When the Institute of Medicine recently put out a call for U.S. healthcare institutions to share data from routine care to create “learning health systems,” it had a few principles in mind:
- Align science, informatics, incentives and culture for continuous improvement
- Seamlessly embed best practices into the care process
- Empower patients to actively take part in all elements of their care
- Systematically capture new knowledge as an integral byproduct of caregiving
“This sounds great in theory, but it’s been relatively uncommon in practice,” says Robert Bermel, MD, Medical Director of Cleveland Clinic’s Mellen Center for Multiple Sclerosis Treatment and Research. The stumbling blocks, he notes, have been mostly logistical and technological.
Introducing MS PATHS
But Dr. Bermel has recently been collaborating with colleagues from other healthcare institutions and Biogen on an initiative to overcome those barriers in multiple sclerosis (MS). The project, sponsored by Biogen, is known as MS PATHS (Multiple Sclerosis Partners Advancing Technology and Health Solutions).
“MS PATHS is a one-of-a-kind collaboration between academic healthcare institutions and industry to create an integrated, efficient data collection system to conduct research and potentially improve clinical care,” Dr. Bermel explains. “We aim to leverage data in aggregate and collaborate across centers to learn more about MS through standardized neuroperformance testing, patient-reported data and imaging.”
Initial MS PATHS efforts are focused on information-sharing via a learning health system to which Cleveland Clinic’s Mellen Center and other leading healthcare institutions in the U.S. and Europe will contribute standardized patient-reported data.
Learning from pooled clinical practice
“Through research, this network of technology-enabled MS centers intends to create a way to learn from clinical practice and generate insights to one day inform point-of-care decision-making, with the goal of improving outcomes,” Dr. Bermel says.
When he and others from the MS PATHS steering committee presented a poster on the initiative in October 2015 at the Congress of the European Committee for Treatment and Research in Multiple Sclerosis, they were struck by the positive response. “We anticipate enthusiasm from MS centers to participate in a system like this, because it meets an unmet need,” Dr. Bermel says. Expansion of the collaboration to other institutions is planned.
Making the most of patient-reported data
At the heart of MS PATHS is the Multiple Sclerosis Performance Test (MSPT), a suite of iPad-based assessments originally developed at Cleveland Clinic that is now being shared by Biogen with all healthcare institutions participating in MS PATHS. Taken by patients before routine appointments, the MSPT comprises a structured patient history, the Neuro-QoL outcome instrument and electronic adaptations of the Multiple Sclerosis Functional Composite to provide quantitative assessments of motor, visual and cognitive performance.
The MSPT allows for patient data collection to be integrated directly into the MS visit workflow. “The data go right into our clinical and research database and can be accessed for research purposes as soon as patients see their provider,” Dr. Bermel notes.
MS PATHS will combine assessments from the MSPT with standardized MRI acquisition sequences. Data can also be linked to biosamples collected under a companion research protocol. Shared data will be aggregated in an informatics infrastructure that provides a platform for conducting research to expedite discoveries in MS and support development of personalized treatment options.
Merging the rigor of trials with the scale of practice
“We’re at a singular stage in our ability to manage MS,” Dr. Bermel says. “Multiple therapies are approved to treat the relapsing-remitting form, but we have little knowledge about how best to use them and which ones to choose when. We hope that collecting data on large numbers of patients like this will enable us to develop a precision approach to managing patients with relapsing-remitting disease.”
The initiative aims to fill a gap in available outcomes data from clinical research, which traditionally is conducted in small patient groups in parallel with clinical practice, with the result that findings are not easily extrapolated to all patients across the healthcare system.
“MS PATHS will take the best aspects of clinical trials — standardized data collection and imaging, rigorous data collection — and apply them to large numbers of patients in clinical care,” Dr. Bermel explains. “We hope to gain fundamental insights about MS itself and how to best use treatments — and to do so much more quickly, less expensively and with data from many more patients than is possible with traditional clinical trials.”
A key role for imaging sequences
An important component of MS PATHS is the sharing of MRIs. “Radiologists have been innovative partners in this collaboration and have developed standard MRI sequences to be shared within the learning health system,” Dr. Bermel says. All MRIs will be aggregated and managed in keeping with a predefined data-handling policy stipulating that only secure encoded data can be shared for research, in order to protect patient privacy.
“Standardized MRI acquisition and image analysis will result in comparable MRI data from all patients across multiple institutions,” Dr. Bermel notes, adding that this could lead to more rapid and reliable treatment decisions.
Potential imaging activities currently under development include quantitative assessment of new or enlarging T2 lesion counts and brain volume changes.
Patients appreciate the bigger picture
Dr. Bermel says that Cleveland Clinic aims to eventually create treatment algorithms and that MS PATHS may catalyze such research. Another goal is to use the information on relapsing-remitting MS gleaned from MS PATHS to take a closer look at the more therapeutically challenging progressive form of MS. Insights might also help inform the study of other neurological conditions, such as Parkinson and Alzheimer diseases.
Therein lies an aspect of the initiative that patients find especially appealing. “It’s been meaningful for our patients that they are able to contribute to MS research during the course of a regular office visit,” Dr. Bermel notes. “At the same time we’re collecting the most advanced data about the status of their MS, they can be confident they are helping advance a greater cause.”