title: A randomised controlled clinical trial of the efficacy of family-based direct observation of anti-tuberculosis treatment in an urban, developed-country setting.
abstract: METHODS
  A randomised, controlled clinical trial of the effectiveness of a family-based programme of directly observed treatment (DOT) for tuberculosis.
  
  
  METHODS
  TB patients seen in Victoria, Australia, were randomly allocated to DOT observed by a family member (FDOT), or to standard supervised but non-observed therapy (ST). The outcome measure was compliance, measured by blinded testing of isoniazid levels in urine. An intention-to-treat analysis was used.
  
  
  RESULTS
  Of 173 patients, 87 were allocated to FDOT and 86 to ST. Only 58% in the FDOT group were able to receive FDOT, the major reason being living alone and not having a family member to observe treatment. The rate of non-compliance was 24% (41/173), with no significant difference between FDOT (22/87) and ST (19/86). No clinical or socio-demographic variable predicted compliance.
  
  
  CONCLUSIONS
  We were unable to demonstrate a benefit of FDOT in an urban, industrialised country setting. FDOT may be more appropriate in developing countries, where extended family support is often available and the burden of TB is much higher. Poor compliance and the difficulty in predicting non-compliance shown in this study highlights the need for DOT for all TB patients.
authors.affiliation: Children's Hospital at Westmead, National Centre for Immunisation Research and Surveillance of Vaccine Preventable Diseases, Westmead, NSW, Australia. RainaM@chw.edu.au
authors.forename: C R
authors.initials: CR
authors.lastname: MacIntyre
authors.forename: K
authors.initials: K
authors.lastname: Goebel
authors.forename: G V
authors.initials: GV
authors.lastname: Brown
authors.forename: S
authors.initials: S
authors.lastname: Skull
authors.forename: M
authors.initials: M
authors.lastname: Starr
authors.forename: R O
authors.initials: RO
authors.lastname: Fullinfaw
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000995:Antitubercular Agents / Q000627:therapeutic use* / Q000652:urine; D005192:Family Health; D005260:Female; D006801:Humans; D007538:Isoniazid / Q000627:therapeutic use* / Q000652:urine; D008297:Male; D008875:Middle Aged; D010349:Patient Compliance; D016896:Treatment Outcome; D014397:Tuberculosis, Pulmonary / Q000188:drug therapy*; D014505:Urban Population
chemical_list: D000995:Antitubercular Agents; D007538:Isoniazid