An international core outcome set for evaluating interventions to improve informed consent to clinical trials: the ELICIT Study
Katie Gillies, Paula R Williamson, Vikki A Entwistle, Heidi Gardner, Shaun Treweek, Marion K Campbell
Journal of Clinical Epidemiology, 26 February 2021
Open Access
Abstract
Objective
To develop a core outcome set for the evaluation of interventions that aim to improve how people make decisions about whether to participate in RCTs (of healthcare interventions), the ELICIT Study.
Study Design
International mixed-method study involving a systematic review of existing outcomes, semi-structured interviews, an online Delphi survey, and a face-to-face consensus meeting.
Results
The literature review and stakeholder interviews (n=25) initially identified 1045 reported outcomes that were grouped into 40 individually distinct outcomes. These 40 outcomes were scored for importance in two rounds of an online Delphi survey (n=79), with 18 people attending the consensus meeting. Consensus was reached on 12 core outcomes: therapeutic misconception; comfort with decision; authenticity of decision; communication about the trial; empowerment; sense of altruism; equipoise; knowledge; salience of questions; understanding, how helpful the process was for decision making; and trial attrition.
Conclusion
The ELICIT core outcome set is the first internationally agreed minimum set of outcomes deemed essential to be measured in all future studies evaluating interventions to improve decisions about participating in an RCT. Use of the ELICIT core set will ensure that results from these trials are comparable and relevant to all stakeholders.

Adding dynamic consent to a longitudinal cohort study: A qualitative study of EXCEED participant perspectives
Research Article
Susan E. Wallace & José Miola
BMC Medical Ethics, 9 February 2021; 22(12)
Open Access
Abstract
Background
Dynamic consent has been proposed as a process through which participants and patients can gain more control over how their data and samples, donated for biomedical research, are used, resulting in greater trust in researchers. It is also a way to respond to evolving data protection frameworks and new legislation. Others argue that the broad consent currently used in biobank research is ethically robust. Little empirical research with cohort study participants has been published. This research investigated the participants’ opinions of adding a dynamic consent interface to their existing study.
Methods
Adult participants in the Extended Cohort for E-health, Environment and DNA (EXCEED) longitudinal cohort study who are members of the EXCEED Public and Participant Engagement Group were recruited. Four focus groups were conducted and analysed for thematic content. Discussion topics were derived from a review of the current literature on dynamic consent.
Results
Participants were in favour of many aspects of a dynamic consent interface, such as being able to update their information, add additional data to their records and choose withdrawal options. They were supportive provided it was simple to use and not intrusive. Participants expressed a markedly high level of trust in the study and its investigators and were unanimously happy with their current participation. No strong support was found for adding a dynamic consent interface to EXCEED.
Conclusions
Trust in the study researchers was the strongest theme found. Openness and good data security were needed to retain their trust. While happy to discuss dynamic consent, participants were satisfied with the current study arrangements. There were indications that changing the study might unnecessarily disturb their trust. This raised the question of whether there are contexts where dynamic consent is more appropriate than others. This study was limited by the small number of participants who were committed to the study and biased towards it. More research is needed to fully understand the potential impact of adding a dynamic consent interface to an existing cohort study.

Patient accrual and understanding of informed consent in a two-stage consent design
Research Article
Andrew J Vickers, Emily A Vertosick, Sigrid V Carlsson, Behfar Ehdaie, Scott Y H Kim
Clinical Trials, 2 February 2021
Abstract
Background
We previously introduced the concept of “two-stage” (or “just-in-time”) informed consent for randomized trials with usual care control. We argued that conducting consent in two stages—splitting information about research procedures from information about the experimental intervention—would reduce the decisional anxiety, confusion, and information overload commonly associated with informed consent. We implemented two-stage consent in a low-stakes randomized trial of a mindfulness meditation intervention for procedural distress in patients undergoing prostate biopsy. Here, we report accrual rates and patient understanding of the consent process.
Methods
Patients approached for consent for the biopsy trial were asked to complete the standard “Quality of Informed Consent” questionnaire to assess their knowledge and understanding of the trial.
Results
Accrual was excellent with 108 of 110 (98%) patients approached for consent signing first-stage consent. All 51 patients randomized to the experimental arm and who later presented for biopsy signed second-stage consent and received the mindfulness intervention. Quality of Informed Consent data were available for 48 patients assigned to the mindfulness treatment arm and 44 controls. The mean Quality of Informed Consent score was similar in the meditation and control arms with and overall mean of 75 (95% confidence interval = 74–76) for the knowledge section and 86 (95% confidence interval = 81–90) for understanding, comparable to the normative scores of 80 and 88. On further analysis and patient interview, two of the Quality of Informed Consent questions were found to be misleading in the context of a two-stage consent study for a mindfulness intervention. Excluding these questions increased knowledge scores to 88 (95% confidence interval = 87–90).
Conclusion
We found promising data that two-stage consent facilitated accrual without compromising patient understanding of randomized trials or compliance with allocated treatment. Further research is needed incorporating randomized comparison of two-stage consent to standard consent approaches, measuring patient anxiety and distress as an outcome, using suitable modifications to the Quality of Informed Consent questionnaire and trials with higher stakes.

Details of risk–benefit communication in informed consent documents for phase I/II trials
Research Article
Hannes Kahrass, Sabine Bossert, Christopher Schürmann, Daniel Strech
Clinical Trials, 24 November 2020
Abstract
Background
Informed consent documents for clinical studies should disclose all reasonably foreseeable risks and benefits. Little guidance exists on how to navigate the complexities of risk–benefit communication, especially in early clinical research. Practice-oriented development of such guidance should be informed by evidence on what and how details of risks and benefits are currently communicated.
Method
We surveyed the responsible parties of phase I/II trials registered in ClinicalTrials.gov that started 2007 or later and completed between 2012 and 2016 to sample informed consent documents from a broad spectrum of early phase clinical trials. Based on an assessment matrix, we qualitatively and quantitatively assessed the informed consent documents for details of risk–benefit communication.
Results
The risk–benefit communication in the 172 informed consent documents differed substantially in several regards. The outcome, extent, and likelihood of health risks, for example, were described in 83%, 32%, and 63% of the informed consent documents. Only 45% of informed consent documents specified the outcome of mentioned health benefits, and the extent and likelihood of health benefits were never specified. From those informed consent documents reporting risk likelihoods, only 57% added frequency numbers to words such as “common” or “rare,” and even in these cases, we found strong variations for presented frequency ranges. Substantial heterogeneity also exists for how informed consent documents communicate other risk and benefit types and related safeguards.
Conclusion
Our study points to several shortcomings and heterogeneities in how informed consent documents communicate risks and benefits to potential research participants. Health risks, for example, should be specified with frequency numbers, and health benefits should be specified at least by mentioning their outcomes. Further demand for research and policy development is needed to harmonize risk–benefit communication and to clarify ways to specify the likelihood of health benefits.