Recruitment characteristics and non-adherence associated factors of fibromyalgia patients in a randomized clinical trial: A retrospective survival analysis.
Recruitment characteristics and non-adherence associated factors of fibromyalgia patients in a randomized clinical trial: A retrospective survival analysis.
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DOI：
10.1016/j.conctc.2021.100860
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发表时间：
2021-12
影响因子：
1.5
通讯作者：
Fregni F
中科院分区：
文献类型：
--
作者：
Cardenas-Rojas A;Castelo-Branco L;Pacheco-Barrios K;Shaikh ES;Uygur-Kucukseymen E;Giannoni-Luza S;Vasconcelos Felippe L;Gonzalez-Mego P;Luna-Cuadros MA;Gianlorenco ACL;Teixeira PEP;Caumo W;Fregni F
纤维肌痛是一种复杂的疼痛状况，主要影响女性。由于对这种疾病缺乏了解，患者报告说，他们对药物的依从性很差，对医疗服务不信任。本研究旨在描述纤维肌痛患者对随机对照试验的招募特征和不依从相关因素。我们对正在进行的随机对照试验的数据进行了回顾性纵向分析。我们调查了受试者的招募、同意和随机化特征。使用生存分析技术研究依从性，并使用考克斯比例风险回归模型确定其相关因素。联系了524例受试者，269例合格，61例知情同意，40例随机化。38%的患者不遵守协议，中位数为5次。招募调查报告称，90%的人可能会参加RCT，52%的人以前参加过RCT，19%的人知道他们的医生参加了RCT。一些障碍与参与者有关（工作人员的友好和接受他们参与试验的结果）和与中心有关（隐私保密问题和机构的声誉），遵守和不遵守参与者之间没有区别。我们报告了不依从的重要因素，如VAS焦虑评分≥ 5分（5.3 HR，p = 0.01）、体重指数（BMI）（0.91 HR，p = 0.041）和生活质量（QoL）-个人发展子域（0.89 HR，p = 0.046）。纤维肌痛患者的招募和依从性是一个挑战;然而，他们似乎渴望参加RCT。我们建议创造一个舒适、友好和信任的环境，以提高招聘率。较高的焦虑、较低的BMI和较低的生活质量与较高的损耗率相关。
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. 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. 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). 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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