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.Type
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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.
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Scholars@Duke
Alaattin Erkanli
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.
Ernesto Ortiz
Lisa Coates Muasher
John Wilson Schmitt
Nimmi Ramanujam
Nirmala (Nimmi) Ramanujam is the Robert W. Carr Professor of Biomedical Engineering, Professor of Cancer Pharmacology and Cancer Biology, and Global Health at Duke University. She founded the Center for Global Women’s Health Technologies (GWHT) in 2013 to reshape women’s health through technology innovation. Her translation program in cervical and breast cancer has brought together multiple partners across U.S. and international academic institutions, hospitals, companies, non-governmental organizations, and ministries of health.
Prof. Ramanujam creates technological solutions to detect cancer at its earliest stages, improve the effectiveness of current treatments and refine them to be more effective and less toxic. Prof. Ramanujam has developed point of care imaging technologies (Pocket colposcope and Callascope) and deep learning algorithms for the global prevention of cervical cancer. She has implemented these technologies in global health care settings where access to cancer prevention and treatment is sparse or non-existent. Towards cancer treatment, Prof. Ramanujam has developed a drug releasing immunomodulating polymer that simultaneously disrupts tumor cells and elicits an immune boost. This injectable therapeutic can be deployed in settings where treatment is unavailable owing to its simple and low-cost formulation, and it can also provide an immune boost to checkpoint inhibitors. To understand why some tumors are resistant to therapy, she has created tools to image basic cellular processes that provide insight into tumor resistance. She has shown that metabolic plasticity in human residual disease can serve as a cue for treatment optimization and patient management.
Prof. Ramanujam has created a global consortium, Women Inspired strategies for health or WISH to establish technology-enabled community clinics for cervical cancer detection in Peru and Kenya. The MacArthur Foundation recognized WISH in 2019 as one of the top 100 most transformative and impactful global solutions. She founded Calla Health in 2019 to commercialize women’s health technologies developed by her group. Through WISH and Calla Health, her femtech innovations have been disseminated in 11 countries and has reached more than 8,000 women globally. She has also co-developed the (In)visible Organ documentary on reshaping the future of women’s health through femtech. Her documentary was officially selected for the Women at the Center Film Festival at the International Papillomavirus Conference in 2020. Prof. Ramanujam has seen the value of co-creating solutions with those that are at the level of the problem. This has led to the creation of a global education program IGNITE that intersects engineering design thinking, STEM concepts, and the U.N. Sustainable Development Goals. This peer mentoring model between undergraduate students and high school and middle students has been deployed in 5 locations globally, reaching more than 2,500 students and the online curriculum has more than 1000 users.
Prof. Ramanujam has received numerous awards, several of which are highlighted here. She received the prestigious DOD Breast Cancer Innovator award in 2024 given to gifted individuals who have a history of visionary scholarship, leadership, and creativity. She received the IEEE Biomedical Engineering Award Technical Field Award in 2023 given annually for outstanding contributions to the field of Biomedical engineering. She is a fellow of and has received several awards from professional societies in the field of biomedical optics. She is a Fulbright scholar, a fellow of the National Academy of Inventors, and the American Institute of Biomedical and Biomedical Engineering (AIMBE). She has been invited as a speaker at the United Nations and at TEDx events. Her textbook, Biomedical Engineering for Global Health (2024), examines the intersection of health systems, point of care technologies, and data analytics / artificial intelligence and how these technological capabilities can broaden access to care in the 21st century.
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