Hepatocellular carcinoma surveillance may be associated with potential psychological harms in patients with cirrhosis.

BACKGROUND AND AIMS: The value of HCC surveillance is determined by the balance between benefits and harms; however, no studies have enumerated psychological harms. APPROACH AND RESULTS: We fielded surveys measuring psychological harms to patients with cirrhosis in a multicenter randomized trial of HCC surveillance outreach. All patients with positive or indeterminate surveillance results and matched patients with negative results were invited to complete surveys measuring (1) depression through the Patient Health Questionnaire-ninth version, (2) anxiety through State-Trait Anxiety Inventory, (3) HCC-specific worry through Psychological Consequences Questionnaire, and (4) decisional regret. Patients were classified into 4 groups: true positive (TP), false positive (FP), indeterminate, and true negative (TN). Multivariable longitudinal regression analysis using the generalized estimating equation method was performed to compare the means of measures across groups. We conducted 89 semistructured interviews in a subset of patients stratified by health system and test results. Of 2872 patients in the trial, 311 completed 1+ follow-up survey (63 FP, 77 indeterminate, 38 TP, and 133 TN). Moderate depression decreased in TN patients, increased in TP, and had intermittent but mild increases in those with FP and indeterminate results. High anxiety temporarily increased in patients with TP results but resolved over time and was stable in those with FP and indeterminate results. Decisional regret was low and did not differ across groups. In semistructured interviews, patients reported apprehension, anxiety, emotional distress, and coping related to HCC surveillance. CONCLUSIONS: Psychological harms of HCC surveillance appear mild but differ by test result. Future research should determine the impact of psychological harms on the value of HCC surveillance programs.

The financial burden after liver transplantation is significant among commercially insured adults: A large US National Cohort.

Liver transplantation (LT) is lifesaving for patients with cirrhosis; however, the resultant financial burden to patients has not been well characterized. We aimed to provide a nationally representative portrayal of patient financial burden after LT. Adult recipients of LT from 2006 to 2021 were identified using IQVIA PharMetrics® Plus for Academics-a large nationally representative claims database of commercially insured Americans. Patient financial liability (ie, what patients owe) was estimated using the difference between allowed and paid costs for adjudicated medical/pharmacy claims. Descriptive statistics were provided stratified by the financial liability group within 1 year after LT. Multivariable logistic regression modeling identified factors associated with high/extreme liability adjusting for covariates. Potential indirect costs of post-LT care were estimated based on hourly wages lost for care. Among 1412 recipients of LT, financial liability was heterogeneous-~3% had no liability and 21% had extreme liability > $10K for 1-year post-LT care; most (69%) paid between $1 and 10K, with 48% having liability >$5K. Factors associated with >$5K liability included older age, insurance/enrollment type, US region, history of HCC, and simultaneous liver-kidney transplant (for liability >$10K). Medication costs comprised ~30% of outpatient financial liability. Potential indirect costs from wages lost were $2,201-$6,073 per person, depending on an hourly wage. In a large national cohort of commercially insured recipients of LT, financial liability was highly variable across sociodemographic and clinical characteristics; nearly 1 out of 2 recipients of LT owed >$5K for 1 year of post-LT care. Transplant programs should help patients anticipate potential costs and identify vulnerable populations who would benefit from enhanced financial counseling.

Effect of Patient Navigation on Completion of Lung Cancer Screening in Vulnerable Populations.

BACKGROUND: Although low-dose, CT-based lung cancer screening (LCS) can decrease lung cancer mortality in high-risk individuals, the process may be complex and pose challenges to patients, particularly those from minority underinsured and uninsured populations. We conducted a randomized controlled trial of telephone-based navigation for LCS within an integrated, urban, safety-net health care system. PATIENTS AND METHODS: Patients eligible for LCS were randomized (1:1) to usual care with or without navigation at Parkland Health in Dallas, Texas. The primary endpoint was completion of the first 3 consecutive steps in a patient's LCS process. We explored differences in completion of LCS steps between navigation and usual care groups, controlling for patient characteristics using the chi-square test. RESULTS: Patients (N=447) were randomized to either navigation (n=225) or usual care (n=222). Mean patient age was 62 years, 46% were female, and 69% were racial/ethnic minorities. There was no difference in completion of the first 3 steps of the LCS algorithm between arms (12% vs 9%, respectively; P=.30). For ordered LCS steps, completion rates were higher among patients who received navigation (86% vs 79%; P=.03). The primary reason for step noncompletion was lack of order placement. CONCLUSIONS: In this study, lack of order placement was a key reason for incomplete LCS steps. When orders were placed, patients who received navigation had higher rates of completion. Clinical team education and enhanced electronic health record processes to simplify order placement, coupled with patient navigation, may improve LCS in safety-net health care systems.

A randomized trial of mail and email recruitment strategies for a physician survey on clinical trial accrual.

BACKGROUND: Patient participation in cancer clinical trials is suboptimal. A challenge to capturing physicians' insights about trials has been low response to surveys. We conducted a study using varying combinations of mail and email to recruit a nationally representative sample of medical, surgical, and radiation oncologists to complete a survey on trial accrual. METHODS: We randomly assigned eligible physicians identified from the American Medical Association MasterFile (n = 13,251) to mail- or email-based recruitment strategies. Mail-based recruitment included a survey packet with: (1) cover letter describing the survey and inviting participation; (2) paper copy of the survey and postage-paid return envelope; and (3) a web link for completing the survey online. Email-based recruitment included an e-mail describing the survey and inviting participation, along with the web link to the survey, and a reminder postcard 2 weeks later. RESULTS: Response was higher for mail-based (11.8, 95% CI 11.0-12.6%) vs. email-based (4.5, 95% CI 4.0-5.0%) recruitment. In email-based recruitment, only one-quarter of recipients opened the email, and even fewer clicked on the link to complete the survey. Most physicians in mail-based recruitment responded after the first invitation (362 of 770 responders, 47.0%). A higher proportion of responders vs. non-responders were young (ages 25-44 years), men, and radiation or surgical (vs. medical) oncologists. CONCLUSIONS: Most physicians assigned to mail-based recruitment actually completed the survey online via the link provided in the cover letter, and those in email-based recruitment did not respond until they received a reminder postcard by mail. Providing the option to return a paper survey or complete it online may have further increased participation in the mail-based group, and future studies should examine how combinations of delivery mode and return options affect physicians' response to surveys.

What is a good medical decision? A research agenda guided by perspectives from multiple stakeholders.

Informed and shared decision making are critical aspects of patient-centered care, which has contributed to an emphasis on decision support interventions to promote good medical decision making. However, researchers and healthcare providers have not reached a consensus on what defines a good decision, nor how to evaluate it. This position paper, informed by conference sessions featuring diverse stakeholders held at the 2015 Society of Behavioral Medicine and Society for Medical Decision Making annual meetings, describes key concepts that influence the decision making process itself and that may change what it means to make a good decision: interpersonal factors, structural constraints, affective influences, and values clarification methods. This paper also proposes specific research questions within each of these priority areas, with the goal of moving medical decision making research to a more comprehensive definition of a good medical decision, and enhancing the ability to measure and improve the decision making process.

Validity of Single-Item Screening for Limited Health Literacy in English and Spanish Speakers.

OBJECTIVES: To evaluate 3 single-item screening measures for limited health literacy in a community-based population of English and Spanish speakers. METHODS: We recruited 324 English and 314 Spanish speakers from a community research registry in Dallas, Texas, enrolled between 2009 and 2012. We used 3 screening measures: (1) How would you rate your ability to read?; (2) How confident are you filling out medical forms by yourself?; and (3) How often do you have someone help you read hospital materials? In analyses stratified by language, we used area under the receiver operating characteristic (AUROC) curves to compare each item with the validated 40-item Short Test of Functional Health Literacy in Adults. RESULTS: For English speakers, no difference was seen among the items. For Spanish speakers, "ability to read" identified inadequate literacy better than "help reading hospital materials" (AUROC curve = 0.76 vs 0.65; P = .019). CONCLUSIONS: The "ability to read" item performed the best, supporting use as a screening tool in safety-net systems caring for diverse populations. Future studies should investigate how to implement brief measures in safety-net settings and whether highlighting health literacy level influences providers' communication practices and patient outcomes.

Independent state health surveys: responding to the need for local population health data.

CONTEXT: There is high demand for local-level population health data. A national system of state and local data collection would help improve both population health and health care delivery. The primary source of state-level population health data for adults is the Behavioral Risk Factor Surveillance System. However, many states need data on children and adolescents, racial and ethnic subpopulations, consistent estimates for localities, or more in-depth information on key topics than the Behavioral Risk Factor Surveillance System provides. Eleven state health surveys (SHSs) have emerged in an effort to address these gaps. DESIGN: Semistructured telephone interviews were conducted in 2009 with representatives of 9 SHSs. The interviews were recorded, and data were transcribed, organized, and analyzed according to the query structure. This analysis identified (1) the core elements of SHS that have been successful in meeting needs for local data and (2) the processes and strategies used by state officials in creating these surveys. RESULTS: Key findings include the following: (1) SHSs provide concrete data on local health issues that meet the needs of policy makers who wish to adopt evidence-based public health policies; (2) data from SHSs allow researchers to identify issues, apply for grants, and evaluate, assess, and track health indicators; (3) a "champion" is required to build the case for a survey and push through barriers to obtain funding and stakeholder buy-in; and (4) SHSs face challenges such as inconsistent funding and lack of uniform standards. CONCLUSION: Opportunities to support SHSs include (1) identifying sustained funding sources; (2) providing technical assistance and facilitating training to foster best practices, quality standards, and comparability across states; and (3) supporting an organization for SHS researchers to share resources, information, and experiences.

Coping During the COVID-19 Pandemic: Experiences of Complex Cancer Survivors.

Patients with cancer and multiple chronic conditions (complex cancer survivors) are vulnerable to the negative impacts of COVID-19. However, their experiences and coping strategies during the COVID-19 pandemic have not been e.

Characteristics of self-triaged emergency department visits by adults with cancer.

OBJECTIVES: Adults with a new diagnosis of cancer frequently visit emergency departments (EDs) for disease- and treatment-related issues, although not exclusively. Many cancer care providers have 24/7 clinician phone triage available, but initial recorded phone messages tend to advise patients to go to the nearest ED if they are "experiencing a medical emergency." It is unclear how well patients triage themselves to the optimal site of care. STUDY DESIGN: Cross-sectional study of tumor registry records (university patients diagnosed 2008-2018 and safety-net patients diagnosed 2012-2018) identifiably linked to electronic health records and a regional health information exchange. METHODS: We geoprocessed addresses to calculate driving time distance from the patient's home to the ED. We used mixed-effects regression to predict the diagnosis code-based severity for ED visits within 6 months of diagnosis, clustering visits within patients and hospitals. RESULTS: A total of 39,498 adults made 38,944 ED visits to 67 different hospitals. Patients self-referred for 85.5% of visits and bypassed a median (IQR) of 13 (4-33) closer EDs. Visits closer to home were not significantly more clinically severe; visits were significantly less severe if the patient self-referred (adjusted odds ratio [AOR], 0.89; 95% CI, 0.81-0.97) or they were on weekends (AOR, 0.93; 95% CI, 0.87-0.99). Reanalyzing within each individual health system also showed similar findings. CONCLUSIONS: Adults with cancer infrequently use available clinician advice before visiting the ED and may use factors other than clinical severity to determine their need for emergency care. Future work should explore the challenges that patients face navigating unplanned acute care, including reasons for underusing existing resources.

Definition and Coordination of Roles and Responsibilities Among Cancer Center Clinic and Research Personnel.

PURPOSE: Effective enrollment and treatment of patients in cancer clinical trials require definition and coordination of roles and responsibilities among clinic and research personnel. MATERIALS AND METHODS: We developed a survey that incorporated modified components of the Survey of Physician Attitudes Regarding the Care of Cancer Survivors. Surveys were administered to clinic nursing staff and research personnel at a National Cancer Institute-designated comprehensive cancer center. Results were analyzed using χ2-tests, t tests, and analyses of variance. RESULTS: Surveys were completed by 105 staff members (n = 50 research staff, n = 55 clinic staff; 61% response rate). Research staff were more likely to feel that they had the skills to answer questions, convey information, and provide education for patients on trials (all P < .05). Both clinic and research staff reported receipt of communication about responsibilities in fewer than 30% of cases, although research staff reported provision of such information in more than 60% of cases. Among 20 tasks related to care of patients in trials, no single preferred model of responsibility assignment was selected by the majority of clinic staff for nine tasks (45%) or by research staff for three tasks (15%). Uncertainty about which team coordinates care was reported by three times as many clinic staff as research staff (P = .01). There was also substantial variation in the preferred model for delivery of care to patients in trials (P < .05). CONCLUSION: Knowledge, attitudes, and perception of care and responsibilities for patients on clinical trials differ between and among clinic and research personnel. Additional research about how these findings affect efficiency and quality of care on clinical trials is needed.

Development and Preliminary Psychometric Evaluation of a Patient-Reported Outcome Measure for Lung Cancer Stigma: The Lung Cancer Stigma Inventory (LCSI).

INTRODUCTION: Among patients with lung cancer, stigma is associated with negative psychosocial and behavioral outcomes. There is a need to develop psychometrically robust patient-reported outcome (PRO) measures for stigma that incorporate perspectives of patients diagnosed with lung cancer. As part of our multi-phase process of measure development and validation, we report on scale formation and preliminary psychometric evaluation of the Lung Cancer Stigma Inventory (LCSI). METHOD: Building on previously reported concept elicitation (Phase I) work, Phase II of LCSI development involved item generation and refinement, informed by literature review, provider input, and patient (N=20) feedback. Phase III focused on initial psychometric scale evaluation in a unique sample of 231 lung cancer patients. RESULTS: Based on provider input and patient cognitive interviews, 49 items were included in a preliminary measure. In an exploratory factor analysis (EFA) of the 37 retained items, three factors emerged: Perceived Stigma, Internalized Stigma, and Constrained Disclosure. Internal consistency of the final, 25-item LCSI scale was high (Cronbach's alpha= 0.89) and the three subscales demonstrated good internal consistency. The test-retest correlation was high (r = 0.91), suggesting strong stability of measurement over time. There was good convergent validity between the LCSI and an existing measure of lung cancer stigma, the Cataldo Lung Cancer Stigma Scale (CLCSS; r= 0.58, p< 0.001). DISCUSSION: In a multi-phase process, we have developed a reliable, multi-dimensional measure of lung cancer stigma, the Lung Cancer Stigma Inventory (LCSI). Subsequent work will be conducted to establish further evidence of validity and clinically meaningful change.

Family and Social Context Contributes to the Interplay of Economic Insecurity, Food Insecurity, and Health.

In this study, we show how household health, economic instability, and food insecurity are inextricably linked; disruptions in individual health or income create cumulative and interdependent challenges faced by multiple household members. Drawing upon semi-structured focus groups with English- and Spanish-speaking clients of an urban food pantry, we demonstrate: (1) the impact of economic scarcity on health, (2) the impact of one household member's health on the health and food security of all household members, and (3) food sharing behaviors among family and social networks, including multi-generational families and non-kin individuals. We identify the gap between household-level assessments of food insecurity and individual-level health reports, which may obscure poor health among other household members. Understanding the social and family context of health and food insecurity may inform future interventions that address the interrelated challenges of diverse and disadvantaged households and communities.

Oncology Nursing Perceptions of Patient Electronic Portal Use: A Qualitative Analysis.

PURPOSE/OBJECTIVES: To identify nursing staff reactions to and perceptions of electronic portal use in a cancer setting.
. RESEARCH APPROACH: Qualitative.
. SETTING: Outpatient clinic at the Harold C. Simmons Comprehensive Cancer Center of the University of Texas Southwestern Medical Center in Dallas.
. PARTICIPANTS: 13 nurses with a range of credentials and experience, representing infusion, medical oncology, and bone marrow transplantation clinics.
. METHODOLOGIC APPROACH: Two focus groups were conducted. Theoretical thematic content analysis of data was performed.
. FINDINGS: Key themes that emerged for consideration of electronic portals included work volume and flow, patient expectations and safety, variation in use of communication technologies, and education and management.
. INTERPRETATION: The current study provides insight into the implications of electronic portals by identifying nursing staff reactions to this technology. These reactions are predominantly related to the impact on clinical workload and patient safety and expectations.
. IMPLICATIONS FOR NURSING: As clinical cancer facilities incorporate electronic portal technology into their operations, attention to the impact on staff workload, division of labor, patient safety, and patient expectations should be considered.

Resolving Rivalries and Realigning Goals: Challenges of Clinical and Research Multiteam Systems.

This article describes the care processes for a 64-year-old man with newly diagnosed advanced non-small-cell lung cancer who was enrolled in a first-line clinical trial of a new immunotherapy regimen. The case highlights the concept of multiteam systems in cancer clinical research and clinical care. Because clinical research represents a highly dynamic entity-with studies frequently opening, closing, and undergoing modifications-concerted efforts of multiple teams are needed to respond to these changes while continuing to provide consistent, high-level care and timely, accurate clinical data. The case illustrates typical challenges of multiteam care processes. Compared with clinical tasks that are routinely performed by single teams, multiple-team care greatly increases the demands for communication, collaboration, cohesion, and coordination among team members. As the case illustrates, the described research team and clinical team are separated, resulting in suboptimal function. Individual team members interact predominantly with members of their own team. A considerable number of team members lack regular interaction with anyone outside their team. Accompanying this separation, the teams enact rivalries that impede collaboration. The teams have misaligned goals and competing priorities that create competition. Collective identity and cohesion across the two teams are low. Research team and clinical team members have limited knowledge of the roles and work of individuals outside their team. Recommendations to increase trust and collaboration are provided. Clinical providers and researchers may incorporate these themes into development and evaluation of multiteam systems, multidisciplinary teams, and cross-functional teams within their own institutions.

Effectiveness of a community research registry to recruit minority and underserved adults for health research.

BACKGROUND: Recruiting minorities and underserved populations into population-based studies is a long standing challenge. This study examined the feasibility of recruiting adults from a community research registry. METHODS: Ethnically diverse, bilingual staff attended health fairs, inviting adults to join a registry. We examined rates of successful contact, scheduling, and participation for studies that used the registry. RESULTS: Five studies queried 6,886 research registry members (48% Hispanic and 38% black) and attempted to contact 2,301 potentially eligible participants; eligibility criteria varied across studies. We successfully contacted 1,130 members, 51.9% were scheduled to participate and of those, 60.8% completed their study appointment. Non-Hispanic whites were less likely than Hispanics to be interested, but among those scheduling an appointment, participation did not differ by race/ethnicity. CONCLUSION: Community research registries are a feasible and efficient method for recruiting minority and underserved adults and may address disparities in access to and participation in health research.

Multiple Comorbidities and Interest in Research Participation Among Clients of a Nonprofit Food Distribution Site.

BACKGROUND: Persons accessing food from nonprofit distribution sites face numerous challenges and typically have significant unmet health needs. However, given limited and intermittent healthcare system engagement, this vulnerable population is underrepresented in clinical research. We sought to better understand the health needs of a nonclinical population to inform future research and interventions. METHODS: Focus groups were conducted in English (n = 4) and Spanish (n = 4) with clients of Crossroads Community Services (CCS), the largest distributor of North Texas Food Bank. Discussions probed participants' health status, healthcare utilization, understanding and utilization of mammography, and attitudes toward participation in research. RESULTS: Participants included 42 CCS clients, primarily Hispanic or African American women. Participants reported multiple comorbid conditions among household members, yet utilization of health services was often limited by cost. The majority expressed interest in participating in research to communicate their health concerns and obtain emotional support. CONCLUSION: CCS clients represent a high-need, under-reached population willing to engage in health-related research that affords them opportunity to connect with peers in group settings and obtain information to improve management of daily life challenges. The Community Assistance Research (CARe) Initiative, a community-academic collaboration, establishes a much-needed opportunity for ongoing clinical research and intervention among this underserved population.

Developing a Brief Suicide Prevention Intervention and Mobile Phone Application: a Qualitative Report.

Suicide is the second leading cause of death among youth and has become a serious public health problem. There has been limited research on strategies to decrease the likelihood of reattempt in adolescents. As phase one of a treatment development study, clinicians, parents and adolescents participated in qualitative interviews in order to gain new perspectives on developing a targeted intervention and a safety plan phone application for suicide prevention. Participants indicated that transition of care, specific treatment targets and safety planning were important parts of treatment. In addition, all participants endorsed the use of a smartphone application for these purposes.

Evaluating a De-Centralized Regional Delivery System for Breast Cancer Screening and Patient Navigation for the Rural Underserved.

Providing breast cancer screening services in rural areas is challenging due to the fractured nature of healthcare delivery systems and complex reimbursement mechanisms that create barriers to access for the under- and uninsured. Interventions that reduce structural barriers to mammography, like patient navigation programs, are effective and recommended, especially for minority and underserved women. Although the literature on rural healthcare is significant, the field lacks studies of adaptive service delivery models and rigorous evaluation of evidence-based programs that facilitate routine screening and appropriate follow-up across large geographic areas. OBJECTIVES: To better understand how to implement a decentralized regional delivery "hub & spoke" model for rural breast cancer screening and patient navigation, we have designed a rigorous, structured, multi-level and mixed-methods evaluation based on Glasgow's RE-AIM model (Reach, Effectiveness, Adoption, Implementation, and Maintenance). METHODS AND DESIGN: The program is comprised of three core components: 1) Outreach to underserved women by partnering with county organizations; 2) Navigation to guide patients through screening and appropriate follow-up; and 3) Centralized Reimbursement to coordinate funding for screening services through a central contract with Medicaid Breast and Cervical Cancer Services (BCCS). Using Glasgow's RE-AIM model, we will: 1) assess which counties have the resources and capacity to implement outreach and/or navigation components, 2) train partners in each county on how to implement components, and 3) monitor process and outcome measures in each county at regular intervals, providing booster training when needed. DISCUSSION: This evaluation strategy will elucidate how the heterogeneity of rural county infrastructure impacts decentralized service delivery as a navigation program expands. In addition to increasing breast cancer screening access, our model improves and maintains time to diagnostic resolution and facilitates timely referral to local cancer treatment services. We offer this evaluation approach as an exemplar for scientific methods to evaluate the translation of evidence-based federal policy into sustainable health services delivery in a rural setting.