Quality and completeness of rheumatoid arthritis (RA) diagnosis in CPRD GOLD and CPRD AURUM

Study type
Protocol
Date of Approval
Study reference ID
20_000064
Lay Summary

Patient medical data using Vision patient management software has been collected for over three decades and is managed by the CPRD. CPRD GOLD data has been well described and validated with over 2,400 peer-reviewed publications in the last 30 years. CPRD is now providing data from a new medical record database, CPRD Aurum, which encompasses data on over 900 general practices and 30 million patients to date. Like CPRD GOLD, CPRD Aurum contains electronic healthcare records entered by GPs, however, CPRD Aurum uses a different GP patient management software, EMIS. Unlike the Vision patient management software that supports CPRD GOLD, EMIS was not developed with the additional intent to provide data for medical research. It is currently unknown what, if any, impact the differences in the two software platforms may have on the quality of the data for research purposes. Understanding the characteristics, strengths, and limitations of any new electronic medical data source is a critical step towards making decisions about its suitability for use in medical research.
CPRD GOLD is regularly used to study many diseases and to estimate prevalence and incidence of diseases, patient characteristics, laboratory measurements, treatment patterns and drug effectiveness and safety. Understanding how the new and larger CPRD Aurum databases compares with CPRD GOLD will enhance research capabilities in setting up and carrying out studies of different disease areas and drug exposures.

Technical Summary

CPRD is now providing data from a new medical record database, CPRD Aurum, which encompasses data on over 900 practices and 30 million patients. Like CPRD GOLD, CPRD Aurum contains electronic healthcare records entered by GPs to facilitate clinical care; however, CPRD Aurum uses a different GP patient management software, EMIS. Unlike the Vision patient management software that supports CPRD GOLD, EMIS was not developed with the additional intent to provide data for medical research. While CPRD GOLD and Aurum data are sourced from the same UK health care system, it is unknown what, if any, impact the differences in the two software platforms may have on the quality of the data for research purposes.
We will describe the presence of codes for RA diagnoses, tests, and treatments consistent with a diagnosis of RA, based on NICE guidelines, and compare the presence of these elements in CPRD Aurum and CPRD GOLD. We will develop an algorithm based on the presence of diagnoses, prescriptions, and/or supporting clinical codes to classify the likelihood that the patient is a “true” RA case based on the codes present in their CPRD Aurum and CPRD GOLD electronic records. Amgen researchers will conduct parallel analyses using the same patient population to confirm the findings.
Using the data quality assessment methodologies described by Weiskopf and Weng (Weiskopf 2013), we will estimate completeness of records in CPRD Aurum and CPRD GOLD compared to those in Hospital Episode Statistics (HES). Completeness estimates the presence or missingness of a diagnosis. Completeness will be calculated as the proportion of patients with ≥1 RA diagnosis recorded in HES who also have RA recorded in CPRD Aurum or CPRD GOLD.
Finally, we will estimate and compare crude and age-standardized incidence rates of RA in CPRD Aurum and CPRD GOLD.

Health Outcomes to be Measured

We will:
• compare the proportion of patients who have the following data elements present (yes/no) in their CPRD Aurum record compared to the proportion of patients with these same elements recorded in CPRD GOLD:
o RA diagnoses
o RA drug treatment
o Analgesic prescriptions
o RA labs
o Supporting Clinical Codes that indicate RA (e.g. specialist referrals and office visits, monitoring for RA drugs, RA symptoms, and disease activity)
• estimate an RA likelihood classification (Likely, Possible, Unsupported) in CPRD Aurum compared to CPRD GOLD;
• calculate crude and age standardized incidence rates of RA in CPRD Aurum compared CPRD GOLD;
• calculate completeness of RA diagnoses recorded in CPRD Aurum and CPRD GOLD compared to HES (APC and OP)

These outcomes will also be compared by time period (2005-2009, 2010-2019) to reflect the changes in the NICE guidelines over time.

Collaborators

Susan Jick - Chief Investigator - BCDSP - Boston Collaborative Drug Surveillance Program
Catherine Vasilakis-Scaramozza - Corresponding Applicant - BCDSP - Boston Collaborative Drug Surveillance Program
David Neasham - Collaborator - Amgen Ltd
George Kafatos - Collaborator - Amgen Ltd
Katrina Hagberg - Collaborator - BCDSP - Boston Collaborative Drug Surveillance Program
Rebecca Persson - Collaborator - BCDSP - Boston Collaborative Drug Surveillance Program
Todd Sponholtz - Collaborator - BCDSP - Boston Collaborative Drug Surveillance Program

Linkages

HES Admitted Patient Care;HES Outpatient