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MCW/CTSI Integrated Clinical and Research Ensemble Review Committee Progress Reports

MCW/CTSI Integrated Clinical and Research Ensemble Review Committee Progress Reports

The MCW/CTSI Ensemble Review Committee recently met with all 8 Ensembles to discuss their team dynamics, goal progression, and future milestones. In early 2020, this committee approved eight Ensembles to receive a $50,000 line of credit.  Despite setbacks due to COVID-19 restrictions on clinical trials, community engagement, and laboratory research, many of these teams have already begun producing significant research products, including clinical research, extramural grants, and scholarly publications. Below are highlights of the Ensemble progress reports outlining what this program has achieved in its initial year.

Shielding Milwaukee Against Antibiotic ResisTance (SMAART) Ensemble

Fig 1The SMAART Ensemble is addressing the problem of multi-drug resistant infections that commonly occur in ventilators. The problem has reached endemic levels among health care facilities in the Greater Chicago Area and have shown progression into the Milwaukee area. Their goal for this Ensemble is to create a surveillance system to track the spread of these antibiotic resistant organisms and alert facilities when these infections occur.  So far, they have started surveillance programs by screening 15 different hospitals (Figure 1) that have 24 ICUs, and overall, they have completed surveillance at 22 of 29 hospital or nursing home locations and have begun genetic sequencing with 30 samples already obtained. This work has allowed them to submit two grant submissions, one of which, has been approved for funding.

Multiple Myeloma Ensemble

The initial goals of the Multiple Myeloma Ensemble were to implement a lifestyle intervention and develop biomarkers of disease progression to follow patients after autologous stem cell transplantation. They also set their goal to obtain patient-derived multiple myeloma samples and identify genetic changes to explain the heterogeneity in multiple myeloma patients.  Updates from their progress report highlight the collaboration with Dr. Patricia Sheehan at Loyola to survey and interview 70 patients about their symptoms and support they are receiving 100 days after stem cell transplant therapy.  An R21 grant focusing on lifestyle interventions for myeloma patients led by Dr. Melinda Stolley and Dr. Patricia Sheehan directly resulted from this Ensemble’s efforts. The proposal had a favorable score in the 11th percentile, and they are awaiting a funding decision. Myeloma sample collection and analysis efforts resulted in identifying and retrieving 262 samples, with another 298 samples to be retrieved soon.  In addition, the group has applied for 3 additional funding opportunities and has collaborated for 9 publications.

Pattern Recognition Early Diagnostic Tool for AL Amyloidosis (PREDICT AL)

This Ensemble identified the unmet medical need to create a tool for early diagnosis of cardiac amyloidosis after determining there are currently no effective tools. The key problem in diagnosis is that patients experience signs and symptoms for years without a definitive diagnosis, and when patients are eventually diagnosed, the disease is in advanced stages. They began by looking at data available from Froedtert Hospital, with the goal of obtaining larger data sets later in the study. They trained 2 medical students to abstract the data, which allowed the ability to distinguish persons who were diagnosed with amyloidosis as opposed to those who have symptoms consistent with amyloidosis, but who were not formally diagnosed. Unfortunately, the source for continued data extraction did not materialize and the project had to be stopped.

Fecal Incontinence Ensemble

Fecal incontinence is a distressing and socially debilitating condition with significant treatment challenges that impacts many Americans and has a high prevalence in nursing homes.  This Ensemble is studying the use of a novel apparatus (Figure 2) with a modified Kegel exercise that includes resistance training to cause muscle overload, as well as data collection from OBGYN, physical therapy, and GI clinics.  This group’s progress so far includes setting up a database for patients’ information with 10 patients enrolled, a virtual presentation at a senior living facility regarding education on topic, understanding baseline measurements for muscle training, and beginning to recruit patients for resistance device training.  The group has also had 3 abstracts accepted at Digestive Disease Week with 1 manuscript was published in the American Journal of Physiology.

Obesity Ensemble

In response to the COVID-19 pandemic, members of the Obesity Ensemble pivoted from initial objectives to focusing on the problem of food insecurity, which has been exacerbated by job loss, transportation challenges, and isolation. The new focus will examine how food insecurity as a social determinant of health could affect metabolic adaptation. The team is working to establish a TOPS (Take Off Pounds Sensibly; TOPS.org) weight loss chapter at a Milwaukee church to evaluate food insecurity prevalence and relevance of food insecurity to patient-driven weight loss recommendations. The team is also analyzing food quality and biomarkers of cardiometabolic health data from the National Health and Nutrition Examination Survey (NHANES) to determine if food insecurity affects obesity and glycemic control and examine potential sex and race differences. They have also begun an extension of their clinical goals with a collaboration studying the impact of social determinants of health, including food insecurity, on attrition, short-term and long-term complications of bariatric surgery. Finally, the team is attempting development of the first animal model to mimic food insecurity as no animal models currently exist to study this question. The team hopes that its three-pronged approach — clinical investigation, basic science, and community research — can increase our understanding of food insecurity and contribute to more effective treatments for obese patients in Milwaukee. This Ensemble has had 3 publications and submitted 5 grants.

Patient-Centered Data Science Ensemble

This Ensemble is addressing four barriers to harnessing data science solutions to provide better treatment options for the individual patient. They are working in four domains to address the barriers and these are: (1) Data Literacy, (2) Data Culture, (3) Organizational Awareness and Readiness, and (4) Patient-Centered Data Science Framework. The Ensemble has begun addressing Data Literacy and Data Culture by planning an “Afternoon with Data Science” seminar, and has already had early success with helping prepare UWM students for careers using data science tools. Members of the ensemble are coordinating a potential pipeline of students at Marquette to be partnered with MCW clinicians to work on independent student projects involving real health care data.  They have begun addressing Organizational Awareness and Readiness by building the first true data science technology platform at MCW. The core system, known as a Jupyter Hub, will provide the resources and environment for application of data science, identification of barriers, and incorporation of various data science languages, so that people can work together. Work continues in this area to build a cohesive environment for data sharing and analysis. CTSI is playing a significant role in building this environment through master agreements, HIPPA adherence, credentialing of systems, and adding layered data that can be operationalized downstream. Lastly, members of the team are authoring a manuscript to describe their proposal to shift to a Patient-Centered Data Science Framework (Figure 3). Patient data is currently aggregated at the institutional level, primarily for operations and business needs. They propose a reorganization of data to build a model for the patient’s value. This is a long-term goal, but they are laying the groundwork to begin the shift.

Figure 3: Patient-Centered Data Science Framework

Epidemics of Non-Alcoholic Fatty Liver Disease (NAFLD) and Community Engagement Ensemble

NAFLD is very serious, eventually leading to death if not diagnosed and treated early. The disease has an elevated prevalence in Hispanics and African Americans, and is associated with obesity and type II diabetes. This team will examine the efficacy of making an early diagnosis using a handheld ultrasound device at point of care visits by non-physician providers. Investigators have fostered a relationship with the 16th Street Community Health Center and church leaders in the African American community to pilot the use of the handheld ultrasound device. The team has also created an educational presentation for laypersons, to use with a CTSI Science Cafe on the day of the pilot studies. The Ensemble is in the process of securing summer/fall dates with church leaders to present the Science Café at church-sponsored health fairs, and provide the NAFLD screenings directly after the presentation. Progress on piloting the study at the 16th Street Community Health Center is still dependent on lifting COVID-19 restrictions.

Drug Oversight – Public Health & Ethics (DOPE) Ensemble – Use of Cannabinoids by Pregnant Women

Shifting societal attitudes towards medicinal and recreational cannabis use, coupled with nation-wide efforts for legalization, have created urgency to understand and articulate the potential risks and benefits associated with exposure to cannabinoids, especially as they concern pregnant women and their fetuses. The DOPE Ensemble began by conducting an exhaustive literature search, in which they found little research on cannabinoid use in pregnant women. They also recently submitted an IRB protocol and finished creation of a questionnaire to gather information from pregnant women on their opinions about cannabinoid risk during pregnancy. The ensemble will hire a medical or graduate student as a study coordinator to begin the study at Froedtert Hospital this fall. The team also established a relationship with the 16th Street Community Health Center, with the help of two health care providers that are Ensemble members. Through this relationship, they were able to obtain critical feedback from staff at the Clinic that helped create a better questionnaire. The Ensemble is hoping to begin administering the questionnaire at the 16th Street Community Health Center after completion of the pilot study at Froedtert, this fall. Results from this pilot study will be analyzed to determine trends among pregnant women and leverage findings to compete for extramural funding to expand the study. The goal is to administer the questionnaire with a larger number of participants and use the analyzed data to create public health messaging regarding the potential risks of using cannabinoids during pregnancy. The project will then undergo an examination of bioethical questions related to the role of health care providers to help women make more informed decisions about the risks of cannabinoid use during pregnancy.

Sample of Ensemble Metrics Data

We are evaluating each Ensemble based upon several metrics pertaining to the unique aspects of the Ensemble structure.  These metrics are not only for productivity reporting, but to help our understanding of what characteristics are important for effective Ensembles.  Listed in Figure 5 are a sample of metrics we are utilizing to measure team progression.  Below in Figure 6 are aggregate productivity metrics outlining some of the accomplishments of the Ensembles.

Figure 6: Aggregate Productivity Metrics—As of 2/1/2021

  • 11 grants submitted
  • 3 grants funded totaling $1,75 Million (Direct Costs)
  • 7 grants pending decision
  • 1 grant declined
  • 12 manuscripts accepted

Interested in participating in an Ensemble?

If you are interested in either learning more about the CTSI Integrated Clinical & Research Ensembles, joining an existing Ensemble, or starting your own team, please contact Mike Anello (manello@mcw.edu) and David Zimmerman (dzimmerman@mcw.edu).



NIH Funding Acknowledgment: Important Reminder – Please acknowledge the NIH when publishing papers, patents, projects, and presentations resulting from the use of CTSI resources by including the NIH Funding Acknowledgement.

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