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Abstract：
BACKGROUND: 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).
CONCLUSIONS: 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.
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).
CONCLUSIONS: 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.
摘要：
背景：纤维肌痛是一种复杂的疼痛状况，主要影响女性。鉴于这种疾病缺乏了解，患者报告对药物的依从性差和对医疗服务的不信任。本研究旨在描述纤维肌痛患者对RCT的招募特征和非依从性相关因素。
方法：我们对正在进行的RCT数据进行了回顾性纵向分析。我们调查了招募的受试者的特征，同意,并随机化。使用生存分析技术研究了依从性，及其相关因素采用Cox比例风险回归模型进行识别。
结果：联系了524名受试者，269人符合条件,61名同意和40名受试者被随机分配。38％的人不遵守该协议，访问次数的中位数为5次。招聘调查报告称，90%的人可能会参加RCT，52%以前曾参与过，19％的医生知道RCT。一些障碍与研究者有关（工作人员的友善和接受他们参与试验的结果）和中心有关（隐私保密问题和机构的声誉），在坚持和不坚持的参与者之间没有差异。我们报告了非依从性的重要因素为5分或更多的VAS焦虑（5.3HR，p=0.01),身体质量指数（BMI）（0.91HR，p=0.041)和生活质量(QoL)-个人发展子域(0.89HR，p=0.046)。
结论：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。我们建议创建一个舒适的，友好和信任的环境，以提高招聘率。更高的焦虑，较低的BMI和较低的生活质量与较高的流失率相关.
方法：我们对正在进行的RCT数据进行了回顾性纵向分析。我们调查了招募的受试者的特征，同意,并随机化。使用生存分析技术研究了依从性，及其相关因素采用Cox比例风险回归模型进行识别。
结果：联系了524名受试者，269人符合条件,61名同意和40名受试者被随机分配。38％的人不遵守该协议，访问次数的中位数为5次。招聘调查报告称，90%的人可能会参加RCT，52%以前曾参与过，19％的医生知道RCT。一些障碍与研究者有关（工作人员的友善和接受他们参与试验的结果）和中心有关（隐私保密问题和机构的声誉），在坚持和不坚持的参与者之间没有差异。我们报告了非依从性的重要因素为5分或更多的VAS焦虑（5.3HR，p=0.01),身体质量指数（BMI）（0.91HR，p=0.041)和生活质量(QoL)-个人发展子域(0.89HR，p=0.046)。
结论：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。我们建议创建一个舒适的，友好和信任的环境，以提高招聘率。更高的焦虑，较低的BMI和较低的生活质量与较高的流失率相关.
