title: A randomized controlled study comparing community based with health facility based direct observation of treatment models on patients' satisfaction and TB treatment outcome in Nigeria.
abstract: BACKGROUND
  Directly observed treatment short-course (DOTS) strategy is an effective mode of treating TB. We aimed to study the cost effectiveness and patients' satisfaction with home based direct observation of treatment (DOT), an innovative approach to community-based DOT (CBDOT) and hospital based DOT (HBDOT).
  
  
  METHODS
  A randomized controlled trial involving 150 newly diagnosed pulmonary TB patients in four TB clinics in Ile Ife , Nigeria, was done. They were randomly assigned to receive treatment with anti TB drugs for the intensive phase administered at home by a TB worker (CBDOT) or at the hospital (HBDOT). Outcome measures were treatment completion/default rates, cost effectiveness and patients' satisfaction with care using a 13 item patients satisfaction questionnaire (PS-13) at 2 months. This trial was registered with pactr.org: number PACTR 201503001058381.
  
  
  RESULTS
  At the end of intensive phase, 15/75 (20%) and 2/75 (3%) of patients in the HBDOT and CBDOT, respectively had defaulted from treatment, p= 0.01. Of those with pretreatment positive sputum smear, 97% (68/70) on CBDOT and 54/67 (81%) on HBDOT were sputum negative for AFB at the end of 2 months of treatment, p=0.01. The CBDOT method was associated with a higher patient satisfaction score compared with HBDOT (OR 3.1; 95% CI 1.25-7.70), p=0.001.The total cost for patients was higher in HBDOT (US$159.38) compared with the CBDOT (US$89.52). The incremental cost effectiveness ratio was US$410 per patient who completed the intensive phase treatment with CBDOT.
  
  
  CONCLUSIONS
  CBDOT is a cost effective approach associated with better compliance to treatment and better patient satisfaction compared to HBDOT.
authors.affiliation: Department of Medicine of Medicine, Obafemi Awolowo University/Teaching Hospitals, Ile Ife. Nigeria adewolef@yahoo.co.uk.
authors.forename: Olanisun O
authors.initials: OO
authors.lastname: Adewole
authors.affiliation: Ministry of Health, Osun State, Nigeria.
authors.forename: T
authors.initials: T
authors.lastname: Oladele
authors.affiliation: Department of Microbiology, Obafemi Awolowo University, Ile Ife, Nigeria.
authors.forename: Arinola H
authors.initials: AH
authors.lastname: Osunkoya
authors.affiliation: Department of Medicine of Medicine, Obafemi Awolowo University/Teaching Hospitals, Ile Ife. Nigeria.
authors.forename: Greg E
authors.initials: GE
authors.lastname: Erhabor
authors.affiliation: Department of Family Medicine, Obafemi Awolowo University Teaching Hospitals, Ile Ife, Nigeria.
authors.forename: Temitayo O
authors.initials: TO
authors.lastname: Adewole
authors.affiliation: Department of Internal Medicine, University of Missouri Hospital and Clinics, Columbia, MO, USA.
authors.forename: Oluwaseun
authors.initials: O
authors.lastname: Adeola
authors.affiliation: Department of Economics, Obafemi Awolowo University, Ile Ife, Nigeria.
authors.forename: Olufemi
authors.initials: O
authors.lastname: Obembe
authors.affiliation: World Health Organization, Brazzaville, Congo.
authors.forename: Martin O C
authors.initials: MO
authors.lastname: Ota
mesh_terms: D000328:Adult; D000995:Antitubercular Agents / Q000627:therapeutic use*; D003153:Community Health Services / Q000379:methods; D003362:Cost-Benefit Analysis; D023801:Directly Observed Therapy / Q000191:economics / Q000379:methods*; D005260:Female; D017048:Health Care Costs; D006801:Humans; D008297:Male; D008875:Middle Aged; D009549:Nigeria; D017060:Patient Satisfaction; D012044:Regression Analysis; D014397:Tuberculosis, Pulmonary / Q000188:drug therapy*; D055815:Young Adult; D016903:Drug Monitoring
chemical_list: D000995:Antitubercular Agents
keywords: Cost effectiveness; Direct observation of treatment; Nigeria; Patient satisfaction; Tuberculosis