Diversity and inclusion in clinical trials remains an important topic, particularly for participants with disabilities such as vision impairment. With advances in smartphone and tablet technologies and their increasing use in clinical trials, accessibility features, such as pinch to zoom, are now at our fingertips. However, implementing such accessibility features when collecting electronic clinical outcomes assessments (eCOA) does not come without risks and must be designed with careful consideration and scientifically tested to ensure no impact to data integrity. Therefore, the objectives of this study were to determine the measurement equivalence of an eCOA questionnaire with and without a zoom accessibility feature and test its usability.
An eCOA app with a zoom accessibility feature was designed following industry standards for eCOA best design. Participants (n = 53) with chronic or recent pain completed a questionnaire with standard response scales (verbal rating scale, numerical rating scale, and visual analog scale), with and without the zoom accessibility feature enabled, in a randomized crossover design. Intraclass correlation coefficients were determined. A subset of participants (n = 10) with vision impairment participated in a usability testing interview.
The intraclass correlation coefficients analysis showed high agreement (0.894-0.982) between zoomed and non-zoomed completions of the verbal rating scale, numerical rating scale, and visual analog scale. Participant usability testing showed good ease of use, ability to read the screen, and usefulness of the zoom feature, especially when not wearing corrective measures for vision impairment.
These findings support the use of a specially designed eCOA zoom accessibility feature for use in clinical trials.
This research is important because it explores how to make clinical trials more inclusive for people with disabilities, especially those with vision impairments. As technology advances, using smartphones and tablets for collecting patient data in clinical trials is becoming common. One key feature is the "zoom" option, which allows users to enlarge text and images for better visibility. However, it is crucial to ensure that using this feature does not compromise the accuracy of the data collected. This study aimed to test whether an electronic clinical outcome assessment tool, which includes a zoom feature, provides reliable results compared to the standard version without zoom.
In the study, 53 participants who experienced chronic or recent pain used the electronic clinical outcome assessment app to complete questionnaires both with and without the zoom feature. The researchers found a high level of agreement in the results from both versions, confirming that the data integrity is maintained when using the zoom function. Participants reported that the zoom feature was easy to use, especially beneficial for those who do not wear corrective lenses, and they appreciated being able to see the text more clearly.
The findings support the inclusion of zoom accessibility features in clinical trials. This is significant because it can encourage participation from individuals with vision impairments, ultimately leading to more diverse trial populations. The study highlights the need for careful design and testing of such tools to ensure they meet the needs of all participants without compromising the validity of the trial results.
In conclusion, implementing a zoom accessibility feature in electronic clinical outcome assessment tools can enhance the experience for vision-impaired participants while maintaining data integrity. This research emphasizes the importance of using technology to create a more accessible healthcare environment and calls for further studies to explore additional accessibility features.