Interest expands as wearable technology advances

Data validation, patient privacy, reimbursement among concerns with wearable devices.

Researchers showed interest in the assessment of physical activity through step counters as early as the 1960s, but the practice was not accepted as scientific research until the 1990s. Wearable technology has come a long way since then and so has the overall interest in using these devices as research tools. Today, however, there are lingering questions regarding which information collected from such devices is most relevant and what should be done with it.

“It is great to have the data, but it is just more data and it may not be actionable data,” Brett D. Owens, MD, professor of orthopedic surgery at Brown University Alpert Medical School, told Orthopedics Today. “That is the challenge in all of research, seeing the signal through the noise.”

As orthopedic researchers begin to integrate wearable devices into their research protocols, the devices will need to be validated and the data collected verified as accurate, Nikhil N. Verma, MD, director of sports medicine at Rush University Medical Center and Midwest Orthopaedics at Rush, said.

Source: Pete Lucas, JH Communications

“Most devices I am familiar with are still undergoing that validation to make sure that, in fact, the data that are being collected are reasonable and accurate data before they can be used,” Verma said.

Validating data

With the surplus of wearable technology available today, which includes the iWatch (Apple) and Fitbit (Fitbit), devices that provide the most accurate data for research need to be identified, Owens said.

Research by Mitesh Patel, MD, and colleagues on the accuracy of step counts generated by smartphones vs. wearable devices showed that although most of the devices were accurate, smartphones were more accurate than watches.

“One of the reasons for that may be because smartphones were worn in your pants pocket and these devices all have an accelerometer which measures the movement of your hip,” Patel, assistant professor at University of Pennsylvania, told Orthopedics Today. “If you are swinging your arms, sometimes if I am giving a talk and I am standing in the same place, I can get a bunch of steps when I am not actually moving [my feet].”

Currently, standard medical practice includes using validated surveys to collect patient-reported outcome measures (PROMs). However, Stephen Lyman, PhD, associate scientist at Hospital for Special Surgery, noted PROMs surveys may be limited by patient health literacy.

“We are increasingly becoming aware that patients have cultural biases,” Lyman said. “They are not biases of the patients. It is just how people from different cultures interpret the same question, even if they speak the same language, may be different.”

Lyman said once the technological challenges associated with wearables are ironed out these may be more reliable and unbiased compared with the PROMs surveys.

Impact on patient treatment

Wearable devices could potentially identify patients who may not meet standard protocols after an intervention or procedure, according to Verma. This would allow orthopedists to adjust the patient’s therapy protocol or medications and turn a potentially bad outcome into a positive outcome earlier, he said.

“The ability to allow patients who are progressing for a normal recovery to do so but identifying those patients who are having a problem early and being able to intervene is the power of these types of wearable devices,” Verma said.

The data collected by wearables, he said, may also provide a way to “track patients in real time in terms of how they are progressing.”

For patients who live a few hours from the physician’s office, the physician “can see how you are doing based on metrics that a wearable is sending to them. You may not need to follow-up with them every 4 to 6 weeks,” Verma told Orthopedics Today. “You could see them once their wound is healed to get their sutures out and then not see them again for 3 months or so, as long as they are meeting all the criteria along the way.”

Possible cost savings

One recent development related to wearable devices is knee braces that play a role in patient recovery. For example, the X4 Smart Brace (DJO Global) monitors patient recovery and compliance in real time after total knee replacement. Data collected from the brace is transmitted to both the patient and provider, which may cut out physical therapists as the middle provider.

“One [advantage with wearables] is the cost associated with physical therapy and particularly in a bundled payment environment when you are trying to reduce the cost in the 90-day episode of care after [TKR],” R. Michael Meneghini, MD, director of the Indiana University Health Hip and Knee Center and associate professor of orthopedic surgery at Indiana University School of Medicine, told Orthopedics Today. “You can take out the costs associated with physical therapy because now you can have the patients more empowered to take control of their own outcome.”

Meneghini and colleagues, in partnership with Rose-Hulman Institute of Technology, have started examining ways to collect patient gait information on a smart phone preoperatively so the patient’s TKR can be tailored specifically to the patient’s gait pattern.

“At the end of the day, the future looks like we can have patients with their own smartphone and some wearable device where we can track their activity and track their gait mechanics before surgery, so we can tailor the surgery, the knee replacement, through things like balance and alignment to make their knee feel better after surgery, to identify the target for them,” Meneghini said.

Expanded use of wearable devices

Although people generally associate wearable devices with step count, Owens noted researchers are finding other ways to use wearable technology.

“A lot of the early work is looking at patient movement as it relates to lower extremity, but there is also some exciting work that has been done looking at upper extremity, so looking at throwers per se or different overhead athletes,” Owens, an Orthopedics Today Editorial Board Member, said. “Using these devices can give us a lot of information as to the change in position and range of motion of the upper extremity.”

Another example is the e-vive device (CyMedica Orthopedics), a wearable device that combines an electrical stimulation unit and a conductive garment that patients with knee osteoarthritis can wear or that can facilitate quadriceps recovery after major knee surgery, according to Verma.

“The associated app allows tracking of patient functional recovery and an integrated sensor reports knee range of motion with real-time feedback to the patient and physician to monitor progress. Physicians can log-in to a portal where data are tracked and identify outliers,” Verma said. “The marriage of therapeutic and data tracking functions in a singular device has the ability to facilitate improved recovery, patient engagement and outcomes reporting in between patient visits.”

Sensors in wearable devices also can be used as prevention and early intervention methods in sports medicine. Companies have implanted sensors into helmets and mouthguards to track whether an athlete may have a concussion or how the athlete is performing based on recorded parameters.

“Accelerometers embedded into helmets can register head accelerations or decelerations that sometimes are associated with concussion episodes. This can be used to monitor players in real time both from a research perspective, and I am even aware of a few situations where they are using it as part of a standard practice during American football,” Owens said.

According to Robert C. Klapper, MD, co-director of the Joint Replacement Program at Cedars-Sinai, infrared cameras can be used during games to identify which athletes are injured. Furthermore, sensors embedded in clothing may help reduce an athlete’s risk of a non-contact ACL tear, he said.

Sensors placed in garments worn by athletes “can help the neuromuscular chain of proprioception,” Klapper told Orthopedics Today.

Check on health, activity

Individual performance data also can be collected by sensors embedded in smartphones. For example, active tasks within an Apple open source software framework uses iPhone (Apple) sensors to analyze gait, balance and range of motion.

“From a researcher’s perspective, active tasks allow us to assign dexterity tasks for patients with hand or wrist conditions or, for example, cerebral palsy patients,” Lyman said. “That gives you a direct measurement of patient functional ability without the limitations of self-administered questionnaires and things like that where patients might not answer the question the way we expect them to.”

Patients who use a wearable device may feel more in control of their health, as having patients keep track of their own recovery may have downsides.

“I think there are concerns in the clinical community about the potential for patients trying to rehab too aggressively because they are monitoring their activity with their wearable device,” Lyman said. “They are trying to beat what they did yesterday and that may not be appropriate clinically because they need to take their time and let their body recover and heal.”

Compliance concerns

Patient compliance is of concern surrounding wearables. Lyman noted some of his early work using smartphones to track activity was disappointing because he found not all patients interact with their phones in the same way.

“For example, a 75-year-old who is not tech savvy, [is] going to be more resistant to using an app and dealing with that than, for example, someone who is 50 [years old] and uses their smartphone for everything,” Meneghini said.

Some patients are not self-motivated and may prefer getting help from a physical therapist when they use these devices, Meneghini noted.

“We need to figure out the right way to make [wearable devices] effective,” Patel said. “Handing out a wearable device is usually not enough to change people’s behavior. It has not been used commonly, so I think there need to be studies showing how these things can help patients before we use them in every day practice.”

Ways to achieve compliance

Patel and his colleagues performed more than 10 clinical trials on behavioral economics and found the extent of compliance associated with each type of wearable device studied. Devices that must be charged and are not waterproof provide opportunities for patients to take them off and forget to put them back on, he noted.

“If you can leverage technology that makes that easier, reduces barriers, meaning they do not have to take it off to charge it, they do not have to take it off to go in the shower every day, that can help,” Patel said.

Simplicity of the device and integration of sensors into technology that patients use daily is also important, according to Verma.

“At the end of the day, just like outcome measures where we ask patients to fill out a form, if the patients have to put some extra time or effort or work to go to a certain website, log-in, fill out the form, we see that the compliance rates with survey completion are drastically diminished,” he said.

Patel found through his research that patients respond better to incentive losses vs. gains or immediate gratification and they are highly influenced by social connections. If these attributes could be integrated into the patient’s care, he said patients may be more compliant.

“Most people know if you go to the gym with a buddy you are more likely to go to the gym than if you are going alone because you feel accountable to that person. That person is there and that motivates you on days when you are not feeling so motivated to go,” Patel said. “The same is true with wearables. If you are doing it with a family member or friend, you are more likely to stick with it than if you are doing it alone,” he said.

FDA hurdles

If adapted for standard equipment, such as a smartphone or an iWatch app, Verma said wearable devices may not require FDA approval before being used in regular medical practice. In fact, he noted, wearable devices may eventually be used as an additive function in FDA-approval trials, he noted.

“[Wearable devices] probably are not going to be a substitute [in FDA trials], but I think, for example, a trial where you are looking for how quickly somebody is able to achieve a certain metric, a number of steps per day or lifting the arm above 140°, where before we could only track patients at study visits, this will now allow us to track patients on a daily, hourly or even minute-by-minute basis. This will give us better information for some of these studies,” Verma said.

However, that does not necessarily mean wearable devices worn in these instances will be covered by insurance or even used in the clinical setting.

“Before [wearable devices] become accepted by insurers, by the FDA for research protocols or by physicians for data capture and reporting, I think the data are going to have to be validated,” Verma said. “You have to make sure the range of motion being collected by the device is accurate and at least as consistent, if not more, than range of motion that would be collected using a goniometer in the office.”

Legal considerations

Verma said the question of compensation for the extra time needed to track the output of patients’ devices through a data metric system, as well as who will provide this compensation, are other unknowns. Some sources noted data collected through wearable devices come with the medicolegal risk of being forwarded and not interpreted properly, which raises concerns regarding patient privacy.

“When the patient is consenting to allow you to tap into their wearable device, conceivably you could get everything, including where they spend every minute of the day, and that obviously has its downsides,” Lyman said.

Lyman said that although an algorithm could be established to protect the privacy of the patient, it would still be possible for someone to obtain patient information through the output of a device worn by a patient. If the patient data collected is being fed through an application programming interface to a health care provider, for example, Lyman said the manufacturers of wearable devices would be able to tell which individuals are under the care of which physicians or physical therapists, breaking HIPAA compliance.

“With this field in general, as it expands, all of us who treat patients must ensure the privacy of the patients and their well-being remains at the forefront of our priorities, for sure,” Meneghini said. – by Casey Tingle

• References:
• Bassett DR Jr., et al. Sports Med. 2017;doi:10.1007/s40279-016-0663-1.
• Case MA, et al. JAMA. 2015;doi:10.1001/jama.2014.17841.
• DonJoy transforms patient-physician communication: Introducing the X4 Smart Brace. Available at: https://www.djoglobal.com/investors/press-releases/donjoy-transforms-patient-physician-communication-introducing-x4-smart. Accessed June 6, 2018.
• ResearchKit framework programming guide. Available at: http://researchkit.org/docs/docs/Overview/GuideOverview.html. Accessed June 5, 2018.

• For more information:
• Robert C. Klapper, MD, can be reached at 8737 Beverly Blvd. #303, Los Angeles, CA 90048; email: diane.wedner@cshs.org.
• Stephen Lyman, PhD, can be reached at 535 E. 70th St., New York, NY 10021; email: ironsm@hss.edu.
• R. Michael Meneghini, MD, can be reached at 13100 E. 136th St., #2000, Fishers, IN 46037; email: rm_meneghini@yahoo.com.
• Brett D. Owens, MD, can be reached at 1 Kettle Point Ave., East Providence, RI 02914; email: owensbrett@gmail.com.
• Mitesh Patel, MD, can be reached at 14-176 South Pavilion, Perelman Center for Advanced Medicine, 3400 Civic Center Blvd., Philadelphia, PA 19104; email: mpatel@pennmedicine.upenn.edu.
• Nikhil N. Verma, MD, can be reached at 1611 W. Harrison St., #300, Chicago, IL 60612; email: nikhil.verma@rushortho.com.

Disclosures: Meneghini reports he is a consultant for and receives royalties from DJO Global and is on the scientific advisory board for and receives stock options from Emovi. Owens reports he is a consultant for ConMed, Musculoskeletal Transplant Foundation, Mitek and Vericel. Patel reports he is the founder of Catalyst Health, a technology and behavior change consulting firm. Verma reports he has stock ownership interest in CyMedica Orthopedics. Klapper and Lyman report no relevant financial disclosures.

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