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To pilot the use of the Multimedia Application/website AboutMyOp.org. To collect the largest PROMs (Patient Reported Outcome Measures) dataset in adult patients undergoing elective Laparoscopic Cholecystectomy for symptomatic gallstones in the UK, and to aid the informed consent process.

Summary:
Patients referred with gallstone disease necessitating surgery (laparoscopic cholecystectomy) will be invited to
engage with our on-line interactive website. This will allow a two-way exchange of information in a secure environment (N3 compliant) to inform the patient about the risks, benefits, alternatives to surgery (cholecystectomy), and postoperative expectations. Furthermore, it will inform clinicians about the patient’s symptoms and history, and record a pre-operative Patient Reported Outcome Measure (PROM). The patient’s understanding of the facts required for
informed consent will be measured and a “Patient Health & Understanding Report” generated for hospital clinicians. This will form part of the electronic patient record, and will be a medico-legal document.

As with current practice patients will still attend their initial outpatient clinic appointment where they will meet a surgeon who will determine the appropriateness of surgery. Informed consent for surgery (cholecystectomy) will be obtained at this initial consultation facilitated by the information obtained from the “Patient Health & Understanding Report”. The patient will then continue to interact with the on-line platform before and after their operation to ensure they are well informed and to monitor their post-operative progress.

7 days after surgery the patient will be prompted to interact with the website to answer questions about their progress and recovery. This will replace the existing telephone follow-up interaction. Any problems identified will trigger a protocol driven interaction between the hospital and the patient.

At 1, 3 and 6 months after surgery a post-operative PROMs questionnaire will be answered by the patient allowing comparison of pre- and post-operative PROMs. This study will lead to the largest PROMs assessment of the effectiveness of laparoscopic cholecystectomy, will study the feasibility of our multimedia platform application in assisting with the process of informed consent, and will determine whether telephone follow-up can be safely replaced by a protocol driven online system.

Inclusion criteria:
INCLUSION CRITERIA:
– Male or female.
– Adults: aged 18 to 85 years.
– Be referred for consideration for an elective laparoscopic cholecystectomy for symptomatic gallstones based on their GPs diagnosis and referral to a general surgeon.
– Patients initially listed for laparoscopic cholecystectomy but subsequently converted to open cholecystectomy or subsequently have a more complex ‘biliary’ procedure (including but not exclusive to bile duct exploration, biliary drain insertion, biliary bypass procedure).

EXCLUSION CRITERIA:
– Patients unable to, or those choosing not to engage with the multimedia process – including patients lacking mental capacity, patients who do not have access to a multimedia device (including but not exclusive to a computer, tablet or multimedia/smart phone), patient who are unable to use a multimedia device unassisted.
– Patients who are unable to read or communicate in English without the presence of a translator (as this is a pilot study it is not possible to offer every language option yet, however we will have voice-over options, sign-language videos, and animations, and the whole system is designed to be screen-reader compliant. In the future hopefully there will be options for additional languages).
– Patients undergoing another major non-biliary operation during the same operation as their cholecystectomy.

Exclusion criteria:
Patients unable to, or those choosing not to engage with the multimedia process – including patients lacking mental capacity, patients who do not have access to a multimedia device (including but not exclusive to a computer, tablet or multimedia phone), patients who are unable to use a multimedia device unassisted.

Patients who are unable to read or communicate in English without the presence of a translator.

Patients undergoing another major non-biliary operation during the same operation as their cholecystectomy.

Principal Investigator for this trial: Dr Prita Daliya

Research Ethics Committee Reference: 16/SW/0088

Contact us about participating in this study by emailing R&IActiveStudyEnquiries@nuh.nhs.uk or telephoning 0115 924 9924 Ext. 70076 Continue reading

Research for Patient Benefit (RfPB) applications open soon

RfPB competition 28 will open for applications on 26 August 2015. This competition will operate a two stage application process with a shortened application form for Stage 1 and the deadline for submission is 02 December 2015.
RfPB … Continue reading

Pre Award Support Service – compilation of research grant funding applications

What we do
It takes time to develop a good application and so you must ensure you have the correct support from your peers and directorate. Help and support is available from R&I who will enable you to consider all … Continue reading

Nottingham University Hospitals Clinical Trial set up performance continues to improve

All NHS trusts undertaking research activities are now required to submit data detailing performance against a benchmark or 70 days from Valid Research Application to first patient recruited to show successful initiation of clinical trials.
The 2013-14 Quarter 4 Clinical … Continue reading

Templates and Forms

Please refer to this page frequently to ensure the correct template or form is used.
All templates and forms are linked to a Standard Operating Procedure (SOP)
TAFQ00701 Standard Operating Procedure Signature Log
Please note some of the forms listed below are also … Continue reading

Post Award Support Service – Successful Research Grant Funding Applications

When your grant is awarded or you receive notification that it has been favourably considered by the awarding body there is a post award team within Research & Innovation ready to assist you in the process of managing the responsibilities … Continue reading

Florence Nightingale Research Scholarships Open for Applications

Florence Nightingale Research Scholarships worth up to £5000 are now open for applications. These scholarships are available to Nurses and Midwives who have current registration with the Nursing and Midwifery Council and work and are resident in the United … Continue reading

Mary Seacole Awards open for application

The Mary Seacole Awards are now open for applications. These awards recognise and honour the name of Mary Seacole, a Jamaican/Scottish nurse and businesswoman celebrated for her bravery in nursing soldiers during the Crimean War (1853-56) and for her … Continue reading

NIHR/CNO Clinical Academic Training Studentship: open events April 16/17, applications close May 17

The NIHR/CNO Clinical Academic Training Studentship at the University of Nottingham will start on 23rd September 2013, and will cover full tuition fees, employee salaries and employers’ back-fill salaries.
This is an exceptional opportunity to develop research skills, build a clinical … Continue reading

Vacancy: Research Contracts Assistant, applications close 5th December

This full time post will support our Research Contracts Manager in providing legal advice to the Trust by facilitating, reviewing and amending as required a wide range of agreements connected to biomedical research carried out at NUH. Continue reading

Fri 9 Nov Lecture: The Nature of the Superior Performance of Experts

Find out what Garry Kasparov, Wolfgang Amadeus Mozart, and Bradley Wiggins might be able to tell you about expert practice and elite performance. Continue reading

Vacancies: Five Clinical Research Nurses needed for our new Clinical Research Nurse Bank, applications close 12th October

NUH is creating a clinical research nurse bank for five clinical research nurses to support our commercial clinical trials. Candidates experienced in setting up and recruiting patients in commercial clinical trials within a large university hospital are strongly encouraged to apply. Continue reading

Vacancy: Research Project Manager, Applications close 11th October

An opportunity has arisen for a Research Project Manager to join the Research & Innovation at Nottingham University Hospitals (NUH) NHS Trust.
You will be a member of the NUH R&I department, responsible for a portfolio of research projects

Burdett Trust for Nursing Burdett bursaries programme opens for applications

Burdett Trust for Nursing Burdett bursaries programme opens for applications
You can apply for up to £5,000 to help defray the costs associated with postgraduate study in a UK academic department if you are a nurse, midwife or an AHP planning … Continue reading

Applications invited for pump prime funding, deadline 7 September

Medical staff at NUH are invited to apply for funding for research projects from NUH Charity and the Department of Research and Development.
The scheme aims to ‘pump prime’ early studies by giving them a cash injection to get up and … Continue reading

Vacancy for Clinical Research Nurse Manager to lead the NUH Clinical Research Nurses Bank, applications close 4th July

Nottingham University Hospitals is recruiting for a Clinical Research Matron (CRM) to lead on the recruitment, development and line management of the NUH clinical research nurses bank. The primary focus of the CRM and the nurse bank will be the … Continue reading

NUH leads in number of successful Research into Practice applications

Six members of staff from NUH were accepted on the Research in Practice programme, run by the regional CLAHRC – more than from any other NHS Trust. Research into Practice has been set up to allow therapists, nurses and NHS managers in the East Midlands to undertake a fast-track piece of research that is immediately relevant to the challenges faced in their workplace. Continue reading

Four full time NUH Research PPI & PPE Facilitator vacancies, applications closing 6th March

Do you wish to make a difference in research? Nottingham University Hospitals is recruiting a team of four full time patient and public involvement and engagement (PPI & PPE) facilitators. Our aims are to foster a culture in which research and innovation are embedded in routine clinical practice. The integrated PPI and PPE team will work across the three Biomedical Research Units, the Arthritis Research UK Pain centre, Trent CLRN and key research programs led by NUH. Continue reading

Nottingham University Hospitals R&I Research Project Manager vacancy, applications close 22nd February

If you have prior experience as a research nurse, clinical trial data manager or any other life sciences research, this post will be an ideal development step in the research management career ladder. You will enjoy a flexible and dynamic working environment in brand new premises at the Nottingham Integrated Clinical Research Centre (NICRC) working among 120 research management experts from different backgrounds. Continue reading

Nottingham University Hospitals R&I Research Manager vacancy, applications close 17th February

Do you wish to make a difference to research in the NHS? An opportunity has arisen for a Research Manager to join the Research & Innovation Department at Nottingham University Hospitals (NUH) NHS Trust. As Research Manager you will be a key member of the NUH R&I department and will play an important role in supporting the implementation of the Trust’s Research Strategy. Continue reading

Applications invited for 2012/2013 research funding from Trent CLRN

NUH Department of Research and Innovation invites applications for research funding from the Trent Comprehensive Local Research Network (Trent CLRN) for the financial period 2012/2013. The deadline for submission is 17:00 on Friday 16th December 2011. Full support of NUH R&I is a requirement for all applications and you are advised to discuss your bid at an early stage. An important change this year is that the delivery Trent CLRN funding awards will be performance managed by the Trust. Continue reading

Call for applications from all professions for Flexibility & Sustainability Funding

NUH Department of Research and Innovation invites applications for research funding, including research PAs. Please note that this competition will serve to replace all existing research PAs held in the Trust from April 2012 (other than those allocated by the … Continue reading

Fully Funded Cranfield & ICR Research Fellowships: Applications Now Open

Cranfield University and the Institute of Clinical Research (ICR) are offering two fully-funded, part-time research training fellowships for healthcare research professionals, clinicians, research nurses or academics:

A Junior Fellowship – MSc by Research (two years part-time)
A Senior Fellowship – PhD (four … Continue reading

MS Society opens 2011 grant round, encouraging translational and clinical biomedical research applications

The MS Society’s research grant round opens on the 24th February 2011, with a deadline for applications on 7th April 2011. As the largest dedicated charitable funder of MS research in the UK, the MS Society welcomes applications for projects … Continue reading

Application and Costing of NIHR Research Grant Bids

Types of NIHR grants
A. Programme Grants
Programme Grants for Applied Research are prestigious awards of up to £2m over a period of three to five years.
The aim is to provide evidence to improve health outcomes in England through promotion of … Continue reading

Applications invited for NUH pump priming grants

A grant scheme established earlier this year is making up to £150,000 available annually for research projects. The ‘pump priming’ competition is being led by Nottingham University Hospitals Charity and the Department of Research and Development. Applications are now invited … Continue reading

Application for Research Funds

Types of funds
Nottingham University Hospitals (NUH) has access to a range of different funds from which research posts can be funded from. Please contact the Director of Research & Innovation or the Deputy Director of Research & Innovation for further … Continue reading

New grant funding opportunities- Prostate Cancer UK and Arthritis Research UK

Prostate Cancer UK has launched a new grant scheme in support of its recently updated ten-year Research Strategy, the Prostate Cancer UK Research Innovation Awards.
The strategy identifies three key areas where there are gaps in knowledge or expertise, which, when … Continue reading

PhD studentship opportunity- care home safety

The Centre for Health Innovation, Leadership and Learning, in collaboration with NIHR CLAHRC East Midlands and the East Midlands Patient Safety Collaborative is pleased to announce the following PhD studentship, which is now open for applications.
Applications are invited for … Continue reading

East Midlands CLAHRC Faculty Membership & Funding Opportunities

CLAHRC East Midlands is launching two new projects to encourage people across the East Midlands to become involved in research activities.
The CLAHRC East Midlands Faculty is for anyone who is:

Interested or involved in original research
Based in East … Continue reading

Nottingham Hospitals Charity and Research and Innovation launch Pump Priming Competition Autumn 2014

Applications are invited from medically qualified staff, nurses, allied health professionals and University staff for grant funding for research projects.
The scheme aims to ‘pump prime’ early studies by giving them a cash injection to get up and running. Projects should … Continue reading

HEEM Clinical Scholar Awards 14/15 announced

Health Education East Midlands (HEEM) are offering up to 10 places for NHS Nurses, Midwives, Allied Health Professionals, Health Visitors and Pharmacists registered in the East Midlands to join the Clinical Scholar Bronze and Silver Awards 2014/15. Applications are invited … Continue reading

NIHR/CNO Clinical Academic Training Studentship at the University of Nottingham

The University of Nottingham is one of only twelve universities in the country contracted by the National Institute for Health Research/Chief Nursing Officer (NIHR/CNO) to undertake a fully-funded Masters degree in Research Methods. The NIHR/CNO Clinical Academic Training Studentship … Continue reading

Nottingham Hospitals Charity and NUH Department of Research and Innovation launch Pump Priming Competition Spring 2014

Applications are invited from medically qualified staff, nurses, allied health professionals and University staff for grant funding for research projects from Nottingham Hospitals Charity and the Department of Research and Innovation.
The scheme aims to ‘pump prime’ early studies by giving … Continue reading

Nottingham Hospitals Charity and NUH Department of Research and Innovation Pump Priming Competition Autumn 2013

Applications are invited from medically qualified staff, nurses, allied health professionals and University staff for grant funding for research projects from NUH Charity and the Department of Research and Innovation.
The scheme aims to ‘pump prime’ early studies by giving them … Continue reading

Research Passports

What is a Research Passport?
The Research Passport System is a process for issuing Honorary Research Contracts or letters of access to researchers who are carrying out research in the NHS.
Why do I need a Research Passport?
If you are carrying … Continue reading

Pump Priming Competition Spring 2013 opens 4th March

Applications are invited from medically qualified staff, nurses, allied health professionals and university staff for grant funding for research projects from NUH Charity through the Department of Research and Innovation.

Research into Practice: Rachel Tomasevic, physiotherapy for patients with severe acute stroke

Rachel Tomasevic, stroke services team lead physiotherapist with Nottingham University Hospitals NHS Trust, was one of 11 successful candidates to gain a place on the Research into Practice programme, with initial research findings expected later in the year.

Research into Practice: Mike Bullock, evidence and interventions for osteoarthritis and falls in older, frail patients

Mike Bullock, a clinical lead physiotherapist with Nottingham University Hospitals NHS Trust, was one of 11 successful candidates to gain a place on the Research into Practice programme, with initial research findings expected later in the year. His research project will focus on the evidence and interventions for osteoarthritis and falls in older, frail patients. Continue reading

Research into Practice: Christine Huston, physiotherapy interventions for Parkinson’s

Christine Huston, a physiotherapist with Nottingham University Hospitals NHS Trust, won a place on the Research into Practice programme which is running from March 2012, with initial research findings expected to be produced later in the summer/autumn of this year. Her research project will focus on exploring specific physiotherapy interventions for patients with Parkinson’s Disease. Continue reading

Mary Seacole 2012/13 Awards: improving care for patients from black and minority ethnic communities

Do you have an idea about improving care for patients from black and minority ethnic communities? If so, make an application to the 2012/2013 Mary Seacole 2012/13 Awards. Closing date 1st May 2012.
Applications are invited from individual nurses, … Continue reading

IRAS e-submission process during new CSP module roll out

A new version of CSP software (the CSP Module) was launched last year in two phases. This phased approach means there are currently two ways to submit your application to CSP through IRAS depending on the version of IRAS your project was created in. This briefing helps you navigate the process. Continue reading

Head of IP and Contracts vacancy at NUH R&I, closing date for applicants 22nd Jan 2012

Do you wish to make a difference to clinical research and intellectual property management in the NHS? As the volume of research and innovation supported by NUH increases, as Head of IP and Contracts you will provide the legal services which NUH requires in the research related fields of intellectual property, commercial, competition, governance and corporate law. Continue reading

The Barbers’ Company Clinical Nursing Scholarship 2012

Enabling nurses in clinical nursing to undertake further education, research or a clinical project. The scholarship is worth up to £7,500 for fees or subsistence in undertaking a taught masters’ programme. The degree can be at an academic … Continue reading

£100,000 Available in Autumn Pump Priming Competition

Medical staff at NUH are being invited to apply for funding for research projects from Nottingham Hospitals Charity and the Department of Research and Innovation.
The scheme aims to “pump prime” early studies by giving them a cash injection to get … Continue reading

NUH Charity and NUH Department of Research and Development Pump Priming Competition Spring 2011

Medical staff at NUH are invited to apply for funding for research projects from NUH Charity and the Department of Research and Development. This scheme aims to “pump prime” early studies by giving them a cash injection to get up … Continue reading

East Midlands Regional Innovation Fund

The East Midlands Regional Innovation Fund for 2010/11 is now open for applications and will close on Friday 10th September 2010.
The primary aim of the 2010/11 RIF is to support the delivery of the Quality, Innovation, Productivity and Prevention (QIPP) … Continue reading

New MyAsthma app can help relieve the stress of asthma management

A new and unique smartphone app to help people with asthma manage their condition has been developed by lung experts at the Nottingham Respiratory Research Unit and the pharmaceutical company GlaxoSmithKline (GSK).
The MyAsthma app has been launched on the … Continue reading

Nottingham University Hospitals top trust in England for meeting the 70 Day benchmark

The Government’s Plan for Growth published in March 2011 publicised the transformation of incentives at local level for setting up and delivering research. At NUH we are committed to ensuring patients have the opportunity to participate in clinical trials when … Continue reading

Bubble: Phase 1B Study of buparlisib with Bortezomib in Defined Genetic Subgroups of Patients with Relapsed or Refractory Multiple Myeloma

Summary:
Multiple myeloma (MM) is an incurable disease that affects approximately 1520 per 100,000 people in the Western World. Advances in our understanding of the biology of MM have shown that there are different forms of the disease, because of the range of genetic lesions. This represents a major challenge in the development of therapies, and there is a great need to develop new drugs for patients with poor outcomes, linked to specific genetic abnormalities. Studies have shown that bortezomib (Bz) may be effective in improving the
outcome of such patients, however, the survival in this group is still poorer compared to patients without these
particular genetic abnormalities. Our group have identified that a new class of drugs may play a crucial role in targeting specific subtypes of MM. One such drug is BKM120 (BKM), which has shown to be effective in patients with other haematological cancers. We propose to evaluate the combination of BKM-Bz in patients with a specific genetic sub-type of MM in this early phase study. Initially, we aim to identify a safe dose of BKMBz
and then explore whether this dose is effective in treating patients with MM. Up to 60 patients in the UK will be recruited to this study.

Inclusion criteria:
• Male or female aged ≥16 years of age
• ECOG performance status ≤2
• Confirmed diagnosis of relapsed/refractory MM according to International Myeloma Working Group (IMWG) guidelines (2003) with 1-4 prior lines of therapy (i.e., relapsed from plateau phase, or refractory to last therapy). [Note: Prior treatment with bortezomib is permitted, provided the patient achieved at least a partial remission (PR) and had not progressed within 6 months of the last dose of bortezomib].
• Measurable disease as defined by one or more of the following criteria (assessed within 28 days prior to
registration):
o serum paraprotein ≥ 5 g/L (for IgA patients whose disease can only be reliably measured by serum quantitative immunoglobulin (IgA): ≥ 7.5 g/L)
o Urine Bence Jones Protein: ≥ 200 mg/24 h
o Serum light chain assay: Involved free light chain (FLC) level ≥ 100 mg/L, provided serum FLC ratio is abnormal
• Life expectancy of at least 3 months
• Patient has adequate bone marrow and organ function as defined by the following laboratory values:
o Neutrophils ≥ 1.5 x 109/L
o Haemoglobin ≥ 90 g/L
o Platelets ≥ 100 x 109/L
o International normalised ration (INR) ≤ 1.5
o Magnesium within normal limits of institution or correctable with supplements
o Potassium and calcium (corrected for albumin) within normal limits of institution or correctable with supplements
o Phosphorous ≥ LLN or correctable with supplements
o Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≤ 1.5 x ULN upper limit of normal range (or Exclusion criteria:
• Impaired cardiac function or clinically significant diseases, including any one of the following:
o Symptomatic congestive heart failure
o history of documented congestive heart failure (New York Heart Association functional classification III-IV),
documented cardiomyopathy
o Left Ventricular Ejection Fraction 480 msec on the screening ECG (using the QTcF formula)
o Currently receiving treatment with medication that has a known risk to prolong the QT interval or inducing Torsades de Pointes, and the treatment cannot be discontinued or switched to a different medication prior to starting study drug.
• Other clinically significant heart disease
• Acute or chronic liver disease
• Acute or chronic renal disease
• Poorly controlled diabetes mellitus
• Impairment of GI function or GI disease that may significantly alter the absorption of BKM )
• Known hypersensitivity to any of the excipients of buparlisib
• History of photosensitivity reactions to other drugs
• Patients with chronic pulmonary disease, including dyspnoea at rest from any cause, or with interstitial lung disease, are excluded from study entry

• Immunocompromised patients, including known seropositivity for HIV, current or chronic hepatitis B and/or hepatitis C infection.[Note: testing is not mandatory to be eligible for the study. However, if subject is at risk for having undiagnosed HBV/HCV (due to history of injection drug use or due to geographic location, for example), testing at screening should be considered]

• Patients who have other concurrent severe and/or uncontrolled medical conditions that would, in the investigator’s judgment, contraindicate patient participation in the clinical study (eg. active or uncontrolled severe infection, chronic active hepatitis, immuno-compromised, acute or chronic pancreatitis, uncontrolled high blood pressure, interstitial
lung disease, etc.)
• Concomitant or/ and previous therapy that precludes enrolment:
• Prior treatment with PI3K or Akt inhibitors
• Patient is concurrently using other approved or investigational antineoplastic agent
• Received anti-myeloma therapy within 28 days of starting treatment, except for dexamethasone, which must be stopped at least 48 hours prior to starting treatment (must have recovered to at least grade 1 or better (except alopecia) from related side effects of any prior antineoplastic therapy)
• Patient who has received wide field radiotherapy ≤ 4 weeks or limited field radiation for palliation ≤ 2 weeks prior to starting study drug or who have not recovered to grade 1 or better from related side effects of such therapy (except alopecia)
• Major surgery within 14 days prior to starting study drug or the patient has not recovered from major side effects of the surgery
• Receiving any of the following drugs at the time of study registration:
o Drugs known to be moderate and strong inhibitors or inducers of isoenzyme CYP3A4 including herbal medications
o Currently receiving increasing or chronic treatment (> 5 days) with corticosteroids or another immunosuppressive
agent, as chronic administration of corticosteroids (>5 days) can induce CYP3A4. The following uses of corticosteroids are permitted: single doses; e.g., with standard premedication for taxanes; topical applications (e.g., rash), inhaled sprays (e.g., obstructive airways diseases), eye drops or local injections (e.g., intra-articular)
o Receiving drugs with a known risk to induce Torsades de Pointes
o the patient must have discontinued strong inducers for at least one week and must have discontinued strong
inhibitors before the treatment is initiated. Switching to a different medication prior to starting study treatment is
allowed.
o Warfarin or other coumarin derived anti-coagulant,
for treatment, prophylaxis or otherwise. Therapy with heparin, low molecular weight heparin (LMWH), or fondaparinux is allowed

• Patient has a concurrent malignancy or malignancy within 3 years of study enrolment

• Patient has a score of ≥12 on the PHQ9
questionnaire, or a GAD-7 mood scale score ≥15.
• Patient selects a response of “1, 2 or 3” to question number 9 on the PHQ-9 questionnaire regarding potential for suicidal thoughts or ideation (independent of the total score of the PHQ-9)
• Patient has a medically documented history of or active major depressive episode
• Participation in a prior investigational study within 30 days prior to enrolment or within 5-half-lives
of the investigational product, whichever is longer
• Patient has a history of non-compliance
to medical regimen or inability to grant consent;
• Pregnant or lactating women
• Adults or reproductive potential not willing to practice effective contraception during the trial and for up to 8 weeks after IMP

Principal Investigator for this trial: Dr Cathy Williams

Research Ethics Committee Reference: 15/LO/0304

Contact us about participating in this study by emailing R&IActiveStudyEnquiries@nuh.nhs.uk or telephoning 0115 924 9924 Ext. 70076 Continue reading

HRA Approval

HRA approval was implemented to make it easier to undertake health research in the NHS in England and to simplify the process of approval for researchers, reducing the time and cost of setting up studies. HRA Approval has been implemented … Continue reading

New NHS Research Approval Process goes live

The Health Research Authority (HRA) is introducing a new approval process for NHS research, which will be implemented from winter 2015.
What does this mean?
This new process will create a single point of assessment for all research studies, which will … Continue reading

Genetic and Physiological Investigation of Patients with Rare Segmental Overgrowth Disorders, Lipoblastomas or Hemihypertrophy

Summary:
Segmental overgrowth, which is abnormal growth confined to only some parts of the body, is a feature of a group of rare, poorly classified disorders which carry a significant burden of morbidity and mortality. Proteus syndrome is one of the better characterised examples of segmental overgrowth and in recently published work has been shown to be due to an activating genetic mutation in AKT1, a gene responsible for growth and metabolism. Lipoblastomas are rare benign fatty tumours arising from embryonal fat and are therefore, a variant form of segmental overgrowth. Hemihypertrophy is a congenital condition in which one side of the body is larger than the other and is clinically and genetically similar to syndromes of segmental overgrowth. The chief investigator has recently identified different activating mutations in the same growth pathway affected in Proteus syndrome in a subset of patients with hemihypertrophy (in AKT2), and in a subset of patients with non Proteus segmental overgrowth (in PIK3CA), establishing a general paradigm, and immediately suggesting the possibility of further mutations in allied conditions. These linked observations suggest new avenues for treatment, and also open up new opportunities to study cells and tissue samples from affected patients in order to improve understanding of the regulation of growth pathways that are closely involved in disorders including cancer and diabetes. The aim of this application is to widen the range of overgrowth disorders studied, and to permit focussed exploration of these questions. Specifically, the study aims to investigate patients with any form of segmental overgrowth, hemihypertorphy or lipoblastomas from a genetic and physiological viewpoint. When we identify new genetic variants, participants will be invited to participate in further phenotyping studies aimed at improving understanding of their condition, informing decisions about therapy, and giving insights into cellular growth control and metabolism.

Inclusion criteria:
Segmental overgrowth OR Lipoblastoma OR Hemihypertrophy AND Clinicall y stable enough to undergo testing safely

Exclusion criteria:
Pregnant or breastfeeding OR Any current medical disorder or medication likely to impair ability to follow the study protocol safely and effectively. OR Incapacity to give informed consent.

Principal Investigator for this trial: Dr Rachel Harrison

Research Ethics Committee Reference: 12/EE/0405

Contact us about participating in this study by emailing R&IActiveStudyEnquiries@nuh.nhs.uk or telephoning 0115 924 9924 Ext. 70076 Continue reading

NUH Research Award Management Services

If you are making an application for research grant funding you will need access to the NUH Research Award Management Service available as part of the business unit in R&I.
The experienced team can support you in:

Identifying appropriate funding streams … Continue reading

Nottingham Dermatology Expert recognised for excellence in research

Professor Hywel Williams, Director of the Centre of Evidence Based Dermatology, has been elected to the Fellowship of the Academy of Medical Sciences for his contribution to the advancement of medical science in skin diseases.
Academy Fellows are elected for excellence … Continue reading

Characteristics and outcomes of childhood moyamoya in the UK

Summary:
Moyamoya is a rare condition affecting the blood vessels of the brain, leading to strokes. Whilst it is common and well studied in Japanese, less is known about how it affects people of other ethnicities. Clinical experience in a UK moyamoya service suggests that there are likely to be important differences in the effects of the condition in UK patients. This information is important as the treatment approach advocated in Japanese (surgery) may not be appropriate or necessary in UK patients. The aims of this proposal are (i) to use an existing system of surveying Paediatric Neurologists in the UK to identify cases of childhood moyamoya (ii)to centrally review the brain scans of these children to establish that all patients have scan changes that meet the disease definition (iii) to obtain simple data on the presenting features and outcomes using a questionnaire. These data will be used to provide support for a funding application for a future more substantial, population based study of moyamoya, investigating its frequency, disease mechanisms and outcomes.

Inclusion criteria:
Children (birth to 18 years) with (i) bilateral occlusive disease of the terminal internal carotid/middle cerebral/anterior cerebral arteries with or without basal collaterals on any imaging modality or (ii) unilateral occlusive disease of the terminal internal carotid/middle cerebral/anterior cerebral arteries with basal collaterals.

Exclusion criteria:
Does not meet radiological disease definition inadequate imaging assessment.

Principal Investigator for this trial: Dr Gabby C S Chow

Research Ethics Committee Reference: 14/LO/0323

Contact us about participating in this study by emailing R&IActiveStudyEnquiries@nuh.nhs.uk or telephoning 0115 924 9924 Ext. 70076 Continue reading

Hemostasis of Active GI Luminal Tract Bleeding (HALT)(study # 10017)

Summary:
Duodenal and gastric ulcers (termed peptic ulcers) are common occurences. Bleeding from these ulcers is one of the
commonest reasons for admission to hospital causing significant clinical and economic burden and resulting in
17,000-20,000
hospital admissions per year in the UK. In the last two decades there have been major advances in the clinical and
endoscopic management of peptic ulcer bleeding. However, mortality remains high at around 10%,particularly in the
elderly and in those with significant other diseases. The National Institute for Clinical Excellence
(NICE) has issued guidance on the management of peptic ulcer bleeds and recommend the early use of endoscopy
(an instrument used to visualize the gastrointestinal tract) to diagnose the source of bleeding and to provide
treatment.Currently we use three different modalities to treat peptic ulcer bleeding: a) injection of adrenaline, b)the use
of electrocautery and c)the use of mechanical devices such as clips. Most of these techniques require direct tissue
contact to stop the bleeding and this can be technically challenging. Therefore, in a number of cases either the
bleeding cannot be controlled at the time of the index endoscopy or there is recurrent bleeding within 72 hours of the
first bleed. Recently a new technique called Hemospray (Cook Medical) has been shown to be effective in controlling
bleeding from peptic ulcers. This technique utilises application of non toxic proprietary powder that is applied onto the
bleeding site via endoscope using a catheter in short spray bursts. The powder adheres to the bleeding source and
rapidly achieve control of bleeding. This study will evaluate the effectiveness of Hemospray to control the more serious
(NICE) has issued guidance on the management of peptic ulcer bleeds and recommend the early use of endoscopy
(an instrument used to visualize the gastrointestinal tract) to diagnose the source of bleeding and to provide
treatment.Currently we use three different modalities to treat peptic ulcer bleeding: a) injection of adrenaline, b)the use
of electrocautery and c)the use of mechanical devices such as clips. Most of these techniques require direct tissue
contact to stop the bleeding and this can be technically challenging. Therefore, in a number of cases either the
bleeding cannot be controlled at the time of the index endoscopy or there is recurrent bleeding within 72 hours of the
first bleed. Recently a new technique called Hemospray (Cook Medical) has been shown to be effective in controlling
bleeding from peptic ulcers. This technique utilises application of non toxic proprietary powder that is applied onto the
bleeding site via endoscope using a catheter in short spray bursts. The powder adheres to the bleeding source and
rapidly achieve control of bleeding. This study will evaluate the effectiveness of Hemospray to control the more serious
bleeds from peptic ulcers (termed Forrest Ia and Ib)

Inclusion criteria:
Patient requires hemostasis for nonvariceal GI bleeding. Specifically, the patient must have an actively bleeding peptic
ulcer with a Forrest score of 1a or 1b (spurting or oozing)

Exclusion criteria:
 Patient is 1.5

Principal Investigator for this trial: Dr Krish Ragunath

Research Ethics Committee Reference: 13/YH/0334

Contact us about participating in this study by emailing R&IActiveStudyEnquiries@nuh.nhs.uk or telephoning 0115 924 9924 Ext. 70076 Continue reading

Vacancies for Divisional Clinical Research Leads in NIHR Clinical Research Network: East Midlands

The National Institute of Health Research (NIHR) Clinical Research Network: East Midlands (hosted by University Hospitals of Leicester) is inviting applications for the role of Clinical Research Lead for each of the six Research Divisions to be established in April … Continue reading

NUH R&I brings clinical trial initiation down to 57 days

NUH has once again achieved an outstanding performance benchmark for initiating clinical trials in a large University hospital setting. We now set up and recruit patients in complex clinical trials in an average of 57 days, an improvement from 65 … Continue reading

Marker Capsules: A new, non-invasive tool for assessing gut motility and sensitivity

A novel diagnostic process involving MRI imaging and High Resolution Manometry (HRM) to provide insight in to the complete function of the gut, has been developed and validated by a team from National Institute of Health Research Nottingham Digestive Diseases … Continue reading

Intellectual Property Management

Nottingham University Hospitals NHS Trust recognises that its staff, from any discipline or sector, can be innovative, generate new ideas and find solutions to problems which given the opportunity, lead to improvements in the delivery of healthcare.
We are here to … Continue reading

Vacancy: Senior Research Manager (Regulatory Compliance & Award Management)

NUH Research & Innovation has a vacancy for a Senior Research Manager to lead on Regulatory Compliance & Award management.

NUH Research, Development and Innovation Annual Report 2012/13

During 2012/13 NUH delivered significant improvements in research initiation and delivery. Performance against NIHR contract benchmarks for research initiation and delivery improved by 36% yoy

Nottingham: how we beat the 70 day benchmark for clinical trial initiation

NUH achieved an outstanding performance benchmark for initiating clinical trials in a large University hospital setting. We now set up and recruit patients in complex clinical trials in just 65 days.

Health Education East Midlands launches Clinical Academic Careers Internship

Health Education East Midlands are launching their new Clinical Academic Careers Internship for the year, following last year’s success.
Information about the programme can be found at on the clinical scholar website, along with information on how to apply to … Continue reading

LEUCOPATCHTM IN THE MANAGEMENT OF HARD-TO-HEAL DIABETIC FOOT ULCERS

Summary:
Diabetic foot ulcers are the source of considerable suffering and cost and there are currently no wound care products
available that have been demonstrated to improve healing, or that are cost effective. There have however been a small
number of studies which have examined the use of platelets or fluid derived from platelets, either from the patients own
blood or from blood bank products. These have suggested some promise, but have suffered from technical difficulties
in making a suitable wound care product or the volume of blood required to derive the product. It is thought that the
reason why they may work is that growth factors released by the platelets may stimulate the wound to heal.
This study will be a formal, randomised controlled trial to assess a new device for creating a wound care product which
is a plug or patch conprising fibrin, white cells and platelets derived from 18 mls of the patients own blood. The
application of this fibrin/white cell/platelet patch to the patients wound on a weekly basis will be compared with usual
best care in patients with hard to heal Diabetic Foot Ulcers in a secondary care setting in 25 centres in the UK,
Denmark and Sweden..

Inclusion criteria:
1.People aged 18 years and over who have diabetes complicated by one or more ulcers of on a foot or both feet below the level of the malleoli, excluding ulcers confined to the interdigital cleft.
2. Those with more than one eligible ulcer will have one ­ -usually the largest or more clinically significant ­ selected at
screening as the index ulcer.
3. Eligible ulcers will be hard-to-heal, meaning that the cross-sectional area will decrease by less than 50 % during a four week runin period.
3. HbA1c 108 mmol/mol at screening
4. The cross-sectional area of the index ulcer will be 50 and 1000 mm2 at the end of the 4 week runin period.
5. The index ulcer will be clinically non-infected according to IDSA criteria
6. Either the ankle-brachial index (ABPI) in the affected limb will be between 0.50 and 1.40 or the dorsalis pedis pulse and/or tibialis posterior pulse will be palpable.
7. Participants will have the capacity to understand study procedures, and will be able to provided written informed
consent.

Exclusion criteria:
1.Haemoglobin concentration Principal Investigator for this trial: Professor William Jeffcoate

Research Ethics Committee Reference: 13/WM/0202

Contact us about participating in this study by emailing R&IActiveStudyEnquiries@nuh.nhs.uk or telephoning 0115 924 9924 Ext. 70076 Continue reading

June Learning Event: Designing Applied Health Research From Idea to Bid Proposal

A 2 Day Learning Event, June 4th and 5th 2013 from Research Design Service for the East Midlands. This course is designed to help in the preparation of applications to the National Institute for Health Research or other research funding body. Continue reading

HRA research approval assessment moves to pilot stage

The HRA is to run a small live pilot in the North West of a single application to further explore the feasibility of streamlining the NHS research approval process. Continue reading

Mentorship Programme

Inspiring and supporting the next generation – The Nottinghamshire Non-Medical Clinical Academic Career Mentorship Programme
With our partners at Nottingham City Care Partnership and the Medical and Health Science Faculty, University of Nottingham, NUH led a successful bid for clinical academic … Continue reading

East Midlands RDS news & funding opportunities updates

The January 2013 edition of Take Five from the East Midlands RDS contains a listing of training events, latest research funding opportunities, health news and links to websites of interest to researchers.

Exciting research in clinical practice training opportunity for graduate nurses, midwives and AHPs

NUH, in partnership with Nottingham City Care Partnership and the University of Nottingham have secured funding for graduate nurses, midwives and AHPs to receive mentorship support and training in combining research within clinical practice roles.

NUH graduate Nurses, Midwives and Allied Health Professionals Internship Opportunities worth up to £10K

Calling all NUH graduate Nurses, Midwives and Allied Health Professionals
If you are interested in gaining more confidence in your use of research evidence in practice – then this is for you!
The Midlands and East, and East Midlands Health Innovation Education … Continue reading

Vacancy: NUH R&I Quality Assurance / GCP Manager, extended to 16th September

NUH R&I seeks to appoint a QA/GCP Manager to assure the quality of clinical research undertaken within Nottingham University Hospitals NHS Trust in accordance with legislative and best practice requirements. This is a key role in the co-ordination of working practices, policy implementation and preparation for external audits and MHRA inspection. Continue reading

EU Commission recommends clinical trial simplification by 2016, including harmonisation across member states

A proposal from the EU Commission seeks to boost clinical research in Europe by simplifying the rules for conducting clinical trials.
Once implemented, the proposed measures will speed up and simplify the authorisation and reporting procedures, while maintaining the highest standards … Continue reading

DeNDRoN Dementia funding call for studies researching prevention through public awareness and earlier presentation

The NIHR and ESRC have launched a call of £13 million into social science research on dementia. This coincides with the launch of a new website for the Dementias & Neurodegenerative Diseases Research Network (DeNDRoN)

Standard Operating Procedures

Please refer to this page frequently to ensure the correct SOP is used
To access templates and forms associated with individual SOPs please refer to Templates and Forms.
All links in this section are direct downloads for pdfs
R&I have reviewed … Continue reading

Three research fellow vacancies at Nottingham’s Centre for Spinal Studies and Surgery

Three research fellow posts have become available at the Centre for Spinal Studies and Surgery at Nottingham University Hospitals. One with immediate effect and two later in the year. The new fellows will join two research fellows already in post. … Continue reading

H@N: Liberation through technology means more time for direct clinical activity

NUH implemented a novel technological solution to address communication issues outside usual working hours in a highly successful project led by Dominick Shaw and Andrew Fearn. The wireless system has won an innovation award from Cisco. The data from the programme is being used by John Blakey to quantify and compare clinical activity, providing rapid and relevant information to improve services and training. Continue reading

Host and viral factors associated with outcomes of infection with hepatitis C virus

Summary:
Chronic hepatitis C virus (HCV) infection is a global health problem with an estimated 170 million people infected worldwide, and at least 250,000 within the UK. Questions relating to the natural history of HCV infection remain unanswered, including (i) Why 25% of infected individuals clear the infection spontaneously, (ii) Why 50% of chronically infected patients treated with current therapy clear the infection, but 50% don’t, and (iii) Why some patients with chronic infection develop lifethreatening complications in a relatively short time period, whereas others don’t? Addressing such questions is fundamental to the development of clear management guidelines for infected patients overall, and of individual patientcentred care. Recently work has identified a genetic marker (IL28B) associated with response to treatment in certain patient subgroups. Other factors, such as age, gender, obesity (body mass index), alcohol consumption, and some features of the virus itself (viral genotype) also influence disease outcome. However, the relative contributions of these different factors towards disease outcome is not clear, and also, the HCV infected population in the UK has characteristics that make it difficult to extrapolate information from studies performed elsewhere. A particular issue is whether knowledge of the IL28B genetic makeup of an individual alters patient management in any way. This application is part of a broader enterprise to collect clinical data and biological samples from 10,000 HCVinfected individuals in the UK to enhance future research and thereby improve patient care. A specific study will be conducted to determine the relative contributions of a range of host and viral factors to disease outcomes (spontaneous clearance/chronic infection sustained virological response/nonresponse to current standard of care therapy development of cirrhosis development of hepatocellular carcinoma). The clinical utility of performing IL28B genotyping as part of routine clinical care of HCVinfected patients in the UK will be determined.

Inclusion criteria:
Patients should have evidence of past or current hepatitis C virus infection.

Exclusion criteria:
Inability to provide written informed consent (either personally or through an appropriate legal guardian in the case of children).

Principal Investigator for this trial: Professor. William L Irving

Research Ethics Committee Reference: 11/EM/0314

Contact us about participating in this study by emailing R&IActiveStudyEnquiries@nuh.nhs.uk or telephoning 0115 924 9924 Ext. 70076 Continue reading

i4i Challenge Awards programme allocated £15 million over the next three years

The NIHR i4i programme is launching a new funding stream – the i4i Challenge Awards programme – that aims to support researchers to demonstrate the healthcare benefits of their prototype medical devices in a clinical setting. The NIHR has allocated £15 million over the next three years to this new programme. A typical i4i Challenge Award project will prototype a medical device that has been developed to aid the identification, diagnosis or monitoring of a single disease in everyday clinical practice. Continue reading

Immediate development opportunity for Research into Practice Placement

CLAHRC-NDL is pleased to provide a fully funded development opportunity for to up to six nurses, Allied Health Professionals or members of other professions, to spend 3-6 months, either full or part time, commencing in January 2012, or as soon … Continue reading

Plan for Growth healthcare research update in Chancellor’s Autumn Statement

The Chancellor’s Autumn Statement includes a report on progress achieved with the measures contained in the March 2011 Plan for Growth. We’ve reproduced here all the 16 paragraphs that relate to Healthcare and Life Sciences. Continue reading

Dr Rachel Evley

Dr Rachel Evley
University Division on Anaesthesia & Intensive Care
C Floor, East Block
QMC Campus
Nottingham University Hospitals NHS Trust
NG7 2UH
Email: Rachel.Evley@nottingham.ac.uk
Tel:0115 8231004
Role
Researcher
University Division of Anaesthesia & Intensive Care
Biography
I qualified in 1995 from Sheffield University and after a brief period at the Derbyshire … Continue reading

NIHR Workshop on Surgery Research: Researcher Briefing Event

NIHR is keen to increase the volume and impact of research in surgery and will be holding a national workshop on surgery research at the Royal College of Surgeons of England, London on Thursday 9 February 2012. The workshop is designed to provide the surgical research community with an opportunity to hear about existing sources of research funding and to help researchers prepare for future funding opportunities. Continue reading

Joseph Manning

Name/Contact details
Joseph Manning
Faculty of Medicine & Health Sciences
School of Nursing, Midwifery & Physiotherapy
Room B43,
Medical School,
Queens Medical Centre
Nottingham
NG7 2UH
Tel: 0115 82 30869
Fax: 0115 8231211
Email: Joseph.Manning@nottingham.ac.uk
Website
Role
Research Fellow / PhD student -NIHR/NUH NHS Trust Translational Research Fellowship
Honorary Paediatric Intensive Care Nurse, Nottingham Children’s … Continue reading

New Health Research Authority will have National Research Ethics Service at its core

Legislation to establish the new Health Research Authority was laid before Parliament today. The Authority will provide a new pathway for the regulation and governance of health research. The aim is to streamline regulation, create a unified approval process, and promote proportionate standards for compliance and inspection within a consistent national system of research governance. Created initially as a Special Health Authority, the Health Research Authority will have the National Research Ethics Service at its core. Continue reading

I would like to involve PPI in the design of my project but I have no budget. Who will pay for this?

Currently the Research Design Service offers a grant of up to £500 for the pre-protocol stage of national and competitively funded research. These awards allow researchers from health and social care to engage patients and the public to develop their … Continue reading

Does it cost money to involve patients and the public?

Yes. You will need to budget for patients and members of the public travel to attend meetings and staff resources required to support them. You may also need to support patients and the public with childcare or carer costs and … Continue reading

R&I Approvals

In 2016 the way that research carried out in the NHS is reviewed has changed. HRA Approval is the new process for the NHS in England that brings together the assessment of governance and legal compliance, undertaken by dedicated HRA … Continue reading

R&I Team Profiles

Dr Steve Ryder
Director of Research
Since June 1994 Dr Ryder has been a consultant Physician in Hepatology and Gastroenterology at the Nottingham Digestive Diseases Centre and Biomedical Research Unit. His major clinical and research interest is hepatitis C infection.
Dr Ryder … Continue reading

Professor Hywel Williams, keynote at Nursing and Midwifery Research Strategy’s Engage, Enthuse, Empower

The Nursing and Midwifery Research Strategy Group’s “Engage, Enthuse, Empower” conference celebrates the diversity of research and innovation undertaken by non-medical professionals within Nottingham University Hospitals NHS Trust. It’s taking place on Tuesday 19th April 2011, 08.30 – 16.00 at … Continue reading

School of Nursing, Midwifery and Physiotherapy fully funded Masters Studentships for 2011

Nottingham University’s School of Nursing, Midwifery and Physiotherapy is delighted to announce the 2011 round of Masters Studentships, fully-funded by the National Institute for Health Research (NIHR).
The Studentship starts in September 2011 and covers full tuition fees, employee salaries and … Continue reading

Regulatory Standards

Below is a selection of links related to regulatory standards which are relevant to Healthcare research in the UK. If you cannot find what you are looking for then please contact us on 0115 9709049.

General

Research Governance Framework, 2nd ed

Legislation & … Continue reading

Life Sciences Industry

Commercial research is important to NUH as the driving force for the adoption and diffusion of innovation.

It is through this process that new treatments, devices or laboratory tests are studied and brought forward for use by patients and staff.
Nottingham … Continue reading

A new guide to NUH R&D finance processes

A comprehensive guide to NUH R&D finance has been written, collated and published by our Corporate Finance Manager Paul Barnett. Available on this site, it includes valuable information for anyone needing to cost a project and go though the financial … Continue reading

Costing Local NUH Non Commercial Studies

Guidance
In comparison with commercial contract NHS research, the funding arrangements for non-commercial NHS research can be more complex and can involve a number of partner organisations. It is essential that both the NHS and its partner organisations understand the full … Continue reading

Nottingham Research Biobank gains Ethics Approval

The Nottingham Research Biobank has now received Ethical Approval. This is the first formal step in our co-ordinated biobanking and patient informatics strategy. The Ethics approval itself has a number of unique features, and is by far the most comprehensive … Continue reading

Shine Awards – Innovation Funding Opportunity

Shine is The Health Foundation’s new annual award focusing on innovation. Each year they will be looking for ideas that tackle a key challenge to high quality care. The Shine challenge for 2011 is: find new approaches to … Continue reading

European Innovation Funding Health Call

A final draft version of this year’s FP7 Health Work Programme is due to be available at the end of the month. (This year’s call is known as the 2011 call as projects are due to start in 2011).
The total … Continue reading

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