NIHR Research Design Service South EastNewsletter 4 • Winter 2012

In this issue:

RDS in the South East

Clinical Trials Unit

Involving thepublic in research

News in brief

Ask Dr Claire Agony Aunt

Over 30 NIHR Research for PatientBenefit programme researchprojects have been funded in thesouth east since 2006 andaccording to Professor Valerie Hall,Director of the Research DesignService South East, ‘researchershave made a big impact on localservices through research projectsfunded by the programme’.

By generating research evidence, theprogramme aims to strengthen the waythat healthcare is delivered for patients, thepublic and users of NHS and social careservices. Researchers can now bid for up to£350,000 over three years, a recent£100,000 hike, making the fund evenmore attractive than before.

Projects include the world’s first controlledstudy of the benefits of community singingwhich recently concluded and reportedpositive impacts for older people. The twoyear research project assessed the impactof singing groups on the physical andmental health of older people in Kent.

Dr John Rodriguez, Assistant Director ofPublic Health, NHS Kent and Medway, said:‘It’s great to have world-class local researchlike this. We now have some of the bestquality evidence there is for the costs andbenefits of group singing for improvingolder people’s mental health and wellbeing.’

Almost all researchers making bids to theRfPB programme come to the RDS SE forhelp to get funded. They appreciatedetailed advice on technical aspects of bid

development and our ability to stand backand give an overview of the whole projectand its likelihood of success.

But Professor Hall warns that an early startis vital. ‘If you have a research idea youwant help developing, involve the RDSright at the start. Up to eight weeks beforethe submission deadline may give usenough time to help you, but it dependson how well formed your proposal is.

Remember, we will be working on anumber of proposals at any given time, socoming to us early is really important.Similarly, if you think you are going to needto involve a clinical trials unit, contact usearly so we can help find the appropriateorganisation to partner you in your bid.’

South East reaping benefit oflocally developed research evidence

www.rds-se.nihr.ac.uk

Dr Edmund Lamb, of East KentHospitals University NHSFoundation Trust, contacted theRDS SE for advice on this project acouple of months beforesubmitting his application to theNIHR Research for Patient Benefitprogramme.

Although the application was welldeveloped, he wanted advice on how toinvolve patients in a study which washighly technical in nature and concept.‘The study is designed to derive estimatesof variation of markers of kidney damage,so called biological variation, and this is adifficult concept to put across to non-scientists’, Dr Lamb explained.

‘After talking to RDS SE PPI lead, AmandaBates, the project was reviewed by theRDS patient and public involvement reviewpanel who worked on ways to make thestudy more acceptable for participants’.

Dr Lamb also wanted advice on how largea sample was needed and how many testswould need to be carried out on eachpatient. ‘It turned out that patients neededto give a blood and urine sample everyweek for six weeks, so improvingacceptability was a real issue. If patientsdrop out of a study because it is difficult orinconvenient for them, then a largersample size would be needed. Gettingpatient views on the practicalities of theproject was really advantageous’, Dr Lambconcluded.

Research Advisor Charlotte Brigdencoordinated delivery of support to Dr Lamband reviewed application drafts. She foundthat ‘Initially, the language would not haveexplained to the funding committee justhow patients would benefit, it was tootechnical’. ‘We helped explain that earlieridentification and treatment of acutekidney injury was dependent on knowingthe normal variation of markers of thedisease, hence enabling suddendeterioration to be identified. It was reallysatisfying to be able to tease out how toturn a great idea into a fundable project’,she concluded.

2

Successful RfPB applications andhow the RDS helped them

www.rds-se.nihr.ac.uk

Dr Lamb’s research team from the Kent and Canterbury Hospital.

Using markers of kidney damage to detect sudden change in acute disease

3Research by design

Hearing voices is not unusual andis common amongst people whohave a diagnosis of schizophrenia.It is often associated with highlevels of distress, low self-esteemand social isolation.

In collaboration with their research teamheaded by Professor Paul Chadwick(Institute of Psychology, London), Dr MarkHayward and Dr Clara Strauss of SussexNHS Partnership Foundation Trust, piloteda mindfulness meditation based group

therapy for people who hear distressingvoices using a pre-post design. They cameto the RDS for help with an application totest its benefits using a more robustdesign. ‘We couldn’t be sure that thebenefits we found in the uncontrolled pilotstudy were attributable to the therapy, asthe changes might have occurredspontaneously or in response to otheraspects of treatment. So we wanted todevelop a strong research design toestablish if therapy groups really add to thebenefits derived from the usual carereceived from mental health teams.’

‘We worked with the RDS statistician whohelped us design a randomised controlledtrial. He also helped us work out howmany patients to recruit to make a robustproject,‘ he explained.

The project was funded by the NIHRResearch for Patient Benefit programme.

Does mindfulness meditation help people who hear voices?

Clinical and Research PsychologistDr Kathryn Greenwood soughtthe help of RDS Advisor ClaireRosten for help with qualitativeresearch methods for a projectto engage young people withEarly Intervention in Psychosis(EIP) services.

Dr Greenwood explained ‘I am workingwith Sussex Partnership NHS FoundationTrust to find out why nearly a third ofyoung patients with psychosis locally,nationally and internationally drop out ofservices in the first 12 months. The RDShelped design a study which comparesthe proportion of people who disengagefrom EIP services pre and post the newengagement intervention to determinethe impact on engagement. Interviewswith service users, carers and staff willexplore perceptions of the intervention inmore depth. The outcomes anddissemination approaches will enable thedevelopment of a larger more definitivestudy by the research team.’

Research Advisor Claire Rosten helpeddesign a study which uses focus groupswith young people, service users andfamilies will find out what helps andhinders engagement. The study teamwill then consult with healthprofessionals, managers andcommissioners to develop serviceadaptations, based on the outcomeof the focus groups.

EIP staff will receive booklets, a website,training and consultancy to enable themto implement the adaptations, which willinclude changes in the use of information,approaches to engagement andinvolvement of young people.

The project was funded by the NIHRResearch for Patient Benefit programme.

See more successful RfPB bids at: www.rds-se.nihr.ac.uk/funding/rfpb-holders/

Testing early intervention for young people with psychosis

4

Standard questions on NIHRfunding programme applicationforms ask which Clinical Trials Unit(CTU) the research team plan towork with. CTU involvement isn’talways necessary, and the RDS SEcan help researchers explain whynot in their application. But someNIHR programmes strongly adviseit, so David Crook, RDS SE ResearchAdvisor and advisor with theClinical Investigation and ResearchUnit (CIRU) in Brighton, answerssome questions about CTUs andwhat they do:

What does a CTU do?CTUs design, coordinate and analyseclinical trials and other studies. Someconcentrate on certain diseases and othersare involved in all aspects of healthcare,but may concentrate on a phase ofresearch or a particular research method.CTUs have expert infrastructure to supportall stages of a trial.

When did CTUs becomeimportant?The Medical Research Council setup thefirst one in 1948, after the introduction ofnew drugs to treat TB. It was hoped thatcentralising trials would increase researchquality. CTUs became centres of excellencefor trials for lung disease, cancer, HIV,multiple sclerosis, rheumatism and bloodtransfusion. This concentration of expertisemade it possible for CTUs to become co-ordinating centres for large multicentretrials. Professor Dame Sally Davies, DirectorGeneral of Research and Development,Department of Health has said that,‘Clinical Trials Units are central to our visionof expanding clinical trials in the country.’

How many CTUs are there?There are 37 fully registered CTUs and nineprovisionally registered units. CTUs arenetworked and the registration processwas introduced to ensure quality. NewerCTUs can apply for provisional registration.

Who works in a CTU?CTU staff include statisticians, trialmanagers, information technologyspecialists and clinicians. Trials units areoften in or nearby hospitals, not leastbecause of the need for rapid medical carein the very rare event of an emergency.Staff are often opinion leaders in their fieldand may specialise in innovative methods.

When do I need to involve a CTU?NIHR looks favourably on applicants whohave partnered with a CTU because theyplay a crucial role in helping to deliver highquality research projects. Both the NIHRHTA and EME funding programmesstrongly advise researchers to collaboratewith a CTU.

How do I find a CTU to work with?If you don’t already have links with a unit,or know of one that shares your researchinterests, then the RDS SE can help brokercollaborations. I am co-located with CIRUat the Royal Sussex County Hospital and If Iam working with a researcher on a trial, Ican go across the corridor and ask aquestion, so it’s a huge advantage.

Why involve a clinical trials unitin a research project?

www.rds-se.nihr.ac.uk

Research by design 5

RDS Advisors in Surrey are co-located withthe Surrey Clinical Research Centre,Relationships are being built with the Bartsand The London Pragmatic Clinical TrialsUnit and Kings Clinical Trials Unit at King’sHealth Partners and we are building linksto other CTUs in England.

When should I start working witha CTU?As with all aspects of research design, theearlier you make contact with a CTU thebetter.

At there any pitfalls I should beaware of?There is potential tension between theresearch team and a prospective CTUpartner. Researchers may be working witha statistician on the design of the trial, butthe CTU may prefer to use their ownstatisticians for the design and if theproject is funded. These issues need to beaddressed and again, the RDS can help.

New Health PsychologyLead for RDS SE

Research Advisor Dr KateHamilton-West is the newlydesignated Health PsychologyLead for the RDS SE. In aninitiative to raise awareness ofthe contribution healthpsychology can make instrengthening research design.

Kate can help identify the mostappropriate theories for a specific researchproject, and advise on appropriatetechniques to effect behaviour change.Kate says that ‘grant awarding bodies areincreasingly aware of the contributionbehavioural medicine and healthpsychology can make towardsstrengthening research proposals’.

The role of health psychologists is tounderstand the link between individualperceptions, beliefs and behaviours andbiological processes which result in healthproblems. Human behaviour isincreasingly recognised as a majordeterminant of health. Examples includesmoking, physical activity levels andalcohol or drug consumption.

Dr Hamilton-West can be contacted at:Centre for Health Services StudiesUniversity of KentE: K.E.Hamilton-West@kent.ac.ukT: 01227 823872

www.rds-se.nihr.ac.uk/contact/hamilton-west

Take a look at the Leicester Clinical Trials Unit’s diagram, which illustrates standardtrial processes and the potential involvement of a trial unit:

For more more information on local units go to:

The Brighton & Sussex University Hospital Foundation Clinical Investigation Research Unitwww.bsuh.nhs.uk/research

The Surrey Clinical Research Centrewww.surreyclinicalresearchcentre.com

Trial Development Trial and Data Management Analysis andReporting

Set up Finalise protocol Write PIS & CFs Obtain REC, MHRA, R&Dapprovals

Database build Site initiation

Concept/designdevelopment

Liaison with the RDS Patient and publicinvolvement

Protocol writing Peer review Funding applicationFunding awarded

Trial conduct Trial oversight (TSG, IDMC) Enrolment of study participants TMF maintenance Budget management Trial coordination Pharmacovigilance Data collection and quality control IMP accountability Monitoring Progress and safety reports Interim analyses

Statistical analysis Final reports to REC& MHRA

Funding reconciliation Report writing Archiving

Close down Last participant followed up Trial reconciliation Site closure Database lock

6

2.Help with involving patients and thepublic in project designSE Research Advisors help researchersto make sure their research is relevant,answers the questions people need tohave answered and help set up linkswith patients and users of NHS services.Recent users of the services have saidthis help:

‘made the study more relevantto the on-going concerns ofcarers and continues to informthe methodologicaldevelopment of the bid.’

‘was invaluable in helping tosecure an RfPB funded grant.’

‘Researchers who do not utilisePPI are missing out on a massiveknowledge base; presumedknowledge is no substitute forlived experience which serviceusers can provide.’

3.Lay review of proposalsThe RDS SE patient and public peerreview panel reviews research studiesand materials associated with bids priorto submission. Comprised of lay peoplein the South East who are willing tocontribute their experience as users ofhealth and social care services the panelis available at most times. If you wouldlike the lay panel to review your project,contact Jo Wunsch.

The NIHR encourages patients and thepublic to be actively involved in all NIHR-funded research and most applicationsrequire an explanation of how patientshave been involved in the design.

Here are four ways RDS SE supportsinvolving patients in research design:

1.RDS SE Public involvement grants The RDS SE grant scheme helpsresearchers with up to £350 of fundingto bring together people to find outabout the best way to recruitparticipants, the relevance of outcomemeasures, and whether participants haveany concerns about the study. Grantscan be requested at any time of the yearand take about three weeks to approve.

Grants have been used to fund:• Costs associated with discussion groupsand other meetings (room hire,refreshments, travel expenses) heldwith patients to increase knowledgeof their views

• Thank you payments or vouchers• Facilitation costs• One to one meeting costs• Postage

Jo Wunsch administers the grant schemeand says, ‘I am happy to help applicants tocomplete the application form and answerquestions about the scheme’. Jo can becontacted at the University of BrightonT: 01273 644064E: J.Wunsch@brighton.ac.uk

Help with developing publicinvolvement in research design

...and more helpfrom the RDS SE pre-submissionpanelThe RDS SE pre-submission panel is amock funding panel. You send usyour nearly-ready funding application.We have it reviewed by the patientand public peer review panel andthen it is discussed by a panel of RDSAdvisors. We assess the readiness ofthe application and offer advice onfinal refinements, or morefundamental changes and feed backto you promptly.

The panel of methodologists,statisticians, health economists and thelay review helps researchers gain an‘outside’ view of their proposal.Researchers have found the feedbackhelpful and encouraging. Some havedelayed submission as a result.

Positive feedback on its value toresearchers means the pre-submissionpanel will now be held four times ayear (December, March, June andSeptember).

Please let us know if you would likethe RDS to review your draft fundingapplication – ask any RDS staff withwhom you are already in contact – oremail us.

In 2012 NIHR surveyed patients and the public to findout what they thought about clinical research. 82%of people said it is important for the NHS to offeropportunities to take part in healthcare research andjust 7% said they would never take part in a clinicalresearch study. (Source: OnePoll survey 2012,Commissioned by the NIHR Clinical Research Network).

NHS focuses on involving public and the public in research

www.rds-se.nihr.ac.uk

7Research by design

RfPB – increase in NIHRfunding will benefit morepatientsThe NIHR has increased the amount offunding which can be made available foran individual NIHR Research for PatientBenefit (RfPB) project. The £100,000increase took effect from Competition 19which launched in July 2012.

The maximum funding available has risenfrom £250,000 to £350,000. Awards aregiven for a period of up to 36 months. Allresearchers in England are eligible to applyto RfPB, and joint applications arewelcomed from NHS researchers partneredwith academics. Funding is normallyawarded to the NHS partner.

For more information on RfPB funding go towww.ccf.nihr.ac.uk

Changes to NIHR HTAprogramme schedule andguidance notesThe NIHR Health Technology Assessment(HTA) programme has announced changesto its schedule which will take effect in2013. These changes are being introducedto reduce the time taken to reach a fundingdecision from two to three months.

Researcher-led calls are open all yearround, with three application cut-off dates.The programme commissions researchusing a range of study designs, not justRCTs. There is no cap on the amount offunding, but all proposals must offer goodvalue for money to the NHS and all costsare carefully reviewed by the programme.

The guidance notes for the newapplication form have been revised.

Further information on the NIHR HTAwebsite: www.hta.ac.uk/funding/index.shtml

Getting Funding via theNIHR EME programmeThe EME Programme bridges the gapbetween pre-clinical studies and evidenceof clinical efficacy. The aim is to secure theprogress of new technologies andinterventions through their early clinicaltrials and onto larger, later clinical trials.

It supports clinical trials and evaluativestudies in patients which: evaluate clinicalefficacy of interventions where proof ofconcept in humans has already beenachieved; add significantly to theunderstanding of biological or behaviouralmechanisms and processes; explore newscientific or clinical principles; and includethe development or testing of newmethodologies.

EME has two workstreams, researcher-ledand commissioned. The commissionedworkstream funds large, often staged,projects with clear milestones. Proposalsmay include pilot and feasibility studies andlate development of technologies.Proposals should be substantialcollaborations with at least twopartnerships with either industry, NHS oracademia. There are three commissionedand three researcher-led calls areadvertised each year.

Senior programme manager, SusanSolomons says ‘the resources link on ourwebsite is an obvious place to start, but tobecome successful with this programme,researchers should use the RDS and thencall us up and ask for advice if necessary.But by offering to peer review for the EMEprogramme, researchers can see howothers put together their applications. Wealso suggest people speak to EME fundedresearchers who they can find on thefunded projects page of the EME website.’

RDS SE and EME are collaborating on anevent for researchers in the South East.To find out more go to the RDS SE website.See back page for links to all NIHR fundingstreams.

News in brief Six Competitions 100Awards: review of NIHRProgramme Grants forApplied Research published

A review of the NIHR Programme Grantsfor Applied Research (PGfAR) programmehas been undertaken, focusing on theapplication process and including detailedcase study analysis. ‘Programme Grants forApplied Research: six competitions, 100awards’ features the outcomes of the firstsix competitions and represents anoverview of the programme. Researchersapplying to the programme will findvaluable advice and guidance in the review.

Programme Grants are prestigious awardsmade by the NIHR to fund high qualityresearch addressing areas of priority orneed for the NHS. Awards of up to£2m over a three to five year period aremade to the best applied research teamsin England from the NHS and academiaworking together to improve healthoutcomes in areas such as diseasemanagement, safety and quality.

Few researchers in the South East areinvolved in Programme Grants yet. ButRDS SE is focusing on this stream in 2013.If you are interested in finding out aboutsupport for PGfAR applications, contact:Annette KingUniversity of KentT: 01227 823672E: a.m.king-9@kent.ac.uk

The review can be downloaded at:www.ccf.nihr.ac.uk/PGfAR/Documents/NIHR_PGfAR_review.pdf

Yes, with its ten funding streams there is a lot of NIHR to keep upto date with, but the information is available, it is more a case ofhow do you want to access it? A good place to start is the RDS SEwebsite where an interactive diagram shows the ten NIHR fundingstreams. It links to each programme webpage.

From here, you can subscribe to news feeds for the some of theprogrammes. News feeds drop straight into your email in box andare the quickest and most reliable way to pick up news. They are asummary of data and are helpful because it avoids you having tomanually check websites for changes. Some of the programmes alsohave a mailing list which you can join. Alternatively, you can sign upto the NIHR news feed which posts updates for every programme.

If you prefer to see the regular pattern of calls on a calendar, theRDS SW updates the calendar on its website every month.

Both the NIHR and RDS use Twitter and tweet funding deadlinenews, but again tweets tend to be repeats of the fundingprogramme news feeds.

Finally, the RDS SE email bulletin which is sent out in the thirdweek of every month contains a list of recent calls. But again, thisis generally a digest of what has been circulated in the precedingweeks.

There is one other thing you can do which you may not knowabout, which is to set up a Google Alert. (To find out how, Googleit!) Google Alerts provide email updates of the latest relevantGoogle results based on your query. If you enter the search queryyou wish to monitor, you will see a preview of the type of resultsyou’ll receive. The alert will email you any reference to your searchterm as it appears on the web.

To work out which funding programme to go for you could startby looking at the NIHR Funding Opportunities brochure. This waspublished in 2012 and as well as a description of each programmehas useful tables which shows the type of research funded byeach, who can apply, how many times a year calls open and theamount of funding offered. You will find this on the NIHR website.

Or you could speak to an RDS SE research advisor, who will knowall of the above and sometimes more!

Dr Claire

Do come and see us.Websites:www.nihr.ac.uk/publications/pages/default.aspxwww.rds-sw.nihr.ac.uk/documents/funding_table.pdf

Contact detailsFor more information and to book an appointment with an advisor, visit the RDS SE website at www.rds-se.nihr.ac.ukor contact the central administrator Domino Moore on 01273 643952 or email d.moore@brighton.ac.uk

Dear Claire,

Help, I keep seeing NIHR funding deadlines too late and I can’t work out when I should be applying to the NIHR.

There are so many funding programmes and deadlines. How do I keep on top of it all and how do I work out

which one to go for?

Yours sincerely,

A frustrated researcher

Dr Claire is a Research Advisor for the Research Design Service. She answers questionsabout designing and submitting research proposals. If you would like to ask Claire aquestion write to her at the address below.

Ask Dr Claire

Dear Reader