Previously, we discussed the 4 criteria of truly informed consent for patients, identifying them as
- Information disclosure
In this post, we delve deeper into the topic, discussing how the use of videos/multimedia can help achieve truly informed consent.
Paper and information overload
As clinical trials are becoming more complex, so too are the informed consent forms. As noted in a study of stakeholders’ views of the process, a participant stated: “I think it’s too much. Then you try to process all this information so quick. You know what I’m saying? You ain’t got time to breathe.”
Faced with pages of text and an expectant trial site staff member, it can be easy to see how a potential participant can feel under pressure to sign something without fully understanding what they’re signing up for. It’s worth spending the time and effort to get this step right, as ensuring that a participant has an absolutely clear understanding of what taking part in a clinical trial involves helps to build trust in the entire process.
Electronic informed consent (e-consent) is a growing phenomenon in clinical trials to help address issues in the process, but what does it actually mean?
Electronic informed consent
According to the US FDA’s guidance, “electronic informed consent refers to the use of electronic systems and processes that may employ multiple electronic media, including text, graphics, audio, video, podcasts, passive and interactive Web sites, biological recognition devices, and card readers, to convey information related to the study and to obtain and document informed consent.”
It’s great to see regulatory agencies embracing technology to enhance this step, with e-consent now practiced in many countries. However, current industry uptake is low, with only 3–5% of studies worldwide using e-consent.
While there are various reasons for this low adoption, we believe that bespoke and engaging videos/animation hold particular value for supporting informed consent and can provide substantial benefits for both participants and clinical trial sites.
Benefits for participants
As noted in a commentary, many studies have shown that participants have better recall of key facts and understanding about a study with e-consent compared to paper forms. For example, in a study evaluating levels of comprehension of procedures and risks for a mock chemotherapy neuropathy trial, those who received information via a combination of an introductory video, standard consent language, and an interactive quiz on an iPad scored higher in a test (mean score of 75%) than those who received the paper form (mean score of 58%).
A common thread of these studies is that the participants significantly prefer the multimedia process compared to the paper form. As one participant said in a survey: “Interactive video allows you to be a participant. You’re actively looking for information. You’re actively retrieving information. You’re getting it verbally and visually, but by you being a participant, the person who’s actively searching through the data that’s being provided for you, it sticks better.”
Benefits for sites
If an agreed script and video is rolled out, institutional review boards and sponsors can gain greater confidence that all trial sites will communicate the requisite information in a consistent manner. Consistency is particularly crucial if the trial is especially complex and the researchers themselves might not fully understand everything in the consent form.
In a focus group of patients, we discovered that patients would like access to information outside the clinical visit setting via a website or mobile-based application. Providing relevant information for participants throughout all stages of the trial is important, but more so right at the start when gaining their trust is paramount to building engagement and a sense of team.