Good morning everyone. My name’s Jonathan Boote and I’m a Research Fellow at the NIHR Research Design Service for Yorkshire and Humber, where I am the regional lead for patient and public involvement (PPI). I’ve been asked to come along today to talk about PPI in research
I plan to speak for about 15-20 minutes and will cover the following topics Firstly, to define what we mean by PPI and to outline the reasons why it is considered to be important I’ll outline how PPI is dealt with in the new NIHR Standard Application Form I’ll suggest some potential contributions that patients and the public can make to the design and conduct stages of research I’ll go on to cover how PPI at the design stage is being supported both in the university and in the wider health community, focusing on PPI panels and the public involvement in grant application funding award that is available from the RDS I’ll outline some examples of existing PPI panels within ScHARR and across the Yorkshire and Humber region I’ll outline the PPI remit of the RDS and the types of PPI initiatives and work that we are currently engaged in And I’ll conclude by proposing possible components of a PPI strategy for the School
The most widely used definition of PPI in research is that provided by INVOLVE, the body that promotes PPI in research in England and Wales, and which I’ve recently become a member of. It is a very simple definition and it essentially means moving the public from a passive to an active role in the research process. So, it means the active involvement of patients and members of the public in one or more stages of the research process, and I’ll go on to discuss the key stages of the research process where the public tends to get involved a bit later. I think of active involvement as meaning the public having a decision-making impact on a key aspect of the research. And finally on this slide, I just want to contrast active involvement with participation in the study, and to make the point that those actively involved are not the subjects of the research
There have been numerous attempts to define the public over years, in order to contrast ‘the public’ with professional researchers. Most people working in the field of PPI use the definition offered by INVOLVE and I’ve provided it on this slide. As you will see it is inclusive, and some people think that this is maybe too inclusive as, for example, all of us are the potential recipients of health promotion programmes. Some statisticians among you may feel the definition lacks sensitivity or specificity
This slide sets out some of the reasons why PPI is thought to matter. You may or may not agree with these arguments Firstly, it is considered morally right that the public, as tax-payers and funders of the NHS and NIHR, should have a say in any research that might impact on their health or the services that they receive. Secondly, there is a theoretical or epistemological argument based around the concept of experiential knowledge. Patients and the public have experiential knowledge of what it is like to have a particular health condition, or to care for someone that does, and researchers may not necessarily have this first-hand knowledge themselves, so PPI helps researchers get closer to those that they are researching. Prof Peter Beresford who considers himself a user-researcher, as he is a long-term user of mental health services, developed the theoretical argument into a provocative hypothesis stating that... Thirdly, there is the effectiveness case that is advocated by INVOLVE, which states that PPI can help to improve the quality, relevance and impact of research The final point on this slide is really the clinching argument. Public involvement in research is a DH policy and funding often depends on it. So, it’s a must do activity.
PPI has been a key part of most grant applications for a few years now, and the NIHR are piloting a new standard application form for all the schemes that it manages. The new form , which is currently being piloted in the RfPB scheme, asks all applicants.... So you are asked to provide information on what PPI you have done to inform the development of your idea and the submission of the grant, and how you plan to involve the public should the funding be awarded. You are also asked to state if the public will be involved in the following specific ways.... And if you plan to have no PPI, then you have to justify this. My advice to researchers as the PPI lead for the RDS is to think very carefully about PPI as the application is likely to be reviewed by at least one lay reviewer
So what specific contributions can patients and the public make at the design or pre-grant submission stage of a proposal. This will of course vary depending on the exact research question and whether the work has a qualitative or quantitative focus, but I have provided some suggestions on this slide It is useful to have some idea if the proposed research is seen as valuable by patients and the public and they can comment on whether your proposed design (in its broadest terms) is appropriate. There is a case reported in the literature of the public providing their views on the proposed content of the control arm of an RCT for example. They could be asked for their views on the appropriateness of data collection methods for specific population groups (for example their views on interviews versus focus groups) They could provide their views on what outcomes from a patient perspective it is important to capture in trials. They could help select the most appropriate measures if their is a choice of measures out there They could help you word data collection tools such as interview and focus group schedules They could have views on the best times and places to collect data and the amount of burden that is to be placed on potential participants They could have views on consenting procedures such the use of proxy consent, and they could help you word participant information sheets They could help you write the lay summary of the grant and help you think about the appriopriate level of PPI to have in the project if it was to be funded
So what support can be provided to support PPI at the design or grant development stages of research. Firstly, institutions and research groups have set up their own PPI panels to provide a forum for patient/public input into grants in development. They tend to be of two types: (1) generic panels where those providing a PPI perspective have experience of a wide variety of diseases and health conditions; and (2) Topic- and disease-specific panels (which provide PPI advice to researchers in particular specialist areas, where all members of the panel have direct experience of a specific topic/disease) I have some examples of Topic- and disease-specific panels on my next slide An alternative approach is to undertake a one-off consultation event prior to the submission of a specific grant. Researchers in the region have made use of the RDSYH Public Involvement in Grant Applications Funding Award to fund such activities, and awards of up to £500 can be made. I should point out that as of very recently, we have agreed that our funding award scheme can also now be used to fund the set up costs of PPI panels
So, here are some examples of PPI panels within ScHARR and the wider health community in Sheffield and the Yorkshire and Humber region I could only find one example from within ScHARR and it is the Sheffield Emergency Care Forum that has been set up by Emergency and Immediate Care Research. The Chair of this panel panel, Mrs Enid Hirst, is also a member of the RDS PPI Forum Examples of PPI panels in STH include the pre-term birth PPI group set up by Dilly Anumba with a start up grant from the RDS. This panel has provided input into 2 recently successful grants to develop devices and technology to predict pre-term - £300,000 from NIHR Invention for Innovation and around £600,000 from the MRC Development Pathway Funding Scheme. I have been costed into both grants to provide PPI advice and consultancy. Other PPI panels at STH include the LEAP (Lay Expert Advisory Group for HIV research) created by Dr Christine Bowman of Genito-urinary medicine, the Non-Epileptic Seizures Treatment Research User Group run by Dr Markus Reuber and the PPI panels linked to the two BRUs, whose funding will be taken over by the CLRN. Linked to the CLAHRC is the aphasia PPI group set up by Dr Rebecca Palmer Within the Yorkshire and Humber region are groups linked to the NIHR topic-specific networks, including the Yorkshire Cancer Research Network PPI Group and the Yorkshire Stroke Research Network Consumer Research Advisory Group
Before I go on to make some suggestions as to a possible ScHARR PPI strategy I thought it worth mentioning the PPI remit of the RDSYH so that there is no duplication of effort. As I’m sure you all know, the RDSYH exists to support health researchers in the region to submit high quality grant applications to national, peer-reviewed funding competitions for applied health or social care research PPI is a key component of the service and here is a list of the PPI support that we provide Bespoke advice on PPI on a project by project basis Briefing notes and support for researchers setting up their own PPI panels As already mentioned, we have a funding award to support PPI at the design stage including help to set up a PPI panel We have an online presentation on PPI in research on our website Signposting researchers to existing PPI panels in the region We have a searchable online database of voluntary groups interested in being involved in research design We Maintain of a bibliography of references on PPI in research We undertake research on the effectiveness of PPI in the research process and have produced a series of narrative reviews of the evidence on the involvement of the public in the design of research, the design and conduct of clinical trials, and in systematic reviews
Here are my contact details at the Research Design Service for Yorkshire and the Humber, Thank you for your attention.
Public involvement in the systematic review process in health and social care: A narrative review of case examples.
Public involvement in the systematic review process in health and social care: A narrative review of case examples 9th HTAi Annual Meeting, Bilbao, Spain, 25-27th June 2012 Jonathan Boote (1), Wendy Baird (1) and Anthea Sutton (2)(1) NIHR Research Design Service for Yorkshire and the Humber, (2) The University of Sheffield
Background to the review• Perhaps the most important type of health research that the public can become involved in is the systematic review – Systematic review has high status in evidence hierarchies• Impetus for involving the public in the systematic review process has come primarily from the Cochrane Collaboration (Bastian, 1994; Horey, 2010) – The public have been part of the Collaboration since its inception – Public representation on the Cochrane steering group – Cochrane Consumer Network• 2 surveys of the extent to which Cochrane review groups involve the public have been published : Kelson, 1999, Wale et al, 2010• 4 Cochrane review groups have published accounts of public involvement within their respective groups: – Musculoskeletal (Shea et al, 2005), Pregnancy and Childbirth (Sakala et al, 2001), Breast cancer (Ghersi, 2002), Haematological malignancies (Skoetz et al, 2005)
Background to the review• Detailed published accounts of public involvement within individual systematic reviews remain scarce• Purpose of the review was to identify and review case examples of public involvement in the design and conduct of individual systematic reviews, to: – examine the methods, levels and stages of involvement reported – synthesise the identified contributions of involving the public – discuss the tensions, facilitating strategies and recommendations for good practice that have been identified• Excluded from the review were: – Viewpoint or discussion papers on public involvement in systematic reviews – Surveys of public involvement in systematic reviews. – Documents with insufficient detail of the contribution(s) of the public to the systematic review.
Searching for evidence • A literature search was undertaken in January 2011 of the following databases, with the aim of identifying peer-reviewed journal articles and reports published in English on public involvement in the systematic review process: – PsycINFO, MEDLINE, and MEDLINE In-Process, CINAHL, EMBASE, Cochrane Methodology Register, HMIC, invoNET. • Search terms included ‘consumer’, ‘user’, ‘participant’, ‘involvement’, ‘inclusion’, ‘review’, ‘systematic review’ and ‘research’. • A further search of a comprehensive bibliography of references on public involvement in health and social care research (Boote et al, 2012) was undertaken, to identify relevant reports of systematic reviews that involved the public
Identifying evidence• A total of 744 documents were identified in the search of databases, discounting duplicates• abstracts were scrutinised for possible inclusion in the review by the lead researcher, and these inclusions were checked for accuracy by a second researcher• Of these 744 documents, three papers were identified on public involvement in the systematic review process on the basis of paper title and abstract (where available)• The search of the bibliography identified a further four further relevant sources.• In total, seven case examples were found.
Included case examples (1)• Braye S, Preston-Shoot M. Emerging out of the shadows? Service user and carer involvement in systematic reviews. Evidence and Policy: A Journal of Research, Debate and Practice 2005;1(2):173–94.• Smith E, Donovan S, Beresford P, Manthorpe J, Brearley S, Sitzia J, et al.Getting ready for user involvement in a systematic review. Health Expectations 2009;12:197–208.• Serrano-Aguilar P, Trujillo-Martín MM, Ramos-Go˜ni JM, Mahtani-Chugan V, Perestelo-Pérez L, Posada-de la Paz M. Patient involvement in health research: a contribution to a systematic review on the effectiveness of treatments for degenerative ataxias. Social Science and Medicine 2009;69(6):920–5.• Brett J, Staniszewska S, Mockford C, Seers K, Herron-Marx S, Bayliss H. The PIRICOM Study: a systematic review of the conceptualisation, measurement, impact and outcomes of patients and public involvement in health and social care research. UK Clinical Research Collaboration; 2010, http://www.ukcrc.org/index.aspx?o=3233
Included case examples (2)• Nilsen ES, Myrhaug HT, Johansen M, Oliver S, Oxman AD. Methods of consumer involvement in developing healthcare policy and research, clinical practice guidelines and patient information material. Cochrane Database of Systematic Reviews 2006;3(September),ncbi-p:1469493X.• Carr S, Fleischmann P. Systematic review of consumers’ perspective on electro-convulsive therapy. In: Carr S, Coren E, editors. Collection of examples of service user and carer participation in systematic reviews. London: SCIE; 2007.http://www.scie.org.uk/publications/researchresources/rr02.pdf• Rees R, Oliver S. An example from sexual health promotion. In: Carr S, Coren E, editors. Collection of examples of service user and carer participation in systematic reviews. London: SCIE; 2007.http://www.scie.org.uk/publications/researchresources/rr02.pdf
Summary of included papers (1)Paper and Topic area Public Stage, method and type ofcountry involvementBraye and teaching, learning Wide range of different Consultation, advisory group,Preston-Shoot, and assessment of types of public define the scope and interpret2005, UK law in social work findings educationSmith et al, User involvement Members of 24 Collaboration (user-2009; UK in nursing, midwifery national service researcher) and consultation and health visiting user organisations (advisory group) researchSerrano- Degenerative 53 patients with Consultation - scoping theAguilar et al, ataxias degenerative review, Choice of outcomes,2009 ataxias Delphi methodCarr and Patients’ 2 service user User-led, All stages of theFleischman et perspectives on researchers with direct research. Use of user-al, 2007 Electro-convulsive experience of ECT and researchers and advisory therapy representatives of user group and voluntary groups with a stake in ECT research
Summary of included papers (2)Paper and Topic area Public Stage, method and typecountry of involvementRees and HIV health promotion for Representatives of a Consultation – define theOliver, 2007. men who have sex with number of health scope of the review,UK men promotion charities e.g. agree outcomes and Terrence Higgins Trust comment on findings. Advisory groupBrett et al, The conceptualisation, 3 lay people on advisory Collaboration –2007. UK measurement, group. Members of membership of advisory impact and outcomes of UNTRAP and Diabetes group; consultation via a public involvement in User Network Research workshop to discuss health research Group findingsNilsen et al, Methods of consumer A panel consisting Consultation through2006 involvement in developing of members of the email discussion list. healthcare policy and Cochrane Consumer Consulted on the review research, clinical practice Network. protocol, literature search, guidelines and patient and the initial draft of the information material review
Reported contributions of the public to systematic reviews1. Refining the scope of the review – In the review of HIV health promotion for MSM, the public identified HIV+ and young MSM as population subgroups on which the review should focus1. Suggesting and locating relevant literature – In the review of patients’ experiences of ECT, a user group located an unpublished study of ECT for the benefit of the review1. Appraising the literature – User researchers were involved in the review of patients’ experiences of ECT and appraised the literature1. Interpreting the findings – Two reviews reported the use of consultation workshops where preliminary findings were discussed with the public1. Writing up the review – Three of the reviews reported the public being involved in the writing up stage of the review process: either as first author, co-author, or as the author of the review’s foreword
Tensions identified when involving thepublic in the review process• Time pressures – It can take time to build up trust between researchers and the public in the review process• Resourcing problems – Lack of funding at the review development (pre-grant) stages to support involvement• Continuity issues – It can be difficult for the public to attend all review meetings• Concerns about group dynamics – The user-led review of experiences of ECT reported tensions regarding the amount of power the user-researchers had in the review process• Research Ethics Committee involvement – One review reported that they had to obtain approval from a REC to involve the public in the review process• Tensions associated with the representativeness of the members of the public involved – Some reviews mentioned that those who get involved in reviews will not be representative of the wider population
Good practice recommendations for involvingthe public in systematic reviews• Funding and payment – The public should be paid for the time they spend contributing to reviews and that this should be budgeted for• Identifying a lead for public involvement – This person should be the contact point for the public and this role should be costed into the review budget• Training, briefing and information provision – Provision of training, briefing notes and background information (such as a glossary) has been recommended. The extent of this will vary depending on the level of involvement.• Structured methods of involvement – Two reviews used structured processes (Delphi and voting at meetings) to capture the views of the public during the review process. This prevents the review process being dominated by particular, more vocal individuals.
Conclusions and implications• The review found examples of the public being involved in the systematic review process at the 3 main levels of involvement (consultation, collaboration and user control) and using a variety of methods, including the Delphi process, advisory group meeting and consultation workshops• It was found that the public were involved at all the key stages of the review process, but no reports were found of the public being involved in meta- analysis of quantitative dataImplications:• Commissioners of systematic reviews need to recognise that public involvement in the review process means that reviews take longer to deliver whilst being more expensive• Financial support is needed to resource public involvement at the design (pre-grant) stage of systematic reviews• Abstracts of systematic reviews should describe the extent of public involvement (if any) in the review process to facilitate more accurate future reviews of the evidence base
Further reading• Boote J, Baird W, Sutton A (2011), Public involvement in the systematic review process in health and social care: a narrative review of case examples. Health Policy, 102, 105– 116.• Kreis J, Puhan M,Schunemann H, Dickersin K (2012), Consumer involvement in systematic reviews of comparative effectiveness research. Health Expectations, DOI: 10.1111/j.1369-7625.2011.00722.x – Explores current approaches to involving consumers in US-based and key international organizations and groups conducting or commissioning systematic reviews• Vale C, Tierney J, Spera N, Whelan A, Nightingale A, Hanley B (2012), Evaluation of patient involvement in a systematic review and meta- analysis of individual patient data in cervical cancer treatment. Systematic Reviews 2012, 1:23 doi:10.1186/2046-4053-1-23 – Key example of involvement of the public in a meta-analysis along with an evaluation of the process
Contact details: Dr Jonathan Boote Research Fellow and PPI Lead NIHR Research Design Service for Yorkshire and the Humber Email: email@example.com Tel: 0114 222 0892 RDS website: http://www.rds-yh.nihr.ac.uk/