title: International Image Concordance Study to Compare a Point-of-Care Tampon Colposcope With a Standard-of-Care Colposcope.
abstract: OBJECTIVE
  Barriers to cervical cancer screening in low-resource settings include lack of accessible, high-quality services, high cost, and the need for multiple visits. To address these challenges, we developed a low-cost, intravaginal, optical cervical imaging device, the point-of-care tampon (POCkeT) colposcope and evaluated whether its performance is comparable with a standard-of-care colposcope.
  
  
  METHODS
  There were 2 protocols, which included 44 and 18 patients. For the first protocol, white-light cervical images were collected in vivo, blinded by device, and sent electronically to 8 physicians from high-, middle-, and low-income countries. For the second protocol, green-light images were also collected and sent electronically to the highest performing physician from the first protocol who has experience in both a high- and low-income country. For each image, physicians completed a survey assessing cervix characteristics and severity of precancerous lesions. Corresponding pathology was obtained for all image pairs.
  
  
  RESULTS
  For the first protocol, average percent agreement between devices was 70% across all physicians. The POCkeT and standard-of-care colposcope images had 37% and 51% agreement with pathology for high-grade squamous intraepithelial lesions (HSILs), respectively. Investigation of HSIL POCkeT images revealed decreased visibility of vascularization and lack of contrast in lesion margins. After changes were made for the second protocol, the 2 devices achieved similar agreement to pathology for HSIL lesions (55%).
  
  
  CONCLUSIONS
  Based on the exploratory study, physician interpretation of cervix images acquired using a portable, low-cost POCkeT colposcope was comparable to a standard-of-care colposcope.
authors.affiliation: 1Department of Biomedical Engineering, Duke University, Durham, NC; 2Duke Global Health Institute, Duke University, Durham, NC; 3Department of Surgery, Duke University Medical Center, Durham, NC; 4Department of Biostatistics and Bioinformatics, Duke University Medical School, Durham, NC; 5Institute of Cytology and Preventative Oncology (ICMR), New Delhi, India; 6Cancer Institute (WIA), Chennai, India; 7Department of Obstetrics and Gynecology, Duke University Medical Center, Durham, NC; 8Kilimanjaro Christian Medical Centre, Moshi, Tanzania; 9Liga Contra el Cáncer, Pueblo Libre, Lima, Peru; and 10Department of Obstetrics and Gynecology, School of Medicine, Kenyatta University, Nairobi, Kenya.
authors.forename: Jenna L
authors.initials: JL
authors.lastname: Mueller
authors.forename: Elizabeth
authors.initials: E
authors.lastname: Asma
authors.forename: Christopher T
authors.initials: CT
authors.lastname: Lam
authors.forename: Marlee S
authors.initials: MS
authors.lastname: Krieger
authors.forename: Jennifer E
authors.initials: JE
authors.lastname: Gallagher
authors.forename: Alaattin
authors.initials: A
authors.lastname: Erkanli
authors.forename: Roopa
authors.initials: R
authors.lastname: Hariprasad
authors.forename: J S
authors.initials: JS
authors.lastname: Malliga
authors.forename: Lisa C
authors.initials: LC
authors.lastname: Muasher
authors.forename: Bariki
authors.initials: B
authors.lastname: Mchome
authors.forename: Olola
authors.initials: O
authors.lastname: Oneko
authors.forename: Peyton
authors.initials: P
authors.lastname: Taylor
authors.forename: Gino
authors.initials: G
authors.lastname: Venegas
authors.forename: Anthony
authors.initials: A
authors.lastname: Wanyoro
authors.forename: Ravi
authors.initials: R
authors.lastname: Mehrotra
authors.forename: John W
authors.initials: JW
authors.lastname: Schmitt
authors.forename: Nimmi
authors.initials: N
authors.lastname: Ramanujam
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D015331:Cohort Studies; D020681:Colposcopes; D003127:Colposcopy / Q000379:methods*; D055088:Early Detection of Cancer / Q000379:methods*; D005260:Female; D006801:Humans; D008875:Middle Aged; D061848:Optical Imaging / Q000379:methods*; D019095:Point-of-Care Systems; D059039:Standard of Care; D002583:Uterine Cervical Neoplasms / Q000175:diagnosis; D055815:Young Adult