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Dive into the research topics where Michael Lay is active.

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Featured researches published by Michael Lay.


Transplantation Reviews | 2013

Campath, calcineurin inhibitor reduction and chronic allograft nephropathy (3C) study: background, rationale, and study protocol

Richard Haynes; Colin Baigent; Paul Harden; Martin J. Landray; Murat Akyol; Argiris Asderakis; Alex Baxter; Sunil Bhandari; Paramit Chowdhury; Marc Clancy; Jonathan Emberson; Paul Gibbs; Abdul Hammad; William G. Herrington; Kathy Jayne; Gareth Jones; N. Krishnan; Michael Lay; David Lewis; Iain C. Macdougall; Chidambaram Nathan; James Neuberger; C. Newstead; R. Pararajasingam; Carmelo Puliatti; Keith Rigg; Peter Rowe; Adnan Sharif; Neil S. Sheerin; Sanjay Sinha

BackgroundKidney transplantation is the best treatment for patients with end-stage renal failure, but uncertainty remains about the best immunosuppression strategy. Long-term graft survival has not improved substantially, and one possible explanation is calcineurin inhibitor (CNI) nephrotoxicity. CNI exposure could be minimized by using more potent induction therapy or alternative maintenance therapy to remove CNIs completely. However, the safety and efficacy of such strategies are unknown.Methods/DesignThe Campath, Calcineurin inhibitor reduction and Chronic allograft nephropathy (3C) Study is a multicentre, open-label, randomized controlled trial with 852 participants which is addressing two important questions in kidney transplantation. The first question is whether a Campath (alemtuzumab)-based induction therapy strategy is superior to basiliximab-based therapy, and the second is whether, from 6 months after transplantation, a sirolimus-based maintenance therapy strategy is superior to tacrolimus-based therapy. Recruitment is complete, and follow-up will continue for around 5 years post-transplant. The primary endpoint for the induction therapy comparison is biopsy-proven acute rejection by 6 months, and the primary endpoint for the maintenance therapy comparison is change in estimated glomerular filtration rate from baseline to 2 years after transplantation. The study is sponsored by the University of Oxford and endorsed by the British Transplantation Society, and 18 centers for adult kidney transplant are participating.DiscussionLate graft failure is a major issue for kidney-transplant recipients. If our hypothesis that minimizing CNI exposure with Campath-based induction therapy and/or an elective conversion to sirolimus-based maintenance therapy can improve long-term graft function and survival is correct, then patients should experience better graft function for longer. A positive outcome could change clinical practice in kidney transplantation.Trial registrationClinicalTrials.gov, NCT01120028 and ISRCTN88894088


Trials | 2016

Cost-effective recruitment methods for a large randomised trial in people with diabetes: A Study of Cardiovascular Events iN Diabetes (ASCEND)

Theingi Aung; Richard Haynes; Jill Barton; Jolyon Cox; Aleksandra Murawska; Kevin Murphy; Michael Lay; Jane Armitage; Louise Bowman

BackgroundClinical trials require cost-effective methods for identifying, randomising, and following large numbers of people in order to generate reliable evidence. ASCEND (A Study of Cardiovascular Events iN Diabetes) is a randomised ‘2 × 2 factorial design’ study of aspirin and omega-3 fatty acid supplements for the primary prevention of cardiovascular events in people with diabetes; this study used central disease registers and a mail-based approach to identify, randomise, and follow 15,000 people. In collaboration with UK consultants and general practitioners (GPs), researchers identified potentially eligible people with diabetes from centrally held registers (e.g. for retinopathy screening) and GP-held disease registers. Permission was obtained under section 251 of the National Health Service Act 2006 (previously section 60 of the NHS act 2001) to allow invitation letters to be generated centrally in the name of the holder of the register. In addition, with the collaboration of the National Institutes for Health Research (NIHR) Diabetes and Primary Care Research Networks (DRN and PCRN), general practices sent pre-assembled invitation packs to people with a diagnosis of diabetes. Invitation packs included a cover letter, screening questionnaire (with consent form), information leaflet, and a Freepost envelope. Eligible patients entered a 2-month, pre-randomisation, run-in phase on placebo tablets and were only randomised if they completed a randomisation form and remained willing and eligible at the end of the run-in. Follow-up is ongoing, using mail-based approaches that are being supplemented by central registry data.ResultsInformation on approximately 600,000 people listed on 58 centrally held diabetes registers was obtained, and 300,188 potentially eligible patients were invited to join the study. In addition, 785 GP practices mailed invitations to 120,875 patients. A further 2,340 potential study participants were identified via other routes. In total, 423,403 people with diabetes were invited to take part; 26,462 entered the 2-month, pre-randomisation, run-in phase; and 15,480 were randomised.ConclusionIf sufficient numbers of potentially eligible patients can be identified centrally and the trial treatments do not require participants to attend clinics, the recruitment and follow-up of patients by mail is feasible and cost-effective. Wider use of these methods could allow more, large, randomised trials to be undertaken successfully and cost-effectively.Trial registrationCurrent Controlled Trials, ISRCTN60635500, registered on 14 July 2005


Maturitas | 2015

Estimation of the optimum dose of vitamin D for disease prevention in older people: Rationale, design and baseline characteristics of the BEST-D trial

Robert Clarke; Connie B. Newman; Joseph Tomson; Harold Hin; Rijo Kurien; Jolyon Cox; Michael Lay; Jenny Sayer; Michael Hill; Jonathan Emberson; Jane Armitage

Highlights • The BEST-D (Biochemical Efficacy and Safety Trial of vitamin D) trial will compare the biochemical and other effects of daily dietary supplementation with 100 μg or 50 μg vitamin D3 or placebo, when administered for 12 months, in 305 ambulant community-dwelling older people living in Oxfordshire, England.• The primary analyses will compare 12-month mean plasma concentrations of 25(OH)D as well as the proportion of participants with a 12-month concentration >90 nmol/L between participants allocated 100 μg and participants allocated 50 μg daily. Secondary analyses will compare the two active doses (both separately and when combined) with placebo.• Additional end-points include biochemical assessments of safety, blood pressure, arterial stiffness, falls, fractures, heel and wrist bone density, grip strength and physical performance and echocardiographic assessments of cardiac function in a random sample of participants.• The results of this trial will help determine the optimum dose of vitamin D to test in a larger trial investigating whether vitamin D supplementation can reduce the risk of fractures, cardiovascular disease or cancer.


Journal of the American Heart Association | 2017

Effects of Vitamin D on Blood Pressure, Arterial Stiffness, and Cardiac Function in Older People After 1 Year: BEST-D (Biochemical Efficacy and Safety Trial of Vitamin D).

Joseph Tomson; Harold Hin; Jonathan Emberson; Rijo Kurien; Michael Lay; Jolyon Cox; Michael Hill; Linda Arnold; Paul Leeson; Jane Armitage; Robert Clarke

Background The relevance of vitamin D for prevention of cardiovascular disease is uncertain. The BEST‐D (Biochemical Efficacy and Safety Trial of vitamin D) trial previously reported effects of vitamin D on plasma markers of vitamin D status, and the present report describes the effects on blood pressure, heart rate, arterial stiffness, and cardiac function. Methods and Results This was a randomized, double‐blind, placebo‐controlled trial of 305 older people living in United Kingdom, who were allocated vitamin D 4000 IU (100 μg), vitamin D 2000 IU (50 μg), or placebo daily. Primary outcomes were plasma concentrations of 25‐hydroxy‐vitamin D and secondary outcomes were blood pressure, heart rate, and arterial stiffness in all participants at 6 and 12 months, plasma N‐terminal prohormone of brain natriuretic peptide levels in all participants at 12 months, and echocardiographic measures of cardiac function in a randomly selected subset (n=177) at 12 months. Mean (SE) plasma 25‐hydroxy‐vitamin D concentrations were 50 (SE 2) nmol/L at baseline and increased to 137 (2.4), 102 (2.4), and 53 (2.4) nmol/L after 12 months in those allocated 4000 IU/d, 2000 IU/d of vitamin D, or placebo, respectively. Allocation to vitamin D had no significant effect on mean levels of blood pressure, heart rate, or arterial stiffness at either 6 or 12 months, nor on any echocardiographic measures of cardiac function, or plasma N‐terminal prohormone of brain natriuretic peptide concentration at 12 months. Conclusions The absence of any significant effect of vitamin D on blood pressure, arterial stiffness, or cardiac function suggests that any beneficial effects of vitamin D on cardiovascular disease are unlikely to be mediated through these mechanisms. Clinical Trial Registration URL: https://www.clinicaltrialsregister.eu/ctr-search/search. Unique identifier: EudraCT number: 2011–005763‐24a


Trials | 2015

Introduction of electronic data capture method using participant-completed online web-based follow up questionnaire in mail-based study achieves expected benefits and positive participant feedback

Jill Barton; Allen Young; Michael Lay

Background To reduce data processing and postal costs, and to potentially enhance data quality in a large long-term mail-based randomised trial, the ASCEND study team developed a bespoke online web-based version of the standard 6-monthly paper follow-up questionnaire. The form incorporates verification checks and study staff were trained to provide IT support for participants. The key IT challenges included ensuring screen format compatibility with different computer devices and software compatibility with multiple browsers and versions, as well as ensuring data security which was enhanced by using a two factor user authentication scheme. The aim was to assess the impact of providing the option to study participants in a small pilot study.


Trials | 2015

Quality by design: using intelligent forms to ensure study protocol compliance and participant safety

Rejive Dayanandan; Elizabeth Wincott; Michael Lay; Richard Haynes; M Landray; Jane Armitage

Methods ‘Intelligent’ electronic case report forms (eCRFs) can allow built-in checks to ensure the Study Protocol is adhered to. For a large, complex, international randomized trial a bespoke eCRF was deployed on laptops provided to study sites which enforced checks at screening of age, previous medical history, concomitant medication and safety blood (ALT, creatinine and CK within range on a desk-top analyser) to ensure that only those eligible entered a pre-randomization run-in and were issued drug. Following an active Run-in, the eCRF ensured that only those still eligible based on updated medication, blood safety checks and the absence of contraindications could be randomized. During the study blood safety checks were mandated and results outside pre-specified ranges prompted additional checks.


Trials | 2015

Methodology for UK recruitment into a large-scale international clinical trial

Elizabeth Wincott; Rejive Dayanandan; Richard Haynes; Michael Lay; M Landray; Jane Armitage

Methods Ethics and Section 251 of the Health and Social Care Act approval allowed potentially eligible patients to be identified (without consent) from local site’s hospital records and invited by a central coordinating office to a local screening appointment. Following a screening visit and initial run-in phase to standardise background LDL-cholesterol management, those remaining eligible entered an active ERN/LRPT run-in to assess their tolerance of the drug and likely long-term compliance. Participants, if still eligible, were then randomized to ERN/LRPT or placebo.


Osteoporosis International | 2017

Optimum dose of vitamin D for disease prevention in older people: BEST-D trial of vitamin D in primary care.

Harold Hin; Joseph Tomson; Connie B. Newman; R. Kurien; Michael Lay; J. Cox; J. Sayer; Michael Hill; Jonathan Emberson; Jane Armitage; Robert Clarke


Trials | 2015

Challenges of linking to routine healthcare records in UK Biobank

Ligia Adamska; Naomi E. Allen; Robin Flaig; Cathie Sudlow; Michael Lay; M Landray


Trials | 2017

Factors influencing recruitment in large randomised trials

D Edwards; Michael Lay; M Landray; Louise Bowman; Jane Armitage

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Jane Armitage

Clinical Trial Service Unit

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Jolyon Cox

Clinical Trial Service Unit

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Louise Bowman

Clinical Trial Service Unit

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M Landray

Clinical Trial Service Unit

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Richard Haynes

Medical Research Council

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Jill Barton

Clinical Trial Service Unit

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Jonathan Emberson

Clinical Trial Service Unit

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Kevin Murphy

Clinical Trial Service Unit

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