title: The challenge of multisite epidemiologic studies in diverse populations: design and implementation of a 22-site study of tuberculosis in foreign-born people.
abstract: OBJECTIVE
  We designed a population-based study of the epidemiology of tuberculosis among foreign-born people in the U.S. and Canada. Challenges included standardizing recruitment and data entry at 22 sites, enrolling individuals who did not speak English and may be undocumented, and obtaining clearance from 36 institutional review boards (IRBs).
  
  
  METHODS
  We used stratified sampling to recruit patients through the Tuberculosis Epidemiologic Studies Consortium, a research consortium funded by the Centers for Disease Control and Prevention. Because recruitment sites were overseen by more than 30 local IRBs, we developed a simple process to designate a central IRB. We translated instruments into 10 main languages, arranged for fast translation of consent "short forms" into other languages, used one telephone interpretation service at all sites, and provided extensive interviewer training including mock interviews with simulated patients.
  
  
  RESULTS
  We interviewed 1,696 participants in 19 states and provinces. Participants from 99 countries were interviewed in 40 languages. Twenty-three percent did not speak English at all; 64% needed an interpreter. More than 20% of participants reported they were undocumented. Participants' age, gender, and birthplaces were broadly similar to the target populations. One-third of local IRBs used the central IRB.
  
  
  CONCLUSIONS
  Special confidentiality protections, substantial resources for translation and interpretation, and a centralized IRB made possible the recruitment of a representative sample of foreign-born people. The approaches may be applicable to studies of other diseases in multinational populations in the U.S. and Canada.
authors.affiliation: Global TB Institute & Department of Preventive Medicine & Community Health, New Jersey Medical School, 185 S. Orange Ave., Newark, NJ 07101, USA. davidoal@umdnj.edu
authors.forename: Amy L
authors.initials: AL
authors.lastname: Davidow
authors.forename: Dolly
authors.initials: D
authors.lastname: Katz
authors.forename: Randall
authors.initials: R
authors.lastname: Reves
authors.forename: James
authors.initials: J
authors.lastname: Bethel
authors.forename: Lolem
authors.initials: L
authors.lastname: Ngong
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D002170:Canada / Q000453:epidemiology; D002487:Centers for Disease Control and Prevention, U.S.; D003219:Confidentiality; D054242:Emigrants and Immigrants; D004812:Epidemiologic Methods; D028744:Ethics Committees, Research; D006801:Humans; D007407:Interviews as Topic; D007802:Language; D008875:Middle Aged; D014376:Tuberculosis / Q000453:epidemiology*; D014481:United States / Q000453:epidemiology