Roadmap to engagement: Bringing patient partners into cancer research and beyond.

The University of Kansas Cancer Center (KU Cancer Center) initiated an engagement program to leverage the lived experience of individuals and families with cancer. KU Cancer Center faculty, staff, and patient partners built an infrastructure to achieve a patient-designed, patient-led, and research-informed engagement program called Patient and Investigator Voices Organizing Together (PIVOT). This special communication offers an engagement roadmap that can be replicated, scaled, and adopted at other cancer centers and academic health systems. PIVOT demonstrates that collaboration among academic leaders, investigators, and people with a lived experience yields a patient-centered, vibrant environment that enriches the research enterprise.

Case example of a jail-based cancer prevention clinical trial: Social determinants of health framework, novel experimental design, and retention strategies to facilitate long-term follow-up of clinical trial participants.

Clinical trials conducted with incarcerated populations are rare. We present a case example of one such jail-based cancer prevention clinical trial to demonstrate the importance of including a theory-driven approach to intervention framing, novel experimental designs to boost access to low-risk trials, and retention strategies for long-term follow-up of hard-to-reach populations. As such we offer a social determinant of health framework to ensure cancer prevention research is conducted through the lenses of health promotion and health equity. Deviations from the gold-standard randomized control design, transparent systematic allotment, and street-based outreach retention strategies contribute to the feasibility of conducting clinical trials in carceral settings and after people leave jail. Best practices presented can be used in design and conduct of future clinical trials with criminal legal system-involved populations.

A community engagement training program for basic and translational cancer researchers.

PURPOSE: There is an increasing awareness of the importance of patient engagement in cancer research, but many basic and translational researchers have never been trained to do so. To address this unmet need, a 1-year patient engagement training program for researchers was developed. METHODS: Eleven researchers and eleven paired research advocates participated. This program, designed for virtual delivery, included 3 didactic modules focused on (1) Community Outreach and Engagement principles and methods, (2) Communication skills, and (3) Team Science. This was followed by longitudinal projects to be completed by the researcher/advocate pairs, including learning about the research project, and co-authoring abstracts, manuscripts and grant proposals. Monthly group meetings allowed pairs to share their experiences. The program culminated in the pairs creating and presenting oral abstracts for the University of Kansas Cancer Center's Annual Research Symposium. RESULTS: All participants indicated that the modules had a positive impact on their ability to collaborate in research. Both researcher self-evaluations and patient advocate evaluations of their researcher partner showed an improvement in researcher communication competency. Results from the Patient Engagement in Research Scale showed that advocates were highly engaged. Within 1 year after program completion, participating pairs have completed four abstracts and 9 grant proposals. CONCLUSION: The program will be modified based on participant feedback, and can be adapted for future cohorts if an increased number of sessions per month and shortened program duration are desired. The program's virtual format allows scalability across institutions to potentially benefit large cohorts of researchers.

Communicating risk and the landscape of cancer prevention - an exploratory study that examines perceptions of cancer-related genetic counseling and testing among African Americans and Latinos in the Midwest.

African American (AA) and Latino populations are impacted disproportionately by cancer incidence and mortality compared to the general US population. Contributing to these rates are multiple inheritable cancers that impact both men and women. Some of these diseases may be detected through genetic counseling and germline DNA testing; however, AA and Latinos are unaware and have limited knowledge and thus significantly underutilize these services and technologies. Research to detect influencing factors to testing uptake has also been slow due to multiple factors. The research team followed a community-based participatory research (CBPR) approach and worked with a Community Advisory Board composed of cancer survivors and co-survivors to design the exploratory study. Six focus groups were held with a pilot sample of African Americans and Latinos who self-reported to be at-risk for cancer (N = 53). The study was held over a 2-month period where attitudes, perceptions, and beliefs about cancer risk and preference regarding cancer-related genetic counseling and testing risk communication were explored. Themes that emerged included (1) the lack of knowledge about cancer-related genetic counseling and testing; (2) cancer is feared often; (3) cancer-related genetic testing was perceived as something that could help but was also perceived as unnecessary testing that exposed individuals to medical harm; and (4) benefits to test were perceived as favorable for medical personnel but not for the patient. Implications of the study provide a unique lens to explore how lived experiences among AA and Latinos may inform strategic risk communication about cancer-related genetic counseling and testing and help advance cancer health equity. Participants viewed cancer genetic testing as important cancer risk prevention strategies. Identification of perceptions of cancer risk and cancer-related genetic counseling and testing in collaboration with members of the community is needed to bolster communication efforts among these populations.

Cross-sectional online survey of clinicians' knowledge, attitudes and challenges to screening and counselling adolescents and young adults for substance use.

OBJECTIVE: To examine adolescent healthcare clinicians' self-reported screening practices as well as their knowledge, attitudes, comfort level and challenges with screening and counselling adolescents and young adults (AYA) for cigarette, e-cigarette, alcohol, marijuana, hookah and blunt use. DESIGN: A 2016 cross-sectional survey. SETTING: Academic departments and community-based internal medicine, family medicine and paediatrics practices. PARTICIPANTS: Adolescent healthcare clinicians (N=771) from 12 US medical schools and respondents to national surveys. Of the participants, 36% indicated male, 64% female, mean age was 44 years (SD=12.3); 12.3% of participants identified as Asian, 73.7% as white, 4.8% as black, 4.2% as Hispanic and 3.8% as other. PRIMARY AND SECONDARY OUTCOME MEASURES: Survey items queried clinicians about knowledge, attitudes, comfort level, self-efficacy and challenges with screening and counselling AYA patients about marijuana, blunts, cigarettes, e-cigarettes, hookah and alcohol. RESULTS: Participants were asked what percentage of their 10-17 years old patients they screened for substance use. The median number of physicians reported screening 100% of their patients for cigarette (1st, 3rd quartiles; 80, 100) and alcohol use (75, 100) and 99.5% for marijuana use (50,100); for e-cigarettes, participants reported screening half of their patients and 0.0% (0, 50), (0, 75)) reported screening for hookah and blunts, respectively. On average (median), clinicians estimated that 15.0% of all 10-17 years old patients smoked cigarettes, 10.0% used e-cigarettes, 20.0% used marijuana, 25.0% drank alcohol and 5.0% used hookah or blunts, respectively; yet they estimated lower than national rates of use of each product for their own patients. Clinicians reported greater comfort discussing cigarettes and alcohol with patients and less comfort discussing e-cigarettes, hookah, marijuana and blunts. CONCLUSIONS: This study identified low rates of screening and counselling AYA patients for use of e-cigarettes, hookahs and blunts by adolescent healthcare clinicians and points to potential missed opportunities to improve prevention efforts.

Perceived barriers to the adoption of active surveillance in low-risk prostate cancer: a qualitative analysis of community and academic urologists.

BACKGROUND: Clinical practice guidelines recommend active surveillance as the preferred treatment option for low-risk prostate cancer, but only a minority of eligible men receive active surveillance, and practice variation is substantial. The aim of this study is to describe barriers to urologists' recommendation of active surveillance in low-risk prostate cancer and explore variation of barriers by setting. METHODS: We conducted semi-structured interviews among 22 practicing urologists, evenly distributed between academic and community practice. We coded barriers to active surveillance according to a conceptual model of determinants of treatment quality to identify potential opportunities for intervention. RESULTS: Community and academic urologists were generally in agreement on factors influencing active surveillance. Urologists perceived patient-level factors to have the greatest influence on recommendations, particularly tumor pathology, patient age, and judgements about the patient's ability to adhere to follow-up protocols. They also noted cross-cutting clinical barriers, including concerns about the adequacy of biopsy samples, inconsistent protocols to guide active surveillance, and side effects of biopsy procedures. Urologists had differing opinions on the impact of environmental factors, such as financial disincentives and fear of litigation. CONCLUSIONS: Despite national and international recommendations, both academic and community urologists note a variety of barriers to implementing active surveillance in low risk prostate cancer. These barriers will need to be specifically addressed in efforts to help urologists offer active surveillance more consistently.

Non-cancer clinical trials start-up metrics at an academic medical center: Implications for advancing research.

The primary goal for any clinical trial after it receives a funding notification is to receive regulatory approval and initiate the trial for recruitment. Every trial must go through documentation and regulatory process before it can start recruiting participants and collecting data; this initial process of review and approval is known as the study start-up process (SSU). We evaluated the average time taken for studies to receive approvals. Using data from clinical trials conducted at the University of Kansas Medical Center, various times to reach the start of the study were calculated based on the dates of individual study. The results of this analysis showed that chart review studies and investigator-initiated trials had a shorter time to activation than other types of studies. Additionally, single-center studies had a shorter activation time than multi-center studies. The analysis also demonstrated that the overall processing time consistently had been reduced over time.

Electronic cigarette use and psychological distress in the Native Hawaiian and Pacific Islander adults compared with other racial/ethnic groups: Data from the National Health Interview Survey, 2014.

Document the prevalence of electronic cigarette (E-cigarette) use among the native Hawaiian and other Pacific Islander (NHPI) adults compared with other racial/ethnic groups, and examine associations between psychological distress and E-cigarette use. 2014 National Health Interview Survey (NHIS) and 2014 NHPI-NHIS were combined for comparisons. Data were analyzed using descriptive statistics, Rao-Scott χ2 test, and multivariable logistic regression. E-cigarette use among NHPI (5.6%) was significantly higher than among Blacks (2.1%), Hispanics (2.2%), and Asians (1.7%; p < .001). NHPI with Kessler 6 (K6) score of 11-24 had greater odds of using E-cigarettes (odds ratio [OR]: 3.90; 95% confidence intervals [CI]: 1.81-8.42) as compared to those with a K6 score of 0. Associations between having a K6 score of 11-24 and using E-cigarettes were also found for Whites (OR: 3.49; CI: 2.44-4.99), Asians (OR: 5.29; CI: 1.29-21.70), and Hispanics (OR: 6.14; CI: 2.72-13.83). E-cigarette use was higher among NHPI relative to other racial/ethnic groups. NHPI with K6 score of 11-24 had greater odds of using E-cigarettes as compared to those with a K6 score of 0. Policies and strategies to reduce E-cigarette use among NHPI should give careful consideration to the associations between E-cigarette use and psychological distress in the NHPI population.

Patient Factors That Influence How Physicians Discuss Active Surveillance With Low-Risk Prostate Cancer Patients: A Qualitative Study.

For men diagnosed with prostate cancer, making treatment decisions can be overwhelming. Navigating treatment options, along with potential treatment side effects, can be difficult, and patients often rely heavily on the advice of their physicians. This study was aimed at understanding more about the way urologists talk with their patients about one treatment option: active surveillance (AS), a recognized management strategy for men with low-risk prostate cancer that includes close observation and monitoring of the cancer. This study reports, through 22 interviews with urologists, that urologists believe patients are hesitant about AS for a number of reasons, including misperceptions about cancer severity, anxiety, aversion to repeated biopsies that accompany AS, or family member preferences. Because urologists play an influential role in educating patients about treatment options, the discussion around AS can be impacted by barriers that physicians believe matter for their patients. Improving awareness among urologists about what factors impact their patient education about low-risk prostate cancer is important. Identifying tools to improve shared decision making in this area could result in treatment decisions that are increasingly concordant with patients' values, concerns, and goals.

Effect of 2 Clinical Decision Support Strategies on Chronic Kidney Disease Outcomes in Primary Care: A Cluster Randomized Trial.

Importance: Information is needed about optimal strategies to improve evidence-based treatment of chronic kidney disease (CKD) in primary care. Objective: To determine whether a multimodal intervention delays annualized loss of estimated glomerular filtration rate (eGFR) in stages 3 and 4 CKD. Design, Setting, and Participants: This pragmatic cluster randomized clinical trial enrolled 42 primary care practices located in nonhospital settings with electronic health record systems. Practices were recruited through the American Academy of Family Physicians National Research Network. The study was conducted January 2013 through January 2016. Interventions: Practices were randomized at the organization level to either the clinical decision support (CDS) plus practice facilitation (PF) group (n = 25) or CDS group (n = 17) using covariate constrained randomization. Both groups received point-of-care CDS to prompt screening, diagnosis, and treatment of CKD; the intervention group also received PF based on the 9-point TRANSLATE model (target, use point-of-care reminder systems, get administrative buy-in, network information systems using registries, site coordination, local physician champion, audit and feedback, team approach, and education). Main Outcomes and Measures: The primary outcome measure was eGFR over time. Secondary outcome measures were systolic blood pressure over time, change in hemoglobin A1c (HbA1c) over time, avoidance of nonsteroidal anti-inflammatory medications, use of angiotensin converting enzyme inhibitor or angiotensin-renin blocker medication, early recognition and diagnosis of CKD, blood pressure control, and smoking cessation. Results: In this cluster randomized trial of 30 primary care practices comprising 6699 patients, there were 1685 patients in the control group (10 practices) and 5014 patients in the intervention group (20 practices). The final sample of practices differed from the original set of randomized practices owing to dropout. Patients in the practices were similar at baseline for age (mean [SD], 71.3 [9.6] years), sex (2716 male [40.5%]), and eGFR. There was a significant difference in eGFR slopes for patients in the intervention vs control group practices. The mean (SE) annualized loss of eGFR was 0.95 (0.19) in the control group in propensity-adjusted longitudinal analyses and 0.01 (0.12) in the intervention group (mean [SE] difference in slopes, 0.93 [0.23]; P < .001). Among patients with HbA1c measures, slopes differed significantly for patients in intervention vs control practices, with a mean (SE) annualized increase of 0.14 (0.03) in HbA1c for patients in control practices and a mean (SE) decline of 0.009 (0.02) for patients in intervention practices. There was a significant difference in HbA1c slopes for patients in the intervention compared with control group practices (control vs intervention, -0.14; P < .001), but no difference in the other secondary outcomes. Conclusions and Relevance: A multimodal intervention in primary care, based on the TRANSLATE model, slowed annualized loss of eGFR. This study had several important strengths, weaknesses, and lessons learned regarding the implementation of pragmatic interventions in primary care to improve CKD outcomes. Trial Registration: ClinicalTrials.gov Identifier: NCT01767883.

Inaccuracy of ICD-9 Codes for Chronic Kidney Disease: A Study from Two Practice-based Research Networks (PBRNs).

BACKGROUND: Inaccurate use of International Classification of Diseases, Ninth Revision (ICD-9), codes obfuscates registries used for research, resulting in unreliable data and inaccurate measurement of outcomes, and it may contribute to mismanagement of patients. Thus it is important to understand the prevalence of ICD-9 code misuse. We chose chronic kidney disease (CKD) as a condition of interest after several patients recruited for a previous study indicated they did not have the disease, despite the presence of the ICD-9 code (585.x) in their electronic medical record (EMR). METHODS: Retrospective chart review of patients with the ICD-9 code for CKD stage 3 (585.3; n = 325). Data were collected from EMRs at 3 primary care practices Buffalo, New York (n = 2), and Kansas City, Kansas (n = 1). RESULTS: Across all practices, 47% of patients with the CKD ICD-9 code did not have clinical indicators for the disease, based on Kidney Disease Outcomes Quality Initiative guidelines. CONCLUSIONS: The CKD stage 3 ICD-9 code usage did not accurately reflect the prevalence of disease among this population. This has clinical implications because patients may be treated or receive tests for a disease they do not have. This also presents an important issue for research projects that rely on accurate data from EMRs to identify and recruit patients.

Understanding the role of violence in incarcerated women's cervical cancer screening and history.

In this exploratory study the authors investigated characteristics, including reported experiences of violence, related to incarcerated women's self-report of cervical cancer screening and cancer history and treatment. During a four month period in 2010, 204 women in Kansas City jails were surveyed. Multiple logistic regression models were used to examine the relations of socio-demographic and community characteristics and history of violence among the women to their cervical cancer screening, diagnosis, and treatment histories. Forty percent of the women in the current sample reported abnormal Pap histories, though only 6% of all Pap smears done in the U.S. are abnormal. Women who reported abuse histories in this study were found to be more likely to report having ever had an abnormal Pap smear (for physical abuse Odds Ratio [OR] = 6.05; CI 2.36, 15.54 and for past year intimate partner violence OR = 2.41; CI 1.09, 5.31). Participants who did not fear neighborhood violence were less likely to report an abnormal Pap history (OR = 0.57; CI 0.34, 0.96) and more likely to visit a family doctor for their Pap screenings (OR = 1.91; CI 1.01, 3.60). Women who perceived greater neighborhood violence had increased odds of reporting that they received Pap screenings in a hospital setting (OR = 1.47; CI 1.08, 2.00). Frequency of Pap screening did not differ in women who did and did not have fear of neighborhood violence. This study highlights the heightened cervical cancer risk experienced by women with criminal justice histories and suggests that violence at several levels has implications for cervical cancer prevention for these women.

Who's enrolled in the State Children's Health Insurance Program (SCHIP)? An overview of findings from the Child Health Insurance Research Initiative (CHIRI).

BACKGROUND: The State Children's Health Insurance Program (SCHIP) was enacted in 1997 to provide health insurance coverage to uninsured low-income children from families who earned too much to be eligible for Medicaid. OBJECTIVES: To develop a "baseline" portrait of SCHIP enrollees in 5 states (Alabama, Florida, Kansas, Indiana, and New York) by examining: 1) SCHIP enrollees' demographic characteristics and health care experiences before enrolling in SCHIP, particularly children with special health care needs (CSHCN), racial and ethnic minority children, and adolescents; 2) the quality of the care adolescents received before enrollment; and 3) the changes in enrollee characteristics as programs evolve and mature. METHODS: Each of 5 projects from the Child Health Insurance Research Initiative (CHIRI) surveyed new SCHIP enrollees as identified by state enrollment data. CHIRI investigators developed the CHIRI common core (a set of survey items from validated instruments), which were largely incorporated into each survey. Bivariate and multivariate analyses were conducted to ascertain whether there were racial and ethnic disparities in access to health care and differences between CSHCN and those without. Current Population Survey data for New York State were used to identify secular trends in enrollee characteristics. RESULTS: Most SCHIP enrollees (65% in Florida to 79% in New York) resided in families with incomes < or =150% of the federal poverty level. Almost half of SCHIP enrollees lived in single-parent households. A majority of SCHIP parents had not had education beyond high school, and in 2 states (Alabama and New York) approximately 25% had not completed high school. The vast majority of children lived in households with a working adult, and in a substantial proportion of households both parents worked. Children tended to be either insured for the entire 12 months or uninsured the entire 12 months before enrolling in SCHIP. Private insurance was the predominant form of insurance before enrollment in SCHIP in most states, but 23.3% to 51.2% of insured children had Medicaid as their most recent insurance. HEALTH CARE USE AND UNMET NEEDS BEFORE SCHIP: The vast majority of all SCHIP enrollees had a usual source of care (USC) during the year before SCHIP. The proportion of children who changed their USC after enrolling in SCHIP ranged from 29% to 41.3%. A large proportion of SCHIP enrollees used health services during the year before SCHIP, with some variability across states in the use of health care. Nevertheless, 32% to almost 50% of children reported unmet needs. CSHCN: The prevalence of CSHCN in SCHIP (between 17% and 25%) in the study states was higher than the prevalence of CSHCN reported in the general population in those states. In many respects, CSHCN were similar to children without special health care needs, but CSHCN had poorer health status, were more likely to have had unmet needs, and were more likely to use the emergency department, mental health care, specialty care, and acute care in the year before enrolling in SCHIP than children without special health care needs. RACE AND ETHNICITY: A substantial proportion of SCHIP enrollees were black non-Hispanic or Hispanic children (Alabama: 34% and <1%; Florida: 6% and 26%; Kansas: 12% and 15%; and New York: 31% and 45%, respectively). Minority children were poorer, in poorer health, and less likely to have had a USC or private insurance before enrolling in SCHIP. The prevalence and magnitude of the disparities varied among the states. QUALITY OF CARE FOR ADOLESCENTS: Seventy-three percent of adolescent SCHIP enrollees engaged in one or more risk behaviors (ie, feeling sad or blue; alcohol, tobacco, and drug use; having sexual intercourse; and not wearing seat belts). Although almost 70% of adolescents reported having had a preventive care visit the previous year, a majority of them did not receive counseling in each of 4 counseling areas. Controlling for other factors, having a private, confidential visit with the physician was associated with an increased liked likelihood (2-3 times more likely) that the adolescent received counseling for 3 of 4 counseling areas. TRENDS OVER TIME: New York SCHIP enrollees in 2001, compared with 1994 enrollees in New York's SCHIP-precursor child health insurance program, were more likely to be black or Hispanic, older, from New York City, and from families with lower education, income, and employment levels. A greater proportion of 2001 enrollees was uninsured for some time in the year before enrollment, was insured by Medicaid, and lacked a USC. Secular trends in the low-income population in the state did not seem to be responsible for these differences. Program modifications during this time period that may be related to the shift in enrollee characteristics include changes to benefits, outreach and marketing efforts, changes in the premium structure, and the advent of a single application form for multiple public programs. CONCLUSIONS: SCHIP enrollees are a diverse group, and there was considerable variation among the 5 study states. Overall, SCHIP enrollees had substantial and wide-ranging health care needs despite high levels of prior contact with the health care system. A sizable minority of SCHIP enrollees has special health care needs. There is racial and ethnic diversity in the composition of enrollees as well, with racial and ethnic disparities present. The quality of care adolescents received before enrollment in SCHIP was suboptimal, with many reporting unmet health care needs and not receiving recommended counseling. The characteristics of SCHIP enrollees can be expected to change as SCHIP programs evolve and mature. POLICY IMPLICATIONS: 1) Benefits should be structured to meet the needs of SCHIP enrollees, which are comparable to Medicaid enrollees' needs in many respects. 2) Provider networks will have to be broad if continuity of care is to be achieved. 3) Multiple outreach strategies should be used, including using providers to distribute information about SCHIP. 4) The quality of care delivered to vulnerable populations (eg, minority children, CSHCN, and adolescents) should be monitored. 5) States and health plans should actively promote quality health care with the goal of improving the care received by SCHIP enrollees before enrollment. 6) States will have to craft policies that fit their local context. 7) Collecting baseline information on SCHIP enrollees on a continuous basis is important, because enrollee characteristics and needs can change, and many vulnerable children are enrolling in SCHIP.