Detecting cervical precancer and reaching underscreened women by using HPV testing on self samples: updated meta-analyses
Detecting cervical precancer and reaching underscreened women by using HPV testing on self samples: updated meta-analyses
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DOI：
10.1136/bmj.k4823
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发表时间：
2018-12-05
影响因子：
105.7
通讯作者：
Castle, Philip
中科院分区：
文献类型：
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作者：
Arbyn, Marc;Smith, Sara B.;Castle, Philip
目的评价高危人乳头瘤病毒（hrHPV）自检检测的诊断准确性及自检策略在未筛查妇女中的应用效果。DESIGNUpdated荟萃分析。数据来源medline (PubMed)， Embase和CENTRAL， 2013年1月1日至2018年4月15日（准确性审查），2014年1月1日至2018年4月15日（参与审查）。准确性审查：hrHPV检测阴道自身样本和临床样本；并通过阴道镜检查和活检验证所有入组妇女或阳性检查的妇女是否存在宫颈上皮内瘤变2级或更严重（CIN2+）。参与审查：研究人群包括不定期或从未接受过筛查的妇女；自我抽样组（干预组）的妇女被邀请收集自我样本进行hrHPV检测；对照组的女性被邀请或提醒接受临床医生样本的筛选测试；两种武器的参加情况都有记录；人口最少为400名女性。结果共纳入56项准确性研究和25项参与试验。基于聚合酶链反应的hrHPV检测对自身样本和临床样本检测CIN2+或CIN3+的敏感性相同（合并比0.99,95%置信区间0.97 ~ 1.02）。然而，基于信号放大的hrHPV检测对自身样本的敏感性较低（合并比0.85,95%置信区间0.80 ~ 0.89）。对于基于聚合酶链反应或信号扩增的hrHPV检测，自身样本排除CIN2+的特异性分别比临床样本低2%或4%。将自己的样本包邮寄到妇女的家庭地址，与邀请或提醒信件相比，临床医生取样的回复率更高（意向治疗分析的综合相对参与率为2.33,95%置信区间为1.86至2.91）。选择加入策略，即女性必须要求一个自我抽样工具包，通常并不比邀请函更有效（相对参与率为1.22,95%置信区间为0.93至1.61）。直接向筛查不足社区的妇女提供自我抽样装置产生了很高的参与率（约75%）。大量的研究间异质性被注意到（I-2 bb0 95%）。结论当与基于聚合酶链反应的hrHPV检测一起使用时，对自身样本的检测与对临床样本的检测同样准确。通常，提供自我抽样包比发送邀请更能有效地接触到筛选不足的女性。然而，由于不同环境下的回复率差异很大，在区域或国家推出自我抽样策略之前，应先建立试点。
OBJECTIVETo evaluate the diagnostic accuracy of high-risk human papillomavirus (hrHPV) assays on self samples and the efficacy of self sampling strategies to reach underscreened women.DESIGNUpdated meta-analysis.DATA SOURCESMedline (PubMed), Embase, and CENTRAL from 1 January 2013 to 15 April 2018 (accuracy review), and 1 January 2014 to 15 April 2018 (participation review).REVIEW METHODSAccuracy review: hrHPV assay on a vaginal self sample and a clinician sample; and verification of the presence of cervical intraepithelial neoplasia grade 2 or worse (CIN2+) by colposcopy and biopsy in all enrolled women or in women with positive tests. Participation review: study population included women who were irregularly or never screened; women in the self sampling arm (intervention arm) were invited to collect a self sample for hrHPV testing; women in the control arm were invited or reminded to undergo a screening test on a clinician sample; participation in both arms was documented; and a population minimum of 400 women.RESULTS56 accuracy studies and 25 participation trials were included. hrHPV assays based on polymerase chain reaction were as sensitive on self samples as on clinician samples to detect CIN2+ or CIN3+ (pooled ratio 0.99, 95% confidence interval 0.97 to 1.02). However, hrHPV assays based on signal amplification were less sensitive on self samples (pooled ratio 0.85, 95% confidence interval 0.80 to 0.89). The specificity to exclude CIN2+ was 2% or 4% lower on self samples than on clinician samples, for hrHPV assays based on polymerase chain reaction or signal amplification, respectively. Mailing self sample kits to the woman's home address generated higher response rates to have a sample taken by a clinician than invitation or reminder letters (pooled relative participation in intention-to-treat-analysis of 2.33, 95% confidence interval 1.86 to 2.91). Opt-in strategies where women had to request a self sampling kit were generally not more effective than invitation letters (relative participation of 1.22, 95% confidence interval 0.93 to 1.61). Direct offer of self sampling devices to women in communities that were underscreened generated high participation rates (>75%). Substantial interstudy heterogeneity was noted (I-2>95%).CONCLUSIONSWhen used with hrHPV assays based on polymerase chain reaction, testing on self samples was similarly accurate as on clinician samples. Offering self sampling kits generally is more effective in reaching underscreened women than sending invitations. However, since response rates are highly variable among settings, pilots should be set up before regional or national roll out of self sampling strategies.