Portable Pocket colposcopy performs comparably to standard‐of‐care clinical colposcopy using acetic acid and Lugol's iodine as contrast mediators: an investigational study in Peru

Mueller, Jenna L.; Lam, Christopher T.; Dahl, Denali K.; Asiedu, Mercy Nyamewaa; Krieger, Marlee; Fuentes, Yenny Marisol Bellido; Kellish, Mark; Peters, Jenna; Erkanli, Alaattin; Ortiz, Ernesto; Muasher, Lisa C.; Taylor, Peyton T.; Schmitt, John W.; Venegas, Gino; Ramanujam, Nirmala

doi:10.1111/1471-0528.15326

Cited by 35 publications

(32 citation statements)

References 35 publications

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“…Biases in the design of the included studies make interpretation of the ndings uncertain. First, there was a high risk of partial veri cation bias in three of ve studies [29,31,32], where less than 90% of index test recipients received the reference standard. Partial veri cation can result in overestimation of both sensitivity and speci city if women with more subtle disease are not identi ed.…”

Section: Discussionmentioning

confidence: 99%

“…In these studies, more than 90% of women who had received the index test also received the reference standard. In contrast, in Mueller et al, 63% of women received biopsy [32], in Nessa et al, 25% of women received biopsy [31], and in Newman et al, only 6% of women received a biopsy [29]. Conduct of the reference standard was problematic in two studies due to incorporation bias, where investigators use the index test to determine the need for reference standard and nal diagnosis [31,33].…”

Section: Quality Assessmentmentioning

confidence: 95%

“…Table 1 shows the characteristics of these studies, which include 2693 women. Four of the studies were conducted in LMIC (India [30], Bangladesh [31], Peru [32] and China [29]) and one was conducted in a high-income country (Sweden [33]). All studies used a single-gate design [12].…”

Section: Literature Search Overviewmentioning

confidence: 99%

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Screening test Accuracy of Portable Devices that can be used to Perform Colposcopy for Detecting CIN2+ in Low- and Middle-Income Countries: A Systematic Review and Meta-Analysis

Taghavi

Rohner

Basu

et al. 2020

Preprint

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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.

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Section: Discussionmentioning

confidence: 99%

Section: Quality Assessmentmentioning

confidence: 95%

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Screening test Accuracy of Portable Devices that can be used to Perform Colposcopy for Detecting CIN2+ in Low- and Middle-Income Countries: A Systematic Review and Meta-Analysis

Taghavi

Rohner

Basu

et al. 2020

Preprint

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“…3. The Pocket colposcope used in this study is unique compared to other colposcopes in its ability to acquire an image an inch away from the cervix, remove a majority of the noise (speculum, vaginal walls), and consequently decrease the level of image processing complexity required for cervix segmentation, which has been documented in previous methods [9][10][11]. When combined with the algorithms introduced here, the Pocket colposcope could enable widespread scalable screening for cervical cancer.…”

Section: Study Goalmentioning

confidence: 99%

“…Our group has developed a low-cost, portable, pointof-care digital colposcope, called the Pocket colposcope, to replace VIA with high-quality colposcopy, which is the established standard-of-care for triage in high-resource settings [9][10][11]. An international study conducted by our group found high concordance between the Pocket colposcope and standardof-care clinical colposcopes [12].…”

Section: A Backgroundmentioning

confidence: 99%

Development of algorithms for automated detection of cervical pre-cancers with a low-cost, point-of-care, Pocket colposcope

Asiedu

Simhal

Chaudhary

et al. 2018

Preprint

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Goal: In this work, we propose methods for (1) automatic feature extraction and classification for acetic acid and Lugol's iodine cervigrams and (2) methods for combining features/diagnosis of different contrasts in cervigrams for improved performance. Methods: We developed algorithms to pre-process pathology-labeled cervigrams and to extract simple but powerful color and textural-based features. The features were used to train a support vector machine model to classify cervigrams based on corresponding pathology for visual inspection with acetic acid, visual inspection with Lugol's iodine, and a combination of the two contrasts. Results: The proposed framework achieved a sensitivity, specificity, and accuracy of 81.3%, 78.6%, and 80.0%, respectively when used to distinguish cervical intraepithelial neoplasia (CIN+) relative to normal and benign tissues. This is superior to the average values achieved by three expert physicians on the same data set for discriminating normal/benign cases from CIN+ (77% sensitivity, 51% specificity, 63% accuracy). Conclusion: The results suggest that utilizing simple color-and textural-based features from visual inspection with acetic acid and visual inspection with Lugol's iodine images may provide unbiased automation of cervigrams. Significance: This would enable automated, expert-level diagnosis of cervical pre-cancer at the point-of-care.

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A systematic review of handheld tools in lieu of colposcopy for cervical neoplasia and female genital schistosomiasis

Søfteland

Sebitloane

Taylor

et al. 2021

Intl J Gynecology & Obste

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Background Visualization of the lesions in the lower genital tract is the mainstay for diagnosis of the four lesions found in female genital schistosomiasis (FGS), but colposcopes are generally not available in low‐resource settings. Objective We sought to review handheld devices that could potentially be used for FGS diagnosis. Search strategy We searched Medline and Embase 2015–2019 for handheld devices used in cervical cancer screening and FGS diagnosis. Selection criteria We excluded studies that did not compare the device to standard‐of‐care colposcopes or histopathology. Main results and conclusion In 11 studies, four handheld colposcopes, two smartphones, and one compact digital camera were evaluated. Two handheld colposcopes were found to be potentially adequate for FGS diagnosis, namely Gynocular and Mobile ODT. The smartphones and digital camera did not have sufficient magnification to diagnose grainy sandy patches, one of the FGS lesion types. Customized software should be made to support the diagnosis of both FGS and cervical neoplasia. Real‐time postgraduate training and quality control should be considered in future studies of handheld colposcopes. For patients from schistosomiasis endemic areas, we recommend that handheld devices are used for FGS. Studies are needed to determine which of the two devices is most adequate for FGS diagnosis in schistosomiasis endemic areas.

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Portable Pocket colposcopy performs comparably to standard‐of‐care clinical colposcopy using acetic acid and Lugol's iodine as contrast mediators: an investigational study in Peru

Abstract: The Pocket colposcope performance was similar to that of a standard-of-care colposcope when identifying cervical lesions.

Cited by 35 publications

References 35 publications

Screening test Accuracy of Portable Devices that can be used to Perform Colposcopy for Detecting CIN2+ in Low- and Middle-Income Countries: A Systematic Review and Meta-Analysis

Screening test Accuracy of Portable Devices that can be used to Perform Colposcopy for Detecting CIN2+ in Low- and Middle-Income Countries: A Systematic Review and Meta-Analysis

Development of algorithms for automated detection of cervical pre-cancers with a low-cost, point-of-care, Pocket colposcope

A systematic review of handheld tools in lieu of colposcopy for cervical neoplasia and female genital schistosomiasis

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