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.

Partnerships Structure

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.

Existing agreements
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.

Data Infrastructure

Patient population
The patient population for this CRN includes individuals with ESRD.

Data sources
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.


I. Background

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.

II. Objectives

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.

Existing Agreements
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

Patient population
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.

Data sources
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.



Temporomandibular disorders (TMD) are common disabling conditions and from 6% to 12% of the population is estimated to experience clinical symptoms23. The treatments include many devices that have limited evidence of safety and effectiveness and little comparative data is available. Data on long-term outcomes is particularly limited, leading to use of trial-and-error approach in treating patients. As a result, some patients develop serious conditions including worsened chronic pain, facial paralysis, disfigurement, infection, device migration within the skull, reduced jaw mobility, increased opioid use and dependence, increased suicidality, and other serious adverse events.

There is an urgent need to understand factors that lead to patients’ experiences of success or failure for all TMD treatments, especially those that are irreversible such as temporomandibular joint implants, and, to share these with health care professionals and regulators for informed decision-making. The TMJ CRN was initiated by MDEpiNet to address these issues. The project aims to ultimately inform the development of scientificallyrobust, comprehensive treatment guidelines to enhance outcomes of TMD treatments based upon knowledge of a patient’s overall phenotype, disease progression, and treatment trajectory, while also improving the lives of patients suffering from TMD.


The main objective of the TMJ CRN is to develop a standardized data infrastructure for capturing patient-generated data, physician experience, and other healthcare ecosystem data necessary to better understand the disparate treatment pathways and outcomes that patients experience. Another goal is to change clinical trial conduct to incorporate patient preference and real-world experience into FDA-regulated and public health trials, beginning with medical devices. The CRN also aims to provide a roadmap for the development of precision medicine algorithms that predict individual outcomes from TMJ therapies, and develop evidence-based protocols, guidelines, and best practices for inclusion in professional health care curriculums.

Partnership Structure

The TMJ-CRN consists of a partnership between the FDA/CDRH, The TMJ Association, AHRQ, Device Manufacturers, FDA/CDER, FDA/OWH, TMJ Patients, Weill Cornell Medicine, and the National Institute of Dental and Craniofacial Research. The TMJ Patient-Led Round Table is supported by a number of agencies including MDEpiNet, The TMJ Association, TMJ Patients, the FDA, National Institute of Dental and Craniofacial Research, FDA/OWH, American Association of Oral and Maxillofacial Surgeons, American Society of Temporomandibular Joint Surgeons, Zimmer Biomet, TMJ Concepts, clinicians, scientists, advocacy organizations, and other experts, all under the auspices of MDEpiNet. The Steering Committee consists of the participating organization listed above.

Four Working Groups have been established focusing on:

  • TMJ Patients: Natural History and Assessment of Biomarkers Associated with Outcomes in TMJ Implant Patients<\li>
  • PRO Evaluation<\li>
  • Physician and Patient Education/Patient-Centered Treatment<\li>
  • Data Collection and Analysis<\li>

Existing agreements
MDEpiNet Coordinating Center established MOU with the CRN’s Leads, including with Terrie Cowley (TMJ Association).

Data Infrastructure

Patient population
The patient population for this CRN includes individuals diagnosed with or receiving treatment for TMJ disorders.

Data sources
The development of a TMJ specific registry is underway. Registries of common overlapping conditions are identified and will be linked and used to perform research evaluating TMJ-related procedures. Examples of common overlapping conditions and registries include the Get with the Guidelines Registry from the AHA for stroke, the Multiple Sclerosis Registry for multiple sclerosis, and the Kaiser Permanent Spine Registry Database for functional disorders of the upper cervical spine. Claims data analyses can also help address specific issues related to reoperations after implant use.

Current Projects and Plans

Current projects for TMJ CRN include the development of a minimum core dataset through the Delphi method and focus on pilot studies to test the data collection methods. The developed minimum core data set of elements will be vetted by the multi-stakeholder community via formal consensus building. The core dataset elements will include a data dictionary with permissible values sets, adherence to international standards, and capture by the NLM’s repository of common data elements. The development of the minimum core dataset is anticipated to take approximately 4 to 6 months. The Delphi process will require approximately 2 to 4 additional months. All pilots are anticipated to be completed within a 3-year timeframe. Following the completion of these projects, a report evaluating these processes will be generated and submitted for publication. The CRN is also planning exploratory claims data analyses and protocol is in development as well.

Summary TMJ components and Repair


I. Background

More than 300,000 breast implant surgeries including augmentation and other reconstructive procedures are conducted annually in the US18. Given recent concerns related to these devices there is a need to evaluate these technologies and improve quality of care for patients that undergo breast implant procedures. To address these gaps, the NBIR was developed as a collaboration of FDA, The Plastic Surgery Foundation (PSF), The American Society of Plastic Surgeons (ASPS), as well as patients and breast implant device manufacturers. The NBIR database is a prospective, opt-out, non-interventional, population-based, outcomes and safety surveillance registry and quality improvement initiative. It collects data at the time of operation and any subsequent reoperations for all US patients receiving breast implants. Collecting this information will allow the NBIR, plastic surgeons, and breast implant manufacturers to identify trends and other helpful safety information.

The NBIR is a quality improvement initiative and safety surveillance registry that collects clinical, procedural and outcomes data at the time of operation and any subsequent reoperations for all US patients receiving breast implants. NBIR collaborates with breast implant manufacturers that can use the registry to further investigate the device safety and improvement. The manufacturers can use the registry for Device Tracking purposes required by the FDA. Additional aims of the NBIR include serving as a potential infrastructure for post-market studies. NBIR data can be used to study trends related to all breast implant procedures.

II. Objectives

The main objectives of the NBIR are to strengthen the national infrastructure for post-market surveillance of breast implants and communicate timely, accurate, systematic, and prioritized assessments of breast implants throughout their marketed life. The NBIR is aiming to 1) leverage high-quality, standardized and structured data; 2) identify potential safety signals in near real‐time from a variety of privacy‐protected data sources; 3) reduce the burdens and costs of medical device post-market surveillance; and 4) facilitate the clearance and approval of new devices, or new uses of existing devices. Additional aims of the NBIR include serving as a potential infrastructure for post-market studies; as well as providing an infrastructure for device manufacturers to facilitate the post-implant component of their device tracking data collection.

III. Partnership Structure

NBIR CRN has partners from government agencies such as the FDA, professional societies like the ASPS, The PSF, and MDEpiNet, as well as the device manufacturers and industry partners, Allergan, Sientra, and Mentor, and patient groups.

NBIR CRN is led by Andrea Pusic (Harvard Medical School) who also co-chairs the NBIR Steering Committee with Charles Verheyden (Baylor Scott & White Health). The NBIR Steering Committee is responsible for developing and implementing the strategic goals of the NBIR and is the governing body that oversees registry operations, including the successful implementation, monitoring, and management of resources and activities.

IV. Data Infrastructure

Patient population
The NBIR patient population includes patients who have had breast implant procedures in the US. There are thousands of patients already registered with the registry.

Data sources
Electronic Case Report Form (eCRF): The NBIR Data is collected at two key clinical points: 1) Initial Implant Procedure and, 2) Any subsequent Reoperation. It also collects other information about the patient and patient procedure, including their contact information for manufacturer follow-up related to device tracking, information about their medical history, their breast implant operation and the implant itself, and any complications that may have occurred from the patient’s breast implant operation.

NBIR Barcode Scanning App: Another source of data is the NBIR Barcode Scanning App, which can be used to assist NBIR participants with the data entry of implanted device-specific data elements. The app scans and decodes both Linear and 2D breast implant device barcodes and pushes the data contained within the barcode to the NBIR directly from FDA’s Global Unique Device Identification Database (GUDID). Electronic data captures with bar code scanning to help decrease burden and improve data quality. More information on how to use the app can be found in the following link: https://www.thepsf.org/documents/Research/Registries/NBIR/how-to-use-the-nbir-barcode-scanner.pdf.

PROFILE Registry: The Patient Registry and Outcomes For breast Implants and anaplastic large cell Lymphoma etiology and Epidemiology (PROFILE) is based on scientific reports of possible association between Anaplastic Large Cell Lymphoma (ALCL) and breast implants. ASPS/PSF and FDA have collaborated to conduct research and launch the PROFILE to increase the scientific data on ALCL in women with breast implants. The primary goal of this registry is to better understand the role of the breast implants in the etiology of primary ALCL in women with breast implants. It can also help identifypotential risk factors and criteria detection and management of this disease. Additionally, the confirmed cases in the registry of primary ALCL in women with breast implants will be available for analytical epidemiological studies.

Just as NBIR, the PROFILE Registry captures data necessary to describe patient demographic characteristics and other medical history, implant procedure information, characteristics of the implant, clinical presentation, pathologic findings, and clinical course, treatment and treatment outcomes of patients with primary Breast Implant Associated ALCL.

V. Current Projects and Plans

In October 2018, the NBIR was launched broadly for use by everyone who performs breast implant procedures in the US. One-year post-launch, the NBIR now has over 500 sites registered to participate and over 4800 patient visits. An annual report summarizing key findings from year one of registry operations is currently underway. As of July 1, 2019, the NBIR can be used as an infrastructure for device tracking. Through this mechanism, we can increase registry participation among surgeons and minimize duplicate data entry in the operating room. The NBIR Steering Committee continues to strategize methods to increase participation and case capture.

ASPS/PSF is in the process of developing a breast implant symptom severity scale to examine common signs and symptoms that patients receiving breast implants may encounter. Upon completion of a Delphi Panel to identify these common symptoms, we will pilot the inclusion of PRO measurement tools for these symptoms within the NBIR. We will identify 10-20 high performing NBIR sites and invite them to participate. Upon completion of the pilot, which we anticipate could take between 12-18 months, we will broadly open up PROs within the NBIR.

International effort: The International Collaboration of Breast Registry Activities (ICOBRA) CRN based in Australia aims to encourage a collaborative approach to sharing registry science and registry data, and support emerging and existing breast device registries to enhance their effectiveness. The US was an inaugural signatory and there are now over 20 signatories. International collaboration including data points from six countries: Australia, Austria, The Netherlands, Sweden, United Kingdom, and United States as well as close partnership with the Australian Breast Device Registry helps identify data sources for this effort. Some of the benefits of a collaborative approach are a standardized minimum dataset, amplified dataset, facilitated data linkage and data comparison, enabled development of evidence-based international early warning systems.