In the rapidly evolving field of clinical trial research, the integration of digital health technologies (DHTs), particularly wearable sensors, has become increasingly prevalent. These devices offer continuous, real-time data collection, providing valuable insights into participants’ health metrics. However, a pertinent question arises: should individual study results from these wearable sensors be returned to participants, and if so, how?
A recent VivoSense article published in the Frontiers in Digital Health Journal titled “Returning Individual Wearable Sensor Results to Participants: Perspectives on Challenges and Lessons Learned” delves into this topic, exploring the benefits, challenges, and potential strategies associated with returning individual results derived from wearable sensors to study participants.
Benefits of Returning Individual Results
The authors highlight several advantages to sharing individual wearable sensor data with participants including:
- – Enhanced Participant Engagement and Compliance: Providing personalized data can foster a sense of involvement and investment in the study, potentially leading to increased adherence to study protocols.
- – Increased Trust and Transparency: Sharing results demonstrates openness, which can build trust between researchers and participants.
- – Empowerment Through Health Ownership: Access to personal health data can empower participants to take a more active role in managing their health.
Challenges and Potential Strategies
Despite the benefits, the article acknowledges several challenges and unanswered questions in returning individual results:
- – Delivering value to participants without creating undue burden: With the increasing capabilities of wearable sensors, the questions of what results to return and how to summarize results in a meaningful and digestible manner remain.
- – Avoiding bias when returning individual study results: Clinical trial sponsors and investigators are unsure when is the most appropriate time to return individual study results.
- – Balancing ethical considerations: Unanticipated or concerning results may lead to distress and thus, there is a need to understand what type of support and/or explanation is needed to accompany returned results.
- – Operational execution: The logistics of how to return individual study results derived from wearable sensors and the feasibility of this process remain.
To address these challenges, the authors suggest:
- – Patient-centric approaches: Understand that returning individual study results is not a one-size fits all approach. Considering individual preferences and contexts when deciding what, how, and when to return results.
- – Offering a choice: Allow participants to have the option to opt-in vs. opt-out of receiving individual study results.
- – Balance efficiency with accuracy: Investigators may want to consider adopting a semi-automated approach to process, clean, and summarize wearable sensor data to be returned to participants.
The article asserts that clinical trial investigators should return individual study results derived from wearable sensors. However, it calls for the need for more research to better understand what, how, and when to return results back to participants.
For a comprehensive exploration of this topic, you can access the full article HERE