Discussion
Our study demonstrates that comprehension of study information conveyed using video-based information is non-inferior to using the conventional approach that uses paper-based information sheets and consent. However, the qualitative findings indicated that there may be areas such as engagement, trust and its potential adaptability in which the video consent approach may be superior.
Overall, the total comprehension score obtained was relatively high. These high scores could have been a result of participants paying more attention to the study information as they were informed that their comprehension would be assessed as part of the trial procedures.
Education level and main activity status were not associated with comprehension in both arms. A possible explanation is that the researcher engaged with participants by taking more time to explain research information and answer questions in both the intervention and control arms such that those who had lower literacy managed to receive the clarity they required before the comprehension assessment. However, comprehension scores in the control arm may have been higher in comparison to comprehension that would be obtained in other research settings given that comprehension was being assessed as part of a trial, and research assistants may have made more effort to explain the procedures. Previous participation was associated with better comprehension in the control arm. This may be due to familiarity with the format of the traditional consent form, which may have resulted in better comprehension in this group.
On the other hand, intervention arm participants who were younger and lived in Harare demonstrated better comprehension compared with their counterparts. Harare is the capital city and research studies are likely to be more common than in Bulawayo (450 km west of Harare) or in Mashonaland East, which includes both peri-urban and urban settings. Better understanding in Harare may likely be due to possibly more familiarity with research and possibly better overall literacy. There was, however, no evidence of an association of comprehension with previous study participation among those in the video consent arm, which may indicate the novelty of the method in this study setting.
Both consent methods were highly acceptable in terms of being interactive and inclusive. Key to the apparent equivalence in both arms may have been that participants opted to have the PIS read to them by the researcher, facilitating a more conversational approach to the consenting process compared with relying on the eligible individual to read the PIS alone. However, to achieve this parity requires a consistent delivery of best practice through attentive research teams. The video method may provide greater consistency in the engaging presentation of information, which in turn may potentially support enhanced comprehension.
In our trial, both methods were supported by the active role of the researcher in answering questions prompted by watching the video or listening to the PIS be read to them. We consider this to be an essential component of a comprehensible and acceptable consenting process. This aligns with research by Anderson et al, which reports that although the use of interactive technology is likely to improve the informed consent process, it cannot replace the human connection that is central to the process.17 If the broader aim is to improve engagement in the consent process, there may be considerable potential for studies to be designed to give a choice between video and paper-based consent processes to eligible study participants.
In this study, the average time taken to complete the consent process using the video information was longer than using the paper-based method. Despite the relative advantages of the video method to convey the information in a more engaging way, across both arms, the volume of information presented was considered burdensome by participants.
Engagement was hampered by the use of complex Shona and Ndebele words. This may be due to the process of translating English information sheets to vernacular, which is usually difficult and can result in the loss of the original simplified text. Videos offer the opportunity to show research processes and thus complex terminology can be minimised, unlike in written information sheets. Flory et al15 and Mack et al29 argue that despite the recognition of the need to make consent documents shorter or more readable, they continue to increase in length and complexity. This illuminates a dilemma. If the information presented is so comprehensive that its extensiveness exceeds what individuals can reasonably absorb and digest, then we risk losing the attention and engagement of participants overall and participation decisions are made without appropriate comprehension and consideration.
The use of the video may not sufficiently address the broader challenge of low literacy. The requirement to include such extensive information may perversely further compromise the extent to which participants can make informed decisions to participate in research. Alongside use of videos as a more creative format to convey information, there is a need for ethical boards and researchers to consider how to reduce and refine the content and volume of information necessary for inclusion in the informed consent process so that it is context-appropriate and age-appropriate and consequently support genuine comprehension and informed consent. Bwakura-Dangarembizi et al reported the inaccessibility of research studies due to ethical and legal frameworks, which do not take into account the cultural context in Zimbabwe, warranting involvement of critical stakeholders such as communities representing the target population in the development of consent procedures.30
In addition to the video being non-inferior to the paper-based consent method, the video presented indirect advantages including evoking trust from the participants. Resnik explains that where informed consent and trust are concerned, the research participants often rely on investigators to help them understand important study information in the consent process.1 The video, in combination with the researchers’ presence to facilitate and answer questions, appears to be a particularly strong combination to support participants’ comprehension and trust in the research process. As indicated by the young people themselves, the video format has considerable potential for adaptation to tailor the delivery of content to meet the differentiated needs of particular groups such as people living with disabilities and the elderly.
The video information was coupled with obtaining consent on a tablet. An advantage of digital methods is reducing the amount of paper used and reduced requirements for physical data storage.
The study has some limitations. The comprehension questionnaire to ascertain the primary outcome was developed for this study and has not been validated or piloted. Furthermore, all questionnaire items were allocated the same score weighting, although some aspects of information may potentially be more important to understand than others. Comprehension assessed immediately after receiving information is likely to be high due to the immediate information recall, which may not reflect true comprehension. A research study by Ndebele et al investigating participants’ understanding of clinical trial concepts reported that most of the trial participants had good knowledge of the concepts but had inadequate understanding of what the concepts entailed suggesting that the consent obtained from these participants may have not been truly informed.31 Further investigation on study information comprehension would need to include later time intervals such as 7 or 14 days after receiving information for optimal validation of the questionnaire.
Current informed consent research studies are limited to the evaluation of comprehension of clinical trial study information and this limits the comparability of our findings. The trial design meant that none of the participants engaged in both formats. The qualitative discussions therefore could only focus on a participant’s experience of one method and there were no opportunities for participants themselves to make a comparison. The analysis presented is a comparison of the participants’ accounts. Finally, as study staff were not blinded to the trial, they may have taken more care to deliver the written information more carefully.
Given that our participants are youth, their reading rate may be faster than for older adults. However, there would be variations in the reading rate due to difference in literacy levels and speaking English as a second language.
Conclusion
Comprehension of study information using the video-based information method is non-inferior to the paper-based consent method. While both methods were acceptable to participants, the video-based method had advantages in improving engagement and building trust. These factors, alongside its inherent adaptability, demonstrate its potential value in supporting the informed consent process for specific population groups, in particular those with low literacy, people living with disabilities and youth. The video consent method shows considerable promise to be used as part of a person-centred, context-sensitive approach to enhance the informed consent process across a broad range of population groups and should be considered as a valuable option for research teams and institutional review boards.
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