There has been ongoing PPI throughout the programme as follows.
Engagement with the Patient Experience Partnership in Research
In 2010 a patient group, the PEP-R group, was established to provide a forum through which patients could provide who contribute to the design and delivery of research in the University of Bristol’s Musculoskeletal Research Unit (MRU). This group currently comprises eight people who have musculoskeletal conditions, many of whom also have had joint replacements. Group members totalled 18 (nine women and nine men, aged 25–85 years), with a maximum of 11 members at any one time. The group meets for 2 hours every 6–8 weeks. In keeping with guidance from INVOLVE – the national advisory group that supports greater public involvement in NHS, public health and social care research228 – group members were reimbursed for their time and travel expenses.
Support and training for the patient partners was provided by a dedicated PPI co-ordinator who is a trained researcher with several years’ experience supporting patient partners in research. Support included structured training sessions and one-to-one meetings with patient partners. Training and learning is incorporated into PEP-R meetings. Researchers have described and discussed study design (e.g. randomised trials) in the context of studies. In response to group members’ feedback, sessions have also included discussion of epidemiology, statistics and qualitative methods. PEP-R members have also visited the MRU.
The co-ordinator liaised between research staff and patient partners. Researchers from the MRU work closely with the new ‘People and Research West of England’ partnership promoting and supporting service user involvement in research, and patient partners had access to events and the service user network. PEP-R group members are regularly provided with information about how their input has influenced the implementation of studies so that they can see their impact on the research, including verbal feedback on previously discussed projects at the start of every meeting and written feedback in the form of leaflets every few months.
Patient Experience Partnership in Research inputs into many studies within the unit and one of them was RESTORE. Researchers from RESTORE have attended eight meetings of the PEP-R group. The format of these sessions includes group discussion, presentations, card-sorting tasks and written answer sheets. It was important for researchers to have a written record of the session, so discussions are recorded on a flip chart or written sheets completed by group members. Material is sent out to group members in advance so that they have the chance to read it beforehand. They had the choice of providing their input verbally during a session, or by telephone or e-mail afterwards.
All of the work packages have been discussed and developed in collaboration with patient representatives and PEP-R. Patient representatives have provided input into patient recruitment and information literature, research processes, identifying outcomes of importance to patients, questionnaire design and dissemination and helped ensure that outputs of packages informed one another.
The work of the PEP-R group, including work on the RESTORE project and other projects was recognised in a University of Bristol’s engagement award 2014.
APEX
Patient representatives inputted into the refinement of patient information materials to ensure that they were clear. One issue with early recruitment materials in APEX was the inclusion of information about spinal anaesthesia. Through discussions with patients it became clear that this was confusing and potentially worrying. Therefore, this information was removed from the recruitment packs. PEP-R has learned about randomised trials through discussion of the APEX trial and of trials in general with researchers facilitating PEP-R sessions. Issues of blinding and sharing results with participants have been discussed with patient representatives and these discussions helped to inform the decision to tell participants in APEX about their allocation to intervention or control groups. Patient representatives advised on the appropriate terminology and the level and amount of information provided to participants when contacted to arrange their 12-month research follow-up visits. They confirmed that the proposed explanation of the visit made the need to undress for an examination explicit and favoured the less clinical term ‘surgical site’ as opposed to ‘wound’ or ‘scar’ with regard to the examination of the replaced joint. As a result, the research nurses were able to incorporate these changes into their subsequent interaction with the participants.
ADAPT
Patient representatives provided suggestions about how to frame the requirements of study participation to participants and in relation to questionnaires. In ADAPT, questionnaires were long and data were collected at three time points. This meant that data collection would involve patients visiting the hospital on three occasions each and also completing long questionnaires. Patient input helped in the presentation of the questionnaires to make them easier to read and complete; however, as these were validated instruments, changes could not be made to the questions or response options. Since study completion, patient representatives provided suggestions for feedback in leaflet form to study participants as well as suggestions of other ways of disseminating findings to the public. Their suggestions included providing a brief summary of the project as participants might have forgotten, using visual representations, signposting to other ways the information will be used and where participants could read about the study in greater detail, for example, giving links to journal articles.
SPIRAL
Patient representatives discussed the study in detail and provided their input into the intervention and study recruitment material, which led to refinements to all these aspects of the study. These discussions resulted in a change in the name of the study to SPIRAL and improving the formatting of the patient information sheet. They also discussed issues around non-participation in the study and made suggestions about how it could be made easier for patients to take part, including providing help with transport and holding the groups in local venues rather than hospitals. These suggestions will be used to guide the design of future research protocols. Since study completion, patient representatives provided suggestions for feedback in leaflet form to study participants.
ARENA
Patient representatives were asked to feedback on the development of this study. They provided input into the development of the exercise class in terms of patients’ requirements during the class and opinions of the exercises proposed. For example, they highlighted the importance of providing assistance with travel arrangements for those with transport difficulties, the inclusion of refreshment breaks and music during the class, and the additional of an exercise aimed to improve patients’ ability to get in and out of bed. They also emphasised the importance of study participants having details of person whom they could contact between classes. In response to this, a contact name and telephone number was available to all participants throughout the study. In addition, they provided the research team with reassurance that the introduction of an exercise class after knee replacement was a positive approach and they supported the concept of providing function-based exercises within a group setting. Following completion of the ARENA study, the patient representatives have supported further proposals to pursue a larger trial comparing the exercise class with usual care. They felt that providing further individualised treatment within the exercise class would be beneficial to patients. This has been included the design of a grant proposal to explore the exercise class in a future study.
PROOF-THR
Patient representatives discussed the protocol and study materials, leading to refinements in these. As a direct result of these discussions, the design of the main study compared with the pilot was changed by adding in a follow-up visit to check progress by the same occupational therapist (OT) who had visited them before surgery if the patient requested one. In addition, as a compromise for the patient input regarding follow-up, the OTs were given a pre-paid mobile phone each and the patients were given the number to call for verbal advice. This was actually used quite a lot and proved very popular with the patients. It was also suggested that the visiting OT give advice on benefits, but this is not standard OT practice as it is a complex area that requires specialist advice. Instead, helpful phone numbers were given to participants if requested.
Systematic reviews
The importance and value of systematic reviews has been discussed with the patient representatives. This has been particularly helpful in developing new projects with extensive discussions on how to follow-up results of reviews relating to comorbidities and rehabilitation.
Patient experience study
Patient representatives discussed this study in detail, leading to the addition of questions in the interview topic guide such as questions around when and why problems first developed with the joint. Other suggestions taken on board include adding an e-mail address to the back of the patient information booklet to enable potential participants to contact the research team via e-mail and the positive implications of including the Hip Disability and Osteoarthritis Outcome Score (HOOS) or KOOS questionnaires in the 12-month follow-up interview in addition to the pre-operation interview. Since study completion, the patient representatives have provided suggestions for feedback in leaflet form to study participants.
In addition, in January 2013 we held a dissemination event with members of PEP-R. Arranged as a ‘science café’, the event provided opportunity for discussion about all work carried out on the RESTORE programme.
Evaluation of patient and public involvement
We assessed patient involvement in the programme by collecting regular, systematic feedback from patient partners and researchers. This helped us refine our involvement processes as the programme progresses, as well as to provide advice on PPI activity to others within NHS and University sectors.
Eight patients, who were members of PEP-R at the time of the evaluation (November 2011), and 14 researchers completed a questionnaire examining the impact of the activity on themselves and the research. Group members described their interest and learning about the topics and research in general. They particularly valued feedback about how PEP-R’s input had shaped studies. Researchers identified the benefits of obtaining patients’ views on the importance, relevance and feasibility of their projects. They welcomed the opportunity to speak to an interested and knowledgeable group and stressed the importance of early involvement. A selection of comments are shown in .
Example comments on PEP-R by group members and researchers
Patient involvement in Patient Experience Partnership in Research: a personal view
Victoria Wells has been a patient-partner in RESTORE throughout its duration. She previously underwent joint replacement. This section outlines her experience of patient involvement in the programme and her views about the research.
I came from the operating table to sitting around the research table. I remember the first research meeting where everyone was introducing themselves and talking about RESTORE. Being part of that from a lay perspective gave the research extra grounding in experiences. It’s been good having nurses, patients, physios and surgeons working alongside researchers as they all bring different views, painting the whole picture. It’s very easy to have research that misses the patient and it’s good to have the patient there.
In RESTORE I’ve had individual conversations with the study leads, and researchers were able to approach me so that I could answer their questions. There were no barriers there and the researchers seemed not to be worried about asking me questions. They were able to ask me questions and were sensitive to the patient journey that I had had. As result of personal experience I’m able to put in real life experience into the research or make suggestions to approach other patient partners. I could also break down academic text into more readable forms, for example for patient leaflets. I was able to bring in some influence from ‘outside the box’ and it was also like being able to turn a box inside out.
With APEX my input was in how the study would be described to patients at the sensitive stage before surgery when people needed to know about their pain relief. My thoughts were listened at that early stage. I really remember coming to my second research meeting as we talked about information in the APEX trial and about the information that would eventually be disclosed to patients in the trial. Blinding was important, and so was the information about the treatment that patients got.
With ADAPT the questionnaires needed a lot of input before they went to patients, and that was important. With ARENA there were quite a few informal conversations for my input, although SPIRAL and ARENA the studies were patient-centred anyway. In the patient experience study I had quite a few conversations looking at the patient experience in the long-term, beyond the ward, and making the most of your joint replacement. I’ve had interesting conversations around the systematic review work, and there were informal discussions and I do feel like that work has taken my views onboard. With the health economics my engagement has also been informal and the cost-effectiveness side of the work is hugely important. With the informality it’s less like being interviewed and it’s more of a discussion and the team members are more relaxed and feel able to ask me questions, which is what you’d get in qualitative research because it would be a conversation and no pressure for a particular outcome because you can just explore the study and think about things in different ways. With the health economics and systematic reviews it’s been explained in ways that I can understand and made me think in a different way, and this is kind of hidden and useful.
Having contact with researchers hasn’t always been about having a specific outcome in mind, it’s about exploring a study that enables involvement, so that the thought processes are clear. Patient and public involvement doesn’t always need to be prescriptive, but this can only happen if you’ve built up a relationship over time and the involvement I have had I have built this up with the RESTORE team.
As a result of early involvement in RESTORE and my understanding of patient and public involvement I was able to advise on the creation of PEP-R (the Unit’s patient forum), which gave richer information from a collective of patients rather than an individual. I feel like it’s creating a minibus of people and we are passengers because no two experiences are the same. I’ve been involved in PEP-R but have also been able to hand over that baton to others, I was on the planning and steering group and was able to hand that over and that felt good.
Victoria Wells, University of Bristol, 2014, personal communication, reproduced with permission
