Chronic fatigue syndrome (Benign myalgic encephalomyelitis)
Conditions
Interventions
Model Construction Phase Case Group(cfs):None
Model Construction Phase control group (non CFS):None
Clinical Validation Phase Case Group(cfs):None
Clinical Validation Phase control group (non CFS):None
Sponsors
The Fifth Affiliated Hospital of Sun Yat-sen University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1.Model Construction Phase: (I) Case Group: 1. Patients with clinically confirmed chronic fatigue syndrome (CFS) were selected from the UK Biobank database (March 2006-July 2010); 2. Aged 40-69 years; 3. No gender restrictions. (II) Control Group: 1. Participants without CFS diagnosis were selected from the same UK Biobank database during the identical period (March 2006-July 2010); 2. Aged 40-69 years; 3. No gender restrictions. 2.Clinical Validation Phase (Retrospective): (I) Case Group: 1. Diagnostic criteria followed the 1994 CDC Revised Case Definition for Chronic Fatigue Syndrome: A. Major Criterion: Unexplained persistent or relapsing severe fatigue lasting =6 months that is not alleviated by rest and results in substantial reduction in occupational, educational, social, or personal activities; B. Minor Criteria (=4 of 8 symptoms persisting >=6 months, not predating fatigue): a) Self-reported memory/concentration impairment affecting daily activities; b) Sore throat; c) Tender cervical/axillary lymph nodes; d) Myalgia; e) Multi-joint pain without swelling/redness; f) New-onset severe headache; g) Unrefreshing sleep; h) Post-exertional malaise >24 hours; C. Exclusion Criteria: Organic diseases or medication-induced fatigue. 2. Age: 40-69 years; 3. No gender restrictions. (II) Control Group: 1. Participants not meeting CFS diagnostic criteria; 2. Age: 40-69 years; 3. No gender restrictions. 3.Clinical Validation Phase (Prospective): (I) Case Group: 1. Diagnostic criteria followed the 1994 CDC Revised Case Definition for Chronic Fatigue Syndrome: A. Major Criterion: Unexplained persistent or relapsing severe fatigue lasting =6 months that is not alleviated by rest and results in substantial reduction in occupational, educational, social, or personal activities; B. Minor Criteria (>=4 of 8 symptoms persisting =6 months, not predating fatigue): a) Self-reported memory/concentration impairment; b) Sore throat; c) Tender cervical/axillary lymph nodes; d) Myalgia; e) Multi-joint pain without inflammation; f) New pattern/severity headache; g) Unrefreshing sleep; h) Post-exertional malaise >24h; C. Exclusion Criteria: Organic disorders or pharmacologically-induced fatigue. 2. Age: 40-69 years; 3. No gender restrictions. (II) Control Group: 1. Participants not meeting CFS diagnostic criteria; 2. Age: 40-69 years; 3. No gender restrictions.
Exclusion criteria
Exclusion criteria: 1.Model Construction Phase: None; 2.Clinical Validation Phase (Retrospective): (I) Case Group: 1. Intellectual disability; 2. Pre-existing severe mental disorders (e.g., schizophrenia, delusional disorder, anorexia nervosa) or dementia diagnosis; 3. Alcohol or substance abuse; 4. Extreme obesity [body mass index (BMI) = 45]; 5. Pregnant or lactating women; 6. Postoperative patients without full recovery; 7. >5% body weight loss within recent 3 months; 8. Current participation in other interventional trials. (II) Control Group: 1. Intellectual disability; 2. Pre-existing severe mental disorders (e.g., schizophrenia, delusional disorder, anorexia nervosa) or dementia diagnosis; 3. Current participation in other interventional trials. 3.Clinical Validation Phase (Prospective): (I) Case Group: 1. Intellectual disability; 2. Pre-existing diagnosis of severe mental disorders (including but not limited to schizophrenia, delusional disorder, anorexia nervosa) or dementia; 3. Current alcohol or substance abuse; 4. Extreme obesity [body mass index (BMI) = 45 kg/m²]; 5. Pregnant or lactating women; 6. Post-surgical patients without complete recovery; 7. >5% body weight reduction within the preceding 3 months; 8. Concurrent participation in other interventional studies; 9. Declined to sign informed consent or specimen consent forms. (II) Control Group: 1. Intellectual disability; 2. Pre-existing diagnosis of severe mental disorders (including but not limited to schizophrenia, delusional disorder, anorexia nervosa) or dementia; 3. Concurrent participation in other interventional studies; 4. Declined to sign informed consent or specimen consent forms.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Accuracy;Specificity; | — |
Secondary
| Measure | Time frame |
|---|---|
| MCC (Matthews Correlation Coefficient);AUC (Area Under the Receiver Operating Characteristic Curve);Recall rate;F1 score; | — |
Countries
China
Contacts
Public ContactLi Peng
The Fifth Affiliated Hospital of Sun Yat-sen University
Outcome results
None listed