Predicting Patient Treatment Deferrals at an Outpatient Chemotherapy Infusion Center: A Statistical Approach

2017 ◽  
pp. 1-8
Author(s):  
Donald B. Richardson ◽  
Seth D. Guikema ◽  
Amy E.M. Cohn

Purpose Patients scheduled for outpatient infusion sometimes may be deferred for treatment after arriving for their appointment. This can be the result of a secondary illness, not meeting required bloodwork counts, or other medical complications. The ability to generate high-quality predictions of patient deferrals can be highly valuable in managing clinical operations, such as scheduling patients, determining which drugs to make before patients arrive, and establishing the proper staffing for a given day. Methods In collaboration with the University of Michigan Comprehensive Cancer Center, we have developed a predictive model that uses patient-specific data to estimate the probability that a patient will defer or not show for treatment on a given day. This model incorporates demographic, treatment protocol, and prior appointment history data. We tested a wide range of predictive models including logistic regression, tree-based methods, neural networks, and various ensemble models. We then compared the performance of these models, evaluating both their prediction error and their complexity level. Results We have tested multiple classification models to determine which would best determine whether a patient will defer or not show for treatment on a given day. We found that a Bayesian additive regression tree model performs best with the University of Michigan Comprehensive Cancer Center data on the basis of out-of-sample area under the curve, Brier score, and F1 score. We emphasize that similar statistical procedures must be taken to reach a final model in alternative settings. Conclusion This article introduces the existence and selection process of a wide variety of statistical models for predicting patient deferrals for a specific clinical environment. With proper implementation, these models will enable clinicians and clinical managers to achieve the in-practice benefits of deferral predictions.

2011 ◽  
Vol 9 (11) ◽  
pp. 1228-1233 ◽  
Author(s):  
Pam James ◽  
Patty Bebee ◽  
Linda Beekman ◽  
David Browning ◽  
Mathew Innes ◽  
...  

Quantifying data management and regulatory workload for clinical research is a difficult task that would benefit from a robust tool to assess and allocate effort. As in most clinical research environments, The University of Michigan Comprehensive Cancer Center (UMCCC) Clinical Trials Office (CTO) struggled to effectively allocate data management and regulatory time with frequently inaccurate estimates of how much time was required to complete the specific tasks performed by each role. In a dynamic clinical research environment in which volume and intensity of work ebbs and flows, determining requisite effort to meet study objectives was challenging. In addition, a data-driven understanding of how much staff time was required to complete a clinical trial was desired to ensure accurate trial budget development and effective cost recovery. Accordingly, the UMCCC CTO developed and implemented a Web-based effort-tracking application with the goal of determining the true costs of data management and regulatory staff effort in clinical trials. This tool was developed, implemented, and refined over a 3-year period. This article describes the process improvement and subsequent leveling of workload within data management and regulatory that enhanced the efficiency of UMCCC's clinical trials operation.


2011 ◽  
Vol 9 (12) ◽  
pp. 1343-1352 ◽  
Author(s):  
Pam James ◽  
Patricia Bebee ◽  
Linda Beekman ◽  
David Browning ◽  
Mathew Innes ◽  
...  

Clinical trials operations struggle to achieve optimal distribution of workload in a dynamic data management and regulatory environment, and to achieve adequate cost recovery for personnel costs. The University of Michigan Comprehensive Cancer Center developed and implemented an effort tracking application to quantify data management and regulatory workload to more effectively assess and allocate work while improving charge capture. Staff recorded how much time they spend each day performing specific study-related and general office tasks. Aggregated data on staff use of the application from 2006 through 2009 were analyzed to gain a better understanding of what trial characteristics require the most data management and regulatory effort. Analysis revealed 4 major determinants of staff effort: 1) study volume (actual accrual), 2) study accrual rate, 3) study enrollment status, and 4) study sponsor type. Effort tracking also confirms that trials that accrued at a faster rate used fewer resources on a per-patient basis than slow-accruing trials. In general, industry-sponsored trials required the most data management and regulatory support, outweighing other sponsor types. Although it is widely assumed that most data management efforts are expended while a trial is actively accruing, the authors learned that 25% to 30% of a data manager's effort is expended while the study is either not yet open or closed to enrollment. Through the use of a data-driven effort tracking tool, clinical research operations can more efficiently allocate workload and ensure that study budgets are negotiated to adequately cover study-related expenses.


2017 ◽  
Vol 1 (S1) ◽  
pp. 30-30
Author(s):  
Daniel L. Hertz ◽  
Kelley M. Kidwell ◽  
Kiran Vangipuram ◽  
Duxin Sun ◽  
N. Lynn Henry

OBJECTIVES/SPECIFIC AIMS: Peripheral neuropathy is the dose limiting toxicity of paclitaxel treatment. Paclitaxel pharmacokinetics (PK), specifically the Cmax and amount of time the concentration remains above 0.05 µM (Tc>0.05), have been associated with occurrence of severe, clinician-documented neuropathy. The objective of this study was to confirm that paclitaxel PK predicts progression of patient-reported neuropathy. METHODS/STUDY POPULATION: This observational trial enrolled breast cancer patients receiving weekly 1-hour paclitaxel infusions (80 mg/m2×12 cycles) at the University of Michigan Comprehensive Cancer Center. Paclitaxel concentration was measured via LC/MS in plasma samples collected at the end of (Cmax) and 16–24 hours after (Tc>0.05) first infusion. Patient-reported neuropathy was collected (EORTC CIPN20) at baseline and each cycle. The rate of neuropathy severity increase per treatment cycle is being modeled for each patient. Cmax and Tc>0.05 values will be introduced into the model to confirm that PK independently contributes to neuropathy progression. RESULTS/ANTICIPATED RESULTS: PK and neuropathy data have been collected from 60 patients for ongoing analysis. Our initial model will characterize the expected severity of neuropathy after each cycle of paclitaxel treatment. The PK-neuropathy model will include either PK parameter to validate their contribution to the progression of neuropathy severity during treatment. We anticipate, based on our preliminary analysis of the first 16 patients, that both PK parameters will significantly contribute to the model but Tc>0.05 will be more strongly associated with neuropathy progression. DISCUSSION/SIGNIFICANCE OF IMPACT: This project will generate a model that can be used to predict a patient’s neuropathy severity throughout treatment using a single, conveniently collected and easily measured PK sample during their first cycle. The next steps of this project include identifying genetic and metabolomic biomarkers that predict which patients experienced more severe neuropathy than would be anticipated based on their paclitaxel PK, and a planned interventional trial of personalized paclitaxel dosing to enhance efficacy and/or prevent neuropathy.


Author(s):  
Mara N Villanueva ◽  
Jennifer E Davis ◽  
Stacey M Sobocinski

Abstract Purpose The processes for formulary implementation and electronic health record (EHR) integration of biosimilar products at a comprehensive cancer center are described. Implications for research protocols are also discussed. Summary The existing literature focuses on practical considerations for formulary addition of biosimilar products, but there is a lack of guidance on how to implement the change, particularly within the EHR. Before building the ordering tools for biosimilars, the clinical and informatics teams should determine the role of biosimilars at the institution, identify drug-specific product characteristics that affect medication build, and characterize implications of future formulary changes or drug shortages. Leveraging an orderable record provides the ability to include logic that maps to multiple products and also allows for future implementation of changes within the medication record rather than requiring “swaps” at the treatment protocol level. The institutional review board should coordinate changes in affected research protocols and consent forms and work with principal investigators to amend protocols when necessary. Pharmacy leaders should develop processes to oversee inventory during the transition period and minimize the risk of errors. Conclusion The development of a standardized approach for evaluating and implementing biosimilar products improves efficiency and collaboration among the various team members responsible for the products’ integration into existing workflows, including implications for clinical research. Implementing biosimilars for agents used to treat cancer will pose new challenges and require additional considerations. Partial implementation of biosimilars continues to pose multiple challenges in the provision of patient care.


2016 ◽  
Vol 17 (5) ◽  
pp. 618-624 ◽  
Author(s):  
Thomas J. Wilson ◽  
Kate W. C. Chang ◽  
Suneet P. Chauhan ◽  
Lynda J. S. Yang

OBJECTIVE Neonatal brachial plexus palsy (NBPP) occurs due to the stretching of the nerves of the brachial plexus before, during, or after delivery. NBPP can resolve spontaneously or become persistent. To determine if nerve surgery is indicated, predicting recovery is necessary but difficult. Historical attempts explored the association of recovery with only clinical and electrodiagnostic examinations. However, no data exist regarding the neonatal and peripartum factors associated with NBPP persistence. METHODS This retrospective cohort study involved all NBPP patients at the University of Michigan between 2005 and 2015. Peripartum and neonatal factors were assessed for their association with persistent NBPP at 1 year, as defined as the presence of musculoskeletal contractures or an active range of motion that deviated from normal by > 10° (shoulder, elbow, hand, and finger ranges of motion were recorded). Standard statistical methods were used. RESULTS Of 382 children with NBPP, 85% had persistent NBPP at 1 year. A wide range of neonatal and peripartum factors was explored. We found that cephalic presentation, induction or augmentation of labor, birth weight > 9 lbs, and the presence of Horner syndrome all significantly increased the odds of persistence at 1 year, while cesarean delivery and Narakas Grade I to II injury significantly reduced the odds of persistence. CONCLUSIONS Peripartum/neonatal factors were identified that significantly altered the odds of having persistent NBPP at 1 year. Combining these peripartum/neonatal factors with previously published clinical examination findings associated with persistence should allow the development of a prediction algorithm. The implementation of this algorithm may allow the earlier recognition of those cases likely to persist and thus enable earlier intervention, which may improve surgical outcomes.


2020 ◽  
Vol 26 (6) ◽  
pp. 1369-1373 ◽  
Author(s):  
Catherine Michelle Laird ◽  
Ashley E Glode ◽  
Kerry Schwarz ◽  
Elaine T Lam ◽  
Cindy L O'Bryant

Introduction At our institution, an increased incidence of hypersensitivity reactions was reported following standardization of fosaprepitant as the preferred agent for the prophylaxis of chemotherapy induced nausea and vomiting (CINV) caused by highly emetogenic therapies. The purpose of this evaluation was to assess the incidence of systemic hypersensitivity reactions (HSRs) to fosaprepitant infusions compared to available literature. Methods This evaluation is a retrospective review of electronic health records of adult patients who received their first dose of fosaprepitant for CINV prophylaxis beginning January 1, 2017 through June 30, 2017 at the University of Colorado Cancer Center outpatient infusion center. Subjects were identified using medication administration reports. Individual chart reviews were performed for all patients who received fosaprepitant during the specified timeframe and had a reaction reported on the same date. Results A total of 868 patients received fosaprepitant in the outpatient infusion center during the study time period. Four patients (0.461%) had a systemic HSR attributed to fosaprepitant. Two of the reactions were reported as HSRs in the adverse reaction reporting system and two were found in provider notes during chart review. Due to the small sample size, risk factors for HSRs to fosaprepitant were not able to be determined. Conclusion The incidence of HSRs to fosaprepitant at our institution was found to be consistent with the <1% incidence currently noted in literature. Based on these findings, opportunities have been identified for education on fosaprepitant-associated HSRs, proper documentation and patient-specific precautions.


2020 ◽  
Author(s):  
Peter E Lonergan ◽  
Samuel L Washington III ◽  
Linda Branagan ◽  
Nathaniel Gleason ◽  
Raj S Pruthi ◽  
...  

BACKGROUND The emergence of the coronavirus disease (COVID-19) pandemic in March 2020 created unprecedented challenges in the provision of scheduled ambulatory cancer care. As a result, there has been a renewed focus on video-based telehealth consultations as a means to continue ambulatory care. OBJECTIVE The aim of this study is to analyze the change in video visit volume at the University of California, San Francisco (UCSF) Comprehensive Cancer Center in response to COVID-19 and compare patient demographics and appointment data from January 1, 2020, and in the 11 weeks after the transition to video visits. METHODS Patient demographics and appointment data (dates, visit types, and departments) were extracted from the electronic health record reporting database. Video visits were performed using a HIPAA (Health Insurance Portability and Accountability Act)-compliant video conferencing platform with a pre-existing workflow. RESULTS In 17 departments and divisions at the UCSF Cancer Center, 2284 video visits were performed in the 11 weeks before COVID-19 changes were implemented (mean 208, SD 75 per week) and 12,946 video visits were performed in the 11-week post–COVID-19 period (mean 1177, SD 120 per week). The proportion of video visits increased from 7%-18% to 54%-72%, between the pre– and post–COVID-19 periods without any disparity based on race/ethnicity, primary language, or payor. CONCLUSIONS In a remarkably brief period of time, we rapidly scaled the utilization of telehealth in response to COVID-19 and maintained access to complex oncologic care at a time of social distancing.


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