Implementing Patient-Centered Outcomes Research Institute Stakeholder Engagement Principles in Models of Palliative Care Delivery and Advance Care Planning Research.

BACKGROUND: Given the many challenges of conducting research that addresses the palliative and end-of-life care needs of patients with serious illnesses, stakeholder engagement starting from the moment of study conceptualization and design is critical to ensure successful participant recruitment, data collection, intervention delivery, data analysis, and dissemination. METHODS: Guided by a conceptual model published by the Patient-Centered Outcomes Research Institute (PCORI) entitled, "Measuring What Matters for Advancing the Science and Practice of Engagement"14 and with the support of a PCORI Engagement Officer, representatives from 9 PCORI-funded study teams formed a working group to survey team members and review, outline, and describe key lessons learned and best practices for promoting stakeholder engagement in palliative care research. RESULTS: Almost all study teams engaged with patients/caregivers, clinicians, researchers, and health care system experts as stakeholder partners. About half the teams also included payers and training institutions as part of their stakeholder advisors as well as a range of content experts. Study teams relied on a variety of support structures and resources, and they employed 10 distinct methods for maintaining engagement. All engagement methods were generally considered to be effective by teams who used the method, though there was some variability in team-rated engagement quality of each method. Nine barriers to stakeholder engagement were identified across the 9 studies as well as 9 strategies (or facilitators) to overcome these barriers. We share examples of how stakeholder engagement impacted studies in all phases, including the preparatory phase, study initiation phase, execution phase, and data analysis/dissemination phase. CONCLUSIONS: Teams utilized a variety of resources and support structures as well as capitalized on multiple engagement methods for fostering stakeholder engagement, resulting in a high level of collaboration and integration.

Design and Rationale of the Phase 2 Baricitinib Study in Apolipoprotein L1-Mediated Kidney Disease (JUSTICE).

Introduction: Individuals of recent West African ancestry develop focal segmental glomerulosclerosis (FSGS) and hypertension-attributed end-stage kidney disease (HTN-ESKD) at 4 times the rate of White Americans. Two protein-coding variants of the Apolipoprotein L1 (APOL1) gene, G1 and G2, explain 50% to 70% of the excess risk of HTN-ESKD and FSGS among this group. Increased expression of G1 and G2 in the kidney, mediated by Janus kinase/signal transducer and activator of transcription (JAK-STAT) signaling, drive pathogenesis of these kidney diseases. Baricitinib is an orally active inhibitor of JAK1/2 that blocks APOL1 synthesis. The Janus kinase-STAT Inhibition to Reduce APOL1-Associated Kidney Disease (JUSTICE) trial is evaluating the antiproteinuric efficacy and safety of baricitinib in patients with APOL1-associated FSGS and HTN-attributed chronic kidney disease (HTN-CKD). Methods: JUSTICE is a single-center, randomized, double-blind, placebo-controlled, pilot phase 2 trial of baricitinib in patients with proteinuria, APOL1-associated FSGS or APOL1-associated HTN-CKD without diabetes. A total of 75 African American patients with APOL1-associated CKD, including 25 with FSGS and 50 with HTN-CKD, aged 18 to 70 years will be randomized 2:1 to daily treatment with baricitinib or placebo, respectively. Results: The primary efficacy end point will be percent change in urine albumin-to-creatinine ratio (UACR) from baseline to end of month 6. The primary safety end point will be incidence of clinically significant decreases in hemoglobin of ≥ 1g/dl. Conclusion: The phase 2 JUSTICE study will characterize the antiproteinuric efficacy and safety of JAK1/2 inhibition with baricitinib in patients with APOL1-associated FSGS and APOL1-associated HTN-CKD.

Mental health needs and barriers to service in the Chinese American community: insights gained from focus groups.

OBJECTIVES: Mental health remains an unmet need among Chinese Americans. This study aims to identify specific needs and strategies that may address the needs. DESIGN: A total of 55 Chinese Americans consented and participated in online focus groups conducted in either Chinese or English using nominal group technique. Participants discussed the following questions, achieved themes, and provided ranking of themes in importance for each: (1) In general, what do people in the Chinese American community think about mental health or emotional well-being? (2) What have you found to be helpful for accessing mental health or emotional well-being services or care in the Chinese American population? And (3) What actions would you suggest to improve mental health and emotional well-being in the Chinese American population? RESULTS: Across the focus groups, we observed high consistency of top ranked themes including lack of knowledge and awareness, negative impression, lack of Chinese-speaking providers, and that the most helpful factor toward access to care was education and increased awareness. Seminars and trainings was the top actionable suggestion. CONCLUSION: The findings are consistent with previous findings and continue to show that Chinese Americans need more education and training and that providers who can speak the language and understand the culture would be very helpful to increase access to care. This study emphasizes addressing mental health disparities in the Chinese American community through awareness, tailored interventions, and barrier removal. Promoting equal access also underscores the need for ongoing assessment and responsive strategies.

The state of Cancer-Focused community outreach and engagement (COE): reflections of black COE directors.

The requirement of community outreach and engagement (COE) as a major component of the National Cancer Institute (NCI) Cancer Center Support Grant has had enormous impact on the way NCI-designated cancer centers identify, investigate, and address the needs of their catchment area (CA) communities. Given the wide-ranging diversity of our nation, COE's scope of work is extremely demanding and complex. Yet, COE is often marginalized and viewed as void of scientific methods when, in fact, it requires specialized scientific knowledge and a broad range of proficiencies. Black COE scientific directors may be particularly attuned to this marginalization as they have often confronted workplace inequities that resemble the health inequities observed within their cancer center's CA. Thus, Black COE leaders are uniquely positioned to offer insight on the past, present, and future of COE. Key areas discussed include low involvement of minoritized group members and those with appropriate expertise in national COE leadership; the lack of established, consistent criteria for evaluation of COE components and qualifications of evaluators; the need for substantial financial investment in COE; potential misalignment of community priorities and cancer center objectives; professional development and growth of COE staff and leaders; the expanding scope of COE across their respective cancer centers and CAs; and the need for center-wide involvement in COE and an "all-hands-on-deck" approach. These areas warrant thoughtful dialogue as COE evolves, for the benefit and success of all COE leaders. However, this dialogue must include diverse voices representing similarly diverse stakeholders at every level.

Oncologist-Reported Barriers and Facilitators to Offering Cancer Clinical Trials to Their Patients.

NCCN guidelines indicate that cancer clinical trials (CCTs) are the best management for patients with cancer. However, only 5% of patients enroll in them. We examined oncologists' perceived barriers and facilitators to discussing CCTs. This qualitative study was part of the ASCO-ACCC Initiative to Increase Racial and Ethnic Diversity in Clinical Trials. Barriers and facilitators at the system, trial, provider, and patient levels were examined. To achieve triangulation, patient encounters were reviewed using chart-stimulated recall (CSR) methods, thereby obtaining a valid assessment of physician performance. Ten oncology providers participated in this study. Nine were oncologists, and one was a clinical research coordinator; five were female; four were White; three were Asian; and three were Black. Barriers to offering CCTs were a lack of trial availability; ineligibility; a lack of knowledge; assumptions about patient interest, benefits, or harms; patient's disease factors; and negative attitudes. Facilitators of offering CCTs were a physical space to discuss trials; greater trial availability; a systematic approach to offering trials; patient factors; patients seeking trials; a lack of comorbidities; patients being younger in age; patients being aware of, asking about, or hearing of trials from their surgeon; and higher levels of altruism. Many of the cited barriers are addressable with the cited facilitators. A larger study is needed to generalize and validate these findings.

An Assessment of the Feasibility and Utility of an ACCC-ASCO Implicit Bias Training Program to Enhance Racial and Ethnic Diversity in Cancer Clinical Trials.

PURPOSE: Cancer trial participants do not reflect the racial and ethnic diversity in the population of people with cancer in the United States. As a result of multiple system-, patient-, and provider-level factors, including implicit bias, cancer clinical trials are not consistently offered to all potentially eligible patients. MATERIALS AND METHODS: ASCO and ACCC evaluated the utility (pre- and post-test knowledge changes) and feasibility (completion rates, curriculum satisfaction metrics, survey questions, and interviews) of a customized online training program combined with facilitated peer-to-peer discussion designed to help research teams identify their own implicit biases and develop strategies to mitigate them. Discussion focused on (1) specific elements of the training modules; (2) how to apply lessons learned; and (3) key considerations for developing a facilitation guide to support peer-to-peer discussions in cancer clinical research settings. We evaluated discussion via a qualitative assessment. RESULTS: Participant completion rate was high: 49 of 50 participating cancer programs completed training; 126 of 129 participating individuals completed the training (98% response rate); and 119 completed the training and evaluations (92% response rate). Training increased the mean percentage change in knowledge scores by 19%-45% across key concepts (eg, causes of health disparities) and increased the mean percentage change in knowledge scores by 10%-31% about strategies/actions to address implicit bias and diversity concerns in cancer clinical trials. Knowledge increases were sustained at 6 weeks. Qualitative evaluation validated the utility and feasibility of facilitated peer-to-peer discussion. CONCLUSION: The pilot implementation of the training program demonstrated excellent utility and feasibility. Our evaluation affirms that an online training designed to raise awareness about implicit bias and develop strategies to mitigate biases among cancer research teams is feasible and can be readily implemented in cancer research settings.

Modifiable patient-reported factors associated with cancer-screening knowledge and participation in a community-based health assessment.

BACKGROUND: We sought to identify modifiable factors associated with cancer screening in a community-based health assessment. METHODS: 24 organizations at 47 community events in central North Carolina distributed a 91-item survey from April-December 2017. Responses about (1) interest in disease prevention, (2) lifestyle choices (e.g., diet, tobacco), and (3) perceptions of primary care access/quality were abstracted to examine their association with self-reported screening participation and knowledge about breast, prostate, and colorectal cancer. RESULTS: 2135/2315 participants (92%; 38.5% White, 38% Black, 9.9% Asian) completed screening questions. >70% of screen-eligible respondents reported guideline-concordant screening. Healthy dietary habits were associated with greater knowledge about breast and colorectal cancer screening; reporting negative attitudes about and barriers to healthcare were associated with less breast, prostate, and colorectal cancer screening. Having a place to seek medical care (a proxy for primary care access) was independently associated with being ∼5 times as likely to undergo colorectal screening (OR 4.66, 95% CI 1.58-13.79, all p < 0.05). CONCLUSIONS: In this diverse, community-based sample, modifiable factors were associated with screening engagement, highlighting opportunities for behavioral intervention.

Health Misinformation Exposure and Health Disparities: Observations and Opportunities.

The concepts of health misinformation and health disparities have been prominent in public health literature in recent years, in part because of the threat that each notion poses to public health. How exactly are misinformation proliferation and health disparities related, however? What roles might misinformation play in explaining the health disparities that we have documented in the United States and elsewhere? How might we mitigate the effects of misinformation exposure among people facing relatively poor health outcomes? In this review, we address such questions by first defining health disparities and misinformation as concepts and then considering how misinformation exposure might theoretically affect health decision-making and account for disparate health behavior and health outcomes. We alsoassess the potential for misinformation-focused interventions to address health disparities based on available literature and call for future research to address gaps in our current evidence base.

Initial Longitudinal Outcomes of Risk-Stratified Men in Their Forties Screened for Prostate Cancer Following Implementation of a Baseline Prostate-Specific Antigen.

PURPOSE: Prostate cancer (PCa) screening can lead to potential over-diagnosis/over-treatment of indolent cancers. There is a need to optimize practices to better risk-stratify patients. We examined initial longitudinal outcomes of mid-life men with an elevated baseline prostate-specific antigen (PSA) following initiation of a novel screening program within a system-wide network. MATERIALS AND METHODS: We assessed our primary care network patients ages 40 to 49 years with a PSA measured following implementation of an electronic health record screening algorithm from 2/2/2017-2/21/2018. The multidisciplinary algorithm was developed taking factors including age, race, family history, and PSA into consideration to provide a personalized approach to urology referral to be used with shared decision-making. Outcomes of men with PSA ≥1.5 ng/mL were evaluated through 7/2021. Statistical analyses identified factors associated with PCa detection. Clinically significant PCa (csPCa) was defined as Gleason Grade Group (GGG) ≥2 or GGG1 with PSA ≥10 ng/mL. RESULTS: The study cohort contained 564 patients, with 330 (58.5%) referred to urology for elevated PSA. Forty-nine (8.7%) underwent biopsy; of these, 20 (40.8%) returned with PCa. Eleven (2.0% of total cohort and 55% of PCa diagnoses) had csPCa. Early referral timing (odds ratio [OR], 4.58) and higher PSA (OR, 1.07) were significantly associated with PCa at biopsy on multivariable analysis (both p<0.05), while other risk factors were not. Referred patients had higher mean PSAs (2.97 vs. 1.98, p=0.001). CONCLUSIONS: Preliminary outcomes following implementation of a multidisciplinary screening algorithm identified PCa in a small, important percentage of men in their forties. These results provide insight into baseline PSA measurement to provide early risk stratification and detection of csPCa in patients with otherwise extended life expectancy. Further follow-up is needed to possibly determine the prognostic significance of such mid-life screening and optimize primary care physician-urologist coordination.

Development and Psychometric Evaluation of Healthcare Access Measures among Women with Ovarian Cancer.

Several proposed theoretical frameworks have defined the complex nature of healthcare access (HCA) [...].

Development and evaluation of a novel training program to build study staff skills in equitable and inclusive engagement, recruitment, and retention of clinical research participants.

Background: Adequate equitable recruitment of underrepresented groups in clinical research and trials is a national problem and remains a daunting challenge to translating research discoveries into effective healthcare practices. Engagement, recruitment, and retention (ER&R) training programs for Clinical Research Professionals (CRPs) often focus on policies and regulations. Although some training on the importance of diversity and inclusion in clinical research participation has recently been developed, there remains a need for training that couples critical equity, diversity, and inclusion (EDI) concepts with skill development in effective recruitment and retention strategies, regulations, and best practices. Approach and methods: We developed the ER&R Certificate program as a holistic approach to provide Duke University CRPs the opportunity to build competency in gap areas and to increase comfort in championing equitable partnerships with clinical research participants. The thirteen core and elective courses include blended learning elements, such as e-learning and wiki journaling prompts, to facilitate meaningful discussions. Pre- and post-assessments administered to CRP program participants and their managers assessed program impact on CRP skills in ER&R tasks and comfort in equitable, diverse, and inclusive engagement of clinical research participants. Results and discussion: Results from the first two cohorts indicate that CRPs perceived growth in their own comfort with program learning objectives, especially those centered on participant partnership and EDI principles, and most managers witnessed growth in competence and responsibility for ER&R-related tasks. Results suggest value in offering CRPs robust training programs that integrate EDI and ER&R training.

A Review of Race and Ethnicity in Hospice and Palliative Medicine Research: Representation Matters.

CONTEXT: Despite documented racial and ethnic disparities in care, there is significant variability in representation, reporting, and analysis of race and ethnic groups in the hospice and palliative medicine (HPM) literature. OBJECTIVES: To evaluate the race and ethnic diversity of study participants and the reporting of race and ethnicity data in HPM research. METHODS: Adult patient and/or caregiver-centered research conducted in the U.S. and published as JPSM Original Articles from January 1, 2015, through December 31, 2019, were identified. Descriptive analyses were used to summarize the frequency of variables related to reporting of race and ethnicity. RESULTS: Of 1253 studies screened, 218 were eligible and reviewed. There were 78 unique race and ethnic group labels. Over 85% of studies included ≥ one non-standard label based on Office of Management and Budget designations. One-quarter of studies lacked an explanation of how race and ethnicity data were collected, and 83% lacked a rationale. Over half did not include race and/or ethnicity in the analysis, and only 14 studies focused on race and/or ethnic health or health disparities. White, Black, Hispanic, Asian, American Indian or Alaska Native, and Native Hawaiian or Other Pacific Islander persons were included in 95%, 71%, 43% 37%,10%, and 4% of studies. In 92% of studies the proportion of White individuals exceeded 57.8%, which is their proportion in the U.S. CONCLUSION: Our findings suggest there are important opportunities to standardize reporting of race and ethnicity, strive for diversity, equity, and inclusion among research participants, and prioritize the study of racial and ethnic disparities in HPM research.

Increasing Racial and Ethnic Diversity in Cancer Clinical Trials: An American Society of Clinical Oncology and Association of Community Cancer Centers Joint Research Statement.

A concerted commitment across research stakeholders is necessary to increase equity, diversity, and inclusion (EDI) and address barriers to cancer clinical trial recruitment and participation. Racial and ethnic diversity among trial participants is key to understanding intrinsic and extrinsic factors that may affect patient response to cancer treatments. This ASCO and Association of Community Cancer Centers (ACCC) Research Statement presents specific recommendations and strategies for the research community to improve EDI in cancer clinical trials. There are six overarching recommendations: (1) clinical trials are an integral component of high-quality cancer care, and every person with cancer should have the opportunity to participate; (2) trial sponsors and investigators should design and implement trials with a focus on reducing barriers and enhancing EDI, and work with sites to conduct trials in ways that increase participation of under-represented populations; (3) trial sponsors, researchers, and sites should form long-standing partnerships with patients, patient advocacy groups, and community leaders and groups; (4) anyone designing or conducting trials should complete recurring education, training, and evaluation to demonstrate and maintain cross-cultural competencies, mitigation of bias, effective communication, and a commitment to achieving EDI; (5) research stakeholders should invest in programs and policies that increase EDI in trials and in the research workforce; and (6) research stakeholders should collect and publish aggregate data on racial and ethnic diversity of trial participants when reporting results of trials, programs, and interventions to increase EDI. The recommendations are intended to serve as a guide for the research community to improve participation rates among people from racial and ethnic minority populations historically under-represented in cancer clinical trials. ASCO and ACCC will work at all levels to advance the recommendations in this publication.

Racial/Ethnic Disparities in Healthcare Worker Experiences During the COVID-19 Pandemic: An Analysis of the HERO Registry.

Background: The extent to which healthcare worker (HCWs) experiences during the COVID-19 pandemic vary by race or ethnicity after adjustment for confounding factors is not currently known. Methods: We performed an observational prospective cohort study of 24,769 healthcare workers from 50 U.S. states and the District of Columbia, enrolled between April 10, 2020 and June 30, 2021, and evaluated participant experiences during the COVID-19 pandemic, including testing, diagnosis with COVID-19, emotional experiences, burnout, and interest in vaccines and vaccine clinical trials. Findings: After adjustment for professional role, medical history, and community characteristics, Black and Asian participants were less likely to receive SARS-CoV-2 viral testing (adjusted odds ratio (aOR) 0·82 [0·70, 0·96], p=0·012 and aOR 0·77 [0·67, 0·89], p<0·001 respectively) than White participants. Hispanic participants were more likely to have evidence of COVID-19 infection (aOR 1·23 (1·00, 1·50, p=0·048). Black and Asian participants were less likely to report interest in a COVID-19 vaccine (aOR 0·11 [0·05, 0·25], p<0·001 and aOR 0·48 [0·27, 0·85] p=0·012). Black participants were less likely to report interest in participating in a COVID-19 vaccine trial (aOR = 0·39 [0·28, 0·54], p<0·001). Black participants were also less likely to report 3 or more daily emotional impacts of COVID-19 (aOR = 0·66 [0·53, 0·82], p=<0·001). Black participants were additionally less likely to report burnout (aOR = 0·66 ([0·49, 0·95], p=0·025). Interpretation: In a large, national study of healthcare workers, after adjustment for individual and community characteristics, race/ethnicity disparities in COVID-19 outcomes persist. Future work is urgently needed to understand precise mechanisms behind these disparities and to develop and implement targeted interventions to improve health equity for healthcare workers. Funding: This work was funded by the Patient-Centered Outcomes Research Institute (PCORI), Contract # COVID-19-2020-001.

The 5Ws of Racial Equity in Research: A Framework for Applying a Racial Equity Lens Throughout the Research Process.

Ensuring equity in research is a critical step in advancing health equity. In this perspective, the authors introduce a guiding framework for advancing racial equity in research processes, environments, and among the research workforce, the 5Ws of Racial Equity in Research. Centering their discussion on the 5Ws: Who, What, When, Where, and Why, they use historical and contemporary examples of research inequities to demonstrate how these five simple questions can encourage open discussion and proactive planning for equity in research. They close with an acknowledgment of the framework's broad utility and a researcher-directed call to action.

Association of Smartphone Ownership and Internet Use With Markers of Health Literacy and Access: Cross-sectional Survey Study of Perspectives From Project PLACE (Population Level Approaches to Cancer Elimination).

BACKGROUND: Telehealth is an increasingly important component of health care delivery in response to the COVID-19 pandemic. However, well-documented disparities persist in the use of digital technologies. OBJECTIVE: This study aims to describe smartphone and internet use within a diverse sample, to assess the association of smartphone and internet use with markers of health literacy and health access, and to identify the mediating factors in these relationships. METHODS: Surveys were distributed to a targeted sample designed to oversample historically underserved communities from April 2017 to December 2017. Multivariate logistic regression was used to estimate the association of internet and smartphone use with outcomes describing health care access and markers of health literacy for the total cohort and after stratifying by personal history of cancer. Health care access was captured using multiple variables, including the ability to obtain medical care when needed. Markers of health literacy included self-reported confidence in obtaining health information. RESULTS: Of the 2149 participants, 1319 (61.38%) were women, 655 (30.48%) were non-Hispanic White, and 666 (30.99%) were non-Hispanic Black. The median age was 51 years (IQR 38-65). Most respondents reported using the internet (1921/2149, 89.39%) and owning a smartphone (1800/2149, 83.76%). Compared with the respondents with smartphone or internet access, those without smartphone or internet access were more likely to report that a doctor was their most recent source of health information (344/1800, 19.11% vs 116/349, 33.2% for smartphone and 380/1921, 19.78% vs 80/228, 35.1% for internet, respectively; both P<.001). Internet use was associated with having looked for information on health topics from any source (odds ratio [OR] 3.81, 95% CI 2.53-5.75) and confidence in obtaining health information when needed (OR 1.83, 95% CI 1.00-3.34) compared with noninternet users. Smartphone owners had lower odds of being unable to obtain needed medical care (OR 0.62, 95% CI 0.40-0.95) than nonsmartphone owners. Among participants with a prior history of cancer, smartphone ownership was significantly associated with higher odds of confidence in ability to obtain needed health information (OR 5.63, 95% CI 1.05-30.23) and lower odds of inability to obtain needed medical care (OR 0.17, 95% CI 0.06-0.47), although these associations were not significant among participants without a prior history of cancer. CONCLUSIONS: We describe widespread use of digital technologies in a community-based cohort, although disparities persist. In this cohort, smartphone ownership was significantly associated with ability to obtain needed medical care, suggesting that the use of smartphone technology may play a role in increasing health care access. Similarly, major illnesses such as cancer have the potential to amplify health engagement. Finally, special emphasis must be placed on reaching patient populations with limited digital access, so these patients are not further disadvantaged in the new age of telehealth.

Characteristics of sickle cell patients with frequent emergency department visits and hospitalizations.

Vaso-occlusive episodes (VOEs) are a hallmark of sickle cell disease (SCD), and account for >90% of health care encounters for this patient population. The Cooperative Study of Sickle Cell Disease, a large study enrolling >3000 patients, showed that the majority of SCD patients (80%) experienced 0-3 major pain crises/year. Only a small minority (~5%) experienced ≥6 VOEs/year. Our study sought to further understand this difference in VOE frequency between SCD patients. We analyzed 25 patients (13M/12F, mean age of 28.8) with ≥6 ED visits or hospitalizations/year (high utilizers), and compared these with 9 patients (6M/3F, mean age of 37.6) who had ≤2 ED visits or hospitalizations/year (low utilizers). All subjects were given a demographic survey along with questionnaires for depression, anxiety, and Health Locus of Control. Each subject then underwent quantitative sensory testing (QST) with three different modalities: pressure pain sensitivity, heat and cold sensitivity, and Von Frey monofilament testing. Laboratory and clinical data were collected through subjects' medical records. CBC and chemistry analysis showed high utilizers had higher WBC (p<0.01), ANC (p<0.01), total bilirubin (p = 0.02), and lower MCV (p = 0.03). Opioid use (morphine equivalents) over the past 6 months was significantly higher in the high utilizer group (12125.7 mg vs 2423.1 mg, p = 0.005). QST results showed lower pressure pain threshold at the ulna (224.4 KPa vs 338.9 KPa, p = 0.04) in the high utilizer group. High utilizers also had higher anxiety (9.0 vs 4.6, p = 0.04) and depression scores (10.0 vs 6.0, p = 0.051). While the low utilizer group had higher education levels with more associate and bachelor degrees (p = 0.009), there was no difference in income or employment. These data show that many biological and psychosocial factors contribute to high health care utilization in SCD. A multi-disciplinary and multi-faceted approach will be required to address this complex problem.

Implementation and Impact of a Risk-Stratified Prostate Cancer Screening Algorithm as a Clinical Decision Support Tool in a Primary Care Network.

BACKGROUND: Implementation methods of risk-stratified cancer screening guidance throughout a health care system remains understudied. OBJECTIVE: Conduct a preliminary analysis of the implementation of a risk-stratified prostate cancer screening algorithm in a single health care system. DESIGN: Comparison of men seen pre-implementation (2/1/2016-2/1/2017) vs. post-implementation (2/2/2017-2/21/2018). PARTICIPANTS: Men, aged 40-75 years, without a history of prostate cancer, who were seen by a primary care provider. INTERVENTIONS: The algorithm was integrated into two components in the electronic health record (EHR): in Health Maintenance as a personalized screening reminder and in tailored messages to providers that accompanied prostate-specific antigen (PSA) results. MAIN MEASURES: Primary outcomes: percent of men who met screening algorithm criteria; percent of men with a PSA result. Logistic repeated measures mixed models were used to test for differences in the proportion of individuals that met screening criteria in the pre- and post-implementation periods with age, race, family history, and PSA level included as covariates. KEY RESULTS: During the pre- and post-implementation periods, 49,053 and 49,980 men, respectively, were seen across 26 clinics (20.6% African American). The proportion of men who met screening algorithm criteria increased from 49.3% (pre-implementation) to 68.0% (post-implementation) (p < 0.001); this increase was observed across all races, age groups, and primary care clinics. Importantly, the percent of men who had a PSA did not change: 55.3% pre-implementation, 55.0% post-implementation. The adjusted odds of meeting algorithm-based screening was 6.5-times higher in the post-implementation period than in the pre-implementation period (95% confidence interval, 5.97 to 7.05). CONCLUSIONS: In this preliminary analysis, following implementation of an EHR-based algorithm, we observed a rapid change in practice with an increase in screening in higher-risk groups balanced with a decrease in screening in low-risk groups. Future efforts will evaluate costs and downstream outcomes of this strategy.

The Durham Initiative for Stomach Health (DISH): a pilot community-based Helicobacter pylori education and screening study.

BACKGROUND: Approximately 15% of all cancers are due to infection. The bacteria Helicobacter pylori is the single leading carcinogenic infectious agent and the main cause of stomach cancer. Prevalence of H. pylori, and, correspondingly, stomach cancer incidence and mortality, is significantly greater among African Americans than whites in the United States. In the present study, we conducted a pilot community-engaged H. pylori education and screening study in partnership with a predominantly African American church in Durham, North Carolina. METHODS: Initially, we consulted with community advisory boards and convened stakeholder meetings with local community members and primary care physicians. We then developed this pilot study through an iterative collaboration with church partners. Our main outcomes were feasibility and acceptability as measured by participation in a one-day H. pylori screening initiative, and participation in follow-up for those who tested positive. We also sought to determine prevalence and determinants of active H. pylori infection in this population. RESULTS: Community engagement informed the event logistics, messaging, educational materials provided, and follow-up plans. A total of 92 individuals participated in the primary study event, 25% of whom had a current H. pylori infection. Of those, 87% returned for the follow-up events, among whom 70% had successfully cleared their infection. CONCLUSIONS: Through community engagement, community-based H. pylori screening and stomach cancer prevention is feasible and acceptable. This is a necessary step in order to move stomach cancer prevention forward to population-based precision H. pylori screening and eradication.