bluuebunny/crossref_metadata_2025_split huggingface dataset:
Breast cancer genetic risk evaluation and referral for assessment.
Authors: Fenton Mary Anne , Szyamnski Tara , Perez Kimberly , Benson Cindy , Phornphutkul Chanika 
Published: February 2017

75 Background: ASCO Quality Oncology Practice Initiative (QOPI) provides tools for oncology practices to assess quality and adherence to clinical guidelines. Following each data submission a QOPI measures summary report is published providing practices the opportunity to compare themselves to QOPI Aggregates. In 2011, QOPI initiated a more stringent evaluation of family history documentation, which would improve rates of referral to genetic counseling for breast and colon cancer. Methods: A review of QOPI measure summary reports is performed by Rhode Island Hospital’s (RIH) Comprehensive Cancer Center Quality Improvement Team after each round of chart abstraction. Following review of QOPI practice results for genetic evaluation in 2011, our interventions included development and implementation of a 3 generation maternal and paternal family history intake form, genetics referral form with criteria to refer patients for genetic evaluation and initiation of a Genetics Clinic on site at the Cancer Center. Results: Presented is a summary of QOPI results for the Breast Cancer measures of complete family history documented and Genetic testing addressed appropriately. Conclusions: Our interventions included a patient intake form, genetics referral form with criteria to refer patients and a Genetics Clinic on site at the Cancer Center. The institution of a patient intake form resulted in a 19-fold improvement in complete family history documentation. The genetics referral form and establishment of an on-site Genetics clinic resulted in a 10% increase in referrals for genetic risk assessment. In spite of these interventions review of our Genetic Risk Evaluation data is notable for a 39% no show rate for the genetic risk assessment appointments. [Table: see text]
Hepatitis B surveillance in adult chemotherapy patients.
Authors: Gordon Sarah , Berenberg Jeffrey L. , Ferguson Tomas , Mitchell Jacqui D. 
Published: February 2017

76 Background: The high prevalence of Hepatitis B virus (HBV) in the Hawaiian and Pacific Islander population and the death of two chemotherapy patients from reactivation led to a screening protocol to identify and treat chronic HBV. The goal of this quality improvement project was to assess the at risk population, compliance with screening between 2009 and 2011 and determine any necessary improvements. Methods: New intravenous chemotherapy patients are tested for Hepatitis B surface antigen (HBSAg), Hepatitis B core antibody (HBc), and Hepatitis B surface antibody (HBSAb) prior to initiation of chemotherapy. HBSAg positive patients receive Infectious Disease referral and treatment. HBc positive patients are monitored with serial hepatic function tests. We documented testing and if the patients were treated or followed with hepatic function tests. We reported all positive screening results (defined as HBsAg positive and HBc positive/HBsAb negative patients) and if the patients were treated or screened. We also characterized our patient population by race. Results: 329 patients received chemotherapy. HBsAg positive patients (5, 1.5%), were referred to Infectious Disease for treatment. The HBc positive patients (55) were followed with serial hepatic function tests for the duration of chemotherapy. 13 of these were HBsAb negative (4% of all patients). A total of 5.5% of all patients had a positive screening result as defined above. Overall compliance was 98%. 85% of individuals with a positive serology result self identified as either Asian or Pacific Islander. Conclusions: Reactivation of chronic HBV in individuals exposed to immunosuppressive treatments has a mortality rate of 4-41%. Expert societies do not agree regarding screening all patients. Hawaii has a higher prevalence of chronic hepatitis B (positive HBsAg) compared to the mainland US population (3.6% vs. 0.4% respectively). We screened 98% of intravenous chemotherapy patients. No patients developed evidence of reactivation. To improve upon our protocol we extended laboratory monitoring to three months following completion of chemotherapy and initiated vaccination for HBc positive HBsAb negative patients. We propose that screening at risk populations should be standard practice.
Structured approach to improving wait times and overall customer service in an oncology outpatient phlebotomy department.
Authors: Forde Patrick M. , Violette Kitty , Maylor Karen , Kasecamp Barbara , Rushworth Beth , Jefferson Cheryl , Wilmore Joan , Fetting John H. , Dean Richard , Cowperthwaite Suzanne , Krumm Sharon 
Published: February 2017

77 Background: Demands on the Johns Hopkins phlebotomy service have increased exponentially over the past several years leading to increased patient (pt) waiting times and reduced patient and staff satisfaction. Methods: The goal of our project was to reduce waiting times for outpatient phlebotomy to <30 mins for 90% of pts by May 2013 using a multi-disciplinary lean sigma approach. The following interventions were implemented - Two weekly multidisciplinary lean sigma meetings; Move to set appointment times; Twice daily staff "huddles" to plan the work schedule; Ensure a minimum of 8 phlebotomists on duty daily; Expand training for clinical assistants (CAs) to access VADs; Introduce pager system for pts to reduce needless waiting; Introduce leadership positions among phlebotomy and CA staff to manage change. Results: Within 6 months of these concerted efforts wait times have reduced to <30 mins and patient satisfaction scores for >90% of pts are very good or excellent. Conclusions: Difficult problems such as increasing patient demand with constrained resources can be ameliorated with a multidisciplinary structured approach. The project as outlined may serve as a template for other oncology services dealing with the increasing demands of an aging population in a time of increasingly limited resources.
Oncology labels with clinical outcomes data since the final PRO guidance.
Authors: Foley Kathleen A. , Meyers Oren I 
Published: February 2017

88 Background: FDA released draft Guidance on Patient-Reported Outcomes (PROs) in 2006 and finalized it in 2009. The Guidance applies equally to clinician and observer outcomes (ClinROs, ObsROs; collectively, clinical outcome assessments - COAs), and defines regulatory expectations for COA instruments in pivotal clinical trials and the inclusion of COA data in approved labeling. The purpose of this review was to survey labels for oncologic drugs approved in the three years since the “PRO Guidance” was finalized and to characterize any COAs in these labels. Methods: CenterWatch maintains a list of FDA approved drugs following definitions established by the Tufts Center for the Study of Drug Development, including only drugs or NMEs newly approved by the FDA Center for Drug Evaluation and Research. From 2010 through 2013, 45 oncologic drugs were approved by the FDA. The labels and other information from the Drugs@FDA website were reviewed. Results: Few of the approved labels included any reference to COAs or data collected using PROs, ClinROs, or ObsROs. Several (e.g., carfilzomib) had clear statements indicating approval for the product was based on a predefined response rate rather than “improvement in survival or symptoms.” The exceptions are fentanyl tablets and spray, and abiraterone, all with PRO data on pain. The number of PROs in the labels reviewed was low, but the trend suggests that products reviewed by Divisions outside the Office of Hematology and Oncology Products were more likely to have a PRO. Abiraterone was an exception as it was reviewed by Oncology Products I and included patient reported pain. Conclusions: There are several explanations for the low rate of COAs in oncology labels, e.g., oncology trials tend to be unblinded. The FDA has stated that open label designs cannot support PRO claims. Yet there is still a heavy reliance on outcomes such as progression free and overall survival. Three labels were identified with PRO data on pain, two of which were specifically indicated for pain rather than tumor control. This review suggests there are opportunities for sponsors and the FDA to increase the degree to which the patient’s voice is heard during the regulatory decision process, particularly, in programs reviewed by the oncology divisions.
Guideline adherence for diagnosis of liver cancer in veterans.
Authors: Sada Yvonne , David Eric , El-Serag Hashem , Singh Hardeep , Davila Jessica 
Published: February 2017

89 Background: The incidence of hepatocellular cancer (HCC) is rising. Practice guidelines provide the recommended approach for HCC diagnosis, but adherence to diagnostic guidelines is unknown. Methods: In a national sample of veterans with confirmed HCC, we performed a retrospective chart review of patients with cirrhosis and a new liver mass on imaging between 2005 and 2011. Clinical data was used to assess adherence to American Association for the Study of Liver Diseases guidelines. Patients with inadequate data to assess guideline adherence (missing liver mass size, imaging technique, or diagnostic report) were excluded. We identified factors that contributed to guideline non-adherence. Initial liver mass date was the first date a liver mass was reported on imaging (CT, MRI, or ultrasound). Gold standard test date was the date a diagnosis of HCC could have been made by guideline recommended testing and criteria. Diagnosis date was the date a provider documented the diagnosis. Results: We reviewed charts for 380 patients. Overutilization of diagnostic tests after a gold standard test occurred in 112 patients (31%), and 17 (4%) had insufficient tests. Guidelines were not followed in 124 (33%). Of these 124, 68 (55%) had liver masses that increased in size during diagnostic work-up. The most common factors associated with guideline non-adherence were unnecessary testing such as biopsy after a gold standard image (43%) and the presence of a contraindication to a guideline recommended image or biopsy (12%). Patient factors (missed appointments, declining work-up) accounted for only 3% of cases. Median time between the initial liver mass and gold standard test was 15 days (IQR: 0-99). Median time between the initial liver mass and diagnosis was 50 days (IQR: 12-191). Most diagnoses were made by gastroenterology (51%), followed by primary care (19%), and oncology (10%). Conclusions: One-third of patients with HCC were not diagnosed based on guidelines. These concerns include confidence in diagnosis (lack of recognizing HCC diagnosis despite gold standard evidence) and over testing, which both lead to diagnostic delay. Our findings warrant further evaluation of contributory factors to develop interventions that improve the diagnostic process for HCC.
Measuring clinical pathway compliance using a simulated patient approach with clinical performance and value (CPV) vignettes.
Authors: Fields Karen K. , Soliman Hatem Hussein , Friedman Eliot Lawrence , Lee Rachel V. , Acelajado Maria Czarina , Tamondong-Lachica Diana , Peabody John W. 
Published: February 2017

96 Background: Although clinical pathways have the promise to improve the quality of care, they have had limited success changing practice or standardizing care. Moffitt Cancer Center (MCC) has > 40 pathways incorporating interdisciplinary care strategies linked to evidence and decision support tools. Methods: To improve compliance with pathways we used an innovative measure to quantify quality of care, CPV vignettes. CPV vignettes are validated, simulated clinical scenarios constructed so that adherence to pathways is clear-cut. Providers care for identical cases so there is no need for case mix adjustment. After completing each case, providers are given personalized feedback. Twelve breast cancer (ca) vignettes were developed by MCC breast medical oncologists and surgeons and QURE, a healthcare measurement company. The cases were developed using MCC pathways, other evidence and core issues such as diagnostic work-up. The vignettes were randomized at the department level and given to all MCC providers who care for breast ca patients. A total of 18 providers took 34 CPVs: 7 medical oncologists, 6 advanced practitioners and 5 surgeons. QURE-trained physician abstractors blinded to the CPV-taker’s identity scored each vignette and provided confidential feedback. Results: Total scores for providers averaged 55.4%, s.d. 12.5%, a typical score for a CPV baseline study. Adherence to pathways varied by area with the highest concordance for radiation and hormonal therapy and the lowest for management of axillary lymph nodes (see Table). Conclusions: Adherence to pathways varied among providers and by clinical domain. Ongoing efforts will evaluate the impact of serial CPV measurement on pathway adherence. Simulations simplified the task of determining pathway adherence making pathway compliance at the physician level a reasonable expectation and standardization at the group level scientifically rigorous and feasible. [Table: see text]
Fast track multidisciplinary approach for gastrointestinal tumours.
Authors: Tytgat Kristien M. A. J. , Greuter H. H. , Molenaar J. , Heukels S. , Fockens Paul , Gouma Dirk J. , Klinkenbijl Jean H.G. 
Published: February 2017

102 Background: The incidence of gastrointestinal (GI) tract tumours in the Netherlands is rising. However, GI oncological medical care is still delayed and fragmented. There is a need for better and faster diagnostic work-up, faster start of treatment, but also for expert multidisciplinary deliberation. Therefore, the GIOCA, Gastro Intestinal Oncological Centre Amsterdam, started in 2009 as a one day fast track multidisciplinary outpatient clinic for patients with GI malignancies. The goal was an admission time (AT, time from referral to consultation) of < 1 week and a run through time (RTT, time from multidisciplinary meeting to start of treatment) of < 3 weeks. The aim of this study was first to evaluate the AT and RTT at GIOCA and secondly to evaluate the subjective impact of this novel strategy on patients burden and satisfaction. Methods: Patients were seen at GIOCA in the morning on a colorectal (CRC ), an oesophago/gastric (OES) or a hepatopancreaticobiliary (HPB) day. That same morning (additional) diagnostics were performed. At the multidisciplinary meeting afterwards, a final diagnosis and treatment plan was made, which was later communicated to the patient. The patient then met all involved specialists. AT and RTT were prospectively recorded for all GIOCA patients. For HPB malignancies, AT and RTT could be compared to historical controls from the preceding year. Patient impact and satisfaction was evaluated using a before/after cohort study design, with a written questionnaire prospectively administered to all GIOCA patients and compared to data obtained 3 months prior to GIOCA start. Results: Analyses of 2009 and 2010 showed the following results: The average AT for CRC, OES and HPB was 7.6, 9.5 and 9 days respectively. The average RTT for CRC, OES and HPB was 20.8, 24 and 25 days respectively. For HPB malignancies, this was 10.4 days (AT) and 59.8 days (RTT) in the year preceding GIOCA. Higher levels of patient satisfaction were obtained in GIOCA patients compared to controls. More than 90% of the patients interviewed would advice the GIOCA outpatient approach to other patients. Conclusions: Progress has been made in the AT and RTT in GI malignancies in GIOCA, but the goals were still not all reached. Patients were very satisfied with this novel approach.
Single-center experience with paclitaxel (T), carboplatin (C), and capecitabine (X) in the treatment of advanced esophagogastric cancer.
Authors: Ruoff Carl Alex , Hong Bennett , Kaplan Barry H. , Pollack Simcha 
Published: February 2017

116 Background: Epirubicin, cisplatin, and 5-FU (ECF) improves overall survival for advanced esopgagogastric adenocarcinoma compared with other protocols but is associated with considerable toxicity. A triple chemotherapy with TCX has shown improved survival with less toxicity at our institution. The aims of this study were to retrospectively analyze overall survival and toxicity of TCX in our patient population and to compare them with published results from ECF and paclitaxel, cisplatin, and 5-FU (TCF), a similar regimen to ours. Methods: We analyzed pts with locally advanced and/or metastatic esophagogastric adenocarcinoma treated in our institution from 2005 to 2012 with TCX (paclitaxel 80mg/m^2 day 1 & 8, carboplatin 5 AUC day 1, capecitabine 750mg/m^2 BID for 14 days). Pts had received no prior chemotherapy. Primary endpoint was overall survival and secondary endpoint was toxicity. We compared our data to historical results from trials of ECF and TCF. Results: 35 pts who received TCX were identified. The median age was 64 years (range 37-91). 20 pts had metastatic disease and 15 had locally advanced disease. Median survival was 21 months (95% CI: 13, 25 months). 1 year survival was 72% (95% CI: 54%, 90%). These data compare favorably to published ECF data (table) with a significant survival benefit of TCX over ECF (p<0.05%). When compared to TCF in pts with metastatic disease 2 year survival was 18%, compared to 32% (95% CI: 10%, 54%) with TCX. Though there is a survival benefit, it was not statistically significant. Grade 3-4 toxicity with ECF has been documented in several studies as above 40%. In our patients treated with TCX, only 4 pts (11%) suffered grade 3-4 toxicity (nausea, vomiting, hearing loss, and neutropenia). Conclusions: In our patient population, triple therapy of paclitaxel, carboplatin, and capecitabine (TCX) is associated with significant improvement in overall survival in advanced esophagogastric cancer with a low rate of toxicity compared to published ECF results. [Table: see text]
A prospective comparison of the FACT-e and EORTC-QLQC30 and OG25 questionnaires for evaluating changes in health-related quality of life in patients with esophageal cancer.
Authors: Darling Gail 
Published: February 2017

130 Background: The FACT-E (Functional Assessment of Cancer Therapy– Esophageal) and the EORTC QLQ-C30 (European Organization for Research on Treatment of Cancer Quality of Life Questionnaire) and its cancer-specific module (OG25) are two validated instruments used to assess quality-of-life (QOL) in patients with esophageal cancer. This study investigates the differences between these two instruments. Methods: This is a prospective study of 22 consecutive patients treated with chemoradiation followed by surgery. Questionnaires were self-administered at each of the following: baseline (prior to treatment), 6-8 weeks and 12-14 weeks following start of chemoradiation, and 1, 3, 6, 9, 12, and 18 months following esophagectomy. Mixed model regression was applied to model the repeated measures of the two questionnaires to compare slopes. Results: Of the 22 patients, 20 proceeded to surgery. Overall survival and disease-free survival at 18 months were 59% and 55% respectively. Comparison of the QOL domains over time showed good correlation for physical and functional well-being, with an apparent variation in the magnitude of the changes over time for the latter. The questionnaires were discordant with respect to social and total well-being. Social well-being showed a return to baseline by 1 month post-op using the FACT, but never recovered to baseline for the EORTC. FACT Total well-being recovered to baseline by 9 months, while the EORTC only approached baseline values by 18 months. The disease-specific modules showed post-operative symptom improvement with the FACT and a deterioration with the EORTC. There was also discordance in emotional well being. Conclusions: Domain comparisons of the EORTC and FACT questionnaires showed differing results. Discordance was seen for emotional, social and overall QOL, as well as symptomatology. The EORTC total and physical well-being domains showed a similar pattern of change over time. These findings might result from the overall tendency of the EORTC to emphasize physical aspects of QOL. Thus these two instruments appear to measure different aspects of QOL, which may affect their clinical utility.
A comparison of outcomes for 3D conformal versus intensity modulated radiation therapy in postoperative gastric cancer.
Authors: McTyre Emory , Freilich Jessica , Chuong Michael , Fulp William J. , Almhanna Khaldoun , Meredith Kenneth , Hoffe Sarah , Shridhar Ravi 
Published: February 2017

139 Background: Postoperative radiation therapy (RT) for gastric cancer results in increased survival. Treatment planning studies have demonstrated improved target coverage and normal tissue sparing with intensity modulated RT (IMRT) versus 3D conformal radiotherapy (3DCRT). The purpose of this study was to compare outcomes of gastric cancer patients treated with IMRT vs 3DCRT. Methods: An IRB approved database was queried for all postoperative gastric cancer patients who received adjuvant chemoradiation with either 3DCRT or IMRT between 2000 and 2012. The primary endpoints were survival and toxicity. Overall (OS) and disease-free survival (DFS) were calculated with Kaplan-Meier analysis and multivariate analysis (MVA) was performed using a Cox proportional hazard ratio model. Results: We identified 39 patients (23 3DCRT, 16 IMRT). Median followup for all patients, 3DCRT patients, and IMRT patients was 16.2, 24.6, and 14.4 months, respectively. The only difference between groups noted was the presence of more positive lymph nodes (p=0.015) and higher N stage (0.012) in the 3DCRT group. There was no difference in OS or DFS on univariate or MVA. The median OS was 27.6 for the IMRT patients versus 27.4 months in the 3DCRT patients (p=0.63). In patients treated with IMRT we observed a nonsignificant decrease in grade ≥3 toxicity (25% vs. 39%; p = 0.50), any hospitalization (25% vs. 30%; p = 0.74), and median weight change (7% vs. 9%; p=0.62). On MVA for grade >3 toxicity age, gender, stage, type of surgery, pre-operative chemotherapy, number of lymph nodes removed and radiation technique were all nonsignificant. The hazard ratio for radiation technique was 0.600 (95% CI 0.118-3.042; p value=0.537). Conclusions: Our data did not demonstrate differences in OS or DFS but did show a decrease in toxicity. Caution should be taken given small sample size and short follow up in IMRT patients. Comparative outcomes for these two techniques therefore warrant continued exploration.