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Lip G.Y.H.,University of Birmingham | Andreotti F.,melli University Hospital | Fauchier L.,University of Tours | Huber K.,Wilhelminenhospital | And 8 more authors.
Thrombosis and Haemostasis | Year: 2011

In this executive summary of a Consensus Document from the European Heart Rhythm Association, endorsed by the European Society of Cardiology Working Group on Thrombosis, we comprehensively review the published evidence and propose a consensus on bleeding risk assessments in atrial fibrillation (AF) patients. The main aim of the document was to summarise 'best practice' in dealing with bleeding risk in AF patients when approaching antithrombotic therapy, by addressing the epidemiology and size of the problem, and review established bleeding risk factors. We also summarise definitions of bleeding in the published literature. Patient values and preferences balancing the risk of bleeding against thromboembolism as well as the prognostic implications of bleeding are reviewed. We also provide an overview of published bleeding risk stratification and bleeding risk schema. Brief discussion of special situations (e.g. periablation, peri-devices such as implantable cardioverter defibrillators [ICD] or pacemakers, presentation with acute coronary syndromes and/or requiring percutanous coronary interventions/stents and bridging therapy) is made, as well as a discussion of the prevention of bleeds and managing bleeding complications. Finally, this document puts forwards consensus statements that may help to define evidence gaps and assist in everyday clinical practice. © Schattauer 2011.


Attard G.,Institute of Cancer Research | Attard G.,Royal Marsden NHS Foundation Trust | Sydes M.R.,University College London | Mason M.D.,University of Cardiff | And 18 more authors.
European Urology | Year: 2014

Take Home Message There are compelling reasons to study the addition of both enzalutamide and abiraterone, in combination, to standard-of-care for hormone-naïve prostate cancer. Through a protocol amendment, this will be assessed in the STAMPEDE trial, with overall survival as primary outcome measure. © 2014 European Association of Urology. Published by Elsevier B.V.


PubMed | Derriford Hospital, Glasgow Caledonian University, St Marys Hospital, Royal Infirmary and 2 more.
Type: Journal Article | Journal: Health technology assessment (Winchester, England) | Year: 2017

The use of mesh in prolapse surgery is controversial, leading to a number of enquiries into its safety and efficacy.To compare synthetic non-absorbable mesh inlay, biological graft and mesh kit with a standard repair in terms of clinical effectiveness, adverse effects, quality of life (QoL), costs and cost-effectiveness.Two randomised controlled trials within a comprehensive cohort (CC) study. Allocation was by a remote web-based randomisation system in a 1 :1 : 1 ratio (Primary trial) or 1 : 1 : 2 ratio (Secondary trial), and was minimised on age, type of prolapse repair planned, need for a concomitant continence procedure, need for a concomitant upper vaginal prolapse procedure and surgeon. Participants and outcome assessors were blinded to randomisation; participants were unblinded if they requested the information. Surgeons were not blinded to allocated procedure.Thirty-five UK hospitals.Anterior or posterior repair alone, or with mesh inlay, biological graft or mesh kit.Prolapse symptoms [Pelvic Organ Prolapse Symptom Score (POP-SS)]; prolapse-specific QoL; cost-effectiveness [incremental cost per quality-adjusted life-year (QALY)].In women who were having primary repairs, there was evidence of no benefit from the use of mesh inlay or biological graft compared with standard repair in terms of efficacy, QoL or adverse effects (other than mesh complications) in the short term. The Secondary trials were too small to provide conclusive results.Women in the Primary trials included some with a previous repair in another compartment. Follow-up is vital to identify any long-term potential benefits and serious adverse effects.Long-term follow-up to at least 6 years after surgery is ongoing to identify recurrence rates, need for further prolapse surgery, adverse effects and cost-effectiveness.Current Controlled Trials ISRCTN60695184.This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in


PubMed | University of Bristol, University of Sheffield, Betsi Cadwaladr University Health Board, University of Southampton and 6 more.
Type: | Journal: British journal of cancer | Year: 2017

Achieving earlier stage diagnosis is one option for improving lung cancer outcomes in the United Kingdom. Patients with lung cancer typically present with symptoms to general practitioners several times before referral or investigation.We undertook a mixed methods feasibility individually randomised controlled trial (the ELCID trial) to assess the feasibility and inform the design of a definitive, fully powered, UK-wide, Phase III trial of lowering the threshold for urgent investigation of suspected lung cancer. Patients over 60, with a smoking history, presenting with new chest symptoms to primary care, were eligible to be randomised to intervention (urgent chest X-ray) or usual care.The trial design and materials were acceptable to GPs and patients. We randomised 255 patients from 22 practices, although the proportion of eligible patients who participated was lower than expected. Survey responses (89%), and the fidelity of the intervention (82% patients X-rayed within 3 weeks) were good. There was slightly higher anxiety and depression in the control arm in participants aged >75. Three patients (1.2%) were diagnosed with lung cancer.We have demonstrated the feasibility of individually randomising patients at higher risk of lung cancer, to a trial offering urgent investigation or usual care.British Journal of Cancer advance online publication 10 January 2017; doi:10.1038/bjc.2016.414 www.bjcancer.com.


Rizzo J.D.,Medical College of Wisconsin | Brouwers M.,McMaster University | Hurley P.,American Society of Clinical Oncology | Seidenfeld J.,American Society of Clinical Oncology | And 9 more authors.
Blood | Year: 2010

Purpose: To update American Society of Hematology/American Society of Clinical Oncology recommendations for use of erythropoiesis-stimulating agents (ESAs) in patients with cancer. Methods: An Update Committee reviewed data published between January 2007 and January 2010. MEDLINE and the Cochrane Library were searched. Results: The literature search yielded one new individual patient data analysis and four literature-based metaanalyses, two systematic reviews, and 13 publications reporting new results from randomized controlled trials not included in prior or new reviews. Recommendations: For patients undergoing myelosuppressive chemotherapy who have a hemoglobin (Hb) level less than 10 g/dL, the Update Committee recommends that clinicians discuss potential harms (eg, thromboembolism, shorter survival) and benefits (eg, decreased transfusions) of ESAs and compare these with potential harms (eg, serious infections, immune-mediated adverse reactions) and benefits (eg, rapid Hb improvement) of RBC transfusions. Individual preferences for assumed risk should contribute to shared decisions on managing chemotherapy-induced anemia. The Committee cautions against ESA use under other circumstances. If used, ESAs should be administered at the lowest dose possible and should increase Hb to the lowest concentration possible to avoid transfusions. Available evidence does not identify Hb levels ≥ 10 g/dL either as thresholds for initiating treatment or as targets for ESA therapy. Starting doses and dose modifications after response or nonresponse should follow US Food and Drug Administration-approved labeling. ESAs should be discontinued after 6 to 8 weeks in nonresponders. ESAs should be avoided in patients with cancer not receiving concurrent chemotherapy, except for those with lower risk myelodysplastic syndromes. Caution should be exercised when using ESAs with chemotherapeutic agents in diseases associated with increased risk of thromboembolic complications. Table 1 lists detailed recommendations. Copyright © 2010 American Society of Hematology and American Society of Clinical Oncology. All rights reserved.


Sabbatini A.K.,University of Washington | Merck L.H.,Brown University | Froemming A.T.,Mayo Medical School | Vaughan W.,Patient Representative | And 5 more authors.
Academic Emergency Medicine | Year: 2015

Patient-centered emergency diagnostic imaging relies on efficient communication and multispecialty care coordination to ensure optimal imaging utilization. The construct of the emergency diagnostic imaging care coordination cycle with three main phases (pretest, test, and posttest) provides a useful framework to evaluate care coordination in patient-centered emergency diagnostic imaging. This article summarizes findings reached during the patient-centered outcomes session of the 2015 Academic Emergency Medicine consensus conference "Diagnostic Imaging in the Emergency Department: A Research Agenda to Optimize Utilization." The primary objective was to develop a research agenda focused on 1) defining component parts of the emergency diagnostic imaging care coordination process, 2) identifying gaps in communication that affect emergency diagnostic imaging, and 3) defining optimal methods of communication and multidisciplinary care coordination that ensure patient-centered emergency diagnostic imaging. Prioritized research questions provided the framework to define a research agenda for multidisciplinary care coordination in emergency diagnostic imaging. © 2015 by the Society for Academic Emergency Medicine.


Batchelor J.M.,University of Nottingham | Ridd M.J.,University of Bristol | Clarke T.,University of Nottingham | Ahmed A.,Patient Representative | And 9 more authors.
British Journal of Dermatology | Year: 2013

Background: Eczema is a common condition, yet there are uncertainties regarding many frequently used treatments. Knowing which of these uncertainties matter to patients and clinicians is important, because they are likely to have different priorities from those of researchers and funders. Objectives To identify the uncertainties in eczema treatment that are important to patients who have eczema, their carers and the healthcare professionals (HCPs) who treat them. Methods: An eczema Priority Setting Partnership was established, including patients, HCPs and researchers. Eczema treatment uncertainties were gathered from patients and clinicians, and then prioritized in a transparent process, using a methodology advocated by the James Lind Alliance. Results: In the consultation stage 493 participants (including 341 patients/carers) made 1070 submissions, of which 718 were uncertainties relating to the treatment of eczema. Treatment uncertainties with more than one submission were grouped into 52 'indicative uncertainties', which were then ranked by 514 participants (including 399 patients/carers). The top 14 treatment uncertainties were prioritized for research. The first four were common to patients/carers and HCPs (shared uncertainties): (i) the best and safest way of using topical steroids (including frequency of application, potency, length of time, alternation with other topical treatments and age limits); (ii) the long-term safety of topical steroids; (iii) the role of food allergy tests; and (iv) the most effective and safe emollients in treating eczema. The remaining 10 of the top 14 uncertainties comprised the next five highest ranked uncertainties for patients and the next five highest ranked uncertainties for HCPs. At a workshop involving 40 participants (patients, HCPs and researchers), shared uncertainties were formulated into possible research questions. Conclusions: The top 14 treatment uncertainties around the treatment of eczema provide guidance for researchers and funding bodies to ensure that future research answers questions that are important to both clinicians and patients. © 2012 British Association of Dermatologists.


Paul L.,University of Glasgow | Coote S.,University of Limerick | Crosbie J.,Patient Representative | Dixon D.,University of Strathclyde | And 7 more authors.
Multiple Sclerosis Journal | Year: 2014

Evidence shows that exercise is beneficial for people with multiple sclerosis (MS); however, statistical pooling of data is difficult because of the diversity of outcome measures used. The objective of this review is to report the recommendations of an International Consensus Meeting for a core set of outcome measures for use in exercise studies in MS. From the 100 categories of the International Classification of Function Core Sets for MS, 57 categories were considered as likely/potentially likely to be affected by exercise and were clustered into seven core groups. Outcome measures to address each group were evaluated regarding, for example, psychometric properties. The following are recommended: Modified Fatigue Impact Scale (MFIS) or Fatigue Severity Scale (FSS) for energy and drive, 6-Minute Walk Test (6MWT) for exercise tolerance, Timed Up and Go (TUG) for muscle function and moving around, Multiple Sclerosis Impact Scale (MSIS-29) or Multiple Sclerosis Quality of Life-54 Instrument (MSQoL54) for quality of life and body mass index (BMI) or waist-hip ratio (WHR) for the health risks associated with excess body fat. A cost effectiveness analysis and qualitative evaluation should be included where possible. Using these core measures ensures that future meta-analyses of exercise studies in MS are more robust and thus more effectively inform practice. © The Author(s) 2014.


Lorell B.H.,FDA and Life science Group | Mikita J.S.,Patient Representative | Anderson A.,Center for Information and Study on Clinical Research Participation | Hallinan Z.P.,Center for Information and Study on Clinical Research Participation | Forrest A.,Clinical Trials Transformation Initiative CTTI
Clinical Trials | Year: 2015

Background Informed consent is the cornerstone for protection of human subjects in clinical trials. However, a growing body of evidence suggests that reform of the informed consent process in the United States is needed. Methods The Clinical Trials Transformation Initiative conducted interviews with 25 experienced observers of the informed consent process to identify limitations and actionable recommendations for change. Results There was broad consensus that current practices often fail to meet the ethical obligation to inform potential research participants during the informed consent process. The most frequent single recommendation, which would affect all participants in federally regulated clinical research, was reform of the informed consent document. The interviews also identified the need for reform of clinical research review by institutional review boards, including transitioning to a single institutional review board for multi-site trials. Conclusion The consensus recommendations from the interviewees provide a framework for meaningful change in the informed consent process. Although some proposed changes are feasible for rapid implementation, others such as substantive reform of the informed consent document may require change in federal regulations. © 2015 The Author(s).


Greenhalgh J.,University of Leeds | Pawson R.,University of Leeds | Wright J.,University of Leeds | Black N.,London School of Hygiene and Tropical Medicine | And 7 more authors.
BMJ Open | Year: 2014

Introduction: The feedback and public reporting of PROMs data aims to improve the quality of care provided to patients. Existing systematic reviews have found it difficult to draw overall conclusions about the effectiveness of PROMs feedback. We aim to execute a realist synthesis of the evidence to understand by what means and in what circumstances the feedback of PROMs data leads to the intended service improvements. Methods and analysis: Realist synthesis involves (stage 1) identifying the ideas, assumptions or 'programme theories' which explain how PROMs feedback is supposed to work and in what circumstances and then (stage 2) reviewing the evidence to determine the extent to which these expectations are met in practice. For stage 1, six provisional 'functions' of PROMs feedback have been identified to structure our review (screening, monitoring, patient involvement, demand management, quality improvement and patient choice). For each function, we will identify the different programme theories that underlie these different goals and develop a logical map of the respective implementation processes. In stage 2, we will identify studies that will provide empirical tests of each component of the programme theories to evaluate the circumstances in which the potential obstacles can be overcome and whether and how the unintended consequences of PROMs feedback arise. We will synthesise this evidence to (1) identify the implementation processes which support or constrain the successful collation, interpretation and utilisation of PROMs data; (2) identify the implementation processes through which the unintended consequences of PROMs data arise and those where they can be avoided. Ethics and dissemination: The study will not require NHS ethics approval. We have secured ethical approval for the study from the University of Leeds (LTSSP-019). We will disseminate the findings of the review through a briefing paper and dissemination event for National Health Service stakeholders, conferences and peer reviewed publications.

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