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BACKGROUND: Patient education is an essential element to quality health care, both in the physical health and mental health care arenas. Providers use written materials as tools to educate, but benefits are dependent on learners' reading and comprehension abilities. OBJECTIVE: The purpose of this descriptive study was to evaluate adequacy of reading level and readability of psychotropic medication patient handouts. STUDYDESIGN: Reading level and readability of 15 psychotropic medication patient handouts were evaluated using the SMOG formula and the Readability Assessment Instrument, respectively. RESULTS: All 15 handouts were written at inadequate reading levels and readability. Reading levels were above 12th grade, with a mean of 13.5 (+/- 1.5 grades), and overall readability was below the acceptable score of 80% (M= 6%). CONCLUSIONS: Inadequate reading skills and comprehension may impede patients' learning and their ability to understand their illness and follow provider instructions. Providers must ensure education materials are written at adequate reading and readability levels to optimize learning and maximize desired outcomes related to treatment. [ABSTRACT FROM AUTHOR]

Background: Seclusion and/or restraints (S/R) usage is a legal, moral, and ethical issue of patient rights and safety. Current emphasis is on using lesser restrictive interventions (LRI) in crisis management. Objective: This descriptive/correlational study examined the relationship of LRI with S/R usage, average years of psychiatric experience of nursing staff, and staff mix. Study design: The sample included 82 events requiring crisis intervention. Data were collected at a state mental health facility using a crisis cycle intervention tool and staff questionnaire. Results: Data revealed a significant relationship between LRI and S/R usage and a significant positive relationship between percentage of licensed nurses and LRI. However, the relationship between average years of psychiatric experience and LRI was not significant. Fourteen percent of LRI could be predicted by percentage of licensed staff. Conclusion: The findings supported using LRI in crisis management. Using LRI individualized to the crisis event promotes a safer, more therapeutic environment for both parties and staff. The findings revealed the need to evaluate the impact of a change in staff mix on quality of care and desired outcomes. Further research is needed to explore the multiple variables that influence LRI. [ABSTRACT FROM AUTHOR]

Racial and ethnic disparities in cancer prevalence, survival, and mortality are thoroughly documented in the literature. Strategies to overcome the barriers to optimal cancer screening and management rely on effective communication and knowledge of sociocultural differences among minority populations. [ABSTRACT FROM AUTHOR]

Informed and shared decision making are hallmarks of quality medical care. Although decision aids (e.g., brochures, decision boards, videos, interactive computer programs) can impart useful information, there is a dearth of work on theory-based approaches that help people clarify preferences and select a favored alternative. Decision counseling is a novel method that has been developed to address this need. In a decision counseling session, provider and patient identify personal values associated with decision alternatives, weigh the influence of relevant factors, clarify preference, and select an option from available alternatives. Decision counseling is described here in relation to 3 decision-making situations (i.e., having cancer screening, being tested for cancer risk, and joining a cancer chemoprevention trial). Preliminary findings suggest that decision counseling can help to clarify personal preferences related to health behavior choices and, thus, facilitate achievement of the ideals of informed and shared decision making. ((c) 2005 APA, all rights reserved). [ABSTRACT FROM AUTHOR]

Focus groups with African American women who - had experienced a breast biopsy were conducted during the process of 'getting ready' for a breast biopsy educational study in which the intervention's educational materials and study instruments were developed and pre-tested. Recommendations were made for revising the breast biopsy educational booklet. As a result of the focus group discussions, changes were made in several of the graphics, the design and size of the booklet, and the tone of the piece. In addition, language describing the biopsy procedure was further simplified. The outcomes of this study were culturally tailored study materials to be used in an educational intervention to prepare African American women undergoing a breast biopsy procedure. [ABSTRACT FROM AUTHOR]

OBJECTIVE: We report race-related differences in response to behavioral interventions in colorectal cancer (CRC) screening. METHODS: From 2002 through 2005, a total of 1430 primary care patients (578 whites and 852 African Americans) from Jefferson Family Medicine Associates, a large primary care practice affiliated with Thomas Jefferson University, completed a baseline survey and were randomized to 1 of 4 groups, as follows: control (usual care), standard intervention (SI), tailored intervention (TI), or tailored intervention plus phone (TIP). The SI group received a targeted print intervention by mail. The TI group received the targeted intervention and tailored message pages that addressed perceptions related to screening. The TIP group received the targeted intervention, tailored message pages, and a telephone reminder. RESULTS: CRC screening rates for whites and African Americans were comparable in usual care (33% versus 32%, respectively). In response to intervention, however, whites exhibited significantly higher (p=0.005) screening rates than African Americans (53% versus 43%, respectively; adjusted OR=1.44; 95% CI=1.12-1.86). This effect is largely explained by differential response to mailed print interventions. CONCLUSIONS: Whites and African Americans may respond differently to mailed interventions intended to increase CRC screening. Research is needed on methods that can both increase screening and racial equity in screening. [ABSTRACT FROM AUTHOR]

Shared decision making (SDM) between health care professionals and patients is essential to help patients make well informed choices about lung cancer screening (LCS). Patients who participate in SDM have greater LCS knowledge, reduced decisional conflict, and improved adherence to annual screening compared with patients who do not participate in SDM. SDM tools are acceptable to patients and clinicians. The importance of SDM in LCS is emphasized in recommendations from professional organizations and highlighted as a priority in the 2022 President's Cancer Panel Report. The updated 2022 national coverage determination from the Centers for Medicare & Medicaid Services reaffirms the value of SDM in offering LCS to eligible beneficiaries. The Shared Decision-Making Task Group of the American Cancer Society National Lung Cancer Roundtable undertook a group consensus process to identify priorities for research and implementation related to SDM for LCS and then evaluated current knowledge in these areas. Priority areas included: (1) developing feasible, adaptable SDM training programs for health care professionals; (2) understanding the impact of alternative health system LCS models on SDM practice and outcomes; (3) developing and evaluating new patient decision aids for use with diverse populations and in varied settings; (4) offering conceptual clarity about what constitutes a high-quality decision and developing appropriate quality measures; and (5) studying the use of prediction-augmented screening to support SDM in practice. Gaps in current research in all areas were observed. The authors conclude with a research and implementation agenda to advance the quality and implementation of SDM for persons who might benefit from LCS., (© 2024 American Cancer Society. This article has been contributed to by U.S. Government employees and their work is in the public domain in the USA.)

Objective: To understand the feelings of pediatrics residents early in the COVID-19 pandemic and to offer insights still relevant today., Methods: We performed a thematic analysis exploring resident feelings early in the pandemic using free-text responses on a national survey distributed between May and June 2020. We analyzed responses from the following multi-part free text question embedded in the larger survey, "Which of the following feelings have you experienced in your role as a pediatric resident during the COVID-19 pandemic" with response prompts including relief, guilt, pride, sadness, worry, fear, and other., Results: While many feelings that respondents shared were common to society at large, some were specific to their intersecting roles as healthcare workers, pediatricians, and trainees. Some issues uncovered have continued relevance today including varied interactions with program and institutional leadership, training away from established support networks and during an important life stage, and societal concerns., Conclusions: This study uncovered vulnerabilities inherent to being a trainee such as limited control over one's own schedule or institutional policies and training away from established supports. Their feelings shine light on the moral distress experienced in residency and the role program and institutional leadership can play in the experiences of residents., Competing Interests: Declaration of Competing Interest Dr. Schumacher is funded by the American Board of Pediatrics Foundation and serves as the chair of the American Board of Pediatrics Competency-Based Medical Education Committee for which he receives honoraria and travel reimbursement. Dr. Schwartz serves as Director of APPD Longitudinal Educational Assessment Research Network through a contract from APPD to his institution. Dr. Winn is funded by the American Board of Pediatrics Foundation and serves on the American Board of Pediatrics Competency-Based Medical Education Committee for which she receives honoraria and travel reimbursement. In addition, Dr. Winn receives compensation for her role as a medical advisor for Goode Health. Dr. Unaka is faculty for the Institute for Healthcare Improvement focused on supporting a collaborative sponsored by Department of Healthcare Services (DHCS). All other authors report no conflicts of interest or disclosures., (Copyright © 2024. Published by Elsevier Inc.)

Introduction: Lung cancer screening rates are very low despite a level B recommendation from the United States Preventive Services Task Force since 2013 and clear evidence that lung cancer screening reduces mortality. The Center for Medicare and Medicaid Services requires shared decision-making (SDM) for lung cancer screening reimbursement. The objective of this study was to determine the effect of an SDM intervention on lung cancer screening in primary care., Methods: The study design was a single-arm clinical trial design. The intervention included phone contact outside of a primary care visit and the use of the Decision Counseling Program ®, an online interactive decision aid focused on determining the factors which influence patients to screen or not screen, prioritizing those factors, and determining a decision preference score. The primary outcome was the completion of low-dose computed tomography scan (LDCT) 1 year after the SDM session compared in participants versus nonparticipants., Results: From six practices, there were 1359 potentially eligible patients in electronic medical record data, and 336 were reached to assess eligibility criteria. A total of 80 patients consented to be in the study, 64 completed a decision counseling session and 16 did not complete a session. Among the 64 people who agreed to have decision counseling, 45% had LDCT, higher than typically seen in routine clinical practice. Although not a comparable group, among the 16 people who declined decision counseling, none had LDCT., Conclusions: Decision counseling is a promising intervention that might support SDM in the context of improving uptake of lung cancer screening in primary care. However, further, larger studies are needed., Competing Interests: Declaration of conflicting interestsThe author(s) declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article.

Introduction: Clinical trials are being conducted and are being planned to assess the safety and efficacy of multi-cancer early detection (MCED) tests for use in cancer screening. This study aimed to determine the feasibility of primary care patient outreach in recruiting participants to a planned MCED clinical trial, assess patient interest in trial participation, and measure decisional conflict related to participation., Methods: The research team used the electronic medical record of a large, urban health care system to identify primary care patients 50-80 years of age who were potentially eligible for a planned MCED trial. We mailed information about the planned MCED trial to identified patients and then contacted the patients by telephone to obtain consent and administer a baseline survey. Subsequently, we contacted consented patients to complete an interview to review the mailed information and elicit perceptions about trial participation. Finally, a research coordinator administered an endpoint telephone survey to assess patient interest in and decisional conflict related to joining the trial., Results: We randomly identified 1000 eligible patients and were able to make contact with 690 (69%) by telephone. Of the patients contacted, 217 (31%) completed the decision counseling session and 219 (32%) completed the endpoint survey. Among endpoint survey respondents, 177 (81%) expressed interest in joining the MCED trial and 162 (74%) reported low decisional conflict., Conclusions: Most patients were contacted and about a quarter of those contacted expressed interest in and low decisional conflict about joining the planned MCED trial. Research is needed to determine how to optimize patient outreach and engage patients in shared decision-making about MCED trial participation., (© 2024 The Author(s). Cancer Medicine published by John Wiley & Sons Ltd.)

Multi-cancer early detection tests (MCEDs) are blood-based tests that detect biomarkers released or induced by cancer cells. If MCED tests are shown to be safe and effective in cancer screening, they are likely to be ordered and managed in primary care. To understand primary care providers' support for and concerns about the implementation and management of MCED testing, the research team developed a cross-sectional survey that was sent to 939 primary care providers (physicians, residents/fellows, and advanced practice providers) in a large academic health system in the greater Philadelphia area. The survey included standard items used to assess provider background characteristics and to measure provider awareness of challenges related to MCED test use (7 items), perceived competence in MCED testing (5 items), and receptivity to MCED test use in the future (4 items). A total of 351 (37.4%) primary care providers completed the survey. Among respondents, the awareness of challenges in MCED testing (mean = 3.95, sd = 0.64), perceived competence (3.67, sd = 0.85), and receptivity to MCED use in practice (mean = 3.62, 0.75) were moderately high. Multiple regression was performed to identify factors associated with receptivity to MCED testing. We found that provider number of years in practice (DATA), awareness of challenges related to MCED testing (DATA), and perceived competence in MCED test use (DATA) were positively and significantly associated with receptivity to MCED test use in practice. An exploratory factor analysis extracted two components: receptivity to MCEDs and awareness of challenges. Surprisingly, these factors had a positive correlation (r = 0.124, p = 0.024). Providers' perceived competence in using MCED tests and providers' experience level were significantly associated with receptivity to MCED testing. While there was strong agreement with potential challenges to implementing MCEDs, PCPs were generally receptive to using MCEDs in cancer screening. Keeping PCPs updated on the evolving knowledge of MCEDs is likely critical to building receptivity to MCED testing.

Multi-cancer early detection (MCED) tests are being developed, but little is known about patient receptivity to their use for cancer screening. The current study assessed patient interest in such testing. Our team conducted a prospective, observational study among primary care patients in a large, urban health system. They were asked to complete a telephone survey that briefly described a new blood test in development to identify multiple types of cancer, but was not currently recommended or covered by insurance. The survey included items to assess respondent background characteristics, perceptions about MCED testing, and interest in having such an MCED test. We also used multivariable analyses to identify factors associated with patient interest in test use. In 2023, we surveyed 159 (32%) of 500 identified patients. Among respondents, 125 (79%) reported a high level of interest in having an MCED test. Interest was not associated with personal background characteristics, but was positively associated with the following expectations: testing would be recommended for cancer screening, be convenient, and be effective in finding early-stage disease (OR = 11.70, 95% CI: 4.02, 34.04, p < 0.001). Research is needed to assess patient interest and actual uptake when detailed information on testing is presented in routine care.

Background: Lung cancer screening uptake for individuals at high risk is generally low across the United States, and reporting of lung cancer screening practices and outcomes is often limited to single hospitals or institutions. We describe a citywide, multicenter analysis of individuals receiving lung cancer screening integrated with geospatial analyses of neighborhood-level lung cancer risk factors., Methods: The Philadelphia Lung Cancer Learning Community consists of lung cancer screening clinicians and researchers at the 3 largest health systems in the city. This multidisciplinary, multi-institutional team identified a Philadelphia Lung Cancer Learning Community study cohort that included 11 222 Philadelphia residents who underwent low-dose computed tomography for lung cancer screening from 2014 to 2021 at a Philadelphia Lung Cancer Learning Community health-care system. Individual-level demographic and clinical data were obtained, and lung cancer screening participants were geocoded to their Philadelphia census tract of residence. Neighborhood characteristics were integrated with lung cancer screening counts to generate bivariate choropleth maps., Results: The combined sample included 37.8% Black adults, 52.4% women, and 56.3% adults who currently smoke. Of 376 residential census tracts in Philadelphia, 358 (95.2%) included 5 or more individuals undergoing lung cancer screening, and the highest counts were geographically clustered around each health system's screening sites. A relatively low percentage of screened adults resided in census tracts with high tobacco retailer density or high smoking prevalence., Conclusions: The sociodemographic characteristics of lung cancer screening participants in Philadelphia varied by health system and neighborhood. These results suggest that a multicenter approach to lung cancer screening can identify vulnerable areas for future tailored approaches to improving lung cancer screening uptake. Future directions should use these findings to develop and test collaborative strategies to increase lung cancer screening at the community and regional levels., (© The Author(s) 2023. Published by Oxford University Press.)

Competing Interests: Declaration of Competing Interest The authors have no conflicts of interest to disclose.

Competing Interests: Declaration of Competing Interest The authors have no conflicts of interest to disclose.

Genomic tests are being developed for use in cancer screening. As most screening is offered in primary care settings, primary care provider and patient perceptions of such tests are likely to affect uptake. We conducted a scoping review to synthesize information on factors likely to affect patient and provider use of biospecimen collection and analysis for cancer screening, methods referred to as liquid biopsy or multi-cancer early detection (MCED) testing when used to detect multiple cancers. We ultimately identified 7 articles for review and analyzed them for major themes. None reported on primary care provider perspectives. Six articles focused on patient perceptions about testing for a single cancer (colorectal), and 1 reported on patient views related to testing for multiple cancers. Factors favoring this type of testing included its non-invasiveness, and the perceived safety, convenience, and effectiveness of testing. There is a dearth of information in the literature on primary care provider perceptions about liquid biopsy and MCED testing. The limited information on patient perceptions suggests that they are receptive to such tests. Research on primary care provider and patient test-related knowledge, attitudes, and behavior is needed to guide future implementation in primary care settings.

Objective: Five pediatric residency programs implemented true X + Y scheduling in 2018 where residents have continuity clinic in "blocks" rather than half-day per week experiences. We report the impact X + Y scheduling has on pediatric resident and faculty perceptions of patient care and other educational experiences over a 3-year timeframe., Methods: Electronic surveys were sent to residents and faculty of the participating programs prior to implementing X + Y scheduling and annually thereafter (2018-2021). Survey questions measured resident and faculty perception of continuity clinic schedule satisfaction and the impact of continuity clinic schedules on inpatient and subspecialty rotations. Data were analyzed using z-tests for proportion differences., Results: One hundred and eight six residents were sent the survey preimplementation and 254 to 289 postimplementation with response rates ranging from 47% to 69%. Three hundred and seventy-eight to 395 faculty members were sent the survey with response rates ranging from 26% to 51%. Statistically significant (P < .05) sustained perceived improvements over 3 years with X+Y were seen in outpatient continuity, inpatient workflow, and time for teaching both inpatient and in continuity clinic., Conclusions: X + Y scheduling can lead to perceived improvements in various aspects of pediatric residency programs. Our study demonstrates these improvements have been sustained over 3 years in the participating programs., (Copyright © 2022 Academic Pediatric Association. Published by Elsevier Inc. All rights reserved.)

Current guidelines recommend annual lung cancer screening (LCS), but rates are low. The current study evaluated strategies to increase LCS. This study was a randomized controlled trial designed to evaluate the effects of patient outreach and shared decision making (SDM) about LCS among patients in four primary care practices. Patients 50 to 80 years of age and at high risk for lung cancer were randomized to Outreach Contact plus Decision Counseling (OC-DC, n = 314), Outreach Contact alone (OC, n = 314), or usual care (UC, n = 1748). LCS was significantly higher in the combined OC/OC-DC group versus UC controls (5.5% vs. 1.8%; hazard ratio, HR = 3.28; 95% confidence interval, CI: 1.98 to 5.41; p = 0.001). LCS was higher in the OC-DC group than in the OC group, although not significantly so (7% vs. 4%, respectively; HR = 1.75; 95% CI: 0.86 to 3.55; p = 0.123). LCS referral/scheduling was also significantly higher in the OC/OC-DC group compared to controls (11% v. 5%; odds ratio, OR = 2.02; p = 0.001). We observed a similar trend for appointment keeping, but the effect was not statistically significant (86% v. 76%; OR = 1.93; p = 0.351). Outreach contacts significantly increased LCS among primary care patients. Research is needed to assess the additional value of SDM on screening uptake., (Copyright © 2022 Elsevier Inc. All rights reserved.)

In this article, the authors describe the impact of the COVID-19 pandemic on pediatric graduate medical education (GME), including the impact on clinical experiences for trainees, teaching methods used, trainee wellness, GME leader wellness and support, and the traditional interview process. A thorough literature review was done to identify impacts of the COVID-19 pandemic on pediatric GME. In addition, information was collected through Association of Pediatric Program Directors virtual cafes and conferences. Positive changes for GME from the COVID-19 pandemic included: the rapid transition to telehealth; asynchronous learning allowing for increased cross-program collaboration; innovative online teaching modalities; increased flexibility and decreased cost of online recruitment; and shared innovations across pediatric GME. Challenging aspects of the COVID-19 pandemic included: decreased learning about common childhood illnesses, such as bronchiolitis, acute otitis media, and influenza; decreased patient volumes and patient complexity in clinics and inpatient wards, leading to less practice developing efficiency, time management, and triaging skills; and an increased burden on trainees, including moral distress and decreased support from one another and other social supports. The COVID-19 pandemic has highlighted important opportunities in U.S. educational systems. As medical educators move forward, it will be important to learn from these while mitigating the negative impacts., (Copyright © 2021 by the Association of American Medical Colleges.)

Background: One challenge in high-quality lung cancer screening (LCS) is maintaining adherence with annual and short-interval follow-up screens among high-risk individuals who have undergone baseline low-dose CT (LDCT). This study aimed to characterize attitudes and beliefs toward lung cancer and LCS and to identify factors associated with LCS adherence., Methods: We administered a questionnaire to 269 LCS participants to assess attitudes and beliefs toward lung cancer and LCS. Clinical data including sociodemographics and screening adherence were obtained from the LCS Program Registry., Results: African-American individuals had significantly greater lung cancer worries compared with Whites (6.10 vs. 4.66, P < .001). In making the decision to undergo LCS, African-American participants described screening convenience and cost as very important factors significantly more frequently than Whites (60% vs. 26.8%, P< .001 and 58.4% vs. 37.8%, P = .001; respectively). African-American individuals with greater than high school education had significantly higher odds of LCS adherence (aOR 2.55; 95% CI, 1.14-5.60) than Whites with less than high school education. Participants who described screening convenience and cost as "very important" had significantly lower odds of completing screening follow-up after adjusting for demographic and other factors (aOR 0.56; 95% CI, 0.33-0.97 and aOR 0.54; 95% CI, 0.33-0.91, respectively)., Conclusion: Racial differences in beliefs about lung cancer and LCS exist among African-American and White individuals enrolled in an LCS program. Cost, convenience, and low educational attainment may be barriers to LCS adherence, specifically among African-American individuals., Impact: More research is needed on how barriers can be overcome to improve LCS adherence., Competing Interests: Disclosure The authors declare no potential conflicts of interest. JB reports research grants from the Genentech Health Equity Innovations Fund and the Prevent Cancer Foundation outside the submitted work., (Copyright © 2021 Elsevier Inc. All rights reserved.)

Few treatment decision support interventions (DSIs) are available to engage patients diagnosed with late-stage non-small cell lung cancer (NSCLC) in treatment shared decision making (SDM). We designed a novel DSI that includes care plan cards and a companion patient preference clarification tool to assist in shared decision making. The cards answer common patient questions about treatment options (chemotherapy, chemotherapy plus immunotherapy, targeted therapy, immunotherapy, clinical trial participation, and supportive care). The form elicits patient treatment preference. We then conducted interviews with clinicians and patients to obtain feedback on the DSI. We also trained oncology nurse educators to implement the prototype. Finally, we pilot tested the DSI among five patients with NSCLC at the beginning of an office visit scheduled to discuss treatment with an oncologist. Analyses of pilot study baseline and exit survey data showed that DSI use was associated with increased patient awareness of the alternatives' treatment options and benefits/risks. In contrast, patient concern about treatment costs and uncertainty in treatment decision making decreased. All patients expressed a treatment preference. Future randomized controlled trials are needed to assess DSI implementation feasibility and efficacy in clinical care.

Purpose: Traditional half-day per week continuity clinic experiences can lead to fragmented education in both the inpatient and outpatient arenas. Five pediatric residency programs were granted the ability from the ACGME to create X+Y scheduling where residents have continuity clinic in "blocks" rather than half-day per week experiences. The aim of this study is to assess the impact X+Y scheduling has on pediatric resident and faculty perceptions of patient care and other educational experiences., Methods: Electronic surveys were sent to residents and faculty of the participating programs both prior to and 12 months after implementing X+Y scheduling. Survey questions measured resident and faculty perception of continuity clinic schedule satisfaction and the impact of continuity clinic schedules on inpatient and subspecialty rotation experiences using a 5-point Likert Scale. Data were analyzed using z-tests for proportion differences for those answering Agree or Strongly Agree between baseline and post-implementation respondents., Results: Hundred and twenty-six out of 186 residents (68%) responded preimplementation and 120 out of 259 residents (47%) responded post-implementation. 384 faculty members were sent the survey with 51% response pre-implementation and 26% response at 12 months. Statistically significant (P < .05) improvements were noted in resident and faculty perceptions of ability to have continuity with patients and inpatient workflow affected by clinic scheduling., Conclusions: From both resident and faculty perspectives, X+Y scheduling may improve several aspects of patient care and education. X+Y scheduling could be considered as a potential option by pediatric residency programs, especially if validated with more objective data., (Copyright © 2021 Academic Pediatric Association. Published by Elsevier Inc. All rights reserved.)

Inflammatory breast cancer (IBC) is the most aggressive form of breast cancer. Although it is a rare subtype, IBC is responsible for roughly 10% of breast cancer deaths. In order to obtain a better understanding of the genomic landscape and intratumor heterogeneity (ITH) in IBC, we conducted whole-exome sequencing of 16 tissue samples (12 tumor and four normal samples) from six hormone-receptor-positive IBC patients, analyzed somatic mutations and copy number aberrations, and inferred subclonal structures to demonstrate ITH. Our results showed that KMT2C was the most frequently mutated gene (42%, 5/12 samples), followed by HECTD1, LAMA3, FLG2, UGT2B4, STK33, BRCA2, ACP4, PIK3CA, and DNAH8 (all nine genes tied at 33% frequency, 4/12 samples). Our data indicated that PTEN and FBXW7 mutations may be considered driver gene mutations for IBC. We identified various subclonal structures and different levels of ITH between IBC patients, and mutations in the genes EIF4G3, IL12RB2, and PDE4B may potentially generate ITH in IBC.

Background: Colorectal cancer (CRC) screening (CRCS) facilitates early detection and lowers CRC mortality., Objectives: To increase CRCS in a randomized trial of stepped interventions. Step 1 compared three modes of delivery of theory-informed minimal cue interventions. Step 2 was designed to more intensively engage those not completing CRCS after Step 1., Methods: Recruitment packets (60,332) were mailed to a random sample of individuals with a record of U.S. military service during the Vietnam-era. Respondents not up-to-date with CRCS were randomized to one of four Step 1 groups: automated telephone, telephone, letter, or survey-only control. Those not completing screening after Step 1 were randomized to one of three Step 2 groups: automated motivational interviewing (MI) call, counselor-delivered MI call, or Step 2 control. Intention-to-treat (ITT) analyses assessed CRCS on follow-up surveys mailed after each step., Results: After Step 1 (n = 1784), CRCS was higher in the letter, telephone, and automated telephone groups (by 1%, 5%, 7%) than in survey-only controls (43%), although differences were not statistically significant. After Step 2 (n = 516), there were nonsignificant increases in CRCS in the two intervention groups compared with the controls. CRCS following any combination of stepped interventions overall was 7% higher (P = 0.024) than in survey-only controls (55.6%)., Conclusions: In a nationwide study of Veterans, CRCS after each of two stepped interventions of varying modes of delivery did not differ significantly from that in controls. However, combined overall, the sequence of stepped interventions significantly increased CRCS., (Copyright © 2021 Elsevier Inc. All rights reserved.)

Liquid biopsy-based biomarkers have advantages in monitoring the dynamics of metastatic castration-resistant prostate cancer (mCRPC), a bone-predominant metastatic disease. Previous studies have demonstrated associations between circulating tumor cells (CTCs) and clinical outcomes of mCRPC patients, but little is known about the prognostic value of CTC-clusters. In 227 longitudinally collected blood samples from 64 mCRPC patients, CTCs and CTC-clusters were enumerated using the CellSearch platform. The associations of CTC and CTC-cluster counts with progression-free survival (PFS) and overall survival (OS), individually and jointly, were evaluated by Cox models. CTCs and CTC-clusters were detected in 24 (37.5%) and 8 (12.5%) of 64 baseline samples, and in 119 (52.4%) and 27 (11.9%) of 227 longitudinal samples, respectively. CTC counts were associated with both PFS and OS, but CTC-clusters were only independently associated with an increased risk of death. Among patients with unfavorable CTCs (≥5), the presence of CTC-clusters signified a worse survival (log-rank p = 0.0185). mCRPC patients with both unfavorable CTCs and CTC-clusters had the highest risk for death (adjusted hazard ratio 19.84, p = 0.0072), as compared to those with <5 CTCs. Analyses using longitudinal data yielded similar results. In conclusion, CTC-clusters provided additional prognostic information for further stratifying death risk among patients with unfavorable CTCs.

Objectives: Mindfulness-Based Positive Behavior Support (MBPBS) has been shown to be effective in reducing stress and burnout in parents and professional caregivers of children and adolescents with intellectual and developmental disabilities (IDD) and autism spectrum disorder (ASD). The aim of this study was to assess the comparative effects of the mindfulness (MB) and positive behavior support (PBS) components against the MBPBS program for mindful parenting., Methods: The study utilized a three-arm randomized controlled trial design, with a 10-week pre-treatment control condition, 30 weeks of intervention, and 3 years of post-intervention follow-up. Mothers of children with ASD were randomly assigned to the MB, PBS, and MBPBS conditions and provided 3 days of training specific to each condition. The effects of these programs were assessed on the mothers (i.e., training attendance, meditation time, perceived psychological stress) and spillover effects were assessed on their children with ASD (i.e., aggression, disruptive behavior, compliance with mothers' requests)., Results: Mothers in the MBPBS condition reported greater reductions in perceived psychological stress, followed by those in the MB condition, and with no significant changes reported by those in the PBS condition. Reduction in the children's aggression and disruptive behavior followed a similar pattern, with most to least significant reductions being in MBPBS, MB, and PBS condition, respectively. Significant increases in compliance (i.e., responsiveness to mothers' requests) were largest in the MBPBS condition, followed by MB, and then PBS. Changes across all variables for both mothers and their children were maintained for 3 years post-intervention. After time and training type were controlled for, meditation time was a significant predictor in reducing aggressive and disruptive behaviors, and in enhancing compliance of the children with mothers' requests., Conclusions: Positive outcomes for mothers and their children with ASD were significantly greater in the MBPBS condition, followed by the MB condition, and least in the PBS condition. MBPBS appears to be an effective mindful parenting program on the assessed variables., Competing Interests: Conflict of InterestNirbhay N. Singh is the developer of the MBPBS program. The authors declare no conflict of interest and they do not work for, consult to, and own shares in or receive funding from any company or organization that would benefit from this article., (© Springer Science+Business Media, LLC, part of Springer Nature 2020.)

Objectives: Self-injurious behavior (SIB) refers to any repeated self-directed, non-suicidal, behavior that may cause or has the potential to cause physical harm to the person's body. Behavioral interventions provide the standard evidence-based treatments for SIB by people with autism spectrum disorder (ASD) and intellectual disabilities (ID). Translating the proven effectiveness of behavioral interventions to treatment of self-injury in community settings by clinicians and caregivers has not been totally successful. The aim of the present study was to advance translational research by providing real-time telehealth consultation to a treatment team at a community-based mental health agency that provided inpatient and outpatient services to individuals with ASD and ID., Method: The participants of this single-case experimental study were three adolescents with ASD who had been referred for services because of their increasingly unmanageable SIB both at home and at school. The telehealth consultant provided real-time assistance to the treatment team within a translational model of care in the development and implementation of a behavior support plan and an informal mindfulness-based Soles of the Feet (SoF) program., Results: Both visual and statistical analyses demonstrated reductions in the frequency of SIB for all three adolescents, with overall clinically significant reductions only with the SoF intervention., Conclusion: The results of this translational study suggest that telehealth consultation might be a viable technological alternative in situations which preclude face-to-face consultation. Telehealth consultation could be one method of supporting people with behavioral difficulties during pandemics, such as COVID-19., Competing Interests: Conflict of InterestThe authors declare that they have no conflict of interest., (© The Author(s), under exclusive licence to Springer Nature Switzerland AG part of Springer Nature 2021.)

Purpose: To evaluate response process validity evidence for clinical competency committee (CCC) assessments of first-year residents on a subset of General Pediatrics Entrustable Professional Activities (EPAs) and milestones in the context of a national pilot of competency-based, time-variable (CBTV) advancement from undergraduate to graduate medical education., Method: Assessments of 2 EPAs and 8 milestones made by the trainees' actual CCCs and 2 different blinded "virtual" CCCs for 48 first-year pediatrics residents at 4 residency programs between 2016 and 2018 were compared. Residents had 3 different training paths from medical school to residency: time-variable graduation at the same institution as their residency, time-fixed graduation at the same institution, or time-fixed graduation from a different institution. Assessments were compared using ordinal mixed-effects models., Results: Actual CCCs assigned residents higher scores than virtual CCCs on milestones and one EPA's supervision levels. Residents who graduated from a different institution than their residency received lower milestone ratings than either group from the same institution; CBTV residents received higher ratings on one milestone (ICS4) and similar ratings on all others compared with non-CBTV residents who completed medical school at the same institution., Conclusions: First-year residents who graduated from CBTV medical school programs were assessed as having the same level of competence as residents who graduated from traditional medical school programs, but response process evidence suggests that members of CCCs may also draw on undocumented personal knowledge of the learner to draw conclusions about resident competence.

Objectives: Caring for individuals with intellectual disabilities (ID) or autism spectrum disorder (ASD) can be gratifying as well as stressful. Professional staff employed as caregivers often report compromised mental and physical wellbeing due to the stressful nature of working with clients who exhibit aggressive and destructive behaviors. Prolonged work-related stress results in diminished quality of life for the caregivers. The aim of the present study was to evaluate the comparative effects of three programs-mindfulness program, psychoeducational program, and inservice training-as-usual-on the quality of life of professional caregivers who provide services to adolescent and adult clients with ID and ASD., Methods: Professional caregivers ( N  = 216) were randomized into three experimental conditions, and trained in mindfulness, psychoeducation, and inservice training-as-usual. The effects of the training on the caregivers' quality of life were assessed in terms of perceived stress, compassion satisfaction, compassion fatigue (i.e. burnout, secondary traumatic stress), and symptoms of depression at the end of 32 weeks of implementation., Results: Perceived stress, burnout, and secondary traumatic stress decreased significantly in the mindfulness condition, followed by psychoeducation, but not in the inservice training-as-usual condition. Compassion satisfaction increased significantly in the mindfulness condition, followed by psychoeducation, but not in the inservice training-as-usual condition. Symptoms of depression, which were rated in the borderline clinical range prior to intervention, decreased significantly to within normal levels in the mindfulness condition, decreased minimally in the psychoeducation condition, and showed no change in the training-as usual condition., Conclusions: A 3-day training in mindfulness meditations and associated contemplative practices provides a better basis for enhancing caregivers' quality of life than psychoeducation or inservice training-as-usual., Competing Interests: The authors declare no conflict of interest and they do not work for, consult to, and own shares in or receive funding from any company or organization that would benefit from this article. Ethical approval All procedures performed in studies involving human participants were in accordance with the ethical standards of the institutional and/or national research committee and with the 1964 Helsinki declaration and its later amendments or comparable ethical standards. Informed consent Informed consent was obtained from all individual participants included in the study, (© The British Society of Developmental Disabilities 2020.)

Purpose: Germline testing (GT) is a central feature of prostate cancer (PCA) treatment, management, and hereditary cancer assessment. Critical needs include optimized multigene testing strategies that incorporate evolving genetic data, consistency in GT indications and management, and alternate genetic evaluation models that address the rising demand for genetic services., Methods: A multidisciplinary consensus conference that included experts, stakeholders, and national organization leaders was convened in response to current practice challenges and to develop a genetic implementation framework. Evidence review informed questions using the modified Delphi model. The final framework included criteria with strong (> 75%) agreement (Recommend) or moderate (50% to 74%) agreement (Consider)., Results: Large germline panels and somatic testing were recommended for metastatic PCA. Reflex testing-initial testing of priority genes followed by expanded testing-was suggested for multiple scenarios. Metastatic disease or family history suggestive of hereditary PCA was recommended for GT. Additional family history and pathologic criteria garnered moderate consensus. Priority genes to test for metastatic disease treatment included BRCA2, BRCA1, and mismatch repair genes, with broader testing, such as ATM , for clinical trial eligibility. BRCA2 was recommended for active surveillance discussions. Screening starting at age 40 years or 10 years before the youngest PCA diagnosis in a family was recommended for BRCA2 carriers, with consideration in HOXB13, BRCA1, ATM , and mismatch repair carriers. Collaborative (point-of-care) evaluation models between health care and genetic providers was endorsed to address the genetic counseling shortage. The genetic evaluation framework included optimal pretest informed consent, post-test discussion, cascade testing, and technology-based approaches., Conclusion: This multidisciplinary, consensus-driven PCA genetic implementation framework provides novel guidance to clinicians and patients tailored to the precision era. Multiple research, education, and policy needs remain of importance.

The national rate of  lung cancer screening, approximately 3-5%, is too low and strategies which include shared decision-making and increase screening are needed. A feasibility study in one large primary care practice of telephone-based delivery of decision support via an online tool, the Decision Counseling Program© (DCP) was administered to patients eligible for lung cancer screening according to USPSTF screening guidelines. We collected data on demographics, decisional conflict, and conducted chart audits to ascertain screening. From electronic medical record data, we identified 829 age-eligible current or former smokers. Of the 297 individuals reached, 54 were eligible and 28 were recruited to the study and 20 underwent the DCP© intervention. Participants in the intervention were more likely to complete low-dose CT scans at 90 days. Current smokers were less likely to complete the DCP. Women were less likely to complete LDCT. This non-persuasive, high-quality shared decision-making intervention significantly increased lung cancer screening and was feasible in real-world clinical care. This intervention offers a promising model whereby patients can be supported in a decision, based on their values and beliefs while also supporting gains in lung cancer screening.

Purpose: Discordance between HER2 expression in tumor tissue (tHER2) and HER2 status on circulating tumor cells (cHER2) has been reported. It remains largely underexplored whether patients with tHER2 - /cHER2 + can benefit from anti-HER2 targeted therapies., Methods: cHER2 status was determined in 105 advanced-stage patients with tHER2 - breast tumors. Association between cHER2 status and progression-free survival (PFS) was analyzed by univariate and multivariate Cox models and survival differences were compared by Kaplan-Meier method., Results: Compared to the patients with low-risk cHER2 (cHER2 +  < 2), those with high-risk cHER2 (cHER2 +  ≥ 2) had shorter survival time and an increased risk for disease progression (hazard ratio [HR] 2.16, 95% confidence interval [CI] 1.20-3.88, P = 0.010). Among the patients with high-risk cHER2, those who received anti-HER2 targeted therapies had improved PFS compared with those who did not (HR 0.30, 95% CI 0.10-0.92, P = 0.035). In comparison, anti-HER2 targeted therapy did not affect PFS among those with low-risk cHER2 (HR 0.70, 95% CI 0.36-1.38, P = 0.306). Similar results were obtained after adjusting covariates. A longitudinal analysis of 67 patients with cHER2 detected during follow-ups found that those whose cHER2 status changed from high-risk at baseline to low-risk at first follow-up exhibited a significantly improved survival compared to those whose cHER2 remained high-risk (median PFS: 11.7 weeks vs. 2.0 weeks, log-rank P = 0.001)., Conclusion: In advanced-stage breast cancer patients with tHER2 - tumors, cHER2 status has the potential to guide the use of anti-HER2 targeted therapy in patients with high-risk cHER2.

Background: Pediatric residency programs offer many conferences and activities to meet the educational needs of their residents. We developed and assessed the Pediatric Chief Resident Exchange Program where pediatric chief residents visited another institution for a day with the goal of sharing educational and curricular innovations between residency programs in an experiential manner., Approach/innovation: Pediatric chief residents participated in various activities during the exchange including educational conferences and discussions with residency program leadership at the host institutions. Surveys were administered to all participating chiefs to determine if any changes to educational conferences or curriculum were made or planned to be made at their home program based upon what they observed at the other institution and to have chiefs reflect on what they gained from the experience., Results: Twenty-eight chief residents from 9 programs participated in the exchange program over 3 academic years (2015-2018). All respondents felt the exchange experience was worthwhile. The majority (67%) of programs planned to implement a change at their institution based on participation in the exchange with over half actually making a change by the end of the academic year. Participating chiefs gained a sense of camaraderie, appreciated that other programs experienced similar struggles, and developed further insight into the chief resident role., Discussion: The Pediatric Chief Resident Exchange Program is a novel method of sharing educational practices between institutions that can lead to curricular changes at participating programs. It can also be an opportunity for chief resident professional development., (Copyright © 2019 Academic Pediatric Association. Published by Elsevier Inc. All rights reserved.)

This study investigated predictors of overall and test-specific colorectal cancer screening (CRCS). Stool blood test (SBT) and/or colonoscopy screening were offered to primary care patients in two randomized controlled trials which assessed the impact of behavioral interventions on screening. Data were obtained through surveys and electronic medical records. Among 1942 participants, 646 (33%) screened. Exposure to interventions was associated with higher overall CRCS by twofold to threefold; older age, African American race, being married, and having a higher screening decision stage were also associated with higher overall CRCS (odds ratios = 1.30, 1.31, 1.34, and 5.59, respectively). Intervention, older age, female gender, and being married were associated with higher SBT adherence, while preference for colonoscopy was associated with lower SBT adherence. Intervention and higher decision stage were associated with higher colonoscopy adherence, while preference for SBT was associated with lower colonoscopy adherence. Among older individuals, African Americans had higher overall CRCS than whites, but this was not true among younger individuals (interaction p = .041). The higher screening adherence of African Americans over whites was due to stronger screening with a non-preferred test, i.e., higher SBT adherence only among individuals who preferred colonoscopy and higher colonoscopy adherence only among individuals who preferred SBT. Intervention exposure, sociodemographic background, and screening decision stage predicted overall CRCS adherence. Gender and test preference also affected test-specific screening adherence. Interactions involving race and test preference suggest that it is important to provide both colonoscopy and SBT screening options to patients, particularly African Americans., (Copyright © 2020 Elsevier Inc. All rights reserved.)