News Brief: CTSA Program Collaboration in Action

Improving Patient-Reported Outcome Data for Research through Seamless Integration of the PROMIS Toolkit and Computer-Adaptive Testing Modules into EHR Workflow

CTSA Program Hub: Northwestern University

Northwestern University team discussing epilepsy

Dr. Stephan Schuele (right) leads the Northwestern University Comprehensive Epilepsy Center based at Northwestern Memorial Hospital. The center's team of neurologists, neurosurgeons, radiologists, neuropsychologists, electrophysiologists, and nuclear medicine specialists apply the latest advances in molecular biology, imaging, and pharmacology to diagnose and treat epilepsy.

Patient-reported outcomes (PROs) reflect the experience of health and health care as reported directly by the patient. There is increasing evidence that capturing PROs is an essential component of quality measurement, quality improvement, and patient engagement in care and research. The Patient-Reported Outcomes Measurement Information System (PROMIS) toolset is a PRO survey system that utilizes computer-adaptive testing (CAT) to provide precise measurements with a minimum number of questions, often shortening conventional PRO surveys 10-fold or more. Unfortunately, previous attempts to integrate PROMIS into electronic health records (EHRs) have not been entirely successful. Working with the PROMIS software team, NUCATS has developed a seamless integration of the PROMIS toolset into our local Epic EHR installation. This experience has convinced us that tight workflow integration brings many benefits and greatly facilitates incorporation of PROs into both quality and clinical research projects, while minimizing the burden on patients and research participants. The response to our presentation of this work has also demonstrated that there is a need for similar integration at many CTSA Program sites. This project represents a collaboration of nine CTSA Program sites, including Northwestern, University of Chicago, University of Illinois at Chicago, University of Alabama at Birmingham, University of Kentucky, University of Florida, University of Utah, Harvard Catalyst CTS, and Southern California CTSI. These sites utilize a variety of different EHR platforms. The team includes the developers of the PROMIS toolkit software, experts in EHR integration, and experts at SMART and FHIR). The goal of this project is to develop and evaluate a suite of software tools that will allow all CTSA Program sites to integrate PROMIS tools directly into their EHRs. To achieve this, we will develop software to support tight integration into the two most common academic medical center EHRs — Epic and Cerner. We will develop a generalized integration of the PROMIS toolset, utilizing the SMART-on-FHIR standard, that can be implemented in multiple EHR platforms. Finally, we will implement and evaluate these software solutions across a number of diverse CTSA Program sites, both within and outside of the project team sites.

Optimizing Translational Veterinary Trials to Advance Human Outcomes

CTSA Program Hub: Ohio State University

Caroline Whitacre working in a lab

Caroline Whitacre, Ph.D., one of the world’s most acknowledged authorities on autoimmune disease, is among hundreds of scientists at The Ohio State University Medical Center who translate innovative research findings into personalized patient care.

The movement of novel discoveries into clinical practice follows a relatively long and inefficient path. More than 50 percent of human clinical trials fail to meet critical endpoints, often late in the course of development, resulting in both financial loss and the lack of additional treatment options for affected patients. Although there are several reasons for these failures, the primary driver is typically lack of efficacy. It is now evident that while induced animal models provide substantial data regarding disease mechanisms, those models likely do not completely recapitulate the biology of a variety of spontaneous conditions that occur in people, so the impact of therapeutic intervention in many models overestimates potential clinical value in human patients. In contrast, there is increasing evidence that spontaneous diseases in veterinary patients represent unique models that more closely parallel the biology of comparable human diseases, including heterogeneity of clinical presentation and response and ensuing resistance to therapy. Importantly, spontaneous diseases in veterinary patients are an inherently less biased setting for therapeutic evaluation than those involving induced disease, in which all affected animals are free of variables and comorbidities that may substantially influence treatment outcome. Therefore, studies incorporating veterinary patients represent a unique opportunity to generate critical data regarding the safety and efficacy of novel drugs and devices that can serve to de-risk subsequent human clinical trials. To this end, the CTSA One Health Alliance (COHA), an affiliation of 11 veterinary academic centers, is working to facilitate therapeutic success in humans by incorporating large animal models of spontaneous disease into the pre- and post-IND process. COHA has established a primary mission of creating an organized network of veterinary academic centers that will conduct translational clinical trials in veterinary patients with spontaneous disease.

To accomplish this goal, a set of standard operating practices and procedures for veterinary trials initially developed at the Ohio State University will be optimized and implemented across the network of 11 COHA institutions, ultimately creating a highly trained veterinary clinical trials consortium that operates under a single set of guidelines. This will be accomplished by (1) optimizing a set of operating practices for the performance of veterinary trials; (2) generating a standard veterinary GCP training module for certification of trials staff; (3) establishing REDCap as the primary mechanism for clinical trial management and reporting across the COHA consortium; (4) forming a data safety management board to oversee trials and facilitate institutional approval; and (5) developing a coordinated outreach effort to ensure adequate enrollment in studies. Successful completion of these goals will enable seamless initiation of veterinary trials over multiple sites, ensure a high level of training of all involved partners, and provide a single platform for data reporting, thereby establishing a well-organized, proficient nationwide network that will generate critical information to accurately inform human translational efforts.

SPARC: The Strategic Pharma-Academic Research

CTSA Program Hub: Indiana University

Melissa Kacena and team working in a lab

Melissa Kacena, Ph.D., right, associate professor of orthopaedic surgery at the Indiana University School of Medicine, works with members of her team to advance research funded by NIH and the U.S. Department of Defense on a compound that could act as a potential new, more effective treatment for broken bones. The project’s early phase received critical support from the Indiana CTSI.

The Strategic Pharma-Academic Research Consortium (SPARC) is an organization to spark innovative collaborations in discovery and “pre-competitive” target discovery stages between academic research institutions who are members of the NIH CTSA Program network and the biopharmaceutical industry. The consortium was established by four Midwestern CTSA Program hubs as founding partners in 2014, along with two large pharmaceutical companies located in the Midwest: Eli Lilly and Company and Takeda Pharmaceuticals. The consortium is housed in the Indiana Clinical and Translational Sciences Institute. SPARC is a platform for research that utilizes the unique strengths of academic and industry for basic discovery, target identification, and testing tool molecule chemical biology and translational research. The vision is to establish a public-private partnership for patient-focused discoveries that generate greater knowledge and better approaches to next-generation and targeted therapies. The intent is also to conduct patient data and samples toward understanding of human physiological traits of different diseases of interest. The current members include Indiana University, the Ohio State University, Northwestern University, University of Chicago, and Washington University in Saint Louis, along with the two major pharmaceutical companies, Eli Lilly and Takeda. In the first round of funding, the consortium focused on autoimmune diseases as the major theme for selecting projects. To date, the consortium has funded five projects involving multiple institutions and 12 faculty investigators and several industry scientists.

Posted February 2017