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.

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2018-09

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Abstract

Objective

Our goal was to develop a tele-colposcopy platform for primary-care clinics to improve screening sensitivity and access. Specifically, we developed a low-cost, portable Pocket colposcope and evaluated its performance in a tertiary healthcare centre in Peru.

Design and setting

Images of the cervix were captured with a standard-of-care and Pocket colposcope at la Liga Contra el Cáncer in Lima, Peru.

Population

Two hundred Peruvian women with abnormal cytology and/or human papillomavirus positivity were enrolled.

Methods

Images were collected using acetic acid and Lugol's iodine as contrast agents. Biopsies were taken as per standard-of-care procedures.

Main outcome measures

After passing quality review, images from 129 women were sent to four physicians who provided a diagnosis for each image.

Results

Physician interpretation of images from the two colposcopes agreed 83.1% of the time. The average sensitivity and specificity of physician interpretation compared with pathology was similar for the Pocket (sensitivity = 71.2%, specificity = 57.5%) and standard-of-care (sensitivity = 79.8%, specificity = 56.6%) colposcopes. When compared with a previous study where only acetic acid was applied to the cervix, results indicated that adding Lugol's iodine as a secondary contrast agent improved the percent agreement between colposcopes for all pathological categories by up to 8.9% and the sensitivity and specificity of physician interpretation compared with pathology by over 6.0 and 9.0%, respectively.

Conclusions

The Pocket colposcope performance was similar to that of a standard-of-care colposcope when used to identify precancerous and cancerous lesions using acetic acid and Lugol's iodine during colposcopy examinations in Peru.

Tweetable abstract

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

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Subjects

Humans, Iodides, Acetic Acid, Contrast Media, Image Enhancement, Colposcopy, Biopsy, Equipment Design, Colposcopes, Adult, Middle Aged, Point-of-Care Systems, Primary Health Care, Peru, Uterine Cervical Diseases, Female, Early Detection of Cancer

Citation

Published Version (Please cite this version)

10.1111/1471-0528.15326

Publication Info

Mueller, JL, CT Lam, D Dahl, MN Asiedu, MS Krieger, Y Bellido-Fuentes, M Kellish, J Peters, et al. (2018). 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. BJOG : an international journal of obstetrics and gynaecology, 125(10). pp. 1321–1329. 10.1111/1471-0528.15326 Retrieved from https://hdl.handle.net/10161/25032.

This is constructed from limited available data and may be imprecise. To cite this article, please review & use the official citation provided by the journal.

Scholars@Duke

Erkanli

Alaattin Erkanli

Associate Professor of Biostatistics & Bioinformatics

Areas of research interests include Bayesian hierarchical models for longitudinal data, Bayesian optimal designs, finite mixtures and Mixtures of Dirichlet Processes, Markov transition models, nonparametrics smoothing and density estimation, survival analysis for recurrent-event data, biomarker selection and detecting early ovarian cancer.

Ortiz

Ernesto Ortiz

Associate In Research
Muasher

Lisa Coates Muasher

Assistant Professor of Obstetrics and Gynecology
Schmitt

John Wilson Schmitt

Medical Professor in the Department of Obstetrics and Gynecology
Ramanujam

Nimmi Ramanujam

Robert W. Carr, Jr., Distinguished Professor of Biomedical Engineering

Nirmala (“Nimmi”) Ramanujam is the Robert W. Carr Professor of Biomedical Engineering and Professor of Cancer Pharmacology, Cancer Biology, and Global Health and founder of the Center for Global Women’s Health Technologies (GWHT) at Duke University. Her work addresses access gaps across the cancer care continuum both locally and globally. Her group develops low-cost imaging, artificial intelligence, and digital health platforms to decentralize the early detection of cervical cancer, and immune-based injectables and metabolic biomarkers for breast cancer treatment. Across both programs, she addresses access in different ways—expanding prevention where healthcare infrastructure is limited and improving access to treatment where therapies are available, yet lengthy and prohibitively expensive. She founded Calla Health to translate women’s health technologies into practice and co-developed The (In)visible Organ, a documentary that raises awareness and addresses stigma as barriers to care. She also leads experiential STEM initiatives that train students in systems-based, equity-centered technology development and she has authored a textbook, Biomedical Engineering and Global Health. She is a Fellow of the National Academy of Engineering and the National Academy of Inventors, a Fulbright Scholar, and recipient of a number of awards, notably of the Department of Defense Breast Cancer Innovator Award, the IEEE Biomedical Engineering Technical Field Award and the Anita B social impact award.


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