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Real word evidence on rituximab utilization: Combining administrative and hospital-pharmacy data.

ABSTRACT: PURPOSE:To describe patterns of utilization, survival and infectious events in patients treated with rituximab at the University Hospital of Siena (UHS) to explore the feasibility of combining routinely collected administrative and hospital-pharmacy data for examining the real-world use of intravenous antineoplastic drugs. METHODS:A retrospective, longitudinal cohort study was conducted using data from the Hospital Pharmacy of Siena (HPS) and the Regional Administrative Database of Tuscany (RAD). Patients aged ?18 years with ?1 rituximab administration recorded between January 2012 and June 2016 were identified in the HPS database. Anonymized patient-level data were linked to RAD. Rituximab utilization during the first year of treatment was described using HPS. Hospital diagnoses of adverse infectious events that occurred during the first year of follow-up and four-year survival were observed using RAD. RESULTS:A total of 311 new users of rituximab were identified: 264 patients received rituximab for non-Hodgkin's lymphoma (NHL) and 47 were treated for chronic lymphocytic leukemia (CLL). Among new users with one complete year of follow-up (n = 203) over 95% received rituximab as the first-line treatment, and approximately 70% of them received 5-8 doses. No patient in the CLL group received >8 administrations. Four-year survival was approximately 70% in both CLL and NHL patients. Sepsis was the most frequent infectious event observed (5.1%). CONCLUSION:HPS and RAD provided complementary information on rituximab utilization, demonstrating their potential for future pharmacoepidemiological studies on antineoplastic medications administered in the Italian hospital setting. Overall, this general description of the real-world utilization of rituximab in patients treated for NHL and CLL at UHS was in line with treatment guidelines and current knowledge on the rituximab safety profile.

SUBMITTER: Roberto G

PROVIDER: S-EPMC7067445 | biostudies-literature | 2020

REPOSITORIES: biostudies-literature

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Real word evidence on rituximab utilization: Combining administrative and hospital-pharmacy data.

Roberto Giuseppe G Spini Andrea A Bartolini Claudia C Moscatelli Valentino V Barchielli Alessandro A Paoletti Davide D Giorgi Silvano S Fabbri Alberto A Bocchia Monica M Donnini Sandra S Gini Rosa R Ziche Marina M

PloS one 20200312 3

<h4>Purpose</h4>To describe patterns of utilization, survival and infectious events in patients treated with rituximab at the University Hospital of Siena (UHS) to explore the feasibility of combining routinely collected administrative and hospital-pharmacy data for examining the real-world use of intravenous antineoplastic drugs.<h4>Methods</h4>A retrospective, longitudinal cohort study was conducted using data from the Hospital Pharmacy of Siena (HPS) and the Regional Administrative Database o ...[more]

PMID: 32163477

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Project description:ContextMany of the publicly available health quality report cards are based on administrative data. ICD-9-CM codes in administrative data are not date stamped to distinguish between medical conditions present at the time of hospital admission and complications, which occur after hospital admission. Treating complications as preexisting conditions gives poor-performing hospitals "credit" for their complications and may cause some hospitals that are delivering low-quality care to be misclassified as average- or high-performing hospitals.ObjectiveTo determine whether hospital quality assessment based on administrative data is impacted by the inclusion of condition present at admission (CPAA) modifiers in administrative data as a date stamp indicator.Design, setting, and patientsRetrospective cohort study based on 648,866 inpatient admissions between 1998 and 2000 for coronary artery bypass graft (CABG) surgery, coronary angioplasty (PTCA), carotid endarterectomy (CEA), abdominal aortic aneurysm (AAA) repair, total hip replacement (THR), acute MI (AMI), and stroke using the California State Inpatient Database which includes CPAA modifiers. Hierarchical logistic regression was used to create separate condition-specific risk adjustment models. For each study population, one model was constructed using only secondary diagnoses present at admission based on the CPAA modifier: "date stamp" model. The second model was constructed using all secondary diagnoses, ignoring the information present in the CPAA modifier: the "no date stamp model." Hospital quality was assessed separately using the "date stamp" and the "no date stamp" risk-adjustment models.ResultsForty percent of the CABG hospitals, 33 percent of the PTCA hospitals, 40 percent of the THR hospitals, and 33 percent of the AMI hospitals identified as low-performance hospitals by the "date stamp" models were not classified as low-performance hospitals by the "no date stamp" models. Fifty percent of the CABG hospitals, 33 percent of the PTCA hospitals, 50 percent of the CEA hospitals, and 36 percent of the AMI hospitals identified as low-performance hospitals by the "no date stamp" models were not identified as low-performance hospitals by the "date stamp" models. The inclusion of the CPAA modifier had a minor impact on hospital quality assessment for AAA repair, stroke, and CEA.ConclusionThis study supports the hypothesis that the use of routine administrative data without date stamp information to construct hospital quality report cards may result in the mis-identification of hospital quality outliers. However, the CPAA modifier will need to be further validated before date stamped administrative data can be used as the basis for health quality report cards.

Project description:BackgroundThe goal of regionalized perinatal care, specifically levels of maternal care, is to improve maternal outcomes through risk-appropriate obstetric care. Studies of levels of maternal care are limited by current approaches to identify a hospital's level of care, often relying on hospital self-reported data, which is expensive and challenging to collect and validate. The study objective was to develop an empiric approach to determine a hospital's level of maternal care using administrative data reflective of the patient care provided and apply this approach to describe the levels of maternal care available over time.MethodsRetrospective cohort study of mother-infant dyads who delivered in California, Missouri, and Pennsylvania hospitals from 2000 to 2009. Linked mother-infant administrative records with an infant born at 24-44 weeks' gestation and a birth weight of 400-8000 g were included. Using the American College of Obstetricians and Gynecologists and the Society for Maternal Fetal Medicine descriptions of levels of maternal care, four levels were classified based on the appropriate location of care for patients with specific medical or pregnancy conditions. Individual hospitals were assigned a level of maternal care annually based on the volume of patients who delivered reflective of the four classified levels as determined by International Classification of Diseases and Current Procedural Terminology.ResultsBased on the included 6,895,000 mother-infant dyads, the obstetric hospital levels of maternal care I, II, III and IV were identified. High-risk patients more frequently delivered in hospitals with higher level maternal care, accounting for 8.9, 10.9, 13.8, and 16.9% of deliveries in level I, II, III and IV hospitals, respectively. The total number of obstetric hospitals decreased over the study period, while the proportion of hospitals with high-level (level III or IV) maternal care increased. High-level hospitals were located in more densely populated areas.ConclusionIdentification of the level of maternal care, independent of hospital self-reported variables, is feasible using administrative data. This empiric approach, which accounts for changes in hospitals over time, is a valuable framework for perinatal researchers and other stakeholders to inexpensively identify measurable benefits of levels of maternal care and characterize where specific patient populations receive care.

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Real word evidence on rituximab utilization: Combining administrative and hospital-pharmacy data.

Publications

Real word evidence on rituximab utilization: Combining administrative and hospital-pharmacy data.

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