Characteristics of Real-World Data Landscape in Spain: A Scoping Review
Author(s)
Nilixa Raval, MDS, MPH1, Nency Joshipura, MD1, Ami Vyas, MBA, MS, PhD2, Amit D. Raval, PhD3.
1Nyra Health LLC, Piscataway, NJ, USA, 2University of Rhode Island, Kingston, RI, USA, 3University of North Texas Health Science Center, Fort Worth, NJ, USA.
1Nyra Health LLC, Piscataway, NJ, USA, 2University of Rhode Island, Kingston, RI, USA, 3University of North Texas Health Science Center, Fort Worth, NJ, USA.
OBJECTIVES: Spain is the fifth most populated country in the European Union, with 47 million people and 99.0% covered through health insurance. Understanding real-world data (RWD) availability and characteristics are key to generate fit-for-purpose evidence; therefore, this study aims to summarize the real-world data landscape within Spain using a scoping review of real-world database studies.
METHODS: An electronic search was performed in PubMed to identify studies utilizing ≥ 1 RWD published between Jan 2019 and Feb 2024. We included RWDs as a byproduct of the healthcare system (claims, electronic medical records, EMRs) and purpose-driven (registries, surveillance, surveys, app) or linkage of different RWDs.
RESULTS: Of 334 retrieved citations, 174 studies included ≥1 RWD. EMRs were the most commonly utilized type of RWD source. Most EMRs were specific to Spanish regions, given that health insurance is administered through 17 autonomous regions within Spain. Valencia, Galicia, Aragon, Madrid, Catalonia, Castilla-La Mancha, and Navarra were common regional EMRs. SIDIAP, BIFAP, BIG-PAC, IQVIA's clinical practice RealWorld Database, National Hospitalization Databases, and Spanish Ministry of Health database were most frequently utilized multi-regional EMRs. In addition, sixteen registry databases were identified with covered disease areas, including COVID-19, cancer, and rare diseases. Two surveillance-based databases were the Spanish National Study of Adverse Events in Primary Care and the Andalusian Epidemiological Surveillance System. Twelve studies utilized Adelphi disease-specific program-based data consisting of chart-review-based data on clinical characteristics, treatment, and outcomes reported by participating physicians as cross-sectional snapshots. Four studies utilized consortium or drug surveillance-based databases. Most databases had a latency period of 1 month to a year. Accessibility and conversation of existing RWDs to common data models were limited.
CONCLUSIONS: This review provides insights into the breadth of the RWD landscape in Spain. Findings showed RWDs were limited EMRs, mostly fragmented across regions, with potential accessibility issues
METHODS: An electronic search was performed in PubMed to identify studies utilizing ≥ 1 RWD published between Jan 2019 and Feb 2024. We included RWDs as a byproduct of the healthcare system (claims, electronic medical records, EMRs) and purpose-driven (registries, surveillance, surveys, app) or linkage of different RWDs.
RESULTS: Of 334 retrieved citations, 174 studies included ≥1 RWD. EMRs were the most commonly utilized type of RWD source. Most EMRs were specific to Spanish regions, given that health insurance is administered through 17 autonomous regions within Spain. Valencia, Galicia, Aragon, Madrid, Catalonia, Castilla-La Mancha, and Navarra were common regional EMRs. SIDIAP, BIFAP, BIG-PAC, IQVIA's clinical practice RealWorld Database, National Hospitalization Databases, and Spanish Ministry of Health database were most frequently utilized multi-regional EMRs. In addition, sixteen registry databases were identified with covered disease areas, including COVID-19, cancer, and rare diseases. Two surveillance-based databases were the Spanish National Study of Adverse Events in Primary Care and the Andalusian Epidemiological Surveillance System. Twelve studies utilized Adelphi disease-specific program-based data consisting of chart-review-based data on clinical characteristics, treatment, and outcomes reported by participating physicians as cross-sectional snapshots. Four studies utilized consortium or drug surveillance-based databases. Most databases had a latency period of 1 month to a year. Accessibility and conversation of existing RWDs to common data models were limited.
CONCLUSIONS: This review provides insights into the breadth of the RWD landscape in Spain. Findings showed RWDs were limited EMRs, mostly fragmented across regions, with potential accessibility issues
Conference/Value in Health Info
2025-11, ISPOR Europe 2025, Glasgow, Scotland
Value in Health, Volume 28, Issue S2
Code
RWD30
Topic
Methodological & Statistical Research, Real World Data & Information Systems, Study Approaches
Topic Subcategory
Distributed Data & Research Networks, Health & Insurance Records Systems
Disease
Cardiovascular Disorders (including MI, Stroke, Circulatory), No Additional Disease & Conditions/Specialized Treatment Areas, Oncology, Rare & Orphan Diseases, Systemic Disorders/Conditions (Anesthesia, Auto-Immune Disorders (n.e.c.), Hematological Disorders (non-oncologic), Pain)