International Image Concordance Study to Compare a Point-of-Care Tampon Colposcope With a Standard-of-Care Colposcope.
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2017-04
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Abstract
Objective
Barriers to cervical cancer screening in low-resource settings include lack of accessible, high-quality services, high cost, and the need for multiple visits. To address these challenges, we developed a low-cost, intravaginal, optical cervical imaging device, the point-of-care tampon (POCkeT) colposcope and evaluated whether its performance is comparable with a standard-of-care colposcope.Materials and methods
There were 2 protocols, which included 44 and 18 patients. For the first protocol, white-light cervical images were collected in vivo, blinded by device, and sent electronically to 8 physicians from high-, middle-, and low-income countries. For the second protocol, green-light images were also collected and sent electronically to the highest performing physician from the first protocol who has experience in both a high- and low-income country. For each image, physicians completed a survey assessing cervix characteristics and severity of precancerous lesions. Corresponding pathology was obtained for all image pairs.Results
For the first protocol, average percent agreement between devices was 70% across all physicians. The POCkeT and standard-of-care colposcope images had 37% and 51% agreement with pathology for high-grade squamous intraepithelial lesions (HSILs), respectively. Investigation of HSIL POCkeT images revealed decreased visibility of vascularization and lack of contrast in lesion margins. After changes were made for the second protocol, the 2 devices achieved similar agreement to pathology for HSIL lesions (55%).Conclusions
Based on the exploratory study, physician interpretation of cervix images acquired using a portable, low-cost POCkeT colposcope was comparable to a standard-of-care colposcope.Type
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Mueller, Jenna L, Elizabeth Asma, Christopher T Lam, Marlee S Krieger, Jennifer E Gallagher, Alaattin Erkanli, Roopa Hariprasad, JS Malliga, et al. (2017). International Image Concordance Study to Compare a Point-of-Care Tampon Colposcope With a Standard-of-Care Colposcope. Journal of lower genital tract disease, 21(2). pp. 112–119. 10.1097/lgt.0000000000000306 Retrieved from https://hdl.handle.net/10161/25034.
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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.
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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