TY - JOUR
T1 - How to enhance recruitment of individuals at risk of rheumatoid arthritis into trials aimed at prevention: Understanding the barriers and facilitators
AU - van Boheemen, Laurette
AU - ter Wee, Marieke M.
AU - Seppen, Bart
AU - van Schaardenburg, Dirkjan
N1 - Funding Information: Contributors MMtW and DvS designed the study. MMtW, LvB and BS contributed to data collection. MMtW, LvB, BS and DvS contributed to data analyses and interpretation. All authors reviewed the manuscript and approved the final version for submission. Funding This study was funded by the Reade Foundation. Competing interests None declared. Patient consent for publication Not required. Ethics approval The study was conducted in accordance with the ethical principles of the Declaration of Helsinki and Good Clinical Practice guidelines. The Ethical Review Board of the VU Medical Center and Reade stated that the focus group discussion (FGD) study was not subjected to the Medical Research Involving Human Subjects Act. All participants signed informed consent before the start of the FGD. Publisher Copyright: © Copyright: Copyright 2021 Elsevier B.V., All rights reserved.
PY - 2021/3/7
Y1 - 2021/3/7
N2 - Objectives Several 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. Methods Individuals 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. Results The 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. Conclusions To 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.
AB - Objectives Several 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. Methods Individuals 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. Results The 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. Conclusions To 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.
KW - psychology
KW - qualitative research
KW - rheumatoid arthritis
KW - therapeutics
UR - http://www.scopus.com/inward/record.url?scp=85102391310&partnerID=8YFLogxK
U2 - https://doi.org/10.1136/rmdopen-2021-001592
DO - https://doi.org/10.1136/rmdopen-2021-001592
M3 - Article
C2 - 33685929
SN - 2056-5933
VL - 7
JO - RMD OPEN
JF - RMD OPEN
IS - 1
M1 - e001592
ER -