On the Clinical Efficacy of the Apple Watch?

New Studies Seek to Define Clinical Efficacy

[By Catalyst @ Health 2.0]

Preliminary results from the Apple Heart Study show the potential health benefits of wearables. Researchers from the Stanford University School of Medicine partnered with Apple to conduct a virtual observational study with more than 400,000 participants. The study used the Apple Watch’s irregular rhythm notification (IRN) system to detect atrial fibrillation (AFib). The results showed 0.5% of participants received irregular rhythm notifications. For those who were notified, 21% received and wore an ECG patch. Of those, Afib was confirmed 34% of the time. The positive predictive value of the overall study was 71%, however, this increased to 84% for the subgroup who also used an ECG patch. It should be noted that the study has not yet been published in a peer-reviewed journal.

Johnson & Johnson’s HEARTLINE Study aims to build on the Apple Heart Study. Announced back in January, the virtual clinical trial will enroll 150,000 Americans 65 years and older to detect AFib and collect outcomes data. Participants will be randomized to either receive the Apple Watch 4 or no watch at all. Compared to the Apple Heart Study, one key technical design difference allows the HEARTLINE Study to draw a clearer connection between AFib observance and confirmation. Instead of waiting for an ECG patch to be mailed to the participant, the ECG app on the user’s Apple Watch 4 will be engaged once the “IRN software detects five out of six consecutive irregular rhythms each lasting one minute.” Both the IRN software and the ECG app are FDA cleared for AFib detection. Although the clinical efficacy of wearables is far from conclusive, the innovative use of virtual clinical trials will likely be commonplace in the future with the continued proliferation of consumer-driven health technologies.

Healthcare Executives Under Threat of Business Model Disruption

Healthcare executives are increasingly worried about business model disruption due to the influx of new entrants, processes, and technologies into the healthcare industry. According to Change Healthcare’s 9th Annual Industry Pulse Survey, 13.3% of 185 healthcare leaders believe that innovations in care delivery will lead to potential advancement within the industry and 11.1% believe that refinement of customer experience will create disruptive change. Other potential disruptors include supply chain innovations (9%), launch of vertical one-stop healthcare companies (8%), and advances in artificial capabilities (7%). However, the survey findings also suggest that healthcare leaders are increasingly embracing healthcare technologies. Thirty percent of leaders indicate that EHRs are their leading source of clinical data and another 30% of respondents say that analytics are “extremely effective” or “very effective” at increasing workflow productivity.

Health systems are also jumping into the digital age, with patients portals employed by 73% and telehealth solutions employed by 54% of all surveyed respondents. Twenty percent of respondents indicate they currently use machine learning and 51% plan to employ the technology in the future. Interestingly, the survey reveals a marked lack of attention toward cybersecurity. Even while 40% of healthcare leaders see cybercrime as a potential risk, 38% answered that there are “too many competing priorities” to warrant the level of attention that cybersecurity needs. Nevertheless, the threat of disruption has charged healthcare leaders to intensify its commitment to combating new market entrants.

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