title: Impact of point-of-care implementation of Xpert® MTB/RIF: product vs. process innovation.
abstract: BACKGROUND
  Both product innovation (e.g., more sensitive tests) and process innovation (e.g., a point-of-care [POC] testing programme) could improve patient outcomes.
  
  
  OBJECTIVE
  To study the respective contributions of product and process innovation in improving patient outcomes.
  
  
  METHODS
  We implemented a POC programme using Xpert(®) MTB/RIF in an out-patient clinic of a tertiary care hospital in India. We measured the impact of process innovation by comparing time to diagnosis with routine testing vs. POC testing. We measured the impact of product innovation by comparing accuracy and time to diagnosis using smear microscopy vs. POC Xpert.
  
  
  RESULTS
  We enrolled 1012 patients over a 15-month period. Xpert had high accuracy, but the incremental value of one Xpert over two smears was only 6% (95%CI 3-12). Implementing Xpert as a routine laboratory test did not reduce the time to diagnosis compared to smear-based diagnosis. In contrast, the POC programme reduced the time to diagnosis by 5.5 days (95%CI 4.3-6.7), but required dedicated staff and substantial adaptation of clinic workflow.
  
  
  CONCLUSIONS
  Process innovation by way of a POC Xpert programme had a greater impact on time to diagnosis than the product per se, and can yield important improvements in patient care that are complementary to those achieved by introducing innovative technologies.
authors.affiliation: McGill University Department of Epidemiology & Biostatistics, Montreal, Canada; McGill International TB Centre, Montreal, Quebec, Canada.
authors.forename: S G
authors.initials: SG
authors.lastname: Schumacher
authors.affiliation: Department of Pulmonary Medicine, Christian Medical College Vellore, India.
authors.forename: B
authors.initials: B
authors.lastname: Thangakunam
authors.affiliation: McGill University Department of Epidemiology & Biostatistics, Montreal, Canada; McGill International TB Centre, Montreal, Quebec, Canada; Division of Infectious Disease, Beth Israel Deaconess Medical Centre, Boston, Massachusetts, USA.
authors.forename: C M
authors.initials: CM
authors.lastname: Denkinger
authors.affiliation: Department of Pulmonary Medicine, Christian Medical College Vellore, India.
authors.forename: A A
authors.initials: AA
authors.lastname: Oliver
authors.affiliation: Department of Pulmonary Medicine, Christian Medical College Vellore, India.
authors.forename: K B
authors.initials: KB
authors.lastname: Shakti
authors.affiliation: McGill University Department of Epidemiology & Biostatistics, Montreal, Canada; McGill International TB Centre, Montreal, Quebec, Canada.
authors.forename: Z Z
authors.initials: ZZ
authors.lastname: Qin
authors.affiliation: Department of Microbiology, Christian Medical College, Vellore, India.
authors.forename: J S
authors.initials: JS
authors.lastname: Michael
authors.affiliation: Department of Pathology, Stanford University, Stanford, California, USA.
authors.forename: R
authors.initials: R
authors.lastname: Luo
authors.affiliation: McGill University Department of Epidemiology & Biostatistics, Montreal, Canada; McGill International TB Centre, Montreal, Quebec, Canada.
authors.forename: M
authors.initials: M
authors.lastname: Pai
authors.affiliation: Department of Pulmonary Medicine, Christian Medical College Vellore, India.
authors.forename: D J
authors.initials: DJ
authors.lastname: Christopher
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D003430:Cross-Sectional Studies; D057210:Delayed Diagnosis; D003955:Diagnostic Tests, Routine; D005260:Female; D006801:Humans; D007194:India; D008297:Male; D008875:Middle Aged; D025202:Molecular Diagnostic Techniques; D009169:Mycobacterium tuberculosis / Q000235:genetics; D010045:Outpatients; D000067716:Point-of-Care Testing; D017064:Process Assessment, Health Care / Q000592:standards*; D012680:Sensitivity and Specificity; D013183:Sputum / Q000382:microbiology*; D062606:Tertiary Care Centers; D014397:Tuberculosis, Pulmonary / Q000175:diagnosis*; D055815:Young Adult