Over the course of two years, the Arthritis Foundation (AF) created and launched a “community patient-reported outcomes (PRO)” program called “INSIGHTS” for capturing insights from people with arthritis to be used to determine the patient-reported outcomes that should be collected from arthritis patients. While not an example of a PC-CIS (because they are still being piloted), the steps taken to create the INSIGHTS program reflect many of the principles and methods key to developing Patient-Centered Core Impact Sets (PC-CIS). INSIGHTS offers an opportunity to highlight these principles and methods. Components of the INSIGHTS program will be used as a case example throughout the PC-CIS Blueprint.
Background and Overview
Prior to creating the program, the Arthritis Foundation held a series of listening sessions with patients to gauge interest in and the potential value of a program that would collect PROs outside of the clinical setting (a “community-based PRO program”). The feedback from those sessions showed there was value in doing something like this as long as:
Establishing Patient Leadership
Assessing and Building Readiness
For the INSIGHTS program, early considerations were technical and functional:
In terms of resources, this was a significant commitment and investment from the Arthritis Foundation. The opportunity to develop and maintain the program was a key element of fundraising efforts both from individual, and corporate donors and sponsors.
Existing Patient-Reported Impact Data
The nominal group technique steps used for the INSIGHTS program provides an example for how PC-CIS co-creation could occur, with very intentional and repeated involvement of patients/families in each step, even during more complicated elements of the project.
Patients and families were able to ask clarifying questions and gain more context, when necessary, which allowed them to participate most fully in the discussion and process. The goal of these discussions was to collaborate fully with the participants rather than to conduct research on them.
Importantly, the pre-project ideation listening sessions, and then key informant interviews occurred before the literature review. Researchers helped identify the primary literature and landscape of what exists in the span of outcomes research for arthropathies but the existing literature, which might have biases, be outdated, or have neglected or over-ridden patient input did not drive the work.
Prioritization Round 2
Again, the nominal group technique steps used for the INSIGHTS program provided an example for how PC-CIS co-creation could occur, with very intentional and repeated involvement of patients/families in each step, even during more complicated elements of the project. In this case, because the ultimate output was a tool to collect PROs in the community setting, there was less of a need to integrate “traditional” outcomes from literature and elsewhere, but the model is a sold basis for those seeking to build a PC-CIS.
In the INSIGHTS program for both adult disease and JIA, multiple in-person and virtual sessions were held with discussion and prioritization of key items, always informed by leadership from patient staff and patient/parent volunteers. This happened iteratively until a key set of items were finalized.
Assembling the Final PC-CIS
The full list of patient-prioritized outcomes was compiled and shared back with patients and families, and the final report was released publicly.
Existing outcome measures were identified and assembled based on the areas of key importance prioritized by the patients. The process asked patients/families to evaluate the importance of each item being evaluated, not just the tool(s) itself for ease of use, clarity, etc.
The patients/families (and other stakeholders) were not limited to assessing items in a single instrument and, instead, opted to carve out specific questions or sets of questions that were most relevant and useful.
Survey cadence and length were carefully evaluated with patient advisors, and even after the program was launched, end-users were queried about whether the surveys were too cumbersome, if the information captured seemed on target, and if there were any unmet needs that should be added.
For the Juvenile Arthritis (JA) iteration of the INSIGHTS program, parents and teens were involved in early ideation and modification of the existing program to fit needs of the community. Questions were added by parents to assess parents’ quality of life, in addition to the patients’ quality of life. The program was also translated to Spanish.
For the Juvenile Arthritis (JA) version of the program, members of the Pediatric Rheumatology Patient-Reported Outcomes Measurement Information System (PROMIS®) measures were involved to help with measure selection as were pediatric rheumatologists.
Stakeholder Development of an Online Program to Track Arthritis-Related Patient-Reported Outcomes Longitudinally: Live Yes! INSIGHTS