How to enhance recruitment of individuals at risk of rheumatoid arthritis into trials aimed at prevention: understanding the barriers and facilitators

Abstract

ObjectivesSeveral trials to test the efficacy of a pharmacological intervention aimed at primary prevention of rheumatoid arthritis (RA) are ongoing or have recently been completed. A common issue in these trials is the severe difficulty with patient recruitment. In order to enhance recruitment, this qualitative study identified barriers and facilitators of individuals at risk of RA to participate in a prevention trial.MethodsIndividuals at risk of developing RA (ie, arthralgia with anticitrullinated protein antibodies and/or rheumatoid factor without arthritis), who had previously been asked to participate in a prevention trial, participated in focus group discussions (n=18) exploring their facilitators and barriers for trial participation. Thematic analysis identified factors that were important in at-risk individuals’ decision about trial participation.ResultsThe prospect of personal benefit, the acknowledgement of one’s symptoms and the desire to contribute to society facilitated trial participation. In contrast, misconception about what it means to be at risk, or about the aim of the prevention trial, negative views on trial medication, and a low perceived urgency to act on the possibility of developing RA versus a high perceived burden of participating in a trial discouraged participation.ConclusionsTo enhance inclusion in trials aimed to prevent RA, the results suggest to use strategies such as optimising education about RA, personal risk, trial aim and trial medication, explicitly addressing misconceptions and concerns, using tools to improve information provision, limiting study burden in trial design and encouraging physicians to mention trial participation.

Risk Factors for Developing Rheumatoid Arthritis in Patients With Undifferentiated Arthritis and Inflammatory Arthralgia

“…Morning stiffness has been evaluated both for its duration and intensity and studies have shown that morning stiffness durations ≥60 min, as well as the severity of morning stiffness as measured by VAS, both correlate with, and constitute a predictive factor for, developing RA ( 17 , 18 ).…”

“…Epidemiological factors include age, sex, family history of RA and race/ethnicity ( 29 ). However, variability in the study designs, outcome definitions, serological subsets and different follow-up times can hamper the ability to obtain robust conclusions ( 18 , 30 , 31 ).…”

“…Nonetheless, a common issue hampering such trials is the great difficulty of patient recruitment. Once again, to improve inclusion in trials, strategies should be implemented, to include optimizing education about RA, personal risks, trial aims and medications, and explicitly addressing any patient concerns; see the recently published results by van Boheemen et al ( 18 ).…”

Can Studying Genetically Predisposed Individuals Inform Prevention Strategies for RA?

“…Identifying participation-related barriers and implementing strategies to address these gaps is critical for improving study recruitment in RA prevention trials [38,39]. While a negative view on the trial drug along with the fear of using medications remains an important barrier, factors such as reluctance toward adopting healthy lifestyle changes such as smoking cessation necessitate the need for looking at alternative strategies for future trials that can be better integrated with cultural habits of the communities [40].…”

“…While a negative view on the trial drug along with the fear of using medications remains an important barrier, factors such as reluctance toward adopting healthy lifestyle changes such as smoking cessation necessitate the need for looking at alternative strategies for future trials that can be better integrated with cultural habits of the communities [40]. Dietary interventions using natural remedies such as dietary supplements along with strategies such as personalized risk-estimation tools and optimal education on perceived disease risk seem to be promising facilitators that can potentially encourage trial participation and are well accepted [39,41,42].…”