Graded exercise therapy for patients with chronic fatigue syndrome in secondary care – a benchmarking study

We investigated the effectiveness of graded exercise therapy (GET) delivered to patients with chronic fatigue syndrome/myalgic encephalomyelitis (CFS/ME) in a routine, specialist clinic by measuring patient-reported outcome data collected prospectively over several timepoints alongside therapy. Benchmarking analyses were used to compare our results with those found in randomised controlled trials (RCTs). Data were collected from patients, with a diagnosis of CFS/ME, who had been referred to a specialist clinical service in South London. Measures included Chalder Fatigue Questionnaire, Physical Functioning Subscale of the Short-Form Health Questionnaire, and the Work and Social Adjustment Scale. Change on each measure was calculated over time using linear mixed-model analyses. Within group effect sizes were calculated and compared with previous RCTs. Fatigue scores were significantly reduced by session 4 (–5.18, 95%CIs −7.90, −2.45) and at follow-up (–4.73, 95%CIs −7.60, −1.85). Work and social adjustment and physical functioning progressively improved over the course of therapy, reaching significance at discharge and maintained at follow-up (WSAS −4.97, 95%CIs −7.97, −1.97; SF-36 10.75, 95%CIs 2.19, 19.31). GET is an effective treatment for CFS/ME within clinical practice. However, effect sizes were smaller in routine clinical practice than RCTs suggesting that avenues for augmentation need to be considered.Implications for rehabilitationIt is important to assess whether patient reported outcomes of treatments that have been evaluated in the context of clinical trials are similar in routine clinical practice.This study shows fatigue severity, physical functioning, and work and social adjustment can significantly improve after graded exercise therapy for patients with chronic fatigue syndrome within a specialist service.Benchmarking methods showed clinical outcomes obtained smaller effect sizes than randomised controlled trials – techniques to maximise patient outcomes should be considered. It is important to assess whether patient reported outcomes of treatments that have been evaluated in the context of clinical trials are similar in routine clinical practice. This study shows fatigue severity, physical functioning, and work and social adjustment can significantly improve after graded exercise therapy for patients with chronic fatigue syndrome within a specialist service. Benchmarking methods showed clinical outcomes obtained smaller effect sizes than randomised controlled trials – techniques to maximise patient outcomes should be considered.

本研究针对慢性疲劳综合征/肌痛性脑脊髓炎（chronic fatigue syndrome/myalgic encephalomyelitis, CFS/ME）患者，在常规专科门诊场景下开展分级运动疗法（graded exercise therapy, GET）疗效评估，通过前瞻性收集治疗期间多个时间节点的患者报告结局数据完成分析。本研究采用基准分析方法，将研究结果与随机对照试验（randomised controlled trials, RCT）的已有结果进行对比。

研究数据来源于转诊至伦敦南部专科临床服务机构的确诊CFS/ME患者。评估工具包括查尔疲劳量表（Chalder Fatigue Questionnaire）、简明健康调查问卷躯体功能维度（Short-Form Health Questionnaire Physical Functioning Subscale）以及工作与社会适应量表（Work and Social Adjustment Scale）。

本研究采用线性混合模型分析方法，计算各项评估指标随时间的变化情况，并计算组内效应量，与既往随机对照试验结果进行对比。

结果显示，疲劳评分在第4次治疗时即出现显著降低（–5.18，95%置信区间：−7.90~−2.45），并在随访阶段持续改善（–4.73，95%置信区间：−7.60~−1.85）。工作与社会适应能力及躯体功能在治疗过程中逐步提升，于出院时达到统计学显著性，并在随访阶段得以维持（工作与社会适应量表评分：−4.97，95%置信区间：−7.97~−1.97；简明健康调查问卷（SF-36）评分：10.75，95%置信区间：2.19~19.31）。

临床实践中，分级运动疗法对CFS/ME患者确为有效治疗手段。但常规临床场景下的效应量小于随机对照试验，提示需探索优化治疗效果的可行途径。

康复领域启示
评估经临床试验验证的治疗方案，其患者报告结局在常规临床实践中是否保持一致，具有重要意义。本研究证实，在专科服务体系中接受分级运动疗法的慢性疲劳综合征患者，其疲劳严重程度、躯体功能及工作与社会适应能力均可获得显著改善。基准分析结果显示，本研究的临床结局效应量小于随机对照试验，因此需探索可最大化患者获益的治疗优化技术。

评估经临床试验验证的治疗方案，其患者报告结局在常规临床实践中是否保持一致，具有重要意义。本研究证实，在专科服务体系中接受分级运动疗法的慢性疲劳综合征患者，其疲劳严重程度、躯体功能及工作与社会适应能力均可获得显著改善。基准分析结果显示，本研究的临床结局效应量小于随机对照试验，因此需探索可最大化患者获益的治疗优化技术。