledge for various reasons e.g. increasing responsibilities at home and at work. Knowledge of diabetes and the link between obesity and diabetes was poor. Conclusion Men in this study had a complex understanding of the interlinked importance of weight and fitness in relation to health. Obesity is understood as a description of people with centrally distributed fat, in association with low fitness levels. There is a need to increase understanding of the causes and consequences of diabetes. Discussion of increased health awareness by men round the age of 40 may indicate a window of opportunity to intervene at this time.
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- 2008
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157. Clinical research without consent in adults in the emergency setting: a review of patient and public views
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Stobbart Lynne, Rapley Tim, Ford Gary A, Rodgers Helen, Lecouturier Jan, Louw Stephen J, and Murtagh Madeleine J
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Medical philosophy. Medical ethics ,R723-726 - Abstract
Abstract Background In emergency research, obtaining informed consent can be problematic. Research to develop and improve treatments for patients admitted to hospital with life-threatening and debilitating conditions is much needed yet the issue of research without consent (RWC) raises concerns about unethical practices and the loss of individual autonomy. Consistent with the policy and practice turn towards greater patient and public involvement in health care decisions, in the US, Canada and EU, guidelines and legislation implemented to protect patients and facilitate acute research with adults who are unable to give consent have been developed with little involvement of the lay public. This paper reviews research examining public opinion regarding RWC for research in emergency situations, and whether the rules and regulations permitting research of this kind are in accordance with the views of those who ultimately may be the most affected. Methods Seven electronic databases were searched: Medline, Embase, CINAHL, Cochrane Database of Systematic Reviews, Philosopher's Index, Age Info, PsychInfo, Sociological Abstracts and Web of Science. Only those articles pertaining to the views of the public in the US, Canada and EU member states were included. Opinion pieces and those not published in English were excluded. Results Considering the wealth of literature on the perspectives of professionals, there was relatively little information about public attitudes. Twelve studies employing a range of research methods were identified. In five of the six questionnaire surveys around half the sample did not agree generally with RWC, though paradoxically, a higher percentage would personally take part in such a study. Unfortunately most of the studies were not designed to investigate individuals' views in any depth. There also appears to be a level of mistrust of medical research and some patients were more likely to accept an experimental treatment 'outside' of a research protocol. Conclusion There are too few data to evaluate whether the rules and regulations permitting RWC protects – or is acceptable to – the public. However, any attempts to engage the public should take place in the context of findings from further basic research to attend to the apparently paradoxical findings of some of the current surveys.
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- 2008
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158. More in hope than expectation: a systematic review of women's expectations and experience of pain relief in labour
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Macphail Sheila, Murtagh Madeleine J, Lally Joanne E, and Thomson Richard
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Medicine - Abstract
Abstract Background Childbirth is one of the most painful events that a woman is likely to experience, the multi-dimensional aspect and intensity of which far exceeds disease conditions. A woman's lack of knowledge about the risks and benefits of the various methods of pain relief can heighten anxiety. Women are increasingly expected, and are expecting, to participate in decisions about their healthcare. Involvement should allow women to make better-informed decisions; the National Institute for Clinical Excellence has stated that we need effective ways of supporting pregnant women in making informed decisions during labour. Our aim was to systematically review the empirical literature on women's expectations and experiences of pain and pain relief during labour, as well as their involvement in the decision-making process. Methods A systematic review was conducted using the following databases: Medical Literature Analysis and Retrieval System Online (MEDLINE), Cumulative Index to Nursing and Allied Health Literature (CINAHL), Bath Information and Database Service (BIDS), Excerpta Medica Database Guide (EMBASE), Midwives Information and Resource (MIDIRS), Sociological Abstracts and PsychINFO. Studies that examined experience and expectations of pain, and its relief in labour, were appraised and the findings were integrated into a systematic review. Results Appraisal revealed four key themes: the level and type of pain, pain relief, involvement in decision-making and control. Studies predominantly showed that women underestimated the pain they would experience. Women may hope for a labour free of pain relief, but many found that they needed or benefited from it. There is a distinction between women's desire for a drug-free labour and the expectation that they may need some sort of pain relief. Inaccurate or unrealistic expectations about pain may mean that women are not prepared appropriately for labour. Many women acknowledged that they wanted to participate in decision-making, but the degree of involvement varied. Women expected to take control in labour in a number of ways, but their degree of reported control was less than hoped for. Conclusion Women may have ideal hopes of what they would like to happen with respect to pain relief, control and engagement in decision-making, but experience is often very different from expectations. Antenatal educators need to ensure that pregnant women are appropriately prepared for what might actually happen to limit this expectation-experience gap and potentially support greater satisfaction with labour.
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- 2008
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159. Professional centred shared decision making: Patient decision aids in practice in primary care
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Murtagh Madeleine J, Thomson Richard G, and Burges Watson Duika
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Public aspects of medicine ,RA1-1270 - Abstract
Abstract Background Patient decision aids are increasingly regarded as important components of clinical practice that enable shared decision making (SDM) and evidence based patient choice. Despite broad acceptance of their value, there remains little evidence of their successful implementation in primary care settings. Methods Health care practitioners from five general practice surgeries in northern England participated in focus group sessions around the themes of patient decision aids, patient and practitioner preferences and SDM. Participants included general practitioners (n = 19), practice nurses (n = 5) and auxiliary staff (n = 3). Transcripts were analysed using a framework approach. Results We report a) practitioners' discussion of the current impetus towards sharing decisions and their perspectives on barriers to SDM, and b) the implementation of patient decision aids in practice and impediments such as lack of an evidence base and time available in consultations. Conclusion We demonstrate two orientations to sharing decisions: practitioner-centred and patient-centred with the former predominating. We argue that it is necessary to rethink the changes required in practice for the implementation of SDM.
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- 2008
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160. A funny thing happened on the way to the journal: a commentary on Foucault's ethics and Stuart Murray's 'Care of the self'
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Murtagh Madeleine J
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Medical philosophy. Medical ethics ,R723-726 - Abstract
Abstract Stuart Murray's 'Care and the self: biotechnology, reproduction, and the good life' utilizes Foucault's "care of the self" to examine health domains in its title. The present author discusses three important articulations of concern with the Foucauldian concepts of care of the self that are absent in the work of Murray and others: first, the voluntarism and individualism inherent in ideas about care of the self; second, the absence of the interactional and relational; and, third, the perpetuation of the interpretation of Foucault's concept of governmentality, 'the conduct of conduct', as primarily coercive.
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- 2008
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161. 'I just keep thinking I haven't got it because I'm not yellow': a qualitative study of the factors that influence the uptake of Hepatitis C testing by prisoners
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Stobbart Lynne, Khaw Fu-Meng, and Murtagh Madeleine J
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Public aspects of medicine ,RA1-1270 - Abstract
Abstract Background Hepatitis C viral (HCV) infection is a significant public health problem. In the UK, an estimated 200,000 individuals have active HCV infection, most of whom are injecting drug users (IDUs). Many IDUs spend time within the prison system therefore screening for HCV infection in this setting is important. However, uptake of testing within prisons is very low. Methods Qualitative interview study. 30 interviews with 25 male and 5 female prisoners with a history of injecting drug use. Results Personal and institutional barriers to uptake of testing for HCV were identified. Personal barriers included: prisoners' fears and lack of knowledge about HCV, low motivation for testing, lack of awareness about the testing procedure, and concerns about confidentiality and stigma. Institutional barriers included: the prisons' applications procedure for testing, inadequate pre- and post-test discussion, lack of pro-active approaches to offering testing, and lack of continuity of care on discharge and transfer. Conclusion This study highlights potential areas of development in the management of HCV in prisons. Further research is needed to evaluate care pathways for HCV in the prison setting and to develop and assess interventions to improve the uptake of testing for HCV by prisoners.
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- 2007
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162. Medical communication and technology: a video-based process study of the use of decision aids in primary care consultations
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Graham Ruth, Murtagh Madeleine, Rapley Tim, Heaven Ben, Kaner Eileen, Thomson Richard, and May Carl
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Computer applications to medicine. Medical informatics ,R858-859.7 - Abstract
Abstract Background Much of the research on decision-making in health care has focused on consultation outcomes. Less is known about the process by which clinicians and patients come to a treatment decision. This study aimed to quantitatively describe the behaviour shown by doctors and patients during primary care consultations when three types of decision aids were used to promote treatment decision-making in a randomised controlled trial. Methods A video-based study set in an efficacy trial which compared the use of paper-based guidelines (control) with two forms of computer-based decision aids (implicit and explicit versions of DARTS II). Treatment decision concerned warfarin anti-coagulation to reduce the risk of stroke in older patients with atrial fibrillation. Twenty nine consultations were video-recorded. A ten-minute 'slice' of the consultation was sampled for detailed content analysis using existing interaction analysis protocols for verbal behaviour and ethological techniques for non-verbal behaviour. Results Median consultation times (quartiles) differed significantly depending on the technology used. Paper-based guidelines took 21 (19–26) minutes to work through compared to 31 (16–41) minutes for the implicit tool; and 44 (39–55) minutes for the explicit tool. In the ten minutes immediately preceding the decision point, GPs dominated the conversation, accounting for 64% (58–66%) of all utterances and this trend was similar across all three arms of the trial. Information-giving was the most frequent activity for both GPs and patients, although GPs did this at twice the rate compared to patients and at higher rates in consultations involving computerised decision aids. GPs' language was highly technically focused and just 7% of their conversation was socio-emotional in content; this was half the socio-emotional content shown by patients (15%). However, frequent head nodding and a close mirroring in the direction of eye-gaze suggested that both parties were active participants in the conversation Conclusion Irrespective of the arm of the trial, both patients' and GPs' behaviour showed that they were reciprocally engaged in these consultations. However, even in consultations aimed at promoting shared decision-making, GPs' were verbally dominant, and they worked primarily as information providers for patients. In addition, computer-based decision aids significantly prolonged the consultations, particularly the later phases. These data suggest that decision aids may not lead to more 'sharing' in treatment decision-making and that, in their current form, they may take too long to negotiate for use in routine primary care.
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- 2007
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163. Photoreflectance Characterisation of Reactive Ion Etched Silicon.
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Murtagh, M., Beechinor, J. T., Herbert, P. A. F., Kelly, P.V., Crean, G. M., and Jeynes, C.
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- 1993
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164. Sensitivity of a modulated optical reflectance probe to process-induced lattice disorder
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Murtagh, M., Crean, G.M., Flaherty, T., and Jeynes, C.
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- 1992
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165. Photoreflectance investigation of dry-etch-induced damage in semi-insulating GaAs substrates
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Murtagh, M., Kelly, P.V., Herbert, P.A.F., O'Connor, M., Duffy, G., and Crean, G.M.
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- 1993
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166. Future long baseline. nu. /sub. mu. /. -->. nu. /sub e/ oscillation searches at accelerators
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Murtagh, M
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- 1987
167. Review of (anti nu)/sub. mu. /e/sup -/ elastic scattering experiments
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Murtagh, M
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- 1984
168. Same-sign dilepton production by neutrinos
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Murtagh, M
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- 1985
169. Recent results from the FNAL 15 foot Bubble Chamber
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Murtagh, M.
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- 1978
170. A search for nu/sub. mu. /. -->. nu/sub e/ oscillations using the E734 detector
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Murtagh, M
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- 1987
171. Neutrino physics at Brookhaven National Laboratory
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Murtagh, M
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- 1988
172. Review of the Brookhaven neutrino workshop
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Murtagh, M
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- 1987
173. DataSHIELD -- shared individual-level analysis without sharing the data: a biostatistical perspective.
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Jones, E. M., Sheehan, N. A., Masca, N., Wallace, S. E., Murtagh, M. J., and Burton, P. R.
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BIOMETRY , *GENETIC research , *META-analysis , *BAR codes , *BIOBANKS , *BIOLOGICAL specimens - Abstract
Very large sample sizes are required for estimating effects which are known to be small, and for addressing intricate or complex statistical questions. This is often only achievable by pooling data from multiple studies, especially in genetic epidemiology where associations between individual genetic variants and phenotypes of interest are generally weak. However, the physical pooling of experimental data across a consortium is frequently prohibited by the ethico-legal constraints that govern agreements and consents for individual studies. Study level meta-analyses are frequently used so that data from multiple studies need not be pooled to conduct an analysis, though the resulting analysis is necessarily restricted by the available summary statistics. The idea of maintaining data security is also of importance in other areas and approaches to carrying out 'secure analyses' that do not require sharing of data from different sources have been proposed in the technometrics literature. Crucially, the algorithms for fitting certain statistical models can be manipulated so that an individual level meta-analysis can essentially be performed without the need for pooling individual-level data by combining particular summary statistics obtained individually from each study. DataSHIELD (Data Aggregation Through Anonymous Summary-statistics from Harmonised Individual levEL Databases) is a tool to coordinate analyses of data that cannot be pooled. In this paper, we focus on explaining why a DataSHIELD approach yields identical results to an individual level meta-analysis in the case of a generalised linear model, by simply using summary statistics from each study. It is also an efficient approach to carrying out a study level meta-analysis when this is appropriate and when the analysis can be pre-planned. We briefly comment on the IT requirements, together with the ethical and legal challenges which must be addressed. [ABSTRACT FROM AUTHOR]
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- 2012
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174. Doctor-patient interaction in a randomised controlled trial of decision-support tools.
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Rapley T, May C, Heaven B, Murtagh M, Graham R, Kaner EFS, and Thomson R
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In this paper, we draw on the analytic perspectives of ethnomethodology to explore doctor-patient encounters in an experimental trial of a complex intervention: an efficacy randomised controlled trial (RCT) of decision-support tools in the UK. We show how the experimental context in which these encounters take place pervades the interactions within them. We argue that two interactional orders were at work in the encounters that we observed: (i) the ceremonial order of the consultation and (ii) the assemblage of the decision-support tool trial. We demonstrate how doctors in the trial oscillate between positions as authoritative clinician and neutralistic decision-support tool-implementer, and patients move between positions as passive recipients of clinical knowledge and as active subjects required to render their experience as calculable in terms of the demands of the decision-support tools and the broader trial they are embedded in. We demonstrate how the RCT coordinates the world of the clinical environment and the world of experimental evidence. [ABSTRACT FROM AUTHOR]
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- 2006
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175. Proceedings of the BNL neutrino workshop: Opportunities for neutrino physics at BNL
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Murtagh, M [ed.]
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- 1987
176. Estimated maintenance and repair requirements for coal-fired propulsion systems. Final report
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Murtagh, M
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- 1982
177. HIV Diagnostics and Vaccines: It Takes Two to Tango.
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Colón W, Oriol-Mathieu V, Hural J, Hattingh L, Adungo F, Lagatie O, Lavreys L, Allen M, Anzala O, Espy N, Fransen K, Garcia PJ, Maciel M Jr, Murtagh M, Peel SA, Peeling RW, Tan LLJ, Warren M, Pau MG, and D'Souza PM
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- Humans, HIV Antibodies blood, HIV Antibodies immunology, Serologic Tests methods, HIV Infections diagnosis, HIV Infections prevention & control, AIDS Vaccines immunology, HIV-1 immunology
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Current serologic tests for HIV screening and confirmation of infection present challenges to the adoption of HIV vaccines. The detection of vaccine-induced HIV-1 antibodies in the absence of HIV-1 infection, referred to as vaccine-induced seropositivity/seroreactivity, confounds the interpretation of test results, causing misclassification of HIV-1 status with potential affiliated stigmatization. For HIV vaccines to be widely adopted with high community confidence and uptake, tests are needed that are agnostic to the vaccination status of tested individuals (ie, positive only for true HIV-1 infection). Successful development and deployment of such tests will require HIV vaccine developers to work in concert with diagnostic developers. Such tests will need to match today's high-performance standards (accuracy, cost-effectiveness, simplicity) for use in vaccinated and unvaccinated populations, especially in low- and middle-income countries with high HIV burden. Herein, we discuss the challenges and strategies for developing modified serologic HIV tests for concurrent deployment with HIV vaccines., Competing Interests: Potential conflicts of interest. W. C. and O. L. are former and current employees of Janssen Pharmaceutica N.V., respectively, and V. O. M. and M. G. P. are current employees of Janssen Vaccines and Prevention B.V. Both are Johnson & Johnson companies, and the authors may own stock or stock options in them. L. L. is a consultant for Janssen Pharmaceutica N.V. All other authors report no potential conflicts. All authors have submitted the ICMJE Form for Disclosure of Potential Conflicts of Interest. Conflicts that the editors consider relevant to the content of the manuscript have been disclosed., (© The Author(s) 2024. Published by Oxford University Press on behalf of Infectious Diseases Society of America. All rights reserved. For commercial re-use, please contact reprints@oup.com for reprints and translation rights for reprints. All other permissions can be obtained through our RightsLink service via the Permissions link on the article page on our site—for further information please contact journals.permissions@oup.com.)
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- 2024
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178. Reconciling the biomedical data commons and the GDPR: three lessons from the EUCAN ELSI collaboratory.
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Bernier A, Molnár-Gábor F, Knoppers BM, Borry P, Cesar PMDG, Devriendt T, Goisauf M, Murtagh M, Jiménez PN, Recuero M, Rial-Sebbag E, Shabani M, Wilson RC, Zaccagnini D, and Maxwell L
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- European Union, Computer Security legislation & jurisprudence
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The coming-into-force of the EU General Data Protection Regulation (GDPR) is a watershed moment in the legal recognition of enforceable rights to informational self-determination. The rapid evolution of legal requirements applicable to data use, however, has the potential to outstrip the capabilities of networks of biomedical data users to respond to the shifting norms. It can also delegitimate established institutional bodies that are responsible for assessing and authorising the downstream use of data, including research ethics committees and institutional data custodians. These burdens are especially pronounced for clinical and research networks that are of transnational scale, because the legal compliance burden for outbound international data transfers from the EEA is especially high. Legislatures, courts, and regulators in the EU should therefore implement the following three legal changes. First, the responsibilities of particular actors in a data sharing network should be delimited through the contractual allocation of responsibilities between collaborators. Second, the use of data through secure data processing environments should not trigger the international transfer provisions of the GDPR. Third, the use of federated data analysis methodologies that do not provide analysis nodes or downstream users access to identifiable personal data as part of the outputs of those analyses should not be considered circumstances of joint controllership, nor lead to the users of non-identifiable data to be considered controllers or processors. These small clarifications of, or modifications to, the GDPR would facilitate the exchange of biomedical data amongst clinicians and researchers., (© 2023. The Author(s).)
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- 2024
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179. Safety and efficacy of gene replacement therapy for X-linked myotubular myopathy (ASPIRO): a multinational, open-label, dose-escalation trial.
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Shieh PB, Kuntz NL, Dowling JJ, Müller-Felber W, Bönnemann CG, Seferian AM, Servais L, Smith BK, Muntoni F, Blaschek A, Foley AR, Saade DN, Neuhaus S, Alfano LN, Beggs AH, Buj-Bello A, Childers MK, Duong T, Graham RJ, Jain M, Coats J, MacBean V, James ES, Lee J, Mavilio F, Miller W, Varfaj F, Murtagh M, Han C, Noursalehi M, Lawlor MW, Prasad S, and Rico S
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- Male, Child, Humans, Infant, Child, Preschool, France, Genetic Therapy adverse effects, Germany, Treatment Outcome, Myopathies, Structural, Congenital genetics, Myopathies, Structural, Congenital therapy, Sepsis
- Abstract
Background: X-linked myotubular myopathy is a rare, life-threatening, congenital muscle disease observed mostly in males, which is caused by mutations in MTM1. No therapies are approved for this disease. We aimed to assess the safety and efficacy of resamirigene bilparvovec, which is an adeno-associated viral vector serotype 8 delivering human MTM1., Methods: ASPIRO is an open-label, dose-escalation trial at seven academic medical centres in Canada, France, Germany, and the USA. We included boys younger than 5 years with X-linked myotubular myopathy who required mechanical ventilator support. The trial was initially in two parts. Part 1 was planned as a safety and dose-escalation phase in which participants were randomly allocated (2:1) to either the first dose level (1·3 × 10
14 vector genomes [vg]/kg bodyweight) of resamirigene bilparvovec or delayed treatment, then, for later participants, to either a higher dose (3·5 × 1014 vg/kg bodyweight) of resamirigene bilparvovec or delayed treatment. Part 2 was intended to confirm the dose selected in part 1. Resamirigene bilparvovec was administered as a single intravenous infusion. An untreated control group comprised boys who participated in a run-in study (INCEPTUS; NCT02704273) or those in the delayed treatment cohort who did not receive any dose. The primary efficacy outcome was the change from baseline to week 24 in hours of daily ventilator support. After three unexpected deaths, dosing at the higher dose was stopped and the two-part feature of the study design was eliminated. Because of changes to the study design during its implementation, analyses were done on an as-treated basis and are deemed exploratory. All treated and control participants were included in the safety analysis. The trial is registered with ClinicalTrials.gov, NCT03199469. Outcomes are reported as of Feb 28, 2022. ASPIRO is currently paused while deaths in dosed participants are investigated., Findings: Between Aug 3, 2017 and June 1, 2021, 30 participants were screened for eligibility, of whom 26 were enrolled; six were allocated to the lower dose, 13 to the higher dose, and seven to delayed treatment. Of the seven children whose treatment was delayed, four later received the higher dose (n=17 total in the higher dose cohort), one received the lower dose (n=7 total in the lower dose cohort), and two received no dose and joined the control group (n=14 total, including 12 children from INCEPTUS). Median age at dosing or enrolment was 12·1 months (IQR 10·0-30·9; range 9·5-49·7) in the lower dose cohort, 31·1 months (16·0-64·7; 6·8-72·7) in the higher dose cohort, and 18·7 months (10·1-31·5; 5·9-39·3) in the control cohort. Median follow-up was 46·1 months (IQR 41·0-49·5; range 2·1-54·7) for lower dose participants, 27·6 months (24·6-29·1; 3·4-41·0) for higher dose participants, and 28·3 months (9·7-46·9; 5·7-32·7) for control participants. At week 24, lower dose participants had an estimated 77·7 percentage point (95% CI 40·22 to 115·24) greater reduction in least squares mean hours per day of ventilator support from baseline versus controls (p=0·0002), and higher dose participants had a 22·8 percentage point (6·15 to 39·37) greater reduction from baseline versus controls (p=0·0077). One participant in the lower dose cohort and three in the higher dose cohort died; at the time of death, all children had cholestatic liver failure following gene therapy (immediate causes of death were sepsis; hepatopathy, severe immune dysfunction, and pseudomonal sepsis; gastrointestinal haemorrhage; and septic shock). Three individuals in the control group died (haemorrhage presumed related to hepatic peliosis; aspiration pneumonia; and cardiopulmonary failure)., Interpretation: Most children with X-linked myotubular myopathy who received MTM1 gene replacement therapy had important improvements in ventilator dependence and motor function, with more than half of dosed participants achieving ventilator independence and some attaining the ability to walk independently. Investigations into the risk for underlying hepatobiliary disease in X-linked myotubular myopathy, and the need for monitoring of liver function before gene replacement therapy, are ongoing., Funding: Astellas Gene Therapies., Competing Interests: Declaration of interests PBS has received funding and provision of study materials from Astellas Gene Therapies (formerly Audentes Therapeutics) to support clinical trial investigations relating to the present manuscript; has received research grants or contracts from Biogen, Novartis Gene Therapies, Pfizer, PTC Therapeutics, Reveragen, Sanofi, Sarepta, and Solid Biosciences; has received consulting fees for advisory board participation from Alexion, Argenx, Biogen, Genentech, Novartis Gene Therapies, UCB, Sanofi, and Sarepta; and has received honoraria for lectures or presentations from Alexion, Argenx, Biogen, Catalyst, CSL Behring, Genentech, and Grifols. NLK has received research funding from Astellas Gene Therapies to her institute as a study site for the ASPIRO clinical trial; has received support from Astellas Gene Therapies for registration fees to attend and present at the International Congress on Neuromuscular Diseases 2022 (travel costs paid personally); has received research grants from Argenx, Biohaven, Biogen, Novartis, Sarepta, and Scholar Rock, consulting fees for participation on medical advisory boards for Argenx, BioMarin, Capacity Bio, and Sarepta, and honoraria for gene therapy lectures for Sarepta; and is on a data safety monitoring board for Sarepta. JJD has received research grants or contracts from Astellas Gene Therapies to his institute as a study site for the ASPIRO clinical trial and for preclinical studies; and has received an honorarium for a sponsored symposium and support for travel to an international meeting to present data from Astellas Gene Therapies. WM-F has received support for study materials and study personnel relating to the present manuscript from Astellas Gene Therapies; consulting fees from Sarepta, PTC Therapeutics, Novartis, and Roche; personal compensation from Novartis and Biogen and institutional funding from Roche, for lectures; and has served on scientific advisory boards for Deutsche Gesellschaft für Muskelkranke and Glykogenosis. CGB has received research grants, contracts, or travel support for various invited lectures at academic meetings from Noelia Foundation, Muscular Dystrophy UK, and Cure CMD; holds a patent for COL6A1 intron 11 pseudoexon skipping technologies unrelated to the present manuscript; has participated (without fees) in advisory boards for Solid Biosciences (IGNITE trial), Rocket Pharma, and Nationwide Children's Hospital; and is Chair of the Scientific Advisory Board of the MDUK Oxford Neuromuscular Centre. LS has received consulting fees and honoraria for lectures from Astellas Gene Therapies; and is coordinating investigator of the European NatHis-CNM study, funded by Dynacure. BKS has received institutional research grants or contracts for her institution to serve as an INCEPTUS and ASPIRO study site from Astellas Gene Therapies. AB reports institutional grants or contracts from PTC Therapeutics; has received payments or honoraria from Roche, Biogen, and Pfizer; and has participated in advisory boards at Roche and Pfizer. ARF has been a member of an independent data monitoring committee for a different clinical trial for MTM1-related myopathy and DNM2-related myopathy (the trial was terminated early). LNA has received grants or contracts from Astellas Gene Therapies via her institution to provide training and quality control services supporting the ASPIRO clinical trial programme. AHB reports research grants or contracts from the NIH, MDA (USA), AFM Telethon, Alexion Pharmaceuticals, Astellas Gene Therapies, Dynacure SAS, Pfizer, Kate Therapeutics, Chan Zuckerberg Initiative, and Avidity; has received consulting fees from Astellas Gene Therapies, Kate Therapeutics, and Roche Pharmaceuticals; has received honoraria for lectures or presentations from GLG and Guidepoint Global; has received support for travel and meeting attendance at the Muscular Dystrophy Association and World Muscle Society; is an executive board member at the World Muscle Society; is an inventor on and has received royalties for a patent for adeno-associated virus gene therapy for X-linked myotubular myopathy; and holds stocks in Kate Therapeutics and Kinea Bio. AB-B has received consulting fees from Astellas Gene Therapies and research funding from the Myotubular Trust for preclinical work related to the present manuscript; and holds a patent on systemic gene replacement therapy for treatment of X-linked myotubular myopathy. MKC has received consulting fees and institutional research funding supporting preclinical experiments for a US investigational new drug application relating to the gene therapy in the present manuscript; holds a patent for a systemic gene replacement therapy for treatment of X-linked myotubular myopathy; and has received option payments from Wake Forest University for the patent. TD has received consulting fees from Astellas Gene Therapies for study training on CHOP INTEND measurement in ASPIRO. RJG reports limited consulting fees from Astellas Gene Therapies for work on the ASPIRO study design and clinical outcome measures. JC is an employee of Astellas Gene Therapies. VMacB has received study funding relating to the present manuscript, in the form of a research grant and consulting fees from Astellas Gene Therapies paid both directly to her and her institution. ESJ was a former employee of Astellas Gene Therapies and formerly held stock in Astellas Gene Therapies. JL, FMa, WM, and FV were formerly employees of Astellas Gene Therapies. MM has received study funding relating to the present publication from Astellas Gene Therapies, formerly held stock in Astellas Gene Therapies, and was formerly employed by Astellas Gene Therepies. CH is an employee of Astellas Pharma Global Development. MN was formerly employed by Astellas Gene Therepies. MWL has received research funding from Astellas Gene Therapies to his academic institution (Medical College of Wisconsin) and to his company (Diverge Translational Science Laboratory) for work related to the present manuscript; has received research grants or contracts to his academic institution from Solid Biosciences, Kate Therapeutics, Taysha Therapeutics, Ultragenyx, and Prothelia; has received consulting fees from Astellas Gene Therapies, Encoded Therapeutics, Modis Therapeutics, Lacerta Therapeutics, AGADA Biosciences, Dynacure, Affinia, Voyager, BioMarin, Locanabio, and Vertex Pharmaceuticals; has received speaker fees and reimbursement for travel related to sponsored research from Astellas Gene Therapies; has received personal fees for scientific advisory board participation for Astellas Gene Therapies and Solid Biosciences; and his institution has received payment from Taysha Therapeutics for his advisory board participation. MWL is currently Chief Executive Officer, founder, and owner of Diverge Translational Science Laboratory, which continues to work under contracts from many gene therapy companies including Astellas Gene Therapies, Solid Biosciences, Rocket Pharma, Kate Therapeutics, Carbon Biosciences, Dynacure, Nationwide Children's Hospital, Taysha Gene Therapies, and Ultragenyx. SP was an employee at Astellas Gene Therapies from February, 2014, to June, 2019, and was the senior physician overseeing the study relating to the present manuscript. SR reports holding stock in Astellas Gene Therapies and was formerly employed by Astellas Gene Therapies. All other authors declare no competing interests., (Copyright © 2023 The Author(s). Published by Elsevier Ltd. This is an Open Access article under the CC BY-NC-ND 4.0 license. Published by Elsevier Ltd.. All rights reserved.)- Published
- 2023
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180. The relevance of target product profiles for manufacturers, experiences from the World Health Organization initiative for point-of-care testing for sexually transmitted infections.
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Murtagh M, Blondeel K, Peeling RW, Kiarie J, and Toskin I
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Background: Sexually transmitted infections (STIs) are a significant global public health issue that cause a high burden of disease, especially in low- and middle-income countries. Screening of key populations and early and accurate diagnosis of infection are critical. Testing for syphilis, Chlamydia trachomatis, Neisseria gonorrhoeae, Trichomonas vaginalis, curable STIs, as well as the human papillomavirus (HPV), is frequently unavailable in low-resource settings. Tests for these STIs that can be used at the point of patient care (POCTs) are needed. In recent years, there has been increased attention for STI POCTs, but technical guidance, financial resources and advocacy for additional platforms/tests are required in order to foster the development of STI POCTs. The WHO Department of Sexual and Reproductive Health and Research (SRH) has developed target product profiles (TPPs), a form of technical guidance, for these STI diagnostics., Methods: SRH conducted a survey of selected companies that are developing POCTs for one or more of the STIs mentioned above to better understand how these TPPs influence the diagnostic development process - to assess their impact., Results: Survey respondents indicated that the STI POCT TPPs provided good guidance with respect to performance expectations and operational characteristics for the tests/platforms. In particular, optimal metrics for sensitivity, specificity, sample types, and time to result were considered to be very useful. Respondents also suggested ways to improve the relevance of the STI POCT TPPs. For example, since it is often not possible for developers to achieve every desired standard, it would be useful to prioritize each performance/operational characteristic of the test and to provide a rationale as to why certain characteristics are considered important. Respondents also emphasized the need to encourage industry participation in the TPP development process and to find creative ways, including via targeted emails, a WHO webpage directed at industry, or a coordinated communications plan to increase awareness of the TPPs., Conclusions: Companies value the STI POCT TPPs and want them to continue. In order to maximize impact, WHO should consider the proposals from the manufacturers in the interest of increasing and accelerating access to STI diagnostics and treatment in low-resource settings., (© 2021. The Author(s).)
- Published
- 2021
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181. Beyond trust: Amplifying unheard voices on concerns about harm resulting from health data-sharing.
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Mulrine S, Blell M, and Murtagh M
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Background: The point of care in many health systems is increasingly a point of health data generation, data which may be shared and used in a variety of ways by a range of different actors., Aim: We set out to gather data about the perspectives on health data-sharing of people living in North East England who have been underrepresented within other public engagement activities and who are marginalized in society., Methods: Multi-site ethnographic fieldwork was carried out in the Teesside region of England over a 6-month period in 2019 as part of a large-scale health data innovation program called Connected Health Cities. Organizations working with marginalized groups were contacted to recruit staff, volunteers, and beneficiaries for participation in qualitative research. The data gathered were analyzed thematically and vignettes constructed to illustrate findings., Results: Previous encounters with health and social care professionals and the broader socio-political contexts of people's lives shape the perspectives of people from marginalized groups about sharing of data from their health records. While many would welcome improved care, the risks to people with socially produced vulnerabilities must be appreciated by those advocating systems that share data for personalized medicine or other forms of data-driven care., Conclusion: Forms of innovation in medicine which rely on greater data-sharing may present risks to groups and individuals with existing vulnerabilities, and advocates of these innovations should address the lack of trustworthiness of those receiving data before asking that people trust new systems to provide health benefits., Competing Interests: Declaration of conflicting interests: The author(s) declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article., (© The Author(s) 2021.)
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- 2021
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182. Call to action for health systems integration of point-of-care testing to mitigate the transmission and burden of sexually transmitted infections.
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Toskin I, Govender V, Blondeel K, Murtagh M, Unemo M, Zemouri C, Peeling RW, and Kiarie J
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- Chlamydia Infections diagnosis, Chlamydia Infections drug therapy, Chlamydia Infections prevention & control, Chlamydia Infections transmission, Female, Gonorrhea diagnosis, Gonorrhea drug therapy, Gonorrhea prevention & control, Gonorrhea transmission, HIV Infections diagnosis, HIV Infections drug therapy, HIV Infections prevention & control, HIV Infections transmission, Humans, Implementation Science, Male, Mycoplasma Infections diagnosis, Mycoplasma Infections drug therapy, Mycoplasma Infections prevention & control, Mycoplasma Infections transmission, Mycoplasma genitalium, Papillomavirus Infections diagnosis, Papillomavirus Infections prevention & control, Papillomavirus Infections transmission, Sexually Transmitted Diseases drug therapy, Sexually Transmitted Diseases prevention & control, Sexually Transmitted Diseases transmission, Syphilis diagnosis, Syphilis drug therapy, Syphilis prevention & control, Syphilis transmission, Trichomonas Vaginitis diagnosis, Trichomonas Vaginitis drug therapy, Trichomonas Vaginitis prevention & control, Trichomonas Vaginitis transmission, Delivery of Health Care organization & administration, Point-of-Care Testing organization & administration, Sexually Transmitted Diseases diagnosis
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Objectives: In 2016, WHO estimated 376 million new cases of the four main curable STIs: gonorrhoea, chlamydia, trichomoniasis and syphilis. Further, an estimated 290 million women are infected with human papillomavirus. STIs may lead to severe reproductive health sequelae. Low-income and middle-income countries carry the highest global burden of STIs. A large proportion of urogenital and the vast majority of extragenital non-viral STI cases are asymptomatic. Screening key populations and early and accurate diagnosis are important to provide correct treatment and to control the spread of STIs. This article paints a picture of the state of technology of STI point-of-care testing (POCT) and its implications for health system integration., Methods: The material for the STI POCT landscape was gathered from publicly available information, published and unpublished reports and prospectuses, and interviews with developers and manufacturers., Results: The development of STI POCT is moving rapidly, and there are much more tests in the pipeline than in 2014, when the first STI POCT landscape analysis was published on the website of WHO. Several of the available tests need to be evaluated independently both in the laboratory and, of particular importance, in different points of care., Conclusion: This article reiterates the importance of accurate, rapid and affordable POCT to reach universal health coverage. While highlighting the rapid technical advances in this area, we argue that insufficient attention is being paid to health systems capacity and conditions to ensure the swift and rapid integration of current and future STI POCT. Unless the complexity of health systems, including context, institutions, adoption systems and problem perception, are recognised and mapped, simplistic approaches to policy design and programme implementation will result in poor realisation of intended outcomes and impact., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2020. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)
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- 2020
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183. Epidemic preparedness: why is there a need to accelerate the development of diagnostics?
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Peeling RW, Murtagh M, and Olliaro PL
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- Biological Assay, Databases, Factual supply & distribution, Ebolavirus isolation & purification, Epidemiological Monitoring, Hemorrhagic Fever, Ebola epidemiology, Hemorrhagic Fever, Ebola virology, Humans, Information Dissemination methods, Public-Private Sector Partnerships organization & administration, Zika Virus isolation & purification, Zika Virus Infection epidemiology, Zika Virus Infection virology, Diagnostic Tests, Routine, Epidemics prevention & control, Hemorrhagic Fever, Ebola diagnosis, Zika Virus Infection diagnosis
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Global epidemics of infectious diseases are increasing in frequency and severity. Diagnostics are needed for rapid identification of the cause of the epidemic to facilitate effective control and prevention. Lessons learned from the recent Ebola virus and Zika virus epidemics are that delay in developing the right diagnostic for the right population at the right time has been a costly barrier to disease control and prevention. We believe that it is possible to accelerate and optimise diagnostic development through a five-pronged strategy: by doing a global landscape analysis of diagnostic availability worldwide; through strategic partnerships for accelerating test development, in particular with vaccine companies to identify novel diagnostic targets; by creating and sharing repositories of data, reagents, and well characterised specimens for advancing the development process; by involving key public and private stakeholders, including appropriate regulatory bodies and policy makers, to ensure rapid access for researchers to diagnostics; and last, by fostering an enabling environment for research and access to diagnostics in the countries that need them. The need is great, but not insurmountable and innovative and faster development pathways are urgently required to address current shortfalls., (Copyright © 2019 Elsevier Ltd. All rights reserved.)
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- 2019
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184. Innovative and New Approaches to Laboratory Diagnosis of Zika and Dengue: A Meeting Report.
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Goncalves A, Peeling RW, Chu MC, Gubler DJ, de Silva AM, Harris E, Murtagh M, Chua A, Rodriguez W, Kelly C, and Wilder-Smith A
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- Antibodies, Viral immunology, Consumer Product Safety, Dengue history, Dengue virology, Dengue Virus genetics, Dengue Virus immunology, Dengue Virus isolation & purification, Enzyme-Linked Immunosorbent Assay history, Enzyme-Linked Immunosorbent Assay methods, Enzyme-Linked Immunosorbent Assay trends, History, 20th Century, History, 21st Century, Humans, Population Surveillance, Reverse Transcriptase Polymerase Chain Reaction history, Reverse Transcriptase Polymerase Chain Reaction methods, Reverse Transcriptase Polymerase Chain Reaction trends, Sensitivity and Specificity, Zika Virus genetics, Zika Virus immunology, Zika Virus isolation & purification, Zika Virus Infection history, Zika Virus Infection virology, Antibodies, Viral blood, Dengue diagnosis, Zika Virus Infection diagnosis
- Abstract
Epidemics of dengue, Zika, and other arboviral diseases are increasing in frequency and severity. Current efforts to rapidly identify and manage these epidemics are limited by the short diagnostic window in acute infection, the extensive serologic cross-reactivity among flaviviruses, and the lack of point-of-care diagnostic tools to detect these viral species in primary care settings. The Partnership for Dengue Control organized a workshop to review the current landscape of Flavivirus diagnostic tools, identified current gaps, and developed strategies to accelerate the adoption of promising novel technologies into national programs. The rate-limiting step to bringing new diagnostic tools to the market is access to reference materials and well-characterized clinical samples to facilitate performance evaluation. We suggest the creation of an international laboratory-response consortium for flaviviruses with a decentralized biobank of well-characterized samples to facilitate assay validation. Access to proficiency panels are needed to ensure quality control, in additional to in-country capacity building.
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- 2018
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185. APPLaUD: access for patients and participants to individual level uninterpreted genomic data.
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Thorogood A, Bobe J, Prainsack B, Middleton A, Scott E, Nelson S, Corpas M, Bonhomme N, Rodriguez LL, Murtagh M, and Kleiderman E
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- Ethics, Research, Genetic Testing, Genomics ethics, Humans, Patients legislation & jurisprudence, Research legislation & jurisprudence, Base Sequence genetics, Genome, Human genetics, Genomics legislation & jurisprudence
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Background: There is a growing support for the stance that patients and research participants should have better and easier access to their raw (uninterpreted) genomic sequence data in both clinical and research contexts., Main Body: We review legal frameworks and literature on the benefits, risks, and practical barriers of providing individuals access to their data. We also survey genomic sequencing initiatives that provide or plan to provide individual access. Many patients and research participants expect to be able to access their health and genomic data. Individuals have a legal right to access their genomic data in some countries and contexts. Moreover, increasing numbers of participatory research projects, direct-to-consumer genetic testing companies, and now major national sequencing initiatives grant individuals access to their genomic sequence data upon request., Conclusion: Drawing on current practice and regulatory analysis, we outline legal, ethical, and practical guidance for genomic sequencing initiatives seeking to offer interested patients and participants access to their raw genomic data.
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- 2018
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186. Advancing prevention of sexually transmitted infections through point-of-care testing: target product profiles and landscape analysis.
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Toskin I, Murtagh M, Peeling RW, Blondeel K, Cordero J, and Kiarie J
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- Adult, Chlamydia Infections prevention & control, Diagnostic Tests, Routine, Female, Gonorrhea prevention & control, Humans, Male, Papillomavirus Infections prevention & control, Reproducibility of Results, Syphilis prevention & control, Trichomonas Vaginitis prevention & control, Chlamydia Infections diagnosis, Gonorrhea diagnosis, Papillomavirus Infections diagnosis, Point-of-Care Testing trends, Public Health, Reproductive Health, Syphilis diagnosis, Trichomonas Vaginitis diagnosis
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Objectives: Advancing the field of point-of-care testing (POCT) for STIs can rapidly and substantially improve STI control and prevention by providing targeted, essential STI services (case detection and screening). POCT enables definitive diagnosis and appropriate treatment in a single visit and home and community-based testing., Methods: Since 2014, the WHO Department of Reproductive Health and Research, in collaboration with technical partners, has completed four landscape analyses of promising diagnostics for use at or near the point of patient care to detect syphilis, Neisseria gonorrhoeae , Chlamydia trachomatis , Trichomonas vaginalis and the human papillomavirus. The analyses comprised a literature review and interviews. Two International Technical Consultations on STI POCTs (2014 and 2015) resulted in the development of target product profiles (TPP). Experts in STI microbiology, laboratory diagnostics, clinical management, public health and epidemiology participated in the consultations with representation from all WHO regions., Results: The landscape analysis identified diagnostic tests that are either available on the market, to be released in the near future or in the pipeline. The TPPs specify 28 analytical and operational characteristics of POCTs for use in different populations for surveillance, screening and case management. None of the tests that were identified in the landscape analysis met all of the targets of the TPPs., Conclusion: More efforts of the global health community are needed to accelerate access to affordable quality-assured STI POCTs, particularly in low- and middle-income countries, by supporting the development of new diagnostic platforms as well as strengthening the validation and implementation of existing diagnostics according to internationally endorsed standards and the best available evidence., Competing Interests: Competing interests: None declared., (© World Health Organization 2017. Licensee BMJ Publishing Group Limited. This is an open access article distributed under the terms of the Creative Commons Attribution IGO License (https://creativecommons.org/licenses/by/3.0/igo), which permits use, distribution,and reproduction for non-commercial purposes in any medium, provided the original work is properly cited. In any reproduction of this article there should not be any suggestion that WHO or this article endorse any specific organization or products. The use of the WHO logo is not permitted. This notice should be preserved along with the article’s original URL.)
- Published
- 2017
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187. Oversight of Genomic Data Sharing: What Roles for Ethics and Data Access Committees?
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Shabani M, Dove ES, Murtagh M, Knoppers BM, and Borry P
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- Committee Membership, Databases, Genetic ethics, Humans, Genomics ethics, Information Dissemination ethics
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Discussions regarding responsible genomic data sharing often center around ethical and legal issues such as the consent, privacy, and confidentiality of individuals, families, and communities. To ensure the ethical grounds of genomic data sharing, oversight by both research ethics and Data Access Committees (DACs) across the research lifecycle is warranted. In this article, we review these oversight practices and argue that they reveal a compelling need to clarify the scope of ethical considerations by oversight bodies and to delineate core elements such as "objectionable" data uses. Ethical oversight of genomic data sharing would be considerably improved if the relevant ethical considerations by research ethics and DACs were coordinated. We therefore suggest several mechanisms to achieve greater clarification of ethical considerations by these committees, as well as greater communication and coordination between both to ensure robust and sustained ethical oversight of genomic data sharing.
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- 2017
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188. Smart homes, private homes? An empirical study of technology researchers' perceptions of ethical issues in developing smart-home health technologies.
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Birchley G, Huxtable R, Murtagh M, Ter Meulen R, Flach P, and Gooberman-Hill R
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- Choice Behavior, Confidentiality, Female, Humans, Male, Privacy, Attitude, Bioethical Issues, Delivery of Health Care methods, Engineering ethics, Home Care Services ethics, Research Personnel ethics, Technology
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Background: Smart-home technologies, comprising environmental sensors, wearables and video are attracting interest in home healthcare delivery. Development of such technology is usually justified on the basis of the technology's potential to increase the autonomy of people living with long-term conditions. Studies of the ethics of smart-homes raise concerns about privacy, consent, social isolation and equity of access. Few studies have investigated the ethical perspectives of smart-home engineers themselves. By exploring the views of engineering researchers in a large smart-home project, we sought to contribute to dialogue between ethics and the engineering community., Methods: Either face-to-face or using Skype, we conducted in-depth qualitative interviews with 20 early- and mid-career smart-home researchers from a multi-centre smart-home project, who were asked to describe their own experience and to reflect more broadly about ethical considerations that relate to smart-home design. With participants' consent, interviews were audio-recorded, transcribed and analysed using a thematic approach., Results: Two overarching themes emerged: in 'Privacy', researchers indicated that they paid close attention to negative consequences of potential unauthorised information sharing in their current work. However, when discussing broader issues in smart-home design beyond the confines of their immediate project, researchers considered physical privacy to a lesser extent, even though physical privacy may manifest in emotive concerns about being watched or monitored. In 'Choice', researchers indicated they often saw provision of choice to end-users as a solution to ethical dilemmas. While researchers indicated that choices of end-users may need to be restricted for technological reasons, ethical standpoints that restrict choice were usually assumed and embedded in design., Conclusions: The tractability of informational privacy may explain the greater attention that is paid to it. However, concerns about physical privacy may reduce acceptability of smart-home technologies to future end-users. While attention to choice suggests links with privacy, this may misidentify the sources of privacy and risk unjustly burdening end-users with problems that they cannot resolve. Separating considerations of choice and privacy may result in more satisfactory treatment of both. Finally, through our engagement with researchers as participants this study demonstrates the relevance of (bio)ethics as a critical partner to smart-home engineering.
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- 2017
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189. The lower body muscle activation of intermediate to experienced kayakers when navigating white water.
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Murtagh M, Brooks D, Sinclair J, and Atkins S
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- Adult, Athletic Performance statistics & numerical data, Electromyography, Humans, Male, Young Adult, Athletes statistics & numerical data, Athletic Performance physiology, Lower Extremity physiology, Muscle, Skeletal physiology, Ships, Sports physiology
- Abstract
In white-water kayaking, the legs play a vital part in turning, stabilising and bracing actions. To date, there has been no reported information on neuromuscular activation of the legs in an authentic white-water environment. The aim of the current study was to identify lower body muscle activation, using 'in-boat' electromyography (EMG), whilst navigating a white-water run. Ten experienced male kayakers (age 31.5 ± 12.5 yr, intermediate to advanced experience) completed three successful runs of an international standard white-water course (grade 3 rapids), targeting right and left sides of the course, in a zigzag formation. Surface EMG (sEMG) outputs were generated, bilaterally, for the rectus femoris (RF), vastus lateralis, biceps femoris and gastrocnemius, expressed as a percentage of a dynamic maximal voluntary contraction (dMVC). Only RF showed significantly higher activation than any muscle on the left side of the body, and only on the left side of the course (P = .004; ETA(2) = 0.56). Other results showed no significant difference between muscle activation in the right and left legs during each run, nor when assessed at either the right or left side of the course (P > .05). These findings indicate that contralateral symmetry in lower limb muscle activation is evident during white-water kayaking. This symmetry may provide a stable base to allow more asymmetrical upper body and trunk movements to be fully optimised. Lower body symmetry development should be considered useful in targeted training programmes for white-water kayakers.
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- 2016
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190. Two-Color, Two-Photon Imaging at Long Excitation Wavelengths Using a Diamond Raman Laser.
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Trägårdh J, Murtagh M, Robb G, Parsons M, Lin J, Spence DJ, and McConnell G
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We demonstrate that the second-Stokes output from a diamond Raman laser, pumped by a femtosecond Ti:Sapphire laser, can be used to efficiently excite red-emitting dyes by two-photon excitation at 1,080 nm and beyond. We image HeLa cells expressing red fluorescent protein, as well as dyes such as Texas Red and Mitotracker Red. We demonstrate the potential for simultaneous two-color, two-photon imaging with this laser by using the residual pump beam for excitation of a green-emitting dye. We demonstrate this for the combination of Alexa Fluor 488 and Alexa Fluor 568. Because the Raman laser extends the wavelength range of the Ti:Sapphire laser, resulting in a laser system tunable to 680-1,200 nm, it can be used for two-photon excitation of a large variety and combination of dyes.
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- 2016
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191. Ultrafast second-Stokes diamond Raman laser.
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Murtagh M, Lin J, Trägårdh J, McConnell G, and Spence DJ
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We report a synchronously-pumped femtosecond diamond Raman laser operating with a tunable second-Stokes output. Pumped using a mode-locked Ti:sapphire laser at 840-910 nm with a duration of 165 fs, the second-Stokes wavelength was tuneable from 1082 - 1200 nm with sub-picosecond duration. Our results demonstrate potential for cascaded Raman conversion to extend the wavelength coverage of standard laser sources to new regions.
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- 2016
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192. Sustainable HIV treatment in Africa through viral-load-informed differentiated care.
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Phillips A, Shroufi A, Vojnov L, Cohn J, Roberts T, Ellman T, Bonner K, Rousseau C, Garnett G, Cambiano V, Nakagawa F, Ford D, Bansi-Matharu L, Miners A, Lundgren JD, Eaton JW, Parkes-Ratanshi R, Katz Z, Maman D, Ford N, Vitoria M, Doherty M, Dowdy D, Nichols B, Murtagh M, Wareham M, Palamountain KM, Chakanyuka Musanhu C, Stevens W, Katzenstein D, Ciaranello A, Barnabas R, Braithwaite RS, Bendavid E, Nathoo KJ, van de Vijver D, Wilson DP, Holmes C, Bershteyn A, Walker S, Raizes E, Jani I, Nelson LJ, Peeling R, Terris-Prestholt F, Murungu J, Mutasa-Apollo T, Hallett TB, and Revill P
- Subjects
- Adolescent, Adult, Africa, Aged, Anti-HIV Agents economics, Anti-HIV Agents pharmacology, Anti-HIV Agents therapeutic use, Cost-Benefit Analysis, HIV Infections diagnosis, HIV Infections economics, Humans, Middle Aged, Precision Medicine economics, Young Adult, HIV Infections drug therapy, HIV Infections virology, Precision Medicine methods, Viral Load drug effects
- Abstract
There are inefficiencies in current approaches to monitoring patients on antiretroviral therapy in sub-Saharan Africa. Patients typically attend clinics every 1 to 3 months for clinical assessment. The clinic costs are comparable with the costs of the drugs themselves and CD4 counts are measured every 6 months, but patients are rarely switched to second-line therapies. To ensure sustainability of treatment programmes, a transition to more cost-effective delivery of antiretroviral therapy is needed. In contrast to the CD4 count, measurement of the level of HIV RNA in plasma (the viral load) provides a direct measure of the current treatment effect. Viral-load-informed differentiated care is a means of tailoring care so that those with suppressed viral load visit the clinic less frequently and attention is focussed on those with unsuppressed viral load to promote adherence and timely switching to a second-line regimen. The most feasible approach to measuring viral load in many countries is to collect dried blood spot samples for testing in regional laboratories; however, there have been concerns over the sensitivity and specificity of this approach to define treatment failure and the delay in returning results to the clinic. We use modelling to synthesize evidence and evaluate the cost-effectiveness of viral-load-informed differentiated care, accounting for limitations of dried blood sample testing. We find that viral-load-informed differentiated care using dried blood sample testing is cost-effective and is a recommended strategy for patient monitoring, although further empirical evidence as the approach is rolled out would be of value. We also explore the potential benefits of point-of-care viral load tests that may become available in the future.
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- 2015
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193. Efficient diamond Raman laser generating 65 fs pulses.
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Murtagh M, Lin J, Mildren RP, McConnell G, and Spence DJ
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We report a synchronously-pumped femtosecond diamond Raman laser operating at 890 nm with a slope efficiency of 32%. Pumped using a mode-locked Ti:Sapphire laser at 796 nm with a pulse duration of 194 fs, the bandwidth of the Stokes output was broadened to enable subsequent pulse compression to 65 fs using a prism-pair. Modelling results provide an understanding of the physical mechanisms involved in the Raman conversion of femtosecond pulses, supporting an in-depth characterization of these ultrashort pulsed lasers.
- Published
- 2015
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194. Using electronic readers to monitor progress toward elimination of mother-to-child transmission of HIV and syphilis: An opinion piece.
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Wedderburn CJ, Murtagh M, Toskin I, and Peeling RW
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- Data Accuracy, Disease Eradication methods, Electronic Data Processing standards, Female, Humans, Mass Screening methods, Pregnancy, Prenatal Diagnosis methods, Computers, Handheld, Electronic Data Processing methods, HIV Infections transmission, Infectious Disease Transmission, Vertical prevention & control, Syphilis transmission
- Abstract
Electronic readers and smartphones have the potential to standardize the interpretation of rapid diagnostic tests (RDTs) and provide timely surveillance program data. RDTs are widely used for HIV and are being increasingly used for syphilis screening in pregnant women. Following the WHO initiative for the validation of elimination of mother-to-child transmission of HIV and syphilis, there is a need for more extensive testing and data monitoring. However, access to timely and accurate data can be challenging once testing is decentralized as data quality at remote sites is often difficult to verify. Electronic RDT readers can help to ensure quality and allow automated data transmission, creating an opportunity for real-time surveillance to inform control strategies and assess intervention impact. Furthermore, by linking the data to existing supply chain management software, stockouts can be minimized. The present opinion piece looks at the opportunities and challenges of using these tools within national elimination programs., (Copyright © 2015 International Federation of Gynecology and Obstetrics. Published by Elsevier Ireland Ltd. All rights reserved.)
- Published
- 2015
- Full Text
- View/download PDF
195. Ti:sapphire-pumped diamond Raman laser with sub-100-fs pulse duration.
- Author
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Murtagh M, Lin J, Mildren RP, and Spence DJ
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- Aluminum Oxide radiation effects, Equipment Design, Equipment Failure Analysis, Light, Titanium radiation effects, Aluminum Oxide chemistry, Lasers, Solid-State, Signal Processing, Computer-Assisted instrumentation, Spectrum Analysis, Raman instrumentation, Titanium chemistry
- Abstract
We report a synchronously pumped femtosecond diamond Raman laser operating at 895 nm with a 33% slope efficiency. Pumped using a mode-locked Ti:sapphire laser at 800 nm with a duration of 170 fs, the bandwidth of the Stokes output is broadened and chirped to enable subsequent pulse compression to 95 fs using a prism pair. Modeling results indicate that self-phase modulation drives the broadening of the Stokes spectrum in this highly transient laser. Our results demonstrate the potential for Raman conversion to extend the wavelength coverage and pulse shorten Ti:sapphire lasers.
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- 2014
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196. Securing the data economy: translating privacy and enacting security in the development of DataSHIELD.
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Murtagh MJ, Demir I, Jenkings KN, Wallace SE, Murtagh B, Boniol M, Bota M, Laflamme P, Boffetta P, Ferretti V, and Burton PR
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- Computer Security ethics, Confidentiality ethics, Confidentiality legislation & jurisprudence, Ethics Committees, Humans, Research, Biomedical Research, Computer Security legislation & jurisprudence, Computer Security standards, Confidentiality standards, Information Storage and Retrieval methods, Research Design
- Abstract
Contemporary bioscience is seeing the emergence of a new data economy: with data as its fundamental unit of exchange. While sharing data within this new 'economy' provides many potential advantages, the sharing of individual data raises important social and ethical concerns. We examine ongoing development of one technology, DataSHIELD, which appears to elide privacy concerns about sharing data by enabling shared analysis while not actually sharing any individual-level data. We combine presentation of the development of DataSHIELD with presentation of an ethnographic study of a workshop to test the technology. DataSHIELD produced an application of the norm of privacy that was practical, flexible and operationalizable in researchers' everyday activities, and one which fulfilled the requirements of ethics committees. We demonstrated that an analysis run via DataSHIELD could precisely replicate results produced by a standard analysis where all data are physically pooled and analyzed together. In developing DataSHIELD, the ethical concept of privacy was transformed into an issue of security. Development of DataSHIELD was based on social practices as well as scientific and ethical motivations. Therefore, the 'success' of DataSHIELD would, likewise, be dependent on more than just the mathematics and the security of the technology., (Copyright © 2012 S. Karger AG, Basel.)
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- 2012
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197. Little bottles and the promise of probiotics.
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Burges Watson D, Moreira T, and Murtagh M
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- Consumer Health Information, Humans, Mass Media, Periodicals as Topic, Dietary Supplements, Food Packaging, Probiotics
- Abstract
In this article we explore; regimes of hope' in contemporary bioscience as articulated in spaces of health consumption. We use the case study of probiotic little bottles, highlighting their promissory branding as consumer products, to consider how hope and truth play out across different spaces of health care - the supermarket, media and laboratory. Drawing on work within both sociological and geographic literatures to think about hope, truth and probiotics, this article explores their ambiguous promise through an analysis of their biomedical and popular representation. The seemingly incommensurate promise of probiotics between popular and medical spheres provides the point of departure for an examination of the geographies of hope, truth and selfhood.
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- 2009
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198. Decision support for women choosing mode of delivery after a previous caesarean section: a developmental study.
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Farnworth A, Robson SC, Thomson RG, Watson DB, and Murtagh MJ
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- Adult, England, Female, Humans, Midwifery, Needs Assessment, Pregnancy, Cesarean Section, Repeat, Decision Making, Patient Education as Topic, Social Support, Vaginal Birth after Cesarean
- Abstract
Objective: To examine the impact of a decision support intervention designed for women choosing mode of delivery after one previous caesarean section., Methods: A decision support intervention was developed comprising of an informational DVD/video and a home visit by a midwife. 16 women received standard clinical care and 16 women additionally received the intervention. Pilot questionnaire data was collected at 12, 28 and 37 weeks gestation from all participants. 18 of the 32 participants also participated in semi-structured interviews after they had decided mode of delivery at 37 weeks gestation., Results: Four themes were identified in the qualitative data relating to decision-making: informational support, emotional support, participation and involvement in decision-making, and the way in which decision support was used., Conclusion: The difficulties experienced by women in this decision-making scenario were confirmed. The intervention was welcomed by the participants and both qualitative and quantitative findings suggest the intervention improved decision-making experiences., Practice Implications: This intervention offers an accessible method of decision support which effectively targets the needs of women choosing mode of delivery after a previous caesarean delivery. Using easily reproducible informational materials, and the pre-existing skills of midwives, it would be relatively straightforward to introduce this intervention into current clinical practice.
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- 2008
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199. Challenges in implementing CD4 testing in resource-limited settings.
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Peter T, Badrichani A, Wu E, Freeman R, Ncube B, Ariki F, Daily J, Shimada Y, and Murtagh M
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- CD4 Lymphocyte Count standards, Humans, Laboratories, Medical Laboratory Science, Point-of-Care Systems, Quality Control, CD4 Lymphocyte Count methods, Health Resources
- Abstract
The scale-up of HIV antiretroviral therapy in recent years has led to a rapid increase in CD4 and CD4% count capacity to meet the diagnostic needs of staging and monitoring disease progression and treatment efficacy in adults and infants. The speed of implementation of this technology has been unrivalled in recent years and has met challenges with technology selection, laboratory infrastructure development, human resource limitations, cost-effectiveness, instrument maintenance, and ensuring testing access and quality. The lessons learned from dealing with these challenges have helped strengthen existing laboratory systems for other diagnostics. They may also facilitate the implementation of new diagnostics in future., (Copyright 2008 Clinical Cytometry Society.)
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- 2008
- Full Text
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200. Medical communication and technology: a video-based process study of the use of decision aids in primary care consultations.
- Author
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Kaner E, Heaven B, Rapley T, Murtagh M, Graham R, Thomson R, and May C
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- Aged, Biomedical Research, Decision Making, Female, Humans, Male, Reproducibility of Results, Sensitivity and Specificity, Time Factors, Total Quality Management, United Kingdom, Verbal Behavior, Video Recording, Communication, Decision Support Systems, Clinical, Patient Participation, Physician-Patient Relations, Primary Health Care methods
- Abstract
Background: Much of the research on decision-making in health care has focused on consultation outcomes. Less is known about the process by which clinicians and patients come to a treatment decision. This study aimed to quantitatively describe the behaviour shown by doctors and patients during primary care consultations when three types of decision aids were used to promote treatment decision-making in a randomised controlled trial., Methods: A video-based study set in an efficacy trial which compared the use of paper-based guidelines (control) with two forms of computer-based decision aids (implicit and explicit versions of DARTS II). Treatment decision concerned warfarin anti-coagulation to reduce the risk of stroke in older patients with atrial fibrillation. Twenty nine consultations were video-recorded. A ten-minute 'slice' of the consultation was sampled for detailed content analysis using existing interaction analysis protocols for verbal behaviour and ethological techniques for non-verbal behaviour., Results: Median consultation times (quartiles) differed significantly depending on the technology used. Paper-based guidelines took 21 (19-26) minutes to work through compared to 31 (16-41) minutes for the implicit tool; and 44 (39-55) minutes for the explicit tool. In the ten minutes immediately preceding the decision point, GPs dominated the conversation, accounting for 64% (58-66%) of all utterances and this trend was similar across all three arms of the trial. Information-giving was the most frequent activity for both GPs and patients, although GPs did this at twice the rate compared to patients and at higher rates in consultations involving computerised decision aids. GPs' language was highly technically focused and just 7% of their conversation was socio-emotional in content; this was half the socio-emotional content shown by patients (15%). However, frequent head nodding and a close mirroring in the direction of eye-gaze suggested that both parties were active participants in the conversation, Conclusion: Irrespective of the arm of the trial, both patients' and GPs' behaviour showed that they were reciprocally engaged in these consultations. However, even in consultations aimed at promoting shared decision-making, GPs' were verbally dominant, and they worked primarily as information providers for patients. In addition, computer-based decision aids significantly prolonged the consultations, particularly the later phases. These data suggest that decision aids may not lead to more 'sharing' in treatment decision-making and that, in their current form, they may take too long to negotiate for use in routine primary care.
- Published
- 2007
- Full Text
- View/download PDF
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