Implementing methods in the ELEGANCE registry to increase diversity in clinical research.

OBJECTIVE: Women and underrepresented minorities (URMs) who are at an increased risk of presenting with severe peripheral artery disease (PAD) and have different responses to treatment compared with non-Hispanic White males yet are underrepresented in PAD research. METHODS: ELEGANCE is a global, prospective, multi-center, post-market registry of PAD patients treated with drug-eluting device that aims to enroll at least 40% women and 40% URMs. The study design incorporates strategies to increase enrollment of women and URMs. Inclusion criteria are age ≥18 years and treatment with any commercially available Boston Scientific Corporation drug-eluting device marketed for peripheral vasculature lesions; exclusion criterion is life expectancy <1 year. RESULTS: Of 750 patients currently enrolled (951 lesions) across 39 sites, 324 (43.2%) are female and 350 (47.3%) are URMs (21.6% Black, 11.2% Asian, 8.5% Hispanic/Latino, and 5.3% other). Rutherford classification is distributed differently between sexes (P = .019). Treatment indication differs among race/ethnicity groups (P = .003). Chronic limb-threatening ischemia was higher for Black (38.3%) and Hispanic/Latino (28.1%) patients compared with non-Hispanic White (21.8%) and Asian patients (21.4%). De-novo stenosis was higher in Asian patients (92.3%) compared with Black, non-Hispanic White, and Hispanic/Latino patients (72.2%, 68.7%, and 77.8%, respectively; P < .001). Mean lesion length was longest for Black patients (162.7 mm), then non-Hispanic White (135.2 mm), Asian (134.8 mm), and Hispanic/Latino patients (128.1 mm; P = .008). CONCLUSIONS: Analyses of data from the ELEGANCE registry show that differences exist in baseline disease characteristics by sex and race/ethnicity; these may be the result of other underlying factors, including time to diagnosis, burden of undermanaged comorbidities, and access to care.

Exploring the Patient Experience with Patient-Reported Outcomes: A Qualitative, Multistakeholder Study.

OBJECTIVES: Although the literature provides guidance regarding patient-reported outcome (PRO) implementation barriers, patients' perspectives are underreported. This study aimed to improve the understanding of patient experiences with PRO tools through examining perceptions of and attitudes toward PROs and expectations of data use after collection. METHODS: Ethnographic human-centered design approaches were used to conduct free-form interviews. Two case studies of existing PRO use in clinics also were examined. Unstructured thematic analyses were performed using notes taken during these interviews. RESULTS: Patients generally reported a good understanding of the need for PRO collection, both for research and clinical use. Many expected that results would be acted upon by the clinicians promptly. Thematic analyses identified the following patient perception topics: transparency, individualization to patient needs, timely response, different "identities" while accessing care locally compared with at a destination center, and preference for brief PROs. CONCLUSIONS: Design and implementation of PRO assessments into patient care should include the patients as key end users. Transparency of the purpose for data collection is critical for broader patient adoption. Ensuring that only necessary and sufficient data are collected for clinical action, and associated research may help minimize burden and maximize patient participation.

Correction: Tracking Healthy People 2020 Internet, Broadband, and Mobile Device Access Goals: An Update Using Data From the Health Information National Trends Survey.

[This corrects the article DOI: 10.2196/13300.].

The Learning Health System Competency Appraisal Inventory (LHS-CAI): A novel tool for assessing LHS-focused education needs.

There is increasing interest in health care organizations functioning as learning health systems (LHSs) to improve the quality and efficiency of health care delivery while generating new knowledge. Individuals must be trained in associated concepts and competencies and subsequently positioned (or embedded) within the delivery system for maximum effect as they perform their scholarship. Potential researchers within LHSs come from many different training backgrounds; therefore, each LHS scholar requires a goal-directed plan tailored to his or her needs. There are few tools available to guide development, training, or evaluation of individuals interested in becoming leaders of research in LHSs. In this paper, we present a newly developed tool for guiding the training of such researchers, the Learning Health Systems Competency Appraisal Inventory (LHS-CAI). The LHS-CAI is modeled after the Clinical Research Appraisal Index (CRAI) used within Clinical and Translational Science Award sites across the United States. The LHS-CAI is a tool for trainees at all levels to use with their mentors in an interactive manner. The tool can then identify areas in which more training is needed and at what level to ensure success as a researcher within LHSs. We further modified the CRAI format to better leverage the LHS-CAI as a key part of an LHS scholar's individual development plan. To implement the LHS-CAI, we have identified key points within the Minnesota Learning Health System Mentored Career Development Program (MN-LHS) at which assessment of expertise for each competency would be useful to LHS scholars, mentors, and program leaders. Scholars in this program come from various clinical and academic backgrounds but are all targeting their career trajectories toward leading embedded LHS research. They will reevaluate their expertise upon completion of the program, with comparison to baseline serving as a key program evaluation tool. The LHS-CAI is currently being implemented with the first cohort of scholars in the MN-LHS program.

Cost and clinical outcomes of postoperative intensive care unit versus general floor management in head and neck free flap reconstructive surgery patients.

PURPOSE: To compare clinical, surgical, and cost outcomes in patients undergoing head and neck free-flap reconstructive surgery in the setting of postoperative intensive care unit (ICU) against general floor management. METHODS: Retrospective analysis of head and neck free-flap reconstructive surgery patients at a single tertiary academic medical center. Clinical data was obtained from medical records. Cost data was obtained via the Mayo Clinic Rochester Cost Data Warehouse, which assigns Medicare reimbursement rates to all professional billed services. RESULTS: A total of 502 patients were included, with 82 managed postoperatively in the ICU and 420 on the general floor. Major postoperative outcomes did not differ significantly between groups (Odds Ratio[OR] 1.54; p = 0.41). After covariate adjustments, patients managed in the ICU had a 3.29 day increased average length of hospital stay (Standard Error 0.71; p < 0.0001) and increased need for take-back surgery (OR 2.35; p = 0.02) when compared to the general floor. No significant differences were noted between groups in terms of early free-flap complications (OR 1.38;p = 0.35) or late free-flap complications (Hazard Ratio 0.81; p = 0.61). Short-term cost was $8772 higher in the ICU (range = $5640-$11,903; p < 0.01). Long-term cost did not differ significantly. CONCLUSION: Postoperative management of head and neck oncologic free-flap patients in the ICU does not significantly improve major postoperative outcomes or free-flap complications when compared to general floor care, but does increase short-term costs. General floor management may be appropriate when cardiopulmonary compromise is not present.

A Graduate-Level Interdisciplinary Curriculum in CAR-T Cell Therapy.

OBJECTIVE: To evaluate the impact of a novel interdisciplinary graduate-level course in chimeric antigenic receptor-T cell therapy on students' knowledge and interests in translational science. MATERIALS/PARTICIPANTS AND METHODS: The course ran November 12 to 16, 2018. Students were surveyed before and after the course. The survey included questions regarding background, self-perceived knowledge/confidence in skills, and interests/predicted behaviors. Students were assigned to work in collaborative interdisciplinary teams to develop a research proposal. RESULTS: A total of 25 students taking the course for graduate-level credit were surveyed. Of these, all 25 (100%) completed the surveys. Students came from variable backgrounds and were at different stages of graduate training. After completion of the course, there was a statistically significant increase in self-perceived knowledge of immunotherapy (mean score of 3.6 postcourse vs 2.6 precourse, on a 5-point Likert scale; P<.001), knowledge of the bench to clinic translational process (3.7 postcourse vs 3.0 precourse; P<.001), confidence in critical reading skills (4.3 postcourse vs 4.0 precourse; P=.008), confidence in immunotherapy-focused grant writing skills (3.6 postcourse vs 2.8 precourse; P<.001), and interest in working in interdisciplinary teams (4.8 postcourse vs 4.6 precourse; P=.02). CONCLUSION: The structure of this innovative and comprehensive course serves as a platform for educational courses in interdisciplinary translational research and helps trainees build knowledge and interest in the fields of chimeric antigenic receptor-T cells, regenerative sciences, and immunotherapy.

Translating innovation in biomedical research: Design and delivery of a competency-based regulatory science course.

As the pace of biomedical innovation rapidly evolves, there is a need to train researchers to understand regulatory science challenges associated with clinical translation. We describe a pilot course aimed at addressing this need delivered jointly through the Mayo Clinic Center for Clinical and Translational Science and the Yale-Mayo Center for Excellence in Regulatory Science and Innovation. Course design was informed by the Association for Clinical and Translational Science's Regulatory Science Working Group's competencies. The course used didactic, case-, and problem-based learning sessions to expose students to regulatory science concepts. Course evaluation focused on student satisfaction and learning. A total of 25 students enrolled in the first two course deliveries. Students represented several disciplines and career stages, from predoctoral to faculty. Students reported learning "an incredible amount" (7/19, 36.8%) or "a lot" (9/19, 47.4%); this was reflected in individual coursework and their course evaluations. Qualitative feedback indicated that assignments that challenged them to apply the content to their own research were appreciated. The heterogeneity of students enrolled, coupled with assessments and course evaluations, supports the statement that there is a growing need and desire for regulatory science-focused curricula. Future research will determine the long-term impact.

Exploring Gender Differences in Student Evaluations of Faculty in a Graduate Clinical Translational Research Program.

This article was migrated. The article was marked as recommended. There has long been an underrepresentation of women in medicine and biomedical research; this is often described as a "leaky pipeline," as the more senior the level of rank, the fewer women are appointed. In evaluating a faculty member for promotion, student evaluations of faculty teaching are often considered; therefore, if gender biases are reinforced by student evaluations of teaching, the gender gap in faculty promotion could remain or increase. In this study, we examine student evaluations of faculty teaching in a graduate biomedical research training program, using data gathered during two academic years. While female faculty received higher quantitative ratings of teaching, subtle gender differences in language existed in the student comments, indicating that implicit biases about women may be present in student evaluations of faculty teaching.

Online Health Information Seeking Among US Adults: Measuring Progress Toward a Healthy People 2020 Objective.

OBJECTIVE: During the past decade, the availability of health information online has increased dramatically. We assessed progress toward the Healthy People 2020 (HP2020) health communication and health information technology objective of increasing the proportion of health information seekers who easily access health information online. METHODS: We used data from 4 administrations of the Health Information National Trends Survey (HINTS 2008-2017) (N = 18 103). We conducted multivariable logistic regression analysis to evaluate trends over time in experiences with accessing health information and to examine differences by sociodemographic variables (sex, age, race/ethnicity, education, income, metropolitan status) separately for those who used the internet (vs other information sources) during their most recent search for health information. RESULTS: Among US adults who looked for health information and used the internet for their most recent search, the percentage who reported accessing health information without frustration was stable during the study period (from 37.2% in 2008 to 38.5% in 2017). Accessing information online without frustration was significantly and independently associated with age 35-49 (vs age 18-34) (odds ratio [OR] = 1.34; 95% confidence interval [CI], 1.03 -1.73), non-Hispanic black (vs non-Hispanic white) race/ethnicity (OR = 2.15; 95% CI, 1.55-2.97), and annual household income <$20 000 (vs >$75 000) (OR = 0.66; 95% CI, 0.47-0.93). The percentage of adults who used an information source other than the internet and reported accessing health information online without frustration ranged from 31.3% in 2008 to 42.7% in 2017. Survey year 2017 (vs 2008) (OR = 1.61; 95% CI, 1.09-2.35) and high school graduate education (vs college graduate) (OR = 0.69; 95% CI, 0.49-0.97) were significantly and independently associated with accessing health information without frustration from sources other than the internet. CONCLUSIONS: The percentage of online health information seekers reporting easily accessing health information did not meet the HP2020 objective. Continued efforts are needed to enable easy access to online health information among diverse populations.

Association of elevated serumfree light chains with chronic lymphocytic leukemia and monoclonal B-cell lymphocytosis.

Chronic lymphocytic leukemia (CLL) and its precursor, monoclonal B-cell lymphocytosis (MBL), are heritable. Serumfree light-chain (sFLC) measures are a prognostic factor for CLL, but their role in susceptibility to CLL is not clear. We investigated differences between sFLC measurements in pre-treatment serum from five groups to inform the association of sFLC with familial and sporadic CLL: (1) familial CLL (n = 154), (2) sporadic CLL (n = 302), (3) familial MBL (n = 87), (4) unaffected first-degree relatives from CLL/MBL families (n = 263), and (5) reference population (n = 15,396). The percent of individuals having elevated monoclonal and polyclonal sFLCs was compared using age-stratified and age- and sex-adjusted logistic regression models. In age groups >50 years, monoclonal sFLC elevations were increased in sporadic and familial CLL cases compared to the reference population (p's < 0.05). However, there were no statistically significant differences in sFLC monoclonal or polyclonal elevations between familial and sporadic CLL cases (p's > 0.05). Unaffected relatives and MBL cases from CLL/MBL families, ages >60 years, showed elevated monoclonal sFLC, compared to the reference population (p's < 0.05). This is the first study to demonstrate monoclonal sFLC elevations in CLL cases compared to controls. Monoclonal sFLC levels may provide additional risk information in relatives of CLL probands.

Tracking Healthy People 2020 Internet, Broadband, and Mobile Device Access Goals: An Update Using Data From the Health Information National Trends Survey.

BACKGROUND: As the year 2020 approaches, there is a need to evaluate progress toward the United States government's Healthy People 2020 (HP2020) health information technology and communication objectives to establish baselines upon which Healthy People 2030 objectives can be based. OBJECTIVE: The aim of this study was to use the National Cancer Institute's (NCI) Health Information National Trends Survey (HINTS) to benchmark progress toward HP2020 goals related to increasing internet access using broadband, and to assess the state of the digital divide for various sociodemographic groups. METHODS: We merged and analyzed data from 8 administrations of HINTS (2003-2017). Descriptive statistics were generated, and predicted marginals were calculated using interaction terms between survey year and selected sociodemographic variables of interest, including age, sex, race and ethnicity, income, education, and geography (rural versus urban), to test for differential change over time. RESULTS: The number of users having access to the internet increased between 2003 and 2014 (63.15% [3982/6358] to 83.41% [2802/3629]); it remained relatively steady from 2014 to 2017 (81.15% [2533/3283]). Broadband access increased between 2003 and 2011 (from 32.83% [1031/3352] to 77.87% [3375/4405]), but has been declining since (55.93% [1364/2487] in 2017). Access via cellular network increased between 2008 and 2017 (from 6.86% [240/4405] to 65.43% [1436/2489]). Statistically significant disparities in overall internet access were noted in the predicted marginals for age, sex, race and ethnicity, income, and education; for age, sex, income, and geography for broadband access; and for age and sex for cellular network. CONCLUSIONS: The targets set forth in HP2020 were met for overall internet access and for internet access via cellular network; however, the target was not met for internet access via broadband. Furthermore, although the digital divide persisted by sociodemographic characteristics, the magnitude of many disparities in access decreased over time.

Perceived knowledge of palliative care among immigrants to the United States: a secondary data analysis from the Health Information National Trends Survey.

BACKGROUND: Immigrants to North America receive more interventions at end of life potentially due to knowledge gaps. The primary objective of this study was to measure and describe levels of perceived knowledge about palliative care among immigrants to the United States (US) compared to those born in the US. Our secondary objective was to identify trusted sources for seeking information about palliative care among immigrants and compare these trusted sources with those born in the US. We hypothesized that immigrants would have less knowledge of palliative care than those born in US and would trust different sources for information about palliative care. METHODS: We analyzed data from the nationally representative 2018 Health Information National Trends Survey (HINTS 5, cycle 2). Questionnaires were administered via mail between January and May 2018 to a population-based sample of adults. The primary outcome of interest was assessed using the item "How would you describe your level of knowledge about palliative care?" The secondary outcome of interest was determined using the item "Imagine you had a strong need to get information about palliative care, which of the following would you most trust as a source of information about palliative care?" Descriptive statistics were calculated, and bivariate analyses run between the outcomes of interest and sociodemographic characteristics (age, sex, education, race/ethnicity, nativity, fluency with English). Multivariable logistic regressions were conducted to assess the role of nativity, controlling for relevant sociodemographic variables. Jackknife weighting was used to generate population-level estimates. RESULTS: About 70% of those born in the US and 77% of immigrants (weighted) responded that they had "never heard of palliative care." Trusted sources of palliative care were very similar between the groups (all P>0.05). Both groups' preferred trusted source of palliative care knowledge was "health care provider," with over 80% of respondents in each group selecting this option. Printed materials and social media were the least popular trusted sources among both groups. After adjusting for relevant sociodemographic characteristics, we found no association between poor knowledge of palliative care and nativity (P=0.22). Female respondents had 2.5-fold increased odds of reporting low levels of perceived knowledge of palliative care (OR =2.58, 95% CI, 1.76-3.78; P<0.001). Education was an important predictor of perceived knowledge of palliative care; as education level increased, so did perceived knowledge of palliative care (P<0.001). CONCLUSIONS: Perceived knowledge of palliative care is poor generally, regardless of birthplace. Trusted sources for palliative care are similar between immigrants and those born in the US. Education is important and is a strong predictor of perceived knowledge of palliative care. Women perceive they have lower levels of knowledge of palliative care (PC) than men. Differences in end of life care between immigrants and non-immigrants cannot be explained by knowledge differences.

Case-Based Learning in Translational Biomedical Research Education: Providing Realistic and Adaptive Skills for Early-Career Scientists.

PROBLEM: Case-based learning is an established means of educating students in law, business, and medicine; however, this methodology is not often applied to educating translational biomedical researchers. The application of case-based learning to translational biomedical research education allows scholars to actively engage with real-world material and apply their newfound knowledge as it is acquired. APPROACH: Through the Mayo Clinic Center for Clinical and Translational Science (CCaTS), three courses were delivered in 2009-2017 which emphasized case-based learning in clinical and translational science, entrepreneurship, and individualized medicine. Quantitative measures collected in student course reviews upon course completion were analyzed. Additionally, products arising from each course were identified, including publications and startups pitched. OUTCOMES: Analyses demonstrate that case-based learning techniques are well suited to graduate biomedical research education. Furthermore, case studies can be employed throughout the entire clinical and translational spectrum, from basic and preclinical work through to clinical and population-based learning. NEXT STEPS: Within CCaTS, next steps include creating case-based courses in regulatory and team science to continue to allow scholars to learn and apply these critical skills to real-world material. The goal is to continue to provide immersive training opportunities in areas of clinical and translational science that cannot be readily learned in a traditional lecture-based class setting.

Establishing a Current Good Manufacturing Practice Facility for Biomaterials and Biomolecules in an Academic Medical Center.

IMPACT STATEMENT: This article describes the feasibility and path to establishing a current good manufacturing practice biomaterial facility in an academic medical center. It presents a solution to overcome the "Valley of Death" in bench to bedside translation of biomaterials-based medical devices. It sets a good and feasible example to those who are interested in joining the path toward clinical practice/commercialization, and helps to spur other institutions and investigators to think about how they could incorporate in-house processes and facilities to help speed up the translation of their work into first-in-human trials.