Limitations
major weakness
SECONDARY, PATHOLOGY
Despite the strengths of SWATs, there are several limitations that need to be acknowledged. The sample size of this study was relatively small, as it was a single-centre study which may have limited the generalizability of the findings to other populations. The major weakness that was associated with this SWAT was that several participants decided not to join the study or left the study for other reasons that were not related to the timing of their consent. We tried to establish this information, yet there was a possibility that participants who withdrew their consent or dropped out from the host trial were not comfortable to convey the real reasons for doing so, and others did not respond back when they were called back by the investigator. Another sample-related limitation is the observational approach of the study. The participants self-selected their choice of consent, thus rather than being the cause of better outcomes it may be the predictor of outcomes. We acknowledge that non-randomization may introduce selection bias. However, we aimed to mimic the real-life consent process as much as possible, without putting the participants under pressure. The rationale behind not randomizing the timing of consent was to avoid coercing participants into having to give an immediate consent if they were randomized to that arm.We acknowledge that this SWAT is an observational study and may be limited by confounding factors. Nevertheless, the baseline characteristics of the participants included in the SWAT show that there was no difference in the mean age, gender distribution or the risk factor burden between both groups. Furthermore, all participants have the same pathology, so there is no difference in the urgency of the treatment. However, not all confounding factors could be accounted for, as limitations secondary to decisiveness, health literacy, and trust in medical research were not assessed at baseline. We acknowledge that these and similar confounding factors may have affected the outcomes. Future studies should be developed to address these factors along with consent choice.Admittedly, the outcomes of such an observational approach may not necessarily be generalizable to clinical trials where participants do not have a choice to select the consent method. However, they still provide meaningful, real-life information regarding participants’ behaviour.