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QUEST-RA 2. National Data Bank for the rheumatic diseases 3. RAPID Scores

Other databases in the United States . QUEST-RA 2. National Data Bank for the rheumatic diseases 3. RAPID Scores. t.pincus@vanderbilt.edu. Quantitative Patient Que stionnaire Monitoring in St andard Clinical Care of Patients with R heumatoid A rthritis (QUEST-RA) .

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QUEST-RA 2. National Data Bank for the rheumatic diseases 3. RAPID Scores

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  1. Other databases in the United States QUEST-RA2. National Data Bank for the rheumatic diseases3. RAPID Scores t.pincus@vanderbilt.edu

  2. Quantitative Patient Questionnaire Monitoring in Standard Clinical Care of Patients with Rheumatoid Arthritis (QUEST-RA) • 100 RA patients from site over 2-6 months • Patient questionnaire: 4 pages HAQ + HAQ II,MDHAQ items; MDHAQ • MD questionnaire: 3 pages SPERA - Standard Protocol to Evaluate RA: clinical features, medications, 42 joint count 4 major goals: • Experience with questionnaires in standard care • Database for patient scores, DAS, work status, etc. in different sites and countries • Compare therapies atdifferent sites • Paient self-report RADAI joint count vs physician/assessor joint count

  3. Quantitative Patient Questionnaire Monitoring in Standard Clinical Care of Patients with Rheumatoid Arthritis (QUEST-RA) Possible advantages over existing databases: • All RA patients over a given period – not only those taking anti-TNF, etc. • Predicition of going on to anti-TNF? • Enhance clinical rheumatology as a quantitaive science Please contact TP if interested. t.pincus@vanderbilt.edu Thank you

  4. The National Data Bank for Rheumatic Diseases (NDB) • Founded 1998 • Goal: a generalizable, comprehensive, valid, reliable, believable national databank for research and teaching • Surveys at 6 month intervals • Mailed surveys, Internet, Telephone interviewing • Follow-up medical records, MD and patient contact • RA 77%, also OA, SLE, fibromyalgia, etc. • Programmers, research analysts, verifiers, QC staff, callers, records department, mortality staff, designers, administrators

  5. Treatment in NDB At Last Assessment (NDB – 2005)

  6. Demographics (full) Treatments (all) Adverse events cardio-vascular, GI, immune disorders, Infection, cancer, etc Hospitalization Work Costs, cost-utility SF-36, HAQ family Pain, fatigue, sleep, satisfaction, anxiety, depression, global, RADAI, Utilities: EuroQol,HUI, Sf6D EuroQol Variables

  7. T1 -> Cisco Router Firewall (Sonicwall) WWW (HTTP) VPN E-mail Network printers (4) High speed scanner Digital scanner 4 Servers (hardware) Web Server NT2 (E-mail) NT1 (SQL Database) FS-ARC (On-line SQL DB for WebQuest) Workstations (27) VPN workstations (5) Tape back-up Disk-based back-up (SQL) NDB Data Processing Hardware

  8. The Report Project

  9. NDB Privacy and Confidentiality Policy • General • Protection of participant identifying information (PII) in computer databases • Faxed questionnaires • Hard Copy questionnaires • Web-based data entry • SSL Encryption

  10. HIPPA Compliance • As a covered entity under HIPAA, NDB has met the timelines for implementation of the initial HIPAA standards (privacy and security) that are applicable to our business. IRB approval of this implementation is available upon request. • The NDB has processes and procedures in place as they relate to the protection of data, as well as patient information.

  11. Data Bank Questions/Projects • Costs of illness, C/E, C/U • Rates/predictors of outcomes: mortality, joint replacement, work disability, ADR • Effectiveness of therapies • Measurement of severity, development of clinical and research instruments • Psychosocial issue & predictors • Statistical techniques

  12. Complexities in assessment of patients with rheumatic diseases: No single “gold standard” (eg, blood pressure, cholesterol) for clinical trials or standard care: therefore, indices of 3-7 measures. Laboratory tests limited in both diagnosis and treatment - primary criteria are clinical. Patient questionnaires to assess physical function, pain, global status, often best quantitative measures.

  13. Indices to assess RA

  14. RAPID (Routine Assessment of Patient Index Data) Measures

  15. RADAI vs Core Data Set measures (n=274) Adjusted for age, disease duration, education and center, All p<0.0001, except *p=0.035, **p=0.003, ***p>0.05

  16. RADAI self-report Jt Count vs MD TJtC

  17. Spearman Correlation Coefficients in 274 Patients with RA – All p<0.001

  18. CDAI by RAPID4 with RADAI Joint • CCC=0.558 • Line of perfect concordance • Actual Concordance

  19. DAS28 Categories <2.6 = Remission 2.6-3.19 = Low DAS 3.2-5.1 = Moderate DAS >5.1 = High DAS

  20. DAS28 and RAPID RA Categories DAS Categories <2.6 = Remission 2.6-3.19 = Low DAS 3.2-5.1 = Moderate DAS >5.1 = High DAS Proposed RAPID Categories < 1.0 = Near Remission 1.01-2 = Low Severity 2.01-4.0 = Moderate Severity >4.0 = High Severity

  21. DAS28 compared to RAPID 3 scores in 274 patients at 3 sites

  22. DAS28 compared to RAPID 4 MDCT scores in 274 patients at 3 sites

  23. CDAI compared to RAPID 3 scores in 274 patients at 3 sites

  24. Saving time and improving care with a multidimensional health assessment questionnaire: 10 practical considerations T Pincus, Y Yazici, M Bergman J Rheumatol 33:448-454, 2006

  25. Question for Rheumatologists For patients with RA under your care (not including patients in clinical trials), how often do you perform formal tender and swollen joint counts? Never 13% 1–24% of visits 32% 25–49% of visits 11% 50–74% of visits 14% 75–99% of visits 16% Pincus and Segurado Ann Rheum Dis 2006 Always 14%

  26. MDHAQPage 1

  27. Median number of seconds to score various RA measures

  28. Methods • A cross-sectional database of 100 consecutive patients with RA was established at 3 sites: • New York –Yazici, Philadelphia – Bergman, Nashville –Pincus. • The rheumatologists completed a 28 joint count. • Patients completed an expanded health assessment questionnaire (HAQ), including a self-report RADAI joint count.

  29. Indices to assess RA

  30. Indices to assess RA + RAPID=Routine Assessment of Patient Index Data

  31. RAPID (Routine Assessment of Patient Index Data) Measures

  32. DAS28 and proposed RAPID Categories DAS28 Categories <2.6 = Remission 2.6-3.19 = Low DAS 3.2-5.1 = Moderate DAS >5.1 = High DAS Proposed RAPID Categories < 1.0 = Near Remission 1.01-2 = Low Severity 2.01-4.0 = Moderate Severity >4.0 = High Severity

  33. DAS28 compared to RAPID 4 MDS&T scores in 274 patients at 3 sites

  34. DAS28 compared to RAPID 3 scores in 274 patients at 3 sites

  35. CDAI compared to RAPID 4 MDS&T scores in 274 patients at 3 sites

  36. CDAI compared to RAPID 3 scores in 274 patients at 3 sites

  37. RAPID 4 RADAI compared to RAPID 4 MDS&T scores in 274 patients at 3 sites

  38. RAPID 3 compared to RAPID 4 RADAI scores in 274 patients at 3 sites

  39. RAPID 3 compared to RAPID 4 MDS&T scores in 274 patients at 3 sites

  40. Criteria for clinical measure • Clinical trials - • Validity – does it measure what is supposed to be measured? • Reliability – is it reproducible? • Clinical care – also consider • Feasibility – can it be performed? • Acceptability – will clinicians assess it?

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