1. CREATE Biostatistics Core Functions Summary of activities Challenges / coming year’s activities

2. 2 Functions Provision of statistical consultative and collaborative services to all CREATE Consortium projects Ensure uniform summarization and flow of data Translate statistical advances into practical applications to extract maximum information from the collected data

3. 3 Biostatistics Core JHU/Oswaldo Cruz Ashraf Chaudhary Larry Moulton Antonio Pacheco Bill Pan LSHTM/Aurum/Stellenbosch Trisha Crawford Katherine Fielding Richard Hayes Kathy Lawrence James Lewis Ab Schaap Babis Sismanidis Andrew Thomson More info at www.CreateBiostats.org (Saad Omer, webmaster)www.CreateBiostats.org

4. 4 Summary of Activities since September 2005 All three studies: –Finalization of case report forms and data base designs –Initial data entry commenced –DSMB shells and reports prepared

5. 5 Summary of Activities since September 2005 Thibela TB –Contributed to analysis of pilot studies –Design of eCRFs for baseline survey & main study –eCRF training (6 training sessions) –Random selection of participants for baseline survey –Collaboration with DM on electronic data capture systems –Preliminary analysis of baseline survey data –Design of sampling strategy for INH urine testing sub-study –Design of DSMB reporting shells & attendance at DSMB meeting –Assessment of HR data – Preliminary analysis of main study enrolment data

6. 6 Summary of Activities since September 2005, continued THRio –Hired new computer subcontractor for completion of data base coding –Collaboration on project: “Usefulness of Rio de Janeiro City Health Secretariat’s Antiretroviral Pharmaceutical Data base as an Ancillary Tool to the THRio Study” –V. Saraceni, P.I. –TB and Mortality data base merging coding –Collaboration on baseline data analyses –Design paper written and submitted –DSMB analyses and additional shells prepared

7. 7 Summary of Activities since September 2005, continued ZAMSTAR –Randomization completed in public ceremony –Mapping and randomly selecting participants for TB prevalence survey –Baseline TB prevalence survey on 4 communities conducted –Preliminary analyses on TB prevalence data performed –TST survey in the 24 ZAMSTAR communities completed –Preliminary analyses of TST data performed –Design paper drafted Other: –Communications: GoToMyPC, website (300-400 pageviews/mo.)

8. 8 Operating System # requests # page requests 1.Windows 15,1914,952 Windows XP 10,8783,752 Windows 2000 2,886 712 Windows 98 874 323 Unknown Windows 92 65 Windows NT 187 51 Windows ME 246 46 Windows 95 25 2 Windows CE 3 1 2.OS unknown 5,3352,796 3.Known robots 1,8551,199 4.Unix 472 427 Linux 470 426 SunOS 1 1 Other Unix 1 0 5.Macintosh 207 59 Macintosh PowerPC207 59 6.WebTV 1 0 CreateBiostats.org hits by requesting operating system

9. 9 Summary of Activities since 9/2005, continued: Publications and Data Sharing Appeared: Dowdy DW, Chaisson RE, Moulton LH, Dorman SE. The Potential Impact of Enhanced Diagnostic Techniques for Tuberculosis Driven by HIV: A Mathematical Model. AIDS 20: 751-762, 2006. Accepted: Chaudhary MA, Moulton LH: A SAS Macro for Constrained Randomization of Group- Randomized Designs. Computer Methods and Programs in Biomedicine. Submitted: Moulton LH, Golub JE, Durovni B, Cavalcante SC, Pacheco AG, Saraceni V, King B, Chaisson RE. Statistical design of THRio: A phased-implementation clinic- randomized study of a tuberculosis preventive therapy intervention. Invited talks: Highly Constrained Randomization of a Clinic-Randomized Study with a Stepped Wedge Design. L. H. Moulton; APHA Annual Meetings, Philadelphia, 2005. Is spatial dependency a problem in community-randomized trials? W. K. Pan; APHA Annual Meetings, Philadelphia, 2005. Estimating Incremental Cost Effectiveness Ratios from Group Randomized Intervention Trials. M. A. Chaudhary, M. Shoukri; APHA Annual Meetings, Philadelphia, 2005. Design and Analysis of Cluster Randomized Phased Implementation Studies. L. H. Moulton; ENAR, Tampa, 2006.

10. 10 Challenges in the Coming Year Preparation of full DSMB statistical analyses (and ad hoc DSMB analyses) Other routine reporting routinized Analyses of pilot data Design articles to write: - ZAMSTAR & Thibela TB Continuation of best practices analysis research Main lesson learned: Takes a great amount of lead time for DSMB report preparation

11. 11 Biostat Breakout Boogie Agenda Wednesday September 20 Analysis & DSMB 9:15 Thibela TB 9:45 THRio 10:15 Break 10:30 ZAMSTAR 11:00 General statistical issues 12:00 Lunch 1:00 DSMB considerations and reporting plans 3:15 Break 3:30 DSMB continued 4:00 Biostat Core support and communications; interaction with sites 5:00 Adjourn for the day Thursday September 21 Data Management Best practices Reporting requirements Sharing of info 9:00 Thibela TB 10:00 THRio 10:45 Break 11:00 ZAMSTAR 11:45 General data management issues 12:15 Lunch 1:00 Adjourn

12. 12 B I O S T A T Is not only S.P.O.T.S.,

13. 13 B I O S T A T

14. 14 B I O S T A T S O T B A I T