Disease registry

Disease or patient registries are collections of secondary data related to patients with a specific diagnosis, condition, or procedure, and they play an important role in post marketing surveillance of pharmaceuticals.[1] Registries are different from indexes in that they contain more extensive data.

In its simplest form, a disease registry could consist of a collection of paper cards kept inside "a shoe box" by an individual physician. Most frequently registries vary in sophistication from simple spreadsheets that only can be accessed by a small group of physicians to very complex databases that are accessed online across multiple institutions.[2]

They can provide health providers (or even patients) with reminders to check certain tests in order to reach certain quality goals.

## Versus electronic medical records

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Registries are less complex and simpler to set up than electronic medical records that according to a recent survey are only used by 9% of small offices where almost half of the US doctors work.[3]

An electronic medical record keeps track of all the patients a doctor follows but a registry only keeps track of a small sub population of patients with a specific condition.

## Types of medical conditions tracked

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More than 130 million Americans live with chronic diseases and chronic diseases account for 70% of all deaths in the US. "The medical care costs of people with chronic diseases account for more than 75% of the nation's $2 trillion medical care costs."[4]

Registries target certain conditions because medical expenses are unevenly distributed: most health care expenses are spent treating patients with a few chronic conditions.[5]

For example, the 2002 expenses with diabetes in the US was $132 billion, and this was around 12% of the US medical budget. Diabetes accounts for 25% of the Medicare budget.[6] Given this, diabetes is one of the conditions targeted by registries. Diabetes is also amenable to this because there is a target population that can be defined according to certain rules and there is evidence that certain tests like retina exams, LDL levels, HgbA1c levels can correlate with quality of care in diabetes.[7]

Because of the diabetes impact, New York City created a HbA1C Registry (NYCAR) to help health providers keep track of patients with diabetes.[8] Another example of disease registry is the New York State CABG Registry that tracks all cardiac bypass surgery performed in the state of New York.[9]

Cerebral palsy is an example of a chronic or lifelong medical condition. It is a major cause of childhood disability worldwide. The Australian cerebral palsy register represents an example of a recognized disease register.[10] The aim of the Australian CP register is to conduct surveillance or constant observation of cerebral palsy prevalence, clinical patterns and complications. It is also tasked with providing recommendations to public health policy makers and improving health service delivery to individuals with cerebral palsy.[11] More recently, several developing countries such as Bangladesh and Sri lanka have established cerebral palsy registers geared toward achieving the same above-noted aims.[12][13][14]

On a survey of 1040 US physician organizations published in Journal of the American Medical Association,[15] diabetes registries are used by 40.3%, asthma registries are used by 31.2% of physician organizations, CHF registries are used by 34.8% and depression registries are used by 15.7%.

Other tests like Pap smears are also useful to keep track in registries because there is evidence that when done annually in women of certain ages groups can detect and prevent cervical cancer.[16]

Many of measures tracked are based on evidence-based medicine and are defined and standardized by national organizations like the NCQA.

Patient registries are particularly useful for evaluating the safety of orphan drug products as well as the safety of drugs in specific populations.[17] However, it is getting more and more common to use data of different healthcare and disease registries innovatively for different purposes such as for generating evidence for healthcare efficiency, market access planning and pharmacovigilance[18]

## Medical devices registries

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Countries like Australia, Britain, Norway, Sweden,[19] and America[20] have a national joint replacement registry to track patients with artificial joints.

"The use of joint registries has proven beneficial abroad. In Australia, regulators use such data to force manufacturers to justify why poorly performing hips or knees should remain available, and products have been withdrawn as a result. In Sweden several years ago, surgeons alerted by their national registry stopped using a badly flawed hip long before their American counterparts did. A few medical organizations in the USA, like Kaiser Permanente, operate their own registries to good effect and the Hospital for Special Surgery in New York has recently set up a registry. Experts say that the United States wastes billions of dollars annually on medical treatments which may not work. But the financial and human consequences are also large when evidence exists but is not collected."[21]

## Cost-effectiveness

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The cost-effectiveness of a disease registry is related with the cost-effectiveness of prevention of specific medical conditions. Increasing compliance through a registry with preventive measures like children vaccination or colonoscopy screening can actually be a cost-saving measure.[22] "A mammogram every 2 years for women aged 50–69 costs only about $9,000 per year of life saved. This cost compares favorably with other widely used clinical preventive services."[23]

## Pay-for-performance (P4P)

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Registries can be associated with pay-for-performance (P4P) quality based contracts for individual doctors, groups of doctors or even all doctors in a country. For example, the United Kingdom, rewards physicians according to 146 quality measures related with 10 chronic diseases that are tracked electronically.[24]

In the United States, Medicare also started a 1.5% P4P contract based on health measures that can be tracked by disease registries.[25]

## Technical aspects of data tracking

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The quality of a disease registry is contingent on the quality of its data and all the processes involved in updating it and keeping its integrity. In every registry there is always a risk of "garbage in, garbage out". Issues that can affect a registry and its acceptance by a physician group:

* Is the registry only updated centrally or can a physician update or correct it? For example, a physician does not want to get reminders from a registry regarding diabetes patients that died, moved to another state or left her/his practice.
* Most frequently, a list of patients with a certain condition (e.g. diabetes) is generated based on certain criteria. In the U.S., Healthcare Effectiveness Data and Information Set (HEDIS) criteria are set annually by the National Committee for Quality Assurance (NCQA). These criteria, in order to avoid paper charts reviews are in most cases based on insurance claims. For example, for diabetes, HEDIS selects an eligible population based on age (18–75 years), continuous enrollment with a certain health insurer and certain "Events/diagnosis" from pharmacy data (electronic), insurance claims data (electronic) or from medical records. Pharmacy data is based on a list of medications prescribed for diabetes.[26][27] Claims data is based on having two outpatient visits with a doctor or one inpatient hospital admission or one emergency room visit with the diagnosis of diabetes. Patients are excluded if they have polycystic ovaries or just gestational diabetes. Despite the strict criteria it is possible for physicians to have patients on their registries that are not truly diabetic.[28]

## Examples

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Below is a growing list of patient registries.

* Newborn Screening (NBS) Connect Patient Registry for patients with inborn errors of metabolism[29]
* DuchenneConnect Patient Registry for patients with Duchenne and Becker Muscular Dystrophy.[30]
* PatientCrossroads – pan disease patient registries[31]
* International Collaborative Gaucher Group (ICGG) Gaucher Registry is largest ongoing longitudinal international database that tracks demographic and clinical outcome data from patients with Gaucher disease[32]
* Vascular health ASsessment Of The hypertENSive patients (VASOTENS) Registry, the international registry for ambulatory blood pressure and arterial stiffness telemonitoring.[33]
* TREAT-NMD patient registries in neuromuscular disorders[34]

## See also

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* Clinical trials registry

## References

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1. ^ McNeil, JJ; Piccenna, L; Ronaldson, K; et al. (2010). "The Value of Patient-Centered Registries in Phase IV Drug Surveillance". Pharm Med. 24 (5): 281–288\. doi:10.1007/bf03256826. S2CID 19091146. Archived from the original on 2012-07-07. Retrieved 2011-06-17.
2. ^ "ACP Observer, September 2005 - Patient registries: a key step to quality improvement". Archived from the original on 2012-07-31.
3. ^ DesRoches, Catherine M.; Campbell, Eric G.; Rao, Sowmya R.; Donelan, Karen; Ferris, Timothy G.; Jha, Ashish; Kaushal, Rainu; Levy, Douglas E.; Rosenbaum, Sara; Shields, Alexandra E.; Blumenthal, David (3 July 2008). "Electronic Health Records in Ambulatory Care — A National Survey of Physicians". New England Journal of Medicine. 359 (1): 50–60\. doi:10.1056/NEJMsa0802005. PMID 18565855.
4. ^ "Chronic Diseases and Health Promotion". Archived from the original on 2011-07-26. Retrieved 2008-07-09.
5. ^ "The High Concentration of U.S. Health Care Expenditures: Research in Action, Issue 19, Chart 1". Archived from the original on 2008-07-09. Retrieved 2008-06-26.
6. ^ "DAGC.ORG - Diabetes Statistics - United States".
7. ^ Association, American Diabetes (1 January 2003). "Standards of Medical Care for Patients With Diabetes Mellitus". Diabetes Care. 26 (suppl 1): s33 – s50. doi:10.2337/diacare.26.2007.S33. PMID 12502618 – via care.diabetesjournals.org.
8. ^ The NYC Hemoglobin A1C Registry (NYCAR) : Diabetes Prevention and Control Program : NYC DOHMH Archived June 9, 2007, at the Wayback Machine
9. ^ Hannan, Edward L.; Racz, Michael J.; Walford, Gary; Jones, Robert H.; Ryan, Thomas J.; Bennett, Edward; Culliford, Alfred T.; Isom, O. Wayne; Gold, Jeffrey P.; Rose, Eric A. (26 May 2005). "Long-Term Outcomes of Coronary-Artery Bypass Grafting versus Stent Implantation". New England Journal of Medicine. 352 (21): 2174–2183\. doi:10.1056/NEJMoa040316. PMID 15917382.
10. ^ "Australian Cerebral Palsy Register Bulletin Birth years 1995-2018, March 2025" (PDF). Retrieved 28 April 2025.
11. ^ Register, C. P. "Home | CP Register". Australian CP Register website. Retrieved 28 April 2025.
12. ^ "Cerebral Palsy Register". srilanka.cpregister.com.
13. ^ Heiyanthuduwage, Thilini Madushika; Sumanasena, Samanmali P; Kitnasamy, Gopi; Smithers Sheedy, Hayley; Khandaker, Gulam; Fernando, Romaniya; Wijesekara, Saraji; Jagoda, Jayatri; Ratnayake, Pyara; Wanigasinghe, Jithangi; Mclntyre, Sarah; Goldsmith, Shona; Waight, Emma; Badawi, Nadia; Muhit, Mohammad; Muttiah, Nimisha (August 2020). "Protocol for the Sri Lankan Cerebral Palsy Register pilot study". BMJ Open. 10 (8): e039353. doi:10.1136/bmjopen-2020-039353. PMC 7443274. PMID 32820001.
14. ^ Khandaker, Gulam; Smithers-Sheedy, Hayley; Islam, Johurul; Alam, Monzurul; Jung, Jenny; Novak, Iona; Booy, Robert; Jones, Cheryl; Badawi, Nadia; Muhit, Mohammad (December 2015). "Bangladesh Cerebral Palsy Register (BCPR): a pilot study to develop a national cerebral palsy (CP) register with surveillance of children for CP". BMC Neurology. 15 (1). doi:10.1186/s12883-015-0427-9. PMC 4582618. PMID 26407723.
15. ^ "JAMA – The Latest Medical Research, Reviews, and Guidelines". jama.ama-assn.org.
16. ^ "Cervical cancer screening guideline: October 2006. - National Guideline Clearinghouse". www.guideline.gov. Archived from the original on 2008-09-28. Retrieved 2008-06-26.
17. ^ McNeil, JJ; Piccenna, L; Ronaldson, K; et al. (2010). "The value of patient-centred registries in phase IV drug surveillance". Pharm Med. 24 (5): 281–288\. doi:10.1007/bf03256826. S2CID 19091146. Archived from the original on 2012-07-07. Retrieved 2011-06-17.
18. ^ "RWD / RWE Guide - RemedyBytes". 2023-02-21. Retrieved 2023-03-16.
19. ^ Larsson, Stefan; Lawyer, Peter; Silverstein, Martin B. (November 2010). "From Concept to Reality: Putting Value-Based Health Care into Practice in Sweden". Boston Consulting Group. Retrieved 2011-07-06.
20. ^ "American Joint Replacement Registry - Improving orthopaedic care through data". ajrr.net. Archived from the original on 2016-02-08. Retrieved 2016-02-03.
21. ^ Meier, Barry (2008-07-29). "A call for a warning system on artificial joints". The New York Times.
22. ^ Cohen, Joshua T.; Neumann, Peter J.; Weinstein, Milton C. (14 February 2008). "Does Preventive Care Save Money? Health Economics and the Presidential Candidates". New England Journal of Medicine. 358 (7): 661–663\. doi:10.1056/NEJMp0708558. PMID 18272889.
23. ^ "Chronic Disease - Overview". Archived from the original on 2011-07-26. Retrieved 2008-07-09.
24. ^ Doran, Tim; Fullwood, Catherine; Gravelle, Hugh; Reeves, David; Kontopantelis, Evangelos; Hiroeh, Urara; Roland, Martin (27 July 2006). "Pay-for-Performance Programs in Family Practices in the United Kingdom". New England Journal of Medicine. 355 (4): 375–384\. doi:10.1056/NEJMsa055505. PMID 16870916. S2CID 22548030.
25. ^ "Overview". www.cms.hhs.gov. 11 October 2017. Archived from the original on 18 March 2023. Retrieved 26 June 2008.
26. ^ "NCQA > 404error". www.ncqa.org.
27. ^ "NCQA > 404error". www.ncqa.org.
28. ^ Newton, K. M.; Wagner, E. H.; Ramsey, S. D.; McCulloch, D.; Evans, R.; Sandhu, N.; Davis, C. (1999). "Redirecting". Journal of Clinical Epidemiology. 52 (3): 199–207\. doi:10.1016/S0895-4356(98)00161-9. PMID 10210237.
29. ^ "Home".
30. ^ "Home".
31. ^ "Invitae - Patient Insights Network". www.patientcrossroads.com.
32. ^ "Gaucher Disease - The ICGG Gaucher Registry". www.gauchercare.com. Archived from the original on 2014-08-26. Retrieved 2014-08-25.
33. ^ "Home page - Vasotens Registry". VASOTENS.
34. ^ "TREAT-NMD : List of registries by disease". www.treat-nmd.eu. Retrieved 2018-06-13.