bluuebunny/crossref_metadata_2025_split huggingface dataset:
Myeloid growth factor utilization in a commercial and Medicare population: Phase 1 of a quality improvement initiative.
Authors: Li Edward C. , Peterson Barry A. , Tran Cecilia , Sturgill Michael , Gill Dudley , Forston Stanley , Bastianpillai Romano 
Published: February 2017

242 Background: Some clinical practice guidelines encourage the judicial use of myeloid growth factors (MGFs) in the prevention of chemotherapy-induced febrile neutropenia (FN) because of efficacy and safety concerns. For example, the ASCO guidelines state that a dose reduction of myelosuppressive chemotherapy in patients with incurable disease rather than prescribing a MGF for secondary prophylaxis is a reasonable alternative. Because there is wide variation in MGF prescribing, New Century Health (NCH) conducted a quality improvement analysis of MGF requests in a commercial and Medicare population. The objectives are to: (1) describe the cohort demographics, (2) identify areas of improvement to promote cost-effective use, and (3) measure the economic impact from interventions. Methods: MGF authorization requests for oncology indications to NCH in 2013 were analyzed for cohort demographics: age, weight, tumor diagnosis, and treatment intention (e.g., metastatic/palliative, curative, etc.). Requests were analyzed for concurrent use with chemotherapy, approval status of the request (including reason for withdrawal), and cost saving associated with interventions. Results: There were 7,958 requests for a MGF; 81% were for pegfilgrastim and 19% for filgrastim. Average age of the cohort was 66 years, weight-based dosing (>70 kg) was appropriate in 43% of patients receiving 300 mcg and 72% of patients receiving 480 mcg. MGFs were most commonly requested in: breast (18%), lung (17%), lymphoma (14%), and gynecologic (8%) tumors. 40% of requests were for metastatic/recurrent disease and 38% for curative intent. 6,724 (84%) of requests were authorized based on established-use criteria. The main reason for not authorizing was lack of compendia support for both primary and secondary prophylaxis; this resulted in approximately $3.5 million in cost savings. Conclusions: There is opportunity to improve efficiency of MGFs use in this population through a dose rounding protocol and by promoting chemotherapy dose reductions, as advocated by the ASCO guidelines. Further analysis will assess the concordance of MGF use with guidelines, specifically in regard to chemotherapy regimens and their risk of FN.
What fixes can improve cancer care quality at safety-net hospitals?
Authors: Bickell Nina A. , Moss Alexandra , Bellacera Bonnie , Franco Rebeca , McAlearney Ann Scheck 
Published: February 2017

243 Background: Safety-net hospitals are at higher risk of poor quality cancer care and vary in levels of quality performance. Types of quality problems may differ and require different interventions. We undertook this study to identify organizational factors affecting quality and assess the early findings of the innovation’s impact on hand-offs between specialists. Methods: As part of a RCT testing a web-based tracking and feedback innovation to close referral loops, new breast cancer cases are rapidly ascertained, and post-surgical medical and radiation oncologist visits are assessed. Surgeons are alerted to patients who do not show to oncology visits to stimulate action. Of 153 enrolled women (98 Intervention/ 55 Control), 4% are white. In addition, we conducted 90 key informant interviews in 9 safety-net hospitals in the NYC metropolitan area and performed a qualitative comparative analysis (QCA), a method to assess causal complexity, to identify organizational factors associated with poor quality. Results: No-shows at oncology appointments triggering surgeon feedback occurred for 5/98 (5%) new breast cancer patients. QCA revealed 6 conditions associated with poor quality-defined as underuse of needed adjuvant treatment: information sharing; follow-up; system support; patient-centered culture; flexibility and private practice. All high-performing hospitals had a patient-centered culture, strong follow-up approaches and shared information. Some of these high-quality sites had robust system support while others had creative workarounds (flexibility) or were responsive to their private practice patients. Overall, these pathways had high consistency (.88) and coverage (.72). Only hospitals with both poor follow-up and system support activated the web-based feedback. Conclusions: Safety-net hospitals with poor follow-up capabilities may benefit from an innovation designed to improve hand-offs across specialties. This trial continues to accrue; we are monitoring the innovation’s effectiveness. Clinical trial information: NCT01544374.
Adjuvant colon cancer care quality, risk, value, and level one data and guideline compliance among the elderly privately insured in southeastern USA.
Authors: Hrushesky William J. , Baranwal Anmol , Huff Dinah Faith Q. , Shimp William S. , Mamgain Avinash , Fishman Marc L. , Schorer Anna E. , Bobolts Laura Rose , Davis Sharon , Kogler Jurgen , Armitage Melissa , Bennett Charles L. 
Published: February 2017

249 Background: Oxaliplatin-containing regimens are among the most efficacious adjuvant treatments for locally-advanced colon cancer, although significant toxicity can occur. Because of relevant level I data, the NCCN revised its guidelines in 2012, recommending omission of oxaliplatin from combination adjuvant chemotherapy regimens for older patients (>70yo) with colon cancer. We examined prescribing behavior of oncologists between 2009 and 2014 to evaluate how rapidly NCCN guidelines were adopted into practice. Methods: This is a retrospective observational study of chemotherapy request data from more than 2,000 community oncologists in the southeastern United States. We examined 57 consecutive months of chemotherapy requests for stage II and III colon cancer patients 70 years and older, based on three epochs. During the middle epoch, one phase III trial evaluating oxaliplatin-containing regimens as adjuvant chemotherapy (NSABP C-07), and a revised 2012 NCCN guidelines, each supported omission of oxaliplatin from adjuvant chemotherapy regimens for older persons with colon cancer. Multivariate analyses evaluated associations among patient characteristics (age, gender, and performance status), disease stage, and time-period, with the odds of receiving oxaliplatin-containing regimens as adjuvant chemotherapy. Results: Among 266 persons with stage II or III colon cancer 70 years of age and older, over the six-year span, most adjuvant chemotherapy requests (184/266, 69.2%) contained oxaliplatin. Older age, male gender, and poor performance status were associated with significantly lower odds of receiving oxaliplatin-containing adjuvant chemotherapy regimens (p<0.05), while time period (epoch) was not significantly associated with temporal changes in patterns of use. Conclusions: Use of oxaliplatin containing adjuvant chemotherapy regimens among older persons with colon cancer did not decrease following publication of phase III clinical trial data and revised NCCN guidelines recommending against oxaliplatin use in this setting. Focused quality improvement initiatives for this population of cancer patients may be helpful.
Quality of care improvement in breast and lung cancer.
Authors: Letson Douglas D. , Lancaster Johnathan M. , Chiappori Alberto , Peabody John W. , DeMaria Lisa , Bacate Marife , Kubal Timothy Edward 
Published: February 2017

252 Background: Despite the growing call for use of guidelines in cancer care, adherence to clinical pathways and clinical care transformation is a challenge. Moffitt Cancer Center (MCC) has addressed this challenge, in multiple service lines, using its clinical pathways and serial measurement in a broad-based initiative to improve quality of clinical care. Methods: Moffitt launched an initiative focused on quality and improvements in care using Clinical Performance and Value (CPV) vignettes to measure multiple aspects of quality including: clinical decision-making, pathway adherence and appropriate utilization of tests/procedures. The CPVs—simulated patients cared for by providers on-line—are based upon the Moffitt Clinical Pathways. CPVs are given serially to benchmark, motivate providers, and provide confidential individual feedback. Data have been collected every 4 months since mid-2013. We report on three rounds in breast cancer and two rounds in lung cancer. Results: A total of 18 providers at MCC completed the breast cancer CPVs and 19 providers at MCC completed the lung cancer CPVs. Overall scores improved significantly and pathway adherence improved significantly for staging work-up and chemotherapy between rounds 1 and 3 for breast cancer (Table). Conclusions: Adherence to Moffitt Clinical Pathways for breast and lung cancer, using serial measurement and feedback with CPVs, improved across multiple providers and two diseases. This may have potential to transform practice. [Table: see text]
Brief versions of the FACIT-fatigue and FAACT subscales for patients with non-small cell lung cancer cachexia.
Authors: Salsman John M , Beaumont Jennifer L , Wortman Katy , Yan Ying , Friend John , Cella David 
Published: February 2017

259 Background: Cancer anorexia-cachexia syndrome (CACS) is common in advanced cancer patients and associated with weight loss, fatigue, impaired quality of life (QoL), and poor prognosis. The goal of this project was to identify the most responsive items and evaluate their validity from two QoL measures in the ROMANA 2 (NCT01387282) Phase III global study evaluating anamorelin HCl in the treatment of non-small cell lung cancer (NSCLC) cachexia: the Functional Assessment of Chronic Illness Therapy–Fatigue (FACIT-F) and the Functional Assessment of Anorexia/ Cachexia Therapy (FAACT). Methods: In the ROMANA 2 trial, 477 patients with unresectable Stage III or IV NSCLC and cachexia were to be enrolled and randomized (2:1) to receive anamorelin HCl or placebo once daily for 12 weeks. All 383 patients who reached the Week 12 visit at the time of this blinded data analysis were included. Co-primary endpoints were change from baseline in lean body mass and handgrip strength. QoL was a key secondary outcome with FACIT-F and FAACT questionnaires administered at baseline and at weeks 3, 6, 9, and 12. Results: Two 4-item scales (referred to as the Simplified Evaluation of Fatigue [SEF] & Simplified Evaluation of Appetite [SEA]) from the FACIT-F and FAACT, respectively, demonstrated good internal consistency reliability with Cronbach’s alphas >0.70. In analysis of known group validity, scores significantly differed between groups defined by performance status and appetite (with effect sizes ≥0.34). Convergent validity analysis showed significant correlations with general QoL/functioning scales (correlation coefficients 0.41–0.77), further demonstrating validity. In terms of responsiveness, changes from baseline to week 12 in SEF and SEA scores were associated with changes in general QoL/ functioning, appetite, weight, and lean body mass (correlations >0.20). The estimated important difference for each scale was ~1-2 points. Conclusions: These brief scales are valid and responsive measures that provide psychometric properties necessary to promote future research in NSCLC patients with CACS. Additional work should examine clinical utility of these scales and their impact on treatment decision-making.
Cost-effectiveness analysis of single fraction of stereotactic body radiotherapy compared to single fraction of external beam radiotherapy for palliation of vertebral bone metastases.
Authors: Kim Hayeon , Rajagopalan Malolan Sri , Beriwal Sushil , Smith Kenneth 
Published: February 2017

26 Background: Stereotactic body radiotherapy (SBRT) has been proposed for the palliation of painful vertebral bone metastases because higher radiation doses may confer better pain control. A Phase III clinical trial comparing SBRT with single fraction external beam radiotherapy (EBRT) is now ongoing. We performed a cost-effectiveness analysis to compare these strategies. Methods: A Markov model, using a 1-month cycle over a lifetime horizon, was developed to compare the cost effectiveness of SBRT (16 or 18 Gy in 1 fraction) to 8 Gy in 1 fraction of EBRT. Transition probabilities, quality of life utilities, and costs associated with SBRT and EBRT were captured in the model. Costs were based on Medicare reimbursement in 2014. Strategies were compared using the incremental cost effectiveness ratio (ICER), and effectiveness was measured in quality-adjusted life years (QALYs). To account for uncertainty, one-way and probabilistic sensitivity analyses were performed. Strategies were evaluated with a willingness-to-pay (WTP) threshold of $100,000/QALY gained. Results: Base case pain relief after the treatment was assumed as 20% higher in SBRT. Treatment costs for SBRT and EBRT were $9000 and $1087, respectively. In the base case analysis, SBRT resulted in an ICER of $124,552/QALY gained. In one-way sensitivity analyses, results were most sensitive to variation of the utility of unrelieved pain (range: $89,330 to $592,720/QALY gained); the utility of relieved pain post-treatment and median survival were also sensitive to variation. If median survival is ≥11 months (base case estimate: 9 months), SBRT cost <$100,000/QALY gained. Probabilistic sensitivity analysis demonstrated that SBRT was favored in 30% of model iterations at a WTP threshold of $100,000/QALY gained. Conclusions: SBRT for palliation of vertebral bone metastases is not cost-effective compared to EBRT based upon the ICER analysis with the WTP of $100,000/QALY gained. However, if median survival is ≥11 months, SBRT is economically reasonable, suggesting that selective SBRT usage in patients with longer expected survival may be the most cost-effective approach.
Cancer patient experience: A pilot survey in Japan.
Authors: Kamiya Izumi , Okuyama Ayako , Katayama Kayoko , Yamashita Natsumi , Akuta Keizo , Yamamoto Shigeko , Ikegami Toshihiko , Fushiki Masato , Yamaki Chikako , Wakao Fumihiko , Higashi Takahiro , Takayama Tomoko 
Published: February 2017

260 Background: Patient-reported experiences of cancer care are an important outcome of cancer control programs. To establish a nation-wide system to monitor progress in cancer control policies, we piloted a patient experience survey to six hospitals in Japan. Methods: We conducted a self-administered questionnaire survey to a total of 1,804 adult cancer patients receiving cancer treatment in six hospitals (three cancer centers, two general hospitals, and one academic institution) from July 2013 to Mar 2014. Patients were asked to answer 94 questions covering eight dimensions of cancer experience: 1) decision-making, 2) care coordination, 3) patient education, 4) pain control, 5) emotional support, 6) family support, 7) access to care, and 8) care continuity. Results: Eighty percent of the patients reported that their treatment preferences were respected in the decision-making process, but a large proportion of patients (60%) also noted that they preferred to have their treatment decisions made for them by their physicians. Many (32%) expressed difficulty in communicating their questions and concerns to their physicians at the time of diagnosis. Only one fifth of patients were informed at the time of diagnosis that they can seek for a second opinion from other providers. Average patient-reported wait time to surgery was 30 days, which was considered to be long by a third of the patients. Eighty percent of patients felt that their care was well-coordinated by a multidisciplinary team, while % also felt that they received adequate emotional support from their medical staff. Relatively small proportion of outpatients (77%) felt that they had access to medical staff when they had medical questions, compared to nearly all patients in an inpatient setting. Only 65% of inpatients and 40% of outpatients felt that they had received best available pain control during their care. Less than half of the patients were able to communicate their preferred place of care after discharge with their healthcare provider. Conclusions: Patient-reported experiences of cancer care are an important outcome measure of cancer policy performance. This pilot study served to reveal some of the important on in future nationwide surveys.
Assessing the impact of a targeted electronic medical record intervention on growth factor usage in cancer patients.
Authors: Bernens Jordan , Hartman Kara , Curley Brendan F. , Wen Sijin , Abraham Jame , Newton Michael David 
Published: February 2017

262 Background: Patients receiving chemotherapy are at risk for febrile neutropenia following treatment. The American Society of Clinical Oncology (ASCO) and National Comprehensive Cancer Network (NCCN) recommend screening patients for risk of febrile neutropenia and risk stratification based on likelihood of febrile neutropenia events. Prophylactic growth factors (G-CSF) should be in patients receiving high-risk regimens or intermediate-risk regimens with individual risk factors. The impact of electronic medical record system (EMR) implementation on compliance with G-CSF support guidelines has not been studied. Methods: At West Virginia University/Mary Babb Randolph Cancer Center we conducted an IRB approved retrospective chart review of cancer patients receiving chemotherapy from January 1, 2007 to August 1, 2008 (pre-EMR) and January 1, 2011 to December 31, 2011 (post-EMR). We reviewed the chemotherapy regimens and patient risk factors for developing febrile neutropenia, and determined if the G-CSF usage was consistent with guideline recommendations. Results: Compliance with prophylactic G-CSF guidelines was 75.6% in the post-EMR arm, compared to 67.5% in the pre-EMR arm (p=0.041, ch-square). The post EMR data of 1,042 new chemotherapy initiations showed: (see Table). The appropriateness of usage in high and low risk patients were the most compliant, as G-CSF orders were built into chemotherapy plans of high risk regimens and omitted from low risk regimens. Conclusions: Appropriate prophylactic G-CSF usage can be improved when orders are integrated into standard chemotherapy order sets in an EMR. An area of further improvement would include automatic identification of individual risk factors by the EMR. [Table: see text]
Measuring quality of life in chronic hematologic malignancy: The QUALMS-1.
Authors: Martins Yolanda , Klaassen Robert , Efficace Fabio , Buckstein Rena , Tinsley Sara , Watts Corey D. , Jurcic Joseph G. , Abel Gregory Alan 
Published: February 2017

263 Background: Disease-specific measures of quality of life (QoL) allow for assessment of disease-specific symptoms and psycho-social factors, an especially important endeavor for patients with chronic hematologic malignancies. We aimed to determine if disease-specific QoL could be measured for patients with myelodysplastic syndromes, and what underlying constructs would inform such a measure. Methods: We previously reported on the development of the QUALMS-1, a 33-item QoL tool for MDS patients. 124 MDS patients completed the QUALMS-1 and the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30). Chart review was conducted to collect disease characteristics, lab tests, treatments, transfusions, and use of growth factors. Participants were recruited from MDS centers across the USA, Canada and Italy. QUALMS-1 items were scored on a scale ranging from 1 “Never” to 5 “Always”, with 4 reverse-scored items. Items were averaged to create a preliminary total scale score, with higher scores indicating poorer MDS-specific QoL. Results: Mean total scores on the QUALMS-1 ranged from 1.0 - 3.9. The measure had excellent internal consistency reliability (α=.92) and was moderately correlated with the QLQ-C30’s global health, physical functioning, role functioning, emotional health, cognitive functioning, social functioning, fatigue, nausea and pain measures (r range from 0.34 – 0.65, all p <.01). Patients with Hg <= 10 showed a small but consistent higher QUALMS-1 score (M = 2.5; SD =.59) than those with Hg >10 (M = 2.1; SD =.54; p =.03). Preliminary analyses suggested that four latent factors underlie the QUALMS-1, corresponding to the following subscales: physical burden, disease information and uncertainty, emotional burden, and disease-related positives. Conclusions: Our data suggest that the QUALMS-1 is internally consistent and has construct validity in patients with MDS. The measure provides a unique assessment of disease information and uncertainty, as well as disease-related positives. These are psychosocial constructs that may be particular to chronic hematologic malignancies such as MDS and are not well-assessed by generic or cancer-related measures.
Justification of more expensive antiemetic use with FOLFOX at an ambulatory cancer center.
Authors: Manoogian Amanda , Rostamnjad Leila , Diviak Michael , Ryan David P. , Blouin Gayle C. 
Published: February 2017

27 Background: According to NCCN, ASCO, and Multinational Association of Supportive Care in Cancer (MASCC) guidelines, palonosetron in combination with dexamethasone is the preferred 5-HT3 antagonist for use with moderately-emetogenic chemotherapy (MEC). NCCN gives all 5-HT3 antagonists a category one recommendation. Currently at the Massachusetts General Hospital (MGH), ondansetron is the 5-HT3 antagonist of choice due to its significant cost advantage and flexibility in dosing. Palonosetron is currently restricted to use in the second-line setting at MGH based on limitations of the evidence currently available supporting its preferred use. The primary objective of this study is to assess antiemetic utilization in patients receiving FOLFOX +/- bevacizumab(B) in an outpatient infusion unit and measure palonosetron and NK-1 antagonist usage. Methods: A retrospective review was conducted of all outpatient chemotherapy orders for FOLFOX +/- B for a six month period from 11/13-4/14. Prophylactic antiemetic use was evaluated over that time period. Data was captured using electronic MARs, prescription records, and drug utilization reports. Results: 184 patients were identified; 858 FOLFOX +/- B treatments were administered during the study period. For emesis prophylaxis, 74.5% received the MGH standard ondansetron and dexamethasone, 10.3% received palonosetron, 9.8% received an NK-1 antagonist, and 5.4% received a combination of palonosetron plus NK-1 antagonist. Mean patient age was 60.8 years; 59.8% of patients were male; 63.6% had a diagnosis of colorectal cancer; 42.9% had metastatic disease. Conclusions: The majority of patients receiving FOLFOX +/- B were well managed on ondansetron and dexamethasone and did not require the use of more costly antiemetics. However 25.5% of patients required alternative/additional antiemetics, suggesting further investigation to determine which patients could benefit from these therapies up-front may be prudent. Study data support continued use of palonosetron as a second line therapy. Larger, pharmacoeconomic comparison studies are necessary to justify frontline use of palonsetron.