1. Meeting the Challenges of Multi-Site Studies in Diverse Populations
THE LITTLE STUDY THAT COULD
Meeting the Challenges of Multi-Site Studies in Diverse Populations
Lolem Ngong, M.P.H. Dolly Katz, Ph.D. Amy Davidow, Ph.D. Randall Reves, M.D. James Bethel, Ph.D. for the Tuberculosis Epidemiologic Studies Consortium

2. Changing Research Needs
Increase in multi-site studies
McWilliams R, et al. JAMA 2003; 290:
U.S. population is increasingly diverse
9.5% born in another country
Studies need to reflect U.S. population

3. Challenges Institutional Review Boards (IRBs) Enrollment barriers
Maintaining data quality
Operational consistency among diverse sites

4. Missed Opportunities for Prevention of Tuberculosis in Foreign-Born Persons
Majority of TB cases in U.S. now in foreign-born
Insufficient data on the epidemiology of TB in the foreign-born population
Study: Interviewed and collected clinical data on 1,695 foreign-born persons with TB

5. CDC’s Division of Global Migration and Quarantine
Elements of the Study 1 3
In-person
interview
(1 hour)
Clinical data
from surveillance
report
Our study is collecting data from 3 sources. The first is an hour-long interview with foreign-born persons newly diagnosed with TB, within six months of diagnosis. That arm of the study started in April 2005 and was completed in January 2007.
We are merging that data with information on the overseas screening exam received by immigrants and refugees who are designated class B on entry. We are currently collecting that data.
And we are capturing clinical data from the surveillance report on each person that is routinely sent to CDC through the TIMS system. We have just completed collection of that information, and have merged it with the questionnaire data. 2
Arrival screening
information from
CDC’s Division of Global
Migration and Quarantine

6. Missed Opportunities for Prevention of Tuberculosis in Foreign-Born Persons
= TBESC site
= Subcontracting site

7. Meeting the Challenges: IRB Review
Approval from 35 IRBs
490 reviews over life of study
Simple process for using central IRB
A third of IRBs ceded oversight
Agreement for no changes to central IRB-approved consent forms

8. Meeting the Challenges: Enrollment (Recruitment)
Participants spoke 35 different languages
Questionnaire and consent forms translated into 10 languages
Short Form translation
turnaround for new forms: 1 week
9 persons not enrolled because of language

9. Meeting the Challenges: Enrollment (Interviewing)
A single phone interpretation company
Access to questionnaire electronically
Adapted interviews to participants' needs
Convenient locations – home, library, etc.
Convenient times – weekends, after hours

10. Meeting the Challenges: Training
Simulated patients, remote observers
3 in-person trainings
Remote training program for new site hires and refresher

11. Meeting the Challenges: Maintaining Data Quality
Enrollment at 22 U.S. and Canadian sites
Site specific implementation and quality assurance plans
Weekly recruitment logs
Biweekly conference calls
Site monitoring visits
Web-based documentation system

12. Meeting the Challenges: Maintaining Data Quality
Web-based secure data entry system
Remote access for all sites
Built in quality assurance checks
Remote trainings and refreshers

13. Conclusions
Multi-site epidemiologic studies require flexibility, innovation, adaptation
Study exceeded enrollment goal of 1,500
8 initial papers in preparation
Approaches may help other investigators contemplating multi-site studies

14. Acknowledgements Task Order 9 Principal Investigators
Katz, Davidow, Reves
TBESC Protocol development team
Participating TBESC sites
CDC
Westat
Asian Health Coalition of Illinois
New York City Department of Health

15. Thank you Lolem Ngong, M.P.H. lngong@cdc.gov 404-639-6279