Ann Intern Med. 2015 Jun 16;162(12):834-40. doi: 10.7326/M15-0443.
The diagnosis of myalgic encephalomyelitis (ME)/chronic fatigue syndrome (CFS) is based on clinical criteria, yet there has been no consensus regarding which set of criteria best identifies patients with the condition. The Institute of Medicine has recently proposed a new case definition and diagnostic algorithm.
To review methods to diagnose ME/CFS in adults and identify research gaps and needs for future research.
MEDLINE, PsycINFO, and Cochrane databases (January 1988 to September 2014); clinical trial registries; and reference lists.
English-language studies describing methods of diagnosis of ME/CFS and their accuracy.
Data on participants, study design, analysis, follow-up, and results were extracted and confirmed. Study quality was dual-rated by using prespecified criteria, and discrepancies were resolved through consensus.
Forty-four studies met inclusion criteria. Eight case definitions have been used to define ME/CFS; a ninth, recently proposed by the Institute of Medicine, includes principal elements of previous definitions. Patients meeting criteria for ME represent a more symptomatic subset of the broader ME/CFS population. Scales rating self-reported symptoms differentiate patients with ME/CFS from healthy controls under study conditions but have not been evaluated in clinically undiagnosed patients to determine validity and generalizability.
Studies were heterogeneous and were limited by size, number, applicability, and methodological quality. Most methods were tested in highly selected patient populations.
Nine sets of clinical criteria are available to define ME/CFS, yet none of the current diagnostic methods have been adequately tested to identify patients with ME/CFS when diagnostic uncertainty exists. More definitive studies in broader populations are needed to address these research gaps.
肌痛性脑脊髓炎（ME）/慢性疲劳综合征（CFS）的诊断基于临床标准，但尚未就哪种标准最能确定该病症患者达成共识。医学研究所最近提出了一种新的病例定义和诊断算法。
综述成人 ME/CFS 的诊断方法，确定研究差距和未来研究需求。
MEDLINE、PsycINFO 和 Cochrane 数据库（1988 年 1 月至 2014 年 9 月）；临床试验登记处；以及参考文献列表。
描述 ME/CFS 诊断方法及其准确性的英文研究。
提取并确认参与者、研究设计、分析、随访和结果的数据。使用预设标准对研究质量进行双重评价，并通过共识解决差异。
44 项研究符合纳入标准。有 8 种病例定义用于定义 ME/CFS；最近医学研究所提出的第 9 种定义包含了以前定义的主要要素。符合 ME 标准的患者代表了更具症状的 ME/CFS 人群亚组。在研究条件下，评估自我报告症状的量表可区分 ME/CFS 患者与健康对照者，但尚未在未经临床诊断的患者中评估其有效性和普遍性。
研究存在异质性，受到大小、数量、适用性和方法学质量的限制。大多数方法都是在高度选择的患者群体中进行测试的。
有 9 套临床标准可用于定义 ME/CFS，但目前尚无任何诊断方法在存在诊断不确定性时充分测试过以识别 ME/CFS 患者。需要在更广泛的人群中进行更明确的研究来解决这些研究差距。
