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OSMB Meeting

Explore key points from the OSMB Meeting Coordinating Center Report by Craig Johnson on September 21, 2011, covering priorities, data collection assessment, quality control, data release status, and predictors of Exam 5 retention.

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OSMB Meeting

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  1. OSMB Meeting Coordinating Center Report Craig Johnson September 21st, 2011

  2. Outline • Coordinating Center Priorities • Data Collection Assessment • Quality Control • Data Release Status • Predictors of Exam 5 retention

  3. Coordinating Center Priorities Exam 5 • Data Collection and Closeout • Reporting • Data Cleaning • Dataset Preparation Data Analyses Committee and Working Group Support Ancillary Studies Support Clinical Events Surveillance Coordination

  4. Timeline: Data Collection

  5. MESA Exam 5 Ancillary Studies

  6. Site Coordination Ancillary Studies • MESA Air • CT, US, and Air Questionnaire at all field centers • New Recruits at COL and UCLA • MESA Lung at all field centers • MESA Elasticity at all field centers • Epigenomics at WFU, COL, JHU, and UMN • COPD at COL, JHU, NWU, and UCLA • Stress at COL, JHU, and UCLA • MESA Sleep at all field centers

  7. Exam 5: Clinical Sites& Ancillary Studies UMN COL NWU JHU WFU UCLA Exam 5 (+Air, +Elasticity, +Lung) Epigenomics Stress COPD

  8. TELEform Data Flow Model • Replacing aging equipment expensive • Participant time burden • Field Center efficiency

  9. Follow-up Electronic Data Collection (EDC) • Data is recorded on the laptop (tablet) • Transfer to FC database then to CC • Point of entry data checking

  10. Exam 5 EDC • Terminal services (application @ CC) • Data is recorded directly to CC DB • Point of entry data checking

  11. Exam 5 EDC

  12. Imaging Data Flow Model(MRI Example) • Completion form follows FC EDC model • Scan transferred to RC • Scored data and image RC to CC

  13. Refraction Data Flow Model • Terminal services (application @ CC) • Data is recorded directly to CC DB • Point of entry data checking

  14. Specimen Data Flow Model

  15. EDC: Assessment • Concern 1: Data security, privacy, and integrity • Concern 2: Data loss prevention • Concern 3: Efficiency • 393 clinic days • 80,188 clinic forms • Central EDC performance (5 failures) • 1X – software auto update w/ failed server reboot • 1X – power outage w/ failed server reboot • 1X – spontaneous server stop and restart (unexplained) • 2X – CC initiated hardware or software adjustments

  16. EDC: Assessment Local causes of EDC failure • IP Address changes without notice (rare) • Same login on multiple computers (rare after E5 start) • Lockout due to repeated incorrect logins (rare after E5 start) • Wireless availability (rare - if persistent went wired) • Screen saver disconnecting session

  17. EDC: Issue Resolution • Central issue: Service restored same day • Backup: paper forms • IP address change: CC adds new IP address to firewall permissions • Most other issues addressed via (re)training (and CC resetting the system • Screen saver policy exception

  18. Quality Control • Steering Committee Report Section 4 • Quality assessments (MRI, ECG, US, CT, retinal photo, spirometry, …) • Repeat procedures (labs, anthro, ABI, FFQ, US, pulse ox, spirometry, pulse wave, …) • Reread (MRI, CT, US, ECG, …) • Phantom reviews (CT) • Harmonization and calibration (insulin, creatinine, …)

  19. Data Release Status • STATA, SAS, and SPSS formats • Exams 1-4, Events thru follow-up 9 (7.1 yrs) • NHLBI Data Repository (formerly LADs) • Exams 1-3, Events thru follow-up 3 • dbGaP • MESA SHARe (Affy 6.0 GWA, Phenotypes) • MESA CARe (IBC 50K, Affy 6.0 GWA) • Complete phenotypes • Updates 4 times/yr (mostly ancillary data)

  20. Data Release Status • Exam 5 Data • Clinical data (visits end NOV 2011) • cleaning ongoing • dataset release May 2012 • Anthro, BP, ABI, Cogn, labs, FFQ, H&L, Med Hx, Personal Hx, Meds/suppl, PA, ECG, Refraction • Scan data (Visits end JAN 2012) • cleaning ongoing • dataset release May 2012 • MRI, CT, US, Retinal Photo

  21. Data Release Status • CMS/Medicare • Complete dataset • NHLBI arranged datasets through Duke • MESA data expected this Fall

  22. Predictors of Exam 5 RetentionBackground • Retention lagged targets in the early months of Exam 5 and appears to be slowing again for the final 3 months of the exam. • Historically, minority retention has lagged non-minority retention. • Questions have been raised as to whether/how SES might also play a role in retention.

  23. Predictors of Exam 5 RetentionMethods • Logistic regression models are used to identify factors that are predictive of Exam 5 clinic exam completion. • Models: • M1: Demographic factors (age, gender, race/ethnicity, education, income, and site). • M2: M1 plus risk factors (htn1c, dm031c, chol1, hdl1, bmi1c, egfr1c, clinical event CVD + CHF + PVD). • M3: M1 plus other factors (Exam 4 completion)

  24. Predictors of Exam 5 RetentionDatasets • Dropped deceased participants only • Outcome variable: dichotomous indicator of whether Exam 5 was completed (1) or not (0) • Variables are defined in the methods/models • Risk factor measures from Exam 1 are used in M2 for simplicity.

  25. Predictors of Exam 5 Retentionmodel 1 (demographics)

  26. Predictors of Exam 5 Retention model 1 continued (field center) …

  27. Predictors of Exam 5 Retention model 1 Comments • Older age is associated w/ poorer retention • Gender is not associated w/ retention • CHN and AFA race (but not HIS) are associated with poorer retention • Less education associated w/ poorer retention • Less income associated w/ poorer retention • Sites 5 & 8 associated with poorer retention

  28. Predictors of Exam 5 Retention model 2a (Exam1 CVD risk factors) • Comments: • E1 Diabetes marginally associated with poorer E5 retention. • Lower E1 HDL may be associated with poorer E5 retention.

  29. Predictors of Exam 5 Retention model 2b (incident CVD, CHF, PVD) • Comments: • An adjudicated clinical event (thru follow-up 9) is associated with poorer E5 retention.

  30. Predictors of Exam 5 Retention model 3 (Exam4 completion status) • Comments: • Ppts who Completed E4 clinic visit are more likely to complete E5 • Ppts who completed E4 telephone interview are more likely to complete E5

  31. CC Staffing and Organization • Dick Kronmal • Robyn McClelland (Co-PI) • Emphasis on Exam 5 clinical operations management and data collection

  32. MESA Coordinating Center Organization

  33. MESA Communication

  34. Committee Coordination

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