Independent hospices can – and should aim to – participate in palliative care research, say Paul Perkins, Rebecca Day, Julie Hapeshi, Lorraine Dixon and Rudo Nyakuhwa, who give tips and advice based on their experience at Sue Ryder

Day, Rebecca

Dixon, Lorraine

Hapeshi, Julie

Perkins, Paul

English

University of Gloucestershire Research Repository 

   This is a peer-reviewed, post-print (final draft post-refereeing) version of the following published document: Perkins, Paul and Day, Rebecca and Hapeshi, Julie and Dixon, Lorraine (2014) How to conduct research in an independent hospice: practical tips and advice. European Journal of Palliative Care, 21 (5). pp. 236-239.  Published in European Journal of Palliative Care, and available online at:  http://www.haywardpublishing.co.uk/_year_search_review.aspx?JID=4&Year=2014&Edition=518    ISSN 1352-2779. We recommend you cite the published (post-print) version.  The URL for the published version is  http://www.haywardpublishing.co.uk/_year_search_review.aspx?JID=4&Year=2014&Edition=518   Disclaimer   The University of Gloucestershire has obtained warranties from all depositors as to their title in the material deposited and as to their right to deposit such material.   The University of Gloucestershire makes no representation or warranties of commercial utility, title, or fitness for a particular purpose or any other warranty, express or implied in respect of any material deposited.   The University of Gloucestershire makes no representation that the use of the materials will not infringe any patent, copyright, trademark or other property or proprietary rights.   The University of Gloucestershire accepts no liability for any infringement of intellectual property rights in any material deposited but will remove such material from public view pending investigation in the event of an allegation of any such infringement.    PLEASE SCROLL DOWN FOR TEXT. 236 EUROPEAN JOURNAL OF PALLIATIVE CARE, 2014; 21(5)Researc h www.ejpc.eu.comL ike other healthcare services, hospicesshould provide the best treatments for patients and their families. The only way to find out what those besttreatments are is through research. However,conducting research in hospices can bechallenging, as they are often relatively smallorganisations inexperienced in overcomingthe usual barriers.Engaging in research activity can beparticularly problematic for independenthospices, which are outside the safety of theNHS and face the added challenge ofindemnity and ensuring essential governancearrangements are in place. Nonetheless,hospices, as centres of excellence, have a dutyto drive and initiate research if they are toprovide high-quality palliative care forpatients and families.Sue Ryder is an international charity whichruns six specialist neurological centres andseven specialist palliative care units in the UK.Ten years ago, the charity had little experienceof research participation and there were nogovernance structures in place to supportresearch. Getting approvals for projects was achallenge for all concerned. Today the charity is keen to promoteresearch. The Sue Ryder Research GovernanceGroup (RGG) meets monthly to discuss anyproject that is being considered by one of itscentres. These could be homegrown projectsor projects from external organisations thatwant to work with us. The RGG has devised apolicy and guidance to support researchersthrough the process.In this paper, we aim to use our experienceat Sue Ryder to provide some insight into howindependent hospices can become active inconducting research.Why should hospices do research?There are compelling reasons to conductresearch in hospices. Many of them areoutlined in a useful publication by Payne et alfor Help the Hospices.1Hospice patients deserve to have the bestand evidence-based treatment. Evidencegained through research is vital todemonstrate cost-effectiveness and helpnegotiations with commissioners. A research-active hospice may be morelikely to attract and retain high-quality staff. Patients do want to participate.2,3 Whenthere might be little else that they can do,they may see it as something worthwhile thatmight help other people in the future. TheNHS Plan suggests that participation inresearch should be offered to all patients.It could also be argued that hospices, likeother healthcare settings, have a duty tocontribute to research.4 This could be by: Conducting research Finding patients and signposting them toresearchers Freeing up time for researchers Providing infrastructure or finance.How to conduct research in an independent hospice:practical tips and adviceIndependent hospices can – and should aim to – participate in palliative care research,say Paul Perkins, Rebecca Day, Julie Hapeshi, Lorraine Dixon and Rudo Nyakuhwa,whogive tips and advice based on their experience at Sue Ryder Conducting research in hospices – particularly independenthospices – can be challenging, as they are often relatively smallorganisations inexperienced in overcoming barriers to research. Despite the apparent hurdles, it is possible to create a researchculture in an independent hospice. Staff will need to engage with people both within and outside theorganisation to allow research to flourish. It will take time for research to be seen as part of the hospice’s corebusiness and perseverance is, therefore, vital.KeypointsCopyright © Hayward Medical Communications 2014. All rights reserved. No unauthorised reproduction or distribution. For reprints or permissions, contact edit@hayward.co.uk237EUROPEAN JOURNAL OF PALLIATIVE CARE, 2014; 21(5)www.ejpc.eu.com Researc hPayne et al also described several potentialbarriers to conducting research in hospices,which are summarised in Box 1.1How to begin to create a researchculture in an independent hospiceGenerating ideasTo generate research ideas, hospice staff needto make time for research and integrate it intotheir everyday work. This could be done byrunning journal clubs, reading widely,attending conferences or inviting experts todo a presentation for small groups of staff.It also helps to identify the problemspatients are faced with each day and prioritisethose whose resolution will make a differenceto patients, families and carers.You can perform literature searches to see ifthere is evidence about the best way ofmanaging a particular problem. Medicallibrarians are often better at conductingliterature searches than clinicians.6 It is a goodidea to seek out your local hospital librarian,talk to them about the clinical problem andlearn from them how to conduct searches –they might even do them for you.Thinking of a research questionThe research question will depend on theproblem being addressed. It is always morerelevant when it emerges from practice. The type of question will often induce theresearch methodology you need to use toinvestigate it; for example, if you are asking‘What is happening now?’, this can beinvestigated with a survey of healthcareprofessionals. A question such as ‘What arethe experiences of people living with aproblem?’ can be investigated usingqualitative methods. If you are asking ‘Whichtreatment is better?’, a randomised controlledtrial might be the best methodology.Building a teamA research team can be built from local peopleinterested in research; this includes staff fromneighbouring hospices. The Palliative CareResearch Society (www.pcrs.org.uk) or theEuropean Association for Palliative Care(www.eapcnet.eu) may be able to advise onuseful contacts. In addition, national orinternational experts may be willing tocollaborate. Authors of research papers areusually happy to have an email conversationabout their research, preferably with someonewho has read their papers. Remember,conducting research on your own isimpossible and undesirable – collaborate asmuch as possible.Gaining management supportTo embed research into the hospice’s strategyand ensure it is seen as core business, it is vitalto have the support of the management.Managers may need persuading about thebenefits of conducting research;points to stress include thepotential benefits to patientcare; how a culture of researchwill enhance job satisfactionand staff retention; and howresearch can improve the organisation’sreputation as a centre of excellence. It is agood idea to present an action plan describinghow you will develop the research culture.Developing the necessary infrastructureInitiating research does not have to beexpensive, but identifying specific funding tosupport research is more likely to lead tosuccess. Trusts and charities may be able toprovide money to support research; forexample, they may support dedicated researchnurse time to start developing researchactivity. Studies being conducted by externalbodies or pharmaceutical companies may belooking for potential research centres, so it isworth investigating whether your hospice canapply to be involved in one of these. TrainingIf hospice staff are inexperienced in research,they may need training. In the UK, the localNHS trust’s research office should be able toprovide support and guidance about trainingopportunities. Potential areas include: • The absence of a pre-existing research culture or staff not beingappropriately trained• The absence of goodrelationships with potentialNHS or university partners• A lack of time and infrastructure• Limited funding• Professional gatekeeping• Concerns around governance and indemnity,and a lack of systems in place to manage them•Methodological issues; for example, outcomemeasurement and attrition5Box 1.Potentialbarriers toconductingresearch inhospices1To generate researchideas, hospice staff need to make time for researchCopyright © Hayward Medical Communications 2014. All rights reserved. No unauthorised reproduction or distribution. For reprints or permissions, contact edit@hayward.co.uk238 EUROPEAN JOURNAL OF PALLIATIVE CARE, 2014; 21(5)Researc h www.ejpc.eu.com Training in research design andmethodology to help write and/or commenton research protocols Training to write bid proposals to securefunding for projects Good Clinical Practice (GCP) training,which will guide staff in how to conducttrials – in particular, adverse event reporting Training in the processes for obtaininginformed consent. This is particularly usefulwhere capacity is limited, as the issues areslightly different in research participationthan in clinical practice.Volunteering for studiesYou should consider participating in externalresearch. This helps to create a climate whereresearch is seen as normal business. The UKClinical Research Network portfolio is a goodsource of opportunities to get involved instudies.7 Local or national colleagues may alsobe able to point organisations looking forresearch centres in your direction if they areaware of your interest.Finding a sponsor for your research ideaFinding a sponsor for a research idea is acrucial step – and a requirement of researchgovernance. The sponsor is often thought tobe the organisation that paysfor the research, but thesponsor and funder can bedifferent. The sponsor isresponsible for the governanceof research from conception tofinal completion – design, management andfinance – and has to satisfy itself thatappropriate checks have been undertaken.8,9A sponsor should conduct a risk assessmentfor the research, asking the following: Is the study scientifically sound? Has it beenpeer-reviewed? Are the chief investigator and hostorganisation competent to conduct theresearch? Has the research team had appropriatetraining in research methods and GCP? How will the study be audited andmonitored?The sponsor is legally responsible for: Requesting clinical trial authorisation andethics approval Allowing inspection of premises by theMedicines and Healthcare ProductsRegulatory Agency (MHRA) if required Giving notice to the MHRA and ethicscommittee of amendments to the protocolor when the trial has ended Keeping records of all adverse eventsreported by investigators Ensuring suspected unexpected seriousadverse reactions (SUSARs) are recorded andreported promptly Ensuring all investigators, including those atother sites, are informed of SUSARs Ensuring all SUSARs are entered into aEuropean database Providing an annual list of SUSARs and asafety report Ensuring indemnity insurance is in place.It is unlikely that the hospice itself will want these responsibilities, particularly forresearch involving drugs. Some hospices mayfeel able to undertake sponsorship of low-riskresearch projects (for example, somequalitative studies or studies involvinghealthcare workers only) if they havesufficient experience of research participation.If you need to look elsewhere for researchsponsorship, talk to your local NHS trust’sresearch management and governancemanager or your local university.Taking legal adviceIt is sensible to involve a legal adviser early inthe process, to ensure the right agreements arein place, especially if there are likely to bequestions concerning intellectual property.Putting in place indemnity insuranceWhen planning research, it is advisable to talk to the hospice’s insurers about the kind of research you want to conduct. They may have a skewed view of what researchinvolves and may not be aware that not allresearch is high-risk. •Training• Responsibilities• Study files and filing• Screening•Consent•Case record formcompletion•Audit•Archiving•Adverse event reporting• Site initiation visits•Monitoring• Study close downBox 2. Whatstandardoperatingproceduresfor researchshould coverIt will take time forresearch to be seen as a core part of hospices’ businessCopyright © Hayward Medical Communications 2014. All rights reserved. No unauthorised reproduction or distribution. For reprints or permissions, contact edit@hayward.co.uk239EUROPEAN JOURNAL OF PALLIATIVE CARE, 2014; 21(5)www.ejpc.eu.com Researc hA risk assessment, with identified controls,will help to demonstrate the magnitude of the risk. If what you are planning does not vary much from standard practice, there may not be any additional cost. There is sometimes concern about cover fornon-negligent harm. This will usually becovered by existing hospice insurance.Researchers should talk to their ownindemnity provider about the fact they areparticipating in research.Updating staff contractsPersonnel engaged in research should havethis covered in their employment contract, orhave an appropriate honorary contract inplace. You will need to discuss this with thehospice’s human resources department.Establishing a governance frameworkThe hospice will need to set up processes for examining research proposals. TheDepartment of Health’s Research governanceframework for health and social care is a usefulstarting point to learn how to do this.8 TheNational Institute for Social Care and HealthResearch has put together a researchgovernance toolkit which could be helpful.10It may also be helpful to ask an externalresearch expert to be part of this process, or toestablish a partnership with a local hospital oruniversity – it may be possible to adapt theirapproval processes to fit your purposes.At Sue Ryder, the RGG is fortunate that theAssociate Director of Research andDevelopment from the Gloucestershire NHSresearch consortium has played an active rolein providing external scrutiny of research. Wealso have representation from the Sue RyderCare Centre for the Study of Supportive,Palliative and End of Life Care.Governance questions to consider includewhether it is appropriate for your hospice toparticipate in a particular research project, andwhether necessary items are in place before itstarts; for example, ethical approval,sponsorship, indemnity cover and contracts.Drawing up standard operating proceduresStandard operating procedures are needed togive staff guidance on how to do research on aday-to-day basis. Box 2 lists what they shouldcover. Your local NHS trust’s researchmanagement and governance manager maybe willing to share their procedures.ConclusionOver the last ten years, Sue Ryder hasparticipated in a number of projects, fromexternal qualitative projects to homegrownrandomised controlled trials of drugs. Therehave been challenges, but the organisation’sattitude is that, just because something isdifficult does not mean it should not be done.It will take time for research to be seen as acore part of hospices’ business and not all staffwill understand why it is being introduced.Perseverance is, therefore, vital if hospices areto develop a research culture and continue tolead in providing high-quality palliative carefor patients and families.Declaration of interestThe authors declare that there is no conflict of interest.AcknowledgementsThe authors are grateful to Lisa Riddington, Library Services Manager,Gloucestershire Hospitals NHS Foundation Trust, for her help with theliterature search for this paper. They would also like to thank Carol Wilkinson,Insurance Office, Sue Ryder, London, for her comments.For more on conducting research in hospices, see: Turner M, Payne S.Methods of building and improving the research capacity of hospices.European Journal of Palliative Care 2012; 19: 34–37.References1. Payne S, Preston N, Turner M, Rolls L. Research in palliative care: canhospices afford not to be involved? A report for the Commission into the Futureof Hospice Care. London: Help the Hospices, 2013. 2. Ross C, Cornbleet M. Attitudes of patients and staff to research in aspecialist palliative care unit. Palliat Med 2003; 17: 491–497.3. Henderson M, Addington-Hall JM, Hotopf M. The willingness of palliativecare patients to participate in research. J Pain Symptom Manage 2005; 29:116–118.4. Roberts I, Chaudhry B, Chalmers I. New GMC guidance takes a major,ethically flawed, backward step. BMJ 2013; 346: f3879.5. Grande GE, Todd CJ. Why are trials in palliative care so difficult? Palliat Med2000; 14: 69–74.6. Brettle A, Maden-Jenkins M, Anderson L et al. Evaluating clinical librarianservices: a systematic review. Health Info Libr J 2011; 28: 3–22. 7. UK Clinical Research Network Portfolio Database.public.ukcrn.org.uk/search/ (last accessed 19/06/2014)8. Department of Health. Research governance framework for health andsocial care, 2nd edn. London: DH, 2005.www.gov.uk/government/publications/research-governance-framework-for-health-and-social-care-second-edition (last accessed 19/06/2014)9. The Medicines for Human Use (Clinical Trials) Regulations 2004.www.legislation.gov.uk/uksi/2004/1031/contents/made (last accessed19/06/2014)10. National Institute for Social Care and Health Research. ResearchGovernance Toolkit. www.nischr-cancerrrg.org/research/ (last accessed19/06/2014)Paul Perkins, Palliative Medicine Consultant,Sue Ryder Leckhampton Court Hospice andGloucestershire Hospitals NHS Foundation Trust,Cheltenham; Rebecca Day, Research Nurse, SueRyder Leckhampton Court Hospice, Cheltenham;Julie Hapeshi, Associate Director R&D and DeputyDirector SW RDS, Gloucestershire Research SupportService (incorporating the Gloucester office of theNIHR Research Design Service – SW); LorraineDixon, Deputy Head of Institute and Head ofProfessional Services, University of Gloucestershire,and ex-Chair of Research Governance Group, SueRyder, Cheltenham; Rudo Nyakuhwa, Learning andQuality Manager and Chair of Research GovernanceGroup, Sue Ryder, London, UKCopyright © Hayward Medical Communications 2014. All rights reserved. No unauthorised reproduction or distribution. For reprints or permissions, contact edit@hayward.co.uk

Attitudes of patients and staff to research in a specialist palliative care unit. Palliat Med

Evaluating clinical librarian services: a systematic review. Health Info Libr J

Health. Research governance framework for health and social care, 2nd edn.

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Research in palliative care: can hospices afford not to be involved? A report for the Commission into the Future of Hospice Care. London: Help the Hospices,

Research Network Portfolio Database.

The Medicines for Human Use (Clinical Trials) Regulations

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How to conduct research in an independent hospice: practical tips and advice

https://eprints.glos.ac.uk/1385/1/Dixon%202014%20Eprint%20record%201358%20with%20cover%20sheet.pdf

How to conduct research in an independent hospice: practical tips and advice

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