Quality of Informed Consent and Interface Usability in Primary Care e-Consultation: Cross-Sectional Study

Background: Patient autonomy through informed consent is a foundational ethical principle for health care practitioners. Online consent processes risk producing “consent in name only,” using manipulative or confusing user interfaces to extract consent artificially. This presents a significant danger for safe and ethical remote consultations for primary care providers, which often extract significant amounts of sensitive personal data. Objective: This study aims to examine the quality of consent obtained through both currently used and novel consent acquisition interfaces for remote e-consultations between a patient and a primary care provider. Methods: A total of 55 adult participants in the United Kingdom completed an interaction with a mock-up e-consultation system’s consent interface for data processing, with 54 completing the full study protocol. The participants were then asked questions regarding what they had provided consent for and the usability of the interface. These responses led to the calculation of an industry-standard System Usability Scale (SUS) score and a novel Quality of Informed Consent Collected Digitally (QuICCDig) score. Results: Users perceiving interfaces to be more usable (with a greater SUS score) were statistically significantly (n=54; P=.004) correlated with an increase in the quality of consent collected from those users (with a higher QuICCDig score). Nonetheless, both existing and novel user interfaces for collecting e-consultation consent were rated poorly, achieving a maximum SUS letter grade of “F.” In total, 45% (25/55) of all the participants reported not recalling making a privacy-related decision at all during their consultation, and 87% (48/55) did not recall being offered any alternatives to e-consultation. Conclusions: The findings demonstrate that current methods for collecting consent in telemedical applications may not be fit for purpose and potentially fail to collect valid informed consent. However, increased usability scores from users do appear to drive improvements in the quality of consent collected. Therefore, decision-makers should place importance on high-quality interface design when building or procuring these systems. We have also provided the QuICCDig score for further use.