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MESA Operations Committee Report

This report discusses the follow-up calls and retention rates in the MESA II study, as well as the completion rates for high-tech tests and the burden on participants. It also covers the reporting of results and protocol deviations/adverse events.

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MESA Operations Committee Report

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  1. MESA Operations Committee Report R Graham Barr, MD DrPH Departments of Medicine and Epidemiology Columbia University Medical Center September 13, 2010

  2. Operations Subcommittee Report • Follow-up calls and Retention • Exam 5 • High Tech Completion • Participant Burden • Results Reporting and Reading • Protocol Deviations/Adverse Events

  3. Follow-up Calls and Retention

  4. Follow-up Calls in MESA II

  5. Follow-up 7 Operational Retention Overall 93% Complete / (Enrolled – Dead) = 89%

  6. Follow-up 8 Operational Retention Overall 93% Complete / (Enrolled – Dead) = 90%

  7. Follow-up 9 Operational Retention Overall 91% Complete / (Enrolled – Dead) = 86%

  8. Follow-up 10 Operational Retention Overall 76% Complete / (Enrolled – Dead) = 74% FU 10 71% Complete

  9. Exam Retention and Exam 5

  10. Exam 2 Retention by Ethnicity Overall 92%

  11. Exam 3 Retention by Ethnicity Overall 89%

  12. Exam 4 Retention by Ethnicity Overall 81%

  13. Exam 5 Retention by Ethnicity Overall 62%

  14. Exam 5 – Target vs. Completed

  15. Exam 5 – Target vs. Completed(April - August)

  16. Exam 5 – Target vs. Completed(Last six weeks)

  17. Exam 5 Completion vs. Target by Site(through August, 2010)

  18. High-Tech Completion

  19. ECG Completion

  20. MRI Completion

  21. MRI with Gadolinium Completion

  22. Retinal Photography Completion

  23. Ultrasound Completion

  24. Cardiac CT Completion

  25. Lung CT Completion

  26. Spirometry Completion

  27. Exam 5 Participant Burden

  28. Exam 5 Components and Time

  29. Clinic Visit Time Burden - Hours Participants not selected for high tech components

  30. Clinic Visit Time Burden (cont.) All Participants -- First visit only

  31. MRI Scanning Time site | N Median p75 p95 min max -------+-------------------------------------------------------------------------------- 3: WFU | 42 46.9 54.8 66.0 28.5 72.2 4: COL | 46 45.6 47.2 59.8 22.7 62.6 5: JHU | 38 42.0 44.8 52.1 29.4 54.3 6: UMN | 32 43.7 47.8 61.5 27.0 71.6 7: NWU | 69 42.5 45.0 50.6 26.8 55.5 8: UCLA| 27 47.0 49.8 54.9 28.2 60.7 -------+-------------------------------------------------------------------------------- Total | 254 44.1 47.6 57.0 22.7 72.2 ----------------------------------------------------------------------------------------

  32. U/S Scanning Time

  33. CT Scanning Time • Clinical scanners – no exact report on scanning/waiting time • Subjectively, considerably briefer scanning times than prior exams (~15 min total) • Scanner proximity • Improved scheduling

  34. Ancillary Study Burden

  35. Results Reporting and Reading

  36. Participant Results Reporting Targets • Ancillary studies: same targets

  37. Participant Results Reporting Targets • Lab target omitted Vermont  Minnesota shipment

  38. Participant Lab Results Reporting

  39. Participant High-tech Results Reporting

  40. High Tech Data/Reports Pending

  41. Clinical Reporting of High Tech Tests • Several sites now require a clinical local read of CT scans • CT scans: JHU, Col, NWU and Wake • MRI: Columbia • Local reporting • Preference for one rather than multiple clinical reads/over-reads • MESA CT, MRI and U/S Reading Centers providing read/over-read for alerts for scans at other FC only

  42. Protocol Deviations & Adverse Events

  43. Protocol Deviations • Remediation • Coordinating Center fixed software • 2-4. CT Completion form changed to clarify body size; CT tech retraining

  44. Other Adverse Events

  45. Alerts

  46. Alerts (cont.)

  47. Operations Summary • Retention stable up to Exam 5 • Variable start-up at Field Centers • Stabilizing • Rate of visits at goal over last month • Working to complete second visits • Participant Burden as forecast • Results reporting catching up

  48. Thank You!!! The MESA Operations Committee

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