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

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 fa...

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Autores principales:	Alejandra Cardenas-Rojas, Luis Castelo-Branco, Kevin Pacheco-Barrios, Emad Salman Shaikh, Elif Uygur-Kucukseymen, Stefano Giannoni-Luza, Luna Vasconcelos Felippe, Paola Gonzalez-Mego, Maria Alejandra Luna-Cuadros, Anna Carolyna Lepesteur Gianlorenco, Paulo E.P. Teixeira, Wolnei Caumo, Felipe Fregni
Formato:	article
Lenguaje:	EN
Publicado:	Elsevier 2021
Materias:	Fibromyalgia Underrepresented population Clinical trials participation Recruitment Therapeutic adherence and compliance Medicine (General) R5-920
Acceso en línea:	https://doaj.org/article/a48d9f31e30d48188119c120a774e3a7
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spelling	oai:doaj.org-article:a48d9f31e30d48188119c120a774e3a72021-11-22T04:28:01ZRecruitment characteristics and non-adherence associated factors of fibromyalgia patients in a randomized clinical trial: A retrospective survival analysis2451-865410.1016/j.conctc.2021.100860https://doaj.org/article/a48d9f31e30d48188119c120a774e3a72021-12-01T00:00:00Zhttp://www.sciencedirect.com/science/article/pii/S2451865421001605https://doaj.org/toc/2451-8654Introduction: 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.Alejandra Cardenas-RojasLuis Castelo-BrancoKevin Pacheco-BarriosEmad Salman ShaikhElif Uygur-KucukseymenStefano Giannoni-LuzaLuna Vasconcelos FelippePaola Gonzalez-MegoMaria Alejandra Luna-CuadrosAnna Carolyna Lepesteur GianlorencoPaulo E.P. TeixeiraWolnei CaumoFelipe FregniElsevierarticleFibromyalgiaUnderrepresented populationClinical trials participationRecruitmentTherapeutic adherence and complianceMedicine (General)R5-920ENContemporary Clinical Trials Communications, Vol 24, Iss , Pp 100860- (2021)
institution	DOAJ
collection	DOAJ
language	EN
topic	Fibromyalgia Underrepresented population Clinical trials participation Recruitment Therapeutic adherence and compliance Medicine (General) R5-920
spellingShingle	Fibromyalgia Underrepresented population Clinical trials participation Recruitment Therapeutic adherence and compliance Medicine (General) R5-920 Alejandra Cardenas-Rojas Luis Castelo-Branco Kevin Pacheco-Barrios Emad Salman Shaikh Elif Uygur-Kucukseymen Stefano Giannoni-Luza Luna Vasconcelos Felippe Paola Gonzalez-Mego Maria Alejandra Luna-Cuadros Anna Carolyna Lepesteur Gianlorenco Paulo E.P. Teixeira Wolnei Caumo Felipe Fregni Recruitment characteristics and non-adherence associated factors of fibromyalgia patients in a randomized clinical trial: A retrospective survival analysis
description	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.
format	article
author	Alejandra Cardenas-Rojas Luis Castelo-Branco Kevin Pacheco-Barrios Emad Salman Shaikh Elif Uygur-Kucukseymen Stefano Giannoni-Luza Luna Vasconcelos Felippe Paola Gonzalez-Mego Maria Alejandra Luna-Cuadros Anna Carolyna Lepesteur Gianlorenco Paulo E.P. Teixeira Wolnei Caumo Felipe Fregni
author_facet	Alejandra Cardenas-Rojas Luis Castelo-Branco Kevin Pacheco-Barrios Emad Salman Shaikh Elif Uygur-Kucukseymen Stefano Giannoni-Luza Luna Vasconcelos Felippe Paola Gonzalez-Mego Maria Alejandra Luna-Cuadros Anna Carolyna Lepesteur Gianlorenco Paulo E.P. Teixeira Wolnei Caumo Felipe Fregni
author_sort	Alejandra Cardenas-Rojas
title	Recruitment characteristics and non-adherence associated factors of fibromyalgia patients in a randomized clinical trial: A retrospective survival analysis
title_short	Recruitment characteristics and non-adherence associated factors of fibromyalgia patients in a randomized clinical trial: A retrospective survival analysis
title_full	Recruitment characteristics and non-adherence associated factors of fibromyalgia patients in a randomized clinical trial: A retrospective survival analysis
title_fullStr	Recruitment characteristics and non-adherence associated factors of fibromyalgia patients in a randomized clinical trial: A retrospective survival analysis
title_full_unstemmed	Recruitment characteristics and non-adherence associated factors of fibromyalgia patients in a randomized clinical trial: A retrospective survival analysis
title_sort	recruitment characteristics and non-adherence associated factors of fibromyalgia patients in a randomized clinical trial: a retrospective survival analysis
publisher	Elsevier
publishDate	2021
url	https://doaj.org/article/a48d9f31e30d48188119c120a774e3a7
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Recruitment characteristics and non-adherence associated factors of fibromyalgia patients in a randomized clinical trial: A retrospective survival analysis

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