title: A randomized controlled trial of standard versus intensified tuberculosis diagnostics on treatment decisions by physicians in Northern Tanzania.
abstract: BACKGROUND
  Routine tuberculosis culture remains unavailable in many high-burden areas, including Tanzania. This study sought to determine the impact of providing mycobacterial culture results over standard of care [unconcentrated acid-fast (AFB) smears] on management of persons with suspected tuberculosis.
  
  
  METHODS
  Adults and children with suspected tuberculosis were randomized to standard (direct AFB smear only) or intensified (concentrated AFB smear and tuberculosis culture) diagnostics and followed for 8 weeks. The primary endpoint was appropriate treatment (i.e. antituberculosis therapy for those with tuberculosis, no antituberculous therapy for those without tuberculosis).
  
  
  RESULTS
  Seventy participants were randomized to standard (n = 37, 53%) or intensive (n = 33, 47%) diagnostics. At 8 weeks, 100% (n = 22) of participants in follow up randomized to intensive diagnostics were receiving appropriate care, vs. 22 (88%) of 25 participants randomized to standard diagnostics (p = 0.14). Overall, 18 (26%) participants died; antituberculosis therapy was associated with lower mortality (9% who received antiuberculosis treatment died vs. 26% who did not, p = 0.04).
  
  
  CONCLUSIONS
  Under field conditions in a high burden setting, the impact of intensified diagnostics was blunted by high early mortality. Enhanced availability of rapid diagnostics must be linked to earlier access to care for outcomes to improve.
authors.affiliation: Duke University Medical Center, Durham, NC, USA. elizabeth.reddy@duke.edu.
authors.forename: Elizabeth A
authors.initials: EA
authors.lastname: Reddy
authors.forename: Boniface N
authors.initials: BN
authors.lastname: Njau
authors.forename: Susan C
authors.initials: SC
authors.lastname: Morpeth
authors.forename: Kathryn E
authors.initials: KE
authors.lastname: Lancaster
authors.forename: Alison C
authors.initials: AC
authors.lastname: Tribble
authors.forename: Venance P
authors.initials: VP
authors.lastname: Maro
authors.forename: Levina J
authors.initials: LJ
authors.lastname: Msuya
authors.forename: Anne B
authors.initials: AB
authors.lastname: Morrissey
authors.forename: Gibson S
authors.initials: GS
authors.lastname: Kibiki
authors.forename: Nathan M
authors.initials: NM
authors.lastname: Thielman
authors.forename: Coleen K
authors.initials: CK
authors.lastname: Cunningham
authors.forename: Werner
authors.initials: W
authors.lastname: Schimana
authors.forename: John F
authors.initials: JF
authors.lastname: Shao
authors.forename: Shein-Chung
authors.initials: SC
authors.lastname: Chow
authors.forename: Jason E
authors.initials: JE
authors.lastname: Stout
authors.forename: John A
authors.initials: JA
authors.lastname: Crump
authors.forename: John A
authors.initials: JA
authors.lastname: Bartlett
authors.forename: Carol D
authors.initials: CD
authors.lastname: Hamilton
mesh_terms: D000328:Adult; D000995:Antitubercular Agents / Q000627:therapeutic use*; D001431:Bacteriological Techniques; D002675:Child, Preschool; D003657:Decision Making; D003955:Diagnostic Tests, Routine; D005260:Female; D015658:HIV Infections / Q000150:complications; D006801:Humans; D007223:Infant; D008297:Male; D008875:Middle Aged; D009169:Mycobacterium tuberculosis; D059039:Standard of Care; D013636:Tanzania; D016896:Treatment Outcome; D014376:Tuberculosis / Q000188:drug therapy; D014397:Tuberculosis, Pulmonary / Q000175:diagnosis* / Q000188:drug therapy*
chemical_list: D000995:Antitubercular Agents