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Table 6 Representative quotations - Acceptable levels of risk in APOSTEL VI specifically

From: A qualitative study on acceptable levels of risk for pregnant women in clinical research

Theme Quotationsa
Perceived risks of APOSTEL VI study HCP06, gynaecologist-in-training: A pessary is low risk, because you don’t have the connection with the child.
HCP03, gynaecologist-in-training: We insert a device that is foreign to the body of which we know that it gives a local reaction, and if that is an inflammatory reaction it might just as well result in premature birth. So therefore it could also actually be a higher risk.
HCP04, gynaecologist-in-training: Why would you do an intervention, why would we do something that has not been proven? I also wonder what the working mechanism of the pessary is, nobody can tell me, not even the big advocates.
HCP14, gynaecologist: I don’t believe in the intervention at all, and luckily I don’t have to counsel for the study, but I do think that if you don’t know if something works the best way to find out is to conduct a study.
PW03, participating in APOSTEL VI: They just don’t know if it [the pessary] results in an extended gestational time. But real risks, no I don’t think those were described.
PW14, participating in APOSTEL VI: It’s very clear in the study that the risks are really very low, and that it won’t result in a premature birth which is the most important thing.
  1. aQuotations are sometimes slightly modified in order to enhance readability