Preferences and Insights for Participation in a Rheumatoid Arthritis Clinical Prevention Trial: A Mixed-Methods Study

Abstract

Objective: In rheumatoid arthritis (RA), anti-citrullinated protein antibodies (ACPA) can be elevated prior to inflammatory arthritis (IA). The potential to intervene in people with ACPA positivity underpins the development of prevention trials in RA. The Research Participation Influences Study examined factors influencing the decisions of individuals who are ACPA(+) to participate in a prevention trial using qualitative and quantitative methods.

Methods: Individuals with ACPA positivity without IA were provided information regarding their risk for future RA, were provided a description of a clinical prevention trial using hydroxychloroquine, and were asked if they would participate in the trial. After agreeing to or declining participation, they were surveyed on what influenced their decision using Likert scales and open-response questions.

Results: Thirty-nine individuals who agreed to trial participation (enrollees) and 31 individuals who declined (nonenrollees) completed surveys. Enrollees expressed greater perceived risk for RA and greater perception of benefit to themselves or others than nonenrollees. Nonenrollees expressed greater concern about medication effects and less personal or family experience with RA than enrollees. There was a higher proportion of first-degree relatives (FDRs) of people with RA in enrollees versus nonenrollees (54% vs. 23%, P = 0.01).

Conclusion: Enrollees were more likely than nonenrollees to be FDRs, exhibit stronger concern for personal risk for RA, and have less concern about adverse effects. Further exploration is needed to determine why these differences were present, including exploration of symptoms and the role of family history. Understanding these issues will better inform researchers and individuals who are candidates for prevention.

Figure 1

Likert question responses among enrollees and nonenrollees. Percentages of enrollees' and nonenrollees' indicated influence for given Likert scale questions are shown in stacked bars. Asterisks denote a significant difference in the proportion of enrollees' compared to nonenrollees' degree of influence for the given Likert scale questions as follows: ns (nonsignificant), *P ≤ 0.05, **P ≤ 0.01, ***P ≤ 0.001, ****P ≤ 0.0001. RA, rheumatoid arthritis.

Figure 2

Likert question responses of first‐degree relatives (FDRs) and non‐FDRs. Percentages of FDRs' and non‐FDRs' indicated influence for given Likert scale questions are shown in stacked bars. Asterisks denote a significant difference in the proportion of FDRs' compared to non‐FDRs' degree of influence for the given Likert scale questions as follows: ns (nonsignificant), *P ≤ 0.05, **P ≤ 0.01, ***P ≤ 0.001, ****P ≤ 0.0001. FDRs are less likely to be influenced by the potential adverse effects of the trial medication (P = 0.01). RA, rheumatoid arthritis.