Maintaining Data & Reporting Integrity with Mobile Health
As the COVID-19 pandemic has forced a shift toward remote modalities, mobile health (mHealth) technologies have been on the rise. There is a plethora of benefits to adopting the technology, including convenience for both participants and staff. It also has the potential to open up clinical trials to a wider pool of participants who may not have originally been able to participate. With a wider range of data collection modalities employed to expand the participant pool, research teams will need to keep in mind how to properly handle and evaluate incoming data.
There are two different ways to gather data in mobile health apps and other technologies: actively and passively. Active data collection occurs when participants intentionally complete activities, whether through taking surveys or other patient-reported outcomes. Passive data collection occurs as data is collected without intentional action by the participants. This may include behavior-related data, such as heart rate, steps, or oxygen levels. It may also include factors such as background audio or video recording a participant and the environment they’re in.
A participant may be able to use their personal device for mHealth research data collection, or sponsors may choose to provide a study-issued device. There are benefits and challenges to using either method; consider what type of data you’re trying to collect for your study and what may be easiest or most convenient for participants.
Additionally, there are options as to how research staff can store and transfer the data. Data can be stored in a cloud or on a research organization’s wireless network that staff can access at any time. This data may be accessed throughout the study, which can allow for ongoing data and safety monitoring.
For studies involving mHealth, telehealth or other remote appointments become a key factor in ensuring participation and overall trial success. When using mHealth apps and other tools, researchers need to account for new variables, such as ensuring:
- Participants are completing tasks
- Participants are taking the time to earnestly answer questions
- Everyone is acting in good faith throughout the entire study
Through these appointments, researchers can use different telehealth or observation tools (e.g., Google Glasses, HIPAA compliant video conference, etc.) to remotely observe data collection events to minimize collection issues, confirm smooth participation, and confirm that protocol required assessments and activities are performed correctly.
A significant advantage to any mHealth study is researchers have the ability to continually collect data and monitor as it comes in. Continuous monitoring can give research teams a holistic view of the data points at any given time during the day, rather than within a specific window of time (i.e., only when participants come in for appointments with study staff). This is also beneficial for studies containing large amounts of data. Researchers should have a clear plan for how data will be stored, accessed, and monitored.
Since staff may be working with a higher volume of data in mHealth studies, there is potential for error when handling each large data set. It’s critical for sponsors and researchers to prioritize precision in outlining their data and statistical analyses. They can achieve this by outlining the specific data they will use for certain objectives and being clear about whether any data will be used for secondary or exploratory analyses. Additionally, research staff will need to have a plan in place for what they will do with any leftover data after the analyses, including if data can be used in a future study.
Understanding an IRB’s Role
Institutional review boards (IRBs) should also have a specific plan for reviewing an mHealth study. It’s incredibly important for IRBs to thoroughly understand how data collection and utilization of mHealth technology impacts the protocol. They will need to review both the research data and statistical plan, and ensure there is a plan in place for any leftover or secondary data a research team may not use.
Public reporting requirements are the same for mHealth studies as for non-mHealth studies. Like non-mHealth studies, research teams must report on whether the objectives were met, but teams do not need to include in their reports any collected data that is not used or analyzed