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

被引：6

作者：

Cardenas-Rojas, Alejandra ^{[1
,2
,3
]}

Castelo-Branco, Luis ^{[1
,2
,3
]}

Pacheco-Barrios, Kevin ^{[1
,2
,3
,4
]}

Shaikh, Emad Salman ^{[1
,2
,3
]}

Uygur-Kucukseymen, Elif ^{[1
,2
,3
]}

Giannoni-Luza, Stefano ^{[1
,2
,3
]}

Felippe, Luna Vasconcelos ^{[1
,2
,3
]}

Gonzalez-Mego, Paola ^{[1
,2
,3
]}

Luna-Cuadros, Maria Alejandra ^{[1
,2
,3
]}

Lepesteur Gianlorenco, Anna Carolyna ^{[1
,2
,3
,5
]}

Teixeira, Paulo E. P. ^{[1
,2
,3
,6
]}

Caumo, Wolnei ^{[7
]}

Fregni, Felipe ^{[1
,2
,3
]}

机构：

[1] Harvard Med Sch, Spaulding Rehabil Hosp, Neuromodulat Ctr, Boston, MA 02115 USA

[2] Harvard Med Sch, Spaulding Rehabil Hosp, Ctr Clin Res Learning, Boston, MA 02115 USA

[3] Harvard Med Sch, Massachusetts Gen Hosp, Boston, MA 02115 USA

[4] Univ San Ignacio Loyola, Unidad Invest Generac & Sintesis Evidencias Salud, Invest, Lima, Peru

[5] Univ Fed Sao Carlos, Dept Phys Therapy, Sao Carlos, Brazil

[6] MGH Inst Hlth Profess, Boston, MA USA

[7] Univ Fed Rio Grande do Sul, Clin Hosp Porto Alegre HCPA, Pain & Palliat Care Serv, Porto Alegre, RS, Brazil

来源：

CONTEMPORARY CLINICAL TRIALS COMMUNICATIONS | 2021年 / 24卷

基金：

美国国家卫生研究院;

关键词：

Fibromyalgia; Underrepresented population; Clinical trials participation; Recruitment; Therapeutic adherence and compliance; VISUAL ANALOG SCALE; HEALTH-CARE COSTS; MINORITY PARTICIPATION; ENHANCING ADHERENCE; ANXIETY; WOMEN; DEPRESSION; METADATA; BARRIERS; CONDUCT;

D O I：

10.1016/j.conctc.2021.100860

中图分类号：

R-3 [医学研究方法]; R3 [基础医学];

学科分类号：

1001 ;

摘要：

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.

引用

页数：10