Provision of knee braces for knee osteoarthritis (PROP OA):

The PROP OA randomised controlled trial (RCT) aimed to determine the clinical and cost-effectiveness of knee braces in the management of knee osteoarthritis. It was a 12 month, multi-centre, two-arm, parallel-group, randomised (1:1), superiority trial, with a 9 month internal pilot. The setting of the trial was primary care and the community, and participants with clinically diagnosed knee OA were identified from general practices and community advertisements around four regions in England. In total, 466 participants were randomised to receive either knee bracing (with brace type matched to participants’ clinical and radiographic presentation and with adherence support) plus advice, written information and exercise instruction, or advice, written information and exercise instruction alone. Both interventions were provided by trained physiotherapists. The primary outcome was the composite patient-reported Knee Osteoarthritis Outcomes Score at 6 months post randomisation. Primary analysis was on an intention-to-treat basis. PROP OA is registered with the ISRCTN registry (ISRCTN28555470), and is currently being written up for publication.

PwA have been involved in all stages of the PROP OA RCT.

1.   Pre-funding

We held a meeting with 6 members of Keele Universities Research User Group (RUG), who had lived experience of knee OA. At the meeting we discussed the proposed interventions and trial design. Discussions impacted on our:

1.     Recruitment strategy. PwA highlighted the importance of including a self-referral option, because “people may put knee pain down to old age”, so may not be seeking health care.

2.     Intervention content. PwA felt that the braces should be adjustable, and there should be an element of patient and a holistic approach to brace allocation (for example also considering factors such as a patient’s ability to apply the brace and their functional goals). They felt that a review at 2 weeks was important in facilitating adherence to brace use, and using text message prompts to support adherence was “a very good idea.”

3.     Choice of primary outcome: Whilst the funder had requested function as the primary outcome measure in their commissioned call for the RCT, PwA told us that pain was equally as important as function: “pain is what you start with so if pain improves then function improves;” “if my function is improved but my pain is still there I would think what has gone on?” Our primary outcome measure was therefore a composite measure including both pain and function (KOOS-5).

4.     Study team. We identified two members of the group who agreed to become co-applicants and members of the study team. One subsequently dropped out due to other commitments. 

      Our two PPI co-applicants co-wrote the trial lay summary. Their input simplified and improved the readability of the initial researcher-led draft of the lay summary, improving its Flesh Index (ease of reading score 0-100, higher = easier to read) by 8 points.  

2.     Study set up

Our remaining PPI co-applicant (Carol Ingram) contributed to study set up in terms of:

1.     Helping to develop patient facing materials (e.g. participant information leaflet, wording on study website)

• Contributed to intervention development. Carol helped us to develop the algorithm for, and content of, motivational prompts that were sent to participants randomised to the bracing arm, to encourage adherence to brace use. Examples of prompts that Carol developed include “It’s easy to say no but get up and go! Try your knee brace!”, “More hours a day helps you on your way!” 
• Helped to train participating physiotherapists. Carol met the physiotherapists when we held our initial face-to-face training programme and told them about her experiences of wearing a knee brace. She also participated in training videos that were developed and provided to participating physiotherapists. One video was about taking informed consent, the other about knee joint examination. 

Active study phase

Carol has attended monthly trial management meetings for ongoing oversight. She has contributed to interpretation of the internal pilot study findings, and has helped with problem solving and decision making. For example, when we had to adapt the PROP OA RCT in response to the COVID-19 pandemic, Carol co-wrote additional wording for our participant facing materials, played a key role in our decision to continue to offer face-to-face treatment (as able), and helped us to decide to transition from paper-based to electronic data collection. 

4.     Interpretation of results

We presented our RCT findings to a group of 7 RUG members who had lived experience of knee OA, including Carol. Their interpretation of the results has informed key discussion points in the manuscript describing the clinical and cost effectiveness findings, which is currently being written up.

5.     Dissemination and implementation

Carol, our PPI co-applicant has already been involved in dissemination of our study findings. She contributed to an invited oral presentation that focused on the role of PPI in the PROP OA RCT that we gave at the Patellofemoral Research Network (iPFRN) Research Retreat, Bologne, Italy in 2023. She has helped to write this case-study and will co-write a lay summary of the study findings in due course. In 2023, she helped to present the study at a Think Tank at the Keele Impact Accelerator Unit, where steps to support early implementation of the study findings were discussed.

We used Keele Universities RUG to find people to become involved in our project, which currently has over 180 members.

Carol was given the opportunity to speak at every monthly study group meeting. I met with Carol separately if she wanted anything explaining in more detail, or if she wanted to tell me something about her life that might impact on her involvement over the coming weeks. Carol’s overall experience of being involved in the PROP OA RCT was positive, as she tells me in the accompanying video.

The PPIE team supported the Public members throughout their involvement in this project by sending invitations for meetings, any documents for reading, arranging payment for their PPIE activity and sending feedback after meetings.

From the above examples, it is clear that PPI has made a significant contribution to the overall success of the PROP OA trial, particularly its ability to continue through the COVID-19 pandemic.

I would find a replacement for the second PPI co-applicant who dropped out early on, just to make sure that the burden was not too great for one PPI co-applicant alone.

Involve PPI at every stage of the research project.

COVID-19 was a particular challenge. We overcame this by reverting to on line meetings using Microsoft Teams.