Anti-KIT monoclonal antibody CDX-0159 induces profound and durable mast cell suppression in a healthy volunteer study.

BACKGROUND: Mast cells (MC) are powerful inflammatory immune sentinel cells that drive numerous allergic, inflammatory, and pruritic disorders when activated. MC-targeted therapies are approved in several disorders, yet many patients have limited benefit suggesting the need for approaches that more broadly inhibit MC activity. MCs require the KIT receptor and its ligand stem cell factor (SCF) for differentiation, maturation, and survival. Here we describe CDX-0159, an anti-KIT monoclonal antibody that potently suppresses MCs in human healthy volunteers. METHODS: CDX-0159-mediated KIT inhibition was tested in vitro using KIT-expressing immortalized cells and primary human mast cells. CDX-0159 safety and pharmacokinetics were evaluated in a 13-week good laboratory practice (GLP)-compliant cynomolgus macaque study. A single ascending dose (0.3, 1, 3, and 9 mg/kg), double-blinded placebo-controlled phase 1a human healthy volunteer study (n = 32) was conducted to evaluate the safety, pharmacokinetics, and pharmacodynamics of CDX-0159. RESULTS: CDX-0159 inhibits SCF-dependent KIT activation in vitro. Fc modifications in CDX-0159 led to elimination of effector function and reduced serum clearance. In cynomolgus macaques, multiple high doses were safely administered without a significant impact on hematology, a potential concern for KIT inhibitors. A single dose of CDX-0159 in healthy human subjects was generally well tolerated and demonstrated long antibody exposure. Importantly, CDX-0159 led to dose-dependent, profound suppression of plasma tryptase, a MC-specific protease associated with tissue MC burden, indicative of systemic MC suppression or ablation. CONCLUSION: CDX-0159 administration leads to systemic mast cell ablation and may represent a safe and novel approach to treat mast cell-driven disorders.

Perceptions of COVID-19 self-testing and recommendations for implementation and scale-up among Black/African Americans: implications for the COVID-19 STEP project.

BACKGROUND: COVID-19 self-testing (ST) is an innovative strategy with the potential to increase the access and uptake of testing and ultimately to limit the spread of the virus. To maximize the uptake and reach of this promising strategy and inform intervention development and scale up, research is needed to understand the acceptability of and willingness to use this tool. This is vital to ensure that Black/African Americans are reached by the Biden-Harris Administration's free national COVID-19 ST program. This study aimed to explore the acceptability and recommendations to promote and scale-up the uptake of COVID-19 ST among Black/African Americans. METHODS: We conducted a cross-sectional qualitative study using a semi-structured questionnaire to assess barriers and facilitators to the uptake of COVID-19 ST among a convenience sample of 28 self-identified Black/African Americans from schools, community centers, and faith-based institutions in Ohio and Maryland. Inductive content analysis was conducted to identify categories and subcategories related to acceptability and recommendations for implementing and scaling up COVID-19 ST in communities. RESULTS: Participants perceived COVID-19 self-testing as an acceptable tool that is beneficial to prevent transmission and address some of the barriers associated with health facility testing, such as transportation cost and human contact at the health facility. However, concerns were raised regarding the accurate use of the kits and costs. Recommendations for implementing and scaling up COVID-19 ST included engagement of community stakeholders to disseminate information about COVID-19 self-testing and creating culturally appropriate education tools to promote knowledge of and clear instructions about how to properly use COVID-19 ST kits. Based on these recommendations, the COVID-19 STEP (Self-Testing Education and Promotion) Project is being developed and will involve engaging community partners such as barbers, church leaders, and other community-based organizations to increase the uptake and use of free COVID-19 ST kits among Black/African Americans. CONCLUSION: Findings showed that most participants considered COVID-19 ST valuable for encouraging COVID-19 testing. However, cost and accuracy concerns may pose barriers. Future work should consider implementing interventions that leverage the benefits of COVID-19 ST and further assess the extent to which these identified facilitators and barriers may influence COVID-19 ST uptake.

Psychosocial morbidity associated with bipolar disorder and borderline personality disorder in psychiatric out-patients: comparative study.

BACKGROUND: The morbidity associated with bipolar disorder is, in part, responsible for repeated calls for improved detection and recognition. No such commentary exists for the improved detection of borderline personality disorder. Clinical experience suggests that it is as disabling as bipolar disorder, but no study has directly compared the two disorders. AIMS: To compare the levels of psychosocial morbidity in patients with bipolar disorder and borderline personality disorder. METHOD: Patients were assessed with semi-structured interviews. We compared 307 patients with DSM-IV borderline personality disorder but without bipolar disorder and 236 patients with bipolar disorder but without borderline personality disorder. RESULTS: The patients with borderline personality disorder less frequently were college graduates, were diagnosed with more comorbid disorders, more frequently had a history of substance use disorder, reported more suicidal ideation at the time of the evaluation, more frequently had attempted suicide, reported poorer social functioning and were rated lower on the Global Assessment of Functioning. There was no difference between the two patient groups in history of admission to psychiatric hospital or time missed from work during the past 5 years. CONCLUSIONS: The level of psychosocial morbidity associated with borderline personality disorder was as great as (or greater than) that experienced by patients with bipolar disorder. From a public health perspective, efforts to improve the detection and treatment of borderline personality disorder might be as important as efforts to improve the recognition and treatment of bipolar disorder.

How many different ways do patients meet the diagnostic criteria for major depressive disorder?

There are 227 possible ways to meet the symptom criteria for major depressive disorder (MDD). However, symptom occurrence is not random, and some symptoms co-occur significantly beyond chance. This raises the questions of whether all of the theoretically possible different ways of meeting the MDD criteria actually occur in patients, and whether some combinations of criteria are much more common than others. More than 1500 patients who met DSM-IV criteria for MDD at the time of the evaluation were interviewed with semi-structured interviews. The patients met the MDD symptom criteria in 170 different ways. Put another way, one-quarter (57/227) of the criteria combinations did not occur. The most frequent combination was the presence of all 9 criteria (10.1%, n=157). Nine combinations (all 9 criteria, 3 of the 8-criterion combinations, 4 of the 7-criterion combinations, and one 6-criterion combination) were present in more than 2% of the patients, together accounting for more than 40% of the diagnoses. The polythetic definition of MDD, which requires a minimum number of criteria from a list, results in significant diagnostic heterogeneity because there are many different ways to meet criteria. While there is significant heterogeneity amongst patients meeting the MDD diagnostic criteria, a relatively small number of combinations could be considered as diagnostic prototypes as they account for more than 40% of the patients diagnosed with MDD.

A brief, clinically useful, clinician-rated dimensional rating system for psychiatric diagnoses: reliability and validity in psychiatric outpatients.

BACKGROUND: In the present report from the Rhode Island Methods to Improve Diagnostic Assessment and Services project, we describe the development of a dimensional rating system for Axis I disorders. METHODS: We evaluated 1,600 psychiatric outpatients with a semi-structured diagnostic interview for Axis I disorders and completed a self-report measure of psychosocial morbidity. A Standardized Clinical Outcome Rating (SCOR), a 7-point dimensional rating, was made for 17 Axis I disorders and 1 symptom construct. RESULTS: The dimensional ratings were highly reliable. After controlling for the number of Axis I disorders, each of the partial correlations between the dimensional rating and the measures of psychosocial morbidity was significant (mean partial r = 0.21). However, when the dimensional score was controlled, none of the partial correlations between the sum of the number of Axis I disorders and measures of psychosocial morbidity were significant (mean partial r = 0.03). CONCLUSIONS: The SCORs are brief standardized outcome ratings that clinicians can incorporate into routine clinical practice without incurring undue burden. These ratings could make it more feasible to conduct effectiveness studies in clinical practice and to extend measurement-based care recommendations to include clinical ratings as well as self-report assessments.

Differences between patients with borderline personality disorder who do and do not have a family history of bipolar disorder.

Diagnostic confusion sometimes exists between bipolar disorder and borderline personality disorder (BPD). To improve the recognition of bipolar disorder researchers have identified nondiagnostic factors that point toward bipolar disorder. One such factor is the presence of a family history of bipolar disorder. In the current report from the Rhode Island Methods to Improve Diagnostic Assessment and Services (MIDAS) project, we compared the demographic, clinical, and psychosocial characteristics of patients with BPD who did and did not have a family history of bipolar disorder. A large sample of psychiatric outpatients were interviewed with semi-structured interviews. Three hundred seventeen patients without bipolar disorder were diagnosed with DSM-IV borderline personality disorder. Slightly less than 10% of the 317 patients with BPD (9.5%, n=30) reported a family history of bipolar disorder in their first-degree relatives. There were no differences between groups in any specific Axis I or Axis II disorder. The patients with a positive family history were significantly less likely to report excessive or inappropriate anger, but there was no difference in the frequency of other criteria for BPD such as affective instability, impulsivity, or suicidal behavior. The patients with a positive family history reported a significantly higher rate of increased appetite and fatigue. There was no difference in overall severity of depression, scores on the Global Assessment of Functioning, history of psychiatric hospitalizations, suicide attempts, time unemployed due to psychiatric reasons during the 5 years before the evaluation, and ratings of current and adolescent social functioning. There was no difference on any of the 5 subscales of the childhood trauma questionnaire. Overall, we found few differences between BPD patients with and without a family history of bipolar disorder thereby suggesting that a positive family history of bipolar disorder was not a useful marker for occult bipolar disorder in these patients.

Climate Change and Cardiovascular Health: A Systematic Review.

Importance: Climate change may increase the risk of adverse cardiovascular outcomes by causing direct physiologic changes, psychological distress, and disruption of health-related infrastructure. Yet, the association between numerous climate change-related environmental stressors and the incidence of adverse cardiovascular events has not been systematically reviewed. Objective: To review the current evidence on the association between climate change-related environmental stressors and adverse cardiovascular outcomes. Evidence Review: PubMed, Embase, Web of Science, and Cochrane Library were searched to identify peer-reviewed publications from January 1, 1970, through November 15, 2023, that evaluated associations between environmental exposures and cardiovascular mortality, acute cardiovascular events, and related health care utilization. Studies that examined only nonwildfire-sourced particulate air pollution were excluded. Two investigators independently screened 20 798 articles and selected 2564 for full-text review. Study quality was assessed using the Navigation Guide framework. Findings were qualitatively synthesized as substantial differences in study design precluded quantitative meta-analysis. Findings: Of 492 observational studies that met inclusion criteria, 182 examined extreme temperature, 210 ground-level ozone, 45 wildfire smoke, and 63 extreme weather events, such as hurricanes, dust storms, and droughts. These studies presented findings from 30 high-income countries, 17 middle-income countries, and 1 low-income country. The strength of evidence was rated as sufficient for extreme temperature; ground-level ozone; tropical storms, hurricanes, and cyclones; and dust storms. Evidence was limited for wildfire smoke and inadequate for drought and mudslides. Exposure to extreme temperature was associated with increased cardiovascular mortality and morbidity, but the magnitude varied with temperature and duration of exposure. Ground-level ozone amplified the risk associated with higher temperatures and vice versa. Extreme weather events, such as hurricanes, were associated with increased cardiovascular risk that persisted for many months after the initial event. Some studies noted a small increase in cardiovascular mortality, out-of-hospital cardiac arrests, and hospitalizations for ischemic heart disease after exposure to wildfire smoke, while others found no association. Older adults, racial and ethnic minoritized populations, and lower-wealth communities were disproportionately affected. Conclusions and Relevance: Several environmental stressors that are predicted to increase in frequency and intensity with climate change are associated with increased cardiovascular risk, but data on outcomes in low-income countries are lacking. Urgent action is needed to mitigate climate change-associated cardiovascular risk, particularly in vulnerable populations.

Informed Inclusion Model: Medical Student Wheelchair User in an Obstetrics and Gynecology Clerkship.

ABSTRACT: Students with physical disabilities are underrepresented in medicine, driven in part by ableist beliefs about the ability of individuals with disabilities to complete procedure-based or surgically oriented clerkships, including obstetrics and gynecology (Ob/Gyn). There is a growing commitment to disability inclusion by medical and specialty training associations. Yet published case studies and accommodation protocols for medical student wheelchair users navigating an Ob/Gyn clerkship are absent in the literature. This article describes successful disability inclusion for an Ob/Gyn clerkship, including accommodations for medical student wheelchair users. The authors share mechanisms to address and combat ableist assumptions and facilitate access for future medical students by working collaboratively with student and key stakeholders to develop an inclusive and accessible training experience.These recommendations are shared through the story of a third-year medical student who rotated through the longitudinal clerkships at the Cleveland Clinic Lerner College of Medicine. The student, an individual with osteogenesis imperfecta who uses a power wheelchair with a seat elevator, completed third-year rotations and thrived in her clinical experiences. The authors describe her journey through a robust 4-week Ob/Gyn clerkship, in which she fulfilled the required clinical core conditions and observation skills with reasonable accommodation. Given the high acuity, surgery, and outpatient demands in Ob/Gyn-and the transferrable skills to other clerkships-the student's experience is an excellent exemplar for demonstrating disability inclusion and reasonable accommodation.Ob/Gyn clerkship directors and clinical faculty can broadly use the recommended timelines and communication protocols to create accessible training environments. With student input, minor scheduling adjustments, ongoing communication, reasonable accommodations, and an open mind, medical students on the clinical wards who are wheelchair users can successfully navigate the required expectations of medical training.

Is the distinction between adjustment disorder with depressed mood and adjustment disorder with mixed anxious and depressed mood valid?

BACKGROUND: In the DSM-IV, adjustment disorder is subtyped according to the predominant presenting feature. The different diagnostic code numbers assigned to each subtype suggest their significance in DSM-IV. However, little research has examined the validity of these subtypes. In the present report from the Rhode Island Methods to Improve Diagnostic Assessment and Services (MIDAS) project, we compared the demographic and clinical profiles of patients diagnosed with adjustment disorder subtypes to determine whether there was enough empirical evidence supporting the retention of multiple adjustment disorder subtypes in future versions of the DSM. METHODS: A total of 3,400 psychiatric patients presenting to the Rhode Island Hospital outpatient practice were evaluated with semistructured diagnostic interviews for DSM-IV Axis I and Axis II disorders and measures of psychosocial morbidity. RESULTS: Approximately 7% (224 of 3,400) of patients were diagnosed with current adjustment disorder. Adjustment disorder with depressed mood and with mixed anxious and depressed mood were the most common subtypes, accounting for 80% of the patients diagnosed with adjustment disorder. There was no significant difference between these 2 groups with regard to demographic variables, current comorbid Axis I or Axis II disorders, lifetime history of major depressive disorder or anxiety disorders, psychosocial morbidity, or family history of psychiatric disorders. The only difference between the groups was lifetime history of drug use, which was significantly higher in the patients diagnosed with adjustment disorder with depressed mood. CONCLUSIONS: There is no evidence supporting the retention of both of these adjustment disorder subtypes, and DSM-IV previously set a precedent for eliminating adjustment disorder subtypes in the absence of any data. Therefore, in the spirit of nosologic parsimony, consideration should be given to collapsing the 2 disorders into 1: adjustment disorder with depressed mood.

Is dimensional scoring important only for subthreshold levels of severity in personality disorders other than borderline?

Research assessing the utility of dimensional and categorical models of personality disorders (PDs) overwhelmingly supports the use of continuous over categorical models. Using borderline PD as an example, recent studies from the Rhode Island Methods to Improve Diagnostic Assessment and Services (MIDAS) project suggested that continuous (criteria count) scoring of PDs is most informative for "subthreshold" levels of pathology, but is less important once a patient meets the diagnostic threshold. Using PD criteria count, the current study compared 7 indices of psychosocial morbidity for patients above and below diagnostic threshold for 3 additional PDs: paranoid, avoidant, and obsessive-compulsive. Results showed that for all tested PDs, only number of current Axis I disorders was more correlated with PD criteria in the sub-threshold group as compared to those who met criteria for the disorder. Results for the remaining 6 indices of psychosocial morbidity varied by PD tested.

A clinically useful social anxiety disorder outcome scale.

Increasingly, emphasis is being placed on measurement-based care to improve the quality of treatment. Although much of the focus has been on depression, measurement-based care may be particularly applicable to social anxiety disorder (SAD) given its high prevalence, high comorbidity with other disorders, and association with significant functional impairment. Many self-report scales for SAD currently exist, but these scales possess limitations related to length and/or accessibility that may serve as barriers to their use in monitoring outcome in routine clinical practice. Therefore, the aim of the current study was to develop and validate the Clinically Useful Social Anxiety Disorder Outcome Scale (CUSADOS), a self-report measure of SAD. The CUSADOS was designed to be reliable, valid, sensitive to change, brief, easy to score, and easily accessible, to facilitate its use in routine clinical settings. The psychometric properties of the CUSADOS were examined in 2415 psychiatric outpatients who were presenting for treatment and had completed a semi-structured diagnostic interview. The CUSADOS demonstrated excellent internal consistency, and high item-total correlations and test-retest reliability. Within a sub-sample of 381 patients, the CUSADOS possessed good discriminant and convergent validity as it was more highly correlated with other measures of SAD than with other psychiatric disorders. Furthermore, scores were higher in outpatients with a current diagnosis of SAD compared to those without a SAD diagnosis. Preliminary support also was obtained for the sensitivity to change of the CUSADOS in a sample of 15 outpatients receiving treatment for comorbid SAD and depression. Results from this validation study in a large psychiatric sample show that the CUSADOS possesses good psychometric properties. Its brevity and ease of scoring also suggest that it is feasible to incorporate into routine clinical practice.

Report on the PET/CT Image-Based Radiation Dosimetry of [18F]FDHT in Women, a Validated Imaging Agent with New Applications for Evaluation of Androgen Receptor Status in Women with Metastatic Breast Cancer.

In a prospective clinical trial, [18F]fluoro-5α-dihydrotestosterone ([18F]FDHT), the radiolabeled analog of the androgen dihydrotestosterone, was used as a PET/CT imaging agent for in vivo assessment of metastatic androgen receptor-positive breast cancer in postmenopausal women. To our knowledge, this article presents the first report of PET/CT image-based radiation dosimetry of [18F]FDHT in women. Methods: [18F]FDHT PET/CT imaging was performed on a cohort of 11 women at baseline before the start of therapy and at 2 additional time points during selective androgen receptor modulator (SARM) therapy for androgen receptor-positive breast cancer. Volumes of interest (VOIs) were placed over the whole body and within source organs seen on the PET/CT images, and the time-integrated activity coefficients of [18F]FDHT were derived. The time-integrated activity coefficients for the urinary bladder were calculated using the dynamic urinary bladder model in OLINDA/EXM software, with biologic half-life for urinary excretion derived from VOI measurements of the whole body in postvoid PET/CT images. The time-integrated activity coefficients for all other organs were calculated from VOI measurements in the organs and the physical half-life of 18F. Organ dose and effective dose calculations were then performed using MIRDcalc, version 1.1. Results: At baseline before SARM therapy, the effective dose for [18F]FDHT in women was calculated as 0.020 ± 0.0005 mSv/MBq, and the urinary bladder was the organ at risk, with an average absorbed dose of 0.074 ± 0.011 mGy/MBq. Statistically significant decreases in liver SUV or uptake of [18F]FDHT were found at the 2 additional time points on SARM therapy (linear mixed model, P < 0.05). Likewise, absorbed dose to the liver also decreased by a small but statistically significant amount at the 2 additional time points (linear mixed model, P < 0.05). Neighboring abdominal organs of the gallbladder wall, stomach, pancreas, and adrenals also showed statistically significant decreases in absorbed dose (linear mixed model, P < 0.05). The urinary bladder wall remained the organ at risk at all time points. Absorbed dose to the urinary bladder wall did not show statistically significant changes from baseline at any of the time points (linear mixed model, P ≥ 0.05). Effective dose also did not show statistically significant changes from baseline (linear mixed model, P ≥ 0.05). Conclusion: Effective dose for [18F]FDHT in women before SARM therapy was calculated as 0.020 ± 0.0005 mSv/MBq. The urinary bladder wall was the organ at risk, with an absorbed dose of 0.074 ± 0.011 mGy/MBq.

Sustained unemployment in psychiatric outpatients with bipolar depression compared to major depressive disorder with comorbid borderline personality disorder.

OBJECTIVES: The morbidity associated with bipolar disorder is, in part, responsible for repeated calls for improved detection and recognition. No such clinical commentary exists for improved detection of borderline personality disorder in depressed patients. Clinical experience suggests that borderline personality disorder is as disabling as bipolar disorder; however, no studies have directly compared the two disorders. For this reason we undertook the current analysis from the Rhode Island Methods to Improve Diagnostic Assessment and Services (MIDAS) project comparing unemployment and disability rates in patients with bipolar disorder and borderline personality disorder. METHODS: Patients were interviewed with semi-structured interviews. We compared three non-overlapping groups of depressed patients: (i) 181 patients with DSM-IV major depressive disorder and borderline personality disorder, (ii) 1068 patients with major depressive disorder without borderline personality disorder, and (iii) 84 patients with bipolar depression without borderline personality disorder. RESULTS: Compared to depressed patients without borderline personality disorder, depressed patients with borderline personality disorder were significantly more likely to have been persistently unemployed. A similar difference was found between patients with bipolar depression and major depressive disorder without borderline personality disorder. No differences were found between patients with bipolar depression and depression with borderline personality disorder. CONCLUSIONS: Both bipolar disorder and borderline personality disorder were associated with impaired occupational functioning and thus carry a significant public health burden. Efforts to improve detection of borderline personality disorder in depressed patients might be as important as the recognition of bipolar disorder.

Does the diagnosis of multiple Axis II disorders have clinical significance?

BACKGROUND: A stated goal of the DSM-5 Work Group on Personality and Personality Disorders (PDs) has been to reduce the high rate of comorbidity among PDs. Few studies have examined whether the diagnosis of multiple PDs has clinical significance. In the present report from the Rhode Island Methods to Improve Diagnostic Assessment and Services project, we tested the hypothesis that patients with >1 DSM-IV PD would have more severe forms of psychopathology than patients who were diagnosed with only 1 DSM-IV PD. METHODS: A total of 2,150 psychiatric outpatients were evaluated with semi-structured diagnostic interviews for DSM-IV Axis I and Axis II disorders and measures of psychosocial morbidity. RESULTS: For 8 of the 10 PDs, the majority of patients had at least 1 additional PD, although at least 20% of patients diagnosed with each PD were diagnosed with only 1 PD. Compared with patients with 1 PD, patients with ≥2 PDs had significantly more psychosocial morbidity. CONCLUSIONS: The co-occurrence of PDs conveys clinically significant information. Moreover, despite high levels of comorbidity, each PD also existed as a stand-alone entity. These findings raise questions about the DSM-5 Work Group's emphasis on reducing comorbidity in Axis II.

Overcoming the problem of diagnostic heterogeneity in applying measurement-based care in clinical practice: the concept of psychiatric vital signs.

Measurement-based care refers to the use of standardized scales to measure the outcome of psychiatric treatment. Diagnostic heterogeneity poses a challenge toward the adoption of a measurement-based care approach toward outcome evaluation in clinical practice. In the present article, we propose adopting the concept of psychiatric vital signs to facilitate measurement-based care. Medical vital signs are measures of basic physiologic functions that are routinely determined in medical settings. Vital signs are often a primary outcome measure, and they are also often adjunctive measurements. In the present report from the Rhode Island Methods to Improve Diagnostic Assessment and Services project, we examined the frequency of depression and anxiety in a diagnostically heterogeneous group of psychiatric outpatients to determine the appropriateness of considering their measurement as psychiatric vital signs. Three thousand psychiatric outpatients were interviewed with the Structured Clinical Interview for DSM-IV supplemented with items from the Schedule for Affective Disorders and Schizophrenia. We determined the frequency of depression and anxiety evaluated according to the Schedule for Affective Disorders and Schizophrenia items. In the entire sample of 3000 patients, 79.3% (n = 2378) reported clinically significant depression of at least mild severity, 64.4% (n = 1932) reported anxiety of at least mild severity, and 87.4% (n = 2621) reported either anxiety or depression. In all 10 diagnostic categories examined, most patients had clinically significant anxiety or depression of at least mild severity. These findings support the routine assessment of anxiety and depression in clinical practice because almost all patients will have these problems as part of their initial presentation. Even for those patients without depression or anxiety, the case could be made that the measurement of depression and anxiety is relevant and analogous to measuring certain physiologic parameters in medical practice such as blood pressure and body temperature regardless of the reason for the visit.

Which DSM-IV personality disorders are most strongly associated with indices of psychosocial morbidity in psychiatric outpatients?

The DSM-5 Work Group for Personality and Personality Disorders (PDs) recommended retaining 6 specific PD "types" (antisocial, avoidant, borderline, narcissistic, obsessive-compulsive, and schizotypal) and eliminating the other 4 PDs currently included in DSM-IV (paranoid, schizoid, histrionic, and dependent). One important clinical aspect of PDs is their association with indices of psychosocial morbidity. Because the literature on the relationship between PDs and psychosocial morbidity in psychiatric patients is limited, we undertook the current analysis of the Rhode Island Methods to Improve Diagnostic Assessment and Services project database to examine which PDs were most strongly associated with a variety of measures of psychosocial morbidity. We tested the hypothesis that the disorders recommended for retention in DSM-5 would be associated with more severe morbidity than the disorders recommended for deletion. A total of 2150 psychiatric outpatients were evaluated with semistructured diagnostic interviews for DSM-IV Axes I and II disorders and 7 measures of psychosocial morbidity. We examined the correlation between each PD dimensional score and each measure of morbidity and then conducted multiple regression analyses to determine which PDs were independently associated with the indices of morbidity. For the 6 PDs proposed for retention in DSM-5, 36 (85.7%) of the 42 correlations were significant, whereas for the 4 PDs proposed for deletion, 26 (92.9%) of the 28 correlations were significant. In the regression analyses for the 6 PDs proposed for retention in DSM-5, 19 (45.2%) of the 42 ß coefficients were significant, whereas for the 4 PDs proposed for deletion, 7 (25.0%) of the 28 ß coefficients were significant. The results of the present study, along with the results of other studies, do not provide clear evidence for the preferential retention of some PDs over others based on their association with indices of psychosocial morbidity.

The Art of Discharge Planning: Teaching Nursing Students to Address Disparities Through Simulation.

Background: Discharge planning is crucial to ensuring that patients' care and recovery needs are addressed. A new nurse graduate must be prepared to enter a clinical practice environment in which hospitals face penalties for patient readmissions. Methods: Student nurses were assigned simulated patients with a variety of health disparities and health-care diagnoses to address. A qualitative research design evaluated student perceptions of discharge planning and cultural competency. Results: Students found the simulation to be vital to their clinical experience. Students were able to develop discharge teaching that was culturally congruent for each simulated patient. Conclusions: Incorporating discharge teaching simulation into the nursing curriculum can positively impact students' ability to transition to clinical practice and build confidence in a skill that is rarely incorporated into nursing curricula.

Imaging Androgen Receptors in Breast Cancer with 18F-Fluoro-5α-Dihydrotestosterone PET: A Pilot Study.

Most breast cancers express androgen receptors (ARs). This prospective imaging substudy explored imaging of ARs with 18F-fluoro-5α-dihydrotestosterone (18F-FDHT) PET in patients with metastatic breast cancer (MBC) receiving selective AR modulation (SARM) therapy (GTx-024). Methods: Eleven postmenopausal women with estrogen receptor-positive MBC underwent 18F-FDHT PET/CT at baseline and at 6 and 12 wk after starting SARM therapy. Abnormal tumor 18F-FDHT uptake was quantified using SUVmax AR status was determined from tumor biopsy specimens. 18F-FDHT SUVmax percentage change between scans was calculated. Best overall response was categorized as clinical benefit (nonprogressive disease) or progressive disease using RECIST 1.1. Results: The median baseline 18F-FDHT SUVmax was 4.1 (range, 1.4-5.9) for AR-positive tumors versus 2.3 (range, 1.5-3.2) for AR-negative tumors (P = 0.22). Quantitative AR expression and baseline 18F-FDHT uptake were weakly correlated (Pearson ρ = 0.39, P = 0.30). Seven participants with clinical benefit at 12 wk tended to have larger declines in 18F-FDHT uptake than did those with progressive disease both at 6 wk after starting GTx-024 (median, -26.8% [range, -42.9% to -14.1%], vs. -3.7% [range,-31% to +29%], respectively; P = 0.11) and at 12 wk after starting GTx-024 (median, -35.7% [range, -69.5% to -7.7%], vs. -20.1% [range, -26.6% to +56.5%], respectively; P = 0.17). Conclusion: These hypothesis-generating data suggest that 18F-FDHT PET/CT is worth further study as an imaging biomarker for evaluating the response of MBC to SARM therapy and reiterate the feasibility of including molecular imaging in multidisciplinary therapeutic trials.

Perceptions of COVID-19 Self-Testing and Recommendations for Implementation and Scale up Among Black/African Americans: Implications for the COVID-19 STEP Project.

Background COVID-19 self-testing (ST) is an innovative strategy with the potential to increase the access and uptake of testing and ultimately to limit the spread of the virus. To maximize the uptake and reach of this promising strategy and inform intervention development and scale up, research is needed to understand the acceptability of and willingness to use this tool. This is vital to ensure that Black/African Americans are reached by the Biden-Harris Administration’s free national COVID-19 ST program. This study aimed to explore the acceptability and recommendations to promote and scale up the uptake of COVID-19 ST among Black/African Americans. Methods We conducted a cross-sectional qualitative study using a semi-structured survey to assess barriers and facilitators to the uptake of COVID-19 ST among a convenience sample of 28 self-identified Black/African Americans from schools, community centers, and faith-based institutions in Ohio and Maryland. Inductive content analysis was conducted to identify categories and subcategories related to acceptability and recommendations for implementing and scaling up COVID-19 ST in communities. Results Participants perceived COVID-19 self-testing as an acceptable tool that is beneficial to prevent transmission and address some of the barriers associated with health facility testing, such as transportation cost and human contact at the health facility. However, concerns were raised regarding the accurate use of the kits and costs. Recommendations for implementing and scaling up COVID-19 ST included engagement of community stakeholders to disseminate information about COVID-19 self-testing and creating culturally appropriate education tools to promote knowledge of and clear instructions about how to properly use COVID-19 ST kits. Based on these recommendations, the COVID-19 STEP (Self-Testing Education and Promotion) Project is being developed and will involve engaging community partners such as barbers, church leaders, and other community-based organizations to increase the uptake and use of free COVID-19 ST kits among Black/African Americans. Conclusion Findings showed that most participants considered COVID-19 ST valuable for encouraging COVID-19 testing. However, cost and accuracy concerns may pose barriers. Future work should consider implementing interventions that leverage the benefits of COVID-19 ST and further assess the extent to which these identified facilitators and barriers may influence COVID-19 ST uptake.

Results: Survey of pediatric urology electronic medical records-use and perspectives.

PURPOSE: The $19.2 billion Health Information Technology for Economic and Clinical Health Act will have a dramatic effect on the adoption of electronic medical records in the United States by directly reimbursing for the adoption of electronic medical records in the future. We sought to gain an understanding of electronic medical record use in pediatric urology to aid in the transition to electronic medical records. MATERIALS AND METHODS: All Fellows and post-fellowship Fellow Candidates of the American Academy of Pediatrics Section on Urology were recruited to participate in the survey. Electronic and paper versions of this 50-question internal review board approved anonymous survey were sent to potential participants. RESULTS: Of 286 pediatric urologists 165 completed the survey for a 65% response rate. Of the respondents 67.3% were pediatric urologists in academic or hospital based practice while the remaining 32.7% were in private practice. Overall 78.8% of respondents reported using electronic medical records at the hospital while 67.3% used them at the office/clinic. Of the physicians 12.1% reported that they would retire if electronic medical record use was federally mandated. CONCLUSIONS: Pediatric urologists in the United States appear to have embraced the adoption of electronic medical records. A large number of academic/hospital based and private practice pediatric urologists have begun to use electronic medical records. Most respondents were interested in improving electronic medical record use in our field, believed that physicians would be most capable of developing ideal electronic medical records and would be interested in participating in a national cooperative effort to improve electronic medical record use.