Assessing and Advancing Progress in the Delivery of High-Quality Cancer Care: Proceedings of a Workshop (2024)

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Proceedings of a Workshop WORKSHOP OVERVIEW1 A 1999 consensus report by the Institute of Medicine (IOM) defined high- quality cancer care as care that provides patients with “appropriate services in a technically competent manner, with good communication, shared decision mak- ing, and cultural sensitivity” (IOM, 1999, p. 3). However, based on a compre- hensive review of the evidence on the effectiveness of cancer services and delivery systems, the adequacy of quality assurance mechanisms, and barriers that impede access to cancer care, the report concluded that “for many Americans with cancer, there is a wide gulf between what could be construed as the ideal and the real- ity of their experience with cancer care” (IOM, 1999, p. 2). In 2013, an IOM consensus report revisited the issue of quality in cancer care and concluded that the cancer care delivery system was in a state of crisis. Finding that “cancer care is often not as patient-centered, accessible, coordinated, or evidence-based as it could be,” the report included a conceptual framework and recommendations for improving the quality of cancer care (IOM, 2013a, p. 2). A decade later, some progress has been made, but the ability of the cancer care delivery system to provide high-quality cancer care to all patients remains elusive, said Patricia 1 This workshop was organized by an independent planning committee whose role was lim- ited to identification of topics and speakers. This Proceedings of a Workshop was prepared by the rapporteurs as a factual summary of the presentations and discussions that took place at the workshop. Statements, recommendations, and opinions expressed are those of individual pre- senters and participants and are not endorsed or verified by the National Academies of Sciences, Engineering, and Medicine, and they should not be construed as reflecting any group consensus. 1 PREPUBLICATION COPY—Uncorrected Proofs 

2 INNOVATION IN ELECTRONIC HEALTH RECORDS Ganz, distinguished professor of health policy and management at the University of California Los Angeles (UCLA) Fielding School of Public Health, professor of medicine in the David Geffen School of Medicine, director of the Center for Cancer Prevention and Control Research at the Jonsson Comprehensive Cancer Center, and chair of the IOM committee that issued the 2013 report. The National Cancer Policy Forum of the National Academies of Sciences, Engineering, and Medicine and the American Society of Clinical Oncology (ASCO) cohosted a public workshop on assessing and advancing progress in the delivery of high-quality cancer care on October 5 and 6, 2023. Robert Winn, director of the Virginia Commonwealth University Massey Cancer Center and chair of the National Cancer Policy Forum, said this workshop was designed to: • Enable the cancer community to gauge progress on implementation of the 2013 report recommendations; • Discuss persistent challenges in achieving excellent and equitable cancer care; • Highlight aspects of cancer care that have changed over the past decade that might require new strategies for quality improvement; and • Explore opportunities to advance progress on the delivery of high-quality cancer care. Winn said that discussions about cancer care frequently focus on patient access. However, he noted that not all cancer care delivery is of high quality, and there is inequitable access to high-quality care. This Proceedings of a Workshop summarizes the workshop presentations and discussions. Observations and suggestions from individual participants are discussed throughout the proceedings, and highlights are presented in Box 1 and Box 2. Appendix A includes the Statement of Task for the workshop; Appendix B includes the workshop agenda; Appendix C includes the recommendations from the 2013 IOM report. Speaker presentations and the workshop webcast have been archived online.2 2 See https://www.nationalacademies.org/event/39827_10-2023_assessing-and-advancing- progress-in-the-delivery-of-high-quality-cancer-care-a-workshop (accessed December 12, 2023). PREPUBLICATION COPY—Uncorrected Proofs 

PROCEEDINGS OF A WORKSHOP 3 BOX 1 Observations on the Delivery of High-Quality Cancer Care: Highlights of Points Made by Individual Workshop Participants Progress and Trends • Many of the key challenges outlined in the 2013 IOM report persist, and some have worsened. (Ganz, Klepin, Levit, Row- land, Siegel, Subbiah) • The percentage of new cancer diagnoses occurring in younger patients, ages 50 to 64, is increasing, which has implications for cancer care delivery. (Siegel) • Racial, ethnic, and geographic disparities in cancer incidence, care, and outcomes persist. (Mooney, Pierce, Siegel) • The composition of the cancer care workforce varies geograph- ically across the U.S., with continued underrepresentation of Black and Hispanic oncologists. (Hendricks, Nekhlyudov) • Developments since 2013 include new treatments and advances in precision medicine; practice consolidation and changes in care delivery; a decrease in the number of oncology clinicians; worsened clinician well-being and practice sustain- ability; continued implementation of the Affordable Care Act with increased patient access to health insurance; increased national attention on health equity; increased need for rural health care; and issues around the use of electronic health records (EHRs) in cancer care. (Levit, Zon) • A learning health care system has not yet been achieved as envisioned in the 2013 IOM report, despite the vast amounts of data available to enable it. (Ganz, Levit, Miller, Zon) • Few health care organizations have full capability to access and use patient data for rapid patient care decision making. The data ecosystem needed for a learning health system requires collaboration across the cancer community, including research- ers, clinicians, patient advocates, industry, and regulatory bod- ies. (Alfano) • Progress toward the goal of facilitating a learning health care information technology system for cancer includes widespread adoption of EHRs, implementation of oncology data reposito- ries, federal mandates for data transmission standards and interfaces, development and use of oncology data standards, increased cloud storage capabilities, and advances in artificial intelligence (AI) and machine learning. (Miller) continued PREPUBLICATION COPY—Uncorrected Proofs 

4 INNOVATION IN ELECTRONIC HEALTH RECORDS BOX 1 Continued Improving Cancer Care Delivery • Ensuring the scalability and sustainability of successful models of cancer care delivery will require adaptations of infrastructure and payment models. (Mooney) • Overcoming clinician, health system, and regulatory challenges to practice change will require new incentives, conducting pragmatic trials, and utilizing implementation science. (Mooney) • Community engagement is a pivotal first step to addressing dispari- ties in cancer care, and initiatives need to include community input, defined goals, and measures of impact. (Winkfield) • Barriers to achieving high-quality psychosocial cancer care are the failure to implement existing evidence-based psychological and behavioral interventions and poor insurance coverage of mental health care. (Rowland) • The success of some cancer treatments in achieving positive long- term outcomes has created the opportunity to de-escalate certain therapies. (Gralow) • More widespread evaluation of new payment models is warranted, and members of the cancer community need to be engaged in design. (Alfano, Dickson, Friese, Keating, Nekhlyudov) • The time oncology clinicians spend on patient-centered care is often not reimbursable, and there is continued reliance on drug profit margins to help cover practice costs. (Langer, Dickson, Subbiah) • A challenge to value-based payment models is that reliable mea- sures of quality at the practice level are lacking. Another challenge is that a significant portion of spending is for cancer drugs, yet oncology practices cannot control drug prices. (Keating) Facilitating Evidence Generation • Cancer therapies need to be evaluated in the populations who will use them, yet a lack of equitable representation in cancer clinical trials persists. (Adjei, Darien, Klepin) • When offered the opportunity, patients agree to participate in clinical trials at the same rate, regardless of race. (Darien, Pierce) • There is a need to significantly improve the translation of existing evidence into practice. Implementation science can help reduce the research-to-practice gap and can facilitate implementation of evidence-based oncology care in an equitable manner. (Levit, Rendle) PREPUBLICATION COPY—Uncorrected Proofs 

PROCEEDINGS OF A WORKSHOP 5 • Patient-reported outcomes (PROs) in clinical trials and in patient care help generate evidence to assess a patient’s experience with treatment and improve equitable access to high-quality care. (Bhat- nagar, Pracht, Snyder) • Efforts to extract real-world data from EHRs continue to be ham- pered by interoperability challenges across systems, including the need for greater use of structured data elements. (Zon) Ongoing Workforce Issues • Comprehensive demographic data for the oncology workforce are lacking, especially for specialties, team-based care, and advanced practice providers. (Hendricks) • Implicit bias leads to diverse clinicians leaving academic medicine. (Florez) • Efforts to increase workforce supply need to prioritize workforce retention; the growing number of vacancies will result in less cohe- sive, less stable care teams. (Friese) • Oncology practices in the U.S. are consolidating, resulting in fewer practices with more oncologists per practice. (Hendricks, Langer, Zon) • Access to cancer care in rural and frontier areas continues to be a challenge. (Hendricks, Mooney, Zon) • Health care systems and payers lag behind in digitizing processes compared to other industries. (Ganz, Robinson) • There are opportunities to leverage digital health to augment the cancer care workforce and improve high-quality care, patient out- comes, and practice efficiencies. (Dickson, Robinson, Zon) • The current fee-for-service payment structure emphasizes patient volume, does not incentivize activities that could promote high- quality cancer care, and contributes to physician burnout. (Zon) • There is no universal approach to improving professional well-being across roles and disciplines; solutions need to be based on core values identified from employee feedback and require institutional and health care policy changes and accountability. (Subbiah) NOTE: This list is the rapporteurs’ synopsis of suggestions made by one or more individual speakers as identified. These statements have not been endorsed or verified by the National Academies of Sciences, Engineering, and Medicine. They are not intended to reflect a con- sensus among workshop participants. PREPUBLICATION COPY—Uncorrected Proofs 

6 INNOVATION IN ELECTRONIC HEALTH RECORDS BOX 2 Suggestions from Individual Workshop Participants to Advance Progress in the Delivery of High-Quality Cancer Care Improving Cancer Care Delivery • Leverage innovations in care delivery and clinical research adopted during the COVID-19 pandemic to improve access to cancer care and clinical trials. (Gralow, Mooney, Pierce) • Ensure that virtual care, including telemedicine, remains accessible without geographic restriction and is reimbursable on par with in- person encounters. (Dickson, Pierce, Rowland) • Implement a “Cancer Groundshot” initiative to improve access to existing high-quality, evidence-based treatments and care. (Gralow, Yabroff) • Enable rural and underserved community access to cancer care and clinical trials. (Mooney, Winkfield) • Fund (through ARPA-H or NCI) a collaboratory of sites to pilot data ecosystems that could support a learning health system. (Alfano) • Identify reliable measures of oncology care quality to identify high- performing practices. (Keating) • Test new payment models across Medicare fee-for-service, Medicare Advantage, Medicaid, and commercial payers, and con- sider mandatory participation. (Alfano, Dickson Friese, Keating, Nekhlyudov) • Reconsider the fee-for-service reimbursement system and whether applying value-based payment models in a fee-for-service environ- ment can be successful. (Yabroff) Facilitating Evidence Generation • Ensure equitable and relevant demographic representation of popu- lations in clinical research. (Adjei, Darien) • Harmonize data elements to optimize data collection and enable data sharing across systems. (Richardson) • Secure national leadership support and funding, and develop the culture and policies needed to enable evidence generation through a learning health system. (Alfano, Ganz, Keating, Yabroff) • Update the Privacy Rule to support data sharing within a learning heath system. (Miller) PREPUBLICATION COPY—Uncorrected Proofs 

PROCEEDINGS OF A WORKSHOP 7 • Leverage innovative trial designs to enable the collection of high- quality evidence to support regulatory and clinical decision making. (Kluetz) • Fund implementation science to close the translational gap between clinical research and application in practice. (Levit, Rendle) • Incorporate the patient voice throughout research and evidence generation. (Kluetz, Pracht, Snyder) • Reconsider the approach to health care delivery research to keep pace with the rapid advances in treatment. (Kluetz, Nekhlyudov) • Redesign the EHR to provide more useful information to support patient care; improve clinical workflow and clinician well-being; and generate evidence to support a learning health system. (Gralow) Improving the Workforce Caring for People Living with and beyond Cancer • Partner across specialty societies to implement national workforce tracking and address the significant gaps in demographic data for the oncology workforce, with particular attention to pediatric oncol- ogy practitioners and advanced practice providers. (Hendricks) • Prioritize health care professional wellness: make operational effi- ciency and implementation science a part of each organization’s mission; develop a feedback-driven approach to the workplace experience, with evaluation and measurement of impact; and account for the unique needs of each team member in the develop- ment of solutions. (Friese, Trockel, Subbiah) • Develop policies and practices that support the retention and growth of a diverse and inclusive oncology workforce, including active listening, understanding, creation of a true sense of community, mentorship, sponsorship, and funding support. (Florez) • Leverage digital innovation to support all aspects of cancer care. (Robinson) • Reduce the burden of uncompensated duties for clinical teams and ensure payers integrate reimbursement for all clinical interactions. (Dickson, Langer, Subbiah, Zon) NOTE: This list is the rapporteurs’ synopsis of suggestions made by one or more individual speakers as identified. These statements have not been endorsed or verified by the National Academies of Sciences, Engineering, and Medicine. They are not intended to reflect a con- sensus among workshop participants. PREPUBLICATION COPY—Uncorrected Proofs 

8 INNOVATION IN ELECTRONIC HEALTH RECORDS PROGRESS SINCE THE 2013 IOM REPORT Overview of the 2013 Report Recommendations and Implementation Progress Ganz presented an overview of the 2013 IOM consensus report, Delivering High-Quality Cancer Care: Charting a New Course for a System in Crisis. The charge to the IOM committee was to “examine opportunities for and chal- lenges to the delivery of high-quality cancer and formulate recommendations for improvement,” with specific attention to cancer care in the context of an aging population. The committee identified six key components of a high-quality can- cer care delivery system (Figure 1): (1) engaged patients; (2) adequately staffed, trained, and coordinated workforce; (3) evidence-based cancer care; (4) a learn- ing health care [information technology] system for cancer; (5) translation of evidence into clinical practice, quality measurement, and performance improve- ment; [and] (6) accessible, affordable cancer care. Recommendations Ganz summarized the goals and recommendations that are detailed in the 2013 report (see Appendix C). The first two goals and recommendations focused on engaging patients in their care and incentivizing patient engagement and coordinated care through innovative payment models. Ganz said that the Oncol- ogy Care Model (OCM) developed by the Centers for Medicare & Medicaid Services (CMS) “was the direct result of our first recommendation from the report” and that CMS is developing a subsequent Enhancing Oncology Model (EOM). Goals 3 and 4 addressed cancer care workforce issues, with the report rec- ommending elimination of barriers to team-based care, interprofessional profes- sional training, and the development of core competencies in cancer care. Ganz noted that the response to these recommendations has been limited. Goals 5 and 6 focused on expanding the evidence-base for cancer care. Recommendations called for clinical trial enrollment to better reflect the popu- lations who ultimately receive cancer therapy, and for the use of common data elements and inclusion of patient-reported outcomes (PROs). Although there is now an initiative to develop common data standards for use across federal agencies, Ganz noted that “very little has been done to actually move this along.” Goal 7 focused on advancing a learning health care information technology (IT) system for cancer. The report called for the development and implementa- tion of digital infrastructure and analytics for cancer care and cancer research. Ganz reported that this goal has not been achieved. Goal 8 highlighted the need for quality measurement and the report recommended that the U.S. Department PREPUBLICATION COPY—Uncorrected Proofs 

A High-Quality Cancer Care Delivery Syste·m Evidence Base to Inform Clinical Care Workforce Patients 1 Quality Measurement Accessible, Affordable, {I nclud"ng patient High-Quality Care outcomes and costs) Learning Health Care Information Tech11ology System Performance Improvement and New Payment Models PREPUBLICATION COPY—Uncorrected Proofs FIGURE 1 Conceptual framework for a high-quality cancer care delivery system Source: Ganz presentation, October 5, 2023, and IOM, 2013. 9 

10 INNOVATION IN ELECTRONIC HEALTH RECORDS of Health and Human Services (HHS) facilitate the development of a national quality reporting program for cancer care. Ganz said a barrier to achieving this goal has been limited funding and interest for developing quality measures. Finally, goals 9 and 10 focused on the accessibility and affordability of can- cer care, with particular attention to reducing disparities. The report called for a national strategy to address these issues, including innovative cancer care deliv- ery and payment models. Ganz noted that disparities in cancer care and health outcomes have persisted, and highlighted discussions from the National Cancer Policy Forum workshop on promoting health equity in cancer care (NASEM, 2022). The 2013 IOM report concluded that “all participants and stakeholders must reevaluate the current roles and responsibilities in cancer care and work together to develop a high-quality cancer care delivery system.” Ganz stressed that “working toward this shared goal, the cancer care community can improve the quality-of-life and outcomes for people facing a cancer diagnosis.” Changes in the Landscape of Oncology Care Since 2013 Robin Zon, president-elect of ASCO,3 discussed developments in cancer treatment, care delivery, and technology since the 2013 IOM report. Scientific Advances “Oncology knowledge continues to explode,” Zon said. This knowledge has led to promising advances in cancer treatment, including precision oncology and biomarker-driven treatment approaches, but keeping up with new oncology knowledge is extremely challenging for clinicians, as well as for developers of practice guidelines and clinical pathways. Furthermore, Zon noted that patients continue to experience challenges with access to care; particularly patients resid- ing in rural areas and those with Medicaid insurance. Care Delivery Challenges and Opportunities. “Practice health, consolidation, [clinician] burnout, and workforce issues affect the quality of care,” Zon said. Health care workers are “time bankrupt and energy depleted,” yet the demand for oncology care is ever increasing due to an aging population. The fee-for-service reimbursement system is one contribu- tor to clinician burnout, Zon said, because clinicians have taken on a number of burdensome administrative tasks, such as prior authorizations for insurance 3 Zon’s term as ASCO President began in June 2024. PREPUBLICATION COPY—Uncorrected Proofs 

PROCEEDINGS OF A WORKSHOP 11 coverage (Lee et al., 2023; NASEM, 2019). Support from advanced practice professionals, such as physician assistants and nurse practitioners, has been cor- related with reducing physician burnout, but Zon said these professionals are also experiencing burnout. Practice consolidation has resulted in a decrease in the number of oncology practices and an increase in the size of practices; Zon said that 40 percent of medical oncologists are employed by 5 percent of practices. There are also high rates of regional hospital consolidation. Rural areas are particularly affected by hospital and practice consolidation, which she said can result in shortages of oncology care clinicians and patients being diagnosed with cancer at later stages of disease. Implementation of the Affordable Care Act (ACA) has had a positive impact on oncology care. For example, Zon said that the expansion of Medicaid has been associated with improved outcomes resulting from earlier cancer diag- noses among patients with Medicaid coverage (Hotca et al., 2023). However, not all states have expanded their Medicaid programs. Furthermore, in spite of ACA coverage expansions, Zon said that many individuals are still uninsured or underinsured, and for those patients, the costs of cancer care are prohibitive. Patients are also facing increased requirements for insurance preauthorization of testing and treatment and more frequent denials of coverage. Zon noted that proposed Federal legislation to address these issues has stalled, and states are now advancing their own legislation. The oncology payment models implemented by the CMS Innovation Cen- ter were designed to shift away from fee-for-service and incentivize value-based care. However, Zon said that demonstrating cost savings and positive impact on patient outcomes has been challenging (Oncology Care Model Evaluation Team, 2023). Technology The U.S. Food and Drug Administration (FDA) recently issued guidance for industry on integrating real-world evidence into drug development,4 and some real-world product safety data are available through FDA’s existing Senti- nel system,5 said Zon. However, she noted that efforts to extract real-world data from electronic health records (EHR) continue to be hampered by interoper- ability challenges across systems, including the need for greater use of struc- tured data elements. Zon noted that patient-facing technologies have enabled 4 See https://www.fda.gov/regulatory-information/search-fda-guidance-documents/con- siderations-use-real-world-data-and-real-world-evidence-support-regulatory-decision-making- drug (accessed March 25, 2024). 5 See https://www.fda.gov/safety/fdas-sentinel-initiative (accessed March 25, 2024). PREPUBLICATION COPY—Uncorrected Proofs 

12 INNOVATION IN ELECTRONIC HEALTH RECORDS telemedicine, remote patient monitoring devices, and collection of PRO data. System-level technologies have also supported quality reporting, health infor- mation exchanges, and the integration of real-world evidence. Again, however, interoperability challenges persist, and “the vision of a learning health care system has been slower to materialize than hoped,” Zon said. Ongoing Developments Implementation of provisions in the Inflation Reduction Act6 aims to lower drug costs and patient out-of-pocket spending (e.g., a yearly cap on patient out- of-pocket spending for Medicare Part D prescription drugs) and has the poten- tial to improve health care cost containment, Zon said. However, she noted that the first round of drug pricing negotiations will only include one oncology drug (Imbruvica),7 and there has been pushback from the pharmaceutical industry due to concerns that pricing policies could discourage innovation. The recent U.S. Supreme Court decision regarding affirmative action8 may also impede efforts to provide equitable cancer care, Zon said. She added that the Dobbs9 decision could impact the ability of clinicians to counsel and treat women diagnosed with cancer who are or might become pregnant, and could influence where, geographically, health care professionals chose to practice.10 The application of artificial intelligence (AI) in cancer care has the potential to improve efficiency of care and patient outcomes, noted Zon. For example, AI is being leveraged to standardize data elements in the EHR, and AI chatbots can respond to patient questions and alert the clinical team when a patient may need follow-up care. Zon suggested that AI has a potential role in quality improve- ment as well, noting that implementation of AI in oncology care will require multidisciplinary collaboration. 6 See https://www.congress.gov/bill/117th-congress/house-bill/5376 (accessed March 25, 2024). 7 See https://www.cms.gov/files/document/fact-sheet-medicare-selected-drug-negotiation- list-ipay-2026.pdf (accessed April 29, 2024). 8 See https://www.supremecourt.gov/opinions/22pdf/20-1199_hgdj.pdf (accessed March 25, 2024). 9 See https://www.supremecourt.gov/opinions/21pdf/19-1392_6j37.pdf (accessed March 25, 2024). 10 See https://www.nationalacademies.org/our-work/the-impact-of-the-dobbs-decision-on- cancer-care-a-virtual-webinar-series (accessed March 25, 2024). PREPUBLICATION COPY—Uncorrected Proofs 

PROCEEDINGS OF A WORKSHOP 13 ASCO Priorities and Initiatives Zon said ASCO’s five-year strategic plan focuses on three main goals: improving access by removing barriers and promoting equitable, patient-cen- tered, high-quality care; improving the clinical and research work environments for oncology professionals; and being a “trusted source for timely and high- impact evidence and continuous learning.” Julie Gralow, chief medical officer and executive vice president of ASCO, said that Medicare initiatives, including value-based payment models, have been the impetus for a range of ASCO quality care programs, starting with ASCO’s first evidence-based practice guideline in 1994. A current initiative is the ASCO Patient-Centered Cancer Care Certification,11 which she said is based on per- formance in seven domains: patient engagement; availability and access to care; evidence-based medicine; equitable and team-based care; continuous quality improvement; goals of care; palliative and end-of-life discussions; and chemo- therapy safety. Perspectives on Progress Survivorship Care Shelley Fuld Nasso, chief executive officer of the National Coalition for Cancer Survivorship (NCCS) shared findings from the annual NCCS survey of patients with cancer, survivors, and caregivers in several key areas.12 • Treatment decision-making. More than half of respondents in the NCCS national patient survey sample said that they rely fully on their doctor to make treatment decisions. While a focus of the 2013 IOM report was engaging patients in their care, Fuld Nasso said the cancer care system needs to do a better job in supporting patients. Gwen Darien, executive vice president of patient advocacy at the National Patient Advocate Foundation (NPAF), noted that NPAF surveys have found that approximately 80 percent of patients would like to be involved in decisions about their care. While a clinician has the medical expertise, the patient is the expert on their personal values and goals, she said. • Care plan. Fuld Nasso said that 80 percent of patients reported having received a care plan that helped them understand what to expect. Patients 11 See https://society.asco.org/practice-patients/quality-improvement/quality-programs/ asco-certified-patient-centered-cancer-care (accessed April 24, 2024). 12 The full report is available at https://canceradvocacy.org/2023-state-of-cancer- survivorship-survey/ (accessed December 12, 2023). PREPUBLICATION COPY—Uncorrected Proofs 

14 INNOVATION IN ELECTRONIC HEALTH RECORDS who said they received a care plan also reported greater satisfaction with their care experience. • Satisfaction with care. About two-thirds to three-quarters of patients reported being very satisfied with their care across the continuum, from screening and diagnosis through post-treatment care. However, only 16 percent of patients with stage 4 cancer were very satisfied with the end- of-life planning and care they received, which Fuld Nasso said emphasizes the need for improving this care. • Clinician visits and helpfulness. “Oncologists and surgeons are seen by the greatest percentage of patients and get high ratings” for helpfulness, Fuld Nasso reported. Yet, despite the recommendations in the 2013 IOM report, less than 10 percent of patients reported seeing a palliative care specialist, rehabilitation specialist, or receiving psychosocial care services, said Fuld Nasso. • Patient experiences with care coordination. Fuld Nasso reported that 70 percent of patients said their care was very well coordinated across the care team. However, more than half of patients reported having to convey information from one clinician to another some, or all, of the time. • Addressing side effects. Most patients (62 percent) said they felt very informed about potential side effects from treatment, Fuld Nasso reported. However, less than half felt their care team was helpful in addressing specific side effects. Inequities in Cancer Care Although there have been many advances in cancer care, inequities in care persist and African Americans have a higher death rate from cancer than other racial and ethnic groups, said Lori Pierce, professor of radiation oncology and vice provost for Academic and Faculty Affairs at the University of Michigan. Inequities in care are associated with social determinants of health, as well as the lack of racial and ethnic diversity in clinical trials (Aldrighetti et al., 2021; Duma et al., 2018; Loree et al., 2019). A meta-analysis of clinical trial participa- tion found that when offered the opportunity to participate in cancer clinical trials, patients agree to participate at the same rate regardless of race (Unger et al., 2021). The onus is on clinicians to inform patients of opportunities to participate in clinical research, Pierce said. Pierce summarized the recommendations of ASCO’s Road to Recovery report on the conduct of clinical research during the COVID-19 pandemic (Pennell et al., 2021). These recommendations include: • Improving patient access to research; • Promoting virtual consent; PREPUBLICATION COPY—Uncorrected Proofs 

PROCEEDINGS OF A WORKSHOP 15 • Bringing studies to patients; • Designing more pragmatic trials;13 • Streamlining protocol requirements so they can be integrated into routine care; • Promoting inclusive enrollment criteria; • Aligning trial selection to population needs; and • Diversifying the clinical research workforce. To increase diversity in cancer clinical trials, Pierce said that ASCO and the Association of Community Cancer Centers (ACCC) have developed a research site self-assessment designed to help sites identify and address barriers to equity, diversity, and inclusion in their clinical research.14 The ASCO Road to Recovery report also highlighted recommendations to improve equity in cancer care, which include (Pennell et al., 2021): • Standardizing and recording data elements that inform issues around disparities in access to care; • Improving patient access through telemedicine; • Advocating for formal training in cultural competency for clinicians and trainees; • Promoting a more diverse workforce; and • Focusing on clinician and patient wellness. Pierce also highlighted the need to learn from existing programs that are successfully reducing disparities in cancer care, citing the Delaware Colorectal Cancer Consortium as one example (Grubbs et al., 2013). Access, Affordability and Value Fumiko Chino, assistant attending physician in radiation oncology and lead of the Affordability Working Group at Memorial Sloan Kettering Cancer Cen- ter, discussed access, affordability, and value as key components of high-quality, patient-centered care. Although value is generally defined as quality divided by cost, she said it is important to recognize that there is no consensus on how this concept is defined or assessed for health care. What constitutes quality, which 13 Pragmatic trials are conducted in real-world clinical practice settings, with typical patients and by qualified clinicians who may have a research background. See https://www.nia.nih.gov/ research/blog/2017/06/pragmatic-clinical-trials-testing-treatments-real-world (accessed April 29, 2024). 14 Available at https://old-prod.asco.org/node/150263/ (accessed December 12, 2023). PREPUBLICATION COPY—Uncorrected Proofs 

16 INNOVATION IN ELECTRONIC HEALTH RECORDS costs matter, and what is considered affordable may differ depending on the perspective taken (e.g., patients, clinicians, health systems, insurers). The 2018 and 2020 ASCO National Cancer Opinion Surveys15 found that the financial burden of cancer and the affordability of treatment are significant concerns for many Americans. The costs of cancer treatment continue to increase, and the monthly costs of treatment with some of the newest cancer drugs can be more than $100,000, Chino said.16 The total annual national patient economic burden associated with cancer care (both out-of-pocket and time costs) is esti- mated to be more than $21 billion (Yabroff et al., 2021). If costs increase, but quality does not keep pace, then value declines, Chino said. The economic burden of the cost of treatment is sometimes referred to as financial toxicity and can especially affect people who are uninsured or those with inadequate health insurance who face substantial out-of-pocket health care expenses (Chino, 2018a). A survey by Chino found that more than half of patients were using savings, and one quarter were borrowing to pay for their care (Chino, 2018b). Patients also reported making sacrifices, such as spending less on essentials like food and clothing. Financial strain can result in treatment nonadherence,17 which can negatively affect the quality of care a patient receives and their health outcomes. The financial harms of paying for cancer care can be long-lasting. Chino shared the results of a survey of adolescent and young adult cancer survivors that found many had postponed major purchases, accumulated credit card debt, had a decrease in credit score, or were contacted by a debt col- lector (Thom et al., 2023). Darien added that there are also opportunity costs for young adult cancer survivors, such as career interruption, reduced lifetime earnings, and interruptions to growing one’s family. Chino offered several opportunities to improve the affordability and qual- ity of cancer care: facilitating shared decision-making about treatment decisions among patients and their cancer care team, as well as health policy solutions that address access to health insurance, meeting patients social care needs, and elimi- nating waste and reducing the use of unnecessary services (e.g., testing or treat- ment approaches that continue to be used despite lack of evidence that they are effective). Chino observed that efforts to incentivize quality and value through payment reform have been modest, and that “some of the key quality measures have been potentially flawed.” For example, Chino said that the provision of 15 See https://society.asco.org/sites/new-www.asco.org/files/content-files/research-and- progress/documents/2018-NCOS-Results.pdf (accessed March 25, 2024). 16 See https://www.mskcc.org/research-programs/health-policy-outcomes/cost-drugs (accessed December 12, 2023). 17 Nonadherence is when a patient does not take a prescribed treatment or follow the clini- cians instructions for taking the treatment. See https://www.cdc.gov/dhdsp/pubs/medication- adherence.htm (accessed April 30, 2024). PREPUBLICATION COPY—Uncorrected Proofs 

PROCEEDINGS OF A WORKSHOP 17 hospice care as a quality measure for oncology care may not be sufficient, because the quality of hospice care can vary widely, including differences among for-profit and not-for-profit hospice providers (Anhang Price et al., 2023). Cancer Care and Older Adults A main challenge to improving the quality of cancer care for older adults is the lack of an evidence base for cancer treatment decision making due to very limited enrollment of older adults in clinical trials that assess cancer therapies, said Heidi Klepin, professor in the Department of Internal Medicine, Section on Hematology and Oncology at Wake Forest University School of Medicine. Klepin noted that the percentage of patients aged 70 and older enrolled in NCI therapeutic trials (approximately 23.5 percent) has remained largely static from 2016 to 2021 (Mishkin et al., 2022). Klepin discussed the importance of increas- ing the participation of older adults in cancer clinical trials and highlighted forward momentum since the 2013 IOM report, as follows: Increased awareness. In 2015, ASCO released recommendations for improving the evidence base for cancer care in older adults, including addressing clinical trial design and infrastructure, FDA authority, and recruitment chal- lenges (Hurria et al., 2015). Klepin said that three subsequent workshops built on these ASCO recommendations. A workshop jointly hosted by FDA and ASCO described potential actions that key participants in cancer research could take and discussed the potential role of real-world data in expanding the evidence base (Levit et al., 2018). In 2021, a National Cancer Policy Forum workshop also explored the ethical imperative to generate data to inform the care of older adults, who comprise a large portion of patients with cancer (Bertagnolli and Singh, 2021; NASEM, 2021). The National Cancer Institute (NCI) also held a workshop focused on increasing enrollment in NCI-sponsored therapeutic trials (Mishkin et al., 2022). Collaboration to expand the evidence base. In 2017, FDA, ASCO, and Friends of Cancer Research18 published a white paper on modernizing eligibil- ity criteria for inclusion of patients with certain comorbidities in clinical trials (Lichtman et al., 2017). While not specific to older patients, Klepin noted these eligibility criteria would enable more older adults to enroll in clinical trials. NIH issued a policy on Inclusion Across the Lifespan in 2018 (Bernard et al., 2018), and FDA issued a Guidance for Industry in 2022; both address the inclusion of older adults in cancer clinic trials, Klepin said.19 18 See https://friendsofcancerresearch.org/ (accessed April 30, 2024). 19 See https://www.fda.gov/regulatory-information/search-fda-guidance-documents/ inclusion-older-adults-cancer-clinical-trials (accessed December 12, 2023). PREPUBLICATION COPY—Uncorrected Proofs 

18 INNOVATION IN ELECTRONIC HEALTH RECORDS Guiding clinical practice. With increasing evidence, Klepin said that ASCO issued a guideline for assessment and management of older adults receiv- ing cancer treatment in 2018 and a guideline update in 2023 (Dale et al., 2023; Mohile et al., 2018). While Klepin expressed enthusiasm about the increased attention focused on improving the quality of care for older adults with cancer, she noted that the cancer community has not yet achieved enough progress. Klepin said that many of the recommendations and guidelines have not been implemented, due in part to inadequate incentives, training, and prioritization. Promoting Behavioral Change: Incentives versus Penalties Several panelists discussed the roles of incentives and enforcement of requirements in changing behaviors. Klepin said that at her cancer center, incen- tives, requirements, and advocacy have each had some impact on increasing the enrollment of older adults in cancer clinical trials, and quality measures have promoted the uptake of guideline-based care by practices. Pierce said that Blue Cross and Blue Shield of Michigan funds collaborative quality initiatives (CQI) that incorporate quality measures, assessments, and incentives, and she said this approach has been successful.20 Chino observed that some existing enforcement penalties need to be stiffer to inspire greater compliance. For example, she said hospitals are required to post their negotiated rates, but a study found that “less than one-quarter of NCI cancer centers were compliant” (Chino et al., 2021). Zon said current payment structures that rate performance based on the num- ber of patients seen are a disincentive for progress, noting that senior executive leadership does not value time spent on activities that could increase care quality (e.g., patient counseling and referral, clinician education and certification). Care delivery models such as the ASCO Patient-Centered Cancer Care Certification promote quality with the incentive of shared savings, she said. ADVANCING THE CONTINUUM OF PATIENT-CENTERED CANCER CARE Three cancer survivors shared their lived experiences with the quality of cancer care (summarized in Box 3). Panelists then discussed changing trends in cancer incidence; the role of strategic partnerships and community engagement; sustainable infrastructure for the delivery of equitable cancer care; and psycho- social care for cancer survivors. 20 See https://www.mroqc.org/our-story (accessed April 30, 2024). PREPUBLICATION COPY—Uncorrected Proofs 

PROCEEDINGS OF A WORKSHOP 19 BOX 3 Patient Voices: Lived Experiences Patty Spears, a research patient advocate at the University of North Carolina, Chapel Hill, Lineberger Comprehensive Cancer Center, discussed how she, at age 40, and her mother, at age 65, were both diagnosed with breast cancer a few months apart. At the time, Spears lived in a mid-sized city near two comprehensive can- cer centers and had her choice of numerous, highly trained cancer specialists. Her mother lived in a small town with one oncology clinic and saw an oncologist who treated patients with all types of can- cer. Spears was covered by the state health care plan, which had high copays, while her mother was well covered through Tricare (a military retiree health care plan). Spears said that when her mother was diagnosed with bladder cancer later in life, the local doctor did not have appropriate expertise, and she experienced serious health complications and pain. After that, her mother was transferred to a comprehensive care center that was two hours from her home to receive better care. Cancer care needs to be accessible and affordable to all patients, she said. “Even with great coverage, good care can be hard to come by,” Spears said, stressing that “quality care should be available for everyone, regardless of where you live.” Spears called for quality measurement that captures the full patient experience, from symptoms or screening, through diagnosis and treatment, to survivorship care. Patients also need assistance navigating their cancer care trajectory, including care coordination, clear communication, and shared decision making. Beverly Canin said that when she was diagnosed with breast cancer in 2000, she reviewed the literature, talked with other cancer survivors, and then shared her concern with her oncologist that the chemotherapy they recommended “would not sufficiently protect me from recurrence to be worth the damage to my immune system.” The oncologist dismissed her concern and told her she needed che- motherapy. Under those circumstances, Canin said she “made the difficult decision not to do any toxic treatment.” She said this experi- ence ignited her passion for patient advocacy. For more than two decades, she has served on the boards and advisory committees of multiple organizations focused on breast cancer care and on cancer and aging. She emphasized that patients need to be made aware of their treatment options, the benefits and risks of these options, and continued PREPUBLICATION COPY—Uncorrected Proofs 

20 INNOVATION IN ELECTRONIC HEALTH RECORDS BOX 3 Continued the fact that they are empowered to choose cancer care—and a cancer care team—that aligns with their goals and preferences. Although patient-clinician communication has improved over the past decade, Canin said that more clinicians need “to discuss their patients’ goals and preferences, as well as socioeconomic status.” For older patients, “paternalism and ageism still too often stifle the patient’s voice.” Doctors tend to focus on treating to extend life, she said, but many patients want to have good quality-of-life for as long as possible. Another consideration when discussing treatment options with older patients is patient fitness, as one can be frail or fit at any age, Canin noted. Impor- tantly, patients also need to be made aware of clinical trials, and she said that patients report not participating because their doctor never told them about clinical trials as an option. Patients need to be confident and proactive in engaging with their clinicians because the patient knows their body and their personal goals best, Canin said. Sarah Greene, who was diagnosed with stage 3C endometrial cancer in 2022, has been a cancer health services researcher for more than 25 years with expertise in learning health systems, health commu- nication, and electronic health data, which provided important insights to navigate the complexity of her cancer care. Greene described being treated in a community oncology set- ting and emphasized the important role of evidence-based clinical practice guidelines in the treatment she received. She described the The Changing Face of Cancer: Progress and Emerging Trends Rebecca Siegel, senior scientific director of surveillance research at the American Cancer Society (ACS), provided a preview of the forthcoming 2024 ACS annual report on cancer statistics.21 It is estimated that there were more than 1.9 million new cancer diagnoses in the U.S. in 2023, of which approxi- mately 20 percent were subsequent primary cancers among cancer survivors. Estimates also suggest that by 2025, nearly 700,000 people in the U.S. will be living with metastatic breast, lung, prostate, colorectal, or bladder cancer, or melanoma (Gallicchio et al., 2022). More than half of new diagnoses are among 21 Siegel noted that data from 2020 are being excluded from modeling of incidence trends as pandemic-related disruption of health care resulted in delays in diagnosis, which appear as an anomalous decline in incidence for that year (Mariotto et al., 2023). PREPUBLICATION COPY—Uncorrected Proofs 

PROCEEDINGS OF A WORKSHOP 21 challenge of receiving access to a new maintenance therapy, pem- brolizumab, because her insurance would not cover the high cost of the immunotherapy unless chemotherapy had failed or a patient had a recurrence. Through the persistence of her oncologist, nurses, and the manufacturer’s patient access program, Greene said she was able to begin immunotherapy. She emphasized the need to address issues of affordability and equitable access to “practice-changing” breakthrough treatments, and said she has persistent worries that she will lose access to the immunotherapy. Relating her personal experiences to the recommendations of the 2013 IOM report, Greene said she “was an engaged patient, . . . encountered no issues with workforce shortages, . . . received evidence- based care, and saw quality improvements in real time.” She was also able to use the EHR portal to communicate with her care team, make appointments, and view test results. Based on her experiences, Greene highlighted three areas that warrant additional attention to improve the quality of cancer care: (1) reduce the complexity of navigating the health care system and equip patients with information and resources (e.g. patient navigation, plain-language communications, just-in-time tools); (2) address the “attrition among physicians and nurses juxtaposed against an aging and at-risk population;” and (3) change public percep- tions about cancer as a “death sentence” and raise awareness of new and emerging treatments. SOURCES: Spears, Canin, and Greene presentations, October 5, 2023. patients aged 65 and older, but the percentage of new cancer diagnoses occur- ring among patients aged 50 to 64 is increasing (from 25 percent in 1995 to 30 percent in 2019–2020), which Siegel said reflects changes in the age distribution of the general population. This shift toward middle age has potential implications for care, as this population tends to be more engaged in their care, is generally not eligible for Medicare coverage, and has more years of potential life (including more time to experience long-term effects of cancer and cancer treatment, as well as second primary cancers), she said. There has been progress in reducing cancer mortality, Siegel said, noting that the current age-adjusted cancer mortality rate is 33 percent lower than in 1991. However, she said that progress on cancer prevention has stalled, and incidence rates of many common cancers are increasing, including melanoma, prostate, breast, and endometrial cancers. Although the incidence of melanoma has increased, advances in immunotherapy over the past 10 years has doubled PREPUBLICATION COPY—Uncorrected Proofs 

22 INNOVATION IN ELECTRONIC HEALTH RECORDS the three-year survival rate for metastatic melanoma from 20 to 40 percent. The uptick in prostate cancer incidence since 2011 is being driven by increased diagnoses of advanced stage disease. Siegel noted this has coincided with the U.S. Preventive Services Task Force’s (USPSTF’s) recommendation against prostate- specific antigen (PSA)-based screening due to concerns about overdiagnosis and overtreatment.22 Although this recommendation was revised in 2017 to include informed decision making for men aged 55–69 years, “PSA testing rates remain very low at 35 percent overall, and 31 percent among Black men” she said, and there are large racial disparities in incidence and mortality of prostate cancer (Cole et al., 2021; Dess et al., 2019). Mortality rates for breast cancer continue to decline, but Siegel stressed that racial disparities persist with 40 percent higher mortality rates among Black women compared to White women despite lower breast cancer incidence in Black women. For endometrial cancer, “incidence and mortality are both increasing steeply,” Siegel said, with death rates among Black women two times that for White women. Although overall incidence and mortality rates for colorectal cancer are declining, Siegel said that incidence rates are increasing among people aged 20 to 49 years, who are often diagnosed with more advanced disease. In addition to persistent racial disparities in incidence and outcomes, Siegel said cancer mortality rates in the U.S. vary widely by geography, with county-level deaths per 100,000 ranging from 57 to 415. Access to high-quality cancer care is a major factor; 75 percent of counties in the top quartile for cancer mortality have no practicing oncologists, she said (Shih et al., 2021). Patient and Community Engagement Strategic Partnerships and Community Engagement for Promoting Equitable Cancer Care Assessment of the quality and value of cancer care often neglects medically underserved individuals who lack access to the health care system, said Karen Winkfield, executive director of the Meharry-Vanderbilt Alliance. She pointed to the publication of the Centers for Disease Control and Prevention (CDC) on Paving the Road to Health Equity, which noted that health equity is built upon programs to improve equity; measurement of effectiveness of programs; and 22 Overdiagnosis is “finding cases of cancer with a screening test (such as a mammogram or PSA test) that will never cause any symptoms. These cancers may just stop growing or go away on their own. Some of the harms caused by overdiagnosis are anxiety and having treatments that are not needed.” See https://www.cancer.gov/publications/dictionaries/cancer-terms/def/ overdiagnosis (accessed April 20, 2024). PREPUBLICATION COPY—Uncorrected Proofs 

PROCEEDINGS OF A WORKSHOP 23 policies that support effective programs.23 She also referred participants to an actionable framework for addressing disparities across the cancer care continuum and emphasized the pivotal importance of community engagement (Winkfield et al., 2021). “Equity work must be intentional,” Winkfield said. She described a logic model she developed for community outreach and education for the Lazarex- Massachusetts General Hospital Cancer Care Equity Program; this model accounts for inputs (stakeholders, programs), outputs (activities and responsible parties), and outcomes (short-, mid-, and long-term goals). At Wake Forest Baptist Health, Winkfield implemented a population health navigation program targeting disadvantaged communities in the area, including Hispanic, African American, rural, and adolescent and young adult populations. This program includes patient support (e.g., cancer screening, transportation, education) and survivorship care. As an example, she said a community assessment for a rural survivorship care navigation program in six Appalachian counties in North Caro- lina found that transportation, poverty, and lack of resources are major challenges to patient care (Falk et al., 2022). A survivorship assessment found that the cost of care and distance to care were key barriers to accessing care and found a need for access to psychosocial care as well as patient education on topics such as nutrition, she said. Winkfield pointed out that the costs of these activities are not reimbursed by payers, and these programs were funded by external grants (e.g., foundations, supplements to existing NCI cancer center grants). She also emphasized the role of community partners and the need for a team approach to promote equitable cancer care (Winkfield and Schlundt, 2023). FDA Patient Engagement Initiatives for Oncology Drug Development Vishal Bhatnagar, associate director for patient outcomes at the FDA Oncology Center of Excellence (OCE) shared examples of FDA initiatives to ensure inclusion of patient voices in cancer therapy development. Public events, such as the Conversations on Cancer series, provide opportunities for patients to share their perspectives on a range of topics.24 FDA also engages patients through OCE-funded external research collaborations on patient-focused drug devel- opment (Schneider, et al., 2021).25 Bhatnagar described two studies designed 23 See https://www.cdc.gov/minorityhealth/publications/health_equity/index.html (accessed December 12, 2023). 24 See https://www.fda.gov/about-fda/oncology-center-excellence/conversations-cancer (accessed December 12, 2023). 25 See https://www.fda.gov/about-fda/oncology-center-excellence/oce-scientific-collaborative (accessed December 12, 2023). PREPUBLICATION COPY—Uncorrected Proofs 

24 INNOVATION IN ELECTRONIC HEALTH RECORDS to improve the collection, analysis, interpretation, and reporting of physical function data in oncology clinical trials. He said these data will provide use- ful information about what patients might experience during treatment. An annual workshop on Clinical Outcome Assessment in Cancer Clinical Trials also focuses on the use of PRO measures in cancer clinical trials and includes patients as panelists.26 He added that OCE issued a draft Guidance for Industry in 2021 on incorporating PROs in cancer clinical trials.27 Other opportunities for patients to engage with FDA include “patient listening sessions, externally led patient-focused drug development meetings, and the FDA representative pro- gram,” Bhatnagar said.28 He also discussed Project Patient Voice, a website that will share PRO data collected in clinical trials to aid in shared decision making for approved cancer therapies.29 Developing the Infrastructure for Sustainable Models of Cancer Care Delivery Cancer symptom management remains suboptimal, and many patients return to the clinic or the emergency department to address poorly controlled symptoms, said Kathi Mooney, co-lead of Cancer Control and Population Sci- ences at the Huntsman Cancer Institute and professor of nursing at the Uni- versity of Utah. However, advances in technology are being leveraged to gather and report symptom data to the patient’s care team, and studies have shown that symptom management based on monitoring of PROs improves outcomes (Basch et al., 2016, 2017; Mooney et al., 2017). In addition, new models of remote care were implemented during the COVID-19 pandemic, including virtual care, home-based chemotherapy, and the hospital-at-home model.30 Mooney said it remains to be seen whether the infrastructure and payment models needed to make these models of remote cancer care scalable and sustainable will be implemented. 26 See https://www.fda.gov/news-events/fda-meetings-conferences-and-workshops/fda- workshop-8th-annual-clinical-outcome-assessment-cancer-clinical-trials-workshop-06272023 (accessed December 12, 2023). 27 See https://www.fda.gov/regulatory-information/search-fda-guidance-documents/core- patient-reported-outcomes-cancer-clinical-trials (accessed December 12. 2023). 28 See https://www.fda.gov/patients/learn-about-fda-patient-engagement/fda-patient- engagement-opportunities (accessed December 12, 2023). 29 See https://www.fda.gov/about-fda/oncology-center-excellence/project-patient-voice (accessed December 12, 2023). 30 The hospital-at-home model enables “some patients who need acute-level care to receive care in their homes, rather than in a hospital.” See https://www.aha.org/hospitalathome (accessed April 22, 2024). PREPUBLICATION COPY—Uncorrected Proofs 

PROCEEDINGS OF A WORKSHOP 25 Although broadly applicable, Mooney said that remote models of care are particularly relevant for addressing inequities in access to cancer care for patients in rural and frontier areas.31 “The quality of cancer care for these communities is not equitable to those living in metropolitan areas,” Mooney said. Huntsman at Home Huntsman at Home is a home-based model of care to address the side effects of treatment and the symptoms of disease progression, Mooney said.32 This model is designed to prevent health problems from escalating through routine monitoring and care, thereby reducing emergency department use or hospitaliza- tion (Titchener at al., 2021). A demonstration project, enabled by foundation grants and philanthropic support, found that patients in the Huntsman at Home care model had reductions in unplanned hospitalizations (55 percent), use of the emergency department (45 percent), length of stay when hospitalized (1.1 day), and costs (47 percent), compared to patients receiving usual care (Mooney et al., 2021). Huntsman at Home currently serves those within a 20-mile radius of the hospital in Salt Lake City, as well as those in three rural/frontier counties in southeastern Utah that Mooney said are served by two safety net hospitals with no oncologists. Mooney described the rural program as “very successful” thus far and noted that formal evaluation is ongoing (Nicholson et al., 2024). Opportu- nities to increase scale and ensure sustainability are also being assessed, includ- ing implementation of a virtual care center and leveraging home health and paramedic services. Facilitating novel, home-based models of cancer care will require adapting the current infrastructure, Mooney concluded. However, “health care systems are very rigidly organized and regulated,” she said, and new incentives, pragmatic tri- als, and implementation science are needed to overcome clinician, health system, and regulatory barriers and to promote practice changes that improve patient access to cancer care. 31 Rural communities are defined as having fewer than 100 people per square mile, and fron- tier communities have fewer than seven people per square mile. 32 See https://healthcare.utah.edu/huntsmancancerinstitute/treatment/huntsman-at-home (accessed December 12, 2023). PREPUBLICATION COPY—Uncorrected Proofs 

26 INNOVATION IN ELECTRONIC HEALTH RECORDS Delivering Equitable, High-Quality Cancer Care in the Veterans Health Administration The Veterans Health Administration (VHA) is “one of the largest integrated oncology care providers in the U.S.” said Justin List, director of health care out- comes in the VHA Office of Health Equity.33 In promoting equity broadly, he said the VHA focuses on building a diverse workforce; identifying and address- ing Veterans’ social risks and needs; providing tools and education; and engag- ing patients and building trust. More than one quarter of Veterans live in rural areas, and List said equity in cancer care is supported by an “equal access system” through which Veterans have access to cancer care specialists via telehealth. VHA is also working to improve equitable access to high-quality screening and early detection programs. And because rates of tobacco use are high in the Veteran population, VHA has implemented comprehensive, evidence-based tobacco ces- sation services and access to treatment. VHA Cancer Care Delivery Programs List elaborated on five VHA oncology care delivery programs that facilitate equitable access to high-quality, patient-centered cancer care. National TeleOncology program. Telehealth serves an important role in ensuring equitable access to high-quality cancer care for Veterans regardless of where they live, said List, and added that approximately 70 percent of counties in the U.S. do not have an oncologist (Kirkwood et al., 2014). The National Tele- Oncology program has nine subspecialty teams that include at least one oncolo- gist, nurse care coordinator, advanced practice provider, and clinical pharmacist. In addition, virtual tumor boards in five subspecialties are available to guide local clinicians in developing treatment plans for VHA patients. Close to Me. This program provides chemotherapy services at commu- nity-based outpatient clinics, mobile infusion units, and patient homes, thereby reducing the need for Veterans to travel and improving continuity of care, List said. Clinical Cancer Genetics Service and the National Precision Oncol- ogy Program. The Clinical Cancer Genetics Service provides “germline genetic testing for hereditary cancer conditions and [to assess a Veteran’s] personalized cancer risk,” as well as results interpretation and assistance navigating personal- ized prevention and surveillance options, List said. He added that the National Precision Oncology Program facilitates molecular testing to guide targeted can- cer treatment for a range of cancers. 33 The VHA integrated health care system has more than 1,300 facilities providing care for more than nine million enrolled Veterans. PREPUBLICATION COPY—Uncorrected Proofs 

PROCEEDINGS OF A WORKSHOP 27 NAVIGATE. The NCI and Department of Veterans Affairs Interagency Group to Accelerate Trials Enrollment (NAVIGATE) program works to facili- tate the enrollment of Veterans in NCI-supported cancer clinical trials and to expand the number of VHA Medical Centers participating as trial sites. Delivering Psychosocial Care to Cancer Survivors Julia Rowland, senior strategic advisor at Smith Center for Healing and the Arts, said psychosocial problems can “significantly increase the national bur- den of cancer,” and have been associated with decreased pursuit of care, treat- ment adherence, chemotherapy effectiveness, and length of survival, as well as increased symptom burden, risk of suicide, and cost of care. There can also be negative impacts on the health and functioning of the patient’s family. A barrier to achieving high-quality psychosocial cancer care is the failure to implement existing psychological and behavioral interventions, Rowland said. She highlighted examples of progress and outstanding needs in psychosocial care for cancer survivors relative to the six elements of high-quality care outlined in the 2013 IOM report. She also referred to a 2008 IOM consensus report as a “blueprint” that offers a model for the delivery of psychosocial health services as part of high-quality cancer care (IOM, 2008). Progress Made in Psychosocial Care and Work in Progress Since the 2013 IOM Report Engaged patients. Since 2013, Rowland said there have been increases in screening of patients for distress, the number of palliative care programs, and communication training for oncology staff. There has also been increased atten- tion on gathering patient and community input (e.g., PROs), providing support for caregivers, and on survivorship planning. Still needed, Rowland said, is a systematic approach for ensuring patients and families receive information about psychosocial care resources; expanded screening (e.g., for social determinants of health, risk of frailty); greater attention on follow-up care after a patient receives abnormal screening results; greater uptake of survivorship planning; and more effective use of peer advocates and community resources. Adequately staffed, trained, and coordinated workforce. Rowland high- lighted the need for staffing standards to ensure the delivery of high-quality psychosocial cancer care, reimbursement for patient navigation, and training more oncology mental health clinicians. Evidence-based cancer care. New or revised psychosocial care guidelines have been released by ASCO and others, and there are opportunities to track their uptake and use (e.g., through standards-setting initiatives). Still needed PREPUBLICATION COPY—Uncorrected Proofs 

28 INNOVATION IN ELECTRONIC HEALTH RECORDS is the “examination and dissemination of models for delivery of high-quality psychosocial oncology care,” Rowland said. A learning health IT system. Although the collection and use of cancer data to inform care has expanded, Rowland said consensus is needed on com- mon data elements for psychosocial care to be collected for all patients in clinical practice and clinical trials. Translation of evidence into clinical practice. Rowland acknowledged NCI’s efforts to promote implementation and dissemination science and support translational research on psychosocial interventions. She highlighted a need for “monitoring the use of guideline-based psychosocial care,” and “development of national measurement approaches to monitoring well-being and function of cancer survivors over time.” Klepin and Rowland discussed the need to identify core pragmatic measures (including PROs) to be collected in cancer clinical trials and clinical care. Accessible, affordable care. Rowland said the ACA has had a positive effect on improving access to cancer care, and the NCI Community Oncology Research Program 34 has expanded access to clinical trials, including trials of psychosocial and behavioral interventions. Rowland said that health systems need to partner with community-based organizations to deliver psychosocial care and called for “major initiatives . . . to expand coverage for mental health care.” Sustainable Rural Cancer Care Models Several panelists stressed the importance of providing high-quality cancer care in rural areas where clinicians are scarce. Mooney said it is important to adapt care models to fit the culture of the community. She added that virtual care models need to partner with existing resources in the community, such as home health agencies and primary care clinicians. Sharing information about patient care among partners remains a challenge due to lack of interoperability of differ- ent EHR systems. Ishwaria Subbiah, executive director for Cancer Care Equity and Professional Wellness at the Sarah Cannon Research Institute and medical director for Supportive Care Oncology and Health Equity for the U.S. Oncology Network, noted that reimbursement challenges can be a barrier to virtual care, because health systems are not able to bill insurers to cover facility fees. However, she stressed that these challenges need to be overcome to expand patient access to care through telehealth. Winkfield said there will still be times when a patient needs to travel for care because costs and workforce shortages can prohibit providing certain care services at the local level. She added that community partnerships are essential, 34 See https://ncorp.cancer.gov/ (accessed April 23, 2024). PREPUBLICATION COPY—Uncorrected Proofs 

PROCEEDINGS OF A WORKSHOP 29 such as programs that provide transportation to medical care. Winkfield also called on large employers as potential partners in cancer prevention and care. Zon and Rowland discussed the challenges of limited mental health work- force capacity in many areas and the need to provide remote mental health care services for patients with cancer. Rowland said payers and state licensing programs are rescinding polices that allowed telehealth to be provided across state lines during the COVID-19 pandemic. This needs to be resolved, she said, so that psychosocial care clinicians who have capacity can provide care to underserved areas. WORKFORCE CONSIDERATIONS: REACHING FOR THE QUADRUPLE AIM The second component of a high-quality cancer care delivery system identi- fied in the 2013 IOM report was “an adequately staffed, trained, and coordinated workforce.” A wide range of health care professionals, both within and beyond the field of oncology, can be involved in a patient’s cancer care.35 Many speakers discussed cancer care workforce considerations in the context of achieving the Quadruple Aim of improving population health, improving patient experience, reducing costs, and “improving the work life of health care providers, including clinicians and staff ” (Bodenheimer and Sinsky, 2014).36 Multidisciplinary, Multispecialty Workforce from Diagnosis Onward Patients living with and beyond cancer often require care from a wide range of clinicians as they navigate cancer diagnosis, treatment, and survivorship care, said Larissa Nekhlyudov, professor of medicine at Harvard Medical School and primary care physician at Brigham and Women’s Hospital. She provided a brief overview of the July 2023 National Cancer Policy Forum workshop, “Develop- ing a Multidisciplinary and Multispecialty Workforce for Patients with Cancer, from Diagnosis to Survivorship.”37 35 See Appendix C for the goals and recommendations associated with the workforce caring for patients with cancer. 36 The Quadruple Aim builds on the Triple Aim developed by the Institute for Healthcare Improvement that identified the core aims of an optimal health system: improving population health, improving patient experience, and reducing costs (Berwick et al., 2008). More recent proposals call for incorporating a fourth aim focused on workforce wellness, health equity, or organizational readiness. 37 See https://www.nationalacademies.org/event/07-17-2023/developing-a-multidisciplinary- and-multispecialty-workforce-for-patients-with-cancer-from-diagnosis-to-survivorship-a- workshop (accessed December 12, 2023). PREPUBLICATION COPY—Uncorrected Proofs 

30 INNOVATION IN ELECTRONIC HEALTH RECORDS Nekhlyudov said that the composition of the cancer care workforce varies geographically across the U.S. Many workshop speakers highlighted workforce- related challenges to providing high-quality cancer care, including shortages of cancer care clinicians; clinical workflows that are not well-designed to address holistic survivorship issues; the challenges of system-wide, cross-specialty col- laboration; disparities in access to care and health outcomes; fee-for-service payment models that do not value complex care coordination; the lack of system infrastructure to provide team-based care across disciplines, locations, or organi- zations; and limited availability of real-time, structured, meaningful EHR data. Many workshop speakers discussed opportunities to promote collaborative care for patients living with and beyond cancer, said Nekhlyudov, spanning top- ics such as: • Workforce education and training, including interprofessional team- based care and competencies for cancer survivorship care; • Developing and implementing guidelines for referring patients to “super- specialists” (e.g., an onco-cardiologist) for addressing adverse health consequences of cancer and its treatment; • Developing a coordinated, collaborative, team-based care approach to identify needs of cancer survivors and determine appropriate interventions; • Optimizing efficiency of care across the entire team; • Collecting and timely disseminating high-quality EHR data, including actionable patient-level data; • Developing policies and interventions that promote health equity; and • Advocating for legislative solutions. Nekhlyudov said that individual champions can instigate change, but sustain- ability requires partnership among professional and community organizations. Oncology Workforce Trends Carolyn Hendricks, a medical oncologist at Maryland Oncology Hematol- ogy, reviewed oncology workforce trends using data from the ASCO Workforce Information System (WIS) and the ASCO interactive map of oncology.38 Although the number of hematologic and medical oncologists involved in patient care has been increasing, nearly one quarter are now ages 64 or older and likely to retire in the next five to ten years; only 11 percent are under the age of 38 See https://asco-interactive-map-of-oncology-covid-19-asco1.hub.arcgis.com (accessed December 12, 2023). PREPUBLICATION COPY—Uncorrected Proofs 

PROCEEDINGS OF A WORKSHOP 31 40, Hendricks said. Thirty-six percent are female, which she said is comparable to other specialties. While 13 percent of the U.S population is Black and 16 percent identify as Hispanic, only 3 percent of hematologic and medical oncologists are Black, and less than 5 percent are Hispanic (ASCO, 2021a). The total number of medical oncology fellows is slowly increasing, but the percentage of Black and Hispanic oncology fellows is very low, at 4 percent and less than 4 percent, respectively. As discussed earlier, oncology practices in the U.S. are consolidating, result- ing in fewer practices with more oncologists per practice, said Hendricks. Prac- tices tend to be concentrated in the Northeast and the West Coast; two-thirds of rural counties have no oncologist (ASCO, 2021b). Numbers of radiation, surgical, gynecologic, and pediatric hematologic oncologists have remained constant since 2014 (ASCO, 2020), said Hendricks. Like medical oncologists, radiation oncologists are also predominantly male and White, and many are approaching retirement. Radiation oncology practices are also consolidating and moving to urban areas and academic medical centers, Hendricks said. In hospice and palliative medicine, there are now more women than men in the under 44 age group and more minority physicians compared to hematologic and medical oncologists, she said. The fields of complex general sur- gical oncology, gynecologic oncology, pediatric hematologic oncology, and pedi- atric radiation oncology are also facing workforce challenges, said Hendricks. The oncology nursing workforce is growing, but there is a large segment of experienced nurses who will be retiring soon, said Hendricks (Nevidjon, 2019). Nursing school enrollment is up, but Hendricks noted that “very few nursing schools offer an oncology concentration.” There is also a shortage of nursing faculty, and the number of nurses entering the Ph.D. programs is declining, said Hendricks. Data on advanced practice providers (APPs) in oncology, including oncology nurse practitioners and physician assistants, are limited, she said. Evidence Gaps Hendricks said assembling demographic data suitable for workforce analyt- ics is challenging due to a lack of comprehensive demographic data for the entire oncology workforce. Much of the data available are self-reported and/or not originally collected for workforce research (e.g., professional society member- ship demographics data, claims data). There are gaps in evidence for specialties (especially pediatrics), team-based care, and APPs. Data are also needed on the impact of factors such as practice consolidation, telemedicine, and the COVID- 19 pandemic. PREPUBLICATION COPY—Uncorrected Proofs 

32 INNOVATION IN ELECTRONIC HEALTH RECORDS Taking a Systematic Approach to Oncology Workforce Wellness A Data-Driven Framework for Professional Well-Being Drivers and consequences of clinician burnout have been well-characterized generally (Brigham et al., 2018; NASEM, 2019), and for the oncology field specifically (Hlubocky et al., 2021), Subbiah said. She proposed the use of the Stanford Model of Professional Fulfillment39 as a data-driven framework for ensuring oncology workforce well-being. This model incorporates workplace factors (efficiency of practice and culture of wellness) as well as individual factors (personal resilience). Measuring Professional Well-Being in Oncology Clinicians Mickey Trockel, director of Evidence-Based Intervention at Stanford Uni- versity School of Medicine WellMD Center, discussed the development and use of measures of professional well-being around the domains of resilience, effi- ciency, and culture (Bohman et al., 2017). He noted that efficiency of practice is an “indirect pathway to well-being” because the lack of efficiency means there is little to no time to devote to improving individual and cultural factors. Trockel described a study, Influencing and Modeling Physician Action for Culture Transformation (IMPACT), which found that an opinion leader-led intervention that increased expression and perception of gratitude among clini- cians was associated with increased professional fulfilment (Trockel et al., 2023). He also shared data that demonstrated the negative effects that work conditions can have on personal relationships, as well as an association between negative effects of work on clinicians’ personal relationships and “unsolicited complaints from the patients that they care for” (Trockel et al., 2022). He added that the U. S. Surgeon General has called for “policies that protect workers’ abilities to nurture their relationships outside of work.”40 Practical Core Values to Optimize Professional Well-Being Subbiah said it is time to institute professional well-being as policy and to establish accountability. She said the oncology community needs to “iden- tify practical core values to optimize professional wellness, while also delivering 39 See https://wellmd.stanford.edu/about/model-external.html?tab=proxy (accessed Janu- ary 10, 2024). 40 See Our Epidemic of Loneliness and Isolation: The Surgeon General’s Advisory on the Heal- ing Effects of Social Connection and Community, p. 61, available at https://www.hhs.gov/sites/ default/files/surgeon-general-social-connection-advisory.pdf, (accessed December 12, 2023). PREPUBLICATION COPY—Uncorrected Proofs 

PROCEEDINGS OF A WORKSHOP 33 patient-centered cancer care and meeting enterprise goals.” Based on employee opinion surveys,41 she said these core values include: • Making operational efficiency and implementation science a part of the organization’s mission. She noted that institutions need to understand how any new initiative impacts workflows, task loads, and the daily experience of those who implement it. • Developing a feedback-driven approach to workplace experience, including steady, high reliability streams of feedback from the ground level teammates. • Measuring the success of any initiative by its impact and considering all the costs of delivering that intervention. These costs include the human effort and the workflows needed. • Having a solutions-focused mindset and maintaining core values in the design and implementation of solutions. • Not losing sight of the unique needs of each team member. There is no universal approach to professional wellness across roles and disciplines. Subbiah elaborated on five core values identified in employee feedback when implementing solutions to improve professional well-being: personaliza- tion; transparency about the elements of the strategy; simplicity (e.g., eliminate activities that do not add value for staff or patients); authenticity (alignment of experiences with culture and values); and responsiveness to feedback (convey what is or is not being done and why) (Lesser et al., 2016). Promoting and Sustaining Diversity in the Oncology Workforce Although diversity among incoming medical school classes is increasing, unconscious biases persist, said Narjust Florez, associate director of the Cancer Care Equity Program at Dana Farber Cancer Institute, emphasizing that “diver- sity without inclusion equals trauma.” Non-inclusive practices impact not only racial and ethnic minority students, but also LGBTQ students, first generation students, students with disabilities, and students from rural areas, said Florez. Originally from Venezuela, Florez said she has often been judged by her ethnic- ity and accent before her credentials (Duma, 2022). She shared data from a study of self-reported gender bias experienced by oncology fellows that found “women are most likely to be mistaken as non-physicians, . . . to experience bias, [and] to be second-guessed by . . . other staff ” (Balanchivadze et al., 2021). 41 Unpublished data. PREPUBLICATION COPY—Uncorrected Proofs 

34 INNOVATION IN ELECTRONIC HEALTH RECORDS Exclusionary practices are resulting in a lack of diverse clinicians in academic medicine (AAMC, 2019; Capers, 2023; Meadows et al., 2023), she said. Florez outlined five opportunities to grow and retain a diverse oncology workforce: • “Listen and avoid tokenism.” • “Understand the concept of intersectionality.” Individuals are the intersection of multiple identities (e.g., race/ethnicity, gender, age). • “Create a sense of community.” Florez emphasized the power of individuals to promote and sustain diversity and inclusion in the workforce. She cofounded Latinas in Medicine to provide support and mentorship via social media and in-person gatherings.42 • Provide funding opportunities and support. Florez and a colleague secured funding to establish the Latinas in Medicine Young Investigator Award in collaboration with ASCO. • Provide mentorship and sponsorship. Florez is working to create an environment in which her mentees “feel like they belong” and have the support to succeed.43 Continuing Education and Training Although the oncology nursing workforce is growing, a recent study by Christopher Friese, the Elizabeth Tone Hosmer Professor of Nursing at the University of Michigan, found that 39 percent of nurses plan to leave their job in the next year, and nurses under the age of 35 have the highest rate of attrition (Medvec et al., 2023). Efforts to increase workforce supply need to focus on workforce retention, Friese said, because the growing number of vacancies will result in less cohesive, less stable care teams. Another challenge is that clinical faculty “are being asked to teach more content, in a shorter period of time, with fewer resources,” which is particularly problematic given the increasing complex- ity of cancer care. Friese summarized several studies looking at associations between care qual- ity and the practice environment. In a study published a decade ago, ambulatory oncology nurses identified unsafe workloads, communication challenges, and financial constraints as quality-of-care concerns, which he noted are still relevant today (Kamimura et al., 2012). From a survey of nurses and prescribers at 29 community-based medical oncology practices in Michigan, Friese found that as the use of EHRs for sharing of information increased, the communication 42 See https://twitter.com/latinasinmed?lang=en (accessed December 12, 2023). 43 For perspectives from Florez Lab (formerly Duma Lab) members, see https://cancerletter. com/guest-editorial/20210702_2/ (accessed December 12, 2023). PREPUBLICATION COPY—Uncorrected Proofs 

PROCEEDINGS OF A WORKSHOP 35 between clinicians and their team members decreased, and “perceived safety scores” declined (Patel et al., 2019). He added that technology is not a stand- alone solution for communication and care coordination, noting that clinical teams need support to integrate technology into care. Looking at the impact of training, he said an interprofessional chemo- therapy safety training program for nurses and pharmacists resulted in improved knowledge and increased confidence in managing the risks of chemotherapy compared to pre-training levels (Aebersold et al., 2021). Importantly, Friese said that 60 percent of study participants implemented practice or policy changes because of the training. In another study, clinicians and patients were surveyed to identify key concerns in care delivery. Clinicians then attended a workshop where they used data from their own practices to identify strategies to improve the patient experience (Blok et al., 2023). From these and other studies, Friese concluded that: lifelong learning on both clinical topics and practice operations needs to be built into systems of care; interprofessional training is effective but is underused; greater institutional investment in continuing education and training is needed; and well-designed virtual training programs are effective for improving clinician knowledge and confidence and are acceptable to clinicians as a format. He called for efforts to support the oncology workforce to be formalized in a policy agenda and the development of business models. Opportunities to Leverage Digital Health to Improve System Efficiencies and Care There has been significant venture capital investment in digital innovation for health care, of which a large portion has been directed toward technologies for the health care workforce, said Edmondo Robinson, head of the Center for Digital Health at Moffitt Cancer Center. Yet, health care systems and health insurers lag behind other industries in digitizing processes (e.g., utilities, financial services, retail, media). In early 2023, the Cancer Moonshot launched CancerX,44 a public-private partnership to leverage digital innovation in efforts to prevent and cure cancer. The CancerX approach has three elements: precompetitive evidence generation (to “develop evidence, best practices, toolkits, and value models”); an accelerator (to develop and support startup companies); and demonstration projects (to pilot digital innovations for value and sustainability). Robinson said the first 44 Cancer Moonshot is a White House initiative to reduce the cancer death rate in the U.S. by 50 percent in 25 years. See https://cancerx.health (accessed December 12, 2023). PREPUBLICATION COPY—Uncorrected Proofs 

36 INNOVATION IN ELECTRONIC HEALTH RECORDS focus area for precompetitive evidence generation is on health equity and finan- cial burden. The Cancer Moonshot included four core competencies for health systems integrating digital technologies: digitally enabled access, technology assisted financial navigation, personalized patient experience, and clinical and opera- tional integration. The clinical and operational integration competency addresses workforce issues, including funding opportunities to leverage digital innovations to “empower cancer care providers” and “engage health system staff in team-based care.” Robinson also discussed opportunities for leveraging AI in the delivery of health care, noting that such use of AI is still in the early development or pilot phase. He drew attention to a framework by Sahni and Carrus (2023) that high- lights potential opportunities to use AI to enhance the workforce, for example, by optimizing clinical workflows, automating payment processes, and managing administrative tasks. He emphasized that the use of AI could augment workforce capabilities, for example, by automating repetitive tasks, but it cannot replace the workforce nor should it automate tasks that could simply be eliminated. An engaged workforce is needed to overcome challenges to the adoption of AI in health care, which Robinson said, “are significant but not insurmountable.” Improving Patient-Centered Care and Clinician Well-Being Many speakers discussed the challenges clinicians face in striving to provide high-quality, patient-centered cancer care in the face of ever-increasing task loads and the growing complexity of care. Subbiah said the lack of implementation science data on the delivery of patient-centered care places the burden on the clinical teams to figure it out in an ad hoc manner. Further, she said time spent on some patient-centered activities (e.g., coordinating complex care) are often not reimbursable and not included in performance-based metrics. Subbiah said the delivery of patient-centered care often depends on altruism of the clinical teams at the expense of their professional well-being, and she posited that this is a reason why health care professionals are leaving clinical medicine. Friese noted that cost-cutting measures often eliminate services such as patient navigation, care coordination, and social services, which increases the burden on the clinician workforce. Subbiah said that retaining such services as essential elements of can- cer care better enables clinicians to deliver the level of quality care they aspire to. Florez said clinicians are not trained in how to engage in effective, empa- thetic, patient-centered communication while maintaining appropriate boundar- ies, and suggested that fellows should receive such training. Rowland said mental health clinicians do receive training on setting boundaries and transitioning patients out of the care relationship but still experience burnout. She suggested that mental health clinicians be included in efforts to reduce burnout for the PREPUBLICATION COPY—Uncorrected Proofs 

PROCEEDINGS OF A WORKSHOP 37 care team. Friese also noted the value of including psychosocial oncology in the cancer care team. Nekhlyudov and Florez said that having enough time to deliver patient-centered care brings “joy in medicine” and adds value for both patients and the care team. Securing Funding and Leadership Support Needed for Improving Care Zon observed that operationalizing ideas for practice improvements can be challenging when there is insufficient funding and lack of support from executive leadership. “Businesspeople have a different language,” she said. Florez agreed and said that in her experience, equity and altruism do not sustain the interest of executive leadership. She described her successful pitch for lung cancer biomarker testing in community practices by making a business case for the longer-term treatment associated with biomarker-driven targeted therapy. Trockel and Friese agreed with the importance of using data to support these conversations. Friese suggested that clinicians implementing changes in their practice collect data to support evaluation and demonstrate improvement (e.g., a reduced number of lost appointments, less clinician turnover, increased patient satisfaction). Hendricks said that models such as the ASCO Patient-Centered Cancer Care Certification provide opportunities for practices to enhance patient care with community engagement and leadership support. Friese said the University of Michigan invites executive leadership to discussions with the clinical changes group in the early stages of a project, which he said increases their engagement. Embracing De-implementation Ray Chen, a professor of cancer nursing from Australia, raised the issue of de-implementing care practices that are not adding value. Subbiah agreed with the need for a concerted effort at de-implementation by first assessing the cogni- tive task load for each clinician on the care team and then removing tasks that consume time but do not improve outcomes in their specific setting. EVOLVING CANCER CARE DELIVERY As introduced in Zon’s overview, the landscape of oncology care has changed in the decade since the 2013 IOM report. Panelists discussed topics such as the learning health system, the role of health insurers and value-based payments models, community oncology practices, primary and specialty care, and cancer clinical trials. PREPUBLICATION COPY—Uncorrected Proofs 

38 INNOVATION IN ELECTRONIC HEALTH RECORDS Developing a Learning Health System to Transform Care and Health Equity There is significant heterogeneity among patients in their response to can- cer therapy, not only with treatment effectiveness but also toxicities, impacts on physical functioning, psychosocial effects, and need for follow-up care, said Catherine Alfano, vice president of Cancer Care Management and Research at Northwell Health Cancer Institute. The push to personalize the delivery of health care has resulted in an exponential increase in the volume of data avail- able for decision making, which she said, “creates cognitive overload and slower clinical decisions.” The aspiration of a learning health system is to enable a lon- gitudinal, personalized cancer care pathway using data from multiple sources for predictive and prescriptive analytics (IOM, 2013b). The system learns by continuous feedback of outcomes data, she said. A key challenge to implement- ing a learning health system, however, is integrating patient data from numerous sources. One survey found that only 15 percent of health care organizations have full capability to access and use diverse patient data for rapid decision making.45 Building a Learning Health System at Northwell Health Cancer Institute Alfano shared three lessons learned from implementing a learning health system at Northwell to transform care and improve health equity. First, “a data ecosystem with a longitudinal view of a patient requires collaboration across siloed sectors and stakeholders,” Alfano said. This includes researchers, clini- cians, patient advocates, industry, regulatory bodies, and others. Next, she said it is necessary to garner leadership support by developing a strong use case based on compelling return on investment (ROI). For Northwell, addressing nursing shortages is a key issue for leadership, Alfano said. A use case was developed with data from a pilot test of a limited learning health system model to predict nursing separation, anticipate hiring needs, and target recruitment to ensure the continued delivery of high-quality care and prevent burnout. Overall, the rationale for implementation of a learning health system is that it delivers ROI for all aspects of the quadruple aim and promotes health equity, she said. Finally, Alfano said, “funding for building a connected data ecosystem is problematic and not in any one agency’s mission.” Health systems are also facing post-pandemic budget challenges, high costs of new EHR systems, and other expenses that are taking priority over addressing data integration issues. 45 See https://hbr.org/resources/pdfs/comm/roche/LeadingANewEraInHealthcare.pdf (accessed December 12, 2023). PREPUBLICATION COPY—Uncorrected Proofs 

PROCEEDINGS OF A WORKSHOP 39 Potential Opportunities to Accelerate Progress Alfano observed that large funding initiatives, such as the Cancer Moonshot and the Advanced Research Projects Agency for Health (ARPA-H), are primar- ily focused on driving innovation in treatments, but until health systems can better leverage data to personalize the delivery of these advances, patients who could benefit might not receive them and health disparities and inequities will be further exacerbated. She suggested applying lessons from NCI’s transdisciplinary initiatives to promote team science and facilitate collaboration to develop of compelling use cases.46 Specifically, Alfano proposed “trans-governmental fund- ing for a collaboratory of 10 pilot sites that create functional data ecosystems with feedback loops and training programs, forming the backbone of a learning health system.” She said the outcome would be “a blueprint for other health sys- tems to follow” (Califf et al., 2023). Alfano, Ganz, and Nancy Keating, professor of health care policy and medicine at Harvard Medical School, and primary care physician at Brigham and Women’s Hospital, discussed the need for national leadership to develop a consolidated system for data collection and sharing to facilitate a learning system. Value-Based Payment and the Delivery of High-Quality and Equitable Cancer Care As the costs of cancer care continue to rise, there is increasing interest in value-based care models, said Keating. The CMS Innovation Center47 was cre- ated under the ACA to test innovative models of service delivery and payment that “reduce program expenditures while preserving or enhancing the quality of care,” Keating said. One goal of the CMS Innovation Center 2021 Strat- egy Refresh is having “all Medicare beneficiaries . . . in a care relationship with accountability for quality and total cost of care by 2030.”48 Keating shared her perspective on lessons learned from CMS oncology payment models.49 46 See https://cancercontrol.cancer.gov/brp/research/team-science-toolkit/about-scits/ studying-team-science (accessed December 12, 2023). 47 See https://www.cms.gov/priorities/innovation/overview (accessed April 24, 2024). 48 See https://www.cms.gov/priorities/innovation/strategic-direction-whitepaper (accessed December 12, 2023). 49 Keating serves as clinical lead of the CMS OCM Evaluation Team, and she clarified that her comments are her personal opinions and do not reflect the opinions of CMS. Information she presented on work by OCM or CMS has been published in annual reports. PREPUBLICATION COPY—Uncorrected Proofs 

40 INNOVATION IN ELECTRONIC HEALTH RECORDS CMS Oncology Care Model The CMS OCM was a voluntary multipayer model that ran from 2016 to 2022. It included supplemental performance-based payments (in one- or two-sided risk models) designed to incentivize practices to improve care quality and reduce spending. Quality measures were related to emergency department visits, timely hospice admission, pain quantification and management, depres- sion screening and management, and patient-reported experiences of care. The final report is forthcoming, but Keating said that by the end of 2021, the OCM included 201 oncology practices and 10 payers, and had completed more than 1.2 million patient care episodes (chemotherapy and related care provided over a six-month period) (Oncology Care Model Evaluation Team, 2023). Evaluation of data from 2016 through 2020 found that the OCM was achieving savings of $499 across all episodes, and cost increases over the period were 1.7 percent lower relative to the comparison group.50 Savings per episode increased over time, Keating said, which “suggests that practices might be learn- ing and identifying opportunities for savings.” There was little impact of the OCM across the range of quality measures assessed (Keating et al., 2023), she noted. CMS Radiation Oncology and Enhancing Oncology Models The CMS Radiation Oncology Model was proposed in 2021 as a “manda- tory model that would provide prospective payment for 90-day episodes of care for 15 cancer types in randomly selected areas,” Keating said, as well as “rewards for maintaining or improving quality and care experiences.” Launch of the model has been delayed twice, first by an act of Congress and later by CMS, which has issued a request for public comment to inform rulemaking regarding future release of a radiation oncology model. The CMS EOM, launched in July of 2023, is a “voluntary model with two- sided risk,” Keating said.51 The EOM seeks to improve care quality and health equity through practice redesign activities for patients receiving chemotherapy for seven cancer types. To advance health equity, the model includes “higher monthly payments for dual-eligible beneficiaries,” she said, and there are require- ments for collecting sociodemographic data and addressing health-related social needs. Thus far, 44 practices are participating, which Keating said is less than 50 See https://www.cms.gov/priorities/innovation/data-and-reports/2023/ocm-evalua- tion-pp1-9-exec-sum (accessed December 12, 2023). 51 See https://innovation.cms.gov/innovation-models/enhancing-oncology-model (accessed December 12, 2023). PREPUBLICATION COPY—Uncorrected Proofs 

PROCEEDINGS OF A WORKSHOP 41 anticipated and might indicate “a lack of enthusiasm for two-sided risk in the provider community.” Challenges to Implementing Value-Based Payment Models in Oncology Cancer care varies by the cancer type, stage, and tumor characteristics and can require a multimodal treatment approach involving surgery, radiation ther- apy, and medical oncology, while the payment models proposed thus far “focus on individual treatments,” Keating said. “For chemotherapy models, drug spend- ing comprises more than half . . . of episode spending,” and she noted that drug prices are not something that oncologists control, and oncologists have expressed concern about the associated risk. She also noted that reliable measures of quality delivered in oncology practices still need to be developed. Health Insurer Perspective on Cancer Care Delivery Transformation Innovative cancer therapies are being introduced at an increasing pace, which is helping many people to live longer with cancer, said Lucy Langer, national medical director of oncology and genomics at United Health Care. However, she said this coincides with increased health care costs, because patients are often receiving treatment for longer time periods, the costs of cancer therapies continue to increase, and increased oncology practice consolidation contributes to price increases. Langer said that higher costs are contributing to an increasing number of under-insured individuals, who often delay or forgo care, contributing to poorer patient outcomes. The Role of the Payer Prior authorization and utilization management have become the primary tools used by payers to promote adherence to clinical practice guidelines and ensure that services and procedures patients will receive are safe, affordable, evi- dence based, and clinically appropriate, Langer said. Ideally, prior authorization should reduce, not amplify, administrative burden and confusion, Langer said. Toward this end, she said that United Healthcare is “reducing the volume of authorizations required, . . . enacting gold-carding solutions,52 and . . . encourag- 52 As defined by ASCO, gold carding is “the practice where payers waive prior authorization on services and prescription drugs ordered by providers with a proven track record of prior authorization approvals.” See https://old-prod.asco.org/sites/new-www.asco.org/files/content- files/advocacy-and-policy/documents/2022-Gold-Carding-Brief.pdf (accessed December 12, 2023). PREPUBLICATION COPY—Uncorrected Proofs 

42 INNOVATION IN ELECTRONIC HEALTH RECORDS ing the rest of the industry to take similar steps.” Specific strategies include, for example, supporting EHR integration, establishing guidelines and standards (e.g., for adopting new therapies, incorporating real-world evidence), and provid- ing greater clarity in coding. The United Healthcare Cancer Guidance Program is one such program that uses real-time information to support decision-making and ensure evidence-based care. Langer said that on average, approximately 55-60 percent of requests are automatically authorized, because clinicians have chosen National Comprehensive Cancer Network-level 1, 2a, or 2b concordant treat- ment. The Cancer Support Program also partners with clinicians on compre- hensive care management. In summary, Langer said, “the U.S. health care system is not keeping up with the complexities of the oncology care delivery ecosystem.” Disruptive solutions are needed to ensure patients receive care that is of high quality and value, and she advocated for “paying oncologists for the work that they do” rather than relying on drug profit margins; “rewarding activities that improve quality and access;” and “realigning benefit design, provider incentives, and quality metrics.” Cancer Care Delivery in Community Practice Most Americans receive their cancer care at community oncology practices, said Natalie Dickson, president and chief strategy officer for Tennessee Oncol- ogy. Community practices deliver comprehensive, personalized, convenient, coordinated, and often more affordable cancer care close to where the patient lives. However, she noted that community oncology practices are facing many challenges to remain competitive in the current market, including payer issues (e.g., prior authorizations, coverage denials), staffing issues, increasing expenses, and declining revenue. In addition, “vertical business relationships among insur- ers, . . . pharmacy benefit managers, and specialty pharmacies have had a sig- nificant impact on drug access and pricing, network access, and patient choice,” she said, noting that many community practices are being acquired or closing (Milligan et al., 2022). To overcome these market challenges and remain independent, Dickson said community oncology practices are scaling up; diversifying services; demon- strating quality and driving payment reform; strategically partnering; staying at the forefront of cancer innovation; and engaging state and federal policy mak- ers on key issues. For example, Tennessee Oncology is taking action in each of these areas by expanding the comprehensive services it offers and participating in multiple initiatives to improve value-based care.53 Tennessee Oncology also helped create the OneOncology network, which enables community practices to 53 Tennessee Oncology has more than 200 oncology care practitioners across 35 locations serving 85 percent of patients in Nashville and more than half of patients in Tennessee. PREPUBLICATION COPY—Uncorrected Proofs 

PROCEEDINGS OF A WORKSHOP 43 share their collective knowledge and exercise drug purchasing power as a group. The practice is also active on policy issues (e.g., advocating for passage of the Tennessee Parity Law, which called for equal reimbursement for telemedicine and office visits). Dickson outlined several areas where action can be taken to optimize the cancer care delivery system: • Improving access and affordability (e.g., addressing preventable causes of health disparities; implementing hospital at home/urgent care at home programs). • Promoting engagement and communication (e.g., providing grant support for patient focus groups; advocating for payers to cover smartphones/ tablets with embedded health apps for patients with cancer; eliminating geographic and site restrictions for telehealth). • Facilitating risk assessment (e.g., creating a national, shared, centralized data warehouse and analytics). • Supporting innovative, evidence-based treatments (e.g., prioritizing clinical trials that could inform new care pathways and guidelines). • Leveraging artificial intelligence (e.g., using machine learning, natural language processing, AI-assisted image analysis, and robotic automation to enhance care delivery). • Incentivizing value-based reimbursement (e.g., eliminating practice reliance on drug margins by covering practice expense to acquire, store, administer, and dispose of drugs; using “clinically defined episode bundles;” and paying for currently unbillable time). Many speakers discussed the potential for home-based oncology services. One challenge, Dickson said, is that home infusion of chemotherapy reduces practice income (versus in-office treatment) and there are hard costs to opera- tionalizing home-based administration of therapy (e.g., specialized equipment; storage, tracking, and dispensing of drugs). Not accounting for this could impact practices’ ability to provide high-quality care. Justin Bekelman, founding direc- tor of the Penn Center for Cancer Care Innovation at the Abramson Cancer Center, said Penn Medicine has a program for cancer treatment at home and acknowledged that current benefit design and reimbursement for community practices is a challenge to scaling such programs nationally. Friese said the VHA is studying models of home infusion of myeloma therapies, which he noted is possible because VHA does not operate under the same reimbursement model or incentive structure (i.e., drug margins). PREPUBLICATION COPY—Uncorrected Proofs 

44 INNOVATION IN ELECTRONIC HEALTH RECORDS Primary Care and Specialty Care Integration Typically, a patient with complex care needs and social challenges would need to access a range of clinicians and services in different places and at differ- ent times, which are often barriers to receiving the care they need, said Kameron Matthews, chief health officer at Cityblock Health. Matthews described City- block Health as a “primary care ecosystem” that takes a personalized approach to managing the complex medical and social needs of its more than 100,000 members, building the trust needed to help members achieve their health goals. Each Cityblock member has an integrated, multidisciplinary care team that partners with specialists and is accountable for meeting the needs of the patient “from start to finish,” Matthews said. Matthews elaborated on some of the ways Cityblock is thinking beyond traditional care models and working to transform the way health care is deliv- ered. Care teams are focused on patient outcomes, experience, and well-being, which she said often means bringing the services to the members (e.g., com- munity-based, home-based, or virtual care). Cityblock offers the collaborative care model, an evidence-based model integrating primary and behavioral health care, which she said has been shown to improve patient access and clinical out- comes, control costs, and increase patient satisfaction. Cityblock also has a pri- mary palliative care pathway. The integration of acute care services, including paramedics, emergency medical technicians (EMTs), and emergency medicine physicians, expands care capabilities (e.g., via timely mobile care) and helps to reduce preventable or nonurgent emergency department visits. Finally, Cityblock integrates social care and social services interventions with clinical care pathways to improve health outcomes and reduce costs of care (e.g., by addressing food insecurity or transportation for appointments). In striving to provide a seamless care experience for members, Matthews said Cityblock is focusing on reducing the burden on patients of navigating a complex health system; promoting effective communication about the patient’s needs and goals among care team members; leveraging health IT to support collaborative care and establish accountability; improving communication with patients; and “recognizing the larger benefits of a whole health approach” for both patients and systems. Assessing Payment Models Many speakers highlighted the need for more widespread assessment of new payment models and strategies. “What we’re doing and where we’re going isn’t working,” Friese said. Keating expressed concern that with only 44 prac- tices participating in the EOM, the findings will not be generalizable. Dickson responded that practices did not have enough time to evaluate historical data for PREPUBLICATION COPY—Uncorrected Proofs 

PROCEEDINGS OF A WORKSHOP 45 performance projections and were thus at risk from the very beginning. Langer said that United Healthcare, which has about 50 million enrolled members, is also having difficulty securing sufficient participation in two payments models it is launching. Keating suggested that mandatory models are needed but added that they must be acceptable to oncology clinicians and practices to prevent pushback that may result in Congressional action to halt implementation, as in the case of the radiation therapy model. Nekhlyudov and Alfano agreed, stressing the importance of engaging the oncology community in the design of payment models. Alfano said the design of models needs to be flexible so that lessons learned from failures can be rapidly assessed to inform the next iteration of the model. She called for “a learning health network of systems” so that different systems testing different payment models can share data and lessons learned. Keating said a learning and implementation contractor was hired by CMS to share lessons learned from the OCM among participating practices. Dickson noted that Ten- nessee Oncology had minimal formal communication with other practices in the OCM. Cardinale Smith, chief medical officer at the Tisch Cancer Institute, vice president of Cancer Clinical Affairs, and chief quality officer for oncology for the Mount Sinai Health System, said that practices affiliated with the Association of American Medical Colleges did communicate and share data through AAMC, which she said was very helpful. The Role of Clinical Trials in Cancer Care Many workshop speakers discussed the role of clinical trials in cancer care. Rowland said advances in the treatment of pediatric cancer are due to the wide- spread enrollment of pediatric patients in clinical trials. Darien said patients are often unaware of clinical trials and clinicians need to inform them of appropriate trial opportunities and ask them to participate. Dickson said better infrastruc- ture is needed to facilitate participation for those who are interested, such as being able to identify potential trial participants from EHR data so that oppor- tunities can be discussed at the point of care. Smith added that availability of clinical trials varies by clinical setting and geography. Rowland highlighted the need for companion trials that capture data on psychosocial and behavioral interventions and social determinants of health, acknowledging the lack of tracking infrastructure for these trials. Alfano noted that these types of trials can facilitate research on how to “address social determi- nants of health alongside cancer.” Subbiah said trial sponsors are often not aware that commonly used eligibility criteria in clinical trials can represent substantial burdens for clinical teams, caregivers, and patients. She suggested independent practice networks and oncology professional societies engage with clinical trial PREPUBLICATION COPY—Uncorrected Proofs 

46 INNOVATION IN ELECTRONIC HEALTH RECORDS sponsors to modify clinical protocol elements that add to burden (e.g., eligibility criteria, study schedules). EVIDENCE GENERATION TO INFORM ONCOLOGY CARE Many speakers discussed advances in research that have changed cancer care delivery, as well as opportunities to leverage evidence generation to support high- quality, equitable cancer care for all patients. Perspectives on Progress in Evidence Generation Since 2013 Practice-Changing Advances Since 2013 Gralow provided a high-level overview of practice-changing research since the 2013 IOM report across seven key areas. Precision Medicine. Examples of advances in genomics and precision medicine in oncology include next-generation sequencing, liquid biopsies that detect circulating tumor DNA (ctDNA), somatic genomic and germline genetic testing, and treatment with molecularly targeted therapies, Gralow said.54 She referred participants to an ASCO Provisional Clinical Opinion on somatic genomic testing in patients with metastatic or advanced cancer that offers guid- ance on which patients should be tested, when, and with which assays (Chakra- varty et al., 2022). New Drugs and Treatment Approaches. FDA approved 207 new oncol- ogy drugs between 2016 and 2021, with treatments for lung cancer topping the list (Benjamin et al., 2022). Key advances include immune checkpoint inhibitors, CAR-T cell therapy, antibody drug conjugates, and targeted therapies, Gralow said. De-escalation of Therapy. For some cancers, treatments have resulted in “such excellent long-term outcomes” that the potential for de-escalation—or scaling back treatment to be less aggressive and reduce toxicities while still pre- serving the desired outcomes—is being studied across drug, surgical, and radia- tion therapies, Gralow said. De-escalation also includes using molecular diag- nostics to identify which patients do or do not need chemotherapy and selecting targeted treatments that result in fewer adverse effects, she said. 54 For a general discussion of the use of genomic data in health care see the workshop proceed- ings, Realizing the potential of genomics across the continuum of precision healthcare (NASEM, 2023). PREPUBLICATION COPY—Uncorrected Proofs 

PROCEEDINGS OF A WORKSHOP 47 A Focus on Patient Quality of Life. Gralow said there is an increased focus on symptoms, quality of life, patient-reported outcomes, financial and time toxic- ity, and survivorship. Equity, Diversity, and Inclusion. “The last decade has really brought equity, diversity, and inclusion to the forefront,” Gralow said. She referred par- ticipants to the NASEM workshop, Promoting Health Equity in Cancer Care (NASEM, 2022), and the recent ASCO State of the Oncology Workforce report (ASCO, 2022). COVID-19 Pandemic-related Changes. Numerous changes in the deliv- ery of care and the conduct of clinical trials were implemented out of necessity during the COVID-19 pandemic, Gralow said. The ASCO Road to Recovery report reviews the lessons learned and makes recommendations for moving for- ward post-pandemic in the areas of “equity, accessibility, quality of care, and clinician well-being,” she said (Pennell et al., 2021). Innovations in Clinical Trial Design. Clinical trial designs are evolving to be more patient-centric, with expanded eligibility criteria and decentralized trial designs (some using telemedicine), Gralow said. New trial designs include pragmatic trials, umbrella trials,55 and basket trials,56 and FDA has issued guid- ances on the use of real-world data in regulatory decision making. Gralow added that ASCO and ACCC have jointly developed resources57 to help increase enrollment of racial and ethnic minority populations in clinical trials, including implicit bias training and a research site self-assessment tool. Evaluations are also being conducted to determine if trial adaptations during the COVID-19 pandemic could become standard practice for future trials. 55 An umbrella trial is “designed to evaluate multiple investigational drugs administered as single drugs or as combination drugs in a single disease population. Sub-studies can include dose-finding components to identify safe doses of an investigational drug combination before proceeding with an activity-estimating component.” See https://www.fda.gov/drugs/ cder-small-business-industry-assistance-sbia/fda-modernizes-clinical-trials-master-protocols (accessed April 29, 2024). 56 A basket trial “involves a single investigational drug or drug combination that is studied across multiple cancer populations defined by disease stage, histology, number of prior therapies, genetic or other biomarkers, or demographic characteristics. It is usually designed as a single-arm, activity-estimating trial with overall response rate as the primary endpoint.” See https://www. fda.gov/drugs/cder-small-business-industry-assistance-sbia/fda-modernizes-clinical-trials- master-protocols (accessed April 29, 2024). 57 See https://society.asco.org/news-initiatives/current-initiatives/cancer-care-initiatives/ diversity-cancer-clinical-trials (accessed May 13, 2024). PREPUBLICATION COPY—Uncorrected Proofs 

48 INNOVATION IN ELECTRONIC HEALTH RECORDS Progress Toward a Learning Heath Care System Since 2013 Goal 7 of the 2013 IOM report focused on advancing a learning health care IT system for cancer, said Robert Miller, chief medical science officer of the ASCO CancerLinQ health technology platform.58 He described the com- ponents of a learning health care IT system, including digital infrastructure for data capture at the point of care; embedded clinical decision support; common data elements; and continuous, automatic, bidirectional exchange of clinical and research data. Miller reviewed some of the advances toward this goal over the past decade, including widespread adoption of EHRs and digital health tools; implementa- tion of oncology data repositories (e.g., ASCO CancerLinQ); and federal man- dates for modern transmission standards and application programming interfaces (APIs)59 for the exchange of health data (e.g., HL7 FHIR).60 There have also been efforts to develop oncology data standards (e.g., the Minimal Common Oncology Data Elements or mCODE initiative),61 increased cloud storage capa- bilities, and advances in AI and machine learning. Despite these advances, Miller said that “the glaring disappointment” is that a learning health system has not yet been achieved. Although data exchange has improved, “molecular data continues to exist in non-computable, nonstructured formats” and most cancer registry data and EHR data remain in silos, inhibiting the continuous and automatic compilation and exchange of these data. The 2013 report also called for CMS to create incentives for clinicians to participate in a learning health system, which Miller said has not occurred. He suggested HHS clarify the extent to which the data sharing actions of a learning heath system are governed by the Privacy Rule promulgated under the Health Insurance Portabil- ity and Accountability Act (HIPAA).62 58 ConcertAI acquired CancerLinQ in December 2023. See https://ascopost.com/news/ december-2023/concertai-to-acquire-cancerlinq/ (accessed April 25, 2024). 59 An API “is a set of rules or protocols that enables software applications to communicate with each other to exchange data, features and functionality.” See https://www.ibm.com/topics/ api (accessed April 30, 2024). 60 HL 7 FHIR (Fast Healthcare Interoperability Resources) is an “interoperability standard created by the standards development organization Health Level 7 (HL7®). FHIR is designed to enable health data, including clinical and administrative data, to be quickly and efficiently exchanged.” See https://www.healthit.gov/sites/default/files/page/2021-04/What%20Is%20 FHIR%20Fact%20Sheet.pdf (accessed April 30, 2024). 61 See https://confluence.hl7.org/display/COD/mCODE (accessed April 25, 2024). 62 The Privacy Rule, promulgated under the Health Insurance Portability and Accountability Act of 1996 (HIPAA), establishes national standards to protect individuals’ medical records and other individually identifiable health information (collectively defined as “protected health information”) and applies to health plans, healthcare clearinghouses, and those health care pro- viders that who conduct certain health care transactions electronically. See https://www.hhs. gov/hipaa/for-professionals/privacy/index.html (accessed April 25, 2024). PREPUBLICATION COPY—Uncorrected Proofs 

PROCEEDINGS OF A WORKSHOP 49 Progress from the Patient Perspective Laurel Pracht, president and cofounder of the West Valley Ovarian Cancer Alliance and a cancer survivor, said although there has been significant progress, there is still much more to do to ensure patients have the information they need when they receive a cancer diagnosis. She also noted the financial and emotional impacts a cancer diagnosis can have for patients and their caregivers. In reviewing a clinical trial concept, she said her focus is always on what will be learned, as well as how the clinical trial could affect patient symptom management and quality of life, and whether the study will advance progress toward equitable cancer care. Health Disparities in Cancer Research and Patient Access to Cancer Care Alex Adjei, chief of the Cleveland Clinic Cancer Institute and the Frank Rudy and Margaret D. Rudy Distinguished Chair in Translational Cancer Research at the Cleveland Clinic, discussed the lack of racial and ethnic diversity in clinical trials. For example, participation of African American and Hispanic individuals in clinical trials declined between 2003 to 2016 (Duma et al., 2018). In another example, a retrospective analysis of clinical trials for immunotherapy for gynecologic and breast cancers found that 2 percent of participants were Black, 7 percent were Asian, and 8 percent identified with another non-white population (Grette et al., 2021). Enrollment of Black participants in breast can- cer trials was 11-fold lower than what would be expected if enrollment mirrored prevalence and 32-fold lower in ovarian cancer trials (Grette et al., 2021). He added that “most cancer-related phase 3 clinical studies fail to report ethnicity.” Adjei stressed that enhancing diversity in clinical trials is both “common sense” and “good science.” He said cancer therapies should be tested for safety and efficacy in the populations that will use them. From a health equity perspec- tive, he said that all patients need to be afforded “equal access to innovative treat- ments.” The consequences of lack of diversity are evident from two phase 3 trials of epidermal growth factor receptor (EGFR) inhibitors for lung cancer from 2005. One study included primarily White participants and the results were negative (Thatcher et al., 2005). The other study included, by chance, enough Asian participants that the trial findings were positive (Shepherd et al., 2005). Adjei pointed out that it was not known at the time that approximately half of Asian patients with lung cancer have EGFR mutations, compared to only about 15 percent of White patients. PREPUBLICATION COPY—Uncorrected Proofs 

50 INNOVATION IN ELECTRONIC HEALTH RECORDS Achieving Equitable Representation in Clinical Trials Adjei outlined the main reasons for the persistent lack of diversity in clinical trials, including socioeconomic factors, real and perceived barriers to participa- tion, inappropriate clinical trials, trial complexity, unconscious bias of clinicians, and patient distrust of the health care system. Inappropriate clinical trials are those that lack equipoise,63 Adjei said. To illustrate, he said that following the accelerated approval of the highly effective immunotherapy pembrolizumab (a PD-1 inhibitor), enrollment began for two other studies that were comparing the efficacy of PD-1 inhibitors against stan- dard of care chemotherapy. Given the effectiveness of pembrolizumab, he said it is understandable why patients would not want to enroll in trials like these and risk being randomized to the chemotherapy arm. Designing studies that have clinical equipoise is essential for achieving equitable representation in clinical trials, said Adjei. He added that it is important to remember the goal is not to enroll patients in clinical trials for the purposes of running the trial, it is to care for patients; for some patients, a clinical trial is their best option. Building trust in the health system is also important, and Adjei said the Cleveland Clinic has a community outreach program that conducts educational events, screenings, and exams in the community. These events are sometimes the first contact an individual has with the health system. Increased diversity in the clinical workforce is also needed and he said, “our caregivers should look like us.” Finally, he noted the need to re-engineer the way clinical trials are conducted to leverage real-world data and pragmatic trial designs. Darien and Adjei both emphasized the need for a trial population to be representative of those impacted by the disease in an effort to generate high- quality evidence to inform patient care. Adjei noted that FDA has issued draft guidance for industry on intentional planning for diverse enrollment in clinical trials,64 and he and Claire Snyder, professor of medicine and oncology at the Johns Hopkins School of Medicine, said that trial eligibility criteria are being broadened and simplified (e.g., to include patients with comorbidities). Nathan Pennell, a medical oncologist at the Cleveland Clinic and professor of medicine at the Lerner College of Medicine at Case Western Reserve University, observed that industry-sponsored trials have been slower to make progress on diversity. Paul Kluetz, deputy director of the Oncology Center of Excellence at FDA, said the Agency engages industry sponsors in the design of clinical trials, and 63 Equipoise refers to a state of genuine uncertainty regarding the comparative therapeutic merits of each arm in a clinical trial (Freedman, 1987). 64 See https://www.fda.gov/regulatory-information/search-fda-guidance-documents/diver- sity-plans-improve-enrollment-participants-underrepresented-racial-and-ethnic-populations (accessed April 25, 2024). PREPUBLICATION COPY—Uncorrected Proofs 

PROCEEDINGS OF A WORKSHOP 51 agency staff reviewing protocols refer to relevant guidance and raise questions, for example, about eligibility criteria that might seem overly restrictive. Kluetz discussed decentralizing clinical trials, reducing trial complexity, and expanding eligibility criteria to improve the diversity of trial populations. He also high- lighted the need to modernize evidence generation, including “making it easier for patients to generate evidence.” Darien stressed the need to remove barriers to access for patients who want to participate in a clinical trial and reiterated that most patients are not asked to participate. Gralow said pilot testing of the ASCO-ACCC site self-assessment found that most sites knew the demographics of their overall patient population and of the trial-enrolled population but had no demographic information on the population that was screened for eligibility, those who were excluded, or those who were offered participation but chose not to participate. She noted that these sites were surprised to learn this, and she said the self-assessment tool is now available for free.65 Adjei said that patient access to care is critical to improving the diversity of clinical trial populations. Adjei and Lisa Richardson, director of the Division of Cancer Prevention and Control in the National Center for Chronic Disease Prevention and Health Promotion at CDC, discussed the need to partner with the community. Florez agreed and emphasized that recruiting patients of diverse backgrounds is pos- sible; she has been successful in enrolling diverse populations in clinical trials by being a part of the community and engaging with members of her community in the clinic and at health fairs. Advancing Equitable Implementation of Evidence-Based Oncology Care Katharine Rendle, assistant professor of family medicine, community health, and epidemiology in the Perelman School of Medicine at the University of Pennsylvania, said that although there have been advances in translational sci- ence since the 2013 IOM report, a recent study found that the average lag time from “landmark publication to implementation” of an evidence-based oncol- ogy intervention was only slightly reduced from 17 years to 15 years (Khan et al., 2021). After implementation, evidence about an intervention continues to evolve, leading to changes in guidelines and sometimes conflicting guidance, Rendle said. As a result, an intervention may need to be updated, replaced, or de-implemented. 65 Available at https://redcap.asco.org/surveys/?s=MNXW38WFA3 (accessed December 12, 2023). PREPUBLICATION COPY—Uncorrected Proofs 

52 INNOVATION IN ELECTRONIC HEALTH RECORDS Implementation science can help to reduce the research-to-practice gap and can also be applied to implementing evidence-based oncology practices in an equitable manner. Rendle defined implementation science as “the scientific study of methods to promote the systematic uptake of research findings and other evidence-based practices into routine practice or care, and, hence, to improve the quality, effectiveness, and . . . equity of health services” (adapted from Eccles and Mittman, 2006). Very simply, the intervention or practice is “the thing” that is being implemented and implementation science is all about how to “help people to do the thing,” she said, drawing from Curran (2020). Rendle illustrated how implementation science can be applied to translating evidence-based innova- tions in oncology into practice (Figure 2). Rendle noted that implementation science can be applied along the translational pathway to generate real-world data on the implementation itself and on the effectiveness of the intervention in practice, adding that it is “never too early” in the research process to design for implementation (e.g., consider how the intervention might be used in different settings). “It is also never too late to generate evidence in practice,” which she said can inform guideline updates or decisions about continued implementation. Rendle highlighted several lessons learned on designing for equitable imple- mentation. First, she said, it is important to “design for different skill levels, . . . rapid test and optimize to reach diverse populations” and ensure the evidence supporting the evidence-based intervention was generated with equity in mind (e.g., were study populations inclusive, were settings relevant for potential imple- mentation in community-based practices). During an implementation trial, it is necessary to monitor reach and adapt as appropriate. After the trial, Rendle stressed the need to evaluate implementation strategies to understand why and for whom there was success or failure and to continue to collect clinical effective- ness data to inform practice. Nekhlyudov said there is a need to rethink how health care delivery research is conducted. In the traditional pathway, by the time grant funding is secured and the trial is launched, the innovative idea is already a few years old. By the time the study ends, the science and the delivery of care have evolved and the study data can be meaningless, she said. Kluetz agreed and said the pace of cancer treatment research has rapidly increased and health care delivery research is not keeping up. Gralow and Robin Yabroff, scientific vice president of Health Services Research at the American Cancer Society, discussed the concept of a “Cancer Groundshot” that has been proposed in tandem with the Cancer Moonshot (see Gyawali et al., 2018). A Cancer Groundshot is focused on equitable implementa- tion of and access to existing, evidence-based cancer interventions. Yabroff said there is “highly effective but very underutilized care,” which is often relatively inexpensive that patients frequently do not have access to. Nekhlyudov suggested that every clinical trial needs to have an implementa- tion design and plan. Subbiah suggested that grant applications also be scored PREPUBLICATION COPY—Uncorrected Proofs 

IMPLEMENTATION SCIENCE LINGO APPLIED TO ONCOLOGY CARE with whom & where stuff we do to help them how much & how how well the thing the thing they do the thing do (or not do) the thing well they do the thing works in practice Evidence-Based Context Implementation Implementation Effectiveness Intervention Patients & Clinicians Strategies Outcomes Outcomes Molecular testing Communities Patient navigation Reach Stage Immunotherapy Hospitals Clinical champions Adoption Recurrence Oral anticancer therapies Insurers Leadership endorsement Fidelity QoL Survivorship care Policymakers Targeted messaging Cost Symptom Burden Tobacco cessation support Peer support Equity Survival PREPUBLICATION COPY—Uncorrected Proofs Homes FIGURE 2 Applying implementation science to oncology care. 11 NOTE: QoL = quality of life 53 SOURCES: Rendle presentation, October 6, 2023; Adapted from Curran, 2020, CC BY 4.0. 

54 INNOVATION IN ELECTRONIC HEALTH RECORDS on feasibility and scalability and that journals need to require manuscripts to include a section describing the implementation plan. Hendricks suggested that ASCO develop a quality training program focused on implementation science. Data Generation and Sharing Toward Efficient Generation of High-Quality Evidence High-quality evidence is needed by regulators, payers, and developers of clinical care guidelines to inform clinical decision making and enable patient access to cancer therapies, said Kluetz. He described some of the key questions for which high-quality evidence is needed: • Does an investigational treatment’s efficacy outweigh its risks? • Is a new treatment better than an existing treatment? • What is the best treatment sequence of approved drugs in a disease? • Is it equally effective to de-escalate a treatment? • Is it more effective to escalate treatment for high-risk groups? • What is the safety and effectiveness of a drug in older adults, racial/ethnic subgroups, patients with organ dysfunction, etc.? • What is the optimal dose and schedule? The evidence needed to answer such questions is commonly generated in traditional randomized clinical trials, which Kluetz said are “large, lengthy, and expensive” and can place significant burden on the clinical staff and the patients who participate. He highlighted three approaches FDA is pursuing to optimize and expand options for collecting high-quality evidence: • Leveraging appropriate design elements (e.g., master protocols, adaptive designs, common controls, decentralized trial elements). • Reducing complexity where possible (e.g., focused objectives, reduced data collection, pragmatic trial elements). • Considering all data sources (e.g., trial data, patient-generated data, EHRs, registries). Kluetz encouraged product sponsors to reach out early to FDA to discuss appropriate innovative trial designs for regulatory submissions. PREPUBLICATION COPY—Uncorrected Proofs 

PROCEEDINGS OF A WORKSHOP 55 Optimizing Communication and Data to Improve Quality of Cancer Care Richardson summarized CDC’s vision for cancer surveillance as receiving and sharing data faster and more efficiently. CDC is building a cloud-based infrastructure that facilitates “streamlined reporting to a single platform” and “timely data exchange between data reporters and registries,” including labora- tories, clinicians, public health agencies, hospital cancer registries, central cancer registries, and CDC’s National Program of Cancer Registries. She noted that CDC has committed to using the HL7 FHIR interoperability standard for data transfer across systems. Communication is bidirectional between reporters and the platform, Richardson said, with the intent of sharing near real-time informa- tion to support cancer prevention and control. CDC is also working to improve communication of complex information to patients. As an example, Richardson showed Talk to Someone, an interactive simulation enabling patients to ask questions of “Linda,” a virtual survivor of triple negative breast cancer.66 Several speakers said that clinicians need to be mindful of using idioms and jargon when communicating information among medical colleagues and with patients. Florez said common American expressions are often not familiar to many for whom English is not their first language (e.g., “carrots and sticks” versus incentives and penalties). Florez, Darien, and Gralow said that many common medical terms are unfamiliar to patients (e.g., metastasis) and need to be clearly explained. Darien stressed that patients are capable of understanding if terminol- ogy is explained appropriately. Florez noted the challenges of tools not being available in languages other than English and said she has paid for the translation of tools she needed to complete grant applications. Real-World Data Kluetz referred participants to the FDA guidances for industry on collec- tion and use of real-world data as clinical evidence.67 He noted that real-world data need not necessarily be retrospective or observational but could be part of a prospective randomized controlled trial that incorporates EHR data or data collected at the point of care. A challenge, he acknowledged, is data management across disparate EHR systems. Ganz noted that the current quality and accuracy of real-world data in the patient’s EHR is very poor and not suitable for supporting a learning health 66 See https://www.cdc.gov/cancer/breast/triple-negative.htm (accessed December 12, 2023). 67 See https://www.fda.gov/science-research/science-and-research-special-topics/real-world- evidence (accessed December 12. 2023). PREPUBLICATION COPY—Uncorrected Proofs 

56 INNOVATION IN ELECTRONIC HEALTH RECORDS system. Templates and billing practices often lead to clinicians entering exams or actions that were not completed in order to close out the record. Ganz said clinicians, hospital systems, and patients need to be involved in ensuring real- world data are “correct, accurate, [and] equitable.” Miller agreed but observed that there is little incentive for clinicians to collect real-world data at the point of care because they do not receive any benefit from the downstream uses of the data they collect. He suggested adopting incentives for high-quality data collection. He added that the goal of mCODE is to identify the minimal number of oncol- ogy data elements that should be universally collected in a structured format without creating excessive burden on clinicians or the EHR system. Miller also suggested there is a role for ONC in data standards. Gralow emphasized the need to redesign the EHR to be a better “natural learning environment” to support patient care, clinical workflow, and evidence generation. This includes implementing existing guidelines and pathways; enter- ing complete, accurate data, in real time; and using agreed-to minimal common data elements to facilitate data sharing across systems. An easier-to-use EHR system could help to reduce clinician burnout, provide useful information back to patients, and contribute real-world data to a learning health system. The Role of Patient-Reported Outcomes (PROs) Snyder said the 2013 IOM report encouraged the collection of PROs in clinical trials and the collection of outcomes data in clinical practice at the point of care (including PROs). She reviewed several tools and guidance documents released over the past decade supporting the increased use of PROs, noting that additional guidances have been issued by FDA and others (Box 4). Snyder said more attention to applying the recommendations from these guidances is needed. In 2019, the PROTEUS Consortium was established to help researchers and clinicians navigate the use of PROs in trials and clinical practice. PROTEUS provides a “roadmap” for incorporating PROs in clinical trials and, in 2023, PROTEUS released a guide synthesizing key information from existing resources for using PROs in clinical practice.68 Snyder said PROs “are the intersection of patient centeredness and evi- dence” and she advocated for the continued collection of PROs in clinical trials and patient care to establish real-world evidence and improve equitable access to high-quality care. Pracht concurred and added that the PROs collected need to be more understandable to patients. Nekhlyudov and Snyder encouraged patient and clinician involvement in the design and implementation of PRO instruments. Nekhlyudov said clinicians are often not aware that the system has 68 See https://theproteusconsortium.org and https://theproteusconsortium.org/wp- content/uploads/2023/04/PROTEUS-Practice-Guide.pdf (accessed December 12, 2023). PREPUBLICATION COPY—Uncorrected Proofs 

PROCEEDINGS OF A WORKSHOP 57 BOX 4 Tools and Guidance Supporting the Use of PROs Since the 2013 IOM Report PROs in Clinical Trials • The SPIRIT-PRO extension provides guidelines for inclusion of PROs in clinical trial protocols (Calvert et al., 2018) • Minimum standards for PRO measures used in patient- centered outcomes research and comparative effectiveness research inform PRO measure selection (Reeve et al., 2013) • SISAQOL develops standards for the analysis of quality-of-life and PRO endpoints in randomized controlled trials for cancer (Coens et al., 2020) • The CONSORT PRO extension provides guidance that aims to improve the reporting of PROs in clinical trials (Calvert et al., 2013) • Recommendations for graphically displaying PRO data help patients and clinicians understand what the PRO scores mean (Snyder et al., 2019a) • Clinician’s checklist for reading and using an article about PROs is for clinicians who are not PRO experts (Wu et al., 2014) PROs in Clinical Practice • User’s guide to implementing PRO assessment in clinical prac- tice (ISOQOL, 2015) • Users’ guide to integrating PROs in electronic health records (Snyder and Wu, 2017) • Recommendations for graphically displaying PROs data (Sny- der et al., 2019a) • A PRO-cision medicine methods to address the challenges of personalizing cancer care using PROs (Snyder et al., 2019b) • ePROs in Clinical Care; Guidelines and Tools for Health Sys- tems (LeRouge et al., 2020) • The PROTEUS Guide to Implementing Patient-Reported Out- comes in Clinical Practice synthesizes key information from all of the above (Crossnohere et al., 2023) SOURCE: Snyder presentation, October 6, 2023. PREPUBLICATION COPY—Uncorrected Proofs 

58 INNOVATION IN ELECTRONIC HEALTH RECORDS sent their patients a PRO survey to complete before their appointment nor do clinicians receive usable results from it. Kluetz agreed and noted the need for implementation science regarding the use of electronic PRO instruments. Data Sharing Pennell questioned the extent to which the HIPAA Privacy Rule, which was implemented before current health IT existed, is a barrier to achieving a learning health care system. Miller said despite the original intent of the HIPAA legisla- tion, patients do not really have control over their health data. He highlighted the need to implement data standards that facilitate data exchange and to enable patients to easily permit downstream reuse of their data. Richardson agreed and added that obtaining data for the cancer registry system is a significant challenge for CDC, even though registry data are de-identified. Ganz said health care regulations are impeding progress toward the sharing of health data. Miller noted the important role of patients in driving data sharing and said, “patients have to recognize that they have the power to control their data.” REFLECTIONS In the final session of the workshop, moderators from the prior sessions highlighted observations made throughout the workshop and proposed strate- gies to advance progress in the delivery of high-quality cancer care (see Boxes 1 and 2), in a discussion moderated by Hedvig Hricak, Carroll and Milton Petrie Chair of the Department of Radiology at Memorial Sloan Kettering Cancer Center. Laura Levit, senior director of Research Analysis and Publications in the Center for Research and Analytics at ASCO, described key themes of the 2013 IOM report: the complexity of cancer treatment, the demands of caring for more patients due to an aging population and a shrinking workforce, the high cost of treatment, and challenges with quality metrics. She noted that these issues per- sist and are, in some cases, worse. Developments since the 2013 report include new treatments and increasing use of precision medicine; more consolidation of oncology practices and other changes in how cancer care is delivered; increasing threats to oncology workforce well-being and practice sustainability; continued implementation of the ACA, with increased patient access to health insurance coverage; a heightened focus on equity in cancer care; increasing care needs in rural areas; and a growing range of issues regarding the use of EHRs in cancer care. Two recurring topics of discussion throughout the workshop, Levit said, were that the vision of a learning heath care system outlined in the 2013 IOM report has not yet been achieved, and there is a need to significantly improve the translation of existing knowledge into practice. PREPUBLICATION COPY—Uncorrected Proofs 

PROCEEDINGS OF A WORKSHOP 59 Subbiah highlighted the rising rates of cancer incidence among younger and middle-aged persons, as well as the persistence of racial and ethnic disparities in cancer incidence, care, and outcomes. She also noted that many workshop speak- ers discussed approaches to improving equitable access to cancer care and clinical research; community engagement and patient-centeredness; dissemination and implementation of existing, evidence-based knowledge and care practices; and psychosocial care for cancer survivors. Hendricks said there is a need to prioritize workforce wellness in an increas- ingly complex cancer care environment, and to advance equitable care by increas- ing the diversity of the workforce to better reflect the population it serves. Nekh- lyudov pointed out that approaches to promoting professional wellness will vary across specialties, generations (e.g., younger clinicians with family responsibilities versus clinicians approaching retirement), and geography. To improve the delivery of cancer care, Smith said there is a need to develop and test new payment models; expand coverage for telehealth without geo- graphic restrictions; establish specific quality measures for oncology; and create a data ecosystem that enables the collection, timely sharing, and use of data. Regarding evidence generation, Pennell said that clinical research needs appropriate demographic representation and improved translation of research findings to improve cancer care (including de-escalation of therapy and de- implementation of practices as appropriate). He noted that throughout the workshop, speakers discussed a host of logistical, technological, structural, and financial challenges to the timely, complete, and accurate collection, aggregation, integration, and sharing of data from multiple sources (e.g., clinical workflow, surveillance, quality improvement, research). Pennell said that these issues need to be addressed to advance the delivery of high-quality cancer care. Yabroff added that many speakers discussed the importance of supportive leadership, culture, policies, and funding for evidence generation. Yabroff also noted that many speakers highlighted concerns about the scal- ability and sustainability of initiatives to improve high-quality cancer care. She highlighted comments from other speakers who discussed the opportunities afforded by digital innovations to improve cancer care, as well as the potential of improved collaboration within the cancer research and care communities to develop a learning health system. In closing comments, Ganz reiterated that engaged patients are a key com- ponent of a high-quality cancer care delivery system and that technology can help enable discussions with patients about their diagnosis, prognosis, and the range of evidence-based treatment options. This is where the Cancer Groundshot approach would come into play, she said, taking into account all of the clinical evidence available. She also highlighted the need to acknowledge and be sensi- tive to how the culture of oncology care has evolved as a result of the pandemic and due to generational differences. She said it was once standard for oncologists PREPUBLICATION COPY—Uncorrected Proofs 

60 INNOVATION IN ELECTRONIC HEALTH RECORDS to gather in person to jointly review patient imaging, pathology, and molecular profiling information to make recommendations regarding a patient’s care plan. There are many such activities that are now done individually and often remotely. Oncology care teams are multigenerational, and individuals have different ways of approaching their work and different perspectives on what is important. Ganz suggested there are opportunities to work across generations in seeking solutions. REFERENCES AAMC (Association of American Medical Colleges). 2019. Diversity in medicine: Facts and figures 2019. https://www.aamc.org/data-reports/workforce/report/diversity-medicine- facts-and-figures-2019 (accessed May 28, 2024). Aebersold, M. L., S. Kraft, K. B. Farris, M. Scherdt, M. Olsen, M. Polovich, B. K. Shelton, G. H. Montgomery, and C. R. Friese. 2021. Evaluation of an interprofessional training program to improve cancer drug therapy safety. JCO Oncology Practice 17(10):e1551-e1558. Aldrighetti, C. M., A. Niemierko, E. Van Allen, H. Willers, and S. C. Kamran. 2021. Racial and ethnic disparities among participants in precision oncology clinical studies. JAMA Network Open 4(11):e2133205. Anhang Price, R., L. Parast, M. N. Elliott, A. A. Tolpadi, M. A. Bradley, D. Schlang, and J. M. Teno. 2023. Association of hospice profit status with family caregivers’ reported care experiences. JAMA Internal Medicine 183(4):311–318. doi:10.1001/ jamainternmed.2022.7076. ASCO. 2020. Key trends in tracking supply and demand for oncologists. https://society.asco.org/ sites/new-www.asco.org/files/content-files/practice-and-guidelines/documents/2020- workforce-information-system.pdf (accessed May 28, 2024). ASCO. 2021a. 2021 Snapshot: State of the oncology workforce in America. JCO Oncology Practice 17(5):249. ASCO. 2021b. 2020 Snapshot: State of the oncology workforce in America. JCO Oncology Practice 17(1):30. ASCO. 2022. 2022 Snapshot: State of the oncology workforce in America. JCO Oncology Practice 18(5):396. Balanchivadze, N., K. D. Passalacqua, S. Askar, P. Kuriakose, N. Duma, V. E. Nambudiri, K. Springer, G. Divine, and V. Donthireddy. 2021.Self-reported gender bias encountered by hematology and oncology fellows. Journal of Clinical Oncology 39:15 suppl, 11017. Basch, E., A. M. Deal, M. G. Kris, H. I. Scher, C. A. Hudis, P. Sabbatini, L. Rogak, A. V. Bennett, A. C. Dueck, T. M. Atkinson, J. F. Chou, D. Dulko, L. Sit, A. Barz, P. Novotny, M. Fruscione, J. A. Sloan, and D. Schrag. 2016. Symptom monitoring with patient-reported outcomes during routine cancer treatment: A randomized controlled trial. Journal of Clinical Oncology 34(6):557-565. Basch, E., A. M. Deal, A. C. Dueck, H. I. Scher, M. G. Kris, C. Hudis, and D. Schrag. 2017. Overall survival results of a trial assessing patient-reported outcomes for symptom monitoring during routine cancer treatment. JAMA 318(2):197-198. Benjamin, D. J., A. Xu, M. P. Lythgoe, and V. Prasad. 2022. Cancer drug approvals that displaced existing standard-of-care therapies, 2016-2021. JAMA Network Open 5(3):e222265. PREPUBLICATION COPY—Uncorrected Proofs 

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