Mesh inlay, mesh kit or native tissue repair for women having repeat anterior or posterior prolapse surgery: randomised controlled trial (PROSPECT)

Funding The project was funded by the National Institute for Health Research Health Technology Assessment Programme (Project Number 07/60/18). The Health Services Research Unit and the Health Economics Research Unit are funded by the Chief Scientist Office of the Scottish Government Health and Social Care Directorates. Acknowledgements The authors wish to thank the women who participated in the PROSPECT study. We also thank Margaret MacNeil for her secretarial support and data management; Dawn McRae and Lynda Constable for their trial management support; the programming team in CHaRT, led by Gladys McPherson; members of the Project Management Group for their ongoing advice and support of the study; and the staff at the recruitment sites who facilitated the recruitment, treatment and follow up of study participants.Peer reviewedPublisher PD

Elucigene FH20 and LIPOchip for the diagnosis of familial hypercholesterolaemia : a systematic review and economic evaluation

PMID: 22469073 [PubMed - indexed for MEDLINE] Free full textPeer reviewedPublisher PD

Dairy cows under experimentally-induced <i>Escherichia coli</i> mastitis show negative emotional states assessed through Qualitative Behaviour Assessment

International audienceMastitis and associated pain have been identified as a major health and welfare problem affecting dairy cows, however little is known about how cows emotionally experience this illness. Qualitative behaviour assessment (QBA) is a 'whole animal' methodology for assessing animal emotion, through description and quantification of the expressive qualities of an animal's dynamic style of behaving (eg as relaxed, anxious). The aim of this study was to use QBA to investigate whether emotional expression in dairy cows is affected by an experimental intra" mammary challenge (mastitis) with Escherichia coli, and to investigate the relationship of QBA scores with nine other clinical, physiological and behavioural welfare indicators. Six Holstein-Friesian cows were inoculated with E. coli in one healthy quarter. Evolution of the disease was assessed using bacteriological growth and somatic cell counts (SCC). The cows' response to the challenge was assessed using QBA, clinical observations, data loggers, rumen temperature sensor, and physiological indicators (inflammation, stress) at ten time-points defining the phase of the disease: before inoculation (Phase 0: 0 h), in the pre-clinical Phase (Phase 1: 8 h), in the acute phase (Phase 2: 12 h, 16 h, 24 h) and in the remission phase (Phase 3 : 32 h, 40 h, 56 h, 64 h and 80 h post-inoculation (hpi)). Principal Component Analysis of QBA scores identified two main dimensions of cow expression: PC1, ranging from active/vigorous/happy/bright to suffering/dejected/lethargic, and PC2, ranging from fearful/tense/anxious to confident/calm/relaxed, together explaining 58% of the total variation. QBA PC1 and PC2 scores varied with mastitis phases: QBA PC1 scores decreased by 4.09 in Phase 2, and by 1.98 in Phase 3, reflecting suffering/dejected/lethargic expressivity. QBA PC2 scores decreased by 1.91 in Phase 3, reflecting a confident/calm/relaxed expressivity. Clinical and physiological welfare indicators were associated with QBA. The higher the udder severity score, the body temperature, the concentrations of cortisol, SAA, TNF-alpha, and IL-1 beta, the more the cows were suffering/dejected/lethargic (PC1) (coefficients:-0.51,-0.92,-2.46, 7.52 x 10-5,-0.72,-1.13 respectively). These findings indicate that dairy cows experienced negative emotional state in the acute phase and positive emotional state in the remission phase of mastitis. This suggests that provision of pain-relief treatment during mastitis may improve animal welfare, and potentially lead to faster disease remission. However the sample size of this study was small, and larger controlled studies are needed to further investigate these findings and hypotheses. The sensitivity of QBA in this small study suggests it could potentially be a useful tool for E. coli mastitis detection

The effectiveness and cost-effectiveness of resuscitative endovascular balloon occlusion of the aorta (REBOA) for trauma patients with uncontrolled torso haemorrhage : study protocol for a randomised clinical trial (the UK-REBOA trial)

Background Haemorrhage is the most common cause of preventable death after injury. REBOA is a novel technique whereby a percutaneously inserted balloon is deployed in the aorta, providing a relatively quick means of temporarily controlling haemorrhage and augmenting cerebral and coronary perfusion, until definitive control of haemorrhage can be attained. The aim of the UK-REBOA trial is to establish the clinical and cost-effectiveness of a policy of standard major trauma centre treatment plus REBOA, as compared with standard major trauma centre treatment alone, for the management of uncontrolled torso haemorrhage caused by injury. Methods Pragmatic, Bayesian, group-sequential, randomised controlled trial, performed in 16 major trauma centres in England. We aim to randomise 120 injured patients with suspected exsanguinating haemorrhage to either standard major trauma centre care plus REBOA or standard major trauma centre care alone. The primary clinical outcome is 90-day mortality. Secondary clinical outcomes include 3-h, 6-h, and 24-h mortality; in-hospital mortality; 6-month mortality; length of stay (in hospital and intensive care unit); 24-h blood product use; need for haemorrhage control procedure (operation or angioembolisation); and time to commencement of haemorrhage control procedure (REBOA, operation, or angioembolisation). The primary economic outcome is lifetime incremental cost per QALY gained, from a health and personal social services perspective. Discussion This study, which is the first to randomly allocate patients to treatment with REBOA or standard care, will contribute high-level evidence on the clinical and cost-effectiveness of REBOA in the management of trauma patients with exsanguinating haemorrhage and will provide important data on the feasibility of implementation of REBOA into mainstream clinical practice. Trial registration ISRCTN1618498

Local and global gravitational aspects of domain wall space-times

Local and global gravitational effects induced by eternal vacuum domain walls are studied. We concentrate on thin walls between non-equal and non-positive cosmological constants on each side of the wall. These vacuum domain walls fall in three classes depending on the value of their energy density $\sigma$: (1)\ extreme walls with $\sigma = \sigma_{{\text{ext}}}$ are planar, static walls corresponding to supersymmetric configurations, (2)\ non-extreme walls with $\sigma = \sigma_{{\text{non}}} > \sigma_{{\text{ext}}}$ correspond to expanding bubbles with observers on either side of the wall being {\em inside\/} the bubble, and (3)\ ultra-extreme walls with $\sigma = \sigma_{{\text{ultra}}} < \sigma_{{\text{ext}}}$ represent the bubbles of false vacuum decay. On the sides with less negative cosmological constant, the extreme, non-extreme, and ultra-extreme walls exhibit no, repulsive, and attractive effective ``gravitational forces,'' respectively. These ``gravitational forces'' are global effects not caused by local curvature. Since the non-extreme wall encloses observers on both sides, the supersymmetric system has the lowest gravitational mass accessable to outside observers. It is conjectured that similar positive mass protection occurs in all physical systems and that no finite negative mass object can exist inside the universe. We also discuss the global space-time structure of these singularity free space-times and point out intriguing analogies with the causal structure of black holes.Comment: UPR-565-T, 26 REVTEX pages, 10 figures available upon reques

Artificial Intelligence, Computational Simulations, and Extended Reality in Cardiovascular Interventions

Artificial intelligence, computational simulations, and extended reality, among other 21st century computational technologies, are changing the health care system. To collectively highlight the most recent advances and benefits of artificial intelligence, computational simulations, and extended reality in cardiovascular therapies, we coined the abbreviation AISER. The review particularly focuses on the following applications of AISER: 1) preprocedural planning and clinical decision making; 2) virtual clinical trials, and cardiovascular device research, development, and regulatory approval; and 3) education and training of interventional health care professionals and medical technology innovators. We also discuss the obstacles and constraints associated with the application of AISER technologies, as well as the proposed solutions. Interventional health care professionals, computer scientists, biomedical engineers, experts in bioinformatics and visualization, the device industry, ethics committees, and regulatory agencies are expected to streamline the use of AISER technologies in cardiovascular interventions and medicine in general

Improving the Quality of Dentistry (IQuaD):a cluster factorial randomised controlled trial comparing the effectiveness and cost-benefit of oral hygiene advice and/or periodontal instrumentation with routine care for the prevention and management of periodontal disease in dentate adults attending dental primary care

Acknowledgements The authors wish to thank Mark Forrest and the programming team at CHaRT; Cynthia Fraser, our information specialist, for assistance with referencing; Moira Swan, who was the dental research nurse and part of the OA team in Newcastle upon Tyne; Louise Campbell for secretarial support and data management; our original statistician in the group, Andy Elders; senior IT manager Gladys Macpherson; senior trial administrator at the TCOD Marilyn Laird; Luke Vale for his involvement with the design of the health economic analysis at the inception of the trial; Maria Dimitrova, who assisted the health economists in the collection of unit costs; staff of the Scottish Primary Care Research Network, who assisted with screening eligible patients at dental practices; staff of the North East Commissioning Support Unit who assisted with research payments to dental practices in the north-east; members of the TMC and Periodontal Advisory Group for their ongoing advice and support of the trial; the independent members of the TSC and DMC; and the staff at recruitment sites who facilitated recruitment, treatment and follow-up of trial participants. The Health Services Research Unit and the Health Economics Research Unit is core funded by the Chief Scientist Office of the Scottish Government Health and Social Care Directorate.Peer reviewedPublisher PD

Examining the effectiveness of different dental recall strategies on maintenance of optimum oral health: the INTERVAL dental recalls randomised controlled trial

Objective To compare the clinical effectiveness of different frequencies of dental recall over a four-year period. Design A multi-centre, parallel-group, randomised controlled trial with blinded clinical outcome assessment. Participants were randomised to receive a dental check-up at six-monthly, 24-monthly or risk-based recall intervals. A two-strata trial design was used, with participants randomised within the 24-month stratum if the recruiting dentist considered them clinically suitable. Participants ineligible for 24-month recall were randomised to a risk-based or six-month recall interval. Setting UK primary dental care. Participants Practices providing NHS care and adults who had received regular dental check-ups. Main outcome measures The percentage of sites with gingival bleeding on probing, oral health-related quality of life (OHRQoL), cost-effectiveness. Results In total, 2,372 participants were recruited from 51 dental practices. Of those, 648 were eligible for the 24-month recall stratum and 1,724 participants were ineligible. There was no evidence of a significant difference in the mean percentage of sites with gingival bleeding on probing between intervention arms in any comparison. For those eligible for 24-month recall stratum: the 24-month versus six-month group had an adjusted mean difference of -0.91%, 95% CI (-5.02%, 3.20%); the 24-month group versus risk-based group had an adjusted mean difference of 0.07%, 95% CI (-3.99%, 4.12%). For the overall sample, the risk-based versus six-month adjusted mean difference was 0.78%, 95% CI (-1.17%, 2.72%). There was no evidence of a difference in OHRQoL (0-56 scale, higher score for poorer OHRQoL) between intervention arms in any comparison. For the overall sample, the risk-based versus six-month effect size was -0.35, 95% CI (-1.02, 0.32). There was no evidence of a clinically meaningful difference between the groups in any comparison in either eligibility stratum for any of the secondary clinical or patient-reported outcomes. Conclusion Over a four-year period, we found no evidence of a difference in oral health for participants allocated to a six-month or a risk-based recall interval, nor between a 24-month, six-month or risk-based recall interval for participants eligible for a 24-month recall. However, patients greatly value and are willing to pay for frequent dental check-ups