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Table 1 Parameters captured by the registry database

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, 10 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]

Kihon checklist [19,20,21,22]

Questionnaire for medical checkup of old-old [23]

Clinical frailty scale [24]