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Implementation of a self-sampling HPV test for non-responders to cervical cancer screening in Japan: secondary analysis of the ACCESS trial
A self-sampling human papillomavirus (HPV) test could improve the morbidity and mortality of cervical cancer in Japan. However, its effectiveness and feasibility have not been demonstrated sufficiently. Hence, we launched a randomized controlled trial, which is ongoing, and report the results of a s...
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Published in: | Scientific reports 2022-08, Vol.12 (1), p.14531-14531, Article 14531 |
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creator | Fujita, Misuzu Nagashima, Kengo Shimazu, Minobu Suzuki, Misae Tauchi, Ichiro Sakuma, Miwa Yamamoto, Setsuko Hanaoka, Hideki Shozu, Makio Tsuruoka, Nobuhide Kasai, Tokuzo Hata, Akira |
description | A self-sampling human papillomavirus (HPV) test could improve the morbidity and mortality of cervical cancer in Japan. However, its effectiveness and feasibility have not been demonstrated sufficiently. Hence, we launched a randomized controlled trial, which is ongoing, and report the results of a secondary analysis. To ensure autonomous participation with a minimum selection bias, opt-out consent was obtained from women who met the inclusion criteria, and written consent was obtained from those who underwent a self-sampling test. The number of women who met the inclusion criteria was 20,555; 4283 and 1138 opted out before and after the assignment, respectively. Of the 7340 women in the self-sampling arm, 1372 (18.7%) ordered and 1196 (16.3%) underwent the test. Younger women in their 30 s and 40 s tended to undertake the test more frequently than older women in their 50 s (
P
for trend |
doi_str_mv | 10.1038/s41598-022-18800-w |
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P
for trend < 0.001). Invalid HPV test results were rare (1.3%), and neither adverse events nor serious complaints were reported. Despite adopting the opt-out procedure, more women than expected declined to participate, suggesting the need for a waiver of consent or assignment before consent to reduce selection bias. A self-sampling HPV test can be implemented in Japan and would be more accessible to young women, the predominant group affected by cervical cancer.</description><identifier>ISSN: 2045-2322</identifier><identifier>EISSN: 2045-2322</identifier><identifier>DOI: 10.1038/s41598-022-18800-w</identifier><identifier>PMID: 36008554</identifier><language>eng</language><publisher>London: Nature Publishing Group UK</publisher><subject>692/308/174 ; 692/308/2779/777 ; 692/4028/67/1517 ; 692/4028/67/2195 ; 692/4028/67/2322 ; 692/700/478 ; Cancer screening ; Cervical cancer ; Cervix ; Consent ; Human papillomavirus ; Humanities and Social Sciences ; Medical screening ; Morbidity ; multidisciplinary ; Sampling ; Science ; Science (multidisciplinary) ; Secondary analysis</subject><ispartof>Scientific reports, 2022-08, Vol.12 (1), p.14531-14531, Article 14531</ispartof><rights>The Author(s) 2022</rights><rights>The Author(s) 2022. This work is published under http://creativecommons.org/licenses/by/4.0/ (the “License”). Notwithstanding the ProQuest Terms and Conditions, you may use this content in accordance with the terms of the License.</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c583t-5c11c29e4f431983da0478f51887d0debca2112a02840dee940f33b23b4b4c4d3</citedby><cites>FETCH-LOGICAL-c583t-5c11c29e4f431983da0478f51887d0debca2112a02840dee940f33b23b4b4c4d3</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktopdf>$$Uhttps://www.proquest.com/docview/2706501281/fulltextPDF?pq-origsite=primo$$EPDF$$P50$$Gproquest$$Hfree_for_read</linktopdf><linktohtml>$$Uhttps://www.proquest.com/docview/2706501281?pq-origsite=primo$$EHTML$$P50$$Gproquest$$Hfree_for_read</linktohtml><link.rule.ids>230,314,727,780,784,885,25753,27924,27925,37012,37013,44590,53791,53793,75126</link.rule.ids></links><search><creatorcontrib>Fujita, Misuzu</creatorcontrib><creatorcontrib>Nagashima, Kengo</creatorcontrib><creatorcontrib>Shimazu, Minobu</creatorcontrib><creatorcontrib>Suzuki, Misae</creatorcontrib><creatorcontrib>Tauchi, Ichiro</creatorcontrib><creatorcontrib>Sakuma, Miwa</creatorcontrib><creatorcontrib>Yamamoto, Setsuko</creatorcontrib><creatorcontrib>Hanaoka, Hideki</creatorcontrib><creatorcontrib>Shozu, Makio</creatorcontrib><creatorcontrib>Tsuruoka, Nobuhide</creatorcontrib><creatorcontrib>Kasai, Tokuzo</creatorcontrib><creatorcontrib>Hata, Akira</creatorcontrib><title>Implementation of a self-sampling HPV test for non-responders to cervical cancer screening in Japan: secondary analysis of the ACCESS trial</title><title>Scientific reports</title><addtitle>Sci Rep</addtitle><description>A self-sampling human papillomavirus (HPV) test could improve the morbidity and mortality of cervical cancer in Japan. However, its effectiveness and feasibility have not been demonstrated sufficiently. Hence, we launched a randomized controlled trial, which is ongoing, and report the results of a secondary analysis. To ensure autonomous participation with a minimum selection bias, opt-out consent was obtained from women who met the inclusion criteria, and written consent was obtained from those who underwent a self-sampling test. The number of women who met the inclusion criteria was 20,555; 4283 and 1138 opted out before and after the assignment, respectively. Of the 7340 women in the self-sampling arm, 1372 (18.7%) ordered and 1196 (16.3%) underwent the test. Younger women in their 30 s and 40 s tended to undertake the test more frequently than older women in their 50 s (
P
for trend < 0.001). Invalid HPV test results were rare (1.3%), and neither adverse events nor serious complaints were reported. Despite adopting the opt-out procedure, more women than expected declined to participate, suggesting the need for a waiver of consent or assignment before consent to reduce selection bias. 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However, its effectiveness and feasibility have not been demonstrated sufficiently. Hence, we launched a randomized controlled trial, which is ongoing, and report the results of a secondary analysis. To ensure autonomous participation with a minimum selection bias, opt-out consent was obtained from women who met the inclusion criteria, and written consent was obtained from those who underwent a self-sampling test. The number of women who met the inclusion criteria was 20,555; 4283 and 1138 opted out before and after the assignment, respectively. Of the 7340 women in the self-sampling arm, 1372 (18.7%) ordered and 1196 (16.3%) underwent the test. Younger women in their 30 s and 40 s tended to undertake the test more frequently than older women in their 50 s (
P
for trend < 0.001). Invalid HPV test results were rare (1.3%), and neither adverse events nor serious complaints were reported. Despite adopting the opt-out procedure, more women than expected declined to participate, suggesting the need for a waiver of consent or assignment before consent to reduce selection bias. A self-sampling HPV test can be implemented in Japan and would be more accessible to young women, the predominant group affected by cervical cancer.</abstract><cop>London</cop><pub>Nature Publishing Group UK</pub><pmid>36008554</pmid><doi>10.1038/s41598-022-18800-w</doi><tpages>1</tpages><oa>free_for_read</oa></addata></record> |
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subjects | 692/308/174 692/308/2779/777 692/4028/67/1517 692/4028/67/2195 692/4028/67/2322 692/700/478 Cancer screening Cervical cancer Cervix Consent Human papillomavirus Humanities and Social Sciences Medical screening Morbidity multidisciplinary Sampling Science Science (multidisciplinary) Secondary analysis |
title | Implementation of a self-sampling HPV test for non-responders to cervical cancer screening in Japan: secondary analysis of the ACCESS trial |
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