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5419
Tracking Neuromodulation Outcomes in a Cloud-Based System: A Call to Action
Session: EX-07
Thurs, April 19, 6:50-7:00 pm
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Tracking Neuromodulation Outcomes in a Cloud-Based System: A North American Neuromodulation Society Registry Initiative

Roger Lee, MD1; Pierre D’Haese, PhD2; Prasad Shirvalkar, MD, PhD1; Christopher Abrecht, MD1; Steven Falowski, MD3; Lawrence Poree, MD, PhD, MPH1

1University of California, San Francisco, Pain Medicine Division  2Vanderbilt University School of Engineering  3St. Luke’s University Health Network, Neurosurgery

 

Introduction

Spinal cord stimulation (SCS) is a well established therapy for pain relief that has seen tremendous growth in the past decade, supported by several randomized clinical trials. However, the long-term impact of SCS on the population of pain patients on a national scale has not been studied.  Furthermore, recent restrictions placed by some insurance carriers limit access of this therapy to many patients. To improve access and further demonstrate the long term improvement in the health of patients with implanted SCS, it is imperative to track the outcomes of these patients on a national registry.

To accomplish this, The North American Neuromodulation Society (NANS) has commissioned the development of a cloud-based registry to track long term outcomes of patients with SCS devices across institutions and practices. The registry is intended to allow for both secure and confidential tracking of individual providers’ outcomes for self assessment, and to provide a way of organizing a database for those electing to participate in multi-institutional research projects. Both the National Institute of Health’s PROMIS™1 initiative and the IMMPACT2  recommendations support the collection of a wide spectrum of clinical data to monitor the long term health of patients beyond pain scales, and such registry was recently recommended as a criterion for institutions to become centers of excellence for neuromodulation3. In this presentation, we propose using a cloud-based system modeled after the CranialCloud4 to collect and securely store de-identifiable clinical data and radiographic images.

Methods

The proposed cloud-based system consists of a network of nodes, each of which are capable of data storage, processing, and normalization around de-identified subjects. Data sharing occurs when connected to the central core, which is maintained by a board of engineering, database, researcher, and clinician experts.

The design of the cloud database revolves around four core ideas:

 

1. Data: integrity, fidelity, complexity

The collected data must be accurate, precise, and relevant to future research. To this end, the IMMPACT2 recommends outcome domains to consider, including pain, function, adverse events, and patient satisfaction. Because of the diversity and complexity of neuromodulation, the system is built to store complex data such as images as well.

2. Usability: simple entry, technical support, integration into workflow

The data should be binary whenever possible, for ease of use and adherence. Accessibility to software and hardware support, as well as designs to facilitate clinician workflow, will be crucial in maintaining user engagement in the project.

3. Security

The system should provide ample access to approved participants while simultaneously protect patient confidentiality. Data security should meet academic, industry, and government standards.

4. Affordability

This pilot project is funded by the North American Neuromodulation Society. Future access to data storage will be offered to members of NANS as benefit of membership to maintain basic storage of data for ongoing self assessment.   More advanced storage access is offered with tiered pricing to accommodate multi-institutional research.   

Impact

Improved outcomes tracking is essential in our understanding of the therapies we prescribe. The cloud-based technology we describe enables us to do so in an efficient, confidential, and collaborative platform. The results from this database can be applied not only to individualized quality improvement, but also help spur interdisciplinary and multi-institutional research to enhance patient care.

 

Figure 1  Pilot sites participating in the NANS Cloud Registry

 

Figure 2 

A. Each center shall be able to have and own its own account, integrated to the clinical flow and PACS to upload data easily to its dedicated repository.

B. Each account is stored in a dedicated infrastructure in the cloud that is HIPAA compliant, using common data standards. Each account has the possibility to interconnect and share data with other members in a de-identified way.

C. The system shall have an infrastructure similar to an AppStore that allows applications to be developed, tested and deployed easily.

D. The society can generate archives and sub-archives to give access de-identified data to its members or the scientific community.

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