■增加宫颈癌筛查的最佳策略可能因患者筛查史和医疗保健环境而异。将人乳头瘤病毒(HPV)自我取样试剂盒邮寄给逾期未进行筛查的个体增加依从性;然而,在美国,尚未对向筛查坚持者提供自我取样试剂盒进行评估。
■通过宫颈癌筛查史(筛查粘附和当前到期,逾期,或未知)。
■在KaiserPermanenteWashington进行的随机临床试验,美国综合医疗保健提供系统。30至64岁的女性,初级保健临床医生,在2020年11月20日至2022年1月28日期间,未通过电子健康记录(EHRs)确认子宫切除术,随访至2022年7月29日.
■个人按到期分层(例如,在随机化的时候,这些个体先前已经过筛查,并且应在≤3个月内进行下一次筛查)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]),直邮(常规护理加上教育材料和邮寄的自我抽样工具包[n=1482]),或选择加入(常规护理加上教育材料和请求工具包的选项[n=3956])。逾期筛查的患者被随机分配接受常规治疗(n=5488),教育(n=1408),或直邮(n=1415)。具有未知筛查史的个体随机接受常规治疗(n=2983),教育(n=3486),或选择加入(n=3506)。
■主要结果是在6个月内完成筛查。主要分析比较了直接邮寄或选择参加的参与者与随机分配到教育组的个体。
■意向治疗分析包括31355名随机个体(平均[SD]年龄,45.9[10.4]年)。在那些应该接受筛查的人中,与单独接受教育相比(1885年[47.6%]),筛查完成度在直邮组(914[61.7%])高14.1%(95%CI,11.2%-16.9%),在选择组(2020年[51.1%])高3.5%(95%CI,1.2%-5.7%).在逾期未交的个人中,与单纯教育(264[18.8%])相比,直邮组(505[35.7%])的筛查完成率高出16.9%(95%CI,13.8%-20.0%).在那些历史未知的人中,与单纯教育(555[15.9%])相比,选择加入组的筛查高出2.2%(95%CI,0.5%-3.9%)(634[18.1%]).
■在美国的医疗保健系统中,在宫颈癌筛查到期或过期的人群中,直邮自我抽样使宫颈癌筛查增加了14%以上.选择加入方法最低限度地增加了筛查。为了提高筛查依从性,实施HPV自采样的系统应优先考虑对到期或逾期筛查的个人进行直邮外展.对于筛查史不详的个体,有必要测试替代的外展方法,并进一步努力记录筛查历史。
■ClinicalTrials.gov标识符:NCT04679675。
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.
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).
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.
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).
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.
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%]).
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.
ClinicalTrials.gov Identifier: NCT04679675.