Pacific Rheumatology Research, 4300 Talbot Road South, Renton, WA 98055, USA.
Curr Pain Headache Rep. 2010 Dec;14(6):470-6. doi: 10.1007/s11916-010-0152-4.
Perspectives of patients with fibromyalgia influence their likelihood of participating in randomized placebo-controlled trials and potentially clash with current, well-established methodology of randomized controlled trial design. Mandates to use only acetaminophen for breakthrough pain and that require discontinuation of concomitant medications, especially in studies lacking an active comparator arm, could bias a trial cohort to thereby reduce the generalizability of study findings and conclusions. This study evaluates factors affecting willingness to participate in such clinical trials, including the impact of altruism, payment, study duration, forced discontinuation of specific medications, and subject demographics for patients seen by rheumatologists proficient and avidly interested in treating fibromyalgia.
纤维肌痛患者的观点会影响他们参与随机安慰剂对照试验的可能性，并且可能与当前既定的随机对照试验设计方法发生冲突。仅规定使用扑热息痛治疗爆发性疼痛，并要求停止同时使用伴随药物，特别是在缺乏活性对照臂的研究中，这可能会使试验队列产生偏差，从而降低研究结果和结论的普遍性。本研究评估了影响患者参与此类临床试验意愿的因素，包括利他主义、报酬、研究持续时间、强制停用特定药物以及接受精通并热衷于治疗纤维肌痛的风湿病学家治疗的患者的人口统计学特征的影响。
