Clinical Research Unit, School of Health and Social Care, Bournemouth University, Bournemouth, Dorset, UK.
J Neurol Neurosurg Psychiatry. 2013 Oct;84(10):1092-9. doi: 10.1136/jnnp-2012-303816. Epub 2013 May 21.
Fatigue is a common and troubling symptom for people with multiple sclerosis (MS).
To evaluate the effectiveness and cost-effectiveness of a six-session group-based programme for managing MS-fatigue (Fatigue: Applying Cognitive behavioural and Energy effectiveness Techniques to lifeStyle (FACETS)).
Three-centre parallel arm randomised controlled trial with economic evaluation. Patients with MS and significant fatigue were randomised to FACETS plus current local practice (FACETS) or current local practice alone (CLP), using concealed computer-generated randomisation. Participant blinding was not possible. Primary outcomes were fatigue severity (Fatigue Assessment Instrument), self-efficacy (Multiple Sclerosis-Fatigue Self-Efficacy) and disease-specific quality of life (Multiple Sclerosis Impact Scale (MSIS-29)) at 1 and 4 months postintervention (follow-up 1 and 2). Quality adjusted life years (QALYs) were calculated (EuroQoL 5-Dimensions questionnaire and the Short-form 6-Dimensions questionnaire).
Between May 2008 and November 2009, 164 patients were randomised; primary outcome data were available for 146 (89%). Statistically significant differences favour the intervention group on fatigue self-efficacy at follow-up 1 (mean difference (MD) 9, 95% CI (4 to 14), standardised effect size (SES) 0.54, p=0.001) and follow-up 2 (MD 6, 95% CI (0 to 12), SES 0.36, p=0.05) and fatigue severity at follow-up 2 (MD -0.36, 95% CI (-0.63 to -0.08), SES -0.35, p=0.01) but no differences for MSIS-29 or QALYs. No adverse events reported. Estimated cost per person for FACETS is £453; findings suggest an incremental cost-effectiveness ratio of £2157 per additional person with a clinically significant improvement in fatigue.
FACETS is effective in reducing fatigue severity and increasing fatigue self-efficacy. However, it is difficult to assess the additional cost in terms of cost-effectiveness (ie, cost per QALY) as improvements in fatigue are not reflected in the QALY outcomes, with no significant differences between FACETS and CLP. The strengths of this trial are its pragmatic nature and high external validity.
Current Controlled Trials ISRCTN76517470.
疲劳是多发性硬化症（MS）患者常见且令人困扰的症状。
评估管理 MS 疲劳的六节小组为基础的方案（疲劳：将认知行为和能量效率技术应用于生活方式（FACETS））的有效性和成本效益。
三中心平行臂随机对照试验，经济评估。患有 MS 且疲劳症状明显的患者被随机分配到 FACETS 加当前当地常规治疗（FACETS）或仅接受当前当地常规治疗（CLP），使用隐藏的计算机生成的随机化。参与者无法被蒙蔽。主要结局指标是疲劳严重程度（疲劳评估工具）、自我效能感（多发性硬化症-疲劳自我效能感）和疾病特异性生活质量（多发性硬化症影响量表（MSIS-29））在干预后 1 个月和 4 个月（随访 1 和 2）。使用欧洲五维健康量表问卷和六维简表问卷计算质量调整生命年（QALY）。
2008 年 5 月至 2009 年 11 月，共纳入 164 例患者；146 例（89%）患者可获得主要结局数据。在随访 1 时，干预组在疲劳自我效能方面有统计学意义的优势（平均差异（MD）9，95%CI（4 至 14），标准化效应量（SES）0.54，p=0.001）和随访 2（MD 6，95%CI（0 至 12），SES 0.36，p=0.05），在随访 2 时，疲劳严重程度也有统计学意义的改善（MD -0.36，95%CI（-0.63 至 -0.08），SES -0.35，p=0.01），但多发性硬化症影响量表-29 或 QALY 无差异。未报告不良事件。FACETS 每人的估计成本为 453 英镑；结果表明，对于疲劳有临床意义改善的患者，每增加一个人，成本效益比（即每增加一个 QALY 的成本）为 2157 英镑。
FACETS 可有效降低疲劳严重程度，提高疲劳自我效能。然而，由于疲劳的改善并未反映在 QALY 结果中，FACETS 与 CLP 之间没有显著差异，因此很难评估其在成本效益方面的额外成本（即 QALY 每增加一个的成本）。该试验的优势在于其务实性和高度的外部有效性。
当前对照试验 ISRCTN76517470。
