Early surgery versus initial conservative treatment in patients with traumatic intracerebral haemorrhage [STITCH(Trauma)] : the first randomized trial

Acknowledgements This project was funded by the NIHR Health Technology Assessment programme (project number 07/37/16). The views and opinions expressed therein are those of the authors and do not necessarily reflect those of the HTA programme, NIHR, NHS or the Department of Health.Peer reviewedPublisher PD

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

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

Christopher Lasch's the culture of narcissism the failure of a critique of psychological politics

Christopher Lasch's bestseller The Culture of Narcissism had, beyond doubt, a significant impact-it was even read in the White House. Today it is not only still frequently taught and referenced, there are also still empirical studies conducted which try to verify Lasch's assertion of the preponderance of the narcissistic personality. This paper re-reads the book as a critique of psychologization processes, and this allows us to discern, besides the flaws in Lasch's approach, a fundamental insight which goes largely unnoticed by both Lasch's opponents and his proponents. Following this, the article will situate subjectivity within the matrix of psychology, science, psychoanalysis, and politics. In this way a critique of contemporary forms of psychologization-psychologization under globalization, as it were-is made possible

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

Protocol for a Randomised controlled trial to Evaluate the effectiveness and cost benefit of prescribing high dose FLuoride toothpaste in preventing and treating dEntal Caries in high-risk older adulTs (reflect trial)

Background Dental caries in the expanding elderly, predominantly-dentate population is an emerging public health concern. Elderly individuals with heavily restored dentitions represent a clinical challenge and significant financial burden for healthcare systems, especially when their physical and cognitive abilities are in decline. Prescription of higher concentration fluoride toothpaste to prevent caries in older populations is expanding in the UK, significantly increasing costs for the National Health Services (NHS) but the effectiveness and cost benefit of this intervention are uncertain. The Reflect trial will evaluate the effectiveness and cost benefit of General Dental Practitioner (GDP) prescribing of 5000ppm fluoride toothpaste and usual care compared to usual care alone in individuals 50years and over with high-risk of caries.Methods/designA pragmatic, open-label, randomised controlled trial involving adults aged 50years and above attending NHS dental practices identified by their dentist as having high risk of dental caries. Participants will be randomised to prescription of 5000ppm fluoride toothpaste (frequency, amount and duration decided by GDP) and usual care only. 1200 participants will be recruited from approximately 60 dental practices in England, Scotland and Northern Ireland and followed up for 3years. The primary outcome will be the proportion of participants receiving any dental treatment due to caries. Secondary outcomes will include coronal and root caries increments measured by independent, blinded examiners, patient reported quality of life measures, and economic outcomes; NHS and patient perspective costs, willingness to pay, net benefit (analysed over the trial follow-up period and modelled lifetime horizon). A parallel qualitative study will investigate GDPs' practises of and beliefs about prescribing the toothpaste and patients' beliefs and experiences of the toothpaste and perceived impacts on their oral health-related behaviours.DiscussionThe Reflect trial will provide valuable information to patients, policy makers and clinicians on the costs and benefits of an expensive, but evidence-deficient caries prevention intervention delivered to older adults in general dental practice.Trial registrationISRCTN: 2017-002402-13 registered 02/06/2017, first participant recruited 03/05/2018.Ethics Reference No: 17/NE/0329/233335.Funding Body: Health Technology Assessment funding stream of National Institute for Health Research.Funder number: HTA project 16/23/01.Trial Sponsor: Manchester University NHS Foundation Trust, Oxford Road, Manchester, M13 9WL.The Trial was prospectively registered

Selective Caries Removal in Permanent Teeth (SCRiPT) for the treatment of deep carious lesions:a randomised controlled clinical trial in primary care

Background Dental caries is one of the most prevalent non-communicable disease globally and can have serious health sequelae impacting negatively on quality of life. In the UK most adults experience dental caries during their lifetime and the 2009 Adult Dental Health Survey reported that 85% of adults have at least one dental restoration. Conservative removal of tooth tissue for both primary and secondary caries reduces the risk of failure due to tooth-restoration, complex fracture as well as remaining tooth surfaces being less vulnerable to further caries. However, despite its prevalence there is no consensus on how much caries to remove prior to placing a restoration to achieve optimal outcomes. Evidence for selective compared to complete or near-complete caries removal suggests there may be benefits for selective removal in sustaining tooth vitality, therefore avoiding abscess formation and pain, so eliminating the need for more complex and costly treatment or eventual tooth loss. However, the evidence is of low scientific quality and mainly gleaned from studies in primary teeth. Method This is a pragmatic, multi-centre, two-arm patient randomised controlled clinical trial including an internal pilot set in primary dental care in Scotland and England. Dental health professionals will recruit 623 participants over 12-years of age with deep carious lesions in their permanent posterior teeth. Participants will have a single tooth randomised to either the selective caries removal or complete caries removal treatment arm. Baseline measures and outcome data (during the 3-year follow-up period) will be assessed through clinical examination, patient questionnaires and NHS databases. A mixed-method process evaluation will complement the clinical and economic outcome evaluation and examine implementation, mechanisms of impact and context. The primary outcome at three years is sustained tooth vitality. The primary economic outcome is net benefit modelled over a lifetime horizon. Clinical secondary outcomes include pulp exposure, progession of caries, restoration failure; as well as patient-centred and economic outcomes. Discussion SCRiPT will provide evidence for the most clinically effective and cost-beneficial approach to managing deep carious lesions in permanent posterior teeth in primary care. This will support general dental practitioners, patients and policy makers in decision making. Trial Registration Trial registry: ISRCTN. Trial registration number: ISRCTN76503940. Date of Registration: 30.10.2019

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

Rituximab in Combination with Corticosteroids for the Treatment of Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis: A NICE Single Technology Appraisal

As part of its single technology appraisal (STA) process, the National Institute for Health and Care Excellence (NICE) invited the manufacturer of rituximab (Roche Products) to submit evidence of the clinical and cost effectiveness of rituximab in combination with corticosteroids for treatment of anti-neutrophil cytoplasmic antibody (ANCA)-associated vasculitis (AAV). The School of Health and Related Research Technology Appraisal Group at the University of Sheffield was commissioned to act as the independent Evidence Review Group (ERG). The ERG produced a critical review of the evidence for the clinical and cost effectiveness of the technology, based upon the manufacturer’s submission to NICE. The evidence was derived mainly from a double-blind, phase III, placebo-controlled trial of rituximab in patients with new or relapsed ‘severe’ AAV, which compared a rituximab treatment regimen with an oral cyclophosphamide treatment regimen. Intravenous cyclophosphamide is also commonly used but was not included in the pivotal trial. The evidence showed that rituximab is noninferior to oral cyclophosphamide in terms of induction of remission in adults with AAV and de novo disease, and is superior to oral cyclophosphamide in terms of remission in adults who have relapsed once on cyclophosphamide. The ERG concluded that the results of the manufacturer’s economic evaluation could not be considered robust, because of errors and because the full range of relevant treatment sequences were not modelled. The ERG amended the manufacturer’s model and demonstrated that rituximab was likely to represent a cost-effective addition to the treatment sequence if given after cyclophosphamide treatment

Psychological and educational interventions for managing eczema

Objectives: This is a protocol for a Cochrane Review (intervention). The objectives are as follows:. 1. To assess the clinical outcomes of psychological and educational interventions in children and adults with eczema. 2. To summarise the availability and principal findings of relevant economic evaluations