Our results indicate that trial participants’ understanding of informed consent was overall satisfactory but highlighted some areas where our expectations were not met. Womens’ primary motivation for deciding to join the study was for the potential benefit of improving their chances of success from their IVF cycle although the importance of undertaking the research was additionally highlighted by many women. Overall their understanding of aspects about their trial participation was high, although five areas were highlighted as areas of concern.
Participants felt they had the opportunity to ask questions and generally these were met to women’s satisfaction. Women’s understanding of why sham acupuncture was used was satisfactory however many women would have liked additional information on both acupuncture and sham acupuncture beyond that provided in the participant information form. Further questioning also confirmed a lack of understanding, or recall about potential side effects that could arise, and the processes for withdrawing from the trial. The terms randomisation and blinding appear to be well understood. The variation of women’s response to this question however reflects the individual’s experiences and their responses to this standardised process.
Our findings indicate high levels of research literacy regarding terminology which could have been influenced by the fact that many of our participants had a tertiary education, and perhaps may be more familiar with some of the research terminology frequently used. Responses to those questions indicating a lack of understanding may be attributed to observations that written information is in fact not well read by some participants, or is only partially understood. Information on this trial is generally presented at the start of an IVF cycle, which coincides with a significant amount of complex information being presented to patients in relation to their medical treatment. This may have influenced women’s comprehension and capacity to retain or recall information that was presented to them about the trial. Despite the potential for an overload of information being presented we found there was high satisfaction with women’s questions being well answered by the trial co-ordinator or research nurses. However, our findings indicate there were some areas that could be re-enforced in subsequent conversations or with the provision of additional supplementary material, this is important to ensure that the trial is being conducted in a sound ethical manner.
Our findings concur with some authors and differ to others. Studies have frequently reported that participants have a poor understanding of research side effects, and other trial processes [5, 12, 13]. However contrary to other studies [14, 15] we found that our participants had a good understanding of randomisation. This may be explained by the relatively higher education attributes of our study population. Participants vary in their information needs, and this has been explored and tested in a simple intervention by Kass et al. to improve informed consent [16]. Their study demonstrated that bulleted fact sheets and a Q and A session demonstrated a greater understanding than the standard process of a written patient information form. These communication formats are more desirable rather that adding more information to standard participant information and consent forms which are already long, and can vary in their format and the identification of information that is most important. Nishimura and colleagues in their systematic review identified use of enhanced consent forms, and extended discussion led to improved knowledge outcomes, and that multi-media interventions may prove most useful with long term retention of study information [17].
There are several limitations to the study. The time between the trial participation and questionnaire was up to six months for some study participants and recall bias could have been significant for some of these women. Participants’ self-rated their understanding of the trial processes, there is a possibility of responder bias. The inclusion of additional follow up questions for some key areas however allowed us to objectively confirm the participants’ understanding. Our response rate was 59 %, with 41 % choosing not to participate, there maybe selection bias. It is possible that women responding to this survey were self-selected based upon their interest in this side study, had a greater understanding and recall of the processes involved with the study. Non responders may have lost interest with participating in the study due to a negative pregnancy outcome. This non response bias may result in our findings being an over-estimate of the study outcome participant’s understanding of the informed consent process. The survey was anonymous and we are unable to compare the socio-demographics of responders and non responders to determine whether this influenced study participation . Although we utilised several questions from previous studies [5, 9, 10, 12] not all questions have established validity and reliability. The survey comprised of mostly closed questionnaires with a limited number of open ended questions. This limited the opportunity to examine participants’ understanding of the informed consent process in detail. Future research could consider the use of a qualitative study. We also had variable responses to questions with missing data. Participants may have randomly forgotten to complete a question, or they may have refused to answer, this may influence the reliability of our findings. We propose the sample is demographically representative of women undertaking IVF. We found that the age of women participating in our study is similar to women undergoing IVF in Australia and New Zealand (<35 years 35 % vs 37 %, 35–44 years 57% vs 60 %). We do not have socio-demographic data from non-responders to our survey due to the anonymous nature of the questionnaire, however we found that the higher educational qualifications of women who participated in this side study compared with the trial as a whole were similar (University educated 57 % vs. 57 %, vocational training 20 % vs. 25 %), although there was a greater disparity between those reported not completing high school (4.2 % vs. 9 %). On the basis of these data we propose that the findings reflect the broader population of women undergoing ART.
The language used in the participant information and consent form seems acceptable and we do not have concerns about scientific literacy in relation to the scientific terms used and how they were explained. Our results do highlight an opportunity to consider how to provide additional information in future studies, and that a feasible strategy could take the form of supplementary material such as Q and A sheets that are made available to trial participants at no significant cost to the researchers or the clinical setting. This approach could be explored with human ethics committees and researchers.
