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Recruitment characteristics and non-adherence associated factors of fibromyalgia patients in a randomized clinical trial: A retrospective survival analysis.


ABSTRACT:

Introduction

Fibromyalgia is a complex pain condition that affects mostly women. Given the disease's lack of understanding, patients report poor adherence to medication and mistrust of medical services. This study aims to describe the recruitment characteristics and non-adherence associated factors of fibromyalgia patients to an RCT.

Methods

We performed a retrospective longitudinal analysis with data from our ongoing RCT. We investigated characteristics of subjects recruited, consented, and randomized. Adherence was studied using survival analysis techniques, and its associated factors were identified using Cox proportional hazards regression model.

Results

524 subjects were contacted, 269 were eligible, 61 consented and 40 subjects were randomized. Thirty-eight percent were non-adherent to the protocol with a median of visits of five. The recruitment survey reported that 90% would likely participate in RCTs, 52% had previous participation, and 19% were aware of RCTs by their physicians. Some barriers were investigator-related (staff's friendliness and receiving the results of their trial participation) and center-related (privacy-confidentiality issues and the institution's reputation), without difference between adherent and non-adherent participants. We report significant factors for non-adherence as VAS anxiety score of 5 or more (5.3 HR, p = 0.01), Body Mass Index (BMI) (0.91 HR, p = 0.041) and Quality of Life (QoL) - Personal development subdomain (0.89 HR, p = 0.046).

Conclusion

Recruitment and adherence of fibromyalgia patients is a challenge; however, they seem eager to participate in RCTs. We recommend creating a comfortable, friendly and trusting environment to increase the recruitment rate. Higher anxiety, lower BMI and lower quality of life were associated with a higher attrition rate.

SUBMITTER: Cardenas-Rojas A 

PROVIDER: S-EPMC8609141 | biostudies-literature | 2021 Dec

REPOSITORIES: biostudies-literature

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Publications

Recruitment characteristics and non-adherence associated factors of fibromyalgia patients in a randomized clinical trial: A retrospective survival analysis.

Cardenas-Rojas Alejandra A   Castelo-Branco Luis L   Pacheco-Barrios Kevin K   Shaikh Emad Salman ES   Uygur-Kucukseymen Elif E   Giannoni-Luza Stefano S   Vasconcelos Felippe Luna L   Gonzalez-Mego Paola P   Luna-Cuadros Maria Alejandra MA   Gianlorenco Anna Carolyna Lepesteur ACL   Teixeira Paulo E P PEP   Caumo Wolnei W   Fregni Felipe F  

Contemporary clinical trials communications 20211117


<h4>Introduction</h4>Fibromyalgia is a complex pain condition that affects mostly women. Given the disease's lack of understanding, patients report poor adherence to medication and mistrust of medical services. This study aims to describe the recruitment characteristics and non-adherence associated factors of fibromyalgia patients to an RCT.<h4>Methods</h4>We performed a retrospective longitudinal analysis with data from our ongoing RCT. We investigated characteristics of subjects recruited, con  ...[more]