Friday, May 21, 2021

AI-Enhanced Cardiology Takes Another Step Forward

Combining a convolutional neural network with routine ECGs detected low ejection fraction, a signpost for Asymptomatic left ventricular systolic dysfunction

John Halamka, M.D., president, Mayo Clinic Platform, and Paul Cerrato, senior research analyst and communications specialist, Mayo Clinic Platform, wrote this article.

Asymptomatic left ventricular systolic dysfunction (ALVSD) may not be the most familiar disorder in medicine, but it nonetheless increases a patient’s risk of heart failure and death. Unfortunately, ALVSD is not that easily detected. Characterized by low ejection fraction (EF) — a measure of how much blood the heart pumps out during each contraction — it’s readily diagnosed with an echocardiogram. But because the procedure is expensive, it’s not recommended as routine screening for the general public. A recently developed AI-enhanced algorithm that’s used in conjunction with an ECG can identify low EF, one of many advances that will eventually make machine learning an essential part of every clinician’s “tool kit.”

The new algorithm, a joint effort between several of Mayo Clinic’s clinical departments and Mayo Clinic Platform, was published online by Nature Medicine. The EAGLE trial included over 22,000 patients, divided into intervention and control groups and managed by 358 clinicians from 45 clinics and hospitals. The algorithm/ECG was used to evaluate patients in both groups but only those clinicians allocated to the intervention arm had access to the AI results when deciding whether or not to order an echocardiogram. In the final analysis, 49.6% of patients whose physicians had access to the AI data underwent echocardiography, compared to only 38.1% (Odds ratio 1.63, P< 0.001). Xiaoxi Yao, with the Kern Center for the Science of Health Care Delivery, Mayo Clinic, and associates reported that “the intervention increased the diagnosis of low EF in the overall cohort (1.6% in the control arm versus 2.1% in the intervention arm) and among those who were identified as having a high likelihood of low EF.” Using the AI tool enabled primary care physicians to increase the diagnosis of low EF overall by 32% when compared to the diagnosis rate among patients who received usual care. In absolute terms, for every 1,000 patients screened, the AI system generated five new diagnoses of low EF compared to usual care.

Earlier research on the neural network used to create the AI tool had shown that it’s supported by strong evidence. A growing number of thought leaders in medicine have criticized the rush to generate AI-based algorithms because many lack a solid scientific foundation required to justify their use in direct patient care. Among the criticisms being leveled at AI developers are concerns about algorithms derived from a dataset that is not validated with a second, external dataset, overreliance on retrospective analysis, lack of generalizability, and various types of bias, issues that we discuss in The Digital Reconstruction of Healthcare. The EAGLE trial investigators addressed many of these concerns by testing its algorithm on more than one patient cohort. An earlier study used the tool on over 44,000 Mayo Clinic patients to train the convolutional neural network and then tested it again on an independent group of nearly 53,000 patients. And while this study was retrospective in design, other studies have confirmed the algorithm’s value in clinical practice by using a prospective design. The most recent study, cited at the beginning of our blog, was not only prospective in nature, it was also pragmatic, which reflects the real world in which clinicians practice. Traditional randomized controlled trials consume a lot of resources, take a long time to conduct, and usually include a long list of inclusion and exclusion criteria for patients to meet. The EAGLE trial, on the other hand, was performed among patients in everyday practice.

Friday, May 14, 2021

A Unique Partnership Delivers Acute and Holistic Home Care

Mayo Clinic, Kaiser Permanente, and Medically Home join forces to offer patients the best of both worlds, forging a partnership that has the potential to redefine the hospital industry.

John Halamka, M.D., president, Mayo Clinic Platform, and Paul Cerrato, senior research analyst and communications specialist, Mayo Clinic Platform, wrote this article.

One of the problems facing most patients who require hospital admission is removing their familiar surroundings and emotional supports. While these resources might be considered less critical than specialized clinical expertise, there's little doubt that these "less important" factors play a crucial role in the healing process. Even the most dedicated nursing staff can never replace having a loved one available 24/7 at home. Nor can the most nutritious hospital food ever replace appetizing home-cooked meals. Equally important are the familiar wake/sleep cycles that patients are accustomed to at home, which usually must give way to hospital routines that demand blood pressure checks at three in the morning.

A new partnership[FJA1]  between Mayo Clinic, Kaiser Permanente, and Medically Home launched recently to expand access to care that combines the comforts of home with the expertise of hospitalists, helping patients receive the holistic care needed to speed long-term recovery and the acute care services to address their immediate medical needs. Stephen Parodi, MD, executive vice president of the Permanente Foundation, summed up the philosophy behind the new initiative succinctly, "Treating patients in their home allows physicians to treat the whole patient. We see their individual needs and can integrate critical information, such as diet, physical environments and social determinants of health, into their care plans."

The challenge, of course, is how to turn this philosophy into a cost-effective, safe program. In fact, that transition has already begun.  As we discussed in a previous blog, Mayo Clinic launched its advanced care at home program last summer at Mayo Clinic in Florida and Mayo Clinic Health System in Eau Claire, Wisconsin, to deliver complex, comprehensive care and restorative services to qualifying patients in their homes. These services, which are provided in-person and virtually, include:

  • Infusions.
  • Skilled nursing.
  • Medication delivery.
  • Laboratory and imaging services.
  • Behavioral health.
  • Rehabilitation services.

Similarly, Kaiser Permanente launched its hospital-at-home program in two regions last year, admitting patients from multiple hospitals across both its Northern California and Oregon locations. In this model, Kaiser Permanente has a single medical command center in each region, supporting multiple hospitals to care for patients longitudinally across their acute and restorative phases.

The new partnership will scale Medically Home’s operations, allowing more providers to offer this unique care model. The model includes a 24/7 medical command center (Figure 1) staffed with clinicians in regular communication with a care team in the community that contains EMTs and nurses who provide bedside care. Among the elements that make the new program unique:

  • Required protocols for high-acuity care in the home.
  • Rapid response logistics systems and providers of care in the home.
  • Integrated communication, monitoring and safety system technology in the home.
  • A software platform, the Cesia® Continuum, for orchestrating high-acuity care in patients’ homes. (Figure 2)

One of the problems with writing about a significant health care event while at the same time being a key player in the event is some outsiders will question our objectivity and immediately assume we exaggerate its importance to gain a competitive advantage. The plain truth is this partnership is not just about Mayo Clinic, Kaiser Permanente, and Medically Home. The partnership's ultimate goal is to bring better care to patients across the country and the globe. With that in mind, the program will provide all the necessary outcomes data, tools, systems, training and technology to enable the model’s widespread adoption.

Figure 1

Figure 2

Wednesday, May 5, 2021

Health Data Privacy Gets the Attention It Deserves

The Partners in Privacy Conference gathered world-class experts to address some of health care’s most vexing problems.

John Halamka, M.D., president, Mayo Clinic Platform, and Paul Cerrato, senior research analyst and communications specialist, Mayo Clinic Platform, wrote this article.

The challenges involved in keeping patient and consumer health data private may seem daunting. Still, a recent virtual conference hosted by Mayo Clinic brought together over 80 world-class experts to address the issues. Their insights are worth a closer look.

During his opening remarks at Partners in Privacy Conference: The Ethical and Responsible Use of Data to Drive Cures (April 22, 2021). Gianrico Farrugia, M.D., CEO of Mayo Clinic, acknowledged the delicate balance required to respect the public’s desire to keep its data confidential and the health care community’s desire to use that data to improve patient care, “What the right thing is is not a simple question to answer  it is complex and can vary in different countries and even under different circumstances. A person may be less or more willing to share information and have a different view on data privacy at different times in their lives.  What degree of data privacy seems right to a healthy 40 year is likely not going to be the same for that same person with advanced cancer or neurodegenerative disease. Moreover, the world of research and collaboration is changing. There are global opportunities for new partnerships among medical centers, industry and government that increasingly involve data sharing.”

With these concerns in mind, Dr. Farrugia introduced the keynote speaker, Micky Tripathi, Ph.D., MPP, the National Coordinator for Health Information Technology for the U.S. Department of Health and Human Services. Micky briefly reviewed the achievements of the HITECH Act and the implementation of EHRs around the country. Still, he also pointed out that the speed with which this rollout occurred has made us all realize that “technology has outpaced policy.” One of the ways in which this disconnect is being addressed is through the 21st Century Cures Act. As of April 5, 2021, the law now requires that providers, health care information networks, and technology developers give the public friction-free access to and control of their health data through apps. But that access also means patients can more easily share that information with third parties that are not required to follow the rules spelled out in HIPAA. And even when such data remains within the confines of a health care provider organization bound by HIPAA regulations, keeping it private and secure remains a challenge, despite the fact that there are ground rules on de-identifying it. 

These challenges were among the many questions addressed by the four breakout groups that followed Micky’s presentation. We discussed privacy laws and regulations; state-of-the-art methods for protecting data privacy used to advance health care; consumer and patient attitudes about privacy; and balancing privacy protection with the benefits of research and commercialism.  The lessons learned from the conference will be presented in a white paper that is currently being developed by the thought leaders involved in the project. But in lieu of that, consider a few takeaways:

  • Patient consent will evolve. In the future, there will be more granular control options; we will likely go from a black and white consent decision to a few more controls based on the use of the data and the actors who have access to it.

  • There will be more transparency in data use. That can take the form of a “nutrition label” type description for every algorithm that clearly spells out the data used to create it, as well as its performance and characteristics.

  • Technology is evolving, with machine learning and natural language processing accelerating very quickly. It will fundamentally change how we deliver care, but it will also mean more data being used for more purposes. It is incumbent upon us to keep that data safe and to respect patient preferences as we develop algorithms. Fortunately, privacy and security technology is evolving as well, including advances in de-identification, encryption, allow lists and tokenization. However, the conference attendees emphasized that these approaches are imperfect, which means we will need a multi-layered approach.

Cris Ross, the CIO at Mayo Clinic, summed up many of the observations gleaned from the conference: “We came into this conference wondering whether matters of law, regulation, policy, technology, and market practice are fully established, or if there’s a need for further exploration and consensus. We concluded there is a need for more exploration, and a need for a group like this to help create a consensus, with the goal of advancing cures with the ethical use of data and preservation of patient privacy?" Cris emphasized that this virtual meeting demonstrated that this need exists and we would like to issue a call to other leaders in this field to advance the agenda. Partners in Privacy Conference: The Ethical and Responsible Use of Data to Drive Cures was only the first step in a journey that will require the input and expertise of stakeholders around the nation and the world.