Implementation of a self-sampling HPV test for non-responders to cervical cancer screening in Japan: secondary analysis of the ACCESS trial
, 2022-08-25 08:47:33,
Through the ACCESS trial, we identified issues related to the informed consent procedure in evaluating population-based interventions such as screening. Overall, we obtained useful results to implement the self-sampling HPV test in practice.
In general, randomized controlled trials require written consent from participants before assignment. However, this kind of conventional consent may not be suitable for evaluating population-based interventions such as screening, where it is important to estimate the effects on the whole population26. In almost all of the previous trials on the effectiveness of the self-sampling HPV test, random assignment took place without consent, and only participants who underwent the screening accordant with the allocated arm gave written consent12,13,19,20,27,28,29, in which Zelen’s design was included27. In other previous trials, although few, the requirement for informed consent was waived16,21,30. In the current study, we adopted a more participant-centered method to obtain informed consent to follow the ethical guidelines for medical and health research involving human subjects in Japan and the opinions of the Committee for Personal Information Protection of Ichihara City. In detail, all participants provided opt-out consent before the assignment, and those who underwent self-sampling HPV testing provided written informed consent. A similar method was adopted in a previous study conducted in the Netherlands31. The percentage of women who opted out before assignment in our trial (20.8%) was higher than that in the previous study (15.1%)31. Since there is no nationwide database for cervical cancer screening in Japan, unlike in the Netherlands, true non-responders to screening are obscure. Therefore, some of the women who met the inclusion criteria might have had the opportunity to receive cervical cancer screening provided by their affiliations, such as workplaces, other than the city. In such cases, women might naturally decline to participate in this trial. Other reasons for the high number of participants who opted out, such as distrust of the research institution and anxiety about personal information leakage, might be plausible. A substantial number of participants opting out before random assignment can cause selection bias. If women who are interested in cervical cancer screening participate more frequently in trials, the screening uptake might be overestimated. In addition, participants opted out throughout the…
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