bluuebunny/crossref_metadata_2025_split huggingface dataset:
Off-label immunotherapy prescription: Financial implications for payers and patients.
Authors: De Souza Jonas A. , Duong Yen Yvonne 
Published: April 2017

6 Background: Pembrolizumab (PEM) and nivolumab (NIV) are FDA-approved immunotherapy agents for specific indications. These drugs are extremely costly to the health care system, payers, and ultimately, patients, and little is known about their utilization for non-FDA labeled indications (off-label). Methods: We reviewed claims for PEM and NIV using the focalPoint database by onPoint oncology, which provides access to clearinghouse data for 168 community oncology practices and 2000+ providers throughout the US. Clearinghouse data is unique as it links claims data with remittance (payer response) data. ICD codes representing malignancies other than head and neck cancer, melanoma, non-small cell lung cancer ,and claims for 3 indications prior to their FDA-approval were considered off-label. Primary insurance for the patients, as well as patients’ financial responsibility and amounts paid by the insurance were evaluated. Results: A total of 1,570 patients received PEM or NIV from January 1st 2015 to September 1st 2016 for a cumulative total of 7,687 distinct claims. Of these patients, 285 (18%) received these agents for off-label indications for a total of 978 distinct claims. The total cost for the insurance for off-label claims was $13.36 million with the following breakdown: $7.74 million for 111 patients with commercial insurance, $125 thousand for 5 patients with Medicaid, $3.85 million for 126 patients with Original Medicare, and $1.90 million for 43 patients with Medicare Advantage. The patient responsibility for the off-label immunotherapy agents, which included the co-insurance and co-pay, totaled to $1.06 million or $3,731 per patient. Patient responsibility for off-label therapy per payer was as follows: $657 per patient for commercial insurance, $0 for Medicaid, $7,436 for Original Medicare, and $1,248 for Medicare Advantage. Conclusions: A substantial number of patients received unsupported off-label immunotherapy treatment. The costs of these therapies to the health care system, payers, and patients warrant increased efforts to regulate their use in off-label settings lacking sufficient scientific evidence or while clinical trials are in progress.
Monitoring and developing volunteer patient navigation intervention to improve mammography compliance in a safety net hospital.
Authors: Srinivasan Anitha , Zwillenberg Judith , Chadda Anisha , Gissel Hannah , Lettera Michael , Bender Sarah , Wallack Marc K. , Greene Margulies Ilana 
Published: April 2017

62 Background: Mammography screening is crucial for cancer detection. Screening rates have been declining in patients of low socioeconomic status and minorities, supporting the need for intervention at our safety-net hospital. Methods: Patients with a primary care provider order for screening mammograms over a one month period were monitored for 90 day compliance. This analysis determined compliance rate and optimal intervention period. A prospective randomized trial was done to improve compliance using a volunteer patient navigator. All patients received educational material and were randomly assigned to the control or intervention group. The latter were further educated on breast cancer and mammograms and, if amenable, were escorted to a walk-in mammogram. The study period was 3 weeks with 49 participants-24 patients in the control and 25 patients in the intervention group. The principal outcome was the 14 day mammography compliance rate. Secondary analysis examined efficacy of the study with respect to patient demographics, prior mammography compliance, family history of cancer, beliefs on mammography and past medical history and analyzed using GraphPad Prism 7. Results: Analysis revealed a noncompliance rate of 52% with majority compliance occurring within two weeks of order placement. The patient navigation intervention significantly improved compliance by 34% (42% in the control group, 76% in the intervention group, p < 0.05 Fisher exact test). Intervention significantly improved compliance in patients with low susceptibility to cancer belief, who understood benefits of mammography and early diagnosis (p < 0.05 Fisher exact test), had a prior mammogram (p < 0.05 Fisher exact test), a family history of cancer (p < 0.01 Fisher exact test), hyperlipidemia (p < 0.05 Fisher exact test), and those employed (p < 0.05 Fisher exact test). Conclusions: A system to monitor compliance and intervene using patient navigation significantly improved mammography compliance of patients in a safety net urban hospital. The relatively straightforward design of the volunteer based intervention makes it affordable, easily replicable and perhaps beneficial at other institutions.
Impact of genomic profiling on treatment decisions for patients with melanoma and colorectal cancer cohorts.
Authors: Biltaji Eman , Au Trang H. , Gligorich Keith , Bronner Mary P. , Stenehjem David D. , Brixner Diana I. 
Published: April 2017

66 Background: Clinical guidelines recommend RAS testing and BRAF testing in CRC and melanoma, respectively, to guide treatment (tx) decisions. However, there are limited data to support routine multi-gene profiling. This study evaluated the impact of multi-gene profiling on genomically-guided tx decisions in patients with CRC or melanoma. Methods: A retrospective cohort study using combined data from UUHC Electronic Warehouse, Huntsman Cancer Institute (HCI) tumor registry, ARUP laboratories, and Foundation Medicine. Included patients were treated at HCI for CRC or melanoma and had genomic profiling (2012-2016). The index date was date of first genomic profiling result and impact on practice was measured by rate of genomically-guided therapy use. Results: Among 127 genomically-profiled patients with CRC, 66 (52%) received therapy. Patients were predominantly male (64%), aged 57 years (median) at diagnosis, had advanced disease (52%), received three tx lines (mean) at baseline, and had three mutations (mean) detected. Actionable mutations, other than RAS,occurred in 43.9% of tested patients; and only 10.1% of these patients received genetically-guided tx. In the CRC cohort 55% are still receiving standard of care tx, and may benefit from testing results in the future. Among 186 genomically-profiled patients with melanoma, 123 (66.1%) received therapy. Patients were predominantly male (63%), aged 60 years (median) at diagnosis, diagnosed at earlier stages (68%), received two tx lines (mean) at baseline, and had two mutations (mean) detected. Actionable mutations, other than BRAF V600E/K, occurred in 14.6 % of tested patients; and only 5.6% of these patients received genetically-guided tx. In the Melanoma cohort 77% are still receiving standard tx. Actionable mutations and genomically guided tx decisions will be presented. Conclusions: Genomic profiling lead to modest increase in genetically-guided therapy. The incremental clinical and economic benefit of guideline-recommended testing needs further investigation by cancer type.
Impact of a nurse-calling program on retaining patients with a new diagnosis of cancer.
Authors: Gross Anne , Leib Ryan , Hilton Nancy , Bagley Janet , Burnard Rachel A. , Hirshfield-Bartek Judith , Dorenzo Eric , Keavany Kathleen , Read David C , Bunnell Craig A. 
Published: April 2017

69 Background: In 2013, Dana-Farber Cancer Institute began an initiative to improve the new patient experience. Our goal was to remove barriers to access and, as much a possible, begin to care for individuals even before they step foot through our door. A key component of this initiative was for each patient to receive a phone call from an oncology nurse shortly after speaking to a new patient coordinator to schedule their first appointment. The purpose of the call was to answer questions about their diagnosis, the care they will receive and to begin the process of assessing their individual needs. Methods: The program was supported by over 40 full and part-time oncology nurses who devote a portion of their time each day to calling new patients prior to their first visit. In total nurses made over 10,000 phone calls per year. Through a survey given to patients after the intake process, we gathered feedback from over 1,200 patients, which overwhelmingly demonstrated a positive response to receiving a phone call from a nurse. We also investigated if receiving a phone call from a nurse prior to the first visit impacted the likelihood of retaining the patient for their treatment. Results: Comparing 9,000 new patients over one year, we found that patients who spoke to a nurse prior to their first appointment had a 13.5% higher relative retention rate compared to patients who did not speak to a nurse (see figure 1, absolute difference is 42.9% vs. 37.8%, odds ratio = 1.24, confidence interval 1.10-1.39, P < 0.0005). Controlling for confounding variables, a logistical regression with 15 variables was performed (e.g. time to first appointment, age,). Receiving a call from a nurse was one of the most predictive, statistically significant variables for patient retention. Conclusions: Given the positive qualitative response from patients and the quantitative impact on retention, we continue to build the program to ensure all patients receive a phone call from a nurse prior to their first visit. [Table: see text]
Learning from near misses: Addressing nursing chemotherapy verification fatigue.
Authors: Shea Meghan , Sato-DiLorenzo Aya , Wright Danielle , Coletti Erika , Carvalho Michael , Zerillo Jessica A. 
Published: April 2017

70 Background: Administration of chemotherapy is high-risk, requiring multiple safety checks, including pre-treatment laboratory value verification by nursing. A recent series of near misses in our event reporting system highlighted that nurses verified chemotherapy orders with pending pre-treatment or abnormal labs, such as grade 2 hyperbilirubinemia and grade 4 neutropenia. Such laboratory results would normally require holding or modifying planned treatment doses. Methods: Nurses treating patients in the outpatient chemotherapy infusion units were surveyed regarding barriers to pre-treatment lab verification. A team of clinicians, nurses, and pharmacists outlined a process map of the order verification process from acknowledging patient assignment and looking at patient oncologic history to sending the physician order to pharmacy. Pharmacists collected baseline data by tracking near-miss incidents. Results: The survey response rate of outpatient treatment nurses was 18 of 32 (56%). Nurses ranked inconsistent notation of treatment criteria in orders, long lab processing time, and patient frustration with a long wait as the most common barriers to lab verification. At baseline, in six non-consecutive weeks from August-October 2016, 31 of 947 (3%) orders were inappropriately verified by nursing in which pre-treatment lab results were pending or lab results did not meet parameters in the chemotherapy order. The team’s aim is by February 1, 2017, to reduce the number of chemotherapy orders sent to pharmacy without proper lab verification by 50%. Conclusions: Chemotherapy verification fatigue, specifically pre-treatment lab near misses, was identified as an area for improvement from recent patient safety reports. Barriers for nurses include inconsistent notation of treatment criteria in orders, long lab processing time, and patient frustration with a long wait. Interventions are underway to improve nursing adherence to pre-treatment lab verification.
Improving oral chemotherapy documentation in a breast medical oncology outpatient practice.
Authors: Bhardwaj Aarti Sonia , FitzPatrick Katherine , Hynes Kathleen , Bivens David , McLean Micheal , Enson Jenna , Hammer Marilyn J. , Holcombe Randall F. 
Published: April 2017

71 Background: The safe administration of oral chemotherapy is a challenging yet important process to ensure patient safety. Comprehensive initial and subsequent documentation especially regarding dosage and toxicities in the plan of care for patients receiving oral chemotherapy can be instrumental in improving patient safety by ensuring comprehensive health information is available to all health team members. Methods: We are undertaking a rapid cycle improvement project to improve initial and subsequent documentation of new oral chemotherapy care plans by increasing our compliance with the number of components of an oral chemotherapy care plan (as outlined by QOPI’s 13 standards). We performed a baseline chart audit to confirm our current low level of compliance. We then created a process to use smart phrases that include necessary QOPI elements for progress notes upon new prescription of oral chemotherapy as well as smart phrases for subsequent patient initiated telephone encounters regarding oral chemotherapy, that feed into a universal “med note” location. Post implementation, we will perform a chart audit to determine our updated compliance. Staff satisfaction with the old vs the new process will be compared to verify that we have created a more efficient system to answer patient questions regarding oral chemotherapy. Results: Baseline chart audit revealed the number of components of an oral chemotherapy care plan (as per QOPI standards) documented in the EMR was 43% (i.e contained 5/13 components). A Pareto chart confirmed that underutilization of current EMR resources and lack of knowledge regarding QOPI standards were common reasons for poor oral chemotherapy documentation. Implementation of smart phrases for documentation for initial patient encounters and subsequent telephone encounters is currently in process to determine our new level of compliance with QOPI standards for a sustained and meaningful improvement. Conclusions: This quality improvement initiative was designed to improve patient safety by enhancing documentation of an oral chemotherapy care plan in the EMR and also to create a more efficient system to answer and document patient phone calls regarding oral chemotherapy.
Post-discharge venous thromboembolism prophylaxis for surgical oncology patients.
Authors: Nadler Ashlie , Morba Mary Ellen , Pezzella Jesse , Farma Jeffrey M. 
Published: April 2017

79 Background: A number of guidelines have been proposed for prolonged venous thromboembolism (VTE) prophylaxis following hospital discharge for cancer patients undergoing major abdominal or pelvic surgery. However, there is disparity in how closely these guidelines are followed. The purpose of this study was to examine the administration and complications of post-discharge chemical VTE prophylaxis (pdVTE) at an institutional level among surgical oncology patients to help inform policy creation. Methods: A retrospective study at a tertiary referral cancer center was performed. Data was analyzed for patients undergoing surgery in 2015. Chi-square tests were performed. Results: Of 566 colorectal, urologic, and gynecologic surgical oncology procedures performed in 2015, 24% (137) were discharged with a prescription for enoxaparin for pdVTE. An additional 24 patients were already on another form of anticoagulation at the time of discharge. Of the patients discharged on pdVTE, 77% (105) had the prescriptions filled. The compliance rate of those patients was 96% (101). The rate of VTE was 3.5% for all patients. There was a significantly greater rate of VTE amongst patients that received pdVTE (10.4%) compared to those who did not (1.6%) (OR 7.20, CI 2.80-18.46, p < 0.001). For each subspecialty, there was also a significantly greater rate of VTE amongst patients that received pdVTE (p < 0.001). Conclusions: There is a very low rate of pdVTE administration despite current guidelines. Identifying patients who received pdVTE appears to identify patients at high risk for VTE rather than the benefits of pdVTE. Institutional policies regarding prolonged VTE prophylaxis should be implemented to target high-risk patients and to ensure appropriate prescribing practices. [Table: see text]
Interventions to improve oral chemotherapy safety and quality: A systematic and grey literature review.
Authors: Zerillo Jessica A. , Goldenberg Benjamin Adam , Kotecha Ritesh R. , Tewari Alok , Krzyzanowska Monika K. , Jacobson Joseph O. 
Published: April 2017

97 Background: With the growing use of oral chemotherapy, there is an urgent need to develop safe and effective systems to administer and manage these agents. A comprehensive synthesis of literature on oral chemotherapy care delivery programs to which clinicians can look for best practices is lacking. Methods: We performed a systematic review of PubMed, EMBASE and CINAHL from 1/1995- 5/2016 and the grey literature to identify publications describing oral chemotherapy care delivery programs. Our population of interest was cancer patients of all ages prescribed cytotoxic or targeted anti-cancer oral agents. Interventions could address any part of the oral chemotherapy delivery process from prescribing through disposal but had to report outcomes (adherence and/or safety or toxicity) in relation to a control group. Results: From 7,984 abstracts in the peer-reviewed and 9 from the grey literature, 16 studies met inclusion criteria (7 of these randomized) with 3,612 patients represented. Interventions focused on prescribing (n = 1), preparation/dispensing (n = 2), education (n = 11), administration (n = 5), monitoring (n = 14), and storage/disposal (n = 1). Of the 10 articles with adherence as an outcome, four different measurement methods were used. Many articles lacked formal statistical testing. In the 6 studies with statistically significant improvement in outcomes, 3 utilized nursing phone calls to patients within the first few days of treatment initiation, which resulted in less toxicity (n = 2) or better adherence (n = 1). None of the four studies that evaluated eHealth strategies to increase patient to care team contact demonstrated a statistically significant improvement in outcomes. Conclusions: Limitations in study design impair our ability to draw definitive conclusions on best practices for oral chemotherapy care delivery. A framework for conducting research in this area that defines the processes of oral chemotherapy delivery and standardizes outcomes of success is needed to address this gap. Existing studies suggest that interventions focusing on education and remote phone-based monitoring of patients at therapy initiation may decrease toxicity, and possibly improve adherence.
Down Syndrome-Associated Diabetes Is Not Due To a Congenital Deficiency in β Cells
Authors: Butler Alexandra E. , Sacks Wendy , Rizza Robert A. , Butler Peter C. 
Published: April 2017

Abstract

Aims/Hypothesis:
We sought to establish whether the increased incidence of diabetes associated with Down syndrome was due to a congenital deficit in β cells.

Methods:
The pancreas was obtained at autopsy from nondiabetic subjects with Down syndrome (n = 29) and age-matched nondiabetic control subjects without Down syndrome (n = 28). The pancreas sections were evaluated for the fractional β-cell area.

Results:
No difference was found in the fractional β-cell area between the subjects with Down syndrome and the control subjects.

Conclusions/Interpretations:
The increased incidence and prevalence of diabetes in individuals with Down syndrome is not due to an underlying congenital deficiency of β cells.
Use of the Electronic Health Record for Coding in Outpatient Neurology
Authors: Weathers Allison L. 
Published: April 2017

ABSTRACT
Diagnostic coding now factors into reimbursement, quality assessments, reputational metrics, and epidemiologic analysis; therefore, it is more critical than ever that neurologists are accurate and precise in their coding. In addition to being the means though which most neurologists are capturing this information, the electronic health record can offer multiple tools to assist in these efforts. With conscientious design, build, and implementation of the electronic health record, diagnostic coding can be effortless, even for the most complex and varied of conditions seen in an outpatient neurology visit.
Urogenital Symptoms in Neurologic Patients
Authors: Panicker Jalesh N. 
Published: April 2017

ABSTRACT

Purpose of Review: Lower urinary tract and sexual dysfunction are commonly reported sequelae of neurologic disease and have a significant impact on quality of life. This article presents an up-to-date summary of the clinical presentation, investigations, and treatment options for urogenital dysfunction in patients with neurologic disease.

Recent Findings: The pattern of lower urinary tract dysfunction is influenced by the site of the neurologic lesion. The risk for developing upper urinary tract damage is considerably less in patients with slowly progressive nontraumatic neurologic disorders, as compared to those with spinal cord injury or spina bifida. Investigations such as urinalysis, ultrasonography, and urodynamics provide further information about the cause and nature of lower urinary tract dysfunction. Antimuscarinic agents are the first-line management of urinary incontinence; however, side effect profile and anticholinergic burden should be considered when prescribing medications. β3-Adrenergic receptor agonists are a promising alternative oral medication. Tibial and sacral neuromodulation have been shown to be effective for managing incontinence, as well as urinary retention due to Fowler syndrome. Intradetrusor injections of onabotulinumtoxinA have revolutionized the management of neurogenic detrusor overactivity.

Summary: Neurologic patients reporting urogenital symptoms require a comprehensive evaluation for planning a patient-tailored approach to management. Neurologists are increasingly inquiring about lower urinary tract and sexual functions and becoming involved in the management of these disorders.
Low Back Pain
Authors: Tavee Jinny O. , Levin Kerry H. 
Published: April 2017

ABSTRACT

Purpose of Review: This article provides an overview of evaluating and treating low back pain in the outpatient setting.

Recent Findings: As most cases of acute low back pain have a favorable prognosis, current guidelines on imaging studies recommend conservative treatment for 6 weeks prior to obtaining an MRI if no red flags are present. Of these red flags, a prior history of cancer is the strongest risk factor for a malignant etiology and requires urgent evaluation with MRI. Management of acute low back pain is mainly conservative with oral non-narcotic analgesics and mobilization as the initial recommendations. For patients with radiculopathy, epidural steroids may result in short-term pain relief, but long-term effects are still unclear.

Summary: A systematic, evidence-based approach to the patient with low back pain is key to providing safe and cost-efficient care.