Arthritis Foundation Case Example

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:

  • Uses of the data were transparent and explained clearly, and
  • Patients themselves could have access to the data

Establishing Patient Leadership

  • Multiple staff project leads had extensive lived experience and a long history of working with patients and families from the AF community. Individual patients living with forms of arthritis were recruited to provide insights on an ongoing basis.
  • The Juvenile Arthritis (JA) version of the INSIGHTS program focused on issues of importance to pediatric populations [*Note: The pediatric surveys are completed by parents as observers of the children since collecting PRO data from those under 18 years of age added complexity and required resources the program did not have access to].

Assessing and Building Readiness

For the INSIGHTS program, early considerations were technical and functional:

  • Who would own the data?
  • What would maintenance and upkeep cost?
  • Would the Health Insurance Portability and Accountability Act (HIPAA) be triggered in any way?
  • How often should PRO surveys be done?
  • How often should analysis and data go to end-users?

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.

Maintaining Transparency

  • Throughout each phase of the project, decisions were made in partnership with various patient staff members and patient/parent volunteers.

Existing Patient-Reported Impact Data

  • The Foundation had already amassed a significant amount of data from prior efforts and years of community programming. Among the specific initiative data sets were two externally-led Patient-Focused Drug Development (PFDD) meetings with Voice-of-the-Patient reports (one on osteoarthritis and one in juvenile idiopathic arthritis(JIA)), the rheumatoid arthritis biologic survey conducted for an Institute for Clinical and Economic Review (ICER)  review, a series of local and national listening sessions with an array of patients and family members, multiple research work groups conducted in partnership with the Childhood Arthritis and Rheumatology Research Alliance (CARRA), and outputs of from a Patient-Centered Outcomes Research Institute (PCORI)-funded Engagement Award to develop a patient-driven research agenda.
  • In addition to all of these sources, the Arthritis Foundation had many years of evaluation data from conferences and local events through which patients and families expressed what they most needed and wanted for disease management and overall improvement of quality of life.
  • Again, as the INSIGHTS program was not itself an effort to develop a PC-CIS, it did not “use” this data in the same way, but the work nonetheless involved leveraging existing data and most importantly beginning with patient-generated data versus beginning with existing published literature on outcomes or outcome sets.


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. 

Environmental Scan

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.

Supplemental Materials/Information

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