MDEpiNet’s Community of Practice was established to promote registry maturity through the harmonization of core minimum data sets, commitment to the incorporation of device identification, patient engagement, and facilitation of registry data linkage to other key data sources. Please read more about our initiative to strengthen CRNs as a National Infrastructure for Technology Affecting Women’s Health – featured on the office of the Assistant Secretary for Planning and Evaluation (ASPE) website here.
Piloting Women’s Health Registries in EHRs – the ULTRA Study at UCSF:
ULTRA study is a pilot study for Uterine Fibroid led by Dr. Vanessa Jacoby (https://fibroids.ucsf.edu/). This collaborative effort aims to help patients and doctors understand how the treatment changes fibroid symptoms, affects fertility and pregnancy, and impacts the need for additional fibroid treatment in the future.
In a post-market observational cohort study, ULTRA assesses safety and effectiveness of women undergoing AcessaTM treatment. The project recruits women through voluntary referrals from clinicians and engaged clinical sites in a multicenter study. UCSF follows up for 3 years after surgery. The outcomes of the study are operative morbidity, change in fibroid, treatment failure, and pregnancy outcomes. The patient population is queried every 6 months with questionnaires to collect PRO, and medical records are obtained for follow-up imaging. ULTRA collaborates with COMPARE-UF for harmonization of outcome assessments (CRFs and questionnaires) as well as WHT-CRN for opportunities to pilot new data elements in an ongoing post-market device study.
The collaborators created a core minimum data set for surgeries and procedures to treat uterine fibroids with a focus on the use of medical devices during these procedures. The minimum data set draws from data collected at the time of surgery (i.e. intraoperative outcomes and events). These data points are structured to serve as a template for a case report form in the research environment (e.g. post-market surveillance) and/or to embed within the electronic health record for use in a general clinical care workflow.
Kidney disease is the ninth leading cause of death in the US with more than 726,000 people living with end-stage renal disease (ESRD) 6. Annually, about $114 billion of Medicare funding is spent to care for ESRD patients but there is a major variation in outcomes. Based on the 2018 annual data report from the United States Renal Data System (USRDS), the adjusted mortality rate for ESRD overall was 134 per 1,000 patient-years and 164 per 1,000 patient-years for dialysis patients7. Given the critical state of care for Americans with kidney disease, there are various national efforts set forth to improve care for patients with kidney disease and reduce healthcare costs, among which is the ESRD Network Program organized by CMS to promote quality and cost-effective healthcare in kidney disease8. CMS maintains the Consolidated Renal Operations in a Web-Enabled Network (CROWNWeb), assisted by ESRD networks for data quality. This data is used for both payment for performance programs and quality improvement activities. All regional networks receive CROWNWeb Data from the central ESRD National Coordination center9.
There are various other programs that collect data in ESRD. The University of Michigan runs the Kidney Epidemiology and Cost Center (KECC), which supports many CMS and Center for Medicare & Medicaid Innovation programs for ESRD data collection and analysis10. The U.S. Chronic Kidney Disease Surveillance System is a collaborative effort among KECC, the Centers for Disease Control and Prevention (CDC), and UCSF. Moreover, Veterans Affairs (VA) maintains several ESRD programs through coordination with CMS and the University of Michigan11. In addition, a proposal was set forth for a national registry of patients requiring vascular access and other resources relating to renal replacement therapy (RRT). A comprehensive ESRD-CRN would further enable examination of more clinical and broader research questions to improve patients’ quality of care and outcomes.
The objective of the ESRD CRN is to establish an infrastructure to capture RWE of patients’ interactions with medical devices. The Kidney Health Initiative (KHI), a public-private partnership between the FDA and American Society of Nephrology (ASN) has developed a Technology Roadmap that defines the priorities and opportunities for innovative RRT. The Kidney Innovation Accelerator (KidneyX), a public-private partnership between the US Department of Health and HHS and the ASN through its prize programs provides the funding mechanism for innovative RRT. Through these collaborative efforts, ESRD CRN aims to ensure the engagement of a variety of key stakeholders including patients in the healthcare ecosystem and a commitment to platform sustainability over time.
The ESRD CRN is a collaborative effort that engages organizations such as the ASN, through its public-private partnerships, KHI and KidneyX, FDA, CMS, and Weill Cornell Medicine. The CRN leverages relationships and contacts with industry, patients, and professional medical societies, both in the U.S. and abroad. Patient organizations will be an important part of the collaboration.
The MDEpiNet Coordinating Center is in the process of establishing MOUs with all participating partners. After the ESRD CRN membership is finalized, MOUs will be finalized with CRN’s leadership.
The patient population for this CRN includes individuals with ESRD.
ESRD CRN data sources include claims and administrative data, as well as registry and other data sources. One of the potential data sources for the CRN is the USRDS, which is funded by the National Institute of Diabetes and Digestive and Kidney Diseases and currently housed by the Chronic Disease Research Group in Minneapolis 12. This national data system collects, analyzes, and disseminates information on chronic kidney disease (CKD) and ESRD. USRDS produces comprehensive annual reports on dialysis and CKD-related metrics for researchers, regulators, and clinicians. The USRDS works collaboratively with CMS and the United Network for Organ Sharing.
Furthermore, dialysis organizations have a network of multisite electronic medical record (EMR) data. Three large dialysis EMRs, which include DaVita, Fresenius Medical Care, and Dialysis Clinic, Inc., encompass 80% of US dialysis patients, while 14 smaller EMRs comprise the rest of the market. These independent dialysis organizations’ data are consolidated though the National Renal Administrators Association health information exchange.
Existing core data sets for chronic kidney disease include the following: (1) Standardized Outcomes in Nephrology, which is an international initiative that aims to establish core outcomes in CKD13; (2) the International Consortium for Health Outcomes Measurement Standard Set for CKD, which are recommendations established by a group of physicians, measurement experts, and patients14; and (3) the European Association of Rehabilitation in CKD recommendations on measurement and interpretation of physical function15.
Current Projects and Plans
Patient Preference Information Pilot Study: This effort aims to develop innovative methodology for patient engagement and input to build a patient-centered CRN. Specifically, a pilot study will be conducted that develops and incorporates patient preference information data into a core data elements set for ESRD. As one of the prime uses of the data and evidence generated by the CRN is for regulatory decision making, it is vital that PPI regarding benefit/risk trade-offs is captured as valid scientific evidence that can be used by regulators as well as payers, providers, and patients. The CRN platform will capture and expand capacity to identify outcomes most important to patients and aid in the design of clinical trials to reduce the time and cost of execution. Data developed from rapid-cycle clinical trials and linked to sources of real-world data will generate evidence for a variety of decision-making and improve patient care.
Collaboration with KHI: The ESRD prioritizes collaborating with KHI to ensure the engagement of a variety of key stakeholders including patients in the healthcare ecosystem and a commitment to platform sustainability over time. The KHI developed a “Technology Roadmap for Innovative Approaches to RRT,”16 which defines the priorities and opportunities for innovative RRT and allocates 2019-2022 for the establishment of the ESRD CRN.
Colon and rectal cancers (CRCs) are the third leading cause of cancer-related deaths in the United States and the third most common cancer in men and in women17. Worldwide, more than a million cases are diagnosed each year. Although these cancers have historically been common in western countries, they now are increasing rapidly in Asia and the Middle East. The recent rapid increase in rates of CRC in patients under 50 years of age is also alarming. With advancement in communication platforms, data sharing networks and advanced analytics now available, it is possible to study international patterns of cancer occurrence and treatment. Using multinational resources, superfast computing, artificial intelligence (AI), and a dedicated team of professionals with expert skills and intimate patient contact, the disease outcomes can be improved in treatment and care of CRC patients.
With this in mind, an international team of healthcare professionals formed a study group in 2016, dedicated to examining colon cancer on a global scale. The International Cooperative of Colorectal Cancer (IC3) pursues improvements in the prevention, treatment, and cure of colon and rectal cancers by studying the similarities and differences in therapies around the world and aims to lower health care costs in colorectal cancer therapies. Collaborators at Weill Cornell Medicine and MDEpiNet Coordinating Center are leading this effort to bring talents from multiple disciplines together. Since its founding, the IC3 collaborative has grown in number of researchers, nations, and continents represented. Currently, the IC3 team include participants from specialty hospitals in China, France, India, Japan, the Netherlands, Saudi Arabia, South Korea, Tanzania, Tunisia and the United States that form a consortium for multicenter prospective observational study comparing oncologic and clinical outcomes in surgery for colon cancer.
The main objective of IC3 is to investigate and compare outcomes of cancer and use of technology in existing databases from each participating country. The secondary objective is to initiate primary data collection from leading institutions within each country to evaluate the devices, treatment methods, and outcomes. The third objective is to plan basic science research as well as cost-analysis studies that have the potential to improve outcomes and advance towards a cure for colon and rectal cancer.
III. Partnerships structure
The IC3 is an international collaborative that partners with the MDEpiNet Coordinating Center. IC3 is led by Jeffrey W. Milsom (Weill Cornell Medicine) with input from Art Sedrakyan and his team from the MDEpiNet Coordinating Center.
MDEpiNet Coordinating Center and IC3 have subcontract agreements with all entities under the protocol titled “Multicenter Prospective Observational Study Comparing Oncologic and Clinical Outcomes in Surgery for Colon Cancer in Specialty Hospitals”.
IV. Data Infrastructure
The patient population includes colorectal cancers patients from various countries around the world, including China, India, Tanzania, Japan, Tunisia, France, The Netherlands, Saudi Arabia, and South Korea.
IC3 utilizes EHRs and registry data for its research projects, including records from its international partners like Japanese Society for Cancer of the Colon and Rectum (JSCCR) and the aforementioned hospital systems. Data-sharing agreements are underway for countries such as Korea University Anam Hospital and NIIT Medical Center in Tokyo.
V. Current Projects and Plans
IC3’s main ongoing studies include evaluating survival following CRC surgery in the US and Japan. The first three studies evaluated the 5-year survival after CRC surgery using US SEER cancer registry and Japanese registry data. US-based claims analysis was performed to evaluate the use and outcomes of bowel stenting in colorectal cancer patients as palliative treatment and as a bridge to surgery.
IC3’s current plan is to expand data infrastructure and data-sharing platforms internationally, using Research Electronic Data Capture (REDCap) or High-Performance Integrated Virtual environment (HIVE) for data capture. A meeting was held in May 2019 that trained coordinators and surgeons to use the REDCap app. The priority is to finalize REDCap data collection forms and finalize data sharing agreements.
The IC3 team is working to advance the international efforts and explore funding opportunities. The Cornell team is planning to run a survey among partner institutions to collect background information on colorectal cancer treatment in order to create an information sheet to be used for potential fundraising for IC3.