多组分跨学科小组干预对纤维肌痛自我管理的影响：一项混合方法随机对照试验
Multicomponent interdisciplinary group intervention for self-management of fibromyalgia: a mixed-methods randomized controlled trial.
作者信息
Bourgault Patricia, Lacasse Anaïs, Marchand Serge, Courtemanche-Harel Roxanne, Charest Jacques, Gaumond Isabelle, Barcellos de Souza Juliana, Choinière Manon
机构信息
École des sciences infirmières, Faculté de médecine et des sciences de la santé, Université de Sherbrooke, Sherbrooke, QC, Canada; Centre de recherche clinique Étienne-Le Bel du Centre hospitalier universitaire de Sherbrooke, Sherbrooke, QC, Canada; Centre de recherche du Centre hospitalier de l'Université de Montréal (CRCHUM), Montréal, QC, Canada.
Centre de recherche du Centre hospitalier de l'Université de Montréal (CRCHUM), Montréal, QC, Canada; Département des sciences de la santé, Université du Québec en Abitibi-Témiscamingue, Rouyn-Noranda, QC, Canada.
出版信息
PLoS One. 2015 May 15;10(5):e0126324. doi: 10.1371/journal.pone.0126324. eCollection 2015.
BACKGROUND
This study evaluated the efficacy of the PASSAGE Program, a structured multicomponent interdisciplinary group intervention for the self-management of FMS.
METHODS
A mixed-methods randomized controlled trial (intervention (INT) vs. waitlist (WL)) was conducted with patients suffering from FMS. Data were collected at baseline (T0), at the end of the intervention (T1), and 3 months later (T2). The primary outcome was change in pain intensity (0-10). Secondary outcomes were fibromyalgia severity, pain interference, sleep quality, pain coping strategies, depression, health-related quality of life, patient global impression of change (PGIC), and perceived pain relief. Qualitative group interviews with a subset of patients were also conducted. Complete data from T0 to T2 were available for 43 patients.
RESULTS
The intervention had a statistically significant impact on the three PGIC measures. At the end of the PASSAGE Program, the percentages of patients who perceived overall improvement in their pain levels, functioning and quality of life were significantly higher in the INT Group (73%, 55%, 77% respectively) than in the WL Group (8%, 12%, 20%). The same differences were observed 3 months post-intervention (Intervention group: 62%, 43%, 38% vs Waitlist Group: 13%, 13%, 9%). The proportion of patients who reported ≥ 50% pain relief was also significantly higher in the INT Group at the end of the intervention (36% vs 12%) and 3 months post-intervention (33% vs 4%). Results of the qualitative analysis were in line with the quantitative findings regarding the efficacy of the intervention. The improvement, however, was not reflected in the primary outcome and other secondary outcome measures.
CONCLUSION
The PASSAGE Program was effective in helping FMS patients gain a sense of control over their symptoms. We suggest including PGIC in future clinical trials on FMS as they appear to capture important aspects of the patients' experience.
TRIAL REGISTRATION
International Standard Randomized Controlled Trial Number Register ISRCTN14526380.
背景
本研究评估了PASSAGE项目的疗效，该项目是一项针对纤维肌痛综合征（FMS）自我管理的结构化多成分跨学科小组干预措施。
方法
对FMS患者进行了一项混合方法随机对照试验（干预组（INT）与等待名单组（WL））。在基线期（T0）、干预结束时（T1）和3个月后（T2）收集数据。主要结局是疼痛强度变化（0 - 10分）。次要结局包括纤维肌痛严重程度、疼痛干扰、睡眠质量、疼痛应对策略、抑郁、健康相关生活质量、患者总体变化印象（PGIC）以及感知到的疼痛缓解情况。还对部分患者进行了定性小组访谈。43例患者有从T0到T2的完整数据。
结果
干预对三项PGIC指标有统计学显著影响。在PASSAGE项目结束时，干预组中认为疼痛水平、功能和生活质量总体改善的患者百分比（分别为73%、55%、77%）显著高于等待名单组（分别为8%、12%、20%）。干预后3个月观察到相同差异（干预组：62%、43%、38% 对比 等待名单组：13%、13%、9%）。报告疼痛缓解≥50% 的患者比例在干预结束时干预组也显著更高（36%对比12%）以及干预后3个月（33%对比4%）。定性分析结果与关于干预疗效的定量研究结果一致。然而，这种改善未反映在主要结局和其他次要结局指标中。
结论
PASSAGE项目有效地帮助FMS患者获得了对其症状的控制感。我们建议在未来关于FMS的临床试验中纳入PGIC，因为它们似乎能体现患者体验的重要方面。
试验注册
国际标准随机对照试验编号注册ISRCTN14526380 。
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