bluuebunny/crossref_metadata_2025 huggingface dataset:
Hepatitis B virus screening in patients receiving intravenous chemotherapy.
Authors: Remo Mylene Hernandez , Chacra Wadih , Cuellar Sandra , Golick Janet , Nguyen Phuc , Armgardt Emily , Venepalli Neeta K.
Published: April 2017

205

Background: Patients with chronic hepatitis B (HBV) who undergo chemotherapy without antiviral prophylaxis may develop HBV reactivation, hepatitis, liver injury, and even death. The University of Illinois Cancer Center (UICC) lacks a standardized guideline for screening patients for HBV prior to chemotherapy initiation. A retrospective chart review was conducted on chemotherapy orders submitted to UICC pharmacy over 4 weeks for both hematological and solid tumor malignancies. Of 63 new orders for intravenous chemotherapy, only 14 patients (22%) underwent HBV screening prior to chemotherapy initiation. We aimed to increase HBV screening from 22% to 50% over 2 months. Methods: A multidisciplinary taskforce comprised of hematology/oncology and hepatology physicians, clinical pharmacy, and nursing was created. An ideal process map was created identifying a clear management schema for HBV screening including differences in screening tests for various populations and management recommendations for positive test results. Two Plan-Do-Study-Act (PDSA) cycles were tested with post intervention data collected over eight weeks. Results: Of 192 chemotherapy orders submitted to outpatient pharmacy over 8 weeks, 62 patients (32%) were determined to be appropriate for HBV screening prior to initiation of chemotherapy. Of these, 36 patients (58%) were screened appropriately for HBV. Additionally, a subset analysis revealed 100% of patients successfully screened for HBV prior to initiation of anti-CD20 therapies. Conclusions: At UICC, a multidisciplinary team created and successfully piloted the implementation of a HBV screening policy in both hematological and solid tumor malignancies. Our initial aim was reached after 8 weeks of implementation, and ongoing efforts are being conducted to further improve HBV screening rates to 90%.
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]
Examining the role of treatment complexity in survivorship care planning.
Authors: Mahr Nicole Marie , de Sola-Smith Karen Marie , Bell Janice
Published: April 2017

242

Background: The cancer survivor population will reach 19M by 2025, increasing demand on primary care providers to manage late and long-term effects of treatment. To improve care quality, the IOM recommends survivorship care plans (SCPs) that include two components: a treatment summary (TS) detailing disease and treatment characteristics; and evidence based follow up care instructions (FCI). SCPs remain underutilized despite evidence they enhance physician communication, increase self-efficacy and improve health outcomes of cancer survivors. Little is known about treatment related and socio-demographic factors associated with receipt of SCPs and their components. The purpose of this study was to examine the relationship between care complexity, operationalized as multiple cancers or treatments, and survivor reported SCP receipt. Methods: This was a secondary analysis of data collected in the 2012 LIVESTRONG Survey for People Affected by Cancer, an online self-selection survey. Descriptive statistics and multivariate regression were used to examine relationships between survivor characteristics and SCP receipt among 3,599 respondents. Results: Half (52%) of survivors received a complete SCP. Care complexity was significantly associated with lower odds of SCP receipt. Each additional treatment modality lowered odds of receipt by 8% (95% CI 0.86-0.99). Survivors with multiple diagnoses had 19% lower odds of receipt than those with single diagnoses (CI 0.68-0.95). Other predictors of SCP receipt were being female (OR 0.56; 95% CI 0.48-0.65), having at least a bachelor’s degree (OR 0.77; CI 0.60-0.99), age over 66 years (OR 1.38; CI 1.01-1.89), and race of “other” (OR 1.56; CI 1.14-2.13). Similar results were found for receipt of TS alone. Conclusions: Only 52% of survivors received SCPs as recommended by the IOM. Increased case complexity was associated with lower odds of SCP receipt, suggesting patients at highest risk are least likely to receive coordination. Results indicate the need to identify and eliminate barriers to SCP implementation, with special focus on high risk patients. Future research should investigate these findings in diverse populations and identify specific characteristics associated with SCP receipt.
Comparison of initial and recertification QOPI scores: Maintaining compliance through direct surveyor and practice interaction.
Authors: Chiang Anne C. , Barysauskas Constance , Conti-Kalchik Tara , Gilmore Terry , Hendricks Carolyn Bennett , Neuss Michael N. , Jacobson Joseph O.
Published: April 2017

246

Background: Since 2006, the ASCO QOPI certification program has certified 322 practices, of which 197 practices have recertified. This retrospective study compares the number and type of standards passed at the time of initial and subsequent re-certification, and examines if on-site audits at the original certification influenced re-certification scores. Methods: 87 unique US practices that obtained QOPI certification with on-site audits at the original and re-certification between 2006 and 2014 were included. 17 QOPI certification standards were included in the analysis. Standards are metric based, except 3 standards that are observable. We defined total score per certification round as the total number of standards passed and used a Wilcoxon Rank Sum Test to test the concordance of standards passed between rounds. Linear regression models were used to identify factors related to higher recertification scores. A two-sided p<0.05 defined statistical significance. Results: 31 practices (36%) showed concordance of the 3 observable standards in the initial and re-certification rounds. For standards that assess policies, procedure and credentials of the practice, and do not require direct observation, 52 practices demonstrated improvement whereas 14 did not (p<0.0001). In contrast, for the standards that require direct observation, only 22 practices showed improvement versus 34 that did not (p=0.07). Three standards were most commonly missed in both rounds: initial chart documentation and at each clinical visit, and double verification of chemotherapy administration. There were no significant predictors of higher recertification scores. Conclusions: Many diverse oncology practices are voluntarily achieving and maintaining QOPI certification. Sustainable improvement is easier to identify in policy-based measures compared to directly observed ones. Three standards not usually passed at recertification highlight the need for assessment of psychosocial and performance status, comprehension of treatment goals, and chemotherapy double-verification. On-site evaluation of practices is key for targeting and sustaining quality efforts.
Treatment patterns among patients with higher-risk myelodysplastic syndromes in a real-world setting: Electronic medical record (EMR)-based data.
Authors: Dezube Bruce Jeffrey , Bell Jill , Galaznik Aaron , Farrelly Eileen , Blazer Marlo , Seal Brian S. , Shih Huai-Che , Eaddy Michael
Published: April 2017

247

Background: Treatment decisions in MDS are based on a prognostic scoring system that divides pts into five distinct risk categories (NCCN 2016). Treatment guidelines for HR MDS pts include hypomethylating agents (HMAs) alone (azacitidine & decitabine), high-intensity induction chemotherapy (IC), & stem cell transplant (SCT) alone or after HMAs. Limited information is available on how these recommendations are applied in practice. This study evaluated the real-world treatment of HR MDS pts. Methods: Newly diagnosed HR MDS pts who were ≥18 years old & initiated first-line therapy (1LT) were retrospectively identified from a large United States EMR database between 1/1/2008 & 7/31/2015. As complete cytogenetics were not available in the database, HR was based on: ICD coding: ≥1 inpatient claim with an HR MDS ICD-9/10 code (ICD-9 code: 238.73; ICD-10 codes: D46.20, D46.21, D46.22), or ≥2 outpatient claims with an MDS ICD-9/10 code, or an adapted HR MDS algorithm (NCCN Guidelines in Oncology for MDS v.1.2016; Greenberg, et al. Blood. 2012;120:2454-65; Schanz et al. J Clin Oncol. 2012;30:820-9). The first MDS claim served as the index date. 1LT was defined as an MDS-specific treatment initiated on or after the index date. Pts were followed until death, progression to acute myeloid leukemia (AML), loss to follow-up, or end of study (9/30/2015). Results: 720 newly diagnosed HR MDS pts were identified; of these, 229 (32%) pts received MDS-specific treatment. Median time to treatment was 22 days (interquartile range [IQR]: 10, 74). HMAs were the most common agents in the 1LT with 60% (n= 138) & 24% (n=54) receiving azacitidine & decitabine, respectively. Lenalidomide was used in 7.4% of pts (n=17), 4.8% received SCT alone (n=11), & 3.9% (n=9) received IC. At median follow-up of 9.4 months (IQR: 4.3, 18.4), 38% (n=86) died & 28% (n=63) progressed to AML. Conclusions: Despite guidelines, most HR MDS pts in a real-world setting were not treated with MDS-specific treatment. Among treated pts, 1LT with HMAs & azacitidine predominated. Subsequent research is needed to understand reasons for lack of treatment.
A method to integrate an institutional database with multiple practice EHRs.
Authors: Barr Louis H. , Wu Meiling , Burner Heather
Published: April 2017

248

Background: Survivorship care plans (SCP) are endorsed or required for accreditation by many organizations including ASCO, NCCN and ACoS. SCP elements include a treatment summary and follow up plan. Information for these elements is usually found in a practice’s electronic health record (EHR), but is not always readily identifiable. Practitioners get information from multiple EHRs across practices and hospitals. Barriers include EHRs not readily accessible to all staff or don’t communicate with each other. No simple means exists for the required data points to auto-populate from practice-based databases. Methods: We approached this by combining Cancer Registry data with an online template to populate a SCP, utilizing the Electronic Registry System, Inc. (ERS), a Cancer Registry software company, and a survivorship template provided by a free online open source company Journey Forward (JF). The Registry is told when a patient is scheduled for a survivorship appointment. A file is created of the patient’s demographics, specific cancer characteristics, and treatment summary. This is sent to the practitioner through a shared drive or secure email. The tumor site-specific JF template is then selected by practice staff who import the Registry file created from ERS. Information required for the SCP is auto-populated in the template during this process. Results: The remainder of the template contains recommendations for follow up and is completed by a physician or designated practitioner working with their EHR. Supplemental tumor site-specific education materials are available in the JF Library. Patient-specific concerns such as cancer recurrence or treatment side-effects can be addressed as well. Any of these prepared documents may be incorporated into the SCP follow up recommendation section with a mouse-click. The printed SCP is given to the patient and forwarded to care providers. A notice of SCP given to the patient is then sent to the Registry which closes the loop. Conclusions: This process utilizes the Cancer Registry, allows specific input from patient care providers, and eliminates the necessity to access multiple EHRs to complete SCPs.
Clinical and nonclinical factors associated with confirmatory biopsy in metastatic breast cancer.
Authors: Griggs Jennifer J. , Braun Thomas , Severson Dawn Marie , Layhe Elizabeth Marie , Gorski David H. , Breslin Tara M. , Henry Norah Lynn
Published: April 2017

249

Background: In patients with metastatic breast cancer, clinical practice guidelines include obtaining histologic confirmation of metastases when possible. The purpose of this study was to investigate patterns and correlates of receipt of a confirmatory biopsy. Methods: Data were abstracted from the records of patients diagnosed with metastatic breast cancer in the Michigan Breast Oncology Quality Initiative (MiBOQI), a statewide registry of 25 health systems. Patients with Stage IV disease at diagnosis were excluded. Analyses investigated associations between receipt of a confirmatory biopsy and disease, clinical and non-clinical factors, and treating health system. Results: Data were available for 1,231 (96%) of eligible patients between 2006 and 2015. Of these, 66% had a confirmatory biopsy; the proportion of patients having a biopsy varied between the 25 sites from 41% to 100% (p = 0.03). In bivariate analyses, younger age (p = 0.02), lower comorbidity (p = 0.007), longer time between the primary and recurrence (p < 0.001), more recent year of recurrence (p = 0.01), having liver, skin, soft tissue, or multiple metastases (p < 0.001), and private or government insurance (p = 0.002) were associated with biopsy. In multivariate analyses, longer time since the primary diagnosis (p < 0.001), more recent year of recurrence (p = 0.03), initial site(s) of recurrence (p < 0.001), and private or government insurance (p = 0.004) remained significant predictors of biopsy. Treatment site was no longer significant (p = 0.14). Minority status, obesity status, and disease characteristics (stage, estrogen receptor, progesterone receptor, HER2, grade) of the primary were not significant in either bivariate or multivariate analyses. Analyses were repeated without insurance with no change in the other findings. Conclusions: In a statewide collaborative, the proportion of patients having a confirmatory biopsy increased over the study period and was associated with several clinical factors. Insurance was an independent and significant predictor of receipt of what is considered standard care.
Pancreatic cancer cost-of-care in inpatient setting.
Authors: Bansal Dhruv , Bansal Pranshu , Kapoor Vidit
Published: April 2017

28

Background: Pancreatic cancer continues to carry bad prognosis with modest improvement in survival in the last decade. SEER analysis from 2006-2012 shows a 5-year survival of 7.7% for pancreatic cancer and number of new diagnoses were 11.3 per 100,000 U.S. population in 2003 and 12.7 in 2013. The mortality rate was 10.5 and 10.8 per 100,000 during the same time period. In spite of modest improvement in survival, the cancer care costs including pancreatic cancer continue to rise and inpatient costs contribute a major chunk to cancer care which is often ignored. Methods: We used National Inpatient Sample (NIS) to extract data for patients hospitalized with primary diagnosis of pancreatic cancer using clinical classification software code 17, and corresponding ICD9 codes for the years 2004-2013. NIS is a nationally representative survey of hospitalizations conducted by the Healthcare Cost and Utilization Project. It represents 20% of all hospital data in the US. Trend of rate of hospitalization, mean length of stay (LOS), and mean cost of hospitalization were analyzed. Results: The rate of hospitalization for pancreatic cancer were 11.0 +/-0.5 in 2004 and 11.0 +/-0.3 per 100,00 hospitalizations in 2013. Mean LOS declined from 8.978 +/-0.141 to 7.616 +/-0.105 days between 2004-2013. In the same time period the mean cost of hospital stay increased from $39,533 +/-1,514 to $74,216 +/- 2,408. Conclusions: In the years 2004-2013 the rate of hospitalization for pancreatic cancer remained stable (z test p = 1.0), LOS decreased significantly by approximately 15% (z test p < 0.001), but the mean cost of hospitalization showed the most significant increase throughout the decade with a mean increase of approximately 47% (p < 0.001) in hospital costs. National inflation rate was 23.3% during this time. The gains made in decreasing the LOS has not lead to a decrease in inpatient cost of care. Pancreatic cancer treatment lags behind other cancers with dismal survival rates, and combination chemotherapies are increasingly being used which may add to inpatient cost in future as well although results at this time remain modest. Further research efforts to better identify the factors contributing to inpatient cost should be undertaken.
Cost and survival analysis before and after implementation of Dana-Farber Clinical Pathways for Patients with Stage IV Non-Small Cell Lung Cancer.
Authors: Zhang Yichen , Fraile Belen , Dalby Carole Kathleen , Nguyen Tom , Nagle Julia , Lydon Christine A. , Rabin Michael S. , McNiff Kristen K. , Jacobson Joseph O. , Jackman David Michael
Published: April 2017

3

Background: Oncologists face challenges associated with increasing cost and medical complexity. The Dana-Farber Cancer Institute (DFCI) has created a customized clinical pathways program that seeks to prospectively support and guide medical decision-making across our network. It also allows the Institute to track and learn from the medical decisions made. We have analyzed cost and outcomes data from before and after the implementation of Dana-Farber Pathways in our thoracic oncology program. Methods: Our lung cancer group created a customized clinical pathway for the treatment of non-small cell lung cancer (NSCLC). We partnered with Via Oncology to provide a web-based platform for real-time pathway navigation and post-treatment data aggregation. DFCI Pathways for NSCLC went live in January 2014. We identified all patients who were diagnosed with and treated for stage IV NSCLC in 2012 (pre-pathways) and 2014 (post-pathways). Demographics, clinical characteristics, treatments, and clinical outcomes were captured. Costs of care for each patient were determined for one year from the time of diagnosis. Results: We identified a total of 160 Stage IV NSCLC patients diagnosed in 2012, and 210 patients diagnosed in 2014. The pretreatment group had more women (61% vs. 50%) but was otherwise similarly matched in terms of smoking status and presence of targetable changes in EGFR and ALK. The total 12-month cost of care (adjusted for age, sex, race, distance to DFCI, clinical trial enrollment, and EGFR and ALK status) demonstrated a $15,013 savings after the implementation of pathways ($67,050 pre, $52,037 post). Clinical outcomes were not compromised, with no significant difference in median overall survival (10.7 months pre, 11.2 months post; p = 0.08). Conclusions: In an era where comparative outcomes analysis and value assessment are increasingly important, the implementation of a clinical pathways program can provide a means to harness and deploy institutional expertise and track and learn from care decisions. Patients treated after the implementation of a clinical pathways program in lung cancer saw preserved clinical outcomes and a significant decrease in cost of care.
Development of a complex patient identification process for the CMS’ Oncology Care Model.
Authors: Sinanis Naralys , Abdelghany Osama , Strait Michael , Lyons Catherine A. , Adelson Kerin B.
Published: April 2017

32

Background: The CMS’ Oncology Care Model (OCM) provides practices with enhanced monthly payments for beneficiaries with cancer receiving chemotherapy. While the program will distribute a retrospective beneficiary list, practices need to track and identify eligible patients upfront to initiate care management and financial counseling processes and to bill for the enhanced payment. The eligibility criteria require information that many practices do not have. We describe a stepwise approach to patient identification that can be used by other OCM practices. Methods: We ran a report that identified patients with Medicare who received an OCM-eligible drug. We classified drugs into four categories: IV chemo confirmed by our own billing, oral specialty tracked and/or filled by our specialty pharmacy, general prescriptions filled at offsite pharmacies, and oral drugs billed under Medicare Part B. Because patients on general oral drugs receive 11 refills when first prescribed, we could not rely on a new prescription to trigger enrollment; we created a candidate list of patients who received oral prescriptions in the last year. Our pharmacists manually checked QS1, to verify Medicare Part D status and Surescripts to confirm that patients filled their prescription. Results: The build took time to validate due to disparate data and incomplete insurance information. 1039 IV chemo, 249 oral chemo, 196 oral Medicare Part B, were definitively eligible. 2991 with general prescriptions made the oral candidate list, which required additional verification of last visit date, Medicare Part D status, and prescription fill date. Approximately 70% of our patients have Medicare Part D and over 90% filled their prescription. We billed IV for July and August and are awaiting final confirmation of drug fill before billing the patients from the oral categories. Conclusions: The patient identification process was more complex than expected. Implementation required a multi-disciplinary effort with extensive collaboration across several departments as well as a time-intensive manual insurance and drug fill-verification process. Opportunities exist to automate Medicare Part D verification using our real-time eligibility software.
Access to care in cancer: Barriers and challenges.
Authors: Gonzalo Maria Belen , House Linda , Santiago Kristen , Buzaglo Joanne S , Zaleta Alexandra K , Gupta Niraj K.
Published: April 2017

33

Background: In the current climate of health care reimbursement, coverage reform, and escalating health care costs, navigating cancer care becomes increasingly complex for patients and caregivers. Given the truly fluid marketplace and many payment and care models being established sans engagement with or even information from the patient, it is imperative to assess the ongoing reality of patient access to comprehensive, quality cancer care: care that includes biomedical as well as psychosocial care. Methods: We launched an online research survey project to further explore the cancer patient experience as it relates to accessing health care and living within a new and evolving system of health care. The analysis is based upon a cross-sectional survey of adults (18 years old and older) affected by cancer. The survey was conducted online between June and August of 2016. 1,218 cancer survivors completed survey questions regarding access to insurance, services, and providers as well as direct and indirect costs of care. Results: 78% of patients with cancer either have not or do not recall discussing costs with their health care team prior to treatment. 53.5% of survey respondents reported not knowing the meaning of the term “Clinical Practice Guidelines,” and 73% of participants had never heard the term “Clinical Pathway.” 25% of patients experienced delays in accessing cancer care, 18% of patients reported that costs inhibited them from filling prescription drugs to treat their cancer, 22% of patients chose not to get some of the healthcare services they needed due to high out-of-pocket costs, and 53% reported not receiving social or emotional support. Conclusions: These findings demonstrate that despite progress being made in expanding access to health care, many patients still experience significant barriers and challenges to accessing care. We also find there is a gap in patient knowledge about practice guidelines and payment policies. To create a system where all patients have access to high-quality and comprehensive cancer care, educational efforts are needed to enhance patient understanding of information about practice guidelines and payment policies, including information regarding health risk and benefits, costs, patient health, and quality-of-life outcomes.