The feasibility and acceptability of an early intervention in primary care to prevent chronic fatigue syndrome (CFS) in adults: randomised controlled trial
The feasibility and acceptability of an early intervention in primary care to prevent chronic fatigue syndrome (CFS) in adults: randomised controlled trial
复制标题
在初级保健中进行早期干预以预防成人慢性疲劳综合症（CFS）的可行性和可接受性：随机对照试验
DOI：
10.1186/s40814-020-00595-0
复制
发表时间：
2020
影响因子：
1.7
通讯作者：
E. Crawley
中科院分区：
文献类型：
--
作者：
H. O’Dowd;L. Beasant;J. Ingram;A. Montgomery;W. Hollingworth;D. Gaunt;S. Collin;Sarah Horne;Beth Jones;E. Crawley
背景慢性疲劳综合征（CFS，也称为肌痛性脑脊髓炎（ME））是指伴有其他症状并持续≥ 4个月的致残性疲劳。CFS/ME的治疗旨在帮助患者控制症状并调整生活方式。我们不知道是否干预早期初级保健（< 4个月后开始疲劳）可以防止CFS/ME. Methods的发展，这是一个可行性随机对照试验与成人（年龄≥ 18岁）比较常规护理与常规护理加早期干预（EI;心理教育和认知行为疗法，CBT）。本研究在英格兰布里斯托的14个初级保健实践中进行，旨在确定全面试验的招募和保留问题。它不足以支持结局差异的统计分析。综合定性方法被用来探讨的可行性和可接受的招募和随机干预。结果招募了44例患者（2012年8月1日至2013年11月28日），低于我们预测的8个月内招募100例患者的比例。来自全科医生的定性数据显示招募是不可行的，因为很难在症状发作后4个月内确定潜在的参与者。一些转诊的全科医生认为NICE推荐的筛查调查是不必要的，他们很难找到符合资格标准的患者。一些参与者访谈的定性数据表明，干预措施目前的形式是不可接受的。虽然大多数参与者认为部分干预措施是可以接受的，但许多人报告了一个或多个可接受性问题。停止干预或发现干预有问题的参与者与治疗模式无关，不喜欢电话咨询或发现自我反思具有挑战性。结论：一项随机对照试验，以测试早期干预疲劳的成年人在初级保健是不可行的，使用这种干预和招募策略。国际标准随机对照试验（ISRCTN 72645894）。2013年5月17日登记的追溯
Background Chronic fatigue syndrome (CFS, also known as myalgic encephalomyelitis (ME)) is defined as fatigue that is disabling, is accompanied by additional symptoms and persists for ≥ 4 months. Treatment of CFS/ME aims to help patients manage their symptoms and make lifestyle adjustments. We do not know whether intervening early in primary care (< 4 months after onset of fatigue) can prevent the development of CFS/ME. Methods This was a feasibility randomised controlled trial with adults (age ≥ 18 years) comparing usual care with usual care plus an early intervention (EI; a combination of psycho-education and cognitive behavioural therapy, CBT). This study took place in fourteen primary care practices in Bristol, England and aimed to identify issues around recruitment and retention for a full-scale trial. It was not powered to support statistical analysis of differences in outcomes. Integrated qualitative methodology was used to explore the feasibility and acceptability of recruitment and randomisation to the intervention. Results Forty-four patients were recruited (1 August 2012–November 28, 2013), falling short of our predicted recruitment rate of 100 patients in 8 months. Qualitative data from GPs showed recruitment was not feasible because it was difficult to identify potential participants within 4 months of symptom onset. Some referring GPs felt screening investigations recommended by NICE were unnecessary, and they had difficulty finding patients who met the eligibility criteria. Qualitative data from some participant interviews suggested that the intervention was not acceptable in its current format. Although the majority of participants found parts of the intervention acceptable, many reported one or more problems with acceptability. Participants who discontinued the intervention or found it problematic did not relate to the therapeutic model, disliked telephone consultations or found self-reflection challenging. Conclusions A randomised controlled trial to test an early intervention for fatigue in adults in primary care is not feasible using this intervention and recruitment strategy. Trial registration International Standard Randomised Controlled Trials, ISRCTN72645894 . Retrospectively registered on 17 May 2013