ESSAG 试验方案:一项随机对照试验,评估由全科医生提供自我采样工具包,以帮助常规宫颈癌筛查计划中筛查不足的妇女的效果。

IF 2 3区 医学 Q3 MEDICINE, RESEARCH & EXPERIMENTAL Contemporary clinical trials Pub Date : 2024-07-06 DOI:10.1016/j.cct.2024.107617
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引用次数: 0

摘要

背景:在比利时法兰德斯,过去三年内未接受过宫颈癌(CC)筛查的妇女会收到一封来自地区筛查机构癌症检测中心(CCD)的邀请信,鼓励她们由全科医生(GP)或妇科医生采集宫颈标本。然而,宫颈癌筛查的覆盖率仍然不理想(63%)。由全科医生提供用于 HPV 检测的自采样试剂盒(SSK)可能会吸引那些没有参加定期筛查的妇女参加筛查:ESSAG-试验是一项分组随机对照试验,共有三组,每组包括1125名年龄在31-64岁之间、在过去6年中未接受过CC筛查的女性。在 A 组中,全科医生会在符合条件的妇女因任何原因咨询时提供 SSK。在B组中,妇女会在其家庭住址收到由全科医生签名的个人邀请函,其中包括一份SSK。在对照组中,妇女会收到来自 CCD 的标准邀请函。主要结果是纳入后三个月的回复率。次要结果包括:筛查阳性率;筛查阳性者对预期随访的依从性;每名受邀妇女和每名筛查妇女的成本;以及试验组之间和社会人口类别之间的对比:ESSAG试验将评估以全科医生为基础、使用SSKs的干预措施对难以接触人群参与CC筛查的影响。研究结果将为政策制定者提供信息,帮助他们制定可行的策略来提高CC筛查率,并在整个地区推广:试验注册:ClinicalTrials.gov:试验注册:ClinicalTrials.gov:NCT05656976。
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The ESSAG-trial protocol: A randomized controlled trial evaluating the efficacy of offering a self-sampling kit by the GP to reach women underscreened in the routine cervical cancer screening program

Background

In Flanders (Belgium), women not screened for cervical cancer (CC) within the last three years receive an invitation letter from the regional screening organization, the Centre for Cancer Detection (CCD), encouraging them to have a cervical specimen taken by their general practitioner (GP) or gynecologist. However, the coverage for CC screening remains suboptimal (63%). The offer of a self-sampling kit (SSK, for HPV testing) by a GP may trigger participation among women who do not attend regular screening.

Methods

The ESSAG-trial is a cluster-randomized controlled trial with three arms, each including 1125 women aged 31–64 years, who were not screened for CC in the last 6 years. In arm A, GPs offer a SSK when eligible women consult for any reason. In arm B, women receive a personal GP signed invitation letter including an SSK at their home address. In the control arm, women receive the standard invitation letter from the CCD. The primary outcome is the response rate at three months after inclusion. Secondary outcomes are: screen test positivity; compliance with foreseen follow-up among screen-positives; costs per invited and per screened women; as well as contrasts between trial arms and between socio-demographic categories.

Conclusion

The ESSAG-trial will assess the effect of GP-based interventions using SSKs on CC screening participation among hard-to-reach populations. Findings will inform policymakers about feasible strategies on increasing CC screening that may be rolled-out throughout the whole region.

Trial registration

ClinicalTrials.gov: NCT05656976

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来源期刊
CiteScore
3.70
自引率
4.50%
发文量
281
审稿时长
44 days
期刊介绍: Contemporary Clinical Trials is an international peer reviewed journal that publishes manuscripts pertaining to all aspects of clinical trials, including, but not limited to, design, conduct, analysis, regulation and ethics. Manuscripts submitted should appeal to a readership drawn from disciplines including medicine, biostatistics, epidemiology, computer science, management science, behavioural science, pharmaceutical science, and bioethics. Full-length papers and short communications not exceeding 1,500 words, as well as systemic reviews of clinical trials and methodologies will be published. Perspectives/commentaries on current issues and the impact of clinical trials on the practice of medicine and health policy are also welcome.
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