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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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.

Muasher

Lisa Coates Muasher

Assistant Professor of Obstetrics and Gynecology
Schmitt

John Wilson Schmitt

Consulting Professor in the Department of Obstetrics and Gynecology
Ramanujam

Nimmi Ramanujam

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

Ramanujam obtained her Ph.D. degree at the University of Texas at Austin. She progressed through the ranks as an academic researcher; the first five years as a research scientist and postdoctoral fellow at the University of Pennsylvania, the next five as an assistant professor at the University of Wisconsin, Madison, and the following five as an associate professor in the Department of Biomedical Engineering at Duke University. In 2011 she was promoted to full professor.  Ramanujam is internationally recognized for her contributions in innovation, education and entrepreneurship and received numerous awards most notably, the IEEE  Biomedical Engineering Award Technical Field Award and the Social Impact Abie award . She is a Fulbright scholar, a member of the National Academy of Inventors, and a fellow of international professional societies in her field. She has also been invited for speaking engagements at the United Nations, as a TEDx speaker, and been invited to give plenary talks on her work all over the world.  

Ramanujam addresses pressing challenges in women’s cancers, specifically, cervical and breast cancer. Ramanujam creates technologies that transform complex diagnostic instruments and therapies into accessible, affordable, and appropriate solutions.  Several of these products are now being used in several countries in the U.S., Latin America, and Africa. She has developed a network of partners including academic institutions and hospitals, non-governmental organizations, ministries of health, and commercial partners to implement these technologies in diverse healthcare settings globally.

She has used her expertise in imaging and human-centered design to develop the Pocket colposcope which is on the WHO list of devices for cervical cancer imaging. A sister device, the Callascope is a self-use speculum-free imaging device, which allows women to screen themselves privately without the need for an intrusive pelvic exam. She has developed a translational microscope called the CapCell Scope to identify biomarkers of metabolism that reflect tumor behavior, including growth, proliferation, and treatment resistance, aimed at informing drug selection for breast cancer treatment. She has developed an ultra-low-cost injectable liquid ablation therapy that disrupts tumors locally as well as elicits an anti-tumor immune response to address an important gap – the lack of access to surgery to the world’s most vulnerable populations. 

Ramanujam has also created several global initiatives that strive to achieve enduring impact in health and education. Her innovations have a common wellspring - they are all connected and come from a place of wanting to create and make something that doesn’t exist.

The most prominent is a consortium called Women Inspired Strategies for Health (WISH) to improve cervical cancer prevention in low-resource settings globally.  She is working with partners worldwide to ensure that technologies and strategies for addressing cervical cancer are adopted by cancer control programs in geographically and economically diverse healthcare settings. These partnerships have resulted in see-and-treat cancer control strategies in the least resourced settings that are in clinical deserts. WISH has been recognized by the MacArthur Foundation as one of the top 100 most transformative and impactful solutions, a testament to its significance in redesigning the health system.

Ramanujam has launched an arts and storytelling initiative, The Invisible Organ to raise awareness of sexual and reproductive health inequities. An educational documentary with a similar name was created and has been screened at conferences and by multiple artists and students across the U.S. This film was officially selected for the Women at the Center Film Festival at the International Papillomavirus Conference in 2020. She also co-led the curation of an art exhibit to bring together a collection of visual arts, medical photography, sculptures, and installations, both a physical exhibit and a digital moving gallery to express the stigma and shame associated with female anatomy.

She has also created a global education program that intersects design thinking, STEM concepts, and the U.N. Sustainable Development Goals to promote social justice awareness: Ignite. The participatory learning curricula have been implemented in more than four countries with broad-ranging impact. For example, students living around the contaminated Lake Atitlan, in Guatemala learned how to design engineering solutions for clean water. Similarly,for personal use during frequent power outages.


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