Concordance between primary and secondary electronic healthcare databases: A multi-database self-controlled case series study

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/49387
• EU PAS number:
  EUPAS49386
• Study ID:
  49387
• Official title and acronym:
  Concordance between primary and secondary electronic healthcare databases: A multi-database self-controlled case series study
• DARWIN EU® study:
  No
• Study countries:
  Netherlands

  United Kingdom
• Study description:
  There is often mismatch between the recording of diagnoses in primary and secondary electronic healthcare data. Differences may exist in the recorded date of the event or whether it is recorded at all. For example, around two-fifths of all recorded stroke events are in both UK primary and secondary healthcare databases (within 120 days of each other) and around half of these had same-day recordings. The lack of concordance between different electronic health care records, which capture the same population, could lead to outcome misclassification and therefore bias, depending on which data domain is correct and then used in the epidemiologic study. Here we will describe the concordance between primary and secondary electronic healthcare data in the United Kingdom and the Netherlands in the occurrence of major bleeding. Agreement between the data settings, time gap between recordings and occurrence of recordings after recorded death date will be assessed. We will also compare the outcomes identified from different healthcare settings when applied to a self-controlled case series (SCCS) study. This will assess the association of major bleeding and use of direct oral anticoagulants or vitamin K antagonists for atrial fibrillation patients. The incidence rate of the outcome in exposed versus non-exposed time (incidence rate ratio) will be assessed, comparing outcomes derived from the different data domains. The aims of this study are to better inform pharmacoepidemiologic decision making.
• Study status:
  Planned

Research institution and networks

Institutions

Division of Pharmacoepidemiology & Clinical Pharmacology (PECP), Utrecht Institute for Pharmaceutical Sciences (UIPS), Utrecht University

Netherlands

Contact details

Klungel Olaf

Study contact

[e-mail]

Hunt Nicholas

Primary lead investigator

Study timelines

Date when funding contract was signed

Planned: 07/10/2022

Data collection

Planned: 01/12/2022

Date of final study report

Planned: 31/08/2023

Sources of funding

Other

More details on funding

none

Study protocol

Initial protocol

databaseconcordance_SCCS_protocol_v2.0

Regulatory

• Was the study required by a regulatory body?:
  No
• Is the study required by a Risk Management Plan (RMP)?:
  Not applicable