Movement and mobility-related information collected passively and continuously from digital health technologies (DHTs) as patients go about their daily lives can significantly advance our understanding of patient functioning. The Best 6-Minute Effort (B6ME)™ is a novel outcome measure that captures the maximum effort exerted by a patient as they go about their typical daily life, providing insight into their lived experience.
Here’s an overview of what B6ME™ is and how it augments the 6MWT to provide additional granularity of patient functioning and novel movement and mobility-related outcomes.
What is B6ME™?
B6ME™ is a passive assessment of effort derived from high-resolution wrist-actigraphy data that can be used in clinical trials and healthcare to better understand how a patient is physically functioning as they navigate the demands of their own environment. It parallels the commonly used 6MWT but with two primary differences:
- 1. It is not an “active” performance test where patients are asked to perform at their maximal capacity, but rather a “passive” test where patients are given no instructions other than to perform their typical daily routine
- 2. It is not measured episodically in a standard clinic or laboratory setting but rather daily in a patient’s own environment. In this sense, it is a measure of a patient’s best natural effort.
Using a wearable DHT, researchers can derive more detailed measures of physical function beyond what is possible from in-clinic standardized assessments. For example, within the daily identified best six minutes, multiple physiological, movement, and mobility-related measures can be derived, such as heart rate, respiration rate, steps, cadence, stride length, and stride velocity. When evaluated in conjunction with one another, such outcomes can provide a contextually rich assessment of patient functioning.
Benefits of Augmenting 6MWT with B6ME™
To measure the impact of new drugs on physical function, scientists have commonly relied on the 6-Minute Walk Test (6MWT). It’s worked well for years, but with the advancement of wearable and connected DHTs, it is now possible to measure aspects of health that are not only clinically relevant but are more meaningful to patients. Further, DHTs provide the opportunity to capture outcomes with higher frequency, less subjectivity, and in settings that are important to patients. Incorporating real-world measures of physical function, such as B6ME™will provide researchers and clinicians a more holistic picture of patient health, allowing for better and quicker scientific outcomes and optimized treatment decisions.
Best 6-Minute Effort (B6ME™)
- • Timing: Daily (Continuous)
- • Environment: Real-World
- • Endpoint Formulation
- ○ Change from Baseline
- ○ Daily Variation
- • Endpoints
- ○ Distance Walked
- ○ Number of Steps
- ○ Cadence
- ○ Duration of Walking
- ○ Timing of Event
- ○ Gait Parameters
6-Minute Walk Test (6MWT)
- • Timing: Pre/Post Intervention (Snapshot)
- • Environment: In Clinic
- • Endpoint Formulation: Change from Baseline
- • Endpoints: Distance Walked