See the published version of this preprint at BMC Women's Health.
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Research article
Katayoun Taghavi
Universitat Bern
Corresponding Author
ORCiD: https://orcid.org/0000-0003-0812-0069
License:
This work is licensed under a CC BY 4.0 License. Read Full License
Objective: Portable devices that can be used to perform colposcopy may improve cervical cancer screening in low- and middle- income countries (LMIC) where access to colposcopy is limited. The objective of this study was to systematically review the diagnostic test accuracy (DTA) of these devices for the detection of cervical intraepithelial neoplasia grade 2 or higher (CIN2+).
Methods: In accordance with our protocol (Prospero CRD42018104286), we searched Embase, Medline and the Cochrane Controlled Register of Trials up to 9/2019. We included DTA studies, which investigated portable devices with moderate-to-high optical magnification (≥6x) for colposcopy, as described in the manual for Colposcopy and Treatment by the International Agency for Research on Cancer, with a histopathological reference standard. We used the QUADAS-2 tool to assess study quality. We examined results for sensitivity and specificity in paired forest plots, stratified by stages in the clinical pathway. We pooled estimates of test accuracy for the index test, used as an add-on to other tests, using a bivariate random-effect model.
Results: We screened 1737 references and assessed 239 full-text articles for eligibility. Five single-gate DTA studies, including 2693 women, met the inclusion criteria. Studies evaluated two devices (GynocularTM and Pocket) at different stages of the screening pathway. In three studies, which used the index test in an add-on capacity in 1273 women, we found a pooled sensitivity of 0.79 (95% CI: 0.55-0.92) and specificity of 0.83 (95% CI: 0.59-0.94). The main sources of bias were partial verification, incorporation and classification bias.
Conclusion: Few studies have evaluated portable devices able to perform colposcopy, so their accuracy for the detection of CIN2+ remains uncertain. Future studies should include patient-relevant and long-term outcomes, including missed cases, overtreatment, residual and recurrent disease. To meet the challenge of eliminating cervical cancer in LMIC, methods for visual assessment of the cervix need urgent redress.
Registration: Prospero, International prospective register of systematic reviews (CRD42018104286). Date of registration 27, July, 2018.
Keywords
sensitivity, specificity, low- and middle-income countries, colposcopy, cervical cancer screening
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CURRENT STATUS: Published
View the published article at BMC Women's Health.
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Editorial decision: Accept
On 04 Nov, 2020
Review #1 received
Received 02 Nov, 2020
Review #2 received
Received 31 Oct, 2020
Reviewer #2 agreed
On 29 Oct, 2020
Reviewer #1 agreed
On 26 Oct, 2020
Editor assigned
On 22 Oct, 2020
Reviewers invited
Invitations sent on 22 Oct, 2020
Submission checks complete
On 21 Oct, 2020
Editor invited
On 21 Oct, 2020
Version 1
Posted 06 Aug, 2020
No comments provided
Editorial decision: Major revision
On 19 Sep, 2020
Review #3 received
Received 08 Sep, 2020
Review #1 received
Received 07 Sep, 2020
Review #2 received
Received 21 Aug, 2020
Reviewer #4 agreed
On 19 Aug, 2020
Reviewer #3 agreed
On 12 Aug, 2020
Reviewer #2 agreed
On 08 Aug, 2020
Editor assigned
On 07 Aug, 2020
Reviewers invited
Invitations sent on 07 Aug, 2020
Reviewer #1 agreed
On 07 Aug, 2020
Submission checks complete
On 05 Aug, 2020
Editor invited
On 04 Aug, 2020
First submitted
On 16 Jul, 2020
Metrics
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PDF Downloads: ...
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See the published version of this preprint at BMC Women's Health.
This is a preprint, a preliminary version of a manuscript that has not completed peer review at a journal. Research Square does not conduct peer review prior to posting preprints. The posting of a preprint on this server should not be interpreted as an endorsement of its validity or suitability for dissemination as established information or for guiding clinical practice.
Learn more about In Review
Research article
Katayoun Taghavi
Universitat Bern
Corresponding Author
ORCiD: https://orcid.org/0000-0003-0812-0069
Badges
Prescreen
This manuscript passed our Prescreen assessment
Complete author information
Appropriate declaration statements
Potential risks to human health
Prescreen
Peer Review Timeline
CURRENT STATUS: Published
View the published article at BMC Women's Health.
No community comments so far
Editorial decision: Accept
On 04 Nov, 2020
Review #1 received
Received 02 Nov, 2020
Review #2 received
Received 31 Oct, 2020
Reviewer #2 agreed
On 29 Oct, 2020
Reviewer #1 agreed
On 26 Oct, 2020
Editor assigned
On 22 Oct, 2020
Reviewers invited
Invitations sent on 22 Oct, 2020
Submission checks complete
On 21 Oct, 2020
Editor invited
On 21 Oct, 2020
Version 1
Posted 06 Aug, 2020
No comments provided
Editorial decision: Major revision
On 19 Sep, 2020
Review #3 received
Received 08 Sep, 2020
Review #1 received
Received 07 Sep, 2020
Review #2 received
Received 21 Aug, 2020
Reviewer #4 agreed
On 19 Aug, 2020
Reviewer #3 agreed
On 12 Aug, 2020
Reviewer #2 agreed
On 08 Aug, 2020
Editor assigned
On 07 Aug, 2020
Reviewers invited
Invitations sent on 07 Aug, 2020
Reviewer #1 agreed
On 07 Aug, 2020
Submission checks complete
On 05 Aug, 2020
Editor invited
On 04 Aug, 2020
First submitted
On 16 Jul, 2020
Metrics
Comments: 0
PDF Downloads: ...
HTML Views: ...
License:
This work is licensed under a CC BY 4.0 License. Read Full License
View the published article at BMC Women's Health.
Objective: Portable devices that can be used to perform colposcopy may improve cervical cancer screening in low- and middle- income countries (LMIC) where access to colposcopy is limited. The objective of this study was to systematically review the diagnostic test accuracy (DTA) of these devices for the detection of cervical intraepithelial neoplasia grade 2 or higher (CIN2+).
Methods: In accordance with our protocol (Prospero CRD42018104286), we searched Embase, Medline and the Cochrane Controlled Register of Trials up to 9/2019. We included DTA studies, which investigated portable devices with moderate-to-high optical magnification (≥6x) for colposcopy, as described in the manual for Colposcopy and Treatment by the International Agency for Research on Cancer, with a histopathological reference standard. We used the QUADAS-2 tool to assess study quality. We examined results for sensitivity and specificity in paired forest plots, stratified by stages in the clinical pathway. We pooled estimates of test accuracy for the index test, used as an add-on to other tests, using a bivariate random-effect model.
Results: We screened 1737 references and assessed 239 full-text articles for eligibility. Five single-gate DTA studies, including 2693 women, met the inclusion criteria. Studies evaluated two devices (GynocularTM and Pocket) at different stages of the screening pathway. In three studies, which used the index test in an add-on capacity in 1273 women, we found a pooled sensitivity of 0.79 (95% CI: 0.55-0.92) and specificity of 0.83 (95% CI: 0.59-0.94). The main sources of bias were partial verification, incorporation and classification bias.
Conclusion: Few studies have evaluated portable devices able to perform colposcopy, so their accuracy for the detection of CIN2+ remains uncertain. Future studies should include patient-relevant and long-term outcomes, including missed cases, overtreatment, residual and recurrent disease. To meet the challenge of eliminating cervical cancer in LMIC, methods for visual assessment of the cervix need urgent redress.
Registration: Prospero, International prospective register of systematic reviews (CRD42018104286). Date of registration 27, July, 2018.
Figure 1
Figure 2
Figure 3
Figure 4
Figure 5
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