8

All abstracts are organized by track and listed in alphabetical order by title.

A Randomized Clinical Trial of Real-time Decision Support During the Evaluation of Abdominal Organ Offers

omni life

Author: 

Eric Pahl, CTO, Head of Research and Development, OmniLife

Co-Author:

Dr. Robert Emery - Professor of Psychology and Director of the Center for Children, Families, and the Law at the University of Virginia

Purpose: Organ transplantation is a cost and clinically effective treatment for patients suffering from end-stage organ failure. According to the Organ Preservation Alliance, one in three deaths in the US might be prevented by an organ transplant. One limitation of organ transplantation is the onerous and disorganized assessment of an organ offer to determine donor/recipient match quality. Real-time clinical decision support (CDS) with artificial intelligence may significantly increase access, increase quality, and reduce the time and cost of organ transplantation.

Methods: Procurement and transplant team members utilized a dedicated mobile application for communicating during the organ offer process. The study was conducted with a year-long, three-arm, open-label, randomized clinical trial at 12 leading transplant centers in the USA. The mobile application was enhanced with two different implementations of CDS, static and dynamic. Static CDS consisted of a prediction environment that was unchanged throughout the trial; it predicted survival benefit for each patient in the match sequence and the national and center-specific organ offer acceptance rates.

Results: Dynamic CDS was initially a replication of the static CDS environment, but the dynamic CDS was modified continuously throughout the trial based on user feedback. The clinical trial was randomized by each incoming organ with a KDPI > 25% into one of three arms: control (no CDS), static CDS, or dynamic CDS.

Conclusion: The investigating team has received early indications of satisfaction and perceived enhancement of medical decisions from directors and surgical leaders at participating centers. This study is ongoing.

Accelerating High Priority Alzheimer’s Disease and Related Dementias Research Through Project-specific Human Biospecimen Collection

NDRI-Logo-color

Author: 

Melissa VonDran, Senior Director, Scientific Services and Fulfillment, NDRI

Co-Author: 

Saboor Shad, Director of Tissue Source Site Management, NDRI

Cristina Kelly, Senior Manager of Scientific Services, NDRI

Jason Cavanaugh, Senior Manager, Logistics Management & Biorepository, NDRI

Bill Leinweber, President & CEO, NDRI

Gene Kopen, PhD, Senior Vice President of Strategic Initiatives, NDRI

Thomas J. Bell, PhD, Vice President of Operations and Biorepository Director, NDRI

Purpose: Accelerating our understanding of pathogenesis and treatment of neurological diseases, including Alzheimer’s disease and related dementias (AD/ADRD), requires experimental analysis on suitable human biospecimens. AD/ADRD are multi-factorial, genetically complex and heterogeneous diseases that progress over approximately two to three decades of life. Access to a diverse range of human biospecimens and donors is essential to support the escalating nature of scientific questions and experimental techniques that investigators are pursuing. More comprehensive AD/ADRD human tissues are needed to advance the field.

Methods: AD and normal donors were screened and authorized based upon specific, project-defined eligibility criteria to recover suitable human tissues with relevant medical history. Relevant AD-specific data was collected, including, but not limited to, date of diagnosis, current medications, secondary illnesses, comorbidities, and cause of death, and provided to AD investigators. Human biospecimens were recovered according to customized recovery protocols to ensure suitability for scientific experimental methodologies.

Results: Here we report the recovery results for a new AD/ADRD-specific tissue collection resource. The primary objective of this resource, AD/ADRD Human Biospecimen Resource (ADBR), was to address high priority needs for human biospecimens in the AD research community. ADBR developed project-specific tools to enhance the screening, authorization and recovery of human biospecimens from AD/ADRD and normal, control donors. Of the eligible donors, 9 donor families consented for research tissue donation. Multiple tissue types, including brain samples, dura mater, blood, plasma and cerebrospinal fluid samples were collected and distributed to AD investigators. To date, these efforts have yielded 3 recoveries from AD/ADRD donors and 6 control donors.

Conclusion: The ADBR is a comprehensive human biospecimen resource that provides biospecimens from two donor profiles, post mortem AD/ADRD and normal, control donors. The biospecimens collected are based on individual investigator project needs. The advantages of the ADBR’s approach are 3-fold. 1) The collection of AD/ADRD and control (non-diseased) biospecimens from the same resource allow for matched data-sets for investigators. 2) The resource remains responsive to the high priority areas of the AD/ADRD research by customizing the collection effort to investigator need.3) Standardization of donor eligibility and biospecimen collection methods will yield more accurate and reproducible experimental data. Collectively, ADBR will provide the AD/ADRD research community an unmatched resource to advance basic research evaluating the etiology of AD/ADRD, as well as translational research assessing effective diagnostics and therapies.

Automated Electronic Hospital Donor Referrals Have Increased Donation

TXSB

Author: 

Patti Niles, President & CEO, Southwest Transplant Alliance

Co-Authors: 

John Piano: Founder, Chairman and CEO; Transplant Connect

Jonathan Hewlett: Business Systems Intelligence; Southwest Transplant Alliance

Wade Liu: VP of Product Development, Transplant Connect

Purpose: It is broadly understood and supported by previous studies that disruptive inefficiencies exist in the hospital to Organ Procurement Organization (OPO) donor referral process, including failure to notify the OPO and delayed referrals. A secure direct and automatic electronic donor referral interface was collaboratively developed and implemented to confront this issue by 1) eliminating the need for a nurse to step away from patient care and place the phone call; and 2) automating the donor referral trigger.

Methods: The multi-disciplinary team collaborated to create a secure technical interface directly connecting the OPO and Hospital systems, as well as design seamless donor referral triggers within the Hospital EMR. These triggers automatically deliver electronic donor referrals from the Hospital to the OPO upon staff entry of pre-determined clinical data into the EMR, greatly reducing the need for donation knowledge and decision making by the hospital staff. The interface includes an additional manual trigger for staff to utilize in cases such as early family mention of donation and other exceptional situations. Upon receipt of the initial electronic referral, the OPO is able to quickly retrieve critical details for donation screening without pulling the hospital staff away from their critical duties of care.

Results: The interface has led to a significant increase in referrals and donations. Comparing the January-October data from the previous (2018) and current years (2019), during which time the only major process change at the hospital was the implementation of the electronic interface, there was a 31% increase in donor referrals (537 to 704) and a 167% increase in organ donors (6 to 16). Over the same period, over 250 hours of staff time were saved by the hospital and the OPO, regardless of the increase in referrals. In addition, there are several case studies of the OPO receiving an automatically triggered donor referral when the nurse was unable to connect on a phone call. OPO staff were then able to retrieve the appropriate data directly from the EMR, allowing them to mobilize, connect with the donor family in a timely fashion, and ultimately recover organs and tissue which likely would have otherwise timed out.

Conclusion: The initiative has been successful due to both the electronic interface and automating the donor referral trigger. This project has reduced burdens on both the Hospital and the OPO and led to a significant increase in the number and timeliness of referrals, leading to more donation and transplantation.

Growth in Brain Donation Efforts are Needed to Further Support the Advancement in Autism Spectrum Disorders Research

NDRI-Logo-color

Author: 

Gene C. Kopen, SVP, Strategic Initiatives, NDRI

Co-Author: 

Saboor Shad, Director of Tissue Source Site Management, NDRI

Melissa VonDran, PhD, Senior Director of Scientific Services and Fulfillment, NDRI

Cristina Kelly, Senior Manager of Scientific Services, NDRI

Jason Cavanaugh, Senior Manager, Logistics Management & Biorepository, NDRI

Bill Leinweber, President & CEO, NDRI

Thomas J. Bell, PhD, Vice President of Operations and Biorepository Director, NDRI

Purpose: Experimental analysis on human biospecimens is a substantially underutilized approach to conduct research and develop new treatment options for Autism Spectrum Disorders (ASD), due to the challenges associated with obtaining the appropriate human biospecimens. More growth and development in resources that obtain and distribute human biospecimens is needed to address this gap for the ASD research community. Here we report our efforts to advance ASD research through supporting the development of a neurological biobank that globally provides high-quality human neurological biospecimens to the ASD research community.

Methods: A multi-year, multi-site recovery model was utilized to provide the opportunity for eligible donors and donor families to donate human biospecimens. Both ASD and pediatric, normal donors were screened and authorized based upon specific, project-defined eligibility criteria to recover appropriate human tissues with relevant medical history. A project-specific authorization and ASD-specific questionnaire were developed and reviewed by an Institutional Review Board. Human brains and temporal muscle samples were recovered from all authorized donors according to project-defined recovery protocols collection and shipped to a neurological biobank.

Results: To address this high priority need for human biospecimens in ASD research, here we present our recovery results and programmatic approaches. The overarching objective of this work is to develop tools to enhance the screening, authorization and recovery of whole brains and temporal muscle samples from eligible ASD and normal control donors for a neurological biobank. To date, fourteen recovery sites actively support the ASD tissue collection initiative. Collectively, these efforts have yielded 38 recoveries from ASD donors and 6 normal control donors.

Conclusion: More translational studies on tissues and cells that are directly relevant to ASD pathophysiology are needed along with growth in donation opportunities to support ASD research. Here we report our ongoing efforts to address this unmet need for the ASD research community. To date, the benefits of this initiative are four-fold. It has: 1) increased the availability of human samples to a neurological biobank with global distribution capabilities, 2) established and maintained a national, multi-site effort to identify, authorize, and recover biospecimens from ASD and normal control donors, 3) implemented a standardized methods across multiple recovery partners, and 4) supported raising public awareness for the need and value of donating human tissue for ASD research. Growth and continued support by the OPO community is necessary to sustain and further advance these impactful benefits to the ASD research and donor communities.

Infectious Disease Heat Map of the United States for Deceased Organ Donors

VRL@4x

Author: 

Brenden O'Neale, Infectious Disease Manager, VRL-Eurofins

Co-Authors: 

Kimberly Elliott, Director of Business Development, VRL-Eurofins

Romano Tamandong, Director of Infectious Disease, VRL-Eurofins

Monette Rockymore, Manager, VRL-Eurofins

Matthew Smith, Manager, VRL-Eurofins

Susann Colquehuance, Manager, VRL-Eurofins

Harun Rashid, Manager, VRL-Eurofins

Eyre Klindt, Manager, VRL-Eurofins

Catherine Springford, Regional Manager East, VRL-Eurofins

Sara Dionne, VP of Operations, VRL-Eurofins

Purpose: Our laboratories performs infectious disease screening throughout the United States. We receive inquiries pertaining to assay Reactive Rates. We were interested in looking at the data based on the location of our laboratory and segregated the results in this manner to develop Infectious Disease Heat Maps of the United States.

Methods: Data from each laboratory was collected and analyzed from our Laboratory Information System. We specifically only queried results from deceased organ donors. Results for HIV-1/2, HBV, HCV Nucleic Acid Tests (NAT) and Syphilis were reviewed. The time frame for this retrospective study was variable. For all labs with the exception of our Cincinnati, OH and San Ramon, CA-based laboratories, one year of data was analyzed. The OH and CA labs began testing in 2019 and 6 months and 9 months, respectively, of data was analyzed.

Results: Figure 1 is a schematic of all of the states in which we receive donor samples to test with corresponding UNOS Regions. NAT results for each virus are presented in Figure 2A-C. Lastly, Syphilis results are presented in Figure 3. States colored in Red had the highest percentages of Reactive Rates and Green states had the lowest rates. The scale ranges from 0.00-0.25%.

Conclusion: The use of heat maps to demonstrate the prevalence of infectious disease is useful to promote awareness for regional prevalence.

Mobile Application for Communication Increases the Efficiency of Organ Procurement and Transplantation

omni life

Author: 

Eric Pahl, CTO, Head of Research and Development, OmniLife

Co-Authors:

Dr. Robert Emery - Professor of psychology and director of the Center for Children, Families, and the Law at the University of Virginia

Michael Noce - COO, Relational Coordination Analytics

Suzanne Conrad - CEO, Iowa Donor Network

Nicole Patterson - Transplant Coordinator, Iowa Methodist Transplant Center

Brynn Timm - Transplant Coordinator, University of Iowa

Purpose: Donor organ recovery is a complex process involving organ procurement organizations and multiple surgical teams from various transplant centers. According to the Organ Preservation Alliance, one in three deaths in the US might be prevented by an organ transplant. Lack of real-time communication results in many hours of preventable delay between procurement and transplant teams resulting in a high volume of organ waste, clinical frustration, and critical delays.

Methods: A Plan-Do-Study-Act performance improvement methodology was utilized to design and implement a dedicated mobile communication application (app). Critical time points in the organ offer, procurement, and transplant processes were analyzed from the report of organ offers, and relation coordination metrics were also measured. Members of procurement and transplant teams in at transplant centers in the Midwest were interviewed and the app was implemented to replace phone calls, emails, faxes, and text messages during a year-long study of deceased donor kidney offers.

Results: Teams reported substantial increases in clinical productivity and case progress awareness. Additionally, we observed a noticeable reduction in phone calls. The relational coordination data indicated a higher relationship and communication quality score with the app. The report of organ offer data revealed a 35% increase in organs transplanted and a 50% reduction in time from initial organ offer to transplant during the use of the app.

Conclusion: The use of a dedicated communication app reduces clinical frustration and delays during the coordination of organ offer, procurement, and transplant processes. Technologies that improve communication have the potential to improve organ utilization.

Project-driven Human Biospecimen Collection From Diseased and Non-diseased Donors is Essential for Advancement of Translational Research

NDRI-Logo-color

Author: 

Thomas J. Bell, PhD, Vice President of Operations, NDRI

Co-Author: 

Saboor Shad, Director of Tissue Source Site Management, NDRI

Melissa VonDran, PhD, Senior Director of Scientific Services and Fulfillment, NDRI

Cristina Kelly, Senior Manager of Scientific Services, NDRI

Jason Cavanaugh, Senior Manager, Logistics Management & Biorepository, NDRI

Bill Leinweber, President & CEO, NDRI

Gene Kopen, PhD, Senior Vice President of Strategic Initiatives, NDRI

 

Purpose: Translational research is variegated, and spans many platforms including analyses on diseased and non-diseased human biospecimens. This research is challenging for numerous reasons, but species-specific differences in genomic, transcriptomic, and proteomic profiles are emerging as major hindrances for translational research modeling both diseased and non-diseased states. Experimental analysis on primary human tissues provides an alternative method to overcome this challenge, but acquiring appropriate diseased and non-diseased biospecimens to develop human model systems is a critical impediment for most investigators. More comprehensive access to diseased and non-diseased biospecimens are needed to support investigators and advance the field.

Methods: A multi-site recovery model was utilized to provide the opportunity for eligible donors and donor families to donate for research. Donors were screened and authorized based upon specific, project-defined eligibility criteria to recover appropriate human organs and tissues from donors with a documented history or absence of specific medical conditions and/ or diseases. Human biospecimens were recovered from authorized donors according to project-defined recovery protocols and shipped to investigators for analysis.

Results: Here we report results of multiple research efforts addressing the need for high-quality human biospecimens to support innovative and ground-breaking experimental techniques. A higher volume of non-diseased organs (75%) compared to diseased organs (25%) were recovered from eligible organ donors with low recovery to preservation intervals. These organs were processed using molecular (RNAseq, single cell, and other transcriptomic, epigenomic, and proteomic analysis) and visual (confocal imaging, in situ hybridization, and 3D imaging) approaches. A summary of the experimental approaches and types of analysis performed are presented here, highlighting the importance of utilizing non-diseased organs to understand normal development and function and diseased organs for identifying appropriate targets for therapeutic intervention.

Conclusion: Requests for human biospecimens continue to be more specific and complex due to the escalating nature of experimental questions and techniques that investigators want to address. Here we report a three pronged approach to meet the translational research needs for diseased and non-diseased human biospecimens. Our program: 1) develops project-specific recovery protocols, 2) provides standardized procurement, processing, preservation and shipping methods, and 3) maintains industry best practices and standards regarding the donation of human tissue for research. In doing so, the biospecimen collection and preservation methods are optimized to the experimental hypotheses and procedures for each scientific study. This approach yields highly suitable biospecimens for accelerating the development of new medical therapies and treatments.

Statistical Comparison of OPO Operations

1280px-University_of_Texas_at_Austin_logo.svg

Author: 

Paola Martin, Ph.D. Student, University of Texas, Austin

Co-Authors: 

Diwakar Gupta, Professor, University of Texas at Austin

Timothy Pruett, John S. Najarian Surgical Chair in Clinical Transplantation, University of Minnesota, Twin Cities

Purpose: To quantify differences in procurement processes of at least two different OPOs and relate them to differences in donor disposition outcomes.

Methods: We used detailed data from different OPOs and advanced statistical and machine learning methods to accomplish our goal.

Results: This is a work in progress. We have preliminary results showing significant differences in decision making processes. We plan to have complete results by June of 2020.

Conclusion: The potential benefit of this study is that it will identify practices that lead to improved potential donor disposition.

Using a Business Intelligence Tool to Increase OPO Reporting Efficiency

INOP

Author: 

Bill Janczak, Report Writer, Indiana Donor Network

Co-Author: 

Nicole Robbs, Clinical Decision Support Analyst, Indiana Donor Network

Purpose: To introduce a business intelligence (BI) tool as a method of increasing reporting efficiency, especially for those metrics that all OPOs are required to track.

Methods: The BI tool was utilized to generate AOPO monthly reporting, regional monthly surveys, late and missed referrals and death lists.

Results: AOPO Monthly Report Before: • Organ data was pulled from the monthly organ referral report. This data was filtered and sorted to obtain each piece of information. • ME declines for organ: cases were located on monthly organ referral report, then on iTransplant, a search was performed for the specific case and the ME page was consulted to obtain required information. • Referral count was pulled from business intelligence dashboard. • Tissue data pulled from tissue eligibility and outcome report, which had to be sorted and filtered multiple times to obtain all of the information. After: • An AOPO monthly profile dashboard has been created. Each line item has a specific widget. • ME declines: within the widget, users can click on the case number, which automatically directs the user to the ME page in iTransplant to obtain information. Region 10 Monthly Survey Before: • Monthly organ referral report was run, sorted and filtered multiple times to obtain information. After: • Region dashboard has been created in the business intelligence tool with a widget for each line item. The OPO has the ability to click on specific cases, which will take the user directly to iTransplant. Linking late and missed organ referrals to variance reporting system Before: • Notification emails were sent for potential late or missed referrals. • All notifications were entered by hand into an excel spreadsheet. • MRR was completed in excel for each month. • Variances were manually entered for late/missed referrals. • Late and missed referrals for the month were housed in quality and hospital services folders. After: • Notification emails sent automatically for potential late or missed referrals and MRR is completed. • This report is automatically delivered each week to ensure all data points are captured.

Conclusion: By implementing a business intelligence tool, the OPO has been able to drastically increase efficiency in reporting. As a result, more time is available for data analysis and process improvement.