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The accuracy of colposcopic biopsy: Analyses from the placebo arm of the Gardasil clinical trials

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dc.creatorStoler M.H.spa
dc.creatorVichnin M.D.spa
dc.creatorFerenczy A.spa
dc.creatorFerris D.G.spa
dc.creatorPerez, Gonzalospa
dc.creatorPaavonen J.spa
dc.creatorJoura E.A.spa
dc.creatorDjursing H.spa
dc.creatorSigurdsson K.spa
dc.creatorJefferson L.spa
dc.creatorAlvarez F.spa
dc.creatorSings H.L.spa
dc.creatorLu S.spa
dc.creatorJames M.K.spa
dc.creatorSaah A.spa
dc.creatorHaupt R.M.spa
dc.date.accessioned2020-05-26T00:11:52Z
dc.date.available2020-05-26T00:11:52Z
dc.date.created2011spa
dc.description.abstractWe evaluated the overall agreement between colposcopically directed biopsies and the definitive excisional specimens within the context of three clinical trials. A total of 737 women aged 16-45 who had a cervical biopsy taken within 6 months before their definitive therapy were included. Per-protocol, colposcopists were to also obtain a representative cervical biopsy immediately before definitive therapy. Using adjudicated histological diagnoses, the initial biopsies and the same day biopsies were correlated with the surgically excised specimens. The overall agreement between the biopsies taken within 6 months of definitive therapy, and the definitive therapy diagnoses was 42% (weighted kappa = 0.34) (95% CI: 0.29-0.39). The overall underestimation of cervical intraepithelial neoplasia grade 2/3 or adenocarcinoma in situ (CIN2-3/AIS) and CIN3/AIS was 26 and 42%, respectively. When allowing for one degree of variance in the correlation, the overall agreement was 92% for CIN2-3/AIS. The overall agreement between the same day biopsy and definitive therapy specimen was 56% (weighted kappa = 0.41) (95% CI: 0.36-0.47), and the underestimation of CIN2-3/AIS was 57%. There were significant associations in the agreement between biopsies and excisional specimen diagnoses when patients were stratified by age, number of biopsies, lesion size, presence of human papillomavirus (HPV)16/18 and region. Of 178 diagnostic endocervical curettages performed, 14 (7.9%) found any HPV disease. Colposcopic accuracy improved when CIN2 and CIN3/AIS were grouped as a single predictive measure of high-grade disease. Colposcopy functioned well when allowed a one-degree difference between the biopsy and the surgical histologic interpretations, as done in clinical practice. Taking more than one biopsy improved colposcopic accuracy and could improve patient management. Copyright © 2010 UICC.eng
dc.format.mimetypeapplication/pdf
dc.identifier.doihttps://doi.org/10.1002/ijc.25470
dc.identifier.issn00207136
dc.identifier.issn10970215
dc.identifier.urihttps://repository.urosario.edu.co/handle/10336/24338
dc.language.isoengspa
dc.relation.citationEndPage1362
dc.relation.citationIssueNo. 6
dc.relation.citationStartPage1354
dc.relation.citationTitleInternational Journal of Cancer
dc.relation.citationVolumeVol. 128
dc.relation.ispartofInternational Journal of Cancer, ISSN:00207136, 10970215, Vol.128, No.6 (2011); pp. 1354-1362spa
dc.relation.urihttps://www.scopus.com/inward/record.uri?eid=2-s2.0-79551491522&doi=10.1002%2fijc.25470&partnerID=40&md5=072fc5618a7903f038b812a013d11a82spa
dc.rights.accesRightsinfo:eu-repo/semantics/openAccess
dc.rights.accesoAbierto (Texto Completo)spa
dc.source.instnameinstname:Universidad del Rosariospa
dc.source.reponamereponame:Repositorio Institucional EdocURspa
dc.subject.keywordPlacebospa
dc.subject.keywordviraleng
dc.subject.keywordWart virus vaccinespa
dc.subject.keywordAdenocarcinoma in situspa
dc.subject.keywordAdolescentspa
dc.subject.keywordAdultspa
dc.subject.keywordArticlespa
dc.subject.keywordCancer gradingspa
dc.subject.keywordCarcinoma in situspa
dc.subject.keywordColposcopyspa
dc.subject.keywordCorrelation analysisspa
dc.subject.keywordDiagnostic test accuracy studyspa
dc.subject.keywordDiagnostic valuespa
dc.subject.keywordDisease severityspa
dc.subject.keywordDouble blind procedurespa
dc.subject.keywordFemalespa
dc.subject.keywordHumanspa
dc.subject.keywordHuman tissuespa
dc.subject.keywordMajor clinical studyspa
dc.subject.keywordPapillomavirus infectionspa
dc.subject.keywordPhase 3 clinical trialspa
dc.subject.keywordPriority journalspa
dc.subject.keywordRandomized controlled trialspa
dc.subject.keywordSensitivity and specificityspa
dc.subject.keywordUterine cervix biopsyspa
dc.subject.keywordUterine cervix cancerspa
dc.subject.keywordUterine cervix carcinoma in situspa
dc.subject.keywordAdenocarcinomaspa
dc.subject.keywordAdolescentspa
dc.subject.keywordAdultspa
dc.subject.keywordCervical intraepithelial neoplasiaspa
dc.subject.keywordCervix uterispa
dc.subject.keywordColposcopyspa
dc.subject.keywordDnaeng
dc.subject.keywordDouble-blind methodspa
dc.subject.keywordFemalespa
dc.subject.keywordFollow-up studiesspa
dc.subject.keywordHumansspa
dc.subject.keywordMiddle agedspa
dc.subject.keywordPapillomaviridaespa
dc.subject.keywordPapillomavirus infectionsspa
dc.subject.keywordPapillomavirus vaccinesspa
dc.subject.keywordPlacebosspa
dc.subject.keywordPrognosisspa
dc.subject.keywordUterine cervical neoplasmsspa
dc.subject.keywordVaginal smearsspa
dc.subject.keywordYoung adultspa
dc.subject.keywordBiopsyspa
dc.subject.keywordCervical cancerspa
dc.subject.keywordColposcopyspa
dc.subject.keywordHpvspa
dc.subject.keywordPapillomavirusspa
dc.subject.keywordVaccinespa
dc.titleThe accuracy of colposcopic biopsy: Analyses from the placebo arm of the Gardasil clinical trialsspa
dc.typearticleeng
dc.type.hasVersioninfo:eu-repo/semantics/publishedVersion
dc.type.spaArtículospa
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