Objective

The GETSET trial found that guided graded exercise self-help (GES) improved fatigue and physical functioning more than specialist medical care (SMC) alone in adults with chronic fatigue syndrome (CFS) 12 weeks after randomisation. In this paper, we assess the longer-term clinical and health economic outcomes.

Methods

GETSET was a randomised controlled trial of 211 UK secondary care patients with CFS. Primary outcomes were the Chalder fatigue questionnaire and the physical functioning subscale of the short-form-36 survey. Postal questionnaires assessed the primary outcomes and cost-effectiveness of the intervention 12 months after randomisation. Service costs and quality-adjusted life years (QALYs) were combined in a cost-effectiveness analysis.

Results

Between January 2014 and March 2016, 164 (78%) participants returned questionnaires 15 months after randomisation. Results showed no main effect of intervention arm on fatigue (chi²(1) = 4.8, p = 0.03) or physical functioning (chi²(1) = 1.3, p = 0.25), adjusting for multiplicity. No other intervention arm or time*arm effect was significant. The short-term fatigue reduction was maintained at long-term follow-up for participants assigned to GES, with improved fatigue from short- to long-term follow up after SMC, such that the groups no longer differed. Healthcare costs were £85 higher for GES and produced more QALYs. The incremental cost-effectiveness ratio was £4802 per QALY.

Conclusions

The short-term improvements after GES were maintained at long-term follow-up, with further improvement in the SMC group such that the groups no longer differed at long-term follow-up. The cost per QALY for GES compared to SMC alone was below the usual threshold indicating cost-effectiveness, but with uncertainty around the result.

中文翻译：

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慢性疲劳综合征的指导分级运动自助：GETSET 试验后的长期随访和成本效益

客观的

GETSET 试验发现，在随机分组后 12 周，对于患有慢性疲劳综合征 (CFS) 的成人，引导式分级运动自助 (GES) 比单独的专科医疗护理 (SMC) 更能改善疲劳和身体机能。在本文中，我们评估了长期的临床和健康经济结果。

方法

GETSET 是一项对 211 名英国二级护理 CFS 患者进行的随机对照试验。主要结果是 Chalder 疲劳问卷和简短形式 36 调查的身体功能分量表。邮寄问卷评估了随机化 12 个月后干预的主要结果和成本效益。在成本效益分析中结合了服务成本和质量调整生命年 (QALYs)。

结果

2014 年 1 月至 2016 年 3 月期间，164（78%）名参与者在随机化后 15 个月返回了问卷。结果显示干预组对疲劳（chi ² (1) = 4.8, p  = 0.03）或身体机能（chi ² (1) = 1.3, p  = 0.25）没有主要影响，调整了多样性。没有其他干预臂或时间*臂效应显着。对于分配到 GES 的参与者，短期疲劳减少在长期随访中得以维持，SMC 后短期到长期随访的疲劳有所改善，因此各组不再存在差异。GES 的医疗保健成本高出 85 英镑，并产生了更多的 QALY。增量成本效益比为每 QALY 4802 英镑。

结论

GES 后的短期改善在长期随访中得以维持，SMC 组进一步改善，使得各组在长期随访中不再存在差异。与单独的 SMC 相比，GES 的每个 QALY 成本低于表明成本效益的通常阈值，但结果存在不确定性。