Validity of Italian administrative healthcare data in describing the real-world utilization of infusive antineoplastic drugs: the study case of rituximab use in patients treated at the University Hospital of Siena for onco-haematological indications

Frontiers in Oncology

Oncology

Sandra Donnini¹  Marina Ziche¹  Valentino Moscatelli¹  Andrea Spini¹  Alberto Fabbri²  Monica Bocchia²  Giuseppe Roberto³  Anna Girardi³  Rosa Gini³  Claudia Bartolini³  Alessandro Barchielli⁴  Maria Cristina Monti⁵ 

[1] Department of Life Sciences, Università Degli Studi di Siena, Siena, Italy;Onco-hematology Unit, Azienda Ospedaliera Universitaria Senese, Siena, Italy;Pharmaecoepidemiology Unit, Agenzia Regionale di Sanità della Toscana, Firenze, Italy;Tuscany Cancer Registry, Istituto per lo Studio e la Prevenzione Oncologica, Firenze, Italy;Università di Pavia, Dipartimento di Sanità Pubblica, Medicina Sperimentale e Forense, Pavia, Italy;

关键词: rituximab;    infusive antineoplastics;    validation;    administrative data;    drug utilisation;   

DOI  :  10.3389/fonc.2023.1059109

 received in 2022-09-30, accepted in 2023-05-18,  发布年份 2023

来源: Frontiers

【 摘 要 】

IntroductionItalian administrative healthcare databases are frequently used for studies on real-world drug utilization. However, there is currently a lack of evidence on the accuracy of administrative data in describing the use of infusive antineoplastics. In this study, we used rituximab as a case study to investigate the validity of the regional administrative healthcare database of Tuscany (RAD) in describing the utilization of infusive antineoplastics.MethodsWe identified patients aged 18 years or older who had received ≥1 rituximab administration between 2011 and 2014 in the onco-haematology ward of the University Hospital of Siena. We retrieved this information from the Hospital Pharmacy Database (HPD-UHS) and linked the person-level information to RAD. Patients who had received ≥1dispensing of rituximab, single administration episodes, and patients treated for non-Hodgkin Lymphoma (nHL) or Chronic Lymphocytic Leukemia (CLL) were identified in RAD and validated using HPD-UHS as the reference standard. We identified the indications of use using algorithms based on diagnostic codes (ICD9CM codes, nHL=200*, 202*; CLL=204.1). We tested 22 algorithms of different complexity for each indication of use and calculated sensitivity and positive predictive value (PPV), with 95% confidence intervals (95%CI), as measures of validity.ResultsAccording to HPD-UHS, 307 patients received rituximab for nHL (N=174), CLL (N=21), or other unspecified indications (N=112) in the onco-haematology ward of the University Hospital of Siena. We identified 295 rituximab users in RAD (sensitivity=96.1%), but PPV could not be assessed due to missing information in RAD on dispensing hospital wards. We identified individual rituximab administration episodes with sensitivity=78.6% [95%CI: 76.4-80.6] and PPV=87.6% [95%CI: 86.1-89.2]. Sensitivity of algorithms tested for identifying nHL and CLL ranged from 87.7% to 91.9% for nHL and from 52.4% to 82.7% for CLL. PPV ranged from 64.7% to 66.1% for nHL and from 32.4% to 37.5% for CLL.DiscussionOur findings suggest that RAD is a very sensitive source of information for identifying patients who received rituximab for onco-haematological indications. Single administration episodes were identified with good-to-high accuracy. Patients receiving rituximab for nHL were identified with high sensitivity and acceptable PPV, while the validity for CLL was suboptimal.

【 授权许可】

Unknown   
Copyright © 2023 Bartolini, Roberto, Girardi, Moscatelli, Spini, Barchielli, Bocchia, Fabbri, Donnini, Ziche, Monti and Gini