The Impact of COVID-19 on the All of Us Research Program.

The All of Us Research Program, a health and genetics epidemiologic data collection program, has been substantially affected by the coronavirus disease 2019 (COVID-19) pandemic. Although the program is highly digital in nature, certain aspects of the data collection require in-person interaction between staff and participants. Before the pandemic, the program was enrolling approximately 12,500 participants per month at more than 400 clinical sites. In March 2020, because of the pandemic, all in-person activity at program sites and by engagement partners was paused to develop processes and procedures for in-person activities that incorporated strict safety protocols. In addition, the program adopted new data collection methodologies to reduce the need for in-person activities. Through February 2022, a total of 224 clinical sites had reactivated in-person activity, and all enrollment and engagement partners have adopted new data collection methods that can be used remotely. As the COVID-19 pandemic persists, the program continues to require safety procedures for in-person activity and continues to generate and pilot methodologies that reduce risk and make it easier for participants to provide information.

Oncologist-Reported Reasons for Not Ordering Multimarker Tumor Panels: Results From a Nationally Representative Survey.

This study examines oncologist-reported reasons for not using multimarker tumor panel testing and the association between these reasons and oncologist-level, facility-level, and patient-mix characteristics. METHODS: We used data collected from a nationally representative sample (N = 1,281) of medical oncologists participating in the National Cancer Institute's National Survey of Precision Medicine in Cancer Treatment. RESULTS: In addition to testing not being seen as relevant (87%) and no evidence of test utility (77%), the most frequently reported reasons for not ordering a multimarker tumor panel test was difficulty in obtaining sufficient tissue (57%) and using individual gene tests (72%). These reasons were more likely to be reported by oncologists practicing in rural clinics and less likely to be reported by oncologists with an academic affiliation or with access to genetic services such as on-site genetic counselors and internal genetic testing policies. CONCLUSION: Modifiable, organizational factors were associated with ordering multimarker tumor panels. Receipt of genomics training and organizational policies related to the use of genomics were associated with lower reporting of barriers to ordering multimarker tumor panels, pointing to potential targets for future studies aimed at increasing appropriate multimarker tumor panel testing in cancer treatment management.

Involving patients and their families in deciding to use next generation sequencing: Results from a nationally representative survey of U.S. oncologists.

OBJECTIVE: Next generation sequencing (NGS) may aid in tumor classification and treatment. Barriers to shared decision-making may influence use of NGS. We examined, from oncologists' perspectives, whether barriers to involving patients/families in decision-making were associated with NGS use. METHODS: Using data from the first national survey of medical oncologists' perspectives on precision medicine (N = 1281), we approached our analyses in two phases. Bivariate analyses initially evaluated associations between barriers to involving patients/families in deciding to use NGS and provider- and organizational-level characteristics. Modified Poisson regressions then examined associations between patient/family barriers and NGS use. RESULTS: Approximately 59 % of oncologists reported at least one barrier to involving patients/families in decision-making regarding NGS use. Those reporting patient/family barriers tended to have fewer genomic resources at their practices, to be in rural or suburban areas, and to have a higher proportion of Medicaid patients. However, these barriers were not associated with NGS use. CONCLUSIONS: Oncologists encounter barriers to involving patients/families in NGS testing decisions. Organizational barriers may also potentially play a role in testing decisions. PRACTICE IMPLICATIONS: To foster patient-centered care, strategies to support patient involvement in genomic testing decisions are needed, particularly among practices in low-resource settings.

Outcomes of multidisciplinary treatment planning in US cancer care settings.

Multidisciplinary treatment planning (MTP) is a process of engaging multiple disciplines to develop or refine the disease management plan. It is widely implemented in US cancer treatment settings and is considered to have favorable effects on both care quality and other outcomes. However, evidence reviews to date regarding MTP effectiveness have based their conclusions on studies conducted predominantly outside the United States. The authors conducted a systematic review of US-based studies to synthesize and critically appraise evidence of the effects of MTP on cancer care quality, health services outcomes, and survival. Database searches identified studies of MTP outcomes conducted in US cancer care settings from 2000 to 2017. Forty-five studies met criteria for inclusion. MTP was associated with favorable effects on several indicators of cancer care quality, including delivery of guideline-concordant treatment and improvements in diagnostic accuracy, staging completeness, surgical technique, and timeliness. Effects on survival and clinical trials enrollment were mixed. Delivery formats for MTP were generally not well described, and study designs were nonrandomized, limiting the ability to identify mediators of intervention effects. Continued study is warranted to clarify effective components of MTP interventions, and to understand the mechanism(s) through which MTP produces favorable effects on outcomes.

The National Cancer Institute Community Cancer Centers Program (NCCCP): Sustaining Quality and Reducing Disparities in Guideline-Concordant Breast and Colon Cancer Care.

BACKGROUND: The National Cancer Institute Community Cancer Centers Program (NCCCP) pilot was designed to improve quality of cancer care and reduce disparities at community hospitals. The NCCCP's primary intervention was the implementation of the Commission on Cancer Rapid Quality Reporting System (RQRS). The RQRS is a hospital-based data collection and evaluation system allowing near real-time assessment of selected breast and colon cancer quality of care measures. Building on previous NCCCP analyses, this study examined whether improvements in quality cancer care within NCCCP hospitals early in the program were sustained and whether improvements were notable for minority or underserved populations. METHODS: We compared changes in concordance with three breast and two colon cancer quality measures approved by the National Quality Forum for patients diagnosed at NCCCP hospitals from 2006 to 2007 (pre-RQRS), 2008 to 2010 (early-RQRS), and 2011 to 2013 (later-RQRS). Data were obtained from NCCCP sites participating in the Commission on Cancer Rapid Quality Reporting System. Logistic regression analyses were performed to identify predictors of concordance with breast and colon cancer quality measures. RESULTS: The sample included 13,893 breast and 5,546 colon cancer patients. After RQRS initiation, all five quality measures improved significantly and improvements were sustained through 2013. Quality of care measures showed sustained improvements for both breast and colon cancer patients and for vulnerable patient subgroups including black, uninsured, and Medicaid-covered patients. CONCLUSIONS: Quality improvements in NCCCP hospitals were sustained throughout the duration of the program, both overall and among minority and underserved patients. Because many individuals receive cancer treatment at community hospitals, facilitating high-quality care in these environments must be a priority. IMPLICATIONS FOR PRACTICE: Quality improvement programs often improve practice, but the methods are not maintained over time. The implementation of a real-time quality reporting system and a network focused on improving quality of care sustained quality improvement at select community cancer centers. The NCCCP pilot increased numbers of patients receiving guideline-concordant care for breast and colon cancer in community settings, and initial improvements noted in earlier years of RQRS were sustained into later years, both overall and among minority and underserved patients. National initiatives that improve care for diverse patient groups are important for reducing and eliminating barriers to care.

ReCAP: Impact of Multidisciplinary Care on Processes of Cancer Care: A Multi-Institutional Study.

PURPOSE: The role of multidisciplinary care (MDC) on cancer care processes is not fully understood. We investigated the impact of MDC on the processes of care at cancer centers within the National Cancer Institute Community Cancer Centers Program (NCCCP). METHODS: The study used data from patients diagnosed with stage IIB to III rectal cancer, stage III colon cancer, and stage III non­small-cell lung cancer at 14 NCCCP cancer centers from 2007 to 2012. We used an MDC development assessment tool­with levels ranging from evolving MDC (low) to achieving excellence (high)­to measure the level of MDC implementation in seven MDC areas, such as case planning and physician engagement. Descriptive statistics and cluster-adjusted regression models quantified the association between MDC implementation and processes of care, including time from diagnosis to treatment receipt. RESULTS: A total of 1,079 patients were examined. Compared with patients with colon cancer treated at cancer centers reporting low MDC scores, time to treatment receipt was shorter for patients with colon cancer treated at cancer centers reporting high or moderate MDC scores for physician engagement (hazard ratio [HR] for high physician engagement, 2.66; 95% CI, 1.70 to 4.17; HR for moderate physician engagement, 1.50; 95% CI, 1.19 to 1.89) and longer for patients with colon cancer treated at cancer centers reporting high 2MDC scores for case planning (HR, 0.65; 95% CI, 0.49 to 0.85). Results for patients with rectal cancer were qualitatively similar, and there was no statistically significant difference among patients with lung cancer. CONCLUSION: MDC implementation level was associated with processes of care, and direction of association varied across MDC assessment areas.

Introduction: Understanding and influencing multilevel factors across the cancer care continuum.

Health care in the United States is notoriously expensive while often failing to deliver the care recommended in published guidelines. There is, therefore, a need to consider our approach to health-care delivery. Cancer care is a good example for consideration because it spans the continuum of health-care issues from primary prevention through long-term survival and end-of-life care. In this monograph, we emphasize that health-care delivery occurs in a multilevel system that includes organizations, teams, and individuals. To achieve health-care delivery consistent with the Institute of Medicine's six quality aims (safety, effectiveness, timeliness, efficiency, patient-centeredness, and equity), we must influence multiple levels of that multilevel system. The notion that multiple levels of contextual influence affect behaviors through interdependent interactions is a well-established ecological view. This view has been used to analyze health-care delivery and health disparities. However, experience considering multilevel interventions in health care is much less robust. This monograph includes 13 chapters relevant to expanding the foundation of research for multilevel interventions in health-care delivery. Subjects include clinical cases of multilevel thinking in health-care delivery, the state of knowledge regarding multilevel interventions, study design and measurement considerations, methods for combining interventions, time as a consideration in the evaluation of effects, measurement of effects, simulations, application of multilevel thinking to health-care systems and disparities, and implementation of the Affordable Care Act of 2010. Our goal is to outline an agenda to proceed with multilevel intervention research, not because it guarantees improvement in our current approach to health care, but because ignoring the complexity of the multilevel environment in which care occurs has not achieved the desired improvements in care quality outlined by the Institute of Medicine at the turn of the millennium.

Time issues in multilevel interventions for cancer treatment and prevention.

The concept of time introduces important complexities in estimating intervention effects, program and evaluation design, and measurement and analysis of individual change in multilevel interventions (MLIs). Despite growing recognition that time is a critical element for assessing both individual-level outcomes and higher-level changes in organizational, community, and policy contexts, most MLI designs and evaluations have not addressed these issues. In this chapter we discuss 1) conceptualizing disease life-course and treatment theory in MLIs, 2) approaches to incorporating time in research and program design for MLIs in cancer treatment and prevention, 3) analysis of time-varying multilevel data in the context of cancer treatment and prevention, and 4) resource considerations and trade-offs of incorporating time as a dimension of MLIs and analysis. Although analytic techniques for analyzing time-related phenomena are becoming more available and powerful, there has not been corresponding progress made in the development of theory to guide the application of these techniques in program design and implementation.

Multilevel interventions and racial/ethnic health disparities.

To examine the impact of multilevel interventions (with three or more levels of influence) designed to reduce health disparities, we conducted a systematic review and meta-analysis of interventions for ethnic/racial minorities (all except non-Hispanic whites) that were published between January 2000 and July 2011. The primary aims were to synthesize the findings of studies evaluating multilevel interventions (three or more levels of influence) targeted at ethnic and racial minorities to reduce disparities in their health care and obtain a quantitative estimate of the effect of multilevel interventions on health outcomes among these subgroups. The electronic database PubMed was searched using Medical Subject Heading terms and key words. After initial review of abstracts, 26 published studies were systematically reviewed by at least two independent coders. Those with sufficient data (n = 12) were assessed by meta-analysis and examined for quality using a modified nine-item Physiotherapy Evidence Database coding scheme. The findings from this descriptive review suggest that multilevel interventions have positive effects on several health behavior outcomes, including cancer prevention and screening, as well improving the quality of health-care system processes. The weighted average effect size across studies for all health behavior outcomes reported at the individual participant level (k = 17) was odds ratio (OR) = 1.27 (95% confidence interval [CI] = 1.11 to 1.44); for the outcomes reported by providers or organizations, the weighted average effect size (k = 3) was OR = 2.53 (95% CI = 0.82 to 7.81). Enhanced application of theories to multiple levels of change, novel design approaches, and use of cultural leveraging in intervention design and implementation are proposed for this nascent field.

Racial differences in follow-up of abnormal mammography findings among economically disadvantaged women.

BACKGROUND: In the United States, and particularly in South Carolina, African-American women suffer disproportionately higher mortality rates from breast cancer than European-American women. The timeliness of patient adherence to the follow-up of mammographic abnormalities may influence prognosis and survival. The objective of the current investigation was to examine racial differences in the completion and completion time of a diagnostic workup after the finding of a suspicious breast abnormality. METHODS: Study participants of the Best Chance Network, a statewide service program that provides free mammography screening to economically disadvantaged and medically underserved women, were included in the study. Racial differences in tumor characteristics and adherence to recommended workup were tested using chi-square tests and t tests. Logistic and Cox regression modeling was used to assess the relation between workup completion and other factors among African-American women and European-American women. RESULTS: Completion of the workup was associated with the number of previous procedures and income, and no significant differences were noted by race. The amount of time to completion of the workup was influenced by previous procedures, income, and race. After accounting for completion time, African-American women were 12% less likely than European-American women to complete the recommended workup (hazard ratio, 0.88; P=.01). CONCLUSIONS: The results from this study established a racial disparity in the time to completion of a diagnostic workup among Best Chance Network participants. These findings highlight the importance of understanding the factors associated with delays in and adherence to completing the recommended workup when breast abnormalities are detected in mammograms.