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Systematic Review of Primary Outcome Measurements for Chronic Fatigue Syndrome/Myalgic Encephalomyelitis (CFS/ME) in Randomized Controlled Trials
| Content Provider | MDPI |
|---|---|
| Author | Kim, Do-Young Lee, Jin-Seok Son, Chang-Gue |
| Copyright Year | 2020 |
| Description | 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. |
| Starting Page | 3463 |
| e-ISSN | 20770383 |
| DOI | 10.3390/jcm9113463 |
| Journal | Journal of clinical medicine |
| Issue Number | 11 |
| Volume Number | 9 |
| Language | English |
| Publisher | MDPI |
| Publisher Date | 2020-10-28 |
| Access Restriction | Open |
| Subject Keyword | Journal of clinical medicine Journal of Clinical Medicine Integrative and Complementary Medicine Chronic Fatigue Syndrome Myalgic Encephalomyelitis Rct Measurement |
| Content Type | Text |
| Resource Type | Article |
