Application of team science best practices to the project management of a large, multi-site lung cancer screening research consortium.

Research is increasingly conducted through multi-institutional consortia, and best practices for establishing multi-site research collaborations must be employed to ensure efficient, effective, and productive translational research teams. In this manuscript, we describe how the Population-based Research to Optimize the Screening Process Lung Research Center (PROSPR-Lung) utilized evidence-based Science of Team Science (SciTS) best practices to establish the consortium's infrastructure and processes to promote translational research in lung cancer screening. We provide specific, actionable examples of how we: (1) developed and reinforced a shared mission, vision, and goals; (2) maintained a transparent and representative leadership structure; (3) employed strong research support systems; (4) provided efficient and effective data management; (5) promoted interdisciplinary conversations; and (6) built a culture of trust. We offer guidance for managing a multi-site research center and data repository that may be applied to a variety of settings. Finally, we detail specific project management tools and processes used to drive collaboration, efficiency, and scientific productivity.

Minimizing Thermal Damage During Thulium Laser-Assisted Partial Arytenoidectomy: Pulsed Versus Continuous Cutting in an Ex-Vivo Calf Model.

OBJECTIVES: The 2 µm-wavelength thulium laser is an effective cutter during partial arytenoidectomy, but thermal trauma can damage adjacent laryngeal tissue. Pulsing laser energy may reduce trauma when compared to continuous-wave cutting. This study measured temperature changes, thermal trauma, and time to complete partial arytenoidectomy, with and without pulsing, in an ex-vivo calf model. METHODS: Tissue temperature and time to complete a trans-cartilaginous cut were measured during partial arytenoidectomy on ex-vivo calf vocal folds (N = 24) using a thulium laser in continuous-wave (CW, N = 12) and pulsed-wave (PW, N = 12) modes. Energy was 5 W for CW and PW cuts; pulse-widths were 250, 500, and 750 ms. Thermal damage was analyzed histologically by measuring the depth of lactate dehydrogenase (LDH) inactivation perpendicular to the laser-cut edge at the vocal process. Paired t-tests compared CW and PW modes. RESULTS: Change in temperature was lower using CW (6.5°C) compared to PW modes (250 ms = 18°; 500 ms = 16°; 750 = 19°; P < .05). Trans-cartilaginous cuts were completed faster using CW (37 seconds) compared to PW (250 ms = 136 seconds; 500 ms = 61 seconds; 750 = 44 seconds; P < .05), and both modes delivered the same total Joules. The average depth of LDH depletion (thermal damage) was similar for all cuts. CONCLUSIONS: 1. Thulium laser cuts in continuous-mode unexpectedly produced less tissue heating yet created similar thermal damage than pulsed-mode cuts during simulated partial arytenoidectomy. 2. Trans-cartilaginous cuts were completed significantly faster in continuous-mode as compared to pulsed-mode cutting. 3. Pulsing the thulium laser does not minimize thermal damage compared to continuous wave cutting during thulium laser-assisted partial arytenoidectomy.

"A Gift to My Family for Their Future": Attitudes about Genetic Research Participation.

BACKGROUND: Broad participation in genetic research is needed to promote equitable advances in disease treatment and prevention. OBJECTIVES: The objective of the study was to assess motivations for, and concerns about, genetic research participation. METHODS: The Genetics in Research and Health Care Survey was sent in winter 2017-2018 to 57,331 adult Kaiser Permanente (KP) members from 7 US regions to assess attitudes about genetic testing in health care and research. The survey included an open-ended question on why members would or would not participate in genetic research. Open text responses to this question were coded in the qualitative analysis software Dedoose and analyzed using a thematic analysis approach. Code summaries were organized by major themes, subthemes, and exemplary quotes. RESULTS: Of the 10,369 participants who completed the survey, 2,645 (25%) provided a comment describing reasons they would or would not participate in research involving genetic testing. Respondents who provided a text comment were 64% female, 49% non-Hispanic (NH) White, 17% Asian/Pacific Islander, 20% Hispanic, and 14% NH Black. The primary themes identified were (1) altruism; (2) decision-making and planning; (3) data use; and (4) data security. These major themes were consistent across each race and ethnic group. CONCLUSIONS: To promote broad participation in genetic research, it is important that recruitment materials address the primary motivators for genetic research participation, including altruism and the potential use of results for personal decision-making. Study materials should also address concerns about possible misuse of genetic information and fears over potential data breaches.

WholeheartedMD: Medical Students Embracing Vulnerability and Finding Fulfillment.

INTRODUCTION: Medical Students experience high levels of stress throughout their four years. When the COVID-19 pandemic exacerbated this, there was a need for programming and this created an opportunity to provide a whole person, lifestyle medicine approach to enhance medical student wellbeing. METHODS: Two student leaders and one faculty member created a 12-week program that addressed the 6 pillars of lifestyle medicine as well as positive psychology. The program was offered to all first year students, and within 12 hours the roster was full with 15 students. The program was held weekly by Zoom for 1-2 hours. RESULTS: Attendance was high each week with full participation from everyone present. In the post program evaluation form, conducted one year after completion of the program, 100% of respondents reported they would recommend this group to another medical student, 71% reported they used tools learned from the group at least weekly. Participants noted that growth mindset, gratitude, mindfulness, priorities, and relationship building were the most used well-being strategies learned in the program. CONCLUSION: An intervention that is based on the 6 pillars of lifestyle medicine and positive psychology and presented by Zoom is feasible in medical school and well accepted by medical students.

Leadership Development in U.S. Undergraduate Medical Education: A Scoping Review of Curricular Content and Competency Frameworks.

PURPOSE: To inform research on developing or adopting leadership competency frameworks for use in U.S. undergraduate medical education (UME), this scoping review describes the content of U.S. UME leadership curricula, associated competency frameworks, and content delivery. METHOD: The authors searched PubMed, Embase, and ERIC databases on June 22, 2020. They included English-language studies that described U.S. UME curricula in which the primary end goal was leadership development. They excluded studies published before January 1, 2000. Data were extracted on leadership competency frameworks and curricular content, audience, duration, electivity, selectivity, learning pedagogies, and outcome measures. The curricular content was coded and categorized within the Medical Leadership Competency Framework (MLCF) using the constant comparative method. A repeated search of the literature on May 14, 2021, did not yield any additional studies. RESULTS: Of 1,094 unique studies, 25 studies reporting on 25 curricula met inclusion criteria. The course content of the curricula was organized into 91 distinct themes, most of which could be organized into the first 2 competencies of the MLCF: Demonstrating Personal Qualities and Working With Others. Thirteen curricula (52%) aligned with leadership competency frameworks, and 12 (48%) did not appear to use a framework. Number of participants and target learner level varied widely, as did curricula duration, with fewer than half (n = 12, 48%) spanning more than 1 semester. Most curricula (n = 14, 56%) were elective, and many (n = 16, 64%) offered experiential learning. Most studies (n = 16, 64%) reported outcomes as student perception data. CONCLUSIONS: The authors found wide variation in content of U.S. UME leadership development curricula, and few curricula aligned with an established leadership competency framework. The lack of professional consensus on the scope of medical leadership and how it should be taught thwarts effective incorporation of medical leadership training within UME.

Three-Dimensional Technology in Rhinoplasty.

Rhinoplasty is uniquely suited to capitalize on different aspects of three-dimensional (3D) modeling technology. Currently, 3D surface imaging of preoperative and postoperative nasal structure provides a platform for better surgical planning and patient counselling as well as objective postoperative measurements. Physical nasal models using 3D printing technology can improve rhinoplasty performance intraoperatively, postoperative outcomes, together with nasal prosthetic manufacture, by tailoring to specific patient anatomy. Advances in tissue engineering using 3D-printed biocompatible scaffolds have shown excellent nasal cartilage mimicry and hold promise for increasingly versatile directed tissue regeneration in rhinoplasty and nasal reconstructive surgery. As health care innovations are expected to become increasingly common in standard rhinoplasty practices in the future, we give an account of how 3D technologies can create new opportunities to optimize surgical planning and improve overall the patient experience.

Feeding intolerance in critically ill patients with COVID-19.

BACKGROUND & AIMS: Early reports suggest significant difficulty with enteral feeding in critically ill COVID-19 patients. This study aimed to characterize the prevalence, clinical manifestations, and outcomes of feeding intolerance in critically ill patients with COVID-19. METHODS: We examined 323 adult patients with COVID-19 admitted to the intensive care units (ICUs) of Massachusetts General Hospital between March 11 and June 28, 2020 who received enteral nutrition. Systematic chart review determined prevalence, clinical characteristics, and hospital outcomes (ICU complications, length of stay, and mortality) of feeding intolerance. RESULTS: Feeding intolerance developed in 56% of the patients and most commonly manifested as large gastric residual volumes (83.9%), abdominal distension (67.2%), and vomiting (63.9%). Length of intubation (OR 1.05, 95% CI 1.03-1.08), ≥1 GI symptom on presentation (OR 0.76, 95% CI 0.59-0.97), and severe obesity (OR 0.29, 95% CI 0.13-0.66) were independently associated with development of feeding intolerance. Compared to feed-tolerant patients, patients with incident feeding intolerance were significantly more likely to suffer cardiac, renal, hepatic, and hematologic complications during their hospitalization. Feeding intolerance was similarly associated with poor outcomes including longer ICU stay (median [IQR] 21.5 [14-30] vs. 15 [9-22] days, P < 0.001), overall hospitalization time (median [IQR] 30.5 [19-42] vs. 24 [15-35], P < 0.001) and in-hospital mortality (33.9% vs. 16.1%, P < 0.001). Feeding intolerance was independently associated with an increased risk of death (HR 3.32; 95% CI 1.97-5.6). CONCLUSIONS: Feeding intolerance is a frequently encountered complication in critically ill COVID-19 patients in a large tertiary care experience and is associated with poor outcomes.

Evaluation of Population-Level Changes Associated With the 2021 US Preventive Services Task Force Lung Cancer Screening Recommendations in Community-Based Health Care Systems.

Importance: The US Preventive Services Task Force (USPSTF) released updated lung cancer screening recommendations in 2021, lowering the screening age from 55 to 50 years and smoking history from 30 to 20 pack-years. These changes are expected to expand screening access to women and racial and ethnic minority groups. Objective: To estimate the population-level changes associated with the 2021 USPSTF expansion of lung cancer screening eligibility by sex, race and ethnicity, sociodemographic factors, and comorbidities in 5 community-based health care systems. Design, Setting, and Participants: This cohort study analyzed data of patients who received care from any of 5 community-based health care systems (which are members of the Population-based Research to Optimize the Screening Process Lung Consortium, a collaboration that conducts research to better understand how to improve the cancer screening processes in community health care settings) from January 1, 2010, through September 30, 2019. Individuals who had complete smoking history and were engaged with the health care system for 12 or more continuous months were included. Those who had never smoked or who had unknown smoking history were excluded. Exposures: Electronic health record-derived age, sex, race and ethnicity, socioeconomic status (SES), comorbidities, and smoking history. Main Outcomes and Measures: Differences in the proportion of the newly eligible population by age, sex, race and ethnicity, Charlson Comorbidity Index, chronic obstructive pulmonary disease diagnosis, and SES as well as lung cancer diagnoses under the 2013 recommendations vs the expected cases under the 2021 recommendations were evaluated using χ2 tests. Results: As of September 2019, there were 341 163 individuals aged 50 to 80 years who currently or previously smoked. Among these, 34 528 had electronic health record data that captured pack-year and quit-date information and were eligible for lung cancer screening according to the 2013 USPSTF recommendations. The 2021 USPSTF recommendations expanded screening eligibility to 18 533 individuals, representing a 53.7% increase. Compared with the 2013 cohort, the newly eligible 2021 population included 5833 individuals (31.5%) aged 50 to 54 years, a larger proportion of women (52.0% [n = 9631]), and more racial or ethnic minority groups. The relative increases in the proportion of newly eligible individuals were 60.6% for Asian, Native Hawaiian, or Pacific Islander; 67.4% for Hispanic; 69.7% for non-Hispanic Black; and 49.0% for non-Hispanic White groups. The relative increase for women was 13.8% higher than for men (61.2% vs 47.4%), and those with a lower comorbidity burden and lower SES had higher relative increases (eg, 68.7% for a Charlson Comorbidity Index score of 0; 61.1% for lowest SES). The 2021 recommendations were associated with an estimated 30% increase in incident lung cancer diagnoses compared with the 2013 recommendations. Conclusions and Relevance: This cohort study suggests that, in diverse health care systems, adopting the 2021 USPSTF recommendations will increase the number of women, racial and ethnic minority groups, and individuals with lower SES who are eligible for lung cancer screening, thus helping to minimize the barriers to screening access for individuals with high risk for lung cancer.

Return of Research-Related Genetic Test Results and Genetic Discrimination Concerns: Facilitators and Barriers of Genetic Research Participation in Diverse Groups.

BACKGROUND: Most genetics studies lack the diversity necessary to ensure that all groups benefit from genetic research. OBJECTIVES: To explore facilitators and barriers to genetic research participation. METHODS: We conducted a survey on genetics in research and healthcare from November 15, 2017 to February 28, 2018 among adult Kaiser Permanente (KP) members who had been invited to participate in the KP biobank (KP Research Bank). We used logistic regression to calculate adjusted odds ratios (ORs) and 95% confidence intervals (CIs) comparing the willingness to participate in genetic research under different return of results scenarios and genetic discrimination concerns between groups, according to their demographic characteristics. RESULTS: A total of 57,331 KP members were invited to participate, and 10,369 completed the survey (18% response rate). Respondents were 65% female, 44% non-Hispanic White (NH White), 22% Asian/Native Hawaiian or other Pacific Islander (Asian/PI), 19% non-Hispanic Black (NH Black), and 16% Hispanic. Respondents willing to participate in genetic research ranged from 22% with no results returned to 87% if health-related genetic results were returned. We also found variation by race/ethnicity; when no results were to be returned, Asian/PIs, Hispanics, and NH Blacks were less likely to want to participate than NH Whites (p < 0.05). However, when results were returned, disparities in the willingness to participate disappeared for NH Blacks and Hispanics. Genetic discrimination concerns were more prevalent in Asian/PIs, Hispanics, and NH Blacks than in NH Whites (p < 0.05). CONCLUSIONS: Policies that prohibit the return of results and do not address genetic discrimination concerns may contribute to a greater underrepresentation of diverse groups in genetic research.

Real-world Clinical Implementation of Lung Cancer Screening-Evaluating Processes to Improve Screening Guidelines-Concordance.

BACKGROUND: Lung cancer screening (LCS) requires complex processes to identify eligible patients, provide appropriate follow-up, and manage findings. It is unclear whether LCS in real-world clinical settings will realize the same benefits as the National Lung Screening Trial (NLST). OBJECTIVE: To evaluate the impact of process modifications on compliance with LCS guidelines during LCS program implementation, and to compare patient characteristics and outcomes with those in NLST. DESIGN: Retrospective cohort study. SETTING: Kaiser Permanente Colorado (KPCO), a non-profit integrated healthcare system. PATIENTS: A total of 3375 patients who underwent a baseline lung cancer screening low-dose computed tomography (S-LDCT) scan between May 2014 and June 2017. MEASUREMENTS: Among those receiving an S-LDCT, proportion who met guidelines-based LCS eligibility criteria before and after LCS process modifications, differences in patient characteristics and outcomes between KPCO LCS patients and the NLST cohort, and factors associated with a positive screen. RESULTS: After modifying LCS eligibility confirmation processes, patients receiving S-LDCT who met guidelines-based LCS eligibility criteria increased from 45.6 to 92.7% (P < 0.001). Prior to changes, patients were older (68 vs. 67 years; P = 0.001), less likely to be current smokers (51.3% vs. 52.5%; P < 0.001), and less likely to have a ≥ 30-pack-year smoking history (50.0% vs. 95.3%; P < 0.001). Compared with NLST participants, KPCO LCS patients were older (67 vs. 60 years; P < 0.001), more likely to currently smoke (52.3% vs. 48.1%; P < 0.001), and more likely to have pulmonary disease. Among those with a positive baseline S-LDCT, the lung cancer detection rate was higher at KPCO (9.4% vs. 3.8%; P < 0.001) and was positively associated with prior pulmonary disease. CONCLUSION: Adherence to LCS guidelines requires eligibility confirmation procedures. Among those with a positive baseline S-LDCT, comorbidity burden and lung cancer detection rates were notably higher than in NLST, suggesting that the study of long-term outcomes in patients undergoing LCS in real-world clinical settings is warranted.

Demographic differences in the utilization of clinical and direct-to-consumer genetic testing.

Genetic testing has increased over the last decade due to growth in the number of clinical and direct-to-consumer (DTC) tests. However, there is uncertainty about how increased DTC genetic testing affects disparities. Between November 2017 and February 2018, a nationwide electronic survey on experiences with genetic testing was conducted among adult Kaiser Permanente members. Logistic regression was used to calculate adjusted odds ratios and 95% confidence intervals comparing receipt of clinical and DTC genetic testing between groups by race and ethnicity. Invitations were sent to 57,331 members, and 10,369 surveys were completed. 22% of respondents had received genetic testing (17% DTC and 5% provider-ordered). Non-Hispanic Whites were more likely than other groups to have clinical genetic testing but were similar to Hispanics and non-Hispanic Blacks in rates of DTC genetic testing. Among those who received any health-related genetic test, 10% reported abnormal results. Of these, non-Hispanic Whites were more likely than other racial/ethnic groups to speak to a medical professional about abnormal results. Results suggest that racial/ethnic disparities in the use of clinical genetic services persist. Additional research is needed to identify lessons learned from DTC genetic testing that may increase equity in the use of clinical genetic services.

Physician Experience with Direct-To-Consumer Genetic Testing in Kaiser Permanente.

Health systems and physicians nationwide aspire to consistently and reliably apply genetic and genomic information to guide disease prevention, management, and treatment. However, clinical information, including genetics/genomics data from within and outside of the care delivery system, is expanding rapidly. Between November 2017 and April 2018, we surveyed 1502 Permanente Medical Group primary care and specialist physicians to assess the degree to which direct-to-consumer genetic test results were being presented to physicians and identify genetics educational needs among physicians (response rate 15%). Adjusted logistic regression (according to respondent characteristics) was used to calculate adjusted odds ratios (ORs) and 95% confidence intervals (CIs) comparing responses within groups. Results showed 35% and 12% of respondents reported receiving at least one direct-to-consumer health risk genetic result (DTC-health risk) or direct-to-consumer pharmacogenomic test result (DTC-PGx), respectively, from a patient in the past year. Of those receiving at least one test result, 40% (DTC-health risk) and 39% (DTC-PGx) of physicians reported 1+ referral(s); 78% (DTC-health risk) and 42% (DTC-PGx) of referrals were to clinical genetics. In total, 85% of physicians would spend ≥2 h/year on genetics/genomics education.

Financial burden and quality of life among early-onset colorectal cancer survivors: A qualitative analysis.

BACKGROUND: Colorectal cancer (CRC) diagnosed at ages <50 years old (early-onset CRC) has been increasing in the United States, resulting in a growing number of early-onset CRC survivors who may face significant financial and quality of life (QOL) challenges. OBJECTIVE: Identify themes from a patient advocate discussion about the impact of CRC on financial burden and QOL among early-onset CRC survivors. METHODS: We conducted a semi-structured, stakeholder discussion among 14 early-onset CRC survivors and one caregiver who were members of an advocacy group. The discussion focused on the financial and overall QOL impacts of CRC. The meeting was recorded, transcribed and coded in ATLAS.ti, using a thematic analysis approach. RESULTS: Cancer stage at diagnosis among advocates with CRC ranged from 2 to 4; about half of the attendees had no evidence of disease, and about half were undergoing treatment. Employment (career trajectory, lost wages, health insurance/benefits, performance) emerged as the dominant theme of the financial impacts discussion. Lifestyle impacts of disease and survivorship included both emotional and physical side-effects. Diagnosis experience, missing information about CRC treatment and side-effects, financial stress and strain on relationships were the primary themes for the overall QOL impacts. CONCLUSION: Given the growing incidence of CRC in those under 50, it is particularly important for providers to be aware of these patients' financial, emotional and QOL needs, and to develop care plans that specifically address these areas of concern for early-onset CRC survivors.

Optimizing patient-reported outcome and risk factor reporting from cancer survivors: a randomized trial of four different survey methods among colorectal cancer survivors.

PURPOSE: The goal of this study was to determine response rates and associated costs of different survey methods among colorectal cancer (CRC) survivors. METHODS: We assembled a cohort of 16,212 individuals diagnosed with CRC (2010-2014) from six health plans, and randomly selected 4000 survivors to test survey response rates across four mixed-mode survey administration protocols (in English and Spanish): arm 1, mailed survey with phone follow-up; arm 2, interactive voice response (IVR) followed by mail; arm 3; email linked to web-based survey with mail follow-up; and arm 4, email linked to web-based survey followed by IVR. RESULTS: Our overall response rate was 50.2%. Arm 1 had the highest response rate (59.9%), followed by arm 3 (51.9%), arm 2 (51.2%), and arm 4 (37.9%). Response rates were higher among non-Hispanic whites in all arms than other racial/ethnic groups (p < 0.001), among English (51.5%) than Spanish speakers (36.4%) (p < 0.001), and among higher (53.7%) than lower (41.4%) socioeconomic status (p < 0.001). Survey arms were roughly comparable in cost, with a difference of only 8% of total costs between the most (arm 2) and least (arm 3) expensive arms. CONCLUSIONS: Mailed surveys followed by phone calls achieved the highest response rate; email invitations and online surveys cost less per response. Electronic methods, even among those with email availability, may miss important populations including Hispanics, non-English speakers, and those of lower socioeconomic status. IMPLICATIONS FOR CANCER SURVIVORS: Our results demonstrate effective methods for capturing patient-reported outcomes, inform the relative benefits/disadvantages of the different methods, and identify future research directions.