ABSTRACT
BACKGROUND: As the COVID-19 pandemic continues, digital exposure notification systems are increasingly used to support traditional contact tracing and other preventive strategies. Likewise, a plethora of COVID-19 mobile applications have emerged. Objective: To characterize the global landscape of pandemic related mobile applications, including digital exposure notification and contact tracing tools. DATA SOURCES AND METHODS: The following queries were entered into the Google search engine: "(*country name* COVID app) OR (COVID app *country name*) OR (COVID app *country name*+) OR (*country name*+ COVID app)". The App Store, Google Play, and official government websites were then accessed to collect descriptive data for each application. Descriptive data were qualified and quantified using standard methods. COVID-19 Exposure Notification Systems (ENS) and non-Exposure Notification products were categorized and summarized to provide a global landscape review. RESULTS: Our search resulted in a global count of 224 COVID-19 mobile applications, in 127 countries. Of these 224 apps, 128 supported exposure notification, with 75 employing the Google Apple Exposure Notification (GAEN) application programming interface (API). Of the 75 apps using the GAEN API, 15 apps were developed using Exposure Notification Express, a GAEN turnkey solution. COVID-19 applications that did not include exposure notifications (n = 96) focused on COVID-19 Self-Assessment (35·4%), COVID-19 Statistics and Information (32·3%), and COVID-19 Health Advice (29·2%). CONCLUSIONS: The digital response to COVID-19 generated diverse and novel solutions to support non-pharmacologic public health interventions. More research is needed to evaluate the extent to which these services and strategies were useful in reducing viral transmission.
ABSTRACT
Background: As research involving human participants increasingly occurs with the aid of digital tools (e.g., mobile apps, wearable and remote pervasive sensors), the consent content and delivery process is changing. Informed consent documents to participate in research are lengthy and difficult for prospective participants to read and understand. As the consent communication will need to include concepts and procedures unique to digital health research, making that information accessible and meaningful to the prospective participant is critical for consent to be informed. This paper describes a methodology that researchers can apply when developing a consent communication for digital health research. Methods: A consent document approved by a US institutional review board was deconstructed into segments that aligned with federal requirements for informed consent. Three researchers independently revised each segment of text with a goal of achieving a readability score between a 6-8th grade level. The team then consulted with an external readability expert well-versed in revising informed consent documents into "plain language." The resulting text was evaluated using Microsoft Word and Online-Utility accessibility software. The final step involved adding visual images and graphics to complement the text. The Digital Health Checklist consent prototype builder was then used to identify areas where the consent content could be expanded to address four key domains of Access and Usability, Privacy, Risks and Benefits, and Data Management. Results: The approved consent was evaluated at a 12.6 grade reading level, whereas the revised language by our study team received 12.4, 12, and 12.58, respectively. The final consent document synthesized the most readable of the three revised versions and was further revised to include language recommended by the software tool for improving readability, which resulted in a final revised consent readability score of a 9.2 grade level. Moreover, word count was reduced from 6,424 in the original consent to 679 in the rewritten consent form. Conclusion: Utilizing an iterative process to design an accessible informed consent document is a first step in achieving meaningful consent to participate in digital health research. This paper describes how a consent form approved by an institutional review board can be made more accessible to a prospective research participant by improving the document readability score, reducing the word count and assessing alignment with the Digital Health Checklist.
