Scopes Rheumatoid arthritis Ankylosing spondyloarthritis Psoriatic arthritis Other
- Slides: 19
Scopes Rheumatoid arthritis ¡ Ankylosing spondyloarthritis ¡ Psoriatic arthritis ¡ Other predefined diseases ¡ 2
Included items ¡ Required l l ¡ Optional l l ¡ Patient information AEs Treatments Essential items of x-ray and Labs Patient reported questionnaire X-rays Can create new items Defined by study group l l Genetic study Pharmacoeconomics 3
Patient information Item Required Name Y (全名) Birthday Y ID Y Sex Y Race Y Residence 鄉鎮市 Optional Deleted (原住民、漢人、 客家人) Telephone Y Email Y Economic status Y Occupational status Y BW, BH, BP Y 4
Disease related characteristics Item Required Diagnosis date (year, month) Y Disease onset Y Initial symptoms - fatigue Optional Y Initial symptoms – pain Y Initial symptoms – stiffness Y 5 Deleted
AE – twice (start and end) for an event and between (if necessary) Item Required Optional Date (year, month, date) Y Categories (system, disease) Y Severity (definition- mild, moderate, severe) Y Outcome Y Comments Y 6 Deleted
AE categories ¡ By major events l l l l l Cancer Cardiovascular Infection (site, diagnosis method (culture), ICD code, virus, bacteria etc. ) Surgical intervention Hospitalization Mortality TB Hepatitis – baseline (HBV, HCV) Pregnancy – outcome 7
Past history Item Required DM Y Hypertension Y Operation Y Hepatitis b (yes or no) Y Hepatitis c (yes or no) Y TB (yes or no) Y Malignancy Y Marriage / Children (no. of children) Y Habit Y Smoking (yes or no) Alcohol drinking / Betel nut Y 8 Y Optional Delete d
Drug categories Item Required DMARD Y NSAID Y Steroid Y Biologics Y Other chronic medications (DM, Anti-hypertension…etc) Reasons for shift to another biological Optional Y Y 9 Deleted
Treatment – record by quarterly Item Required Optional Start and stop date Y Drug name (or by categories) Y Dose Y Duration Y 10 Deleted
Indices Item Required Optional DAS 28 Y ACR core Deleted Y HAQ Y SF-36 Y Fatigue questionaire Y MMSE Y 11
TB screening Item Required Optional CXR (report or image) Y Quantiferon Y PPD skin (size) Y 12 Deleted
PE – record by quarterly Item Required Optional Deformity (yes or no) Y Rheumatoid nodule(yes or no) Y Scleritis (yes or no) Y SICCA Y RA non-related Y 13 Deleted
PE ¡ By system or selective items 14
Laboratory – record by quarterly Item Required Optional ESR CRP Y Y CBC Y Liver function Y Renal function Y RF Y Anti. CCP Y TNF Y HLA typing Y Urine routine Y ANA Y Hepatitis marker 15 Y Deleted
X-rays CXR - record by yearly ¡ Hand - record by yearly ¡ Spine, etc. ¡ BMD ¡ Reporting method ¡ l l image (? ) report – free typing or structured report 16
Other items Pharmacoeconomics ¡ Genetics ¡ 17
Patient questionnaire DAS 28 ¡ ACR coreset ¡ SF 36 ¡ HAQ ¡ BASDAI ¡ BASFI ¡ ACR 66/68 ¡ PASI ¡
Outputs ¡ ¡ ¡ ¡ ¡ Patient list, brief report Treatment Labs Patient reports Adverse events Pharmacoeconomics Other pre-defined pages Cross-tabulation and figures Export as excel or access format 19
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