bluuebunny/crossref_metadata_2025 huggingface dataset:
Ad5 immunity after multiple safe, homologous immunizations against tumor-associated antigens with new recombinant Ad5 vector.
Authors: Gabitzsch Elizabeth Susan , Morse Michael , Hobeika Amy , Xu Younong , Balint Joseph , Balcaitis Stephanie , Lyerly H. Kim , Jones Frank R.
Published: February 2017

85

Background: The major limitation for the use of Ad5 and other vectored vaccines is the inability to be effective in the presence of pre-existing or concomitant vector immunity. An Ad5-based vector with deletions of the E1 and the E2b regions (Ad5 [E1-, E2b-]), by virtue of diminished late phase viral protein expression, avoids immunological clearance and induces immune responses. Methods: The Ad5 [E1-, E2b-] platform encoding tumor associated antigen(s) (TAA) such as a modified carcinoembryonic antigen (CEA(6D)), HER2 and HPV E6/E7, were evaluated for the induction of TAA specific immune responses and anti-tumor effects in murine models. In a phase I/II clinical trial, cohorts of patients (n=25 total) with advanced colorectal cancer, refractory to prior therapies, received escalating doses of Ad5 [E1-, E2b-]-CEA(6D) (109 to 1011 vp) subcutaneously every 3 weeks for 3 immunizations. CEA-specific cell mediated immunity was measured by ELISPOT. Results: In murine immunotherapy studies, mice implanted with tumors expressing TAA and subsequently treated with the Ad5 [E1-, E2b-] platform expressing that TAA had significant inhibition of tumor progression. Pre-vaccination against the TAA utilizing the Ad5 [E1-, E2b-]-TAA resulted in inhibition of tumor establishment. In a clinical trial, patients who received the highest dose of Ad5 [E1-, E2b-]-CEA(6D) exhibited the highest levels of CEA-specific CMI responses. The induction of CEA-specific CMI responses increased over the course of the 3 injections despite the presence of pre-existing Ad5 immunity in the majority (75%) of patients. There were no drug related grade 3/4 toxicities. Conclusions: The results demonstrate that the novel Ad5 [E1-, E2b-] gene delivery platform can both break tolerance and generate significant CMI responses to the TAA CEA in the setting of both naturally acquired Ad5-specific immunity and/or immunization-induced Ad5 immunity.
Circulating mediators of inflammation in AIDS-related non-Hodgkin lymphoma.
Authors: Nolen Brian Michael , Jenkins Frank J. , Kingsley Lawrence , Jacobson Lisa P. , Rinaldo Charles R. , Lokshin Anna
Published: February 2017

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Background: Non-Hodgkin lymphoma (NHL) is the most common AIDS-related malignancy in developed countries, accounting for 3-6% of AIDS-defining illnesses and 23-30% of AIDS-related mortality. The risk of developing NHL is estimated to be 60 times greater in HIV-infected individuals in comparison to the general population and this rate has remained elevated despite the advent of HAART. The mechanisms underlying the development of AIDS-related NHL (A-NHL) are not fully understood, but likely involve persistent B-cell activation and inflammation. Methods: This was a nested case-control study within the ongoing prospective Multicenter AIDS Cohort Study (MACS). Cases included 47 HIV-positive male patients diagnosed with high-grade B-cell NHL. Controls were matched to each case from among those participants who developed an AIDS-defining opportunistic infection in the absence of any malignancy. Matching criteria included age and CD4+ cell count. Sera obtained from each patient near the time of NHL or AIDS diagnosis was tested for a panel of 171 serum biomarkers using multiplexed bead-based immunoassays. Biomarker measurements were evaluated to identify significant alterations between the experimental groups, correlations with disease progression and interactions between biomarkers. Results: A subset of 21 biomarkers was identified to be significantly altered in A-NHL cases in comparison to the AIDS controls. This subset included cytokines, chemokines, acute phase proteins, tissue remodeling agents and bone metabolic mediators. Many of the biomarkers included in this subset were positively correlated with disease progression. A pathway analysis of our results revealed an extensive network of interactions between current and previously identified biomarkers. Conclusions: These findings support the current hypothesis that A-NHL develops in response to persistent immune stimulation and inflammation. A network of inflammatory mediators was identified demonstrating correlations with disease progression and overexpression in A-NHL patients. Further analysis of these biomarkers should enhance our ability to diagnose, monitor, and treat this disease.
Ki-67 expression in residual triple-negative breast tumors after neoadjuvant chemotherapy to predict for recurrence-free survival.
Authors: Pinto Joseph A. , Doimi Franco F. , Balko Justin M. , Arteaga Carlos L. , Gómez Henry L.
Published: February 2017

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Background: Ki-67 expression in breast cancer has been described as predictive of pathological complete response and prognostic of recurrence free survival (RFS). Our aim was to evaluate in a retrospective cohort of triple negative breast cancer patients if tumor proliferation measured by ki-67 expression is correlated with the outcome. Methods: We evaluated a retrospective cohort of 109 cases of triple negative breast cancer (ER-, PR- and HER2- determined by immunohistochemistry). Ki-67 labeling index was determined in Formalin-Fixed, Paraffin-Embedded residual tumors after neoadjuvant chemotherapy. Patients were stratified in Ki67<15% and Ki67≥15%. Clinicopathological data was retrieved from clinical records. RFS and overall survival (OS) were calculated using the Kaplan–Meier method and variables compared using the log-rank or Breslow test and Hazard Ratios (HR) estimated by the Cox regression. Results: The median age for patients was 47.5 years, 55 (50.5%) were premenopausal and 54 (49.5%) postmenopausal. Eight patients (7.3%) were clinical stages II and 101 (92.7%) stages III. Median of Ki-67 expression was 35.97% (0.96% - 77.7%). There was not association between Ki-67 expression (<15% VS ≥15%) with tumor size, nodal involvement, clinical stage and menopausal status. After a median of follow of 21.6 months, 62 patients (56.9%) have relapsed and 53 (48.6%) have die. The median time for RFS and OS were 21.2 and 31.4 months, respectively. Median of RFS was 12.6 months for Ki67<15% vs 21.2 months for Ki67≥15%, P=0.421 (HR=0.91). Median of OS was 34.9 months for Ki67<15% vs 31.4 months for Ki67≥15%, P=0.755 (HR=1.18). Only nodal involvement was found predictor of shorter RFS (0 nodes, 25.2 months vs 1 -3 nodes, 26.1 months, vs >3 nodes, 9.4 months, P=0.020). Conclusions: Ki-67 labeling index was not related with the outcome in terms of OS and RFS in patients with residual triple negative breast tumors that were treated with neoadjuvant chemotherapy.
Effect of distinct EGFR downstream pathways on resistance to dual EGFR/ErbB2 combined targeted therapy of lapatinib (LPT) and cetuximab (CTX).
Authors: Deeken John F. , Ramos Corinne , Barcus Mary , Hwang Jimmy J. , Marshall John , Subramaniam Deepa Suresh , He Aiwu Ruth , Zhuang Tingting , Hardesty Rosemarie A. , Pishvaian Michael J.
Published: February 2017

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Background: Resistance to EGFR therapy is poorly understood. We performed a phase I study in which pre- and post-treatment biopsies were profiled to assess the impact of CTX and LPT on downstream pathways that drive cancer progression. Methods: Between 10/2010 and 5/2012, 16 patients (pts) were enrolled in a 3+3 dose escalation trial, including: colon (7), lung (4), head and neck (3), and anal cancers (2). Prior EGFR therapy was allowed. CTX was 400mg/m2 on D1, then 250 mg/m2 weekly. LPT dose levels were 750 mg, 1000 mg, and 1250 mg daily. Cycles were 21 days in length; pts were assessed for response every 2 cycles. Pts underwent pre- and post-cycle 1 tumor biopsies. Biopsies were evaluated with a Reverse Phase MicroArray (RPMA) platform. Protein lysates were robotically immobilized in defined spots on nitrocellulose-coated slides; each printed array was then interrogated with a highly specific antibody. A total of 36 different proteins were analyzed, including total and phosphorylated EGFR, ErbB2, ErbB3, MET, IGF, MAPK, PI3K, Jak-Stat, and other subpathways. Relative baseline expression levels were determined, as were percent change in matched samples. Results: Of 12 pts evaluable for response, 2 had a partial response (PR), 5 had stable disease (SD), and 5 had disease progression (DP). Baseline tumor measurements of total ERK, p90RSK, and p38MAPK correlated with response (p<0.05), with a trend towards significance between response and expression of pEGFR, pMEK, pNFKB, and p4EBP1 (p<0.10). Nine patients had paired pre- and post-treatment biopsies. In tumors from pts with PR and SD, consistent down regulation of the EGFR pathway was detected. In the four patients with DP, up-regulation of distinct pathway components was detected, including of IGF (1 pt), Mek1/Erk (2 pts), mTOR (2 pts), and STAT3 (3 pts). Conclusions: A tumor profile was defined that correlated with clinical benefit to LPT+CTX. Resistance to this combination was due to upregulation of EGFR pathway components, components that are druggable. This analysis highlights the potential of personalizing therapy with combined EGFR therapies, and for adding additional targeted therapies to patients with resistant tumors.
Establishment of esophagogastric xenografts: A model for characterizing disease heterogeneity.
Authors: Janjigian Yelena Yuriy , Gromisch Christopher M. , Carbonetti Gregory , Tang Laura H. , Kelsen David Paul , Coit Daniel G. , Vakiani Efsevia , de Stanchina Elisa , Strong Vivian E.
Published: February 2017

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Background: Gastric cancer is a heterogeneous disease that may be subdivided into distinct subtypes—proximal/gastroesophageal (GE) junction, diffuse/signet ring type, and distal gastric cancer/intestinal type—based on histopathologic and anatomic criteria. Each subtype is associated with unique epidemiology and gene expression. Human epidermal growth factor receptor (HER2) is a validated treatment target in gastric cancer. For patients with metastatic disease, the available cytotoxic agents are applied indiscriminately to all disease subtypes, and with only modest success. The purpose of this study is to establish xenograft models from gastric cancer subtypes to improve our understanding of disease heterogeneity and develop therapies geared for each subtype of gastric cancer. Methods: Fresh specimens obtained from resected primary or metastatic tumors under aseptic conditions. 1 g tumor samples injected SQ into flanks of NSG mice. Xenografts established after 5 passages and maintained by serial transplantation into new mice. Cell cultures established after 5 in vitro passages; cell lines after 15 passages Results: To date, 66 tumor samples have been implanted from which 16 xenografts have been established. The table below summarizes the results. Single-agent afatinib (pan-ErbB inhibitor) demonstrated antitumor activity in an HER2-positive xenograft established from MSKCC patient’s tumor harvested from a skin metastasis. Conclusions: We have established xenograft models of gastric cancer. In vivo testing of afatinib showed a reduction of tumor growth of HER2-positive gastric cancer. These models provide a platform to study potential therapeutics for esophagogastric cancer to further validate difference in their biology and guide rational design of clinical trials. [Table: see text]
Drug resistance induced by paclitaxel and carboplatin plasmatic concentrations in lung cancer cell lines.
Authors: Luque Raquel , González Vicente Aranzazu , Soberino Jesús , Prados Jose Carlos , Melguizo Consolación , González Rivas Cynthia S. , Ruiz Vozmediano Julia , Conde Veronica , Garcia Garcia Javier , Aránega Antonia
Published: February 2017

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Background: Multidrug resistance (MDR) phenotype is the major cause of chemotherapy failure. It has been related to several proteins expression: P-glycoprotein (PgP), MRP family, LRP, and BCRP. We study the resistance pattern induced after paclitaxel and carboplatin in non-small cell lung cancer (NSCLC). Methods: We used 5 different cell lines. A549 and A427 cell lines were derived from lung epithelial carcinoma. NODO line was obtained from lung carcinoma metastases, and 3 cell lines derived from other tumours: gastric cancer (GAS), seminoma (SEM), breast cancer (MCF7). The cell lines were exposed to paclitaxel, carboplatin, and the combination of both drugs. The concentrations we used were similar to the plasma concentrations observed in patients treated previously. Results: A549 cell line did not show basal expression of MDR1, but a weak basal expression of MRP3 was observed. After chemotherapy, we observed that paclitaxel induced MDR1 and carboplatin induced MRP3. The combination of both drugs induced MDR1 and MRP3 expression, however, when paclitaxel is associated to carboplatin, MRP3 expression did not increase significantly. A427 cell line did not show basal expression of MDR1 and MRP3. Paclitaxel induced MDR1 and carboplatin induced MRP3. The association of both drugs increased significantly the expression of MDR1, and very few the expression of MRP3. NODO cell line did not show any basal expression. Paclitaxel induced MDR1 and carboplatin induced MRP3. Cell lines derived from other tumours not show any basal expression. Paclitaxel induced MDR1 in all cell lines. Carboplatin did not induce MDR1, nor MRP3 in GAS cell line. Conclusions: Plasma concentrations of paclitaxel induced MDR1 expression but not MRP3 in lung cancer and other tumours derived cell lines. Carboplatin produced overexpression of MRP3 but not MDR1 in the same cell lines. The combination of both drugs at plasma concentrations was not able to activate a new resistance mechanism in the studied cell lines, but improve the resistance mechanism induced by each one of the drugs individually.
Evaluating a preference-tailored decision tool for increasing colorectal cancer screening.
Authors: Hawley Sarah T. , Ling Bruce , Fagerlin Angela , Vernon Sally W. , Vijan Sandeep
Published: February 2017

10

Background: Incorporating patient preferences into CRC screening decisions has been identified as one method for improving informed decision making and increasing screening adherence, yet the impact of tailoring screening recommendations to patients’ preferences on these outcomes has not been evaluated. Methods: We compared the effect of a web-based preference-tailored decision tool (intervention) to a standard information decision tool (control) through an RCT at two VA sites. Eligible subjects were age 50-77, due for CRC screening, with a scheduled primary care visit. Participants arrived 45 minutes early to complete consent and were randomized online. Telephone surveys were conducted 3-5 days post-enrollment and CRC screening adherence was collected from medical charts 6 months later. We evaluated the effect of the tool on adherence and compared stated test preferences to test recevived through Chi-square tests and regression. Results: 468 subjects were enrolled from two VAs. CRC screening adherence 6-months post-enrollment was 38.6% and was not significantly different between groups (37.4% intervention, 39.7% control). Most were adherent with fecal occult blood test (FOBT) (22.4%), followed by colonoscopy (COL) (16.7%). The most commonly recommended test by physicians was COL (59.2% of tests recommended), though veterans most commonly stated a preference for FOBT (60.1%). The features of tests most important to veterans were nature of the test (32.8%), effectiveness (27.1%), and risk of complications (17%). Participants significantly more often adhered to the test that they stated they preferred after the intervention than with a non-preferred test (30.4% adhered to preferred test vs. 7.6% adhered to non-preferred test, P<0.001). Conclusions: CRC screening adherence in this population of veterans was low and the preference-tailored intervention did not significantly improve adherence relative to standard information. Veterans preferred a non-invasive test (FOBT) despite higher rates of recommendation for COL by their physicians. Improving concordance between physician recommendations and patients’ preference may be one method for improving CRC screening adherence in this population.
Feasibility and savings of a suspicion of cancer clinic at a large county hospital.
Authors: Mougalian Sarah Schellhorn , Wang Jennifer , Zarzour Maria Alejandra , Quinn Doris , Rieber Alyssa G.
Published: February 2017

104

Background: The Lyndon B. Johnson General Hospital (LBJGH) is part of the Harris County Hospital District (HCHD), serving the third largest county in the United States. Many patients are admitted to the hospital for expedited workup when cancer is suspected to avoid outpatient delays. We sought to establish the main contributors to delays in cancer diagnosis and to calculate the potential savings, both in terms of time and expense, of an ambulatory Suspicion of Cancer Clinic. Methods: The charts of 327 consecutive new patients to the LBJGH medical oncology clinic between June 2011 and November 2011 were reviewed. Only patients whose cancer was diagnosed within HCHD (n=165) were included in the analysis. Dates of initial presentation, emergency department (ED) visits, abnormal imaging, admissions, diagnosis, and initial oncology visit were collected, along with the method of diagnosis. Additional chart review was performed to determine which admissions were solely for expedited work up based on the documentation provided. The project was approved by the MD Anderson Quality Improvement Assessment Board. Results: 60% of cancer diagnoses were made in the ambulatory setting, whereas 40% of patients were diagnosed inpatient. Breast cancer was the most frequent cancer diagnosis. The mean time from presentation to diagnosis in the inpatient setting was 3.9 days for breast cancer, 12.9 days for colon cancer, and 5.5 days for lung cancer. For patients diagnosed in the ambulatory setting, the times were 77.1 days, 65.4 days, and 70.8 days respectively. 15.6% of patients were admitted to the hospital for expedited work up, accounting for 130 hospital days. Based on the average costs in HCHD, elimination of hospitalizations and multiple ED visits using an ambulatory suspicion of cancer clinic could save more than $300,000 annually. Conclusions: We propose a Suspicion of Cancer Clinic to expedite outpatient diagnostic workup, in collaboration with diagnostic imaging, surgical specialties, and pathology. The establishment of a Suspicion of Cancer Clinic could reduce ambulatory diagnostic times, decrease the frequency of admissions, and potentially improve patient outcomes. Piloting of this clinic is underway.
Increasing genetics referrals: The National Cancer Institute Community Cancer Centers Program (NCCCP) network performance improvement project.
Authors: Cohn Jeffrey , Carrigan Angela , Palaniappan Selvi , Rivero Silvana , Castro Kathleen M.
Published: February 2017

111

Background: A NCCCP goal is to improve quality of care through increasing guideline adherence at participating community cancer centers. 14 NCCCP sites participated in a performance improvement project to (1) increase genetics referral and counseling services by 10% in accordance with established guidelines for breast or colorectal cancer. The project hypothesized that data collection and feedback improves referral rates by better targeting eligible populations for improvement interventions. Methods: Sites recorded the source and outcome of each breast/colon referral using a tool developed by the NCCCP. Aggregate data were shared on monthly project calls where site staff shared best practices/issues with peers and received feedback. Results: Data were collected Jul 2011-Apr 2012 and analyzed at 2-week intervals. The number of colorectal and breast patients referred for genetics counseling remained stable through the 9-month period. Despite no change in the rates of referrals the data were hypotheses generating. Colorectal cases of all ages were being correctly referred in accordance with established guidelines; project calls demonstrated sites’ efforts to improve referral processes, such as including genetics counselors in the multidisciplinary team discussions, implementing universal screening for Lynch syndrome, and developing new linkages with referring staff. Conclusions: The project was a successful proof of concept study showing the feasibility of pooling genetic counseling data across diverse community cancer centers. Robust data collection is inadequate to drive sustainable improvement; specific process changes are also required. Future NCCCP collaborative initiatives are needed to ensure all eligible patients have access to genetic counseling referral services as there remain a significant group of patients eligible for genetic counseling who are not being seen. Funded by HHSN261200800001E.
Unanticipated hospital admissions in patients undergoing radiotherapy with or without concurrent chemotherapy: Incidence and predictive factors.
Authors: Arastu Nabeel H. , Chen Ronald C. , Jackson Marianne , Green Rebecca L. , Qaqish Bahjat F. , Xu Zijie S. , Camporeale Jayne , Collichio Frances A. , Marks Lawrence Bruce
Published: February 2017

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Background: Unanticipated admissions are burdensome for patients and the healthcare system. An improved understanding of their frequency and predictive factors can inform initiatives to prevent such admissions and mitigate their associated human and financial costs. Methods: Electronic medical records of all patients (n=1144) undergoing external beam radiotherapy (RT) at our center in 2010 were reviewed in this retrospective study. Unanticipated admission within 90 days of initiating RT, and associated clinical factors, were recorded. Chi-squared and uni- and multivariate logistic regression was used to examine factors associated with admission. Results: Unanticipated admissions occurred in 19% (213/1144) of patients, median length of stay was 3 days (range 1-22), and the mean interval between the start of RT till admission was 28 days (1-89 days). The most common indications for admissions were pain (19% of admissions), GI toxicity (18%), and respiratory distress (15%). On univariate analysis, admission rates were higher in patients treated with palliative vs. curative intent (30% vs. 14%, p<0.001), with concurrent chemotherapy (23% vs. 18% RT alone, p=0.047), in those who had a recent admission prior to RT initiation (37% vs. 14% with no prior admission, p<0.001), and patients on their second or third course of RT (27% vs. 16% first treatment course, p<0.001). Multivariable analysis showed treatment intent, chemotherapy, and prior admissions to be associated with unplanned admissions (Table). Conclusions: Rates of unanticipated admissions are ≈20% in patients undergoing RT. Slightly less than 1/3 of patients receiving palliative RT, and nearly 1/4 receiving concurrent chemoradiation, experienced an unplanned admission. Prophylactic measures should be studied in these high-risk patients to reduce admission rates, as unplanned admission may be an important quality of care indicator in oncology. [Table: see text]
Time to antibiotic.
Authors: Equila Everett John , So Tonette , Leon-Guerrero Velma , Moller Keriann , Cooper Robert Michael
Published: February 2017

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Background: The aim of this quality improvement (QI) project is to identify the interdisciplinary factors that cause delay of antibiotic administration to febrile Hematology/Oncology patients directly admitted to Pediatric department. Pediatric oncology research has shown that there is significant lower mortality associated with antibiotics given within one hour vs. delayed or no treatment (Adderson, Flynn, and Hoffmann, 2011). Methods: This QI project is conducted at a 32 bed pediatric unit at Kaiser Permanente Los Angeles Medical Center. Hematology/oncology patients admitted to the pediatric floor with fever were included in the study. A six month audit (n=22) showed that current workflow was inadequate and did not meet the time to antibiotic (TA) goal. A three-point workflow was designed to improve the TA outcome. The workflow includes initial documentation of actual time patient arrived to pediatric floor to the time admitted patient is entered in the electronic medical record (EMR) system. This is followed by auditing actual time patient is admitted to EMR to the actual time computerized physician order entry (CPOE) for time to antibiotic protocol is entered. Lastly, CPOE to actual time antibiotic was administered was audited. An ongoing six month audit has begun with the implementation of changes to workflow. Results: Audit prior to TA workflow: Patients (n=22) who met the criteria showed that (22.7%) received initial antibiotics within 1 to 2 hours. Eight patients (36.4%) received the antibiotics within 2 to 3 hours of admission. Four patients (18.2%) received initial antibiotics at 3 to 4 hours of admission. Notably, none (0%) of these patients received antibiotic within the goal of one hour. Audit after implementation of TA workflow: A three month audit (n=14) showed that (57.1%) received antibiotic less than 1 hour from time of admission. Two patients (14.2%) received antibiotic less than 2 hours of admission. Two patients (14.2%) received antibiotic less than 3 hours of admission. Two patients (14.2%) of these patients received antibiotics 3 to 4 hours of admission. Conclusions: Based on current data, the TA protocol showed marked improvement in the delivery and administration of antibiotic received by hematology/oncology patients.
The incidence of acute kidney injury among children treated for fever and neutropenia after elimination of empiric gentamycin use.
Authors: Heczey Andras , McCarthy Kathy , Wu Meng-Fen , Kennedy Curtis , Hockenberry Marilyn
Published: February 2017

120

Background: The mortality rate of chemotherapy-related fever and neutropenia (F&N) has decreased significantly in recent years with attention shifting to antibiotic regimens with the least side effects. Multiple randomized controlled clinical trials have demonstrated that antibiotic regimens without aminoglycosides are sufficient for successful treatment of F&N and the addition of aminoglycosides significantly increases the risk of acute kidney injury among adults. The institutional F&N Guideline of Texas Children’s Hospital (TCH) mandated the use of gentamycin in combination vancomycin and piperacillin-tazobactam (P-T) for the treatment of hig- risk (HR) patients with F&N. To decrease the incidence of nephrotoxicity while maintaining excellent survival, empiric gentamycin use was stopped. Methods: Bacterial susceptibility and characteristics of patients with positive blood cultures treated at TCH during 2009 were retrospectively analyzed (pre-intervention group). Negligible P-T resistance was confirmed among bacterial isolates and empiric use of gentamycin for HR patients with F&N was stopped. After a 6 month adjustment period, data for all patients treated according to the new HR algorithm were prospectively collected (post-intervention group) for 12 months. The pre- and post-intervention groups were evaluated for differences in treatment success and incidence of nephrotoxicity. Results: Data from 69 patients from the pre-intervention group and 39 patients from the post-intervention group who had bacteremia were analyzed. No statistical difference was found between pre- and post-intervention groups for age, gender, survival, baseline creatinine level and baseline estimated creatinine clearance. However, significant difference was found for change in creatinine levels (0.12 vs. 0.04 mg/dl p=0.01), change in estimated creatinine clearance (24.8 vs. 12.1ml/min/1.73m2, p=0.01) and incidence of acute kidney injury (30.1 vs. 11.1%, p=0.04). Conclusions: Children with high risk F&N episode may be treated effectively and safely with decreased incidence of acute kidney injury without the empiric use of gentamycin.
Improvement of time to develop treatment plan at a specialized sarcoma center.
Authors: Chavez Adriana , Singh Prachee , Anderson Jaime , Aleman Andrea , Jernigan Colleen , Ravi Vinod
Published: February 2017

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Background: Treatment of new patients at the MD Anderson Sarcoma Medical Oncology Clinic can take up to 1 to 2 weeks from their initial consultation depending on the information available for review. Treatment delays can result in poor patient outcomes, adversely affecting the quality of care provided. There are numerous processes involved in the development of a treatment plan that could be improved to reduce the time to finalization of treatment plan. Methods: We undertook a quality improvement project involving key clinic and administrative team members. We performed detailed process mapping and developed a cause and effect diagram to identify and prioritize opportunities for improvement. We measured the time in hours from the patient’s initial appointment to finalization of a treatment plan. Baseline data (before process improvement implementation) was collected retrospectively through chart review. Post-implementation data was collected prospectively. For process improvement, we focused on two deficiencies that were regarded as the key causes of delay to develop a finalized treatment plan (1) insufficient data for decision making at the time of new patient visit, and (2) delays in obtaining diagnostic imaging. Results: Due to insufficient data for decision-making available at the time of initial consultation, the median time to develop a treatment plan is 72 hours. After initiating process improvement, the median time to develop a treatment plan decreased to approximately 7 hours. Conclusions: Improving the quality of data available for the medical oncologist prior to initial consultation greatly enhances the rapid development of finalized treatment plan. Availability of an early treatment plan improves patient outcomes, diminishes patient anxiety, and decreases the costs incurred by the patient awaiting a treatment plan at a specialized oncology clinic.
Electronic medical records: Assessment of recorded cancer stage in support of quality of care.
Authors: Hess Gregory P.
Published: February 2017

129

Background: Electronic medical records (EMRs) are being increasingly adopted in part driven by reports of their positive impact on patient’s quality of care. An underlying assumption is that data recorded will be relatively complete. As a field of primary importance, this study assessed the frequency with which cancer stage was recorded within an EMR data field during a historical and recent 12-month period. A random sample of records with missing stage was assessed to identify at a qualitative level reasons that stage may be omitted. Methods: Two datasets were constructed. The first comprised of oncology EMRs from 77 practices covering 476 sites of care across 34 states from 1/1/2000-12/31/2010. The second dataset from 58 practices covering 391 sites of care across 37 states. Inclusion criteria required patients to have a valid visit (i.e., not simply ‘scheduled’) and ≥ 1 diagnosis of a primary, malignant, neoplasm (except brain or spine). All data fields utilized to record stage (stage I, II, etc.) or from which stage could be reliably derived (T, M, N fields) were defined as "recorded." Practices were not required to exist in each dataset. Recorded stage by age, gender, state, and payer type was also assessed. Results: Reasons reported for absent stage within the data field included: consult visit only, written in the progress notes, text present in a scanned report, stage X (insufficient information), continuing treatment initiated elsewhere, and missing entry error. Conclusions: A significant proportion of cancer patients may not have stage recorded in the designated, searchable, data field within an EMR. The frequency of recorded stage is increasing over time. Reasons for unpopulated stage field(s) include use of nonsearchable text entries, scanned reports, and short episodes of care. Further research is needed to validate the observations in this study, determine root causes, and employ appropriate solutions. [Table: see text]
Improving chemotherapy consent compliance.
Authors: Hegedus Patricia D. , Bearden James D. , Grant Bruce
Published: February 2017

130

Background: Palmetto Hematology Oncology (PHO) is the medical oncology practice of Spartanburg Regional Healthcare System (SRHS) and has participated in QOPI since 2009 and earned QOPI certification in September 2011. Our Fall 2010 QOPI Patient Consent for Chemotherapy score was 70.73%, lower than the QOPI aggregate score of 86.46%. Methods: A workgroup was convened to address chemotherapy consent documentation compliance. QOPI data revealed the need for a uniform, system-wide chemotherapy consent process. A chemotherapy consent form specifically for our cancer center was created following an extensive literature review and benchmarking with American Society of Clinical Oncology guidelines, NCI Designated Cancer Centers, NCI Community Cancer Centers Program (NCCCP funded with federal funds from the NCI, Contract # HHSN261200800001E) resources, and other healthcare institutions. Our chemotherapy administration policy was revised to include a “hard stop” if a signed chemotherapy consent was not available prior to administration of chemotherapy in all areas of our institution. Results: Patient Consent for Chemotherapy QOPI scores revealed an increase from Fall 2010 to Spring 2012 of 70.73% to 100%. As a result of the workgroup’s efforts, it was approved by our Cancer Care Committee to develop a Chemotherapy Safety Committee (CSC) to standardize chemotherapy practices throughout our system. The CSC integrated key staff responsible for chemotherapy administration. The CSC was instrumental in reviewing and updating policies and procedures during our QOPI certification efforts. Conclusions: Our participation in QOPI provided data to support efforts for a system-wide chemotherapy consent revision and process implementation. The availability of ASCO, Oncology Nursing Society, and other key resources provided turn key processes for this performance improvement project. Practice scores for the Patient Consent for Chemotherapy have reached 100% compliance signifying our performance at a “best practice” level. References: QOPI The Quality Oncology Practice Initiative, available at: http://qopi.asco.org/program .
Quality improvement for symptom control in underserved Chinese cancer patients.
Authors: Dhingra Lara , Lam Kin Y. , Cheung William , Shao Theresa , Chang Victor Tsu-Shih , Chen Jack , Cheng Sabrina , Li Vanessa , Lam Wan , Chan Selina , Bookbinder Marilyn , Lo Graciete , Portenoy Russell
Published: February 2017

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Background: Chinese Americans, the largest Asian subgroup, have high cancer rates. Many are recent immigrants who are economically disadvantaged. Patients often present with advanced illness and poorly controlled pain. Although quality improvement (QI) methodologies, such as rapid-cycle QI, may improve clinical practice and patient outcomes, few QI programs for pain management exist for this population. We aim to 1) test the effectiveness of a rapid-cycle QI intervention to enhance the processes and outcomes of pain management for poor and underserved ethnic Chinese patients; 2) determine whether a rapid-cycle QI intervention for pain can be generalized to other symptoms (fatigue and dyspnea), and 3) identify demographic, cultural, and other barriers and facilitators that are related to intervention uptake. Methods: In this ongoing community study, we are developing and testing a rapid-cycle QI model to improve pain among underserved Chinese American cancer patients, and evaluating factors that influence its uptake and sustainability. Ethnic Chinese patients and clinicians from four oncology practices are the intervention targets. The systems-based intervention incorporates repeated “plan-do-study-assess” QI cycles, including: pain screening, follow-up and early treatment for pain, referral, and provider education. Results: Initial data demonstrates that documentation of pain scores improved from 24-71% of patients overall. In one practice, 37% of 89 patients screened over 45 days had moderate or severe pain; 90% with moderate pain had follow-up appointments within 1 week; 92% with severe pain had immediate clinician attention. Intervention effectiveness will be determined by 2-week longitudinal surveys. The primary outcome is the change in the proportion of patients who achieve adequate and timely pain control after initial presentation. Conclusions: Multiple cultural, system-related, and provider challenges to QI implementation are being addressed. Findings will show the importance of QI interventions to reduce pain disparities, the importance of programs that address underserved Chinese Americans, and the relevance of community-based QI programs for long-term changes in clinical pain management.
Can we improve community adjuvant treatment reporting to a hospital tumor registry?
Authors: Bickell Nina , Wellner Jill , Franco Rebeca , McAlearney Ann
Published: February 2017

136

Background: Accurate cancer treatment reporting to a hospital tumor registry (TR) is critical as data measurement is the foundation for improvement. Yet as adjuvant treatment moves to outpatient settings, reporting is problematic. We undertook a solutions-focused exercise to identify reporting barriers and facilitators and devise a pilot intervention to improve reporting. Methods: We convened a multidisciplinary group of community-based surgical and medical oncologists, TR staff, and hospital leadership. The group identified 3 key barriers: 1) inability to identify correct managing MD, 2) poor communication, and 3) manual reporting burden. The intervention focused on the 1st 2 barriers—those with easy fixes and great potential impact: TR obtained correct information, changed contact forms, worked with pathology to ascertain cases in real-time, tracked and reported practice responses weekly; MDs primed office staff to respond to TR requests. Results: Pre-intervention, the TR identified none of 20 pilot patients’ managing medical oncologist or adjuvant treatment. During the April to May 2012 intervention, 22 breast cancer patients listed our volunteer surgeon as managing MD. The TR sent 22 treatment letters to the surgeon’s office, received 20 (91%) responses with managing MD data provided for all. Patients were referred to full-time (26%) and community (74%) medical oncologists; 64% of required adjuvant treatment was reported. 47% of cases were closed; 53% remain open. Closed cases required 5.9 contacts (38.9 mins; sd=8.99), open cases had 8.2 contacts (48.4 mins; sd=2.85). Surgical staff spent ~1/2 hour per case to identify the oncologist prescribing adjuvant treatment. Conclusions: The solutions-focused exercise successfully improved identification of managing oncologists from 0% to 86% for patients treated by community oncologists. Treatment reporting increased from 2.6% to 64%. The pilot did not address the burden of reporting which remains great for both TR and community oncologists. While electronic access can reduce this burden through direct interface between an EMR and TR software, this approach is not currently feasible for community-based oncologists.
Implementing independent double checks for patient-controlled analgesia (PCA) pump programming.
Authors: Bohlen Nie , Lyons Hannah Felton , Cashavelly Barbara J. , Lennes Inga Tolin
Published: February 2017

153

Background: Pain is the most common symptom experienced by oncology patients. Up to 90% of all patients with advanced cancer experience pain and 50% of those describe their pain as moderate to severe. The patient controlled analgesia (PCA) is commonly used to treat pain on the acute care oncology unit at The Massachusetts General Hospital (MGH). The PCA pump can be programmed incorrectly, resulting in over or under dosing of patients with opiates. Both the Federal Drug Administration (FDA) and the Institute for Safe Medication Practice (ISMP) recommend an independent double check (IDC) be done on error prone processes like the use of high alert medications. An IDC involves two clinicians separately checking (alone and apart from each other, then comparing results) the infusion settings in accordance with the physician’s order. Methods: The nurses on the acute care oncology unit at MGH were surveyed to determine their baseline understanding of an IDC. Training was conducted and a process for documentation implemented. A second intervention included further education initiatives such as posters of key points and a web-based knowledge survey of the IDC definition, process, and documentation. Results: Prior to the initial implementation 80% (32/40) of the nurses provided a partially correct definition of an IDC, 17.5% (7/40) an incorrect definition of an IDC and only 2.5% (1/40) provided a correct definition of an IDC. After the initial educational activities, a second knowledge survey was administered. Performance improved with only 13.4% (7/52) of the nurses missing one or more of the three questions on survey. After the initial education, of the 126 opportunities to document an IDC 21.4% (27/126) were done correctly. Performance improved to 80.7% (67/83) after the second intervention. Conclusions: Prior to implementing this IDC education, nurses at MGH did not have a clear understanding of what is required for an IDC of a PCA. This pilot education module was effective in decreasing the knowledge gaps and improving performance. Education must be concise and repetitive to change practice. Successful implementation of an IDC process improves the safety of a high-alert medication for the patient.
Redesigning the transfer center process to adapt to increasing demands for services.
Authors: Douglas-Ntagha Pamela Bernice
Published: February 2017

156

Background: Hospitals are faced with limited resources and a need to provide care to patients with the greatest needs. Methods: Develop a systematic approach for accepting external transfers to the appropriate setting of care based on clinical criteria Initiate communication between external physicians and accepting MDA (MD Anderson) physicians and ICU physicians as appropriate Identify a process for documenting clinical information to ensure appropriate and timely transfers to MDA Ensure policies and procedures align with EMTALA regulation. Results: MDA ICU physicians involved in the initial decision, as appropriate External transfer acceptance based on bed availability MDA physician must be physically present to manage transfer, conduct evaluation and develop treatment plan Incorporate into procedure telephone communication with external physician, TC Medical Director, MDA accepting physician (ICU and Pedi physician as appropriate) Operational definitions for routine and urgent have been established Non-emergent transfers occur weekdays between the hours of 8AM and 5PM Transfer Acceptance Form to capture clinical information was developed. Conclusions: Problem 1: Suboptimal Communication Developed a TC form. During first eight months of operation we achieved 85% compliance with regards to documentation of transfer. Compliance continues to trend upward. Problem 2: Placement of Patients in Appropriate Care Settings Decreased utilization of MDA Emergency Center beds noted as external transfer to inpatient beds increased. Problem 3: Sporadic Arrival of Non-emergent Transfers The majority of after-hours (between 5PM and 8AM) transfers were routine and urgent prior to project. After the intervention, the number of routine and urgent after-hours transfer trended downwards. After-hour emergent transfers increased indicating appropriate utilization of beds for patients with the greatest needs. Problem 4: Lack of Systematic Screening and Documentation Retrospective medical record audits of 100% of emergent transfers were conducted by the TCMedical Directors in collaboration with the Director of Patient Resources. 97% of emergent transfers were confirmed as emergent on retrospective review.
Clinical process analysis.
Authors: Barnes Courtney , Hayes Beverly , Aranzamendez Gina , Kaufman Laurie
Published: February 2017

157

Background: MD Anderson has been working with Harvard on a pilot project for Time Driven Activity Based Costing: a component is Clinical Process Analysis, which brings value on its own. It provides a visualization that “speaks” to those delivering the service. This brings great awareness of frontline reality for staff and leaders alike and the many “ah-ha” moments creates a urgency for improvement. As Berwick shared in his keynote speech at IHI 2011, "the quality movement will rise or fall on its success in reducing the cost of health care.” In order to make the right changes, who best to reduce the cost, than those delivering the service? According to Don Berwick and Dr. Brent James, the burden of changing the face of healthcare lies with us. Methods: When frequencies, probabilities and salaries are incorporated into processes of patient care, the cost of direct labor can be determined and opportunities for improvement visualized. Based on lessons learned, tools (data driven road maps, blueprints) and successful strategies (standardized process flow maps templates) have been developed to efficiently and effectively disseminate Clinical Process Analysis throughout clinical areas. Results: Data analysis and front-line reality are synchronized. Allows a “broader” view of the patient’s journey outside of one’s own discipline. Builds bridge between financial and clinical worlds by engaging clinicians through a patient-centered care perspective rather than a perspective of budget, variance and financial cost reduction. Identifies opportunities for improvement. Provides opportunities to build “psychological safety” in order for frontline staff to share with clinical area leadership the process realities of patient care. Based on feedback from physicians, managers, staff and financial experts, the process flow charts are useful to track patient flow, resource utilization, customer satisfaction, patient education, and on-boarding of new staff. Conclusions: Clinical Process Analysis provides an engaging first step to drive improvement in clinical quality and financial performance.