Kim Do-Young, Lee Jin-Seok, Son Chang-Gue
Department of Korean Medicine, Korean Medical College of Daejeon University, 62, Daehak-ro, Dong-gu, Daejeon 34520, Korea.
Institute of Bioscience & Integrative Medicine, Dunsan Oriental Hospital of Daejeon University, 75, Daedeok-daero 176, Seo-gu, Daejeon 35235, Korea.
J Clin Med. 2020 Oct 28;9(11):3463. doi: 10.3390/jcm9113463.
Due to its unknown etiology, the objective diagnosis and therapeutics of chronic fatigue syndrome/myalgic encephalomyelitis (CFS/ME) are still challenging. Generally, the patient-reported outcome (PRO) is the major strategy driving treatment response because the patient is the most important judge of whether changes are meaningful.
In order to determine the overall characteristics of the main outcome measurement applied in clinical trials for CFS/ME, we systematically surveyed the literature using two electronic databases, PubMed and the Cochrane Library, throughout June 2020. We analyzed randomized controlled trials (RCTs) for CFS/ME focusing especially on main measurements.
Fifty-two RCTs out of a total 540 searched were selected according to eligibility criteria. Thirty-one RCTs (59.6%) used single primary outcome and others adapted ≥2 kinds of measurements. In total, 15 PRO-derived tools were adapted (50 RCTs; 96.2%) along with two behavioral measurements for adolescents (4 RCTs; 7.7%). The 36-item Short Form Health Survey (SF-36; 16 RCTs), Checklist Individual Strength (CIS; 14 RCTs), and Chalder Fatigue Questionnaire (CFQ; 11 RCTs) were most frequently used as the main outcomes. Since the first RCT in 1996, Clinical Global Impression (CGI) and SF-36 have been dominantly used each in the first and following decade (26.1% and 28.6%, respectively), while both CIS and Multidimensional Fatigue Inventory (MFI) have been the preferred instruments (21.4% each) in recent years (2016 to 2020).
This review comprehensively provides the choice pattern of the assessment tools for interventions in RCTs for CFS/ME. Our data would be helpful practically in the design of clinical studies for CFS/ME-related therapeutic development.
由于慢性疲劳综合征/肌痛性脑脊髓炎（CFS/ME）的病因不明，其客观诊断和治疗仍然具有挑战性。一般来说，患者报告结局（PRO）是推动治疗反应的主要策略，因为患者是判断变化是否有意义的最重要评判者。
为了确定CFS/ME临床试验中应用的主要结局测量的总体特征，我们在2020年6月期间使用两个电子数据库PubMed和考克兰图书馆系统地检索了文献。我们分析了CFS/ME的随机对照试验（RCT），特别关注主要测量指标。
根据纳入标准，从总共检索到的540项研究中选择了52项RCT。31项RCT（59.6%）使用单一主要结局，其他研究采用了≥2种测量方法。总共采用了15种源自PRO的工具（50项RCT；96.2%）以及针对青少年的两种行为测量方法（4项RCT；7.7%）。36项简短健康调查问卷（SF-36；16项RCT）、个人力量检查表（CIS；14项RCT）和查尔德疲劳问卷（CFQ；11项RCT）最常被用作主要结局。自1996年首个RCT以来，临床总体印象（CGI）和SF-36在第一个十年和随后十年中分别占主导地位（分别为26.1%和28.6%），而近年来（2016年至2020年）CIS和多维疲劳量表（MFI）均为首选工具（各占21.4%）。
本综述全面提供了CFS/ME的RCT干预评估工具的选择模式。我们的数据在实际设计与CFS/ME相关治疗开发的临床研究中会有所帮助。
