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Pamala A. Pawloski, Gabriel A. Brooks, Matthew E. Nielsen, and Barbara A. Olson-Bullis

Background: Electronic health records are central to cancer care delivery. Electronic clinical decision support (CDS) systems can potentially improve cancer care quality and safety. However, little is known regarding the use of CDS systems in clinical oncology and their impact on patient outcomes. Methods: A systematic review of peer-reviewed studies was performed to evaluate clinically relevant outcomes related to the use of CDS tools for the diagnosis, treatment, and supportive care of patients with cancer. Peer-reviewed studies published from 1995 through 2016 were included if they assessed clinical outcomes, patient-reported outcomes (PROs), costs, or care delivery process measures. Results: Electronic database searches yielded 2,439 potentially eligible papers, with 24 studies included after final review. Most studies used an uncontrolled, pre-post intervention design. A total of 23 studies reported improvement in key study outcomes with use of oncology CDS systems, and 12 studies assessing the systems for computerized chemotherapy order entry demonstrated reductions in prescribing error rates, medication-related safety events, and workflow interruptions. The remaining studies examined oncology clinical pathways, guideline adherence, systems for collection and communication of PROs, and prescriber alerts. Conclusions: There is a paucity of data evaluating clinically relevant outcomes of CDS system implementation in oncology care. Currently available data suggest that these systems can have a positive impact on the quality of cancer care delivery. However, there is a critical need to rigorously evaluate CDS systems in oncology to better understand how they can be implemented to improve patient outcomes.

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Pamala A. Pawloski, Gabriela Vazquez-Benitez, Jeanette Y. Ziegenfuss, Terese A. DeFor, and Elisabeth M. Seburg

Background: Older patients diagnosed with colorectal cancer are not routinely included in clinical trials and are frequently treated with less aggressive chemotherapy. To identify factors associated with treatment initiation in older adults, we conducted an observational study of patients diagnosed with stage I–IV colon or rectal cancer at 65 years and older between 2010 and 2014 across 6 integrated health care systems. Methods: Data were obtained from cancer registries based on chart abstraction and medical records. Time from diagnosis to surgery, chemotherapy, and radiation was measured in weeks and censored when disenrollment, death, or the end of the study period occurred. We assessed patient factors associated with time to chemotherapy initiation using survival analysis methods. Results: Among 8,088 patients diagnosed after the age of 65 with colon cancer, the mean age at diagnosis was 76 years (SD 7.7), 4,150 (51%) were female, and 34% were stage 3 or greater. More than half, 55% (n=4,434) of colon cancers were right-sided (RCC), 23% (n=1833) were left-sided (LCC), and 19% (n=1,559) were rectal cancers. Two-thirds (n=5,201) had moderately differentiated disease. Most (57%) received surgery within 4 weeks and 89% within 6 months of diagnosis (median, 3.4 weeks). At 6 months following diagnosis, 33% of patients had received chemotherapy, and only 4% received radiation. Factors associated with the receipt of chemotherapy were assessed in a multivariable survival model that included age, gender, stage, and site. Patients of older age were less likely to receive chemotherapy (HR, 0.49; 95%CI, 0.45–.53 for 75–79 vs 65–69 years), and more likely for advanced stage, and rectal site. No difference was observed between men and women. Refusal of chemotherapy was reported for only 6% of patients and was associated with age, stage, and site. Six month mortality was 13.3%. Conclusions: Factors associated with the receipt of treatment among older cancer survivors are similar to those in the general population.

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Matthew P. Banegas, Donna R. Rivera, Maureen C. O’Keeffe-Rosetti, Nikki M. Carroll, Pamala A. Pawloski, David C. Tabano, Mara M. Epstein, Kai Yeung, Mark C. Hornbrook, Christine Lu, and Debra P. Ritzwoller

Background: Oral tyrosine kinase inhibitors (TKIs) have been the standard of care for chronic myeloid leukemia (CML) since 2001. However, few studies have evaluated changes in the treatment landscape of CML over time. This study assessed the long-term treatment patterns of oral anticancer therapies among patients with CML. Methods: This retrospective cohort study included patients newly diagnosed with CML between January 1, 2000, and December 31, 2016, from 10 integrated healthcare systems. The proportion of patients treated with 5 FDA-approved oral TKI agents—bosutinib, dasatinib, imatinib, nilotinib, and ponatinib—in the 12 months after diagnosis were measured, overall and by year, between 2000 and 2017. We assessed the use of each oral agent through the fourth-line setting. Multivariable logistic regression estimated the odds of receiving any oral agent, adjusting for sociodemographic and clinical characteristics. Results: Among 853 patients with CML, 81% received an oral agent between 2000 and 2017. Use of non-oral therapies decreased from 100% in 2000 to 5% in 2005, coinciding with imatinib uptake from 65% in 2001 to 98% in 2005. Approximately 28% of patients switched to a second-line agent, 9% switched to a third-line agent, and 2% switched to a fourth-line agent. Adjusted analysis showed that age at diagnosis, year of diagnosis, and comorbidity burden were statistically significantly associated with odds of receiving an oral agent. Conclusions: A dramatic shift was seen in CML treatments away from traditional, nonoral chemotherapy toward use of novel oral TKIs between 2000 and 2017. As the costs of oral anticancer agents reach new highs, studies assessing the long-term health and financial outcomes among patients with CML are warranted.

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Pamala A. Pawloski, Cara L. McDermott, James H. Marshall, Vanita Pindolia, Catherine M. Lockhart, Catherine A. Panozzo, Jeffrey S. Brown, and Bernadette Eichelberger

Background: Chemotherapy-induced febrile neutropenia (FN) is prevented or minimized with granulocyte colony-stimulating factors (G-CSFs). Several G-CSF biosimilars are approved in the United States. The Biologics and Biosimilars Collective Intelligence Consortium (BBCIC) is a nonprofit initiative whose objective is to provide scientific evidence on real-world use and comparative safety and effectiveness of biologics and biosimilars using the BBCIC distributed research network (DRN). Patients and Methods: We describe real-world G-CSF use in patients with breast or lung cancer receiving first-cycle chemotherapy associated with high FN risk. We assessed hospitalizations for FN, availability of absolute neutrophil counts, and G-CSF–induced adverse events to inform future observational comparative effectiveness studies of G-CSF reference products and their biosimilars. A descriptive analysis of 5 participating national health insurance plans was conducted within the BBCIC DRN. Results: A total of 57,725 patients who received at least one G-CSF dose were included. Most (92.5%) patients received pegfilgrastim. FN hospitalization rates were evaluated by narrow (<0.5%), intermediate (1.91%), and broad (2.99%) definitions. Anaphylaxis and hyperleukocytosis were identified in 1.15% and 2.28% of patients, respectively. This analysis provides real-world evidence extracted from a large, readily available database of diverse patients, characterizing G-CSF reference product use to inform the feasibility of future observational comparative safety and effectiveness analyses of G-CSF biosimilars. We showed that the rates of FN and adverse events in our research network are consistent with those reported by previous small studies. Conclusions: Readily available BBCIC DRN data can be used to assess G-CSF use with the incidence of FN hospitalizations. Insufficient laboratory result data were available to report absolute neutrophil counts; however, other safety data are available for assessment that provide valuable baseline data regarding the effectiveness and safety of G-CSFs in preparation for comparative effectiveness studies of reference G-CSFs and their biosimilars.