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

Kim, Do-Young; Lee, Jin-Seok; Son, Chang-Gue

doi:10.3390/jcm9113463

Cited by 24Fibromyalgia and Chronic Fatigue Syndrome ResearchLong-Term Effects of COVID-19Musculoskeletal pain and rehabilitation

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

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Kim, Do-Young, Lee, Jin-Seok, Son, Chang-Gue·2020·Journal of Clinical Medicine

DOI 10.3390/jcm9113463PMC PMC7692998

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Abstract

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.

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The measures of fatigue and perceived health status are self-report ratings.
“Additionally, in line with Kim et al.’s [55] findings on measures used in CFS trials, the measures of fatigue and perceived health status are self-report ratings.”
From Efficacy and Acceptance of Cognitive Behavioral Therapy in Adults with Chronic Fatigue Syndrome: A Meta-analysis. (2024) · cites this paper as [55]

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Instruments to measure anxiety in children, adolescents, and young adults with cancer: a systematic review
Lazor, T., Tigelaar, L., Pole, J. D., De Souza, C., Tomlinson, D., & Sung, L. (2017) · Supportive Care in Cancer · doi:10.1007/s00520-017-3743-3 · Cited by 42 · see citing works
Supplementation with Guanidinoacetic Acid in Women with Chronic Fatigue Syndrome
Ostojić, S. M., Stojanović, M. D. M., Drid, P., Hoffman, J. R., Sekulić, D., & Zenić, N. (2016) · Nutrients · doi:10.3390/nu8020072 · Cited by 40 · cited 1× · see citing works
“Total score (4) [53–56] General fatigue (2) [57,58]”
Background
A placebo-controlled, double-blind, randomized controlled trial of a natural killer cell stimulant (BioBran MGN-3) in chronic fatigue syndrome
McDermott, C. (2006) · QJM · doi:10.1093/qjmed/hcl063 · Cited by 39 · cited 1× · see citing works
“Total score (10) [7,21,24,26,27,41–45] Physical score (1) [46]”
School Functioning in Adolescents With Chronic Fatigue Syndrome
Knight, S., Politis, J., Christine, G., Scheinberg, A. M., & Tollit, M. A. (2018) · Frontiers in Pediatrics · doi:10.3389/fped.2018.00302 · Cited by 39 · see citing works
The IDO Metabolic Trap Hypothesis for the Etiology of ME/CFS
Kashi, A. A., Davis, R. W., & Phair, R. D. (2019) · Diagnostics · doi:10.3390/diagnostics9030082 · Cited by 39 · see citing works
Suicide risk in people with chronic fatigue syndrome
Kapur, N., & Webb, R. T. (2016) · The Lancet · doi:10.1016/s0140-6736(16)00270-1 · Cited by 28 · cited 1× · see citing works
“It is well recognized that the HRQOL of CFS/ME sufferers is notoriously poor and has been linked to a 7-fold higher risk of suicide than healthy controls [74,75].”
Background
Dietary intervention in chronic fatigue syndrome
Hobday, R. A., Thomas, S., O’Donovan, A., Murphy, M., & Pinching, A. J. (2008) · Journal of Human Nutrition and Dietetics · doi:10.1111/j.1365-277x.2008.00857.x · Cited by 25 · see citing works
Pathological Mechanisms Underlying Myalgic Encephalomyelitis/Chronic Fatigue SyndromePreprint
Missailidis, D., Annesley, S. J., & Fisher, P. R. (2019) · Preprints.org · doi:10.20944/preprints201907.0196.v1 · Cited by 24 · see citing works
Use of lisdexamfetamine dimesylate in treatment of executive functioning deficits and chronic fatigue syndrome: A double blind, placebo-controlled study
Young, J. L. (2013) · Psychiatry Research · doi:10.1016/j.psychres.2012.09.007 · Cited by 23 · see citing works
Acupuncture for chronic fatigue syndrome: a randomized, sham-controlled trial with single-blinded design.
Ng, S., & Yiu, Y.-M. (2013) · PubMed · Cited by 23 · see citing works
PACE trial claims for recovery in myalgic encephalomyelitis/chronic fatigue syndrome – true or false? It’s time for an independent review of the methodology and results
Shepherd, C. B. (2017) · Journal of Health Psychology · doi:10.1177/1359105317703786 · Cited by 23 · cited 1× · see citing works
“There is however a fair amount of controversy surrounding this PACE trial, likely due to the debates regarding its efficacy and criticisms by researchers and patients due to judgments of restoration as well as side effects [8].”
Background
The Efficacy and Safety of Myelophil, an Ethanol Extract Mixture of Astragali Radix and Salviae Radix, for Chronic Fatigue Syndrome: A Randomized Clinical Trial
Joung, J., Lee, J., Cho, J.-H., Lee, D., Ahn, Y., & Son, C. (2019) · Frontiers in Pharmacology · doi:10.3389/fphar.2019.00991 · Cited by 23 · cited 1× · see citing works
“Thus, some studies have adopted a modified CFQ-11 as a 10-point Likert scale (from 0 points for healthy conditions to 9 points for the worst status) in RCTs for drug development related to CFS/ME [41].”
BackgroundSelf-citation
The Effect of Acclydine in Chronic Fatigue Syndrome: A Randomized Controlled Trial
The, G. K. H., Bleijenberg, G., & van der Meer, J. W. M. (2007) · PLoS Clinical Trials · doi:10.1371/journal.pctr.0020019 · Cited by 22 · see citing works
A Randomized, Placebo-Controlled, Double-Blinded Trial of Duloxetine in the Treatment of General Fatigue in Patients With Chronic Fatigue Syndrome
Arnold, L. M., Blom, T. J., Welge, J. A., Mariutto, E., & Heller, A. (2014) · Psychosomatics · doi:10.1016/j.psym.2014.12.003 · Cited by 21 · see citing works
Efficacy of two delivery modes of behavioral self-management in severe chronic fatigue syndrome
Friedberg, F., Adamowicz, J. L., Caikauskaite, I., Seva, V., & Napoli, A. (2016) · Fatigue Biomedicine Health & Behavior · doi:10.1080/21641846.2016.1205876 · Cited by 19 · see citing works
Effectiveness of a group-based self-management program for people with chronic fatigue syndrome: a randomized controlled trial
Pinxsterhuis, I., Sandvik, L., Strand, E. B., Bautz‐Holter, E., & Sveen, U. (2015) · Clinical Rehabilitation · doi:10.1177/0269215515621362 · Cited by 18 · see citing works
Human Placental Extract as a Subcutaneous Injection Is Effective in Chronic Fatigue Syndrome: A Multi-Center, Double-Blind, Randomized, Placebo-Controlled Study
Park, S. B., Kim, K.-N., Sung, E., Lee, S. Y., & Shin, H. C. (2016) · Biological and Pharmaceutical Bulletin · doi:10.1248/bpb.b15-00623 · Cited by 18 · cited 1× · see citing works
“Single item score (2) [33,53] Fatigue symptom (2) [20,62]”
Background
A randomised controlled trial of the monoaminergic stabiliser (−)-OSU6162 in treatment of myalgic encephalomyelitis/chronic fatigue syndrome
Nilsson, M. K. L., Zachrisson, O., Gottfries, C., Matousek, M., Peilot, B., Forsmark, S., Schuit, R. C., Carlsson, M. L., Kloberg, A., & Carlsson, A. (2017) · Acta Neuropsychiatrica · doi:10.1017/neu.2017.35 · Cited by 16 · see citing works
The Effect of Ondansetron, a 5-HT3Receptor Antagonist, in Chronic Fatigue Syndrome
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Chronic Fatigue Syndrome
Chalder, T. (2014) · doi:10.1002/9781118453940.ch24 · Cited by 13 · see citing works
Effect of Galantamine Hydrobromide in Chronic Fatigue Syndrome
Blacker, C. V. R., Greenwood, D. T., Wesnes, K. A., Wilson, R. J., Woodward, C., Howe, I., & Ali, T. (2004) · JAMA · doi:10.1001/jama.292.10.1195

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Prevalence of cancer-related fatigue based on severity: a systematic review and meta-analysis
Kang, Y.-E., Yoon, J.-H., Park, N.-H., Ahn, Y., Lee, E., & Son, C. (2023) · Scientific Reports · doi:10.1038/s41598-023-39046-0 · Cited by 165 · see citing works
“Because there is no objective biomarker to measure fatigue level, the CRF are commonly assessed via patient-reported questionnaires 50 .”
MethodSelf-citation
Post-viral fatigue in COVID-19: A review of symptom assessment methods, mental, cognitive, and physical impairment
Campos, M. C., Nery, T., Starke, A. C., Alves, A. C. D. B., Speck, A. E., & Aguiar, A. S. (2022) · Neuroscience & Biobehavioral Reviews · doi:10.1016/j.neubiorev.2022.104902 · Cited by 66 · see citing works
Evaluating fatigue in patients recovering from COVID-19: validation of the fatigue severity scale and single item screening questions
Naik, H., Shao, S., Tran, K. C., Wong, A. W., Russell, J. A., Khor, E., Nacul, L., Mckay, R. J., Carlsten, C., Ryerson, C. J., et al. (2022) · Health and Quality of Life Outcomes · doi:10.1186/s12955-022-02082-x · Cited by 63 · see citing works
“This negatively skewed data is also a recognized limitation of generic fatigue instruments in patients with CFS [46], but several of these instruments, including the FSS continue to be used in clinical trials [47, 48].”
Shadow Burden of Undiagnosed Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS) on Society: Retrospective and Prospective—In Light of COVID-19
Arāja, D., Berķis, U., Lunga, A., & Murovska, M. (2021) · Journal of Clinical Medicine · doi:10.3390/jcm10143017 · Cited by 41 · see citing works
“The review comprehensively provides the choice pattern of the assessment tools for interventions in RCTs for ME/CFS [25].”
Advancing Research and Treatment: An Overview of Clinical Trials in Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS) and Future Perspectives
Seton, K. A., Espejo, J., Giménez-Orenga, K., Haagmans, R., Ramadan, D. J., & Mehlsen, J. (2024) · Journal of Clinical Medicine · doi:10.3390/jcm13020325 · Cited by 36 · see citing works
“The 36-item short-form health survey (SF-36), the checklist individual strength (CIS), and the Chalder Fatigue Questionnaire (CFQ) are common frequently used PROMs in ME [243].”
BackgroundMethod
Efficacy and Acceptance of Cognitive Behavioral Therapy in Adults with Chronic Fatigue Syndrome: A Meta-analysis.
Maas genannt Bermpohl, F., Kucharczyk-Bodenburg, A.-C., & Martin, A. (2024) · International Journal of Behavioral Medicine · doi:10.1007/s12529-023-10254-2 · Cited by 29 · see citing works
Nationwide epidemiological characteristics of chronic fatigue syndrome in South Korea
Lim, E., Lee, J., Lee, E., Jeong, S.-J., Park, H., Ahn, Y., & Son, C. (2021) · Journal of Translational Medicine · doi:10.1186/s12967-021-03170-0 · Cited by 23 · see citing works
“All 5 studies applied CDC-1994 criteria in the CFS diagnosis process, which is the most commonly used criterion in clinics and clinical trials [7, 37].”
MethodSelf-citation
Cognitive Dysfunction in Myalgic Encephalomyelitis/Chronic Fatigue Syndrome—Aetiology and Potential Treatments
Bansal, A. S., Seton, K. A., Brooks, J. C. W., & Carding, S. R. (2025) · International Journal of Molecular Sciences · doi:10.3390/ijms26051896 · Cited by 15 · see citing works
“Unsurprisingly, early non-pharmacological therapeutic interventions for ME/CFS have often included participants with conditions causing CFS-like symptoms, owing to the use of less stringent criteria [147].”
Activity monitoring and patient-reported outcome measures in Myalgic Encephalomyelitis/Chronic Fatigue Syndrome patients
Rekeland, I. G., Sørland, K., Bruland, O., Risa, K., Alme, K., Dahl, O., Tronstad, K. J., Mella, O., & Fluge, Ø. (2022) · PLoS ONE · doi:10.1371/journal.pone.0274472 · Cited by 13 · see citing works
Effect of transcutaneous auricular vagal nerve stimulation on the fatigue syndrome in patients with gastrointestinal cancers — FATIVA: a randomized, placebo-controlled pilot study protocol
Gierthmuehlen, M., Höffken, N., Timmesfeld, N., Schmieder, K., & Reinacher‐Schick, A. (2023) · Pilot and Feasibility Studies · doi:10.1186/s40814-023-01289-z · Cited by 12 · see citing works
“It is commonly applied in patients with fatigue [28, 29], autoimmune diseases [30, 31], Parkinson’s [32], and cancer [33– 36].”
Background
Fatigue in ANCA-associated vasculitis (AAV) and systemic sclerosis (SSc): similarities with Myalgic encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS). A critical review of the literature
van Eeden, C., Osman, M. S., & Tervaert, J. W. C. (2022) · Expert Review of Clinical Immunology · doi:10.1080/1744666x.2022.2116002 · Cited by 12 · see citing works
“Many of the tools that have been used to assess fatigue in patients with SARDs (MFI, CFS, SF36), are validated for use in ME/CFS clinical trials [129].”
Method
Comparison of assessment scores for fatigue between multidimensional fatigue inventory (MFI-K) and modified chalder fatigue scale (mKCFQ)
Lim, E., & Son, C. (2022) · Journal of Translational Medicine · doi:10.1186/s12967-021-03219-0 · Cited by 11 · see citing works
Self-citation
Faecal microbiota transplantation (FMT) in Norwegian outpatients with mild to severe myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS): protocol for a 12-month randomised double-blind placebo-controlled trial
Skjevling, L. K., Goll, R., Hanssen, H. M., & Johnsen, P. H. (2024) · BMJ Open · doi:10.1136/bmjopen-2023-073275 · Cited by 3 · see citing works
Assessment of symptoms in myalgic encephalomyelitis/chronic fatigue syndrome: a comparative study of existing scales
Lu, J. N., Sun, W., Li, S., Qu, Y., Liu, T., Guo, S., Feng, C., & Yang, T. (2025) · Frontiers in Neurology · doi:10.3389/fneur.2025.1618272 · Cited by 3 · see citing works
Characteristics associated with physical functioning and fatigue in patients with chronic fatigue syndrome (CFS): secondary analyses of a randomized controlled trial
Gotaas, M. E., Landmark, T., Helvik, A., & Fors, E. A. (2023) · Fatigue Biomedicine Health & Behavior · doi:10.1080/21641846.2023.2175521 · Cited by 2 · see citing works
“…CFS treatment studies are self-reported physical function, fatigue, and global impression of change, often measured with the Short Form-36 Health Survey physical function subscale, the Fatigue Severity Scale, and the Clinical Global Impression of change (CGI) rating, respectively [16, 41 – 44].”
Effect of Prolong-life-with-nine-turn-method (Yan Nian Jiu Zhuan) Qigong on fatigue and gastrointestinal function in patients with chronic fatigue syndrome: Study protocol for a randomized controlled trial
Gu, Y., You, Y., Guo, G., Xie, F., Guan, C., Xie, C., Cheng, Y., Ji, Q., & Yao, F. (2023) · PLoS ONE · doi:10.1371/journal.pone.0287287 · Cited by 2 · see citing works
Severe fatigue is associated with diminished lung function and elevated Galectin-9 levels in early systemic sclerosis
van Eeden, C., Rezaeifar, M., Elezzabi, M., Redmond, D., Gniadecki, R., Abey, A., Reynolds, E. S., SHOLTER, D. E., Shahbaz, S., Elahi, S., et al. (2025) · Frontiers in Immunology · doi:10.3389/fimmu.2025.1655414 · Cited by 3 · see citing works
“To address this, we applied the international consensus criteria for myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS) to patients with SSc (3).”
Clinical Effectiveness of Ikgibohyeol-tang(Yìqìbǔxuè-tāng) and Deer Antler on Fatigue Symptoms and HRV Results in Outpatients at Korean Medical Hospital: A Retrospective Chart Review Study
Ha, W. J., Moon, S., Lee, H., Cho, S., Park, S.-U., Jung, W., Park, J., Ko, C., Cho, K., & Kwon, S. (2022) · 대한한의학회지 · doi:10.13048/jkm.22036 · Cited by 1 · see citing works
Special Issue “Chronic Fatigue Syndrome/Myalgic Encephalomyelitis: Diagnosis and Treatment”
Lorusso, L., & Ricevuti, G. (2022) · Journal of Clinical Medicine · doi:10.3390/jcm11154563
“This information could be helpful in clinical practice in the design of medical studies for CFS/ME-linked therapeutic development [14].”
Method
Evaluating pacing therapy (PT) versus graded exercise therapy (GET) for improving fatigue, pain, and quality of life in adults with myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS): A systematic review
Cooper, C., & Papadopoulos, K. (2025) · Journal of Bodywork and Movement Therapies · doi:10.1016/j.jbmt.2025.05.048
Additional file 1 of Comparison of assessment scores for fatigue between multidimensional fatigue inventory (MFI-K) and modified chalder fatigue scale (mKCFQ)
Lim, E.-J., & Son, C.-G. (2022) · Figshare · doi:10.6084/m9.figshare.17799758
Self-citation
Additional file 1 of Evaluating fatigue in patients recovering from COVID-19: validation of the fatigue severity scale and single item screening questions
Naik, H., Shao, S., Tran, K. C., Wong, A. W., Russell, J. A., Khor, E., Nacul, L., Mckay, R. J., Carlsten, C., Ryerson, C. J., et al. (2024) · Figshare · doi:10.6084/m9.figshare.26557661
Potential application of brain-gut axis-based treatments in Long COVID and ME/CFS: a case-based systematic review
Kim, D.-Y., Youn, J., Kang, N., Cho, S.-I., & Ha, I. (2026) · Journal of Translational Medicine · doi:10.1186/s12967-026-07807-w
Self-citation
Myalgic Encephalomyelitis/chronic fatigue syndrome: a critical narrative review of modern concepts and unani perspectives
Israr, I. M., Eram, F., & Ahmed, M. M. (2026) · EXPLORE · doi:10.1016/j.explore.2026.103545

Systematic review of randomized controlled trials for chronic fatigue syndrome/myalgic encephalomyelitis (CFS/ME)
Kim, D.-Y., Lee, J., Park, S.-Y., Kim, S., & Son, C. (2020) · Journal of Translational Medicine · doi:10.1186/s12967-019-02196-9 · Cited by 83 · see citing works
Self-citation
Quality and acceptability of patient-reported outcome measures used in chronic fatigue syndrome/myalgic encephalomyelitis (CFS/ME): a systematic review
Haywood, K. L., Staniszewska, S., & Chapman, S. (2012) · Quality of Life Research · doi:10.1007/s11136-011-9921-8 · Cited by 83 · see citing works
Psychometric properties of the PROMIS® Fatigue Short Form 7a among adults with myalgic encephalomyelitis/chronic fatigue syndrome
Yang, M., Keller, S., & Lin, J.-M. S. (2019) · Quality of Life Research · doi:10.1007/s11136-019-02289-4 · Cited by 30 · see citing works
Systematic review of fatigue severity in ME/CFS patients: insights from randomized controlled trials
Park, J., Park, B., Lee, J., Lee, E., Ahn, Y., & Son, C. (2024) · Journal of Translational Medicine · doi:10.1186/s12967-024-05349-7 · Cited by 15 · see citing works
Self-citation
Comparing Operationalized Approaches for Substantial Reduction of Functioning in Chronic Fatigue Syndrome and Myalgic Encephalomyelitis
Wiedbusch, E. K., & Jason Leonard, A. (2022) · doi:10.36959/547/653 · Cited by 4 · see citing works

Authors: Kim, D.-Y., Lee, J.-S., & Son, C.-G.
Affiliations: Daejeon University (KR)
Corresponding author: Son, Chang-Gue
ORCID: Kim, Do-Young
Lee, Jin-Seok
Son, Chang-Gue
Venue: Journal of Clinical Medicine
Publisher: MDPI AG
Published: 2020-10-28
Volume: 9
Issue: 11
Pages: 3463
ISSN: 2077-0383 (ISSN-L)
DOI: 10.3390/jcm9113463
PMC: PMC7692998
OpenAlex: W3097045854
Cited by: 24
References: 86
Citations by year: 2026: 2 · 2025: 4 · 2024: 4 · 2023: 4 · 2022: 8 · 2021: 2
FWCI: 0.58
Type: journal article
Language: en
Open access: gold
doi.org
Licence: cc-by
creativecommons.org/licenses/by/4.0/ (vor)
Locations: Journal of Clinical Medicine (publishedVersion, cc-by)
PubMed Central (publishedVersion, cc-by)
PubMed (publishedVersion)
DOAJ (DOAJ: Directory of Open Access Journals) (submittedVersion, cc-by-sa)
Funders: National Research Foundation of Korea (NRF-2018R1A6A1A03025221)
Topics: Health Sciences › Medicine › Psychiatry and Mental health › Fibromyalgia and Chronic Fatigue Syndrome Research
Health Sciences › Medicine › Neurology › Long-Term Effects of COVID-19
Health Sciences › Medicine › Pharmacology › Musculoskeletal pain and rehabilitation
Keywords: chronic fatigue syndrome, primary outcomes, patient-reported outcomes, outcome assessment instruments, SF-36, Checklist Individual Strength, Chalder Fatigue Questionnaire, Multidimensional Fatigue Inventory, Clinical Global Impression Scale, randomized controlled trials, clinical trial design

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

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