RWD researchers from Pfizer–BMS approached the NHC and A-A to partner with them on the AdBoard. The NHC is a non-profit membership organization that works on behalf of people living with chronic diseases and disabilities and has a great deal of experience with patient engagement in RWE [4, 6, 7]. The A-A is a non-profit organization that provides information, support, education, and awareness for all those affected by cardiac arrhythmias, particularly AF. A-A led AF patient-recruitment efforts for the AdBoard and ensured materials were appropriate for patients with AF. The project team included representatives from Pfizer–BMS’s health economics and outcomes research group, NHC research staff, and the A-A founder and CEO. The team met regularly by teleconference from July to December 2019.
Advisory Board (AdBoard) Participant Identification
A-A recruited AdBoard participants through advertisements in its monthly newsletter and US- and UK-based online forums. A-A staff screened and selected applicants according to inclusion criteria: a confirmed AF diagnosis, over 50 years of age, US or UK resident, and ability to travel to New York for a 1-day, in-person meeting. Nine patients with AF were recruited (two from the UK and seven from the US), equally distributed by gender and with diverse comorbidities.
Patient-Friendly Introduction to Real-World Data (RWD)/Real-World Evidence (RWE)
Since RWD/RWE are new to most members of the patient community, introductory webinars were hosted by the NHC prior to the in-person AdBoard meeting . The objectives of the “prep” webinar sessions were to (1) provide an opportunity for the group to meet before the in-person session; (2) introduce RWD/RWE, including non-AF and AF-specific examples ; and (3) review the AdBoard purpose and goals. Participants also received a plain language RWD/RWE glossary in advance of the in-person AdBoard meeting.
In-Person AdBoard Meeting
The in-person, “Patient Perspectives on RWD” AdBoard meeting was held on November 14, 2019, in New York City, NY, USA. Prior to the AdBoard meeting, the project team developed a detailed discussion guide to ensure optimal use of participants’ time. The AdBoard started with an abbreviated review of the RWD/RWE introduction covered during the “prep” sessions, followed by three AF-specific sessions enumerated in the following sections. In addition, the agenda featured a “wrap up discussion” in which participants were invited to provide considerations and advice to researchers from the Pfizer–BMS Alliance (see the agenda in the electronic supplementary material [ESM]).
Session 1: Experiences and Perspectives on Living with Atrial Fibrillation (AF) and Anticoagulation Medication for Reducing Risk of AF-Related Stroke
Using a patient experience-mapping visual aid, we asked participants to describe experiences before their AF diagnosis, while being diagnosed with AF, and with treatment to reduce the risk of stroke. The visual aid used in this session was co-developed by a separate NHC multi-stakeholder advisory board . It depicts the process of pre-diagnosis (e.g., noticing something is wrong, annual wellness visit), deciding to see a health professional to receive a diagnosis (or misdiagnosis), and experiences after diagnosis (e.g., treatments, outcomes experienced). It also depicts modifiers, including family or support systems, costs, health insurance, comorbidities, etc. During these discussions, participants were asked to reflect on personal experiences and more general experiences as a patient with AF but to specifically avoid provider and treatment names.
Session 2: Obtain Input on Outcomes Important to Patients with AF
To solicit inputs on which outcomes are most important for researchers to study, participants were separated into two working groups to (1) brainstorm and list the AF outcomes most important to them, (2) discuss/critique outcomes evaluated in AF-related RWD studies from the past 5 years (obtained from a landscape analysis) and others proposed by participants, and (3) rank all outcomes from both discussions based on what is most important to them. Each group tracked their discussion and came up with a list of upwards of 20 ways in which AF impacts them. Following the small-group work, participants reconvened for a full-group discussion to produce a final ranked list. To further narrow down the most important outcomes, all patients rated their top five. Results were tabulated and discussed among the entire group.
Session 3: Opportunities to Engage Patients with AF in RWE and Effective Communication of RWE to Patients
To understand perspectives on preferred methods for communicating RWE, key findings from a published AF RWD study were presented using different visuals, including bar graphs, infographic style, and the article’s original tables . The positives and negatives of the communication vehicles were discussed.