TY - JOUR
T1 - Diagnosing cervical neoplasia in rural Brazil using a mobile van equipped with in vivo microscopy
T2 - A cluster-randomized community trial
AU - Hunt, Brady
AU - Fregnani, Jose Humberto Tavares Guerreiro
AU - Schwarz, Richard A.
AU - Pantano, Naitielle
AU - Tesoni, Suelen
AU - Possati-Resende, Julio Cesar
AU - Antoniazzi, Marcio
AU - De Oliveira Fonseca, Bruno
AU - De Macêdo Matsushita, Graziela
AU - Scapulatempo-Neto, Cristovam
AU - Kerr, Ligia
AU - Castle, Philip E.
AU - Schmeler, Kathleen
AU - Richards-Kortum, Rebecca
N1 - Funding Information:
Research reported in this publication was supported by the NCI of the NIH under Award Numbers UH2CA189910, UH3CA189910, and CA016672. The content is solely the responsibility of the authors and does not necessarily represent the official views of the NIH.
Publisher Copyright:
© 2018 American Association for Cancer Research.
PY - 2018/6
Y1 - 2018/6
N2 - Cervical cancer is a leading cause of death in underserved areas of Brazil. This prospective randomized trial involved 200 women in southern/central Brazil with abnormal Papanicolaou tests. Participants were randomized by geographic cluster and referred for diagnostic evaluation either at a mobile van upon its scheduled visit to their local community, or at a central hospital. Participants in both arms underwent colposcopy, in vivo microscopy, and cervical biopsies. We compared rates of diagnostic follow-up completion between study arms, and also evaluated the diagnostic performance of in vivo microscopy compared with colposcopy. There was a 23% absolute and 37% relative increase in diagnostic follow-up completion rates for patients referred to the mobile van (102/117, 87%) compared with the central hospital (53/83, 64%; P = 0.0001; risk ratio = 1.37, 95% CI, 1.14–1.63). In 229 cervical sites in 144 patients, colposcopic examination identified sites diagnosed as cervical intraepithelial neoplasia grade 2 or more severe (CIN2þ; 85 sites) with a sensitivity of 94% (95% CI, 87%–98%) and specificity of 50% (95% CI, 42%–58%). In vivo microscopy with realtime automated image analysis identified CIN2þ with a sensitivity of 92% (95% CI, 84%–97%) and specificity of 48% (95% CI, 40%–56%). Women referred to the mobile van were more likely to complete their diagnostic follow-up compared with those referred to a central hospital, without compromise in clinical care. In vivo microscopy in a mobile van provides automated diagnostic imaging with sensitivity and specificity similar to colposcopy.
AB - Cervical cancer is a leading cause of death in underserved areas of Brazil. This prospective randomized trial involved 200 women in southern/central Brazil with abnormal Papanicolaou tests. Participants were randomized by geographic cluster and referred for diagnostic evaluation either at a mobile van upon its scheduled visit to their local community, or at a central hospital. Participants in both arms underwent colposcopy, in vivo microscopy, and cervical biopsies. We compared rates of diagnostic follow-up completion between study arms, and also evaluated the diagnostic performance of in vivo microscopy compared with colposcopy. There was a 23% absolute and 37% relative increase in diagnostic follow-up completion rates for patients referred to the mobile van (102/117, 87%) compared with the central hospital (53/83, 64%; P = 0.0001; risk ratio = 1.37, 95% CI, 1.14–1.63). In 229 cervical sites in 144 patients, colposcopic examination identified sites diagnosed as cervical intraepithelial neoplasia grade 2 or more severe (CIN2þ; 85 sites) with a sensitivity of 94% (95% CI, 87%–98%) and specificity of 50% (95% CI, 42%–58%). In vivo microscopy with realtime automated image analysis identified CIN2þ with a sensitivity of 92% (95% CI, 84%–97%) and specificity of 48% (95% CI, 40%–56%). Women referred to the mobile van were more likely to complete their diagnostic follow-up compared with those referred to a central hospital, without compromise in clinical care. In vivo microscopy in a mobile van provides automated diagnostic imaging with sensitivity and specificity similar to colposcopy.
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U2 - 10.1158/1940-6207.CAPR-17-0265
DO - 10.1158/1940-6207.CAPR-17-0265
M3 - Article
C2 - 29618459
AN - SCOPUS:85048629212
SN - 1940-6207
VL - 11
SP - 359
EP - 369
JO - Cancer Prevention Research
JF - Cancer Prevention Research
IS - 6
ER -