f4359663fa6639777f79689df4b77208 311736.pdf 056bd03efbc0c1617b2b37634cd28e6b5dba8004 311736.pdf 70bb42635679ac81af829347d915cbaaf4a248789ada5c0bd8b5dd6ffc2d0162 311736.pdf Title: Evaluating the Quality of Real-World Data on Adherence to Oral Endocrine Therapy in Breast Cancer Patients: How Real Is Real-World Data? Subject: Purpose: The aim of this study was to compare estimates of adherence to oral endocrine therapy (OET) based on real-world data (RWD) and on clinical evaluation in people diagnosed with breast cancer in the public healthcare system in Catalonia (Spain). Methods: We conducted two retrospective cohort studies. Cohort 1 (RWD) consisted of women diagnosed with breast cancer in 2021 in the public healthcare system of Catalonia (Spain). Sources of RWD were the pharmacy billing register, hospital discharge records, and the Catalan health division’s central insurance registry. Nonadherence was defined as below 80% adherence in the first year of treatment. Data for cohort 2 came from two population-based cancer registries in Girona and Tarragona (Catalonia), with diagnoses from 2007 to 2011. We evaluated the impact of variables missing from RWD, such as stage and hormonal status. Analyses were performed using a chi-square test and logistic regression, with results stratified by age group and drug type. Results: Nonadherence at one year was 10.9% in cohort 1 and 11.3% in cohort 2. When we reviewed the medical records of a selection of nonadherent women from cohort 1, we found only 59.4% had documented treatment interruptions. Reasons for interruptions in the patients from RWD cohort included adverse effects (48.8%), patient decision (40.0%), medical reasons (29.4%), and other clinical causes (14.7%). Women aged under 50 years and those receiving tamoxifen or a sequential regimen had lower adherence. Determinants associated with nonadherence were similar in both approaches used. Conclusions: This study confirms the validity of estimating adherence with RWD from the Spanish national health system, although when combined with reviewing medical records, this may provide more reliable and higher-quality data. The RWD method provides valuable evidence to help oncologists discuss adherence with their patients. Keywords: breast cancer; oral endocrine therapy; real-world-data; adherence validation Author: A Navarro-Sabaté, R Font, JA Espinàs, J Solà, F Martínez-Soler, M Gil-Gil, G Viñas, A Tibau, M Borrell, M Segui, M Margelí, S Servitja, C Perez, M Domenech, M Nava, M Marin, S Gonzalez and JM Borràs Creator: LaTeX with hyperref Producer: pdfTeX-1.40.25 CreationDate: Fri Jan 10 03:39:14 2025 CET ModDate: Fri Jan 10 03:42:19 2025 CET Custom Metadata: no Metadata Stream: no Tagged: no UserProperties: no Suspects: no Form: none JavaScript: no Pages: 11 Encrypted: no Page size: 595.276 x 841.89 pts (A4) Page rot: 0 File size: 598478 bytes Optimized: no PDF version: 1.7 name type encoding emb sub uni object ID ------------------------------------ ----------------- ---------------- --- --- --- --------- WNWTFR+VnURWPalladioL-Bold Type 1 Custom yes yes yes 10 0 RIREYM+URWPalladioL-Roma Type 1 Custom yes yes yes 16 0 BNHASN+URWPalladioL-Bold Type 1 Custom yes yes yes 22 0 VZLIEB+URWPalladioL-Ital Type 1 Custom yes yes yes 27 0 AIRHKL+VnURWPalladioL Type 1 Custom yes yes yes 32 0 MKHAGN+PalatinoLinotype,Bold TrueType WinAnsi yes yes no 70 0 MKHAHO+PalatinoLinotype CID TrueType Identity-H yes yes yes 73 0 MKHAHP+PalatinoLinotype TrueType WinAnsi yes yes no 79 0 MKHAIB+PalatinoLinotype,Italic TrueType WinAnsi yes yes no 82 0 MKHBBO+PalatinoLinotype TrueType MacRoman yes yes no 85 0 PDTLUH+CMSY10 Type 1 Builtin yes yes yes 92 0 WBVKDJ+URWPalladioL-BoldItal Type 1 Custom yes yes yes 100 0 Jhove (Rel. 1.28.0, 2023-05-18) Date: 2025-05-23 02:49:37 CEST RepresentationInformation: 311736.pdf ReportingModule: PDF-hul, Rel. 1.12.4 (2023-03-16) LastModified: 2025-05-22 20:00:41 CEST Size: 598478 Format: PDF Version: 1.7 Status: Well-Formed and valid SignatureMatches: PDF-hul MIMEtype: application/pdf PDFMetadata: Objects: 242 FreeObjects: 1 IncrementalUpdates: 0 DocumentCatalog: PageLayout: SinglePage PageMode: UseNone Outlines: Item: Title: Introduction Destination: section.1 Item: Title: Materials and Methods Destination: section.2 Children: Item: Title: Cohort 1: Based on Real-World Data Destination: subsection.2.1 Item: Title: Cohort 2: Breast Cancer Patients Identified in Population-Based Cancer Registries Destination: subsection.2.2 Item: Title: Statistical Analysis Destination: subsection.2.3 Item: Title: Results Destination: section.3 Children: Item: Title: Analysis of Cohort 1 Destination: subsection.3.1 Item: Title: Reanalysis of Cohort 2 Destination: subsection.3.2 Item: Title: Discussion Destination: section.4 Item: Title: Conclusions Destination: section.5 Item: Title: References Destination: section.6 Info: Title: Evaluating the Quality of Real-World Data on Adherence to Oral Endocrine Therapy in Breast Cancer Patients: How Real Is Real-World Data? Author: A Navarro-Sabaté, R Font, JA Espinàs, J Solà, F Martínez-Soler, M Gil-Gil, G Viñas, A Tibau, M Borrell, M Segui, M Margelí, S Servitja, C Perez, M Domenech, M Nava, M Marin, S Gonzalez and JM Borràs Subject: Purpose: The aim of this study was to compare estimates of adherence to oral endocrine therapy (OET) based on real-world data (RWD) and on clinical evaluation in people diagnosed with breast cancer in the public healthcare system in Catalonia (Spain). Methods: We conducted two retrospective cohort studies. Cohort 1 (RWD) consisted of women diagnosed with breast cancer in 2021 in the public healthcare system of Catalonia (Spain). Sources of RWD were the pharmacy billing register, hospital discharge records, and the Catalan health division’s central insurance registry. Nonadherence was defined as below 80% adherence in the first year of treatment. Data for cohort 2 came from two population-based cancer registries in Girona and Tarragona (Catalonia), with diagnoses from 2007 to 2011. We evaluated the impact of variables missing from RWD, such as stage and hormonal status. Analyses were performed using a chi-square test and logistic regression, with results stratified by age group and drug type. Results: Nonadherence at one year was 10.9% in cohort 1 and 11.3% in cohort 2. When we reviewed the medical records of a selection of nonadherent women from cohort 1, we found only 59.4% had documented treatment interruptions. Reasons for interruptions in the patients from RWD cohort included adverse effects (48.8%), patient decision (40.0%), medical reasons (29.4%), and other clinical causes (14.7%). Women aged under 50 years and those receiving tamoxifen or a sequential regimen had lower adherence. Determinants associated with nonadherence were similar in both approaches used. Conclusions: This study confirms the validity of estimating adherence with RWD from the Spanish national health system, although when combined with reviewing medical records, this may provide more reliable and higher-quality data. The RWD method provides valuable evidence to help oncologists discuss adherence with their patients. 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