Research and Development Unit, Parc Sanitari Sant Joan de Déu., Sant Boi del Llobregat, Barcelona, Spain.
Clin J Pain. 2013 Aug;29(8):702-11. doi: 10.1097/AJP.0b013e318270f99a.
To determine the effectiveness of adding psychoeducational treatment implemented in general practice to usual care for patients with fibromyalgia (FM), and to analyze the cost-utility of the intervention from health care and societal perspectives.
Twelve-month randomized controlled trial. A total of 216 primary care patients meeting the American College of Rheumatology criteria for FM participated in the study. The intervention included 9, 2-hour sessions of psychoeducation (5 sessions of education about the illness+4 sessions of autogenic relaxation) added to usual care provided by a multidisciplinary group in general practice was compared to usual care in the public health system.
At 12-month follow-up, patients who received psychoeducation showed greater improvement in global functional status (Cohen d=0.36; -2.49 to 3.81), physical functioning (Cohen d=0.56; 0.08 to 1.00), days feeling well (Cohen d=0.40; -0.16 to 1.02), pain (Cohen d= 0.35; -0.04 to 0.80), morning fatigue (Cohen d=0.24; -0.20 to 0.76), stiffness (Cohen d=0.34; -0.10 to 0.87), and depression (Cohen d=0.30; -0.26 to 0.93). Mean incremental cost per person receiving the intervention was &OV0556;-215.49 (-615.13 to 287.81) from the health care perspective, and &OV0556;-197.32 (-785.12 to 395.74) from the societal perspective. The incremental gain in quality-adjusted life-years per person was 0.12 (0.06 to 0.19), yielding a "dominant" intervention from both perspectives. The sensitivity analysis suggested that the intervention was cost-effective even imputing all missing data.
Our findings demonstrate the long-term clinical effectiveness of a psychoeducational treatment program for FM implemented at primary care level and the cost-utility from a health care and societal perspective.
NCT00550966.
确定在一般实践中添加心理教育治疗对纤维肌痛（FM）患者的常规护理的有效性，并从医疗保健和社会角度分析干预措施的成本效益。
为期 12 个月的随机对照试验。共有 216 名符合美国风湿病学会纤维肌痛标准的初级保健患者参加了这项研究。该干预措施包括在一般实践中的多学科小组提供的常规护理基础上，增加 9 次、每次 2 小时的心理教育（5 次疾病教育+4 次自生松弛）。与公共卫生系统中的常规护理进行比较。
在 12 个月的随访中，接受心理教育的患者在整体功能状态（Cohen d=0.36；-2.49 至 3.81）、身体功能（Cohen d=0.56；0.08 至 1.00）、感觉良好的天数（Cohen d=0.40；-0.16 至 1.02）、疼痛（Cohen d=0.35；-0.04 至 0.80）、晨僵（Cohen d=0.24；-0.20 至 0.76）、僵硬（Cohen d=0.34；-0.10 至 0.87）和抑郁（Cohen d=0.30；-0.26 至 0.93）方面有更大的改善。从医疗保健角度看，接受干预的每个人的平均增量成本为-215.49 欧元（-615.13 至 287.81 欧元），从社会角度看，为-197.32 欧元（-785.12 至 395.74 欧元）。每人的质量调整生命年的增量增益为 0.12（0.06 至 0.19），从两个角度来看，这都是一种“优势”干预。敏感性分析表明，即使对所有缺失数据进行推测，该干预措施也是具有成本效益的。
我们的研究结果表明，在初级保健层面实施的纤维肌痛心理教育治疗方案具有长期的临床效果，从医疗保健和社会角度来看，该方案具有成本效益。
NCT00550966。
