Improving uptake of Fracture Prevention drug Treatments: Development of a consultation intervention (iFraP)

The iFraP (Improving uptake of Fracture Prevention drug Treatments) study aimed to codevelop and test an osteoporosis decision support tool (and associated clinician training) to be used in bone health appointments to facilitate shared decision making about osteoporosis medicines.

Public contributors, including people with osteoporosis and their caregivers, were involved throughout the research cycle.

Setting the context for the study

Public contributors facilitated the development and conceptualisation of the iFraP study. The osteoporosis research group worked in partnership with public contributors to conduct a research priority setting exercise, consisting of focus groups followed by a survey. Public contributors identified ‘information needs’ as an important (yet missing) theme in the analysis of focus group data. This directly informed the analytical data interpretations. The ‘information needs’ theme was then included in the linked national survey priority setting exercise. This survey found that ‘improving information from health professionals‘ the highest-rated research priority for people with osteoporosis. The iFraP study was developed with public contributors to address this need.

Public contributors often share lived experiences that shape priority research questions for future research projects. To demonstrate, the Keele osteoporosis public contributors highlighted the inequities they faced, as public members from underserved groups, to access high quality osteoporosis care. Public contributors are now co-applicants on spin-off grants to address this priority area. This demonstrates the need for diverse perspectives in public contributor activities.

Codeveloping the iFraP intervention

During the intervention development phase of the study, public contributors were involved in various ways, such as:

• Contributing to Study Management Group and Award Steering Committee meetings to ensure public study oversight and monitoring
• Attending six dedicated public contributor meetings to inform study design and set up, review recruitment materials and pilot surveys, facilitate qualitative data interpretation and, feedback about intervention design and usability. 
• Integrating into the iFraP Community of Practice as expert stakeholders (alongside clinical, third sector and industry experts) to facilitate shared learning about the iFraP study.
• Supporting the development of training materials by ‘role playing’ the patient in video demonstrations of the iFraP intervention being used in a mock bone health consultation.

During the iFraP randomised controlled trial 

Public contributors continued their involvement into the trial phase of the research, such as:

• Contributing to Trial Management Group as a team member and Trial Steering Group meetings, providing study oversight and ensuring public contributor involvement throughout operational decision-making. This has been particularly helpful for discussions about research inclusion and in developing study glossary and ‘no acronym rule’ which all related staff in the Clinical Trials Unit have felt they have benefited from attending a further four dedicated public contributor meetings (to date) to discuss the planned trial, pilot baseline and follow up questionnaires, choosing relevant and important outcome measures and facilitating qualitative interview data interpretation. To demonstrate the impact of public contributor involvement on the iFraP trial, public contributors advised that we move away from a clinical primary outcome (osteoporosis medicine initiation) to a patient experience outcome about involvement and decision-making. This was agreed.
  
• Co-authoring an abstract presented at a national conference demonstrating the impact of public contributor involvement.
• Co-authors on publications: Public contributors have worked together with the wider academic team to co-author peer reviewed publications. 

Keele University School of Medicine has an established large and active Research User Group (RUG) including people with lived experience of osteoporosis and their caregivers. Additional public contributors have been identified by clinical study team members via our local osteoporosis NHS service.

Plans for PPIE were designed with public contributors at the start of the research study and revisited at regular points throughout the study to ensure that involvement was appropriate and meaningful. We followed the INVOLVE guidelines to support people with osteoporosis to be involved in the iFraP study, focusing on the principles of:

• ·        Communication: we provided regular and accessible study updates to public contributors in-preparation for, and between meetings (e.g. newsletters) and provided resources to facilitate meaningful involvement in discussions (e.g. acronym and jargon busters). Communications with public members was individualised to support involvement, including telephone discussions (where conferencing software use was not possible) and posting of preparation materials.
• ·        Support and learning: PPIE is central to all our research activity and Keele University School of Medicine. All PPIE activity at Keele University School of Medicine is supported by professional services staff including PPIE project coordinators and User Support Workers to guide and support PPIE activities. Where required, the PPIE team offer public contributors with accessible resources and training to facilitate their learning in research.
• ·       Inclusive opportunities: we remained reflexive and flexible to facilitate an inclusive environment for PPIE activities. For example, we accommodated both remote and in-person attendance at meetings to support diversity of attendees (e.g. people of working age who are often excluded from osteoporosis research). Importantly, we provide reimbursement for time and expenses in line with INVOLVE standards facilitating attendance at meetings.
• ·        Governance: Public contributors are supported to be involved in research management, regulation, and decision making. For the iFraP study, we provide the  support (guidance documents, preparation discussions, debrief meetings) for public contributors to sit in key roles e.g. Trial Management Group and Trial Steering Group.
• ·        Working together: All public contributor activities were underpinned by values such as: equal partnership, reciprocity, and ownership. These values foster a culture of openness and honesty.

Importantly, following each public contributor activity, we asked for feedback to inform future collaborative working and critically reflected on our practices.

PPIE impact was enabled through a culture of reciprocity and respectful challenge, where trust was built through listening to and valuing contributions. The impact of PPIE on iFraP intervention and research design was captured using an impact log and can be summarised into two broad categories:

1. holistic person-centred care: the iFraP intervention was originally conceptualised to focus on supporting shared decision-making discussions about osteoporosis medicines. Public contributors discussed osteoporosis care aside from osteoporosis medicine. For example, public contributors discussed the fear and worry associated with osteoporosis, guiding incorporation of a ‘getting support’ component of iFraP intervention. This change, guided by public contributor lived insights, had wide impacts e.g. when feasibility testing the intervention at one site, the ‘getting support’ element of the intervention instigated discussions with patients about fractures caused by domestic abuse. Discussions with public contributors about holistic person-centred care also impacted research design, with a measure of patient experience (decision-making about medicines) chosen as the trial primary outcome rather than a clinical outcome (e.g. medicine adherence), as this was perceived to be a more meaningful outcome.
2. equality, diversity and inclusion: Discussions with public contributors informed the iFraP intervention design (e.g. to facilitate intervention use in remote consultations) and study documents (e.g. data collection instruments) to support accessibility. Public contributors increased the representativeness of intervention content (e.g. using inclusive terminology e.g. ‘low sex hormones’ rather than ‘menopause’ when considering osteoporosis risk factors). Public contributors emphasised the need to support underserved groups’ research participation by ensuring that study invites included translation and additional costs acquired for translation services.

Understanding the impact of PPIE: The iFraP research team (including public contributors) worked closely to unpick how PPIE has impacted the iFraP intervention and research design. Public contributors were instrumental in sharing how their involvement in the iFraP study impacted them, as well as reflecting on PPIE activity that went well, and areas for improvement. One public contributor was shortlisted as a finalist at the Patient Experience Network National Awards (PENNA) for the work they had achieved alongside clinical and research colleagues, titled ‘stronger together’, where they showcased their work as part of the iFraP study team.

In the iFraP study, public contributor involvement was largely supported via traditional PPIE meetings (located at Keele University or remotely). In future linked projects, we are aiming to complement this traditional approach with community engagement work. This will facilitate the research team to build relationships with and collaborate alongside (underserved) communities affected by our research.  

Capture impact: It is important to demonstrate the value that PPIE brings to our research. Using impact logs throughout the research cycle supports reflexive practice and helps to demonstrate the difference working alongside public contributors as part of the team has on our work.

Remain flexible and reflexive: One size does not fit all. Public contributors may require different levels of support and these support needs might change over the course of a research project. It is helpful to remain critically reflexive of our PPIE practices and flexible to accommodate changing support needs or requirements. As researchers, we should talk to public contributors to understand how they wish to engage with study (how often, when, where) and how contributors can be best supported to meaningfully engage in PPIE activities.

During the COVID pandemic, in-person meetings were paused in line with social distancing requirements. Online conferencing software became the primary method to facilitate public contributor involvement. However, this meant that some contributors were unable to access meetings because of digital accessibility. Efforts were made by the research team to facilitate ongoing relationships during this time, including telephone discussions prompted by printed materials sent in the post.