Recruitment characteristics and non-adherence associated factors of fibromyalgia patients in a randomized clinical trial : a retrospective survival analysis
Autor(a) principal: | |
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Data de Publicação: | 2021 |
Outros Autores: | , , , , , , , , , , , |
Tipo de documento: | Artigo |
Idioma: | eng |
Título da fonte: | Repositório Institucional da UFRGS |
Texto Completo: | http://hdl.handle.net/10183/247674 |
Resumo: | 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. Thirtyeight 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. |
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Cardenas-Rojas, AlejandraCastelo Branco, LuisBarrios, Kevin PachecoShaikh, Emad SalmanKucukseymen, Elif UygurLuza, Stefano GiannoniFelippe, Luna VasconcelosGonzalez-Mego, PaolaLuna-Cuadros, Maria AlejandraGianlorenco, Anna CarolynaTeixeira, Paulo Eduardo PortesCaumo, WolneiFregni, Felipe2022-08-21T04:39:19Z20212451-8654http://hdl.handle.net/10183/247674001147877Introduction: 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. Thirtyeight 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.application/pdfengContemporary clinical trials communications. [Amsterdam]. Vol. 24 (2021), artigo 100860, 10 p.FibromialgiaEstudo clínicoAdesão à medicaçãoFibromyalgiaUnderrepresented populationClinical trials participationRecruitmentTherapeutic adherence and complianceRecruitment characteristics and non-adherence associated factors of fibromyalgia patients in a randomized clinical trial : a retrospective survival analysisEstrangeiroinfo:eu-repo/semantics/articleinfo:eu-repo/semantics/publishedVersioninfo:eu-repo/semantics/openAccessreponame:Repositório Institucional da UFRGSinstname:Universidade Federal do Rio Grande do Sul (UFRGS)instacron:UFRGSTEXT001147877.pdf.txt001147877.pdf.txtExtracted Texttext/plain64898http://www.lume.ufrgs.br/bitstream/10183/247674/2/001147877.pdf.txt55723553e261a26c0954fd278427c4eeMD52ORIGINAL001147877.pdfTexto completo (inglês)application/pdf3007231http://www.lume.ufrgs.br/bitstream/10183/247674/1/001147877.pdf073fdd06e3401de277ea93b74ba76eb8MD5110183/2476742022-08-22 04:35:13.358635oai:www.lume.ufrgs.br:10183/247674Repositório de PublicaçõesPUBhttps://lume.ufrgs.br/oai/requestopendoar:2022-08-22T07:35:13Repositório Institucional da UFRGS - Universidade Federal do Rio Grande do Sul (UFRGS)false |
dc.title.pt_BR.fl_str_mv |
Recruitment characteristics and non-adherence associated factors of fibromyalgia patients in a randomized clinical trial : a retrospective survival analysis |
title |
Recruitment characteristics and non-adherence associated factors of fibromyalgia patients in a randomized clinical trial : a retrospective survival analysis |
spellingShingle |
Recruitment characteristics and non-adherence associated factors of fibromyalgia patients in a randomized clinical trial : a retrospective survival analysis Cardenas-Rojas, Alejandra Fibromialgia Estudo clínico Adesão à medicação Fibromyalgia Underrepresented population Clinical trials participation Recruitment Therapeutic adherence and compliance |
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 |
author |
Cardenas-Rojas, Alejandra |
author_facet |
Cardenas-Rojas, Alejandra Castelo Branco, Luis Barrios, Kevin Pacheco Shaikh, Emad Salman Kucukseymen, Elif Uygur Luza, Stefano Giannoni Felippe, Luna Vasconcelos Gonzalez-Mego, Paola Luna-Cuadros, Maria Alejandra Gianlorenco, Anna Carolyna Teixeira, Paulo Eduardo Portes Caumo, Wolnei Fregni, Felipe |
author_role |
author |
author2 |
Castelo Branco, Luis Barrios, Kevin Pacheco Shaikh, Emad Salman Kucukseymen, Elif Uygur Luza, Stefano Giannoni Felippe, Luna Vasconcelos Gonzalez-Mego, Paola Luna-Cuadros, Maria Alejandra Gianlorenco, Anna Carolyna Teixeira, Paulo Eduardo Portes Caumo, Wolnei Fregni, Felipe |
author2_role |
author author author author author author author author author author author author |
dc.contributor.author.fl_str_mv |
Cardenas-Rojas, Alejandra Castelo Branco, Luis Barrios, Kevin Pacheco Shaikh, Emad Salman Kucukseymen, Elif Uygur Luza, Stefano Giannoni Felippe, Luna Vasconcelos Gonzalez-Mego, Paola Luna-Cuadros, Maria Alejandra Gianlorenco, Anna Carolyna Teixeira, Paulo Eduardo Portes Caumo, Wolnei Fregni, Felipe |
dc.subject.por.fl_str_mv |
Fibromialgia Estudo clínico Adesão à medicação |
topic |
Fibromialgia Estudo clínico Adesão à medicação Fibromyalgia Underrepresented population Clinical trials participation Recruitment Therapeutic adherence and compliance |
dc.subject.eng.fl_str_mv |
Fibromyalgia Underrepresented population Clinical trials participation Recruitment Therapeutic adherence and compliance |
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. Thirtyeight 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. |
publishDate |
2021 |
dc.date.issued.fl_str_mv |
2021 |
dc.date.accessioned.fl_str_mv |
2022-08-21T04:39:19Z |
dc.type.driver.fl_str_mv |
Estrangeiro info:eu-repo/semantics/article |
dc.type.status.fl_str_mv |
info:eu-repo/semantics/publishedVersion |
format |
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http://hdl.handle.net/10183/247674 |
dc.language.iso.fl_str_mv |
eng |
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dc.relation.ispartof.pt_BR.fl_str_mv |
Contemporary clinical trials communications. [Amsterdam]. Vol. 24 (2021), artigo 100860, 10 p. |
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