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  1. Article ; Online: Defining Peri-Operative Myocardial Injury during Cardiac Surgery Using High-Sensitivity Troponin T

    Vikram Sharma / Huili Zheng / Luciano Candilio / Jennifer M. Nicholas / Tim Clayton / Derek M. Yellon / Heerajnarain Bulluck / Derek J. Hausenloy

    Journal of Clinical Medicine, Vol 12, Iss 4291, p

    2023  Volume 4291

    Abstract: Objective: Cut-offs for high-sensitivity troponin (hs-Tn) elevations to define prognostically significant peri-operative myocardial injury (PMI) in cardiac surgery is not well-established. We evaluated the associations between peri-operative high- ... ...

    Abstract Objective: Cut-offs for high-sensitivity troponin (hs-Tn) elevations to define prognostically significant peri-operative myocardial injury (PMI) in cardiac surgery is not well-established. We evaluated the associations between peri-operative high-sensitivity troponin T (hs-TnT) elevations and 1-year all-cause mortality in patients undergoing cardiac surgery. Methods: The prognostic significance of baseline hs-TnT and various thresholds for post-operative hs-TnT elevation at different time-points on 1-year all-cause mortality following cardiac surgery were assessed after adjusting for baseline hs-TnT and EuroSCORE in a post-hoc analysis of the ERICCA trial. Results: 1206 patients met the inclusion criteria. Baseline elevation in hs-TnT >x1 99th percentile upper reference limit (URL) was significantly associated with 1-year all-cause mortality (adjusted hazard ratio 1.90, 95% confidence interval 1.15–3.13). In the subgroup with normal baseline hs-TnT ( n = 517), elevation in hs-TnT at all post-operative time points was associated with higher 1-year mortality, reaching statistical significance for elevations above: ≥100 × URL at 6 h; ≥50 × URL at 12 and 24 h; ≥35 × URL at 48 h; and ≥30 × URL at 72 h post-surgery. Elevation in hs-TnT at 24 h ≥ 50 × URL had the optimal sensitivity and specificity (73% and 75% respectively). When the whole cohort of patients was analysed, including those with abnormal baseline hs-TnT (up to 10 × URL), the same threshold had optimal sensitivity and specificity (66% and 70%). Conclusions: Both baseline and post-operative hs-TnT elevations are independently associated with 1-year all-cause mortality in patients undergoing cardiac surgery. The optimal threshold to define a prognostically significant PMI in our study was ≥50 × URL elevation in hs-TnT at 24 h.
    Keywords peri-operative myocardial injury ; high-sensitivity troponin ; coronary artery bypass graft surgery ; mortality ; Medicine ; R
    Subject code 610
    Language English
    Publishing date 2023-06-01T00:00:00Z
    Publisher MDPI AG
    Document type Article ; Online
    Database BASE - Bielefeld Academic Search Engine (life sciences selection)

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  2. Article ; Online: Patient and public involvement prior to trial initiation

    Zahra Jamal / Alexander Perkins / Christopher Allen / Research Advisory Group / Richard Evans / Joanna Sturgess / Claire Snowdon / Tim Clayton / Diana Elbourne

    Research Involvement and Engagement, Vol 7, Iss 1, Pp 1-

    lessons learnt for rapid partnership in the COVID-19 era

    2021  Volume 7

    Abstract: Plain English summary Patient and Public Involvement (PPI) describes the active involvement of patients and the public in the research process. Through PPI, patients and members of the public are increasingly involved in the design and conduct of ... ...

    Abstract Plain English summary Patient and Public Involvement (PPI) describes the active involvement of patients and the public in the research process. Through PPI, patients and members of the public are increasingly involved in the design and conduct of clinical trials. PPI has been shown to improve the quality and relevance of research. During the COVID-19 pandemic, clinical trials have been playing a vital role in helping us find ways to prevent and treat the infection and improve our understanding of the virus. It is important that patients and the public are actively involved in deciding how COVID-19 research is carried out. Unfortunately, Research Ethics Committees in the UK have seen far less PPI for COVID-19 research studies compared with research before the pandemic. A key reason for this is that research is being designed much faster than normal and researchers may feel they do not have time to properly involve patients and the public. In this paper, we share our experiences of PPI for a COVID-19 clinical trial. We show that it is possible to rapidly involve patients and the public in COVID-19 clinical trials. We also explain how the design of the clinical trial was changed in response to feedback from public contributors. Lastly, we discuss the wider learning from this process which might be useful for researchers planning PPI activities for COVID-19 clinical trials in the future. Abstract Background: Clinical trials are playing a critical role in the global public health response to the COVID-19 pandemic. Despite the increasing recognition of the value of PPI in clinical trials, just 22% of the COVID-19 research proposals reviewed by Research Ethics Committees in the UK at the start of the pandemic reported PPI. There is a perception that PPI might result in delays in delivering research and therefore delays in obtaining important results. In this paper, we report our experience of rapid PPI for a COVID-19 clinical trial. Methods: RAPID-19 is a COVID-19 clinical trial which was planned to be submitted for fast-track ethics review in the United Kingdom. During the development of the trial protocol, the PPI Panel at the London School of Hygiene & Tropical Medicine Clinical Trials Unit was involved in the design of the study. The meeting with the PPI Panel lasted just over 1 h and was conducted by teleconference. Results: Although we only had a short period of time to explore the study with the PPI Panel, we were able to gain valuable insight into how the trial would be perceived by potential trial participants. Substantive changes were made to the trial to improve the acceptability of the research without compromising the study timelines. Having access to public contributors with relevant lived experience is an important resource for a Clinical Trials Unit and is critical for rapid PPI. The move to remote working due to lockdown required virtual discussions which helped to overcome some of the barriers to organising face-to-face meetings at short notice. Conclusions: PPI for clinical trials can be conducted in a time-efficient manner within the pressured environment of a pandemic. Involving PPI contributors at an early stage in protocol development maximised the opportunity to shape and influence the trial as well as limited potential delays which could occur if changes to the protocol had to be made at a later stage.
    Keywords Patient and public involvement ; Clinical trials ; COVID-19 ; Medicine ; R ; Medicine (General) ; R5-920
    Subject code 610
    Language English
    Publishing date 2021-03-01T00:00:00Z
    Publisher BMC
    Document type Article ; Online
    Database BASE - Bielefeld Academic Search Engine (life sciences selection)

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  3. Article ; Online: Estimating burden of syphilis among men who have sex with men – Authors' reply

    R Matthew Chico / Motoyuki Tsuboi / Jayne Evans / Ella P Davies / Jane Rowley / Eline L Korenromp / Tim Clayton / David Mabey / Melanie M Taylor

    The Lancet Global Health, Vol 9, Iss 12, Pp e1649- (2021)

    2021  

    Keywords Public aspects of medicine ; RA1-1270
    Language English
    Publishing date 2021-12-01T00:00:00Z
    Publisher Elsevier
    Document type Article ; Online
    Database BASE - Bielefeld Academic Search Engine (life sciences selection)

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  4. Article ; Online: REmote preconditioning for Protection Against Ischaemia–Reperfusion in renal transplantation (REPAIR)

    Raymond MacAllister / Tim Clayton / Rosemary Knight / Steven Robertson / Jennifer Nicholas / Madhur Motwani / Kristin Veighey

    Efficacy and Mechanism Evaluation, Vol 2, Iss

    a multicentre, multinational, double-blind, factorial designed randomised controlled trial

    2015  Volume 3

    Abstract: Background: Long-term kidney allograft survival has remained unchanged in recent years despite immunosuppressive and surgical advances. Ischaemia–reperfusion (IR) injury sustained at transplantation contributes to kidney damage that limits allograft ... ...

    Abstract Background: Long-term kidney allograft survival has remained unchanged in recent years despite immunosuppressive and surgical advances. Ischaemia–reperfusion (IR) injury sustained at transplantation contributes to kidney damage that limits allograft lifespan. Interventions to reduce IR injury may prolong graft life, delaying the need for a return to dialysis. Remote ischaemic preconditioning (RIPC), in which brief episodes of non-lethal ischaemia applied to the limb activate a systemic protective reflex against subsequent damaging IR injury, has been reported to cause cardiac, renal and neurological protection in small-scale trials. Objectives: The REmote preconditioning for Protection Against Ischaemia–Reperfusion in renal transplantation (REPAIR) trial investigated whether RIPC improves kidney function and other outcomes following living-donor renal transplantation. Design: Multicentre, multinational, double-blind, 2 × 2 factorial designed randomised controlled trial. Setting: Thirteen tertiary care hospitals in the UK, the Netherlands, Belgium and France. Participants: The REPAIR trial recruited 406 live donor–recipient pairs aged ≥ 18 years. Patients on adenosine triphosphate (ATP)-sensitive potassium channel opening or blocking drugs, on ciclosporin, with a known iodine sensitivity or with ABO incompatibility or those requiring human leucocyte antigen (HLA) antibody removal therapy were excluded. Interventions: Each pair was randomised using a factorial design to one of four groups: sham RIPC, early RIPC (immediately before surgery), late RIPC (24 hours before surgery) and dual RIPC (early and late RIPC). The donor and recipient received the same intervention (active RIPC or sham RIPC) at the two time points. Main outcome measures: The primary outcome was glomerular filtration rate (GFR) 12 months after transplantation measured by iohexol clearance. Important secondary outcomes were estimated GFR (eGFR) (using routine clinical assessment), safety, inflammatory cytokine profile and biological mechanisms. ...
    Keywords randomised controlled trial ; remote ischaemic preconditioning ; kidney ; ischaemia–reperfusion ; transplantation ; Medicine ; R
    Subject code 610
    Language English
    Publishing date 2015-05-01T00:00:00Z
    Publisher NIHR Journals Library
    Document type Article ; Online
    Database BASE - Bielefeld Academic Search Engine (life sciences selection)

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  5. Article ; Online: Safetxt

    Ford Colin Ian Hickson / Ian Roberts / Melissa J Palmer / George B Ploubidis / Kaye Wellings / Paula Baraitser / Caroline Free / Julia V Bailey / Ona L McCarthy / Rosemary Knight / Phil Edwards / Rebecca French / Graham Hart / Tim Clayton / James R Carpenter / Katy M E Turner / Kimberley Potter

    BMJ Open, Vol 10, Iss

    a safer sex intervention delivered by mobile phone messaging on sexually transmitted infections (STI) among young people in the UK - protocol for a randomised controlled trial

    2020  Volume 3

    Abstract: IntroductionYoung people aged 16 to 24 have the highest prevalence of genital chlamydia and gonorrhoea compared with other age groups and re-infection rates following treatment are high. Long-term adverse health effects include subfertility and ectopic ... ...

    Abstract IntroductionYoung people aged 16 to 24 have the highest prevalence of genital chlamydia and gonorrhoea compared with other age groups and re-infection rates following treatment are high. Long-term adverse health effects include subfertility and ectopic pregnancy, particularly among those with repeated infections. We developed the safetxt intervention delivered by text message to reduce sexually transmitted infection (STI) by increasing partner notification, condom use and (STI) testing among young people in the UK.Methods and analysisA single-blind randomised trial to reliably establish the effect of the safetxt intervention on chlamydia and gonorrhoea infection at 1 year. We will recruit 6250 people aged 16 to 24 years who have recently been diagnosed with chlamydia, gonorrhoea or non-specific urethritis from health services in the UK. Participants will be allocated to receive the safetxt intervention (text messages designed to promote safer sexual health behaviours) or to receive the control text messages (monthly messages asking participants about changes in contact details) by an automated remote online randomisation system. The primary outcome will be the cumulative incidence of chlamydia and gonorrhoea infection at 1 year assessed by nucleic acid amplification tests. Secondary outcomes include partner notification, correct treatment of infection, condom use and STI testing prior to sex with new partners.Ethics and disseminationEthics approval was obtained from NHS Health Research Authority - London – Riverside Research Ethics Committee (REC reference: 15/LO/1665) and the London School of Hygiene & Tropical Medicine. We will submit the results of the trial for publication in peer-reviewed journals.Trial registration numberInternational Standard Randomised Controlled Trials Number: ISRCTN64390461. Registered on 17th March 2016. WHO trial registration data set available at: http://apps.who.int/trialsearch/Trial2.aspx?TrialID=ISRCTN64390461.Trial protocol version12, 19th July 2018.
    Keywords Medicine ; R
    Subject code 170
    Language English
    Publishing date 2020-03-01T00:00:00Z
    Publisher BMJ Publishing Group
    Document type Article ; Online
    Database BASE - Bielefeld Academic Search Engine (life sciences selection)

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  6. Article ; Online: Red blood cell transfusion and mortality in trauma patients

    Pablo Perel / Tim Clayton / Doug G Altman / Peter Croft / Ian Douglas / Harry Hemingway / Aroon Hingorani / Katherine I Morley / Richard Riley / Adam Timmis / Danielle Van der Windt / Ian Roberts / PROGRESS Partnership

    PLoS Medicine, Vol 11, Iss 6, p e

    risk-stratified analysis of an observational study.

    2014  Volume 1001664

    Abstract: Haemorrhage is a common cause of death in trauma patients. Although transfusions are extensively used in the care of bleeding trauma patients, there is uncertainty about the balance of risks and benefits and how this balance depends on the baseline risk ... ...

    Abstract Haemorrhage is a common cause of death in trauma patients. Although transfusions are extensively used in the care of bleeding trauma patients, there is uncertainty about the balance of risks and benefits and how this balance depends on the baseline risk of death. Our objective was to evaluate the association of red blood cell (RBC) transfusion with mortality according to the predicted risk of death.A secondary analysis of the CRASH-2 trial (which originally evaluated the effect of tranexamic acid on mortality in trauma patients) was conducted. The trial included 20,127 trauma patients with significant bleeding from 274 hospitals in 40 countries. We evaluated the association of RBC transfusion with mortality in four strata of predicted risk of death: <6%, 6%-20%, 21%-50%, and >50%. For this analysis the exposure considered was RBC transfusion, and the main outcome was death from all causes at 28 days. A total of 10,227 patients (50.8%) received at least one transfusion. We found strong evidence that the association of transfusion with all-cause mortality varied according to the predicted risk of death (p-value for interaction <0.0001). Transfusion was associated with an increase in all-cause mortality among patients with <6% and 6%-20% predicted risk of death (odds ratio [OR] 5.40, 95% CI 4.08-7.13, p<0.0001, and OR 2.31, 95% CI 1.96-2.73, p<0.0001, respectively), but with a decrease in all-cause mortality in patients with >50% predicted risk of death (OR 0.59, 95% CI 0.47-0.74, p<0.0001). Transfusion was associated with an increase in fatal and non-fatal vascular events (OR 2.58, 95% CI 2.05-3.24, p<0.0001). The risk associated with RBC transfusion was significantly increased for all the predicted risk of death categories, but the relative increase was higher for those with the lowest (<6%) predicted risk of death (p-value for interaction <0.0001). As this was an observational study, the results could have been affected by different types of confounding. In addition, we could not ...
    Keywords Medicine ; R
    Subject code 610
    Language English
    Publishing date 2014-06-01T00:00:00Z
    Publisher Public Library of Science (PLoS)
    Document type Article ; Online
    Database BASE - Bielefeld Academic Search Engine (life sciences selection)

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