bluuebunny/crossref_metadata_2025_split huggingface dataset:
The use of real-world data to examine comparative effectiveness research (CER) and treatment patterns in HER2-negative and triple-negative metastatic breast cancer (MBC): A systematic literature review.
Authors: Parisi Monika , Pelletier Corey , Cherepanov Dasha , Broder Michael S , Noormohamed Nadia 
Published: April 2017

210 Background: With the accumulation of RWD in healthcare, CER continues to expand. RWD are becoming increasingly relevant in oncology, particularly since the onset of care pathways and CMS’ Oncology Care Model pilot program; yet, CER in oncology presents several challenges as disease biology differs by cancer type and many RWD sources do not capture clinical response, progression or survival. This review examined common endpoints reported in RWD studies on CER and TxP in MBC, focusing on HER2-negative and Triple Negative (TN) MBC. Methods: PubMed (2006-January 2016) and 4 conferences (2011-January 2016)—ASCO and SABC meetings/symposiums—were searched using MeSH/keywords, e.g., metastatic breast cancer, treatment, and comparative effectiveness. RWD CER and TxP studies in U.S. patients with HER2-negative or TNMBC were included; clinical trials were excluded. Results: Of1,782 total records, 17 articles and 9 conference abstracts were included. Studies using RWD increased over time with 2 studies published in 2010, 1 in 2012, 6 in 2013, 6 in 2014, 10 in 2015, and 1 as of January 2016. Of these, 8 were CER and 18 examined TxP. Most studies were retrospective chart reviews (7 CER; 10 TxP studies), others were retrospective secondary database analyses (1 CER; 6 TxP) and physician surveys (2 TxP). RWD sources included commercial insurance claims, SEER-Medicare, and California Cancer Registry data. Nineteen studies reported results in patients with HER2-negative MBC and 7 reported in TNMBC patients. Primary endpoints included overall survival (OS), progression-free survival (PFS), and treatment duration (TD). CER studies most commonly reported TD and survival outcomes (e.g., OS, PFS), each reported in 75% of the studies. TxP studies also most commonly examined survival outcomes (61% of studies), in addition to various treatment patterns and duration outcomes. Conclusions: This literature review indicates that in parallel to the availability of RWD, published CER studies and analysis of treatment patterns have grown in the last 5 years. The most commonly reported outcomes include OS, TD and PFS.
Identification of quality care indicators in prostate cancer.
Authors: Guillem Vicente , Diaz Rubio Eduardo , Camps Carlos , Cassinello Javier , Castellano Daniel E. , Carrato Alfredo , Gascon Pedro 
Published: April 2017

213 Background: Despite the attempts made to improve prostate cancer management with the development and implementation of clinical practice guidelines, the inefficiencies and differences that usually occur in ordinary clinical care of patients with prostate cancer significantly contribute to increase the variations in the patterns of care and patients outcomes, and costs to the health system. The goal of this project was to establish parameters for improving the care of patients with prostate cancer through the development and validation of quality indicators for the management of this disease. Methods: The ECO Foundation is a platform of experts representing the major Spanish hospitals involved in the treatment of cancer patients. A multidisciplinary group of experts supported by ECO, extracted potential indicators for prostate cancer care from the relevant medical literature. After two consecutive rounds of rating in a modified Delphi approach, followed by a consensus discussion, the expert panel prioritized the indicators selected. Results: Forty indicators were selected with a high level of agreement. They were grouped into four main groups: general, localized disease, metastasized disease, and results-related indicators. Only two indicators did not reach an agreement or disagreement. The indicators with the highest level of agreement ( > 95%) were the appropriateness of diagnostic confirmation through the pathology report; patient participation in clinical decisions; complete re-staging with study of regional and bone extension; or the establishment of individual therapeutic plan with multidisciplinary participation. Conclusions: We conclude that currently available prostate cancer quality indicators represent clinical practices that are necessary for high-quality care in prostate cancer. The finalized indicator list can be directly adopted or adapted for deployment within a performance improvement program.
Improving consistency of high quality diagnosis, staging, and treatment using measurement.
Authors: Mukhi Shaheena , Srigley John , Daly Corinne , Agent-Katwala Mary 
Published: April 2017

217 Background: To improve variability in diagnosing and treating cancer resection cases, six Canadian provinces implemented standardized pathology checklists to transition from narrative to synoptic reporting. In clinical practice, pathologists are electronically capturing data on the resected cancer specimens synoptically for breast, colorectal, lung, prostate, and endometrial cases. Though data were collected in a standardized format, consensus based indicators were unavailable to coordinate action across Canada. Objectives: We aimed to develop indicators to measure consistency of high quality cancer diagnosis, staging, prognosis and treatment, and coordinate action. Methods: A literature review was conducted with the input of clinical experts to inform the development of indicators. 50 clinicians from x jurisdictions reviewed, selected and ranked 33 indicators, initially drafted. Clinicians also provided input on the clinical validity of the indicators and set targets based on evidence. Clinicians reviewed the baseline data, confirmed the clinical usefulness of indicators, and assigned indicators into three pioneered domains. Results: 47 indicators were developed and categorized into one of three domains: descriptive, which provide data on intrinsic measures of a patient’s tumour, such as stage or tumour type; process, which measure the quality of data completeness, timeliness and compliance; and clinico-pathologic outcome, which examine surgeon or pathologist effect on the diagnostic pathway, such as margin positivity rates or adequacy of lymph node removal. Examples of indicators are: margin status; lymph node examined, involved and retrieval; histologic type and grade distribution; lympho-vascular invasion; pT3 margin positivity rate. Conclusions: The indicators have set a framework for: measuring consistency and inconsistency in diagnosing and staging cancer; for organizing conversations and multidisciplinary group discussions; and establishing the culture of quality improvement.
Improving the measurement of clinician response to symptom screening: Auditing the symptom management of cancer patients in Ontario.
Authors: Hurwitz Gillian , Montgomery Nicole , Moody Lesley , Bedford Colleen , Barbera Lisa Catherine 
Published: April 2017

218 Background: Since 2007, Cancer Care Ontario has provincially mandated symptom screening of cancer patients using the Edmonton Symptom Assessment Scale (ESAS). Screening rates are the primary performance metric used across 14 Regional Cancer Centres (RCCs), however this indicator does not detail how symptoms are managed during the clinic visit. The objective is to share our accomplishments using a chart audit process and share upcoming changes aimed to improve the measurement of clinician response to symptom screening. Methods: The initial chart audit tool was created by regional stakeholders who oversee cancer symptom management. The tool measures the concordance between clinician response to the patient symptom screen and best practices outlined in the Cancer Care Ontario Symptom Management Guides. RCCs conduct an annual chart audit for seven of the ESAS symptoms, and sample at least 20 patients with high symptom scores (>=4). Chart documentation is analyzed to determine whether the patient received appropriate assessment and interventions. Results: 7,952 chart audits have been completed since 2012. Patients reporting symptom burden in FY 2015/16 often received an assessment (72-93%) and intervention (48-79%) during the clinic visit, depending on the symptom. Annual provincial aggregate results are intended to support quality improvement, inform clinician symptom management education, and provide a snapshot of resource utilization. Shortcomings of the audit have been identified over time. These highlight the need for more actionable items and a standardized process to ensure representative sampling, as aggregate results can be biased when RCCs co-opt the audit to measure local projects. This prompted an overhaul of the audit process: new audit tool created; results linkable to administrative data; and objectives clearly defined to balance local and provincial needs. Conclusions: Measuring the frequency of symptom screening is important, but the most clinically relevant question is whether the patient’s symptoms are being managed. Changing the chart audit process will ease the burden on auditors, improve data quality, and ensure data utility at all levels.
Examining measurement properties of the consumer-based cancer care value index (CCCVI) survey: A measure to identify quality improvement priorities in cancer care.
Authors: Keller San , Yang Manshu , Yost Kathleen J. 
Published: April 2017

222 Background: Current approaches to measuring the quality of cancer care may not produce sufficient information to enable providers to structure care that aligns closely with their patients’ preferences. To close this gap, we developed the Consumer-based Cancer Care Value Index (CCCVI) survey, which assesses the aspects of cancer care that patients value the most and how their values align with their experience in receiving cancer care. Methods: The CCCVI field test included 721 adults who received cancer care in the last 12 months from 4 geographically diverse cancer care centers, including patients with varying stages of cancer, types of cancer, types of treatment (e.g., surgery, radiation, medical oncology), and demographic characteristics. The survey included items that asked patients to directly rate the “importance” of 24 aspects of cancer care, along with 24 corresponding items that measured the “frequency” with which they received each aspect of care. We evaluated the reliability and validity of the survey items, and developed “value grids” plots which visually depicted the “importance” scores against the “frequency” scores. We conducted subgroup analysis to examine income and racial/ethnic disparities in the extent of misalignment between patients’ values and experiences. Results: The survey demonstrated good internal consistency reliability (Cronbach’s alpha = 0.91) and acceptable-to-good construct and criterion validity. Value grids identified potential areas of improvement in the areas of how doctors communicate and how quickly patients get care. The subgroup analysis showed the most misalignments between patients’ values and experiences in the aspects of doctor communication for lower-income patients and in the aspects of getting care quickly for patients from racial/ethnic minority groups. Conclusions: The CCCVI survey is a reliable and valid tool for cancer care providers to identify top priority areas (i.e., high-importance but low-frequency areas) to facilitate their quality improvement efforts. It also recognizes subgroup variations in the misalignment between patients’ values and care experiences.
Site variation in assessment of biomarkers on biopsy specimens in patients with metastatic disease.
Authors: Griggs Jennifer J. , Braun Thomas , Severson Dawn Marie , Layhe Elizabeth Marie , Gorski David H. , Breslin Tara M. , Henry Norah Lynn 
Published: April 2017

224 Background: Clinical practice guidelines in patients with metastatic breast cancer recommend assessment of biomarkers—estrogen receptors (ER), progesterone receptors (PR), and HER2—on metastatic lesions. The purpose of this study was to identify factors associated with assessment of these biomarkers in patients who had undergone confirmatory biopsies. We were particularly interested in variation between treatment sites. Methods: Eligible patients were those diagnosed with metastatic breast cancer who had undergone a confirmatory biopsy and who were part of the Michigan Breast Oncology Quality Initiative (MiBOQI) registry, a statewide registry of 25 health systems. Analyses investigated associations between assessment of ER, PR, HER2 and treating center, disease, clinical and non-clinical factors. Results: Between 2006 and 2015, 805 patients had a confirmatory biopsy. Of these, 66% had ER, 63% had PR, 62% had HER2, and 57% had all three assessed on the biopsy specimen. In bivariate analysis, characteristics associated with assessment of biomarkers were earlier stage and hormone receptor-positive primary tumors, private or military insurance, white race, longer time since initial diagnosis, and bone only, liver only, lung only, chest wall, skin, and lymph nodes, and multiple sites of metastases. Younger age was positively associated with assessment of HER2. Biomarker assessment also varied significantly between treatment sites and increased over time. In multivariate analyses, time since diagnosis of the primary (p < 0.001) and treatment site (p < 0.001) remained significant. With the exception of ER (p = 0.09), performance of biomarkers increased significantly over time. Conclusions: Across 25 health systems in a quality improvement collaborative, the proportion of patients with metastatic disease who underwent a confirmatory biopsy increased over time. Nonetheless, treatment site continued to be independently associated with the odds of having biomarkers assessed on biopsy specimens. Our findings suggest that there are opportunities for improvement to provide guideline-concordant care in patients treated in diverse settings.
Understanding the patient experience of cancer treatment in Ontario, Canada: A qualitative study.
Authors: Bridge Erica , Gotlib Conn Lesley , Dhanju Suman , Singh Simron , Moody Lesley 
Published: April 2017

225 Background: In cancer care, patient experience is most often measured quantitatively. However, this approach has limitations in understanding the entire patient experience. Qualitative methods provide an opportunity to understand self reported and more complex issues most important to patients and their family members. This qualitative study explores the patient experience of outpatient cancer treatment throughout Ontario, Canada. Methods: Qualitative content analysis was done by two researchers using data from the annual Ambulatory Oncology Patient Satisfaction Survey (AOPSS) from 2013-15. The AOPSS is a retrospective, paper-based, mailed survey, designed to capture the experiences of patients who are currently receiving cancer treatment or who have received cancer treatment within the previous six months. Patients surveyed were asked “Is there anything else you would like to tell us about your cancer care services?” The National Research Corporation of Canada’s eight dimensions of patient-centred care was used to guide the analysis. Results: 5,391 patients responded to the open-ended question. Demographic information includes: gender, age, education level and disease site. 7,328 coded responses were generated, of which 3,658 (49.9%) were related to eight dimensions of patient-centred care with accompanying sub-dimensions: patients’ preferences (23.5%): dignity and respect; preferences and decision-making; care provider behaviours; emotional support (21.5%): caring, compassion and comfort; anxiety and stress; resources; and sensitive diagnosis; coordination of care (15.8%): care provider and treatment coordination; wait times; information and education (15.7%): patient-care provider communication; information needs; care provider knowledge and skills; access (9.4%): centre location; transportation and accommodation; system; parking; continuity and transition (8.1%): centre personnel; continuity between departments; continuity in the community; discharge; physical comfort (5.1%): environment; pain management and family and friends (0.8%). Conclusions: Qualitative analysis is an effective tool to capture patient experience on a population level.
A retrospective analysis of the quality of care in patients with advanced malignancies who received nivolumab at an upstate NY tertiary referral center.
Authors: Zayac Adam , Poudel Aarati , Lemke Sheila M. 
Published: April 2017

233 Background: Immune checkpoint inhibitors, such as nivolumab, have rapidly gained in popularity and use since their development and subsequent FDA approval. With an ever burgeoning list of indications for its use, we evaluated its use within our tertiary care center as well as its impact on our healthcare system to investigate the quality of care these patients received as well as the extent of the benefit that they received from this novel therapy. Methods: Charts were collected of patients at SUNY Upstate Cancer Center who were started on treatment with Nivolumab between March 4, 2015 and June 1, 2016. This returned a total of 88 (eighty-eight) patients who underwent chart review process for this IRB-exempt retrospective study. Patients who were lost to follow-up or received their oncology care outside of the Upstate Regional Cancer Center were excluded from the final analysis, leaving 83 (eighty-three) patients on whom the final analyses were performed. Statistical analyses were performed using Microsoft Excel and Apple Numbers. Results: Nivolumab was predominantly used as second or third line therapy (45% and 34%) respectively; while it was used as first line therapy in 4% of patients. Performance status was only documented in 53% of patients within two weeks of Nivolumab initiation. Fifty-eight percent of our patients were admitted to the hospital after Nivolumab initiation. Only 50% of those patients received a palliative care consultation. Twenty-six percent of our patients were admitted with an adverse effect to Nivolumab. Nearly 25% of our patients had multiple hospitalizations. Nivolumab was discontinued in 67% of our patients after an average of eight cycles. Conclusions: Nivolumab has been a relatively well tolerated novel treatment for a multitude of malignancies. However, constant re-evaluation of patients for appropriateness of treatment is needed. It is unclear how much quality of life these patients are gaining, as many patients had to discontinue therapy and had numerous hospitalizations. Palliative care remains an important intervention in this patient population that is under-utilized.
Adherence to ASTRO ‘Choosing Wisely’ recommendations for radiation therapy in low-risk endometrial cancer.
Authors: Roth Joshua A. , McDougall Jean A. , Halasz Lia Moriguchi , Fedorenko Catherine R. , Sun Qin , Goulart Bernardo H. L. , Patel Shilpen A. 
Published: April 2017

240 Background: The American Society for Radiation Oncology (ASTRO) ‘Choosing Wisely’ (CW) list notes radiation interventions lacking evidence of benefit in cancer care. This study characterizes adherence to the 2014 CW item to ‘not recommend radiation following hysterectomy in low-risk endometrial cancer’ (Stage I, Grade 1-2). No studies have previously evaluated adherence to this CW item. Methods: SEER records for patients age >65 at first primary diagnosis of Stage I (Grade 1-2) endometrial cancer between 2008-2011 were linked with Medicare files. Included cases had Medicare Part A and B coverage for ≥12 months before/after diagnosis and had a hysterectomy 1 month prior to 4 months following diagnosis. We used logistic regression to evaluate associations between socio-demographic and clinical characteristics (Table 1) and receipt of radiation therapy within 1 year of diagnosis. Results: Among 2,938 women meeting eligibility criteria, mean age was 74, 90% were white, and 55% lived in a ‘big metro’ area (population >1m). The non-adherent fraction was 24%. Among non-adherent cases, 76% received brachytherapy. In adjusted analyses (Table 1), only tumor grade was associated with non-adherence. Conclusions: More than 20% of low-risk endometrial cancer cases in our sample were non-adherent to ASTRO CW recommendations, and this only varied significantly by tumor grade. Therefore, use of radiation therapy following hysterectomy appears to be a widespread issue. This is important because non-adherence may result in side effects or substantial cost without commensurate clinical benefit. This study’s follow-up period was prior to the ASTRO CW list, but similar recommendations existed in ASCO, ESMO and NCCN guidelines at the time—suggesting work is need to align practice with guidelines. Our findings provide a baseline measure against which future studies can measure progress. [Table: see text]
The morbidity and mortality conference (MMC) concept applied to contemporary oncology practice: Retrospective findings on management of 233 patients (pts) who died of ovarian cancer (OC), colorectal cancer (CRC), and wild-type (no identified targetable mutation) nonsquamous non-small cell lung cancer (WTLC).
Authors: Love Neil , Birrer Michael J. , Hecht J. Randolph , Wakelee Heather A. , Chen Gigi Qiqi , Deutsch Margaret Ann , Picton Maria Eugenia , Rodriguez Estelamari , Willmott Lyndsay , Kelly Gloria , Miller Kirsten , Moss Jonathan , Paley Douglas , Ziel Kathryn 
Published: April 2017

241 Background: MMC have traditionally evaluated pt management and potential areas for quality improvement. We hypothesized that this approach could be adapted and extrapolated to gain increased insight into how pts with common solid tumors are being treated in general oncology practice and how the approaches used align with evidence-based guidelines. Methods: 102 randomly recruited US-based general medical oncologists from a proprietary database of 4,019 agreed to consult their medical records and provide information on biomarkers assessed, systemic therapies administered and other treatment-related factors for the last pt in their practice to die from OC, CRC and/or WTLC. An IRB exemption was obtained and a modest honorarium was provided. Results: Pts with OC, CRC and WTLC received a median of 3, 3 and 2 lines of therapy, respectively, the majority of which were supported by guidelines, but in more than half of cases, the regimen administered required dose adjustment/discontinuation due to toxicity. Less than half of pts were offered trial participation and only 15 (6%) entered a trial. 19 pts with OC (25%), 25 pts with CRC (32%) and 58 pts with WTLC (73%) did not undergo BRCA, MSI and multiplex genomic testing, respectively, despite the recommendation of available guidelines. Conclusions: The MMC model may be an effective means to document variability as well as consistency in current oncologic care. Data generated via this assessment juxtaposed with current clinical evidence and available guideline recommendations could potentially serve as a powerful educational intervention. These findings require additional validation but provide initial support for future iterations of this exercise. [Table: see text]