Research Design Service South EastNewsletter 6 • Spring 2015

In this issue:

Funding in the region

Focus onNIHR Fellowships

News in brief

Ask Dr Claire Agony Aunt

The ten Research Design Servicesin England are celebrating anothersuccessful year helping researcherssubmit bids to health and socialcare funding programmes. InEngland, the number of bidssupported by the RDS was up by12% on the previous year.

38% of the 2,790 bids supported by theRDS were successful across all the fundingprogrammes to which RDS helpedresearchers submit.

In the South East, 94 bids were submittedwith RDS SE support. Ten applications weremade for NIHR research training awards.These offer an amazing package toclinicians wishing to become researchers.See the feature on page five for an insightinto how nurses have been successful withthis programme.

RDS SE supported 20 applications to theregionally administered Research forPatient Benefit (RfPB) programme.Nationally, the number of applications toRfPB have declined since the peak in 2010-2011. Overall success rates remain ataround 22%.

Bids to a wide range of charities form asignificant part of the RDS SE workload.We are tracking the progress of charity-funded researchers to see if they progressto NIHR and other national fundingprogrammes.

NIHR reports that bids are most commonlyrejected because of lack of detail in themethodology. Other reasons for failure areinappropriate design, lack of overall clarity,unsuitable outcome measures and finally;lack of expertise in the research team andinsufficient quality of patient and publicinvolvement.

But help is at hand. The RDS SE can helpwith methods design, finding potentialacademic, clinical and lay collaborators andinvolving patients and the public in theresearch design and refining the researchquestion. We can also help withinterpreting feedback from funding panelsand encourage you to have another go ifyour bid is rejected.

Around half of RDS SE clients come fromthe region’s universities and half from theNHS, with a handful of clients coming fromcharities and industry. Anyone who wouldlike help submitting a bid for peerreviewed, health and social care funding iswelcome to seek advice from the RDS SE.Meet the Adviser team on the RDS SEwebsite.

See inside for more about researcherswho submitted successful research fundingapplications.

Celebrating another successful year

www.rds-se.nihr.ac.uk

Mr Haythem Ali, ConsultantSurgeon at Maidstone andTunbridge Wells NHS Trustand Professor Ian Swaine, fromthe Department of Life and SportsSciences at the University ofGreenwich, derived the full benefitof RDS support when they appliedfor NIHR funding for a feasibilitystudy of a muscle-strengtheningexercise programme for patientsundergoing abdominal cancersurgery.

They came to RDS SE in January 2012 andsubmitted to the NIHR Research for PatientBenefit (RfPB) Programme competition 21.Despite first time rejection, positivecomments from the RfPB panel encouragedthem to resubmit. They returned to RDS foradvice on specific points

RDS Research Adviser Dr Ferhana Hashemsaid: ‘We made several recommendations,including ensuring the team built inrealistic and relevant patient and publicinvolvement (PPI).They applied for andwere given a small RDS SE PPI grant, whichthey used to link up with a cancer supportgroup at the Trust. The patients coulddirectly input into developing the researchproposal. We were able to invite a layrepresentative from the group as coapplicant on the bid’.

PPI specialist Amanda Bates honed thatpart of the bid and included suggestions fortraining and support for PPI representativesso they could play an active, meaningfulrole in the implementation andinterpretation of the study.

Ferhana also brought qualitative methodsexpertise to the team. She said: ‘What’sgreat about this project is the team effort.It’s a really exciting collaboration across theregion and organisations. Dr DavidStephenson, Physiotherapist, from EastKent Hospitals University Trust and DrKevin Corbett from Middlesex Universityare also core team members.

The final RDS input came from the RDS SEPre-Submission Panel (PSP) which helpsresearchers decide whether their projectsare ready to go to the funder. Theresearchers submitted to the June PSP toensure time for tweaks before theSeptember RfPB deadline. They receivedexcellent feedback and resubmitted toRfPB competition 22. They were delightedwhen they were awarded £342,000 forthe study, titled Development of anisometric-resistance exercise programme(BETTER: Basic Exercise Training to EnhanceRecovery) for patients undergoing electiveabdominal surgery for cancer.

Mr Ali, Consultant Surgeon (leadapplicant), and Professor Swaine, said ‘RDSSE gave lots of support building up PPI,advising on statistics, health economicsand helping us get a first class teamtogether. We knew we had a potentiallyfundable project, but the RDS helped usfocus and refine the study. We originallyplanned a pilot study, but in ourdiscussions we changed it to a two phasedevelopment study. Phase one consists ofpatient focus groups and an online Delphisurvey to develop the exercise intervention.

We will also identify suitable functionaloutcome measures. Phase two will be amini pilot and evaluation (effectiveness andcost effectiveness) study, based on twogroups randomised to either interventionor usual treatment’.

It is usual, after cancer surgery, for there tobe some loss of physical function andmuscle wastage. Isometric exercise iseffective in increasing muscle strength. Theprogramme will be delivered in hospital,needing very little equipment and space,and patients can continue to perform theexercises after discharge at home.

The three year BETTER project aims to pavethe way for a larger-scale multi-centreclinical trial which is the gold standard testof the value of the muscle-strengtheningintervention for this type of patient.

2

Supporting researchers towardsfunding success

www.rds-se.nihr.ac.uk

RDS support and patient involvement results in BETTER outcome

Researcher breathes easywith RDS SE supportDr Rowena Merritt is a ResearchFellow at the University of Kentand as a specialist in socialmarketing, particularly valuedrecent RDS SE help with samplesize calculations for a British LungFoundation funded project.

‘My background is not in academia andI mainly work on qualitative studies, soI was clueless when it came to quantitativework. Without the support of the RDS SEstatisticians talking me through how torandomise the groups and set up a trial,I would not have been able to apply forthe funding. They explained it in a reallyclear way, so that even someone likemyself – who hates maths and anythingstatistical, could clearly understand it’,reports Rowena.

Rowena was funded to conduct a processand impact evaluation and demonstratewhether the charity’s ‘Breathe Easy’voluntary group network when integratedinto local respiratory care pathways helpspatients and carers achieve better healthand well-being outcomes.

RDS SE Advisers supported Rowena byidentifying the skills needed for herresearch team and providing examples ofrespiratory projects. Statistician TracyHiggins helped Rowena with the statisticsand trial set up. Research Adviser FerhanaHashem also read and commented oneach draft of the proposal.

Breathe Easy voluntary groups have helpedfacilitate greater knowledge acquisition(from peers and clinicians) which resultsin increasing levels of self-managementand a stronger understanding of clinicaland community based support.

3

Dr Nicola Carey is a Senior Lecturerin Health and Social Care at theUniversity of Surrey and SpecialistPrescriber in Practice Nursing,Nurse Independent andSupplementary Prescriber. Dr Careycame to the RDS SE for help afterdrafting a proposal for theDepartment of Health’s PolicyResearch Programme (PRP).

‘The RDS SE gave me a wide variety ofsupport and the project was funded’ saidDr Carey. ‘I was initially advised to lookcarefully at the research team. My projectis an evaluation of physiotherapist andpodiatrist independent prescribing, mixingof medicines, and prescribing of controlleddrugs. The RDS SE made valuablesuggestions about the membership ofthe team and study design’.

Following advice on involving members ofthe public in the research design, Dr Careywas put in touch with a researcher whohad run a physiotherapy service user group.‘This was really helpful because it made itclearer how to usefully involve people. Weincluded patient and public involvementmeetings and a patient advisory group inthe research design’, reports Dr Carey.

RDS SE Health Economist Professor HeatherGage was called in to give advice on thepotential economic impact of the study.

The project will provide support for revisedprescribing regulation. It will compareservices provided by physiotherapists andpodiatrists who are qualified toindependently prescribe, to servicesprovided by those who are not qualified toprescribe. This will help determine whetherthere are any differences in the quality ofcare or cost of services.

RDS prescribes public involvement in research design

Not all allied health professionals are qualified to prescribe

• Clinical Trials and KnowledgeMobilisation Fellowships

• Infrastructure Doctoral TrainingExchange Scheme allowing doctoraltrainees to spend time in other parts ofNIHR infrastructure.

The research must be relevant to the NHS,focused on the current and future needsof patients and the public and be expectedto have an impact.

Here we explore two types of NIHRFellowship and the support RDS SEprovides to applicants.

The NIHR is passionate about itspeople and about developing thenext generation of researchers.The NIHR Trainees CoordinatingCentre (NIHR TCC) makes trainingawards to researchers whose workfocuses on people and patient-based applied health research.

Director of the NIHR TCC, Dr Lisa Cotterillsays: ‘We pride ourselves on the supportour Programme Managers give toapplicants and trainees. We want todevelop a cadre of individuals who can takethe NIHR forward to develop researchoutputs that are going to benefit patients’.

NIHR offers a large range of awardsavailable at different levels, to suit differentwork arrangements and career pathwaysincluding the:• Fellowship Scheme where you applydirectly through an application which isassessed in open competition

• Integrated Academic Training Schemewhere individuals who are on anacademic and clinical training pathwayare supported

• Research Professorships • Clinical Academic Training Programmefor Nurses, Midwives and Allied HealthProfessionals in collaboration withHealth Education England

4 www.rds-se.nihr.ac.uk

NIHR fellowships

NIHR Fellowships supportoutstanding individuals tobecome the health researchleaders of the future by buyingout their salary costs, meetingtheir training and developmentcosts and by contributing to thecosts of completing an identifiedresearch project.

Individuals working in any sector orscientific discipline who propose toundertake people or patient-based clinicaland applied health research at aninstitution based in England can apply.

Check out some success stories here andon the RDS SE website.

NIHR Fellowships for future research leaders There are five levels of NIHRFellowship:

1 Doctoral Research Fellowship – 3 years funding

2 Transitional Research Fellowship – 18-24 months funding

3 Post-doctoral Research Fellowship – 3 years full-time funding

4 Career Development ResearchFellowship – 5 years funding

5 Senior Research Fellowship – 5 years funding

NIHR awards are designed to suit different career pathways

Dr Kirstie Coxon, now a SeniorLecturer at the FlorenceNightingale Faculty of Nursingand Midwifery at King’s CollegeLondon (KCL), was first awardedan NIHR Doctoral ResearchFellowship and then an NIHRKnowledge MobilisationFellowship (KMF). She has alsorecently returned to practice asa midwife. Kirstie was previouslya researcher at the University ofKent. She still lives in Kent, butcommutes to London.

‘Before I came to the University of Kent, Iwas a nurse and a midwife. With the NIHRdoctoral fellowship, I was able to researchin maternity care, but my midwiferyregistration had lapsed.

After finishing my doctorate, I feltdistanced from what was really happeningfor women and midwives. I wanted mymaternity research to be rooted in therealities of the NHS, so I completed a‘Return to Practice’ course.

The NIHR doctoral fellowship enabled meto pursue a long held interest in whatinfluences where women decide to givebirth. Delivering babies again meantI developed better clinical and academic

links and put me in touch with womenand partners’ experiences of health care.King’s College London had the expertise inmaternity research, and of course, thereare lots of babies to be delivered. I wasfortunate to work in a clinical academiccentre, where researchers and clinicianswork side by side. My colleagues areactive researchers, lecturers and clinicalpractitioners.

My PhD was adopted as an adjunct studyby the Birthplace in England researchprogramme. I attended the ‘Birthplace’research meetings where I observed howhard the researchers worked to giveconsistent and measured messages abouttheir findings. Despite this, some tabloidnewspapers published sensationalised,unbalanced reports.

Much of the subsequent debate wasbetween clinicians and professional bodies,but I wondered how the main findings,which are generally reassuring, would becommunicated to women and theirpartners, and indeed to midwives. I appliedfor a KMF so that I could explore thechallenges of communicating this researchto a range of audiences.

The KMF allows researchers to learn aboutwhat knowledge mobilisation is, and toapply that knowledge to sharing good

quality research with a range of research‘consumers’ – in this case, women,partners, midwives, antenatal teachers,the Royal College of Midwives and alsoclinical commissioners.

My main focus has been on developingvisual graphics that help convey risks andbenefits associated with different placesof birth. This has brought me into contactwith data analysts, computerprogrammers, artists, designers,photographers and local Maternity ServicesLiaison Committees. I have also worked onbriefings for the Royal College of Midwivesand for commissioners’.

Kirstie’s top tips for NIHR KMF applicationsare:1 Take at least six months to develop anapplication and set up collaborativerelationships and networks.

2 Persuade the NIHR panel that you haveidentified a way of improving uptake ofhigh quality, published research intopractice, and that you will evaluate theeffectiveness of your knowledgemobilisation in a robust and useful way.

3 Clearly outline which theory of change,or of the KM techniques is being applied,and why.

4 Speak to the RDS early – and often!

Dr Kirstie Coxon shares her experiences of two NIHR fellowships...

NIHR Knowledge MobilisationResearch Fellowships (KMF) aredesigned to advance knowledgeabout research use, influence andimpact.

KMF are personal awards designed to buyout an individual’s salary costs, provide atraining and development programme andfund completion of an identifiedknowledge mobilisation research project.

NIHR Knowledge Mobilisation Research Fellowships

1 Work with one of NIHR’s 13 Collaborationsfor Leadership Applied Health ResearchCentres (CLAHRC) to strengthen the casefor funding. Check the list and identify theCLAHRC that best fits your research theme.

2 Look at the TCC KMR Fellowship webpages to be sure you understand whatknowledge mobilisation aims to do.

3 Read previously funded KMF abstracts tosee what kind of bids get supported.

Awards are for two years full time, or canbe part time if the applicant wishes to carryon working part time.

KMF usually launch in spring and close inAugust. Only around five are awardedeach year.

NIHR KMF Scheme Senior ProgrammeManager Dr Mal Palin urges applicants tocontact TCC for advice and offers threetop tips for applications to the programme:

5

6 www.rds-se.nihr.ac.uk

Clare wasawarded anNIHR DoctoralFellowship inNovember2013. Beforemaking thisapplication,she hadcompleted anNIHR Clinical Academic TrainingProgramme Internship, duringwhich she developed researchknowledge, new skills and aresearch proposal.

Why apply for an NIHR fellowship?NIHR fellowships offer an exciting andunique opportunity. I wanted to developways to improve practice, but I did notwant to leave my clinical position. Thefellowship allowed me to develop asresearcher and as a clinician.

What was the applicationtimescale and process?After the internship, I was on a really tightdeadline. I could either apply within eightweeks or wait another year. Eight weekssounds like loads of time, but it was reallynot. I referred myself using the RDS website,as advised by my internship supervisor.

What did the RDS SE do?The RDS helped me to develop and refinemy proposal, highlighting areas thatneeded improvement and helped me forma protocol that focused on patient benefit.I had help with the application form, theproject methodology, defining disabilityand feedback on ethics and publicinvolvement, including costings. Aftershortlisting, I was supported with a mockinterview and tips from a Research Adviserwho had been through the process herself.

I had fantastic support from the university,however I was one of the first applicantsapplying for this award and the RDSknowledge was invaluable. There were acouple of key things, in particular the mockinterviews and advice from the RDS SEwhich ensured I was well prepared.

Knowing how much support can be offeredby the RDS, I think I should have asked forhelp sooner.

Did the RDS help meet yourexpectations?I expected assistance in refining myproposal, but I thought this would justbe via email. I had help from four advisersin meetings and by email. I did not realisethe support would be so personal to myproposal. I am passionate about myresearch and the care of children withdisabilities. The RDS SE understood andreflected this passion for improvingnursing care.

The RDS SE met all of my expectationsand had I asked for further help, I am sureit would have been offered.

Clare’s Fellowship will investigate viewsabout whether nurses meet disabledchildren’s – and their parents’ – needs,during emergency and inpatientadmissions.

NIHR fellowships

Doctoral Research Fellow Clare Austin, Children’s Nurse, Frimley Park NHS Trust, Surrey talks about her experience...

7

Is your research ideareally novel? Demonstrating that your research ideais novel is essential to the success of yourbid, so it’s worth checking before youapply for funding.

A video presentation by an RDSInformation Specialist explains how tosearch four open access databases whichrecord registered, ongoing and publishedresearch. It covers the best searchstrategies to use with each. It recommendsfinding a published Cochrane Reviewwhich identifies your research area asneeding further investigation.

Find the video by searching You Tube with:‘checking research is novel’.

What makes a goodapplication?Professor Chris Salisbury, University ofBristol, a reviewer for NIHR fundingprogrammes, explains the essentials ofgood NIHR application.

Find the video by searching with: ‘whatmakes a good NIHR application?’

Training for researchersThe NHS Health Research Authority runstraining days for its committee membersand the research community. These includeresearcher training days and specialistaspects of research such as research withchildren, the use of human samples inresearch, research involving thedisadvantaged and vulnerable, usingpersonal data in research and ethicalreview of qualitative research.

The training days are free, but book upquickly. For the course programme go tothe Health Research Authority website.

Writing a Plain EnglishSummary?The NIHR ‘make it clear’ website gives tipsand guidance on how to write a goodquality summary. The resources sectionbrings together advice from charities suchas the Stroke Association and provideslinks to good examples of summaries.

Find the website by searching with ‘make itclear campaign’.

GPs consulted on futureresearch topicsAn exciting collaboration between theNIHR and the Royal College of GeneralPractitioners has been announced. In thebest interests of patient safety and care,the Royal College’s membership of 49,000is being asked to help inform and directfuture NIHR research for primary care inthe NHS.

As frontline providers of the majority ofpatient care in the NHS, GPs have specialinsight into the issues and challengesin primary care. Members have beenasked to set out what important questionsneed to be answered by research and theareas where new research evidence ismost needed.

Find out more by searching with: ‘NIHRRCGP collaboration’.

Anyone can make a suggestion online forNIHR research by searching with‘identifying NIHR research’.

News in brief

Want to receive more newsfrom NIHR and RDS?The RDS SE e-bulletin bringsresearchers up to date with newsabout regional and national events,training opportunities, fundingcalls and more.

It goes out to researchers, clinicians, alliedhealth professionals and members of thepublic at the end of every month, and ittakes just a minute to subscribe:www.rds-se.nihr.ac.uk/join-our-mailing-list

For full details of the the range of freeRDS support available to researchers visitour website:www.rds-se.nihr.ac.uk

Follow national RDS on Twitter

NIHR_RDS

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

Dear Claire,

Randomised controlled trials (RCTs) – are they the be all and end all of clinical research?

Yours sincerely,

Dominic

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

Ask Dr Claire

RCTs are the gold-standard design for investigating the efficacyand effectiveness of interventions. Their strength lies in therandom allocation of participants into groups that are treatedwith either the intervention under investigation or a comparator.This minimizes bias1 – reducing the risk that an intervention’seffectiveness will be either inflated or masked. As a ResearchAdviser, I recognise the strengths of RCTs. When properlyrandomised, appropriately controlled and double-blinded(wherever possible), RCTs provide the most robust evidence forthe efficacy and effectiveness of interventions.

However, researchers often do not give enough thought to anappropriate comparator. It is not enough that a trials unit is doingthe randomisation, that participants and researchers will beblinded, and that treatment as usual (TAU) or a waiting list will bethe control. Often, like a waiting list, TAU turns out to be notreatment and this is not a robust design.

The placebo effect is well-established and is why an appropriatecomparator is a necessity. In surgical trials, participants undergoingsham surgery have been shown to have improved outcomes2.In psychological therapies, using a waiting list control has beenshown to inflate intervention effect sizes3. Ideally all RCTs wouldhave a NICE-recommended, gold-standard treatment as theircomparator. By comparing against an active control, the resultsof the RCTs have real meaning in a clinical context. What you needto show is that the new therapy is better (or at least as good andmore cost-effective) than the current best therapy. This kind ofresult can lead to policy change.

Issues arise when there isn’t a current gold-standard treatment.It can be tempting to use TAU or a waiting list as the comparatorin these cases. However, this reintroduces bias. You risk inflatingthe effect size and unblinding participants. The answer is toconduct feasibility work. Give some thought about what wouldmake a good, active comparator. Talk to patients and others.Work out some options. Do some pilot work.

By concentrating on RCTs alone, researchers may missopportunities for engaging with mixed-methods research. Mixed-methods studies incorporate an RCT alongside qualitative work.Health technology assessment cannot be conducted without theresults of RCTs, but qualitative research can help support anargument for the implementation of a particular health technologyby addressing various views in a systematic way. By doing this,researchers have a better view of the impact of an interventionand it may lead to studies having a greater and more relevantimpact on patient care.

Dr Claire

Dear Dominic

1 P Sedgwick BMJ 2012;345:e55842 BMJ 2014;348:g32533 Furukawa TA, Noma H, Caldwell DM, Honyashiki M, Shinohara K, Imai H, Chen P,Hunot V, Churchill R. Waiting list may be a nocebo condition in psychotherapy trials:a contribution from network meta-analysis. Acta Psychiatr Scand. 2014