Implementing a breast cancer registry and treatment plan/summary program in clinical practice: a pilot program.

BACKGROUND: There is a need to better measure and improve the quality of oncology care and improve communication with patients and other providers. The American Society of Clinical Oncology Breast Cancer Registry (BCR) pilot evaluated the feasibility and acceptability of prospective data collection for quality assessment in daily clinical practice. Data were used to create and share treatment plans/summaries (TPSs) at the point of care. METHODS: Using a web-based tool, 20 diverse practices entered clinical data on each new early-stage breast cancer patient into the BCR for 14 months (September 2009 through November 2010). The tool created individual TPSs that were shared with patients. Practices received practice-specific and aggregate BCR quality measures data, participated in a survey, and received a participation stipend. RESULTS: Twenty practices entered 2014 patients into the BCR, collecting demographic, clinical, and treatment information. Fifty-two percent of practice participants replied to an end-of-pilot survey: 73% were satisfied with the BCR and web-based tool, 31% expressed concern regarding time and effort, and 52% reported additional practice costs during the pilot. Among those who created or shared the TPSs, 90% thought the documents improved oncologist-patient communication, and 95% favored using BCR data for practice quality improvement. CONCLUSIONS: Prospective data collection for quality assessment is feasible and allows sharing of TPSs with patients at the point of care. Future efforts should focus on decreasing implementation burden to practices, broadening participation, examining costs, and, most importantly, assessing its effects on patient outcomes.

Performance Measures Based on How Adults With Cancer Feel and Function: Stakeholder Recommendations and Feasibility Testing in Six Cancer Centers.

PURPOSE: Patient-reported outcome measures (PROMs) that assess how patients feel and function have potential for evaluating quality of care. Stakeholder recommendations for PRO-based performance measures (PMs) were elicited, and feasibility testing was conducted at six cancer centers. METHODS: Interviews were conducted with 124 stakeholders to determine priority symptoms and risk adjustment variables for PRO-PMs and perceived acceptability. Stakeholders included patients and advocates, caregivers, clinicians, administrators, and thought leaders. Feasibility testing was conducted in six cancer centers. Patients completed PROMs at home 5-15 days into a chemotherapy cycle. Feasibility was operationalized as ≥ 75% completed PROMs and ≥ 75% patient acceptability. RESULTS: Stakeholder priority PRO-PMs for systemic therapy were GI symptoms (diarrhea, constipation, nausea, vomiting), depression/anxiety, pain, insomnia, fatigue, dyspnea, physical function, and neuropathy. Recommended risk adjusters included demographics, insurance type, cancer type, comorbidities, emetic risk, and difficulty paying bills. In feasibility testing, 653 patients enrolled (approximately 110 per site), and 607 (93%) completed PROMs, which indicated high feasibility for home collection. The majority of patients (470 of 607; 77%) completed PROMs without a reminder call, and 137 (23%) of 607 completed them after a reminder call. Most patients (72%) completed PROMs through web, 17% paper, or 2% interactive voice response (automated call that verbally asked patient questions). For acceptability, > 95% of patients found PROM items to be easy to understand and complete. CONCLUSION: Clinicians, patients, and other stakeholders agree that PMs that are based on how patients feel and function would be an important addition to quality measurement. This study also shows that PRO-PMs can be feasibly captured at home during systemic therapy and are acceptable to patients. PRO-PMs may add value to the portfolio of PMs as oncology transitions from fee-for-service payment models to performance-based care that emphasizes outcome measures.

Evolution and elements of the quality oncology practice initiative measure set.

BACKGROUND: Over the past 5 years, the American Society of Clinical Oncology (ASCO) has supported the development of a Web-based quality-reporting tool in response to a recognized need to provide medical oncologists the opportunity to demonstrate the quality of care that they are providing to patients. METHODS: The development of quality measures, their basis in the literature, and the descriptions and organizational structure of the measures are discussed. RESULTS: Specific results are the property of practices and are not shared outside of the practices except in aggregate. The system allows collection of information concerning a wide range of quality measures in a short period of time. In the last data collection period in the fall of 2008, information was submitted concerning 81 measures of quality divided into one required and six optional modules from over 250 practices concerning 15,000 patients. CONCLUSIONS: The timely collection of information on a wide range of quality measures regarding cancer patients can be efficiently collected using a Web-based data collection tool allowing for practice self-examination and comparison with other practices.

A Case Report of Severe Type B Lactic Acidosis Following First Dose of Nivolumab in a VHL-Mutated Metastatic Renal Cell Carcinoma.

We report a case of severe type B lactic acidosis (LA) in a 51-year-old male, 12 days after he received his first dose of nivolumab for metastatic Von Hippel Lindau (VHL)-mutated, clear cell renal cell carcinoma. Throughout his hospital course, infection, hypoperfusion, and tissue necrosis were not identified. We propose that his LA may have resulted from either inherent tumor glycolysis or immune activation and enhanced metabolism. The patient's course was complicated by acute renal failure, and his LA rose progressively, eventually necessitating daily hemodialysis (HD). After receiving five consecutive days of HD, the patient started everolimus daily with the intent of reducing glycolytic metabolism. Subsequently, the rate of lactic acid production slowed, and HD was no longer required after two doses of everolimus. To our knowledge, this is the first reported case of type B LA following nivolumab administration, and the use of everolimus to treat type B LA in a patient with renal cancer.

A process for measuring the quality of cancer care: the Quality Oncology Practice Initiative.

PURPOSE: The Quality Oncology Practice Initiative (QOPI) is a practice-based system of quality self-assessment sponsored by the participants and the American Society of Clinical Oncology (ASCO). The process of quality evaluation, development of the pilot questionnaire, and preliminary results are reported. METHODS: Physicians from seven oncology groups developed medical record abstraction measures based on practice guidelines and consensus-supported indicators of quality care. Each practice completed two rounds of records review and received practice and aggregate results. Mean frequencies of responses for each indicator were compared among practices. RESULTS: Participants universally, if informally, find QOPI helpful, and results show statistically significant variation among practices for several indicators, including assessing pain in patients close to death, documentation of informed consent for chemotherapy, and concordance with granulocytic and erythroid growth factor administration guidelines. Measures with universally high concordance include the use of serotonin antagonist antiemetics according to the ASCO guideline; the presence of a pathology report in the record; the use of chemotherapy flow sheets; and adherence to standard chemotherapy recommendations for patients with certain stages of breast, colon, and rectal cancer. Concordance with quality indicators significantly changed between survey rounds for several measures. CONCLUSION: Pilot results indicate that the QOPI process provides a rapid and objective measurement of practice quality that allows comparisons among practices and over time. It also provides a mechanism for measuring concordance with published guidelines. Most importantly, it provides a tool for practice self-examination that can promote excellence in cancer care.

ReCAP: Feasibility and Accuracy of Extracting Cancer Stage Information From Narrative Electronic Health Record Data.

PURPOSE: Cancer stage, one of the most important prognostic factors for cancer-specific survival, is often documented in narrative form in electronic health records (EHRs). Such documentation results in tedious and time-consuming abstraction efforts by tumor registrars and other secondary users. This information may be amenable to extraction by automated methods. METHODS: We developed a natural language processing algorithm to extract stage statements from machine-readable EHR documents, including automated rules to choose the most likely stage when discordance was present in the EHR. These methods were developed in a training set of patients with lung cancer, independently validated in a test set of patients with lung cancer, and compared with the gold standard of Vanderbilt Cancer Registry­determined stage (when available). RESULTS: In the combined data set of 2,323 patients (training set, n = 1,103; validation set, n = 1,220), 751,880 documents were analyzed. A stage statement was extracted from 2,239 (98.6%) patient EHRs (median, 24 documents per patient). Stage discordance was common, affecting 83.6% of these EHRs. Nevertheless, algorithmically derived stage accuracy was high in the validation set (κ = 0.906; 95% CI, 0.873 to 0.939), when including notes generated within 14 weeks from diagnosis. CONCLUSION: Accurate stage determination can be achieved through automated methods applied to narrative text, despite the frequent presence of discordance in such data. Our results also indicate that stage can be automatically captured in a shorter timeframe than the 6-month window used by cancer registries, as early as 5 weeks from diagnosis. These methods may be generalizable to large narrative cancer data sets.

American Society of Clinical Oncology Policy Statement on Clinical Pathways in Oncology.

The use of clinical pathways in oncology care is increasingly important to patients and oncology providers as a tool for enhancing both quality and value. However, with increasing adoption of pathways into oncology practice, concerns have been raised by ASCO members and other stakeholders. These include the process being used for pathway development, the administrative burdens on oncology practices of reporting on pathway adherence, and understanding the true impact of pathway use on patient health outcomes. To address these concerns, ASCO's Board of Directors established a Task Force on Clinical Pathways, charged with articulating a set of recommendations to improve the development of oncology pathways and processes, allowing the demonstration of pathway concordance in a manner that promotes evidence-based, high-value care respecting input from patients, payers, and providers. These recommendations have been approved and adopted by ASCO's Board of Directors on August 12, 2015, and are presented herein.

2016 Updated American Society of Clinical Oncology/Oncology Nursing Society Chemotherapy Administration Safety Standards, Including Standards for Pediatric Oncology.

Purpose To update the ASCO/Oncology Nursing Society (ONS) Chemotherapy Administration Safety Standards and to highlight standards for pediatric oncology. Methods The ASCO/ONS Chemotherapy Administration Safety Standards were first published in 2009 and updated in 2011 to include inpatient settings. A subsequent 2013 revision expanded the standards to include the safe administration and management of oral chemotherapy. A joint ASCO/ONS workshop with stakeholder participation, including that of the Association of Pediatric Hematology Oncology Nurses and American Society of Pediatric Hematology/Oncology, was held on May 12, 2015, to review the 2013 standards. An extensive literature search was subsequently conducted, and public comments on the revised draft standards were solicited. Results The updated 2016 standards presented here include clarification and expansion of existing standards to include pediatric oncology and to introduce new standards: most notably, two-person verification of chemotherapy preparation processes, administration of vinca alkaloids via minibags in facilities in which intrathecal medications are administered, and labeling of medications dispensed from the health care setting to be taken by the patient at home. The standards were reordered and renumbered to align with the sequential processes of chemotherapy prescription, preparation, and administration. Several standards were separated into their respective components for clarity and to facilitate measurement of adherence to a standard. Conclusion As oncology practice has changed, so have chemotherapy administration safety standards. Advances in technology, cancer treatment, and education and training have prompted the need for periodic review and revision of the standards. Additional information is available at http://www.asco.org/chemo-standards .

Results of the 2013 American Society of Clinical Oncology National Oncology Census.

PURPOSE: The American Society of Clinical Oncology (ASCO) National Oncology Census (Census) provides a mechanism for ASCO to systematically gather and analyze information about current practice structures and potential changes at a time when practices are working to adapt to increasing administrative and financial pressures. The Census is conducted annually and reports on new and trending data. METHODS: The 2013 Census was launched on May 30, 2013, as a national survey of oncology practices. The survey required practices to answer 11 questions and provided additional optional questions. RESULTS: The Census collected 530 useable responses in 2013 compared with 632 respondents in 2012. Practices reporting in 2013, however, represented a total of 8,011 physicians compared with only 5,018 in 2012. CONCLUSION: The pace of policy change in oncology practice is changing the landscape of how practices are organized. A greater number of practices with more than seven physicians responded in 2013, which could indicate overall growth in the size of oncology practice. Practices reported increased affiliations with hospitals through a variety of contractual mechanisms. In subsequent census efforts, ASCO will have the capability to match 2013 respondents to future respondents, allowing for increased precision in comparison of longitudinal data.

Quality of cancer family history and referral for genetic counseling and testing among oncology practices: a pilot test of quality measures as part of the American Society of Clinical Oncology Quality Oncology Practice Initiative.

PURPOSE: Family history of cancer (CFH) is important for identifying individuals to receive genetic counseling/testing (GC/GT). Prior studies have demonstrated low rates of family history documentation and referral for GC/GT. METHODS: CFH quality and GC/GT practices for patients with breast (BC) or colon cancer (CRC) were assessed in 271 practices participating in the American Society of Clinical Oncology Quality Oncology Practice Initiative in fall 2011. RESULTS: A total of 212 practices completed measures regarding CFH and GC/GT practices for 10,466 patients; 77.4% of all medical records reviewed documented presence or absence of CFH in first-degree relatives, and 61.5% of medical records documented presence or absence of CFH in second-degree relatives, with significantly higher documentation for patients with BC compared with CRC. Age at diagnosis was documented for all relatives with cancer in 30.7% of medical records (BC, 45.2%; CRC, 35.4%; P ≤ .001). Referall for GC/GT occurred in 22.1% of all patients with BC or CRC. Of patients with increased risk for hereditary cancer, 52.2% of patients with BC and 26.4% of those with CRC were referred for GC/GT. When genetic testing was performed, consent was documented 77.7% of the time, and discussion of results was documented 78.8% of the time. CONCLUSION: We identified low rates of complete CFH documentation and low rates of referral for those with BC or CRC meeting guidelines for referral among US oncologists. Documentation and referral were greater for patients with BC compared with CRC. Education and support regarding the importance of accurate CFH and the benefits of proactive high-risk patient management are clearly needed.

American Society of Clinical Oncology National Census of Oncology Practices: preliminary report.

In response to reports of increasing financial and administrative burdens on oncology practices and a lack of systematic information related to these issues, American Society of Clinical Oncology (ASCO) leadership started an effort to collect key practice-level data from all oncology practices in the United States. The result of the effort is the ASCO National Census of Oncology Practices (Census) launched in June 2012. The initial Census work involved compiling an inventory of oncology practices from existing lists of oncology physicians in the United States. A comprehensive, online data collection instrument was developed, which covered a number of areas, including practice characteristics (staffing configuration, organizational structure, patient mix and volume, types of services offered); organizational, staffing, and service changes over the past 12 months; and an assessment of the likelihood that the practice would experience organizational, staffing, and service changes in the next 12 months. More than 600 practices participated in the Census by providing information. In this article, we present preliminary highlights from the data gathered to date. We found that practice size was related to having experienced practice mergers, hiring additional staff, and increasing staff pay in the past 12 months, that geographic location was related to having experienced hiring additional staff, and that practices in metropolitan areas were more likely to have experienced practice mergers in the past 12 months than those in nonmetropolitan areas. We also found that practice size and geographic location were related to higher likelihoods of anticipating practice mergers, sales, and purchases in the future.

Measuring the improving quality of outpatient care in medical oncology practices in the United States.

PURPOSE: The American Society of Clinical Oncology Quality Oncology Practice Initiative (QOPI) has provided a method for measuring process-based practice quality since 2006. We sought to determine whether QOPI scores showed improvement in measured quality over time and, if change was demonstrated, which factors in either the measures or participants were associated with improvement. METHODS: The analysis included 156 practice groups from a larger group of 308 that submitted data from 2006 to 2010. One hundred fifty-two otherwise eligible practices were excluded, most commonly for insufficient data submission. A linear regression model that controlled for varied initial performance was used to estimate the effect of participation over time and evaluate participant and measure characteristics of improvement. RESULTS: Participants completed a mean of 5.06 (standard deviation, 1.94) rounds of data collection. Adjusted mean quality scores improved from 0.71 (95% CI, 0.42 to 0.91) to 0.85 (95% CI, 0.60 to 0.95). Overall odds ratio of improvement over time was 1.09 (P < .001). The greatest improvement was seen in measures that assessed newly introduced clinical information, in which the mean scores improved from 0.05 (95% CI, 0.01 to 0.17) to 0.69 (95% CI, 0.33 to 0.91; P < .001). Many measures showed no change over time. CONCLUSION: Many US oncologists have participated in QOPI over the past 6 years. Participation over time was highly correlated with improvement in measured performance. Greater and faster improvement was seen in measures concerning newly introduced clinical information. Some measures showed no change despite opportunity for improvement.

2013 updated American Society of Clinical Oncology/Oncology Nursing Society chemotherapy administration safety standards including standards for the safe administration and management of oral chemotherapy.

In 2009, the American Society of Clinical Oncology (ASCO) and the Oncology Nursing Society (ONS) published standards for the safe use of parenteral chemotherapy in the outpatient setting, including issues of practitioner orders, preparation, and administration of medication. In 2011, these were updated to include inpatient facilities. In December 2011, a multistakeholder workgroup met to address the issues associated with orally administered antineoplastics, under the leadership of ASCO and ONS. The workgroup participants developed recommended standards, which were presented for public comment. Public comments informed final edits, and the final standards were reviewed and approved by the ASCO and ONS Boards of Directors. Significant newly identified recommendations include those associated with drug prescription and the necessity of ascertaining that prescriptions are filled. In addition, the importance of patient and family education regarding administration schedules, exception procedures, disposal of unused oral medication, and aspects of continuity of care across settings were identified. This article presents the newly developed standards.

2013 updated American Society of Clinical Oncology/Oncology Nursing Society chemotherapy administration safety standards including standards for the safe administration and management of oral chemotherapy.

In 2009, ASCO and the Oncology Nursing Society (ONS) published standards for the safe use of parenteral chemotherapy in the outpatient setting, including issues of practitioner orders, preparation, and administration of medication. In 2011, these were updated to include inpatient facilities. In December 2011, a multistakeholder workgroup met to address the issues associated with orally administered antineoplastics, under the leadership of ASCO and ONS. The workgroup participants developed recommended standards, which were presented for public comment. Public comments informed final edits, and the final standards were reviewed and approved by the ASCO and ONS Boards of Directors. Significant newly identified recommendations include those associated with drug prescription and the necessity of ascertaining that prescriptions are filled. In addition, the importance of patient and family education regarding administration schedules, exception procedures, disposal of unused oral medication, and aspects of continuity of care across settings were identified. This article presents the newly developed standards.

Measuring and Improving Value of Care in Oncology Practices: ASCO Programs from Quality Oncology Practice Initiative to the Rapid Learning System.

Rising cancer care costs are no longer sustainable. Medical oncologists must focus on providing the maximum value to their patients; improving short-term, intermediate and long-term outcomes; and managing overall costs. Accurate measurement of outcomes and overall cost is essential to informing providers and institutions and in the quest for continuous improvement in value. The ASCO Quality Oncology Practice Initiative (QOPI) is an excellent tool for sampling processes of care in medical oncology practices. To achieve the larger goal of improving the value of cancer care, ASCO is investing in the development of a Rapid Learning System, which will leverage emerging information technologies to more accurately measure outcomes (including those reported by the patient) and costs, resulting in highly efficient, effective, and safe cancer care.

Revisions to the 2009 American Society of Clinical Oncology/Oncology Nursing Society chemotherapy administration safety standards: expanding the scope to include inpatient settings.

In November 2009, the American Society of Clinical Oncology (ASCO) and the Oncology Nursing Society (ONS) jointly published a set of 31 voluntary chemotherapy safety standards for adult patients with cancer, as the end result of a highly structured, multistakeholder process. The standards were explicitly created to address patient safety in the administration of parenteral and oral chemotherapeutic agents in outpatient oncology settings. In January 2011, a workgroup consisting of ASCO and ONS members was convened to review feedback received since publication of the standards, to address interim changes in practice, and to modify the standards as needed. The most significant change to the standards is to extend their scope to the inpatient setting. This change reflects the conviction that the same standards for chemotherapy administration safety should apply in all settings. The proposed set of standards has been approved by the Board of Directors for both ASCO and ONS and has been posted for public comment. Comments were used as the basis for final editing of the revised standards. The workgroup recognizes that the safety of oral chemotherapy usage, nononcology medication reconciliation, and home chemotherapy administration are not adequately addressed in the original or revised standards. A separate process, cosponsored by ASCO and ONS, will address the development of safety standards for these areas.

Revisions to the 2009 american society of clinical oncology/oncology nursing society chemotherapy administration safety standards: expanding the scope to include inpatient settings.

In November 2009, ASCO and the Oncology Nursing Society (ONS) jointly published a set of 31 voluntary chemotherapy safety standards for adult patients with cancer, as the end result of a highly structured, multistakeholder process. The standards were explicitly created to address patient safety in the administration of parenteral and oral chemotherapeutic agents in outpatient oncology settings. In January 2011, a workgroup consisting of ASCO and ONS members was convened to review feedback received since publication of the standards, to address interim changes in practice, and to modify the standards as needed. The most significant change to the standards is to extend their scope to the inpatient setting. This change reflects the conviction that the same standards for chemotherapy administration safety should apply in all settings. The proposed set of standards has been approved by the Board of Directors for both ASCO and ONS and has been posted for public comment. Comments were used as the basis for final editing of the revised standards. The workgroup recognizes that the safety of oral chemotherapy usage, nononcology medication reconciliation, and home chemotherapy administration are not adequately addressed in the original or revised standards. A separate process, cosponsored by ASCO and ONS, will address the development of safety standards for these areas.

Advancing performance measurement in oncology.

The American healthcare system, including the cancer care system, is under pressure to improve patient outcomes and lower the cost of care. Government payers have articulated an interest in partnering with the private sector to create learning communities to measure quality and improve the value of healthcare. In 2006, the American Society of Clinical Oncology (ASCO) unveiled the Quality Oncology Practice Initiative (QOPI), which has become a key component of the measurement system to promote quality cancer care. QOPI is a physician-led, voluntary, practice-based, quality-improvement program, using performance measurement and benchmarking among oncology practices across the United States. Since its inception, ASCO's QOPI has grown steadily to include 973 practices as of November 2010. One key area that QOPI has addressed is end-of-life care. During the most recent data collection cycle in the fall of 2010, those practices completing multiple data collection cycles had better performance on care of pain compared with sites participating for the first time (62.61% vs 46.89%). Similarly, repeat QOPI participants demonstrated meaningfully better performance than their peers in the rate of documenting discussions of hospice and palliative care (62.42% vs 54.65%) and higher rates of hospice enrollment. QOPI demonstrates how a strong performance measurement program can lead to improved quality and value of care for patients.

Report on the ASCO 2010 Provider-Payer Initiative Meeting.

The ASCO Provider-Payer Initiative meeting was convened to explore ways in which providers and payers could work together to improve patient care.