Effect of Mailed Human Papillomavirus Test Kits vs Usual Care Reminders on Cervical Cancer Screening Uptake, Precancer Detection, and Treatment A Randomized Clinical Trial
Effect of Mailed Human Papillomavirus Test Kits vs Usual Care Reminders on Cervical Cancer Screening Uptake, Precancer Detection, and Treatment A Randomized Clinical Trial
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DOI：
10.1001/jamanetworkopen.2019.14729
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发表时间：
2019-11-01
影响因子：
13.8
通讯作者：
Buist, Diana S. M.
中科院分区：
文献类型：
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作者：
Winer, Rachel L.;Lin, John;Buist, Diana S. M.
在美国，超过50%的宫颈癌是在筛查不足的妇女中诊断出来的。宫颈癌筛查指南现在包括初级人乳头瘤病毒（HPV）检测作为推荐策略。家庭HPV自我采样是提高筛查依从性和有效性的可行选择;然而，美国的数据需要告知卫生保健系统的实施。目的评估邮寄HPV自我采样试剂盒与通常的护理提醒在诊所筛查中的有效性，以增加宫颈上皮内瘤变2级或更严重（CIN2+）的检测和治疗以及宫颈癌筛查的摄取。和参与者在美国综合医疗保健提供系统Kaiser Permanente华盛顿进行的随机临床试验。年龄在30至64岁之间的女性，健康计划入组3年5个月或更长时间，初级保健医生，3年5个月内没有巴氏试验，并且没有子宫切除术，通过电子病历确定，并于2014年2月25日至2016年8月29日入组，随访至2月26日，对照组接受常规护理（年度患者提醒和初级保健诊所的临时外展）。干预组接受常规护理加邮寄HPV自采样试剂盒。主要结局和测量两个主要结局是（1）CIN2+检测6个月内的筛选和（2）治疗CIN2+检测6个月内。随机分组后6个月内的筛查摄取率是次要outcome.RESULTS，共纳入19851名女性（平均[SD]年龄，50.1 [9.5]岁），其中9960名随机分配至干预组，9891名随机分配至对照组。所有随机化的女性均纳入分析。在干预组中，12例CIN2+参与者被检测到，而对照组中有8例（相对风险，1.49; 95%CI，0.61 - 3.64），12例接受治疗，而对照组中有7例（相对风险，1.70; 95%CI，0.67 - 4.32）。干预组的筛查摄取率较高（2618名参与者[26.3%] vs 1719名参与者[17.4%];相对危险度，1.51; 95%CI，1.43 - 1.60）。结论和相关性与单独常规护理相比，向筛查不足的妇女邮寄HPV试剂盒增加了筛查摄取率，在癌前检测或治疗方面没有显著差异。结果支持邮寄HPV试剂盒给逾期筛查的妇女作为一种外展策略的可行性，以增加美国卫生保健系统的筛查吸收。努力增加试剂盒的使用和对阳性结果的随访是必要的，以最大限度地检测和治疗CIN2+。
IMPORTANCE In the United States, more than 50% of cervical cancers are diagnosed in underscreened women. Cervical cancer screening guidelines now include primary human papillomavirus (HPV) testing as a recommended strategy. Home-based HPV self-sampling is a viable option for increasing screening compliance and effectiveness; however, US data are needed to inform health care system implementation.OBJECTIVE To evaluate effectiveness of mailed HPV self-sampling kits vs usual care reminders for in-clinic screening to increase detection and treatment of cervical intraepithelial neoplasia grade 2 or worse (CIN2+) and uptake of cervical cancer screening.DESIGN, SETTING, AND PARTICIPANTS Randomized clinical trial conducted in Kaiser Permanente Washington, a US integrated health care delivery system. Women aged 30 to 64 years with health plan enrollment for 3 years and 5 months or more, a primary care clinician, no Papanicolaou test within 3 years and 5 months, and no hysterectomy were identified through electronic medical records and enrolled from February 25, 2014, to August 29, 2016, with follow-up through February 26, 2018.INTERVENTIONS The control group received usual care (annual patient reminders and ad hoc outreach from primary care clinics). The intervention group received usual care plus a mailed HPV self-sampling kit.MAIN OUTCOMES AND MEASURES Two primary outcomes were (1) CIN2+ detection within 6 months of screening and (2) treatment within 6 months of CIN2+ detection. Screening uptake within 6 months of randomization was a secondary outcome.RESULTS A total of 19 851 women (mean [SD] age, 50.1 [9.5] years) were included, with 9960 randomized to the intervention group and 9891 randomized to the control group. All women randomized were included in analysis. In the intervention group, 12 participants with CIN2+ were detected compared with 8 in the control group (relative risk, 1.49; 95% CI, 0.61-3.64) and 12 cases were treated vs 7 in the control group (relative risk, 1.70; 95% CI, 0.67-4.32). Screening uptake was higher in the intervention group (2618 participants [26.3%] vs 1719 participants [17.4%]; relative risk, 1.51; 95% CI, 1.43-1.60).CONCLUSIONS AND RELEVANCE Mailing HPV kits to underscreened women increased screening uptake compared with usual care alone, with no significant differences in precancer detection or treatment. Results support the feasibility of mailing HPV kits to women who are overdue for screening as an outreach strategy to increase screening uptake in US health care systems. Efforts to increase kit uptake and follow-up of positive results are warranted to maximize detection and treatment of CIN2+.