bluuebunny/crossref_metadata_2025_split huggingface dataset:
Do patients participating in oncology clinical trials understand the informed consent form? A Brown University Oncology Research Group study.
Authors: Schumacher Andrew , Bartley Carolyn , Kaplan Anne , Murphy Benjamin , Safran Howard , Rosati Kayla , Wilson Donna 
Published: February 2017

23 Background: The informed consent process is used to provide research participants information that includes the purpose and procedures of the research study, risks, benefits, potential alternatives and that participation is voluntary. The goal of informed consent to is to provide this information in language that is understandable to the research participant. The aim of this study is to evaluate whether research participants in adult hematology/oncology clinical trials understand the information presented during the informed consent process. Methods: Patients receiving active treatment on an oncology clinical trial that utilizes chemotherapy, radiation, targeted agents, biologic therapy or hormonal therapy were eligible to participate in this study. After informed consent was obtained, research participants are given a 14-question test. The questions evaluate whether patients understand the following elements on the informed consent related to their oncology treatment study: The purpose and procedures of the research study, risks, benefits, potential alternatives, research related injury compensation, study contact information, measures used to protect confidentiality, and that participation is voluntary. The possible answers to each question are disagree, unsure, and agree. Results: This study was initiated in June 2012. Eleven patients enrolled on this study within the first month. Participants include those on cooperative group studies, pharmaceutical industry trials and investigator initiated trials. The average length of the informed consent document exceeded 20 pages. An initial analysis of data is planned after the study has been open for six months. Conclusions: Informed consents are becoming increasingly lengthy and complex. Much of the language added is regulatory and legal in nature and used to protect the institutions conducting the research. This study will assess the readability of the informed consent and whether patients participating in oncology research trials understand the essential elements of the informed consent document. The first data analysis will be December 2012.
The value of a quality metric.
Authors: Hoverman J. Russell , Schwartz Jim R. 
Published: February 2017

239 Background: The value of a quality metric is tied to improving outcomes or reducing costs while maintaining outcomes. In the last year ASCO/ONS Chemotherapy Safety metric 1F has changed from requiring current BLS (Basic Life Support) certification for all clinical personnel to requiring only one currently certified professional be present during chemotherapy administration (CA). For this study we evaluated the need for BLS training in outpatient chemotherapy delivery. Methods: Texas Oncology maintains a voluntary drug occurrence system, web-based and accessible at all sites. Occurrences with severity Grade 6 (transfer to a more intensive facility or temporary harm to patient) or higher (7 or 8) were collected for 2008-2ndq 2011. Use of BLS and AED and outcomes were tracked through chart review. Results: There were 188 instances of Grade 6 or higher events of which 5 involved BLS. There were no events where an AED was triggered. All 5 patients were transferred alive to a hospital. All events were drug reactions. During the same period there were 779, 805 CAs, 371,693 unique patients with 15,394,601 patient visits. Facility reports were also queried for 2010 with no additional events identified. Conclusions: 1) The need for BLS recertification is unproven in this setting. 2) AED triggering did not occur in this time frame, 3) Protocols for addressing severe drug reactions are of prime importance. 4) Quality metrics may or may not add value to a quality program and require validation. 5) The original BLS requirement was burdensome. 6) The incidence of true cardiac arrest in this setting is remarkably low.
Using quality indicators to monitor changes in adherence to clinical practice guidelines for treatment of ductal carcinoma in situ (DCIS) of the breast.
Authors: Chin-Lenn Laura , Mack Lloyd , Temple Walley J. , Craighead Peter S. , Bryant Heather E. , Quan May Lynn 
Published: February 2017

246 Background: Evaluation of the management of DCIS poses challenges, as standard breast cancer outcome measures such as mortality do not apply. Therefore, quality indicators (QIs) were previously developed through an interprovincial, multidisciplinary Delphi process to assess the quality of DCIS treatment and adherence to clinical practice guidelines. Population based treatment of DCIS was then compared over time using these QIs. Methods: Patients diagnosed with DCIS from 2000 to 2001 and 2009 to 2011 were identified on a population basis from the Alberta Cancer Registry and a province-wide prospectively collected synoptic medical report (WebSMR) in Alberta, Canada. Patient charts were reviewed retrospectively and QIs abstracted. Results: A total of 620 patients were identified in the study periods. Results are summarized in the table. In comparison to the earlier group, the recent cohort showed significant improvement in radiation oncology referral, radiation post lumpectomy, and complete pathology reporting. Axillary staging significantly increased from 20% (axillary dissection in 2000 to 2001) to 73% (sentinel node biopsy 2009 to 2011). Other QIs did not differ significantly. Conclusions: Adherence to clinical practice guidelines for DCIS in Alberta measured using developed QIs have shown significant improvements, particularly in pathology reporting, referral to radiation oncologists and uptake of radiation therapy for patients treated with breast conserving surgery. Rates of sentinel node biopsy seem unacceptably high, which requires further investigation. [Table: see text]
A comparison of chemotherapy use in stage IV pancreatic cancer.
Authors: Whittaker Naomi , Hueftle Kristin , Warlaumont Mary , Brin Lauren , Olson David C. , Ganti Apar Kishor , Fang Xiang , Silberstein Peter T. 
Published: February 2017

257 Background: Palliative chemotherapy is the standard of care for stage IV pancreatic cancer patients (SFPC). Methods: This study compares the amount of chemotherapy given for SFPC across insurance types using the National Cancer Database (NCDB), which contains 70% of U.S. cancer cases. Results: The NCDB reported 115,512 patients diagnosed with SFPC from 2000 to 2009. Overall, 38.3% of SFPC patients received chemotherapy. The VAH (28.3%) and Medicare (29.7%) provided significantly less chemotherapy to SFPC patients as compared to Managed Care (48.2%), Private Insurance (46.7%), Tricare/Military (42.8%), Medicaid (37.8%), Medicare Plus Supplement (35.5%), and Uninsured (34.4%). From 2000 to 2009, the rate of chemotherapy for SFPC increased for both VAH (22.9% to 34.3%) and non-VAH (31.1% to 44.1%). At time of diagnosis, the percent of patients less than 60 at the VAH was 32%, non-VAH was 25.5% and Medicare was 7%. From age 20 to 59, the rate of chemo was stable at approximately 49%, but each successive decade demonstrated a marked reduction in use of chemotherapy (from 44% for 60 to 69 years of age to 21% for 80 to 89 and 5% for >90). The VAH PC population diagnosed with PC included 71.1% whites (W), 21.1% blacks (B), 4.8% Hispanics (H), 0.8% Asian-Pacific Islander (API), and 0.6% Native American (NA). Among all insurance types, only Medicaid (25%* B, 14%* H, 6%* API) and Uninsured (20% B, 15%* H, 4%* API) had a greater percentage of minorities. Compared to the average of all patients treated for SFPC (38.3%), blacks (34.7%*) and Hispanics (35.7%*) received less chemotherapy and whites received more (39.1%*). Conclusions: This is the largest study to analyze the use of chemotherapy in stage IV pancreatic cancer. Patients treated within the VAH were less likely to receive chemotherapy compared to all other patients except those with Medicare, who tend to be older at time of diagnosis. As age increases above 59, chemotherapy treatment for SFPC decreases. VAH patients receive less chemotherapy than Medicaid and Uninsured patients, though Medicaid and Uninsured have a greater percentage of minorities, who tend to get less chemotherapy for SFPC.
The evolution of supportive care quality measures portfolio and conformance.
Authors: Nipp Ryan D. , Kelley Michael J. , Williams Christina D. , Kamal Arif 
Published: February 2017

259 Background: A growing set of quality measures is being implemented to evaluate all components of cancer care ranging from diagnosis through the end-of-life (EOL). With an increasing emphasis from ASCO and others on the regular delivery of supportive care principles throughout the cancer trajectory, we investigated our longitudinal Quality Oncology Practice Initiative (QOPI) data to understand the trends in supportive and EOL measures. Methods: We performed twice-yearly QOPI data collections from 2007 through Spring 2012 using chart review of the Durham Veterans Administration (VA) outpatient oncology clinic, staffed by VA and Duke faculty as well as Duke fellows. QOPI measures were categorized as non-treatment related supportive care (SC) (NTSC), treatment-related SC (TSC), diagnostic (D), or therapeutic (T). Descriptive statistics and chi square were used to compare longitudinal conformance. Results: The majority of QOPI measures assess processes of chemotherapy treatment (49.1% T and 11.1% TSC) or diagnostic modalities (21.1% D). Measures targeting NTSC are few (18.6%), but increased from two SC measures in 2007 to eight in Spring 2012, including the addition of two EOL measures. Over the five years, average conformance to NTSC, TSC, D, and T measures was 71.4%, 86.1%, 89.3%, and 75.4%, respectively (p<0.001). Within the NTSC measures, emotional well-being, and constipation assessment were least documented (41.0%, and 46.3% respectively). In Spring 2012, SC measure conformance (76.0%) remained significantly lower than D measure conformance (91.5%) (p<0.001). Potential explanations include heterogenous and non-standardized ways to document non-treatment measures despite an increasing emphasis within cancer care on supportive and palliative care. Conclusions: Most QOPI quality measures assess diagnosis or treatment processes of cancer care. Aggregate conformance to the NTSC measures was lower than other categories over five years. This disparity persists in the latest 2012 collection, and novel SC measures have been added. The differential conformance demonstrates the necessity of quality improvement efforts that stay commiserate with the increasing portfolio of SC measures.
Is contralateral prophylactic mastectomy (CPM) overused? Results from a population-based study.
Authors: Hawley Sarah T. , Jagsi Reshma , Katz Steven J. 
Published: February 2017

26 Background: The growing rate of CPM among women diagnosed with breast cancer has raised concerns about potential for over-treatment yet, little is known about factors that affect the decisions for this surgical treatment option. Methods: We surveyed 2,245 women newly diagnosed with breast cancer and reported to the Detroit and Los Angeles SEER registries from 6/05-2/07. We merged these data to SEER and re-surveyed them again approximately 4 years later (n=1,525). The primary outcome was receipt of CPM. We modeled surgical treatment decision making in two stages: any mastectomy (including CPM) vs. lumpectomy, and CPM vs. unilateral mastectomy (UM) among mastectomy-treated patients. The primary independent variable was clinically significant risk of developing contralateral disease (family history of at least 2 family members with breast cancer and/or a positive genetic test). We also evaluated the degree to which worry about recurrence drove initial treatment decisions (very vs. somewhat/not at all) and controlled for race/ethnicity, age, stage and SEER site. Results: Of the 1,446 women who had not had a recurrence of breast cancer by the time 2 survey, 35% considered CPM and 7.4% received it. Among those who received a mastectomy for the affected breast the figures were 53% and 19%, respectively. About 70% of patients who received CPM were clinically at very low risk for contralateral disease. 90% of those who got CPM reported being very worried about recurrence when making their treatment decision, compared to 80% of those who received UM (p<0.05). Multivariate regression showed that receipt of CPM vs. UM was associated with having a family history (OR 5.1; 95% CI: 2.49-10.1) and a positive genetic test (OR: 10.93; 95% CI: 3.37-35.71), but was also associated with greater worry about recurrence (OR: 2.07; 95% CI: 1.01-4.51). Conclusions: Many women considered CPM despite the fact that very few of them had clinically significant risk of contralateral breast cancer. Most women who had CPM did not have a clinical indication for considering it and thus not expected to benefit in terms of disease free survival. More research is needed about the underlying factors driving decision-making for CPM.
Where you stand depends on where you sit: Alignment of quality measures to strategic intentions.
Authors: Dilts David M. , Peters Christopher , Cheng Steven Kunyuan , Stadum Steven 
Published: February 2017

265 Background: Identifying quality measurements for discovering and delivering effective cancer care are dependent on the strategic vision of the cancer center and its respective units yet, each unit encompasses a distinctive set of competencies. We propose a framework for evaluating and structuring the alignment of quality and unit strategy measures within the overall vision of a cancer center. Methods: Prospective analysis was conducted with structured interviews across leadership and key opinion leaders (1) at the executive level, (2) within cancer center units (including basic science, cores, clinical research, and oncology service lines) and (3) across key hospital and research integration points. Quality and strategic areas reviewed were success measures, strategic focus, competitive dimensions, key strategies, and significant barriers. Risk of bias was accounted for through interrater reliability across the consensus of three independent reviewers. Measures of consistency were quantitatively assessed through triangulation of multiple perspectives based on roles and responsibilities. Results: 61 individuals were interviewed, generating 875 responses across the five areas. Responses were grouped into 303 categories, and then into 32 specific perspectives. These perspectives were linked with each of the five quality and strategic categories. Assessment and prioritization of quality and strategic measures were calculated based on tabulation of responses. Conclusions: While overarching strategy is well understood throughout the cancer center, quality, and strategic measures must be developed to integrate activities of each functional units across the cancer center to support overall goals. The framework for aligning quality measures to strategy facilitates the ability for centers to develop, align, and prioritize quality measures across the institution. [Table: see text]
“Stop smoking!” Do we say it enough?
Authors: Reifer Hildebrand Jessica Ann , Sastry Sangeeta , Adams Ashley 
Published: February 2017

268 Background: There are clear benefits of smoking cessation after the diagnosis of Bronchogenic Carcinoma (BC). Patients who quit smoking report lower levels of pain and are less likely to develop a second primary tumor when compared to patients who continue to smoke after they are diagnosed with BC. Persistent smoking is also associated with poor performance status and survival outcomes. Evidence suggests that smokers are more likely to quit if they are counseled by their physicians yet, there may be a prevailing belief among physicians that treating tobacco dependence is futile in this population. The purpose of this study was to investigate whether physicians addressed smoking cessation with patients who were diagnosed with BC. Methods: A retrospective chart review of patients who were diagnosed with BC was conducted at a community medical center between 2008 and 2010, using the hospital’s cancer registry. Demographic information including age, race, sex, AJCC stage, and smoking status at the time of diagnosis was collected. Evidence of tobacco cessation counseling was sought through billing codes, physician notes, and orders surrounding the time of diagnosis. Results: A total of 948 patients were diagnosed with lung cancer between 2008 and 2010. 438 were current smokers at diagnosis, 422 were former smokers, and 88 had never smoked. Of the 438 smokers, only 36% were counseled on smoking cessation. On average, each patient encountered 3 different physicians in both the inpatient and outpatient settings. Of note, stage I patients were 1.7 times more likely to be counseled than those with stage IV disease (p=0.017). There was no significant difference between the counseled group and the non-counseled group in regards to age, race, or sex. Conclusions: In spite of evidence that smoking cessation is beneficial even after the diagnosis of BC, physicians are not counseling their patients sufficiently. Reasons physicians may fail to counsel include an inability to effectively assess tobacco dependence, competing concerns during patient encounters, and reduced awareness of current quality measures. With the implementation of quality improvement programs, it will be interesting to see if smoking cessation counseling for patients with BC improves in the community setting.
Development of an evidence-based, patient-centered breast cancer chemotherapy and survivorship quality measures (QM) by the Oncology Nursing Society (ONS).
Authors: Fessele Kristen , Yendro Susan , Mallory Gail ,   BCC and BCS Project Teams
Published: February 2017

273 Background: QM focused on areas illustrating high-quality cancer care valued by nurses and patients are needed to complement existing measures in the ambulatory oncology setting. ONS has utilized a reproducible process for pilot testing two sets of evidence-based QM for validity and reliability in the breast cancer population, drawing on evidence from ONS Putting Evidence into Practice (PEP), Institute of Medicine (IOM) recommendations and other resources. Methods: The ONS Foundation supported teams of expert nurses to review evidence, draft and prioritize topic areas for potential QM. Final QM were selected after soliciting national public comment from stakeholders, and were judged on importance to clinical care, prevalence and potential for impact, scientific basis and link between process and outcome. The Joint Commission (TJC) was contracted to conduct testing, and diverse pilot sites were recruited to perform retrospective data abstraction on patient charts. The Breast Cancer Care (BCC) QM set focused on symptom management for patients receiving chemotherapy, and the Breast Cancer Survivorship (BCS) set explores needs in the first year post-treatment. TJC and ONS staff co-managed development of QM specifications, abstractor training, clinical and technical support of pilot sites, and re-abstracted 15% of 2,835 submitted cases for reliability testing. Results: QM scores were examined for gaps in care; there are clear opportunities to improve the consistency of symptom assessment and management. Symptom intensity, trajectory over time, success/failure of interventions are frequently undocumented, impacting coordination of care. Post-treatment/transition to survivorship education and resource provision as recommended by the IOM are lacking. Conclusions: Audit and feedback to practices using valid and reliable QM provide a strategy to link high-level evidence-based interventions and practice changes to improve quality cancer care. National testing across diverse practice sites illustrates a strong need to improve the consistency of symptom assessment/management and post-treatment survivorship interventions.
Postoperative complications as a predictor of 30-day hospital readmission following gastrointestinal cancer surgery.
Authors: McCahill Laurence E. , May Mary , Davis Alan T. , Taylor Wendy K. 
Published: February 2017

274 Background: Hospital readmissions have recently been identified as a benchmark for quality of care. Gastrointestinal (GI) cancer surgeries are complex and associated with higher rates of post-operative complications and hospital readmissions. Identifying factors associated with readmission could allow for strategies to reduce readmissions. Methods: Patients undergoing pancreatic (n=43), esophageal (n=20), gastric (n=14), and rectal (n=22) tumor resections were evaluated to assess if initial inpatient post-operative complications predispose patients to hospital readmission within 30 days. Patients’ charts were audited by a clinical quality specialist and complications stratified by using the Clavien Classification Schema. Hospital readmission causes were categorized as surgical procedure specific, general postoperative complication, failure to thrive, or general medical problem. Data were analyzed using the Fisher’s Exact test. Results: A total of 99 patients underwent GI tumor resections (Male:female 56:43, median age 65) between January 2010 and April 2012, and 20% were readmitted within 30 days. Of those readmitted, six had no complications in the initial hospitalization, eight had minor complications, and six had major complications, Table. When examining reasons for readmission, the majority of patients were surgical procedure specific (50%), such as anastomotic leaks or abscesses. Conclusions: Our data demonstrate that postoperative complications during initial hospitalization did not predict hospital readmissions. Readmissions, however, appear related to surgical specific complications that develop after an uneventful initial hospitalization. The goal of shorter hospitalizations following complex GI cancer surgery may result in unavoidable readmissions related to delayed presentation of procedure specific complications. [Table: see text]