TY - JOUR
T1 - Factors influencing clinical trial participation of women with fibromyalgia across the United States
T2 - a cross-sectional survey
AU - Cardenas-Rojas, A.
AU - Pacheco-Barrios, K.
AU - Castelo-Branco, L.
AU - Gonzalez-Mego, P.
AU - Marduy, A.
AU - Vásquez-Ávila, K.
AU - Caumo, W.
AU - Fregni, F.
N1 - Publisher Copyright:
© 2024 Taylor & Francis Group, LLC.
PY - 2024
Y1 - 2024
N2 - Although fibromyalgia is a widespread chronic pain condition where 90 percent of patients are women, they are underrepresented in Randomized Clinical Trials (RCTs). We aim to describe the willingness to participate, assess different factors, and explore the impact of sociodemographic and clinical characteristics on perceived barriers to trial participation. This is a cross-sectional survey targeting women with fibromyalgia. Univariate and multivariate logistic regression were performed. Of the 436 women with fibromyalgia, 56 percent were very likely to participate in RCTs. Minorities expressed less interest than non-minorities, while higher pain scores, previous participation, and younger patients reported a higher interest. Barriers significantly associated with a reduced willingness were: the participant’s perception (side effects, distance, potential negative impact), the center (reputation), the trial protocol (number of visits, placebo), and trial awareness by their physician. In a multivariate analysis, older age, low education, lower income, and higher pain scores were associated with perceived barriers to RCT participation. Despite the high interest to participate, factors such as side effects, the center’s distance, number of visits, placebo treatments, and the institution’s reputation must be considered in clinical trials for women with fibromyalgia.
AB - Although fibromyalgia is a widespread chronic pain condition where 90 percent of patients are women, they are underrepresented in Randomized Clinical Trials (RCTs). We aim to describe the willingness to participate, assess different factors, and explore the impact of sociodemographic and clinical characteristics on perceived barriers to trial participation. This is a cross-sectional survey targeting women with fibromyalgia. Univariate and multivariate logistic regression were performed. Of the 436 women with fibromyalgia, 56 percent were very likely to participate in RCTs. Minorities expressed less interest than non-minorities, while higher pain scores, previous participation, and younger patients reported a higher interest. Barriers significantly associated with a reduced willingness were: the participant’s perception (side effects, distance, potential negative impact), the center (reputation), the trial protocol (number of visits, placebo), and trial awareness by their physician. In a multivariate analysis, older age, low education, lower income, and higher pain scores were associated with perceived barriers to RCT participation. Despite the high interest to participate, factors such as side effects, the center’s distance, number of visits, placebo treatments, and the institution’s reputation must be considered in clinical trials for women with fibromyalgia.
KW - Clinical trials participation
KW - fibromyalgia
KW - questionnaire
KW - recruitment
UR - http://www.scopus.com/inward/record.url?scp=85192987713&partnerID=8YFLogxK
U2 - 10.1080/03630242.2024.2334700
DO - 10.1080/03630242.2024.2334700
M3 - Artículo
AN - SCOPUS:85192987713
SN - 0363-0242
JO - Women and Health
JF - Women and Health
ER -