(B46) Maximising the use of real-world data from multiple sources to generate comprehensive evidence: insights from retrospective cohorts of allogeneic hematopoietic cell transplant recipients with adenovirus infection
Background: Administrative claims databases are increasingly used for pharmacoepidemiology studies, supported by the development of patient identification and variable definition algorithms. However, there is limited guidance on making the best use of data, including when and how to complement claims data with data derived from medical charts. Another important consideration is whether the study population and endpoints derived from these data sources would be comparable, especially when evidence is sparse, or conditions are rare.
Objectives: This study aims to assess and compare the incidence of adenovirus (AdV) infection and patient characteristics among allogeneic hematopoietic cell transplant (allo-HCT) recipients in France using data from administrative health claims vs. patient medical charts.
Methods: A retrospective analysis using the French SNDS (‘Système National des Données de Santé’) was conducted to identify all allo-HCT recipients (using procedure code) between 2011-2016 and, among them, patients with documented AdV infection (using International Classification of Diseases, 10th revision [ICD-10] codes). A retrospective chart review (‘AdVance’ study) was also conducted in ten French centers. Comparisons of AdV infection incidence and patient characteristics between SNDS and AdVance data were conducted at an aggregated level.
Results: 1,302 pediatric and 7,412 adult allo-HCT recipients were identified in the SNDS, showing good consistency with numbers of allo-HCTs reported by the European Society for Blood and Marrow Transplantation (EBMT) Transplant Activity Survey during the same time period. Among them, 9.8% pediatric and 1.3% adult patients were hospitalized with an ICD-10 code reflecting AdV infection. In the AdVance study, 20.6%, 13.6%, and 5.6% of allo-HCT pediatric patients presented with any AdV positive test, any AdV viremia, and AdV viremia ≥1,000 c/mL, respectively. Among adult patients, 4.1%, 1.7%, and 1.1% presented with any AdV positive test, any AdV viremia, and AdV viremia ≥1,000 c/mL, respectively. Distributions of clinical and demographic characteristics were comparable for both studies.
Conclusions: This study suggests good representativeness of the SNDS in terms of capturing allo-HCT patients. Comparison of the incidence of reported AdV infection in both studies suggests the ICD-10 codes for AdV infection are more likely to be reflective of patients with AdV viremia. Further studies linking SNDS with medical chart data will provide additional insight into the validation of codes and allow for the use of more granular clinical data from charts and additional longitudinal follow-up data from claims.