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Systematic Review of Primary Outcome Measurements for Chronic Fatigue Syndrome/Myalgic Encephalomyelitis (CFS/ME) in Randomized Controlled Trials

1
Department of Korean Medicine, Korean Medical College of Daejeon University, 62, Daehak-ro, Dong-gu, Daejeon 34520, Korea
2
Institute of Bioscience & Integrative Medicine, Dunsan Oriental Hospital of Daejeon University, 75, Daedeok-daero 176, Seo-gu, Daejeon 35235, Korea
*
Author to whom correspondence should be addressed.
J. Clin. Med. 2020, 9(11), 3463; https://doi.org/10.3390/jcm9113463
Received: 9 October 2020 / Revised: 24 October 2020 / Accepted: 26 October 2020 / Published: 28 October 2020
Background: 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. Methods: 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. Results: 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). Conclusions: 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. View Full-Text
Keywords: chronic fatigue syndrome; myalgic encephalomyelitis; RCT; measurement chronic fatigue syndrome; myalgic encephalomyelitis; RCT; measurement
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MDPI and ACS Style

Kim, D.-Y.; Lee, J.-S.; Son, C.-G. Systematic Review of Primary Outcome Measurements for Chronic Fatigue Syndrome/Myalgic Encephalomyelitis (CFS/ME) in Randomized Controlled Trials. J. Clin. Med. 2020, 9, 3463. https://doi.org/10.3390/jcm9113463

AMA Style

Kim D-Y, Lee J-S, Son C-G. Systematic Review of Primary Outcome Measurements for Chronic Fatigue Syndrome/Myalgic Encephalomyelitis (CFS/ME) in Randomized Controlled Trials. Journal of Clinical Medicine. 2020; 9(11):3463. https://doi.org/10.3390/jcm9113463

Chicago/Turabian Style

Kim, Do-Young; Lee, Jin-Seok; Son, Chang-Gue. 2020. "Systematic Review of Primary Outcome Measurements for Chronic Fatigue Syndrome/Myalgic Encephalomyelitis (CFS/ME) in Randomized Controlled Trials" J. Clin. Med. 9, no. 11: 3463. https://doi.org/10.3390/jcm9113463

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