bluuebunny/crossref_metadata_2025 huggingface dataset:
Effects of radium-223 dichloride (Ra-223) on risk for hospitalization and health care resource use in the phase 3 ALSYMPCA trial.
Authors: Cislo Paul , Reuning-Scherer Jonathan
Published: February 2017

21

Background: Ra-223 is a first-in-class alpha-emitter approved for treatment (tx) of patients (pts) with castration-resistant prostate cancer and symptomatic bone metastases. In ALSYMPCA, Ra-223 significantly improved overall survival by 3.6 months vs placebo (pbo) (HR = 0.70; 95% CI, 0.58-0.83; P < 0.001) and was well tolerated. To understand whether the tx benefit corresponds to differences in utilization, hospitalization and other types of health care resource use were evaluated. Methods: Data on hospitalization, nursing home visits, home health care and adult day care services use, and physician visits were captured for each pt. Tx groups were compared, based on percentage needing each type of health care resource, using Fisher’s exact test. To account for differences in each pt resource use in ALSYMPCA, the number of encounters (eg, office visits) and duration of encounters (eg, days hospitalized) were divided by observation time. The mean number and duration of encounters were compared using analysis of variance. To compare tx groups based on the rate of use per year, incidence rates and ratios were calculated using a generalized estimating equation (GEE) regression model. Results: The mean follow-up time in months for Ra-223 vs pbo was 10.0 vs 8.6. The incidence rate for Ra-223 vs pbo was 1.1 vs 1.4 (incidence rate ratio = 0.77; 95% CI, 0.62-0.95; P = 0.013). The mean number of hospitalizations and hospitalization days per year for Ra-223 vs pbo were 1.3 vs 1.7 (P = 0.020) and 8.1 vs 14.6 (P < 0.001), respectively. The percentage of pts that required hospitalization was nominally lower for Ra-223 vs pbo (42.3% vs 49.0%, P = 0.062). Among pts who experienced at least one hospitalization, the mean number of hospitalization days per year for Ra-223 vs pbo pts was 19.4 vs 30.4 (P < 0.001). No significant differences were found between tx groups in terms of visits or durations of time in nursing homes per year, amount of adult day care and home health care services utilized per year, and number of physician visits per year. Conclusions: Compared with pbo, Ra-223 tx resulted in a 23% reduction in incidence of hospitalizations per year and about 6.5 fewer hospitalization days per pt per year. Clinical trial information: NCT00699751.
Improving chemotherapy ordering process.
Authors: Bryant Jill
Published: February 2017

213

Background: Chemotherapy ordering process can be unsafe and inefficient, putting patients at risk for medication errors. Documentation is essential in decreasing the incidence of errors with ordering and administration. The goal is to provide safe, efficient and quality care to oncology patients. Methods: The aim of the project was to decrease the number of deviations on the chemotherapy order forms by 50% within five months. Deviations identified were documentation inconsistency; checking of chemotherapy dosing at the provider level; and difficulty in updating the original order when changes were required. Large amount of time was spent in reconciling deviations. A multidisciplinary team collaborated on identifying root causes, such as, variances in completion of the forms, knowledge deficit of the ordering process, and staff accepting incomplete orders. Results: Order forms were reviewed and real time observations of the process were conducted. Data was collected on the types of deviations on the forms. The top three deviations were: 1. Lab values were not being completed within seven days; 2. Physician’s name and pager number were not provided; and 3. Order forms were missing the day of the chemotherapy cycle. Interventions included the education in entering complete and pertinent information on orders; institution of same day labs on day of visit; standardizing lab parameters; manual audits; and Nursing education regarding the acceptance of orders with deviations. Prior to intervention, 70% of the chemotherapy order forms had at least one deviation. At the five month evaluation, there was a reduction of 13%. Although a modest decrease, interventions continued. In follow-up, a random sample of orders was reviewed reflecting a reduction of 51%. Conclusions: Interventions continue with anticipation for further improvement in the chemotherapy ordering process. With decreasing the number of deviations, there will be an increase in safe, efficient and quality care for oncology patients. This project showed an initiative of improving a process to provide efficient care throughout the healthcare continuum. [Table: see text]
Applying clinical process analysis in patient access.
Authors: Aranzamendez Gina , Barnes Courtney , Enriquez Eric , Hayes Beverly A , Haywood Valerie , Kaufman Laurie , Quinn Doris , Rohe Duke
Published: February 2017

214

Background: Patient access is the entry point for new and established patient registration and scheduling process. It serves as the doorway in aligning the need of the patients to the vision of the organization, ensuring financial viability of all parties involved. The increasing demands for regulatory requirements, changes in reimbursement policies, technological and medical advancement, and steep competition, patient access becomes a vital improvement initiative in many healthcare organizations. In FY 2013, our group, the Clinical Process Analysis (CPA) team was tasked to assess the patient access work processes of our clinic areas. Methods: Through a series of structured group interview meetings, the interdisciplinary team (frontline staff, clinical leadership and financial teams) reflects and articulates their current work processes. These work processes are translated into an electronic process map, inclusive of the activities, job roles, estimated times, probabilities, and opportunities for improvement (OFIs). With these elements, CPA delivers a visual display of current work processes which can be utilized for onboarding, visualization of OFIs, and calculation of direct labor cost. A completion of a facilitated PDSA project further infuses the science of improvement. Results: Six centers completed the CPA projects since September 2013. 98 OFIs identified with 91% identified as efficiency and timely issues. 10 PDSA projects initiated, 50% reached completion and 50% are in progress. Clinical teams continue to work on the improvement projects even after the facilitation were completed. Conclusions: Drawing from system thinking and Time-Driven Activity-Based Costing (TDABC) methodology, CPA provides a comprehensive analysis of the current work flow. This allows for both a clinic specific and institutional comparative analysis for identification, implementation and improvement plan. Through facilitation of an interdisciplinary team, from frontline to leadership, process realities are visualized and work-list of opportunities for improvement are identified and worked on. This enables a quality improvement culture of providers and staff to drive quality and financial improvement.
Cost of treatment failure in patients with chronic lymphocytic leukemia: Results of a large U.S. observational study.
Authors: Senbetta Mekre , Robitaille Marie-Noelle , McKenzie R. Scott , Lefebvre Patrick
Published: February 2017

22

Background: Patients with chronic lymphocytic leukemia (CLL) who eventually experience disease progression are offered a limited choice of treatments. This retrospective observational study assesses healthcare resource utilization and costs in patients with CLL who have received one prior therapy and experience treatment failure (TF). Methods: Adult patients with ≥1 diagnosis of CLL and ≥1 claim for a medication used to treat CLL were identified in the IMS PharMetrics Plus database (01/2008 – 09/2013). Patients were excluded if they had evidence of a non-hematologic malignancy, used a non-CLL antineoplastic agent, or received a stem cell transplant during the 12-month baseline period. TF was identified based on earliest occurrence of one of the following events: initiation of a new treatment for CLL that was not part of the 1st-line therapy, resumption of any CLL treatment following a minimum of 3-month break in treatment, stem cell transplant, radiotherapy, hospital mortality, or hospice care. Resource utilization was reported as monthly incidence rates, and costs were reported in 2013 $US per patient per month (PPPM), comparing patients with and without TF. Results: A total of 6,015 patients with CLL were identified (mean patient age: 63 years old; proportion female: 36%), of which 2,734 (45%) experienced TF. Patients with TF tended to require more OP visits (3.2 vs. 2.5). Average total cost PPPM was $7,850 for patients with TF and $4,555 for patients without TF. The main cost drivers were outpatient (OP) costs ($4,355 for patients with TF; $3,022 for patients without TF) and hospitalization costs ($2,659 for patients with TF; $1,038 for patients without TF). Once adjusted for baseline characteristics, average total cost difference between patients with and without TF was $3,757 PPPM. This difference was largely due to hospitalization (45%) and to OP costs (46%). Conclusions: Patients with CLL experiencing TF appear to require more OP visits and to be associated with higher OP and hospitalization costs PPPM compared to those without TF. These data help in our understanding of the healthcare resource utilization and costs associated with the treatment of patients with CLL.
Application of lean methodology to improve quality and efficiency of molecular diagnostic testing in non-small cell lung cancer (NSCLC).
Authors: Wagman Lawrence David , Maurice John , Crabtree Peggy , Horblyuk Ruslan
Published: February 2017

220

Background: The advent of targeted cancer therapies has triggered an increase in the volume of molecular testing performed across multiple tumor types. This raises concern about the efficiency of associated operational and quality processes. This study’s objective was to apply lean methodology, using NSCLC as a pilot disease state, to evaluate current molecular testing processes, identify existing inefficiencies, design an improved process and assess scalability for application across other tumor sites at the pilot site. Methods: Modified Lean methodology was employed. Semi-structured 1:1 interviews with multidisciplinary team (MDT) stakeholders representing oncology, pathology, interventional radiology, pulmonology and administration were conducted. MDT-based value stream mapping workshops were carried out to describe the “current” and design the “future” state of molecular testing process in NSCLC. The goal was to identify existing inefficiencies and inform targeted process improvement efforts. Results: Interviews with 25 MDT stakeholders revealed substantial variability in the molecular diagnosis processes and a lack of coordinated communication across disciplinary silos. Specifically, the consensus-derived “current” state map identified appropriate biopsy tissue (quality and quantity) and inconsistent protocol utilization among the major inefficiencies resulting in repeat biopsies. Development and implementation of the MDT-based molecular testing protocol, including introduction of a tissue acquisition protocol, were identified as target areas for process variability improvement. Conclusions: Inefficiencies exist in molecular testing processes and need to be identified and minimized as the burden of molecular testing increases. This pilot successfully employed modified Lean methodology to identify areas of improvement in the molecular testing process in NSCLC and could be replicated in other relevant disease states. Program evaluation is underway to quantify the impact of this initiative on operational and patient care metrics.
Sharing experiences and building collective projects in quality management: The strength of UNICANCER group.
Authors: Sieradzki Gregory , Esperou Helene , De Jesus Anne
Published: February 2017

226

Background: UNICANCER is a hospital group entirely devoted to fighting cancer. UNICANCER groups together 20 French Comprehensive Cancer Centers (FCCC), which are private, non-profit establishments with a threefold mission of patient care, research and oncology teaching. They share the same organizational model to take care the patients and they have organized an informal network of quality and risk management In 2005, the FCCC federation (former Unicancer group) was created a Quality department in order to build a common approach to improve the quality of care and patient management in Cancer Centers. One the most important tools to set up this shared works were comparative analysis and feedback system. Methods: Every year, the quality department of Unicancer group coordinated the results of several indicators recorded by each centers. These results were summarized in the benchmarks dashboards to identify the priority actions for the group. Results: Between 2006 and 2014, some collaborative projects have been carried out in various fields: (1) development of the culture of continuous improvement, (2) involvement to the national implementationof hospital quality and safety indicators in France, (3) development of specific indicators of cancer care, (4) implementation of questionnaire survey to assess the in- or outpatient satisfaction. As far as concerned the different results of external assessment (1) the values of quality and safety indicators are above the national average, (2) the Cancer Centers have the best level of “certification” for the French National Authority for Health. Conclusions: The teamwork and benchmarking is an innovative way of working. The level of quality of care and patient management increases steadily in Cancer Centers in France. The next step consists of developing a common standard to keep competitive edge. [Table: see text]
Quality of care study in the surveillance of curable colon cancer.
Authors: Bhardwaj Aarti Sonia , Holcombe Randall F.
Published: February 2017

237

Background: The 2005 ASCO surveillance guidelines for Stage II/III colon cancer recommended chest, abdomen (and pelvis) imaging annually for 3 years, checking a CEA every 3 months for the first 3 years and colonoscopy 1 year after surgery or preoperatively. Our primary aim was to determine Mount Sinai Hospital’s (MSH) compliance rate with ASCO surveillance guidelines, with a goal of achieving 80% compliance. We hypothesized a bias to over-imaging. A secondary aim was to determine the frequency at which high risk Stage II patients were referred to medical oncology. Methods: A retrospective study of 118 patients with newly diagnosed stage II or III colon cancer at MSH in 2011 and 2012 was undertaken. Results: Compliance rates for early surveillance measures included. 1. Checking CEA approximately every 3 months: Stage II - 84%; Stage III - 88%. 2. Colonoscopy guidelines: Stage II - 72% and Stage III - 94%. Imaging post surgery or adjuvant treatment: Stage II - 48% and Stage III - 70%. Subsequent imaging: Stage II - 44%; Stage III - 28%. (See Table.) Overall compliance with early surveillance guidelines was 55% for Stage II patients and 83% for Stage III patients. All of the non-compliance for subsequent imaging was due to overscanning. Only 62% of high risk Stage II patients were referred to medical oncology. Conclusions: Our baseline compliance to early surveillance measures for colon cancer did not consistently achieve our pre-specified benchmark. Specific areas of improvement include avoidance of overscanning during colon cancer surveillance after adjuvant chemotherapy and an improved rate of referral of high risk Stage II patients to medical oncology after surgery. [Table: see text]
Evaluating oncology pharmacist safety reporting in an outpatient cancer center.
Authors: Blouin Gayle C. , Chio Christine , Kim E. Bridget , McGladrigan Conor , Bohlen Nie , Lafleur Katie
Published: February 2017

238

Background: Safety reporting is imperative because it provides an opportunity to identify and address preventable errors to enhance patient safety. Pharmacists at the Massachusetts General Hospital cancer center have historically submitted the highest number of safety reports compared to clinicians/nursing. This past year, however, there was a decline in the number of reports submitted. Because pharmacists are in a key position to monitor patient safety, this study was conducted to characterize safety reports submitted by pharmacists and describe subsequent action plans. Additionally, pharmacists’ attitudes towards safety reporting were assessed and obstacles identified. Methods: A retrospective analysis of medication safety reports submitted by outpatient staff over the past 4 years was conducted. Data were obtained from institutional safety reporting system. Pharmacy procedures and education materials were compared against safety reports. Pharmacists’ attitudes were assessed using online survey adapted from the AHRQ. Results: Pharmacists consistently submitted more safety reports compared to other disciplines. However, safety reporting declined from a mean of 61 reports annually to 40 in 2013. The majority of reported events involved prescribing errors, followed by orders submitted to pharmacy without meeting treatment criteria. Actions plans included: protocol checklists, staff education and updating order sets. The majority of pharmacists surveyed agreed/strongly agreed that the practice is actively doing things to improve patient safety and mistakes have led to positive changes. When an event is reported, almost 50% of pharmacists indicated infusion unit staff perceive the person is being written up, not the problem. Common barriers to reporting were time constraints, nurses taking reports personally and not knowing which events warrant reporting. Conclusions: Pharmacists at our institution play an integral role in safety reporting which is essential to provide quality patient care and enhance patient safety. Obstacles identified in this study may have contributed to the recent decline in reporting. Opportunities exist to reinforce non-punitive nature of safety reporting.
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.
Readmissions following umbilical cord blood stem cell transplantation.
Authors: Crombie Jennifer , Spring Laura Michelle , Li Shuli , Soiffer Robert , Antin Joseph Harry , Alyea Edwin , Glotzbecker Brett
Published: February 2017

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Background: Readmission within 30 days of discharge has been perceived by the Centers for Medicare and Medicaid Services to be an indicator of poor healthcare quality, however it is unclear how accurately this applies to oncology patients. Patients treated with allogeneic hematopoietic stem cell transplantation (HSCT) have high rates of readmission, but the incidence following umbilical cord blood transplantation (UCBT) is poorly described. The goal of this study was to identify the incidence, reasons, and risk factors for readmission following UCBT. Methods: A retrospective review of patients receiving an UCBT at Dana-Farber/Brigham and Women’s Hospital between January 1, 2004 and December 31, 2013 was performed. The 30-day and the day +100, a traditional assessment point in transplantation, readmission rates were examined. Reasons for readmission, as well as sociodemographic and disease and stem cell transplant related variables were evaluated. Predictors of readmission were identified using multivariate regression analysis. Results: 33.6% (42/125) of patients were readmitted within 30 days of discharge. Of patients who survived until day +100, 46.7% (57/122) were readmitted within 100 days of UCBT. The most common cause for readmission was infection (38.3%), followed by fever without a source (14.8%) and graft vs. host disease (GVHD) (8.6%) (Table). A multivariate logistic regression model of the probability of being readmitted within 30 days and by day +100 suggested that infection during transplant admission was a significant risk factor for readmission (OR: 5.1, p=0.003 and OR: 2.9, p=0.014, respectively). Conclusions: There is a high rate of readmission within 30 days and by day +100 following UCBT. The most common causes of readmission were infection and fever without a source. Infection during the transplant admission predicted a higher risk of readmission, suggesting a possible group to target for interventions aimed at reducing readmissions and improving quality of care. [Table: see text]
Incidence and determinants of 1-month mortality after cancer-directed surgery.
Authors: Mahal Brandon Arvin Virgil , Inverso Gino , Aizer Ayal Aaron , Ziehr David R. , Hyatt Andrew , Choueiri Toni K. , Hoffman Karen Elizabeth , Hu Jim C. , Beard Clair , D'Amico Anthony Victor , Martin Neil E. , Orio Peter F. , Trinh Quoc-Dien , Nguyen Paul Linh
Published: February 2017

282

Background: Death within 1 month of surgery is considered treatment related and serves as an important healthcare quality metric. We sought to identify the incidence of and factors associated with 1-month mortality after cancer-directed surgery. Methods: We used the Surveillance, Epidemiology and End Results Program to study a cohort of 1,110,236 patients diagnosed from 2004-2011 with cancers that are among the 10 most common or most fatal who received cancer-directed surgery. Multivariable logistic regression analyses were used to identify factors associated with 1-month mortality after cancer-directed surgery. Results: 53,498 patients (4.8%) died within 1 month of cancer-directed surgery. Patients who were married, insured, or who had a top 50th percentile income or educational status had lower odds of 1-month mortality from cancer-directed surgery ([adjusted odds ratio (AOR) 0.80; 95% CI 0.79 – 0.82; P<0.001], [AOR 0.88; (0.82 – 0.94); P<0.001], [AOR 0.95; (0.93 – 0.97); P<0.001], and [AOR 0.98; (0.96 – 0.99); P=0.043], respectively). Patients who were non-white minority, male, or older (per year increase), or who had advanced tumor stage 4 disease all had a higher risk of 1-month mortality after cancer-directed surgery, with AORs of 1.13 (1.11 – 1.15), P<0.001; 1.11 (1.08 – 1.13), P<0.001; 1.02 (1.02 – 1.03), P<0.001; and 1.89 (1.82 – 1.95), P<0.001 respectively. Conclusions: Unmarried, uninsured, non-white, male, older, less educated, and poorer patients were all at a significantly higher risk for death within 1 month of cancer-directed surgery. Efforts to reduce 1-month surgical mortality and eliminate sociodemographic disparities in this adverse outcome could significantly improve survival among patients with cancer.
The impact of physician use of electronic medical records on colorectal cancer screening.
Authors: Richardson Devon Paula , Daly Corinne , Li Qing , Sutradhar Rinku , Del Giudice Elisabeth M. , Paszat Lawrence Frank , Tinmouth Jill , Rabeneck Linda , Baxter Nancy N.
Published: February 2017

288

Background: The use of electronic medical records (EMR) by primary care physicians (PCP) is promoted as a method to enhance screening rates, however the impact of these systems on screening participation is uncertain. The purpose of this study was to determine if the use of EMR among a population-based sample of Ontario PCPs affects the colorectal cancer (CRC) screening participation of their patients. Methods: A survey was sent to 1,463 randomly selected PCPs in Ontario regarding adoption of EMR and cancer screening management enabled by EMR. Patients who were treated by PCP survey respondents were identified from administrative health care databases and were included if they were eligible for CRC screening (age 50-74) during the study window (April 1, 2012 – March 31, 2013). We identified patients who were up to date with CRC screening (FOBT within 2 years, flexible sigmoidoscopy within 5 years or colonoscopy within 10 years) as of March 31, 2013. Logistic regression models were created to examine the association between EMR usage and screening participation, adjusted for physician practice model, physician sex, years in practice, patient age patient sex, patient SES, and patient comorbidities using propensity scores. Results: A total of 855 PCPs responded to the survey (58.4% response rate) and 845 could be linked to administrative databases. The patient cohort included 330,441 eligible patients linked to a PCP included in the study. The proportion of patients up to date with CRC screening as of March 31, 2013 was 61.6% (203,720/330,441). After propensity score adjustment, patients were more likely to be up to date with CRC screening if their physician used an EMR (OR 1.16, 95% CI 1.04 – 1.29). Conclusions: PCP use of EMR was associated with a small, but measurable increase the likelihood that their patients were up to date with CRC screening. Enhanced use of the EMR might improve the uptake of CRC screening on a population level.