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dc.contributor.authorCremer, Miriam
dc.contributor.authorPaul, Proma
dc.contributor.authorBergman, Katie
dc.contributor.authorHaas, Michael
dc.contributor.authorMaza, Mauricio
dc.contributor.authorZevallos, Albert
dc.contributor.authorOssandon, Miguel
dc.contributor.authorGarai, Jillian D
dc.contributor.authorWinkler, Jennifer L
dc.date.accessioned2017-06-23T21:43:59Z
dc.date.available2017-06-23T21:43:59Z
dc.date.issued2017-03-24
dc.identifier.citationA Non-Gas-Based Cryotherapy System for the Treatment of Cervical Intraepithelial Neoplasia: A Mixed-Methods Approach for Initial Development and Testing 2017, 5 (1):57 Global Health: Science and Practiceen
dc.identifier.issn2169-575X
dc.identifier.pmid28351879
dc.identifier.doi10.9745/GHSP-D-16-00270
dc.identifier.urihttp://hdl.handle.net/10150/624357
dc.description.abstractBackground: Gas-based cryotherapy is the most widely used treatment strategy for cervical intraepithelial neoplasia (CIN) in low-resource settings, but reliance on gas presents challenges in low-and middle-income countries (LMICs). Our team adapted the original CryoPen Cryosurgical System, a cryotherapy device that does not require compressed gas and is powered by electricity, for use in LMICs. Methods: A mixed-methods approach was used involving both qualitative and quantitative methods. First, we used a user-centered design approach to identify priority features of the adapted device. U.S.-based and global potential users of the adapted CryoPen participated in discussion groups and a card sorting activity to rank 7 features of the adapted CryoPen: cost, durability, efficacy and safety, maintenance, no need for electricity, patient throughput, and portability. Mean and median rankings, overall rankings, and summary rankings by discussion group were generated. In addition, results of several quantitative tests were analyzed including bench testing to determine tip temperature and heat extraction capabilities; a pathology review of CIN grade 3 cases (N=107) to determine target depth of necrosis needed to achieve high efficacy; and a pilot study (N=5) investigating depth of necrosis achieved with the adapted device to assess efficacy. Results: Discussion groups revealed 4 priority themes for device development in addition to the need to ensure high efficacy and safety and low cost: improved portability, durability, ease of use, and potential for cure. Adaptions to the original CryoPen system included a single-core, single-tip model; rugged carrying case; custom circuit to allow car battery charging; and sterilization by high-level disinfection. In bench testing, there were no significant differences in tip temperature or heat extraction capability between the adapted CryoPen and the standard cryotherapy device. In 80% of the cases in the pilot study, the adapted CryoPen achieved the target depth of necrosis 3.5 mm established in the pathology review. Conclusion: The LMIC-adapted CryoPen overcomes barriers to standard gas-based cryotherapy by eliminating dependency on gas, increasing portability, and ensuring consistent freeze temperatures. Further testing and evaluation of the adapted CryoPen will be pursued to assess scalability and potential impact of this device in decreasing the cervical cancer burden in LMICs.
dc.description.sponsorshipNational Institutes of Health [1UH2CA189883-01]en
dc.language.isoenen
dc.publisherUS AGENCY INT DEVELOPMENT-USAIDen
dc.relation.urlhttp://www.ghspjournal.org/lookup/doi/10.9745/GHSP-D-16-00270en
dc.rights© Cremer et al. This is an open-access article distributed under the terms of the Creative Commons Attribution License.en
dc.rights.urihttps://creativecommons.org/licenses/by/4.0/
dc.titleA Non-Gas-Based Cryotherapy System for the Treatment of Cervical Intraepithelial Neoplasia: A Mixed-Methods Approach for Initial Development and Testingen
dc.typeArticleen
dc.contributor.departmentUniv Arizona, Mel & Enid Zuckerman Coll Publ Hlthen
dc.identifier.journalGlobal Health: Science and Practiceen
dc.description.noteOpen access journalen
dc.description.collectioninformationThis item from the UA Faculty Publications collection is made available by the University of Arizona with support from the University of Arizona Libraries. If you have questions, please contact us at repository@u.library.arizona.edu.en
dc.eprint.versionFinal published versionen
refterms.dateFOA2018-06-18T09:20:25Z
html.description.abstractBackground: Gas-based cryotherapy is the most widely used treatment strategy for cervical intraepithelial neoplasia (CIN) in low-resource settings, but reliance on gas presents challenges in low-and middle-income countries (LMICs). Our team adapted the original CryoPen Cryosurgical System, a cryotherapy device that does not require compressed gas and is powered by electricity, for use in LMICs. Methods: A mixed-methods approach was used involving both qualitative and quantitative methods. First, we used a user-centered design approach to identify priority features of the adapted device. U.S.-based and global potential users of the adapted CryoPen participated in discussion groups and a card sorting activity to rank 7 features of the adapted CryoPen: cost, durability, efficacy and safety, maintenance, no need for electricity, patient throughput, and portability. Mean and median rankings, overall rankings, and summary rankings by discussion group were generated. In addition, results of several quantitative tests were analyzed including bench testing to determine tip temperature and heat extraction capabilities; a pathology review of CIN grade 3 cases (N=107) to determine target depth of necrosis needed to achieve high efficacy; and a pilot study (N=5) investigating depth of necrosis achieved with the adapted device to assess efficacy. Results: Discussion groups revealed 4 priority themes for device development in addition to the need to ensure high efficacy and safety and low cost: improved portability, durability, ease of use, and potential for cure. Adaptions to the original CryoPen system included a single-core, single-tip model; rugged carrying case; custom circuit to allow car battery charging; and sterilization by high-level disinfection. In bench testing, there were no significant differences in tip temperature or heat extraction capability between the adapted CryoPen and the standard cryotherapy device. In 80% of the cases in the pilot study, the adapted CryoPen achieved the target depth of necrosis 3.5 mm established in the pathology review. Conclusion: The LMIC-adapted CryoPen overcomes barriers to standard gas-based cryotherapy by eliminating dependency on gas, increasing portability, and ensuring consistent freeze temperatures. Further testing and evaluation of the adapted CryoPen will be pursued to assess scalability and potential impact of this device in decreasing the cervical cancer burden in LMICs.


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© Cremer et al. This is an open-access article distributed under the terms of the Creative Commons Attribution License.
Except where otherwise noted, this item's license is described as © Cremer et al. This is an open-access article distributed under the terms of the Creative Commons Attribution License.