Leveraging sensor-based functional outcomes to enhance understanding of the patient experience: challenges and opportunities

ABSTRACT

Introduction

Sensor-based digital health technology (DHT) has emerged as a promising means to assess patient functioning within and outside clinical trials. Sensor-based functional outcomes (SBFOs) provide valuable insights that complement other measures of how a patient feels or functions to enhance understanding of the patient experience to inform medical product development.

Areas covered

This perspective paper provides recommendations for defining SBFOs, discusses the core evidence required to support SBFOs to inform decision-making, and considers future directions for the field.

Expert commentary

The clinical outcome assessment (COA) development process provides an important starting point for developing patient-centered SBFOs; however, given the infancy of the field, SBFO development may benefit from a hybrid approach to evidence generation by merging exploratory data analysis with patient engagement in measure development. Effective SBFO development requires combining unique expertise in patient engagement, measurement and regulatory science, and digital health and analytics. Challenges specific to SBFO development include identifying concepts of interest, ensuring measurement of meaningful aspects of health, and identifying thresholds for meaningful change. SBFOs are complementary to other COAs and, as part of an integrated evidence strategy, offer great promise in fostering a holistic understanding of patient experience and treatment benefits, particularly in real-world settings.

KEYWORDS:

• Clinical outcome assessments
• digital health technology
• patient-centered outcomes
• patient experience data
• patient-focused drug development
• sensor-based functional outcomes

Article highlights

• Sensor-based functional outcomes (SBFOs) offer the ability to passively capture physical movement, activity levels, sleep measures, or other parameters in a manner associated with reduced patient burden.

• SBFOs may offer a unique approach to collecting data on functional outcomes that cannot be accurately or conveniently collected using other methods.

• SBFOs can substantially add to our understanding of treatment effects across a variety of therapeutic areas by providing further context to study endpoints.

• The combination of SBFOs and other clinical outcome assessments (COAs), including patient-reported outcome measures, can provide a comprehensive, reliable, and valid evaluation of the patient’s experience.

• Further refinement of existing frameworks for COA development is needed to reflect SBFO-specific considerations and attain the best approach to developing patient-centered SBFOs that are part of an integrated evidence plan and regulatory engagement strategy.

Declaration of interest

K.R. Keyloun, J. Abel, J. Garcia, E. J. Papadopoulos, and R. T. Carson are employees of AbbVie and may hold shares and/or stock options in the company. C. Gwaltney has received consulting fees from AbbVie. A. F. Slagle has received consulting fees from AbbVie. B. Byrom is an employee of Signant Health, which receives consulting fees from AbbVie, and holds Signant Health stock options. The authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed.

Reviewer disclosures

Peer reviewers on this manuscript have no relevant financial or other relationships to disclose.

Acknowledgments

The authors thank Cassondra Saande, and Brian Samsell, of RTI Health Solutions for medical writing assistance. Ashley Slagle, Bill Byrom, Chad Gwaltney served as key expert authors in Regulatory Science, eCOA, and Digital Health Technology for the Expert Opinion Section.

Additional information

Funding

AbbVie funded editorial support and Open Access. No honoraria or payments were made for authorship.