By Bill Byrom 

 

July 21, 2014 | Guest Commentary | Thanks to technology innovations, health and wellness treatment has become accessible to patients in ways never available before. For example, Dr Eric Topol, an eminent cardiologist based in San Diego, has twice in recent years offered his services while on a commercial flight to help diagnose a fellow passenger experiencing health problems.   In both cases, Topol was carrying with him an AliveCor Heart Monitor, a portable device attached to his iPhone that enabled him to record and evaluate the patient’s full ECG trace.  In one case, he diagnosed an atrial fibrillation and calmed and stabilised the patient so that the flight could continue and land as scheduled, some 90 minutes later.  In the earlier case, Topol identified that a passenger was experiencing a heart attack, requiring the plane to make an emergency landing to enable the passenger to receive emergency treatment.

 

We see a growing number of examples of innovative and creative use of mobile and associated devices, with health and wellness being one of the most rapidly expanding areas.  The miniaturization of sensors and circuitry has enabled considerable proliferation in the development and commercialisation of wearable and external monitoring devices during the last decade.  Some are beginning to leverage the smartphone’s native features in new and inventive ways.

 

CellScope, for example, has developed an otoscope that fits directly in front of a smartphone’s inbuilt camera lens to enable clinicians to perform ear examinations.  They can use the smartphone screen to view and zoom in on the image and take snapshots to retain for patient records. VitalConnect produces a patch that adheres to the chest. The device uses a biosensor that can capture numerous measures, such as a single lead ECG, heart rate, respiratory rate, skin temperature, body posture including the detection of a fall and the number of steps taken throughout a day.  

 

In the areas of wellness and fitness, there is significant growth in commercially-available products that help users improve fitness or manage their weight through regular exercise regimens, in particular through use of activity monitors.  Using the smartphone as a channel to conveniently receive data from a wearable device (via Bluetooth for example), and automatically transmit data to a cloud-based data store via a secure web connection, enables real-time and interactive reporting and exploration of a user’s personal performance data.

 

Interestingly, over the years, healthcare professionals have needed to adapt to a more highly informed patient population due to greater availability of accessible healthcare information through the internet.  Many years ago, I recall my personal family doctor reacting with frustration when I referred to information I had researched online during a discussion of treatment options.  Today, however, this is much more commonplace.  Perhaps the next challenge doctors will face will be patients bringing self-monitoring data—whether sleep, activity or cardiac monitoring, for example—to their physicians and expecting that information to be analysed as part of the patient-doctor consultation.  This is already being formally conducted in home monitoring for certain patient populations, but the rise in commercially available devices and proper associated apps and software opens the door for this information to be collected in informal, non-prescribed settings.  Received correctly, this could be an opportunity for physicians to learn far more about their patients and their conditions than previously possible.  

 

Wearables in Clinical Trials 

 

The same is true in clinical trials. Focusing on activity monitors, there is a wealth of clinical applications explored in academia that may yield potential clinical trial benefits.  Not all commercial devices have the degree of accuracy and precision that would warrant their use in clinical trials, but many do.  These include the ActiGraph device, which has a large amount of scientific literature to support its validation.  Obvious applications for monitoring include disease areas where patients have limited mobility or activity, such as COPD, asthma, heart failure, multiple sclerosis, and obesity.  In these cases, successful treatments would be expected to improve mobility or activity.  While these can be measured under clinical conditions—such as treadmill tests and the six-minute walk test—having information about the subject’s actual activity under normal conditions provides valuable insight into how treatment affects this aspect of their life and their quality of life.  

 

There has been much academic research into innovative application of activity monitors in measuring clinical outcomes, but few of these have yet to be used in clinical trials.

 

In Parkinson’s disease (PD), for example, researchers have shown that activity monitors could provide valuable information that cannot be obtained during routine clinic visits.  Where medication may require adjustment based on a patient’s activity and motor symptoms, this may be more accurately measured using continuous activity monitoring data collected prior to a clinic visit as opposed to observation in clinic or via outcomes reported in a patient diary.  In addition, some research groups have found that an activity meter placed on the shoulder of a PD patient to measure the degree of involuntary muscle movements correlates well with activity data collected, and may provide a useful way to objectively measure this side effect. 

In epilepsy, seizure monitoring is normally performed by electroencephalogram (EEG) monitoring.  However, as EEG electrodes are attached to the scalp, this method is impractical for monitoring outside the clinic.  Researchers have shown that by using more than one accelerometer attached to the patient (in this case on the right arm, left arm and left thigh) they can use an algorithm that differentiates seizure movements from normal movements.  Additional proposed system functionality includes detecting the patient location and including this information in automated alerts to caregivers or healthcare professionals in the event of seizure detection.

 

Researchers have also used accelerometers integrated within a watch worn on the dominant arm to explore whether data collected could help to evaluate night-time scratching behaviour in children suffering from eczema.  While study results were not conclusive in evidencing the value of this approach, this example serves to encourage creative thinking as to how these devices could be leveraged to measure interesting and important clinical endpoints.

 

While there is more work to do in understanding how to manage and interpret data collected using activity monitors, they may provide a valuable source of information that could not have been easily collected until recently.  Closer collaboration with researchers in academia will help enable the biopharmaceutical industry to leverage the benefits of this technology. 

 

Bill Byrom is senior director, Patient Direct, PAREXEL Informatics, Nottingham, UK. He can be reached at Bill.Byrom@perceptive.com  

 

For more information:  

 

Manson AJ et al. (2000) An Ambulatory Dyskinesia Monitor.  Journal of Neurology, Neurosurgery and Psychiatry; 68:196-201 

Borujeny GT et al. (2013) Detection of Epileptic Seizure Using Wireless Sensor Networks.  Journal of Medical Signals and Sensors; 3:63-68

Wootton CI et al. (2012)  Are Accelerometers a Useful tool For Measuring Disease Activity in Children With Eczema?  Validity, Responsiveness to Change, and Acceptability of Use in a Clinical Trial Setting.  British Journal of Dermatology; 167:1131-1137