Index Date Validation in OCEANIA a Real-World Database Study – The Importance of Looking Back
Author(s)
Abreu G1, Queiroz J1, Nogueira T1, Soares C1, Menezes P1, Santana P1, Bernardino G1, Pires T1, Carrizo M2, Criniti J2, Felice RM2, Scibona P3, Savoy NE3, Simonovich V4, Zamora L3, Riggi MC3, Cravero F3, Odetto D3, Saadi J3, Luiz Alves Ribeiro de Souza A5, Gomes ALBB5, Jotimliansky L2
1GSK, Rio de Janeiro, Brazil, 2GSK, Buenos Aires, Argentina, 3Hospital Italiano de Buenos Aires, Buenos Aires, Argentina, 4Hospital Italiano de Buenos Aires, CABA, B, Argentina, 5Orizon, Sao Paulo, Brazil
Presentation Documents
OBJECTIVES: A concern in database studies is the index date definition, which impacts how survival and exposure outcomes are measured/reported. Most studies use first medical code as standard. This analysis compared the validity of this approach against a multi-coding approach in two real-world databases of patients with ovarian cancer (OC).
METHODS: OCEANIA, a retrospective cohort study, assessed data from patients with OC from a Brazilian health claims (2015–2020) database and Argentinian hospital (2010–2019) database. In the standard approach, the index date (proxy for diagnosis) was defined as either the first date of an OC-related medical code (Argentina) or an ICD-10 code assignment (Brazil). In the multi-coding approach, the index date was determined by reviewing patient records to identify the first event/procedure that could retrospectively be considered OC-related ≤180 days prior to the first OC code. Mean, median and standard deviation (SD) of patient follow-up durations were calculated.
RESULTS: In the Brazilian database, 2529 patients with OC were identified. Mean follow-up duration from the standard index date to last database input was 542.9 (SD=472.3; median 394.0) days. Using the multi-coding approach, mean follow-up changed to 623.5 (SD=476.5; median 479.0) days. Among 2126 patients that had their index updated, mean follow-up increased by 95.8 (SD=53.9; median 97.0) days. In the Argentinian database, 741 patients with OC were identified. Mean follow-up duration was 938.7 (SD=925.7; median 664) days with the standard approach. The multi-coding approach increased the mean follow-up to 965.2 (SD=932.3; median 709.0) days. Among 347 patients that had their index updated, mean follow-up period increased by 76.0 (SD=176.8; median 31) days.
CONCLUSIONS: The choice of index date for database studies requires careful consideration to ensure accurate interpretation of time-dependent outcomes, which may help minimise bias and improve data validity.
Funding: GSK213815. Editorial support by Fishawack Health, funded by GSK.Conference/Value in Health Info
Value in Health, Volume 25, Issue 12S (December 2022)
Code
RWD155
Topic
Real World Data & Information Systems
Topic Subcategory
Data Protection, Integrity, & Quality Assurance, Health & Insurance Records Systems, Reproducibility & Replicability
Disease
SDC: Reproductive & Sexual Health, STA: Drugs, STA: Surgery