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期刊来源：JAMA

文献发表时间：2023-11-28

原文链接：https://jamanetwork.com/journals/jama/article-abstract/2812323

关键点内容如下：

问题

提供邮寄人乳头瘤病毒（HPV）自采样试剂盒（通过直接邮寄分发或选择加入）的策略与单独使用教育材料相比，是否会增加宫颈癌筛查？

调查结果

在这项包含31355名受试者的随机临床试验中，36%的过期筛查者和62%的筛查依从性（DUE）受试者在收到直邮试剂盒后接受筛查，而19%的过期筛查者和48%的筛查依从性受试者仅在接受教育后接受筛查。差异显著。

意义

在即将接受筛查或筛查历史未知的个体中，与单独接受教育相比，选择加入的效果最小。实施HPV自我采样试剂盒的卫生保健系统应优先考虑对到期和逾期筛查的个人进行直接邮寄宣传，以最大限度地提高筛查依从性。

摘要内容如下：

重要性

增加宫颈癌筛查的最佳策略可能因患者筛查史和卫生保健环境而异。将人乳头瘤病毒（HPV）自采样试剂盒邮寄给逾期未进行筛查的个人可提高依从性；然而，美国尚未对向筛查依从性个体提供自我取样试剂盒进行评估。

目的

根据宫颈癌筛查史（筛查依从性和当前到期、过期或未知），评估直接邮寄和选择加入方法向个体提供HPV自采样试剂盒的有效性。

研究设计和参与者

随机临床试验在华盛顿凯萨医疗机构（Kaiser Permanente Washington）进行，这是一家美国综合医疗保健提供系统。通过电子健康记录（EHR）确定年龄在30至64岁的女性、初级保健临床医生且未行子宫切除术的个体，并在2020年11月20日至2022年1月28日期间登记，随访至2022年7月29日。

干预措施

按到期日进行分层的个体（例如，在随机分组时，这些个体之前已接受过筛查，并且下一次筛查的到期日≤3个月）被随机分配接受常规护理（患者提醒和临床医生EHR警报[n=3671]）、教育（常规护理加上关于筛查的教育材料[n=3960]）、直接邮寄（常规护理加教育材料和邮寄的自我取样工具包[N=1482]），或选择加入（常规护理加教育材料和申请工具包的选项[N=3956]）。筛查逾期的个体随机接受常规护理（n=5488）、教育（n=1408）或直接邮寄（n=1415）。筛查史不明的个体随机接受常规护理（n=2983）、教育（n=3486）或选择（n=3506）。

主要结局

在6个月内完成筛查。初步分析比较了直接邮寄或选择加入的参与者与随机分配到教育组的个人。

结果

意向治疗分析包括31355名随机个体（平均[SD]年龄，45.9[10.4]岁）。在那些应该接受筛查的人中，与仅接受教育的人（1885[47.6%]）相比，直接邮件组（914[61.7%]）的筛查完成率高出14.1%（95%CI，11.2%-16.9%），选择加入组（2020[51.1%]）的筛查完成率高出3.5%（95%CI，1.2%-5.7%）。在过期的个体中，直接邮件组（505[35.7%]）的筛查完成率比单独教育组（264[18.8%]）高16.9%（95%CI，13.8%-20.0%）。在病史不明的患者中，选择加入组（634[18.1%]）的筛查率比单纯教育组（555[15.9%]）高2.2%（95%CI，0.5%-3.9%）。

结论和相关性

在美国卫生保健系统中，直接邮寄自我抽样使宫颈癌筛查到期或逾期的个人增加了14%以上。选择加入方法最低限度地增加了筛查。为了提高筛查的依从性，实施HPV自我采样的系统应优先考虑对到期或逾期筛查的个人进行直接邮寄宣传。对于筛查史未知的个人，有必要测试替代外展方法和记录筛查史的额外努力。

英文原文如下：

Key Points

Question  Does a strategy that offers mailed human papillomavirus (HPV) self-sampling kits (via direct-mail distribution or opt-in choice) compared with educational materials alone increase cervical cancer screening?

Findings  In this randomized clinical trial of 31 355 individuals, 36% of those overdue for screening and 62% who were screening-adherent (due) were screened after receiving a direct-mail kit vs 19% of those overdue and 48% who were due for screening after receiving education only. Differences were significant. The opt-in choice was minimally effective vs education alone in individuals who were due for screening or had unknown screening history.

Meaning  Health care systems implementing HPV self-sampling kits should prioritize direct-mail outreach for individuals who are due and overdue for screening to maximize screening adherence.

Abstract

Importance  Optimal strategies for increasing cervical cancer screening may differ by patient screening history and health care setting. Mailing human papillomavirus (HPV) self-sampling kits to individuals who are overdue for screening increases adherence; however, offering self-sampling kits to screening-adherent individuals has not been evaluated in the US.

Objective  To evaluate the effectiveness of direct-mail and opt-in approaches for offering HPV self-sampling kits to individuals by cervical cancer screening history (screening-adherent and currently due, overdue, or unknown).

Design, Setting, and Participants  Randomized clinical trial conducted in Kaiser Permanente Washington, a US integrated health care delivery system. Individuals aged 30 to 64 years with female sex, a primary care clinician, and no hysterectomy were identified through electronic health records (EHRs) and enrolled between November 20, 2020, and January 28, 2022, with follow-up through July 29, 2022.

Interventions  Individuals stratified as due (eg, at the time of randomization, these individuals have been previously screened and are due for their next screening in ≤3 months) were randomized to receive usual care (patient reminders and clinician EHR alerts [n = 3671]), education (usual care plus educational materials about screening [n = 3960]), direct mail (usual care plus educational materials and a mailed self-sampling kit [n = 1482]), or to opt in (usual care plus educational materials and the option to request a kit [n = 3956]). Individuals who were overdue for screening were randomized to receive usual care (n = 5488), education (n = 1408), or direct mail (n = 1415). Individuals with unknown history for screening were randomized to receive usual care (n = 2983), education (n = 3486), or to opt in (n = 3506).

Main Outcomes and Measures  The primary outcome was screening completion within 6 months. Primary analyses compared direct-mail or opt-in participants with individuals randomized to the education group.

Results  The intention-to-treat analyses included 31 355 randomized individuals (mean [SD] age, 45.9 [10.4] years). Among those who were due for screening, compared with receiving education alone (1885 [47.6%]), screening completion was 14.1% (95% CI, 11.2%-16.9%) higher in the direct-mail group (914 [61.7%]) and 3.5% (95% CI, 1.2%-5.7%) higher in the opt-in group (2020 [51.1%]). Among individuals who were overdue, screening completion was 16.9% (95% CI, 13.8%-20.0%) higher in the direct-mail group (505 [35.7%]) compared with education alone (264 [18.8%]). Among those with unknown history, screening was 2.2% (95% CI, 0.5%-3.9%) higher in the opt-in group (634 [18.1%]) compared with education alone (555 [15.9%]).

Conclusions and Relevance  Within a US health care system, direct-mail self-sampling increased cervical cancer screening by more than 14% in individuals who were due or overdue for cervical cancer screening. The opt-in approach minimally increased screening. To increase screening adherence, systems implementing HPV self-sampling should prioritize direct-mail outreach for individuals who are due or overdue for screening. For individuals with unknown screening history, testing alternative outreach approaches and additional efforts to document screening history are warranted.

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