From: Late-onset rheumatoid arthritis registry study, LORIS study: study protocol and design
Category | Items |
---|---|
Sociodemographic data | Age, sex, education, marital status |
Medical history | Onset time Current symptoms of RA compared to those in the previous year Surgery for RA, site, type Total number of medications taken Vaccination history (Streptococcus pneumoniae, herpes zoster) |
Medication | Use/non-use of MTX, start date, dose, reason for non-use (cognitive decline, interstitial pneumonia (IP), pulmonary diseases other than IP, renal dysfunction, hepatic dysfunction, history of infection, peripheral blood test results, complication/history of malignant tumor, and HBV carrier/infection, among others) Use/non-use of other csDMARDs Use/non-use of GCs, dose, administration period, and reason for administration Use/non-use of NSAIDs Use/non-use of opioids Use/non-use of molecular targeted drugs, start date, and dose Use/non-use of osteoporosis drugs (bisphosphonates, PTH preparations, denosumab, romosozumab, vitamin D preparations, and SERM) |
Symptoms | Tender joint count (28・44) Swelling joint count (28・44) Physician global assessment (VAS) Patient global assessment (VAS) Physical function (HAQ-DI) Health-related QOL (EQ-5D-5L) Depression (PHQ-2) Pain and fatigue (VAS) |
Laboratory data | Inflammation marker (CRP, MMP3, ESR) Blood cell count (White blood cell, neutrophil, total lymphocyte, red blood cell, hemoglobin, and platelet) Nutritional marker (Serum total protein, serum albumin, Hemoglobin A1c, serum total cholesterol, LDL, HDL cholesterol, TG) Infection tests (HBs antigen, HBs antibody, HBc antibody, HCV antibody, IGRA, and β-D-glucan) Autoimmune tests (rheumatoid factor, antinuclear antibody, anti-SS-A/Ro antibody, and anti-CCP antibody) Renal function (Serum creatinine, Serum cystatin C, eGFR-Cre) Liver function (AST or ALT) 25-hydroxy vitamin D (25OHD) Krebs von den Lungen-6 (KL-6) |
Radiological examination | Plain X-ray (Xp) imaging (frontal and lateral chest, both upper and lower limbs, or all frontal images). The modified Sharp score will be calculated every year to assess the progression of joint destruction Bone density (DXA method, lumbar spine, or mean value for both sites) |
Comorbidity | Malignant tumor (solid cancer, hematological cancer, among others, the presence or absence of metastasis) Lung disease (IP, COPD, pulmonary tuberculosis, atypical mycobacteriosis, bronchiectasis, or bronchiolitis, among others) Heart disease (myocardial infarction, other cardiovascular disease, chronic heart failure, or peripheral vascular disease, among others) Stroke Hemiplegia or paraplegia Hypertension Diabetes mellitus Hyperlipidemia (hypo-HDL-emia (< 40 mg/dl), hyper-LDL-emia (≥ 140 mg/dl), hypertriglyceridemia (≥ 150 mg/dl) Fracture (spine or femur, among others) Depression Gastrointestinal disease (peptic ulcer or colonic diverticulitis) Liver disease (hepatitis B, hepatitis C, or liver cirrhosis, among other liver dysfunctions) Renal disease (dialysis, decreased renal function [eGFR < 60]) Osteoarthritis (DIP, shoulder, elbow, knee, or hip joints) Herpes zoster Venous thromboembolism (pulmonary thromboembolism or deep vein thrombosis) |
Lifestyle and health behavior | Smoking status Physical disability certification and the grade Certification of long-term care needs and the care level Social participation status Exercise habits |
Physical examination | Height and body weight Grip strength Body composition (only at institutions where it is possible) Walk speed (only at institutions where it is possible, 10Â m at comfortable walking speed) The five-times sit-to-stand test (only at institutions where it is possible) |
Cognitive assessment | MMSE [17] will be performed for cognitive function assessment. It will be implemented on patients aged ≥ 75 years at enrollment, who are starting csDMARDs for the first time in this study, and when treatment contents are changed due to cognitive decline |
Frailty assessment | Physical frailty based on J-CHS criteria [18] Questionnaire for medical checkup of old-old [23] Clinical frailty scale [24] |