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Clinical Registries Are Crucial to Protect Public Health. They Need More Support.

Wednesday, June 17, 2020   (0 Comments)
Posted by: Kasia Januszewski
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Published June 17, 2020, on


COVID-19 was first detected at the end of December 2019 by a clinical registry network. China’s disease surveillance system identified an unusual cluster of pneumonia cases of unknown cause in Hubei province (1, 2). Based on the type and pattern of symptoms alone, researchers suspected a new coronavirus similar to those causing SARS and MERS (3) – before biomedical tests confirmed it.

China was able to make this early call because it strengthened its registry and infectious diseases response infrastructure (4) after being caught off guard by SARS in 2003. This enhanced registry system helped coordinate their COVID-19 response, guiding lockdowns and effectively allocating resources across the country.

Similar surveillance registry improvements in West Africa (5) proved essential in the 2014 Ebola outbreak. They helped contain what might have become a worldwide outbreak.

These examples demonstrate the value of maintaining and improving clinical registry networks to protect public health and increase epidemic preparedness. Without the accurate data and timely insights that registries provide, the health of the public is placed at risk.

The current crisis reveals cracks in our registry network. Credible private and public sources report varying numbers. New registries pop up almost daily (6) tracking everything from local outbreaks, to potential treatments, to trying to find hot spots using crowd-sourced data.

While useful and well-intentioned, this proliferation also can be confusing. More importantly, inconsistent data definitions and collection standards make it difficult to compare and combine findings across registries, limiting their potential utility. Better coordination and standardization of registries and their data are required to realize the value of this vital piece of health infrastructure.

Unfortunately, the trend has been in the opposite direction. Worldwide funding for public health prevention and detection has flattened in recent years (7), and registries and data standardization research often suffer.

For example, the federal government has required data standardization and promoted interoperability in electronic health records from the Health Information Technology for Economic and Clinical Health (HITECH) Act in 2009 (8) through the latest regulations implementing the 21st Century Cures Act this March (9). Yet most of the work to develop it has been voluntary, often led by medical specialty societies with limited resources. Compounding the issue, last year the Registry of Patient Registries – a federal program designed specifically to coordinate and leverage data from hundreds of diverse registries – closed due to funding cuts (10).

Such moves weaken registry networks just when they are needed most. In addition to disease surveillance, registries are essential for improving patient care while reducing waste (11), developing new medicines and finding new uses for existing therapies (12, 13), and developing lifesaving personalized treatments (14). They also help identify unmet medical and social needs (15).

Bottom line, clinical data registries contribute to better patient care and better health outcomes across the board. They are the backbone not only of public health, but of health services improvement overall. But they need to be strengthened to achieve their full potential. As a leading developer of clinical registries and quality measures, we at PCPI believe the following steps should be taken:

  • Restore funding for and expand the Registry of Patient Registries. This will help get the most out of registry data by ensuring that it can be shared, combined and analyzed across registries.
  • Increase support for standardizing how registry data are formatted and exchanged electronically. The Department of Health and Human Services started this work with its interoperability and data sharing rules. However, much technical work remains before health databases everywhere can fluently talk to each other. Among other things, this means adopting uniform standards for gathering, formatting and reporting registry data, including the Fast Healthcare Interoperability Resources (FHIR, 16, 17) and the Systematized Nomenclature of Medicine (SNOMED, 18).
  • Support medical specialty societies in developing registries and registry-based quality measures. While the federal government requires doctors to measure performance and improve quality, it provides no funding for developing the registries and measures needed to do so.

It takes money and both clinical and IT expertise to develop registry systems capable of accomplishing these essential health missions. But the health returns will be immense.

In the current crisis, better coordinated and standardized case definitions, and other data norming could make it easier to answer critical questions. These include what early symptoms look like, when symptoms require hospitalization and when patients recover. It could also help develop more-reliable risk models to triage patients to different levels of care, and more accurately track the number of cases and deaths.

Moreover, large data sets often contain previously unrecognized patterns and associations only detectable through artificial intelligence. Linking structured registry data with administrative claims data on long-term survival, readmissions, re-interventions and resource use, as well as unstructured electronic health record data, will help answer diagnostic and therapeutic questions that elude traditional approaches, according to David M. Shahian, M.D., professor of surgery at Harvard Medical School and co-chair of the NQRN Advisory Committee.

We urge Congress to fund clinical data registries as the vital public health and health improvement infrastructure that they are. Our lives may literally depend on it.

References and links:

(1) Guo YR et al. The origin, transmission and clinical therapies on coronavirus disease 2019 (COVID-19) outbreak – an update on the status. Mil Med Res. 2020; 7: 11.

(2) Pneumonia of unknown cause – China. Disease outbreak news, World Health Organization. 5 January 2020.

(3) Huang C et al. Clinical features of patients infected with 2019 novel coronavirus in Wuhan, China. The Lancet Feb 15 2020;395:497-506.

(4) Chan LH et al. China's Engagement with Global Health Diplomacy: Was SARS a Watershed? PLoS Med. 2010 Apr; 7(4): e1000266.

(5) National and regional surveillance systems. Ebola: Health systems recovery. World Health Organization 2016.

(6) Doctors Are Pooling Data to Help Understand Covid-19. Wired March 25, 2020.

(7) Breaking Down the U.S. Global Health Budget by Program Area. Kaiser Family Foundation March 12, 2020.

(8) Public Health and Promoting Interoperability Programs. US Centers for Disease Control and Prevention. Sept 9, 2019.

(9) HHS Finalizes Historic Rules to Provide Patients More Control of Their Health Data. US Dept of Health and Human Services, March 9, 2020.

(10) Registry of Patient Registries. AHRQ April 2019.

(11) Dewan EH et al. Impact of clinical registries on quality of patient care and clinical outcomes: A systematic review. PLoS One. 2017; 12(9): e0183667.

(12) Andre EB et al. Trial designs using real‐world data: The changing landscape of the regulatory approval process. Pharmacoepidemiology and Drug Safety. Dec 10, 2019;

(13) Use of Real-World Evidence to Support Regulatory Decision-Making for Medical Devices: Guidance for Industry and Food and Drug Administration Staff. US Food and Drug Administration. Aug 31, 2017. Document number 1500012.

(14) The Importance of Registries in the Personalized Medicine Revolution: A Q&A With the President of CURE-1, Dane Dickson, MD. American Journal of Managed Care Supplements. Aug 24, 2017.

(15) Capturing Social and Behavioral Domains and Measures in Electronic Health Records: Phase 2. Institute of Medicine (IOM). Washington, D.C.: National Academies Press; 2015.

(16) Fast Healthcare Interoperability Resources. HL7 FHIR Release 4.

(17) Logica Implementation Guide: Covid-19 - Local Development build (v0.5.1).

(18) SNOMED International.

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