Defining Trajectories of Linguistic, Cognitive-Communicative, and Quality of Life Outcomes in Aphasia: Longitudinal Observational Study Protocol.

Objective: To describe the trajectories of linguistic, cognitive-communicative, and health-related quality of life (HRQOL) outcomes after stroke in persons with aphasia. Design: Longitudinal observational study from inpatient rehabilitation to 18 months after stroke. Setting: Four US mid-west inpatient rehabilitation facilities (IRFs). Participants: We plan to recruit 400 adult (older than 21 years) English speakers who meet the following inclusion criteria: (1) Diagnosis of aphasia after a left-hemisphere infarct confirmed by CT scan or magnetic resonance imaging (MRI); (2) first admission for inpatient rehabilitation due to a neurologic event; and (3) sufficient cognitive capacity to provide informed consent and participate in testing. Exclusion criteria include any neurologic condition other than stroke that could affect language, cognition or speech, such as Parkinson's disease, Alzheimer's disease, traumatic brain injury, or the presence of right-hemisphere lesions. Interventions: Not applicable. Main Outcome Measures: Subjects are administered a test battery of linguistic, cognitive-communicative, and HRQOL measures. Linguistic measures include the Western Aphasia Battery-Revised and the Apraxia of Speech Rating Scale. Cognitive-communicative measures include the Communication Participation Item Bank, Connor's Continuous Performance Test-3, the Communication Confidence Rating Scale for Aphasia, the Communication Effectiveness Index, the Neurological Quality of Life measurement system (Neuro-QoL) Communication short form, and the Neuro-QoL Cognitive Function short form. HRQOL measures include the 39-item Stroke & Aphasia Quality of Life Scale, Neuro-QoL Fatigue, Sleep Disturbance, Depression, Ability to Participate in Social Roles & Activities, and Satisfaction with Social Roles & Activities tests, and the Patient-Reported Outcome Measurement and Information System 10-item Global Health short form. The test battery is administered initially during inpatient rehabilitation, and at 3-, 6-, 12-, and 18-months post-IRF discharge. Biomarker samples are collected via saliva samples at admission and a subgroup of participants also undergo resting state fMRI scans. Results: Not applicable. Conclusions: This longitudinal observational study will develop trajectory models for recovery of clinically relevant linguistic, cognitive-communicative, and quality of life outcomes over 18 months after inpatient rehabilitation. Models will identify individual differences in the patterns of recovery based on variations in personal, genetic, imaging, and therapy characteristics. The resulting models will provide an unparalleled representation of recovery from aphasia resulting from stroke. This improved understanding of recovery will enable clinicians to better tailor and plan rehabilitation therapies to individual patient's needs.

Adherence to quality indicators and best practices in surveillance endoscopy of Barrett's esophagus: A video-based assessment.

Background and study aims Adherence to quality indicators (QIs) and best practices (BPs) for endoscopic surveillance of Barrett's esophagus (BE) is low based on clinical documentation which is an inaccurate representation of events occurring during procedures. This study aimed to assess adherence to measurable QI and BP using video evaluation. Methods We performed a single center video-based retrospective review of surveillance endoscopies performed for BE ≥1 cm between March 1, 2018 and October 1, 2020. Adherence to QIs and BPs was assessed through video review and documentation. Videos were evaluated by five gastroenterologists. Interrater variability was determined using 10 videos before reviewing the remaining 128 videos. A generalized linear regression model was used to determine predictors of adherence to QIs and BPs. Results There were 138 endoscopies reviewed. Inspection with virtual chromoendoscopy (VC) occurred in 75 cases (54%) on video review with documentation in 50 of these cases (67%). Adherence to the Seattle protocol (SP) occurred in 74 cases (54%) on video review with documentation in 28 of these cases (38%). Use of VC or the SP was documented but not observed on video review in 16 (12%) and 30 (22%) cases, respectively. Length of BE was associated with increased use of the Prague classification (odds ratio [OR] 1.21, 95% confidence interval [CI] 1.07-1.37) while years in practice was associated with a decreased likelihood of VC use (OR 0.93, 95% CI 0.88-0.99). Conclusions This study validates prior data demonstrating poor adherence to QIs and BPs and highlights discrepancies between clinical documentation and events occurring during procedures.

Do gender differences exist in letters of recommendation for reproductive endocrinology and infertility fellowship?

OBJECTIVE(S): To determine if gender differences exist in letters of recommendation (LORs) for reproductive endocrinology and infertility fellowship. DESIGN: Cohort study. SETTING: Academic medical center. PATIENTS: A cohort of applicants to a reproductive endocrinology and infertility fellowship program at a single Midwestern academic institution in a single year. INTERVENTIONS: None. MAIN OUTCOME MEASURES: Quantitative measures included linguistics inquiry and word count analysis, with 4 summary variables and 25 word categories, to quantify tone and themes present by gender. Performing qualitative analysis in parallel to linguistic analysis allowed for the exploration of themes not conveyed in quantitative methods alone. Qualitative measures included the frequency of code themes in LOR by applicant gender. RESULTS: There were 272 letters from 72 applicants, 54 (76%) of which were women and 17 (24%) were men. One applicant was excluded because gender information was not specified; 269 letters were included in the quantitative linguistics and qualitative coding analysis. One hundred 10 letters (41%) were written by women and 159 (59%) by men. LOR written for men had a higher mean word count than those written for women (537 vs. 474, P=.04). Linguistics Inquiry and Word Count analysis exhibited more risk words used to describe men applicants (P=.01). When comparing word categories by letter writer gender, women letter writers more frequently used communal, affect, and home word categories whereas men writers more frequently used affiliation-related words. Qualitative analysis revealed that letters for men applicants described leadership, altruism, rapport with patients, and strong endorsements more frequently, whereas women applicants' letters more often mentioned doubt raisers and disclosures of personal life. In addition, letters for women applicants more often described candidates as drama free, not easy to "fluster," and not complainers. Furthermore, letters for women more frequently disclosed parenthood status. CONCLUSIONS: Gender differences exist among both letter writers and applicants. Qualitative analysis revealed that women applicants were more likely to be described with doubt raisers and personal life disclosures, whereas men were more likely to be described by their altruism and with a strong endorsement. Increasing bias awareness and implementing mitigation strategies would improve gender equity in LOR.

MidCog study: a prospective, observational cohort study investigating health literacy, self-management skills and cognitive function in middle-aged adults.

INTRODUCTION: The lack of definitive means to prevent or treat cognitive impairment or dementia is driving intense efforts to identify causal mechanisms. Recent evidence suggests clinically meaningful declines in cognition might present as early as middle age. Studying cognitive changes in middle adulthood could elucidate modifiable factors affecting later cognitive and health outcomes, yet few cognitive ageing studies include this age group. The purpose of the MidCog study is to begin investigations of less-studied and potentially modifiable midlife determinants of later life cognitive outcomes. METHODS AND ANALYSIS: MidCog is a prospective cohort study of adults ages 35-64, with two in-person interviews 2.5 years apart. Data will be collected from interviews, electronic health records and pharmacy fill data. Measurements will include health literacy, self-management skills, cognitive function, lifestyle and health behaviours, healthcare use, health status and chronic disease outcomes. Associations of health literacy and self-management skills with health behaviours and cognitive/health outcomes will be examined in a series of regression models, and moderating effects of modifiable psychosocial factors.Finally, MidCog data will be linked to an ongoing, parallel cohort study of older adults recruited at ages 55-74 in 2008 ('LitCog'; ages 70-90 in 2023), to explore associations between age, health literacy, self-management skills, chronic diseases, health status and cognitive function among adults ages 35-90. ETHICS AND DISSEMINATION: The Institutional Review Board at Northwestern University has approved the MidCog study protocol (STU00214736). Results will be published in peer-reviewed journals and summaries will be provided to the funders of the study as well as patients.

Effects of a Smartphone-Based Self-management Intervention for Individuals With Bipolar Disorder on Relapse, Symptom Burden, and Quality of Life: A Randomized Clinical Trial.

Importance: Bipolar disorder-specific psychotherapy combined with pharmacotherapy improves relapse risk, symptom burden, and quality of life, but psychotherapy is not easily accessible. Objective: To determine if a smartphone-based self-management intervention (LiveWell) can assist individuals with bipolar disorder to maintain wellness. Design, Setting, and Participants: An assessor-blind randomized clinical trial enrolled participants from March 20, 2017, to April 25, 2019, with 48-week follow-up ending on April 10, 2020. Participants were randomly assigned to usual care or usual care plus the smartphone intervention stratified by relapse risk based on initial clinical status (low risk: asymptomatic recovery; high risk: continued symptomatic, prodromal, recovering, symptomatic recovery). Participants with bipolar disorder I were recruited from clinics in the Chicago and Minneapolis-Saint Paul areas. Data were analyzed from June 19, 2020, to May 25, 2022. Interventions: The smartphone-based self-management intervention consisted of an application (app), coach, and website. Over 16 weeks, participants had a coach visit followed by 6 phone calls, and they completed daily and weekly app check-ins. The app provided adaptive feedback and information for developing a personalized wellness plan, the coach provided support, and the website provided summary data and alerts. Main Outcomes and Measures: The primary outcome was time to relapse. Secondary outcomes were percentage-time symptomatic, symptom severity, and quality of life. Results: Of the 205 randomized participants (mean [SD] age, 42 [12] years; 125 female individuals [61%]; 5 Asian [2%], 21 Black [10%], 13 Hispanic or Latino [6%], 7 multiracial [3%], 170 White [83%], 2 unknown race [1%]), 81 (40%) were randomly assigned to usual care, and 124 (60%) were randomly assigned to usual care plus the smartphone intervention. This clinical trial did not detect a reduction in relapse risk for the smartphone intervention (hazard ratio [HR], 0.65; 95% CI, 0.39-1.09; log-rank P = .08). However, decreased relapse was observed for low-risk individuals (HR, 0.32; 95% CI, 0.12-0.88; log-rank P = .02) but not high-risk individuals (HR, 0.86; 95% CI, 0.47-1.57; log-rank P = .62). Reduced manic symptom severity was observed for low-risk individuals (mean [SE] difference, -1.4 [0.4]; P = .001) but not for high-risk individuals (mean [SE] difference, 0 [0.3]; P = .95). The smartphone-based self-management intervention decreased depressive symptom severity (mean [SE] difference, -0.80 [0.34]; P = .02) and improved relational quality of life (mean [SE] difference, 1.03 [0.45]; P = .02) but did not decrease percentage-time symptomatic (mean [SE] difference, -5.6 [4.3]; P = .20). Conclusions and Relevance: This randomized clinical trial of a smartphone-based self-management intervention did not detect a significant improvement in the primary outcome of time to relapse. However, a significant decrease in relapse risk was observed for individuals in asymptomatic recovery. In addition, the intervention decreased depressive symptom severity and improved relational quality of life. These findings warrant further work to optimize the smartphone intervention and confirm that the intervention decreases relapse risk for individuals in asymptomatic recovery. Trial Registration: ClinicalTrials.gov Identifier: NCT03088462.

Prevalence and risk factors of sleep disturbance in adults with underlying health conditions during the ongoing COVID-19 pandemic.

To determine the prevalence of sleep disturbance during the coronavirus disease 2019 (COVID-19) pandemic among US adults who are more vulnerable to complications because of age and co-morbid conditions, and to identify associated sociodemographic and psychosocial factors. Cross-sectional survey linked to 3 active clinical trials and 2 cohort studies, conducted between 11/30/2020 and 3/3/2021. Five academic internal medicine practices and 2 federally qualified health centers. A total of 715 adults ages 23 to 91 years living with one or more chronic conditions. A fifth (20%) of participants reported poor sleep. Black adults were twice as likely to report poor sleep compared to Whites. Self-reported poor physical function (51%), stress (42%), depression (28%), and anxiety (36%) were also common and all significantly associated with poor sleep. Age ≥70 years and having been vaccinated for COVID-19 were protective against poor sleep. Sex, education, income, alcohol use, and employment status were not significantly associated with sleep quality. In this diverse sample of adults with chronic conditions, by race, ethnicity, and socioeconomic status, disparities in sleep health amid the ongoing pandemic were apparent. Worse physical function and mental health were associated with poor sleep and should be considered targets for health system interventions to prevent the many subsequent consequences of disturbed sleep on health outcomes. Measurements: self-reported sleep quality, physical function, stress, depression, and anxiety.

Trajectories of perceived susceptibility to COVID-19 over a year: The COVID-19 & chronic conditions (C3) cohort study.

ABSTRACT: The U.S. public health response to coronavirus disease 2019 (COVID-19) has been widely criticized as having downplayed the potential implications COVID-19 could have on one's personal health. Despite the unprecedented threat of COVID-19, many individuals still believed that it was not at all likely that they would become infected. We sought to investigate trends in adults' perceived susceptibility to COVID-19 over the first year of the pandemic, whether distinct trajectories emerged, and if these trajectories differed by participant socio-demographic characteristics.This was a longitudinal cohort study with 5 time points of data collection (March 13, 2020-March 3, 2021). Subjects included 627 adults living with ≥1 chronic conditions, who completed a baseline interview and at least one follow-up interview. In addition to collecting relevant socio-demographic characteristics, participants' perceived susceptibility to COVID-19 across time was assessed and classified into distinct trajectories.Nearly two-thirds (62.2%) of participants perceived themselves to be highly susceptible to COVID-19 from the onset of the pandemic ("early responders") and sustained this over a year, a third (29.0%) eventually perceived themselves to be highly susceptible ("late responders"), and 8.8% maintained a low likelihood of susceptibility throughout the pandemic ("non-responders"). In multivariable analyses, compared to White participants, Latinx participants were significantly more likely to be non-responders and report low likelihood of perceived susceptibility (Risk Ratio [RR]: 3.46; 95% confidence interval: 1.19, 10.1), as were Black participants (RR: 5.49; 95% confidence interval: 2.19, 13.8).A year into the COVID-19 pandemic, 1 out of 11 participants persistently did not think they might be susceptible and potentially infected. Future studies are needed to understand reasons why certain individuals, particularly those of racial/ethnic minorities, did not perceive themselves at risk for infection.

Micrographic dermatologic surgery (MDS) diplomates: a demographic evaluation and comparison of Medicare case volume.

Micrographic dermatologic surgery (MDS) recently became a board-certified field within dermatology with the first board examination administered in October 2021. To be eligible, dermatologists must have completed a fellowship through the Accreditation Council for Graduate Medical Education (ACGME) or attest to active practice of Mohs micrographic surgery. Attestation of active practice is available from 2021-2025, after which, those sitting for the certifying examination must demonstrate completion of an ACGME-accredited fellowship. This study aimed to compile demographic information on physicians who passed the MDS board certification examination. Medicare Mohs micrographic surgery case volume was compared between fellowship-trained and non-fellowship-trained physicians as well as between members and non-members of Mohs organizations. Names of physicians who passed the examination were accessed on the publicly available American Board of Dermatology website. The Medicare database was used to screen for Mohs surgery case numbers from 2019, and the American College of Mohs Surgery (ACMS) and American Society for Mohs Surgery (ASMS) physician finder tools were used to determine active membership. Physicians not in the Medicare database and those who completed an ACGME-accredited fellowship within the past three years were excluded from case volume analysis. 1673 dermatologists passed the first certifying examination. Medicare Mohs case volumes were compared for 1310 of these physicians. The median number (interquartile range (IQR)) of Mohs surgery cases was significantly higher for physicians who were ACMS/ACGME-fellowship-trained compared to those who were not (370 cases (IQR: 211-560) vs 138 cases (IQR: 37-284), p < 0.001). Members of ACMS and/or ASMS also performed a higher median number of cases compared to non-members (334 cases (IQR: 160-526) vs 95 cases (IQR: 6-246), p < 0.001). Given the 5-year window to take the MDS examination without having completed an ACMS/ACGME-accredited fellowship, more physicians without formal training may choose to become board certified. In addition, less dermatologists may choose to complete an ACMS/ACGME-accredited fellowship since it is not required for board certification. As more dermatologists become board certified in MDS, it may become important to assess for active practice of Mohs surgery and define proficiency metrics.

A Smartphone-Based Self-management Intervention for Individuals With Bipolar Disorder (LiveWell): Empirical and Theoretical Framework, Intervention Design, and Study Protocol for a Randomized Controlled Trial.

BACKGROUND: Bipolar disorder is a severe mental illness with high morbidity and mortality rates. Even with pharmacological treatment, frequent recurrence of episodes, long episode durations, and persistent interepisode symptoms are common and disruptive. Combining psychotherapy with pharmacotherapy improves outcomes; however, many individuals with bipolar disorder do not receive psychotherapy. Mental health technologies can increase access to self-management strategies derived from empirically supported bipolar disorder psychotherapies while also enhancing treatment by delivering real-time assessments, personalized feedback, and provider alerts. In addition, mental health technologies provide a platform for self-report, app use, and behavioral data collection to advance understanding of the longitudinal course of bipolar disorder, which can then be used to support ongoing improvement of treatment. OBJECTIVE: A description of the theoretical and empirically supported framework, design, and protocol for a randomized controlled trial (RCT) of LiveWell, a smartphone-based self-management intervention for individuals with bipolar disorder, is provided to facilitate the ability to replicate, improve, implement, and disseminate effective interventions for bipolar disorder. The goal of the trial is to determine the effectiveness of LiveWell for reducing relapse risk and symptom burden as well as improving quality of life (QOL) while simultaneously clarifying behavioral targets involved in staying well and better characterizing the course of bipolar disorder and treatment response. METHODS: The study is a single-blind RCT (n=205; 2:3 ratio of usual care vs usual care plus LiveWell). The primary outcome is the time to relapse. Secondary outcomes are percentage time symptomatic, symptom severity, and QOL. Longitudinal changes in target behaviors proposed to mediate the primary and secondary outcomes will also be determined, and their relationships with the outcomes will be assessed. A database of clinical status, symptom severity, real-time self-report, behavioral sensor, app use, and personalized content will be created to better predict treatment response and relapse risk. RESULTS: Recruitment and screening began in March 2017 and ended in April 2019. Follow-up ended in April 2020. The results of this study are expected to be published in 2022. CONCLUSIONS: This study will examine whether LiveWell reduces relapse risk and symptom burden and improves QOL for individuals with bipolar disorder by increasing access to empirically supported self-management strategies. The role of selected target behaviors (medication adherence, sleep duration, routine, and management of signs and symptoms) in these outcomes will also be examined. Simultaneously, a database will be created to initiate the development of algorithms to personalize and improve treatment for bipolar disorder. In addition, we hope that this description of the theoretical and empirically supported framework, intervention design, and study protocol for the RCT of LiveWell will facilitate the ability to replicate, improve, implement, and disseminate effective interventions for bipolar and other mental health disorders. TRIAL REGISTRATION: ClinicalTrials.gov NCT03088462; https://www.clinicaltrials.gov/ct2/show/NCT03088462. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/30710.

Threshold evaluation for optimal number of endoscopic treatment sessions to achieve complete eradication of Barrett's metaplasia.

BACKGROUND: Endoscopic eradication therapy (EET) is the standard of care for Barrett's esophagus (BE)-associated neoplasia. Previous data suggest the mean number of EET sessions required to achieve complete eradication of intestinal metaplasia (CE-IM) is 3. This study aimed to define the threshold of EET sessions required to achieve CE-IM. METHODS: The TREAT-BE Consortium is a multicenter outcomes cohort including prospectively enrolled patients with BE undergoing EET. All patients achieving CE-IM were included. Demographic, endoscopic, and histologic data were recorded at treatment onset along with treatment details and surveillance data. Kaplan-Meier analysis was performed to define a threshold of EET sessions, with 95 %CI, required to achieve CE-IM. A secondary analysis examined predictors of incomplete response to EET using multiple logistic regression and recurrence rates. RESULTS: 623 patients (mean age 65.2 [SD 11.6], 79.6 % male, 86.5 % Caucasian) achieved CE-IM in a mean of 2.9 (SD 1.7) EET sessions (median 2) and a median total observation period of 2.7 years (interquartile range 1.4-5.0). After three sessions, 73 % of patients achieved CE-IM (95 %CI 70 %-77 %). Age (odds ratio [OR] 1.25, 95 %CI 1.05-1.50) and length of BE (OR 1.24, 95 %CI 1.17-1.31) were significant predictors of incomplete response. CONCLUSION: The current study found that a threshold of three EET sessions would achieve CE-IM in the majority of patients. Alternative therapies and further diagnostic testing should be considered for patients who do not have significant response to EET after three sessions.

The effect of depression and anxiety symptom severity on clinical outcomes and app use in digital mental health treatments: Meta-regression of three trials.

A large number of trials have consistently shown that guided digital mental health treatments (DMHTs) are effective for depression and anxiety. As DMHTs are adopted by healthcare organizations, payers, and employers, they are often considered most appropriate for people with mild-to-moderate levels of symptom severity. Thus, the aim of this study was to examine the effects of symptom severity on depression and anxiety outcomes and app use across three trials of a guided DMHT, IntelliCare. Participants were categorized into mild, moderate, moderately severe, and severe symptom severity groups on depression and anxiety. All symptom severity groups showed significant reductions in depression and anxiety in a clear ordinal pattern, with the mild symptom severity group showing the smallest changes and the severe symptom group showing the largest improvements. Those with the lowest levels of educational attainment showed the largest symptom improvement. Baseline symptom severity was not significantly related to app use. App use was significantly related to depression and anxiety outcomes. These findings suggest that depression and anxiety symptom severity is not useful in determining who should be referred to a guided DMHT.

Do gender and racial differences exist in letters of recommendation for obstetrics and gynecology residency applicants?

BACKGROUND: Studies in several fields demonstrate gender and racial differences in descriptions of applicants in letters of recommendation. However, gender and racial biases in obstetrics and gynecology residency letters of recommendation are understudied. OBJECTIVE: This study aimed to determine whether there are differences in the letters of recommendation written for medical students applying for obstetrics and gynecology residency based on applicant gender and underrepresented in medicine status. STUDY DESIGN: We analyzed all letters of recommendation submitted to a single obstetrics and gynecology residency program during the 2019-2020 application cycle using a computerized text analysis software to evaluate the presence of 25 word categories. Multivariable regression was used to compare differences in the frequency of word categories by gender and underrepresented in medicine status. Concurrently, we performed a qualitative content analysis of letters from a random sample of applicants balanced for gender and underrepresented in medicine status and explored emerging themes until thematic saturation was reached. RESULTS: We analyzed 3060 letters written for 834 applicants, 721 (87%) of whom were women and 198 (24%) of whom were underrepresented in medicine. Men authored 1605 letters (53%). There was no difference in word categories used in letters written for men and women applicants on multivariable analysis. Similarly, there was no word category difference between letters written for applicants who were underrepresented in medicine compared with White and Asian applicants. However, women letter writers used more communal (relationship-oriented) words compared with men letter writers (P<.001). Moreover, on the qualitative analysis of letters from a random sample of 30 applicants, comments about personality traits were frequent in all letters. Comments on surgical skills, work ethic, and leadership were found more in letters for White and Asian applicants, and phrases that were doubt raisers were found more in letters written for underrepresented medicine applicants. CONCLUSION: On linguistic analysis, letters of recommendation written for obstetrics and gynecology residency applicants were similar overall compared with applicant race and gender.

Targeting subjective engagement in experimental therapeutics for digital mental health interventions.

Engagement is a multifaceted construct and a likely mechanism by which digital interventions achieve clinical improvements. To date, clinical research on digital mental health interventions (DMHIs) has overwhelmingly defined engagement and assessed its association with clinical outcomes through the objective/behavioral metrics of use of or interactions with a DMHI, such as number of log-ins or time spent using the technology. However, engagement also entails users' subjective experience. Research is largely lacking that tests the relationship between subjective metrics of engagement and clinical outcomes. The purpose of this study is to present a proof-of-concept exploratory evaluation of the association between subjective engagement measures of a mobile DMHI with changes in depression and anxiety. Adult primary care patients (N = 146) who screened positive for depression or anxiety were randomized to receive a DMHI, IntelliCare, immediately or following an 8-week waitlist. Subjective engagement was measured via the Usefulness, Satisfaction, and Ease of Use (USE) Questionnaire. Across both conditions, results showed that individuals who perceived a mobile intervention as more useful, easy to use and learn, and satisfying had greater improvements in depression and anxiety over eight weeks. Findings support our proposed experimental therapeutics framework that hypothesizes objective/behavioral and subjective engagement metrics as mechanisms that lead to changes in clinical outcomes, as well as support directing intervention design efforts for DMHIs to target the user experience.

Perceived Adequacy of Tangible Support during Stay-at-Home Orders in Chicago and New York.

OBJECTIVES: Physical distancing precautions during the COVID-19 pandemic may challenge the provision of tangible support many middle age and older adults receive in managing their health. We examined the association between unmet tangible support needs and self-management behaviors and mental health status during the stay-at-home orders in Chicago and New York. METHODS: We used data from the COVID-19 & Chronic Conditions study collected between May 1st and May 22nd, 2020. A total of 801 middle age and older adults with ≥1 chronic condition in Chicago and New York City completed the telephone interview. Adequacy of tangible social support was measured using a brief, validated scale that determined whether an individual needed assistance managing his or her health, and if yes, whether this need was met. Participants reported their level of difficulty engaging in self-management behaviors using 2 discrete items; they also self-reported medication adherence using the ASK-12 medication adherence scale. Mental health status was measured using the depression and anxiety PROMIS short-form instruments. RESULTS: Participants' mean age was 63 years; 30% identified as Black, 26% identified as Latino, and 12% identified unmet support needs. Inadequacy of tangible support was associated with greater difficulty managing one's health and accessing medications due to COVID-19, as well as poorer medication adherence, increased anxiety and depressive symptoms, and poorer overall well-being (P's < .05). CONCLUSIONS: Perceived unmet support needs during stay-at-home orders were associated with greater difficulty engaging in self-management behaviors and poorer overall well-being. Two brief items quickly identified individuals with unmet support needs.

Clinical Features Observed in General Practice Associated With the Subsequent Diagnosis of Progressive Supranuclear Palsy.

Background: Progressive supranuclear palsy (PSP) is a rare neurodegenerative disorder that is difficult for primary care physicians to recognize due to its progressive nature and similarities to other neurologic disorders. This case-control study aimed to identify clinical features observed in general practice associated with a subsequent diagnosis of PSP. Methods: We analyzed a de-identified dataset of 152 PSP cases and 3,122 matched controls from electronic medical records of general practices in Germany. We used a random forests algorithm based on machine learning techniques to identify clinical features (medical conditions and treatments received) associated with pre-diagnostic PSP without using an a priori hypothesis. We then assessed the relative effects of the features with the highest importance scores and generated multivariate models using clustered logistic regression analyses to identify a subset of clinical features associated with subsequent PSP diagnosis. Results: Using the random forests approach, we identified 21 clinical features associated with pre-diagnostic PSP (odds ratio ≥2.0 in univariate analyses). From these, we constructed a multivariate model comprising 9 clinical features with ~90% likelihood of identifying a subsequent PSP diagnosis. These features included known PSP symptoms, common misdiagnoses, and 2 novel associations, diabetes mellitus and cerebrovascular disease, which are possible modifiable risk factors for PSP. Conclusion: In this case-control study using data from electronic medical records, we identified 9 clinical features, including 2 previously unknown factors, associated with the pre-diagnostic stage of PSP. These may be used to facilitate recognition of PSP and reduce time to referral by primary care physicians.

Association of Chest Dysphoria With Anxiety and Depression in Transmasculine and Nonbinary Adolescents Seeking Gender-Affirming Care.

PURPOSE: The purpose of this study was to determine the existence and strength of association between chest dysphoria and mental health in transmasculine and nonbinary adolescents. METHODS: This is a cross-sectional cohort study of transmasculine and nonbinary adolescents designated female at birth between 12 and 18 years old. None had undergone prior top surgery. Patients complete the Chest Dysphoria Measure and Youth Inventory-4 (YI-4) upon presentation to our institution. Outcomes were retrospectively reviewed. The primary outcome of interest was the association between chest dysphoria and anxiety and depression symptom severity, as measured by the YI-4. RESULTS: One hundred fifty-six patients met inclusion criteria. Mean age was 15.3 years (standard deviation [SD] = 1.7). Most patients identified as transmasculine (n = 132); 18 identified as nonbinary and 6 as questioning. Mean (SD) YI-4 symptom severity scores were 10.67 (6.64) for anxiety and 11.99 (7.83) for depression. Mean (SD) Chest Dysphoria Measure composite score was 30.15 (9.95); range 2-49. Chest dysphoria was positively correlated with anxiety (r = .146; p = .002) and depression (r = .207; p < .001). In multivariate linear regression models, chest dysphoria showed a significant, positive association with anxiety and depression, after accounting for gender dysphoria, degree of appearance congruence, and social transition status. CONCLUSIONS: Chest dysphoria is associated with higher anxiety and depression in transmasculine and nonbinary adolescents designated female at birth. This association is independent of level of gender dysphoria, degree of appearance congruence, and social transition status. Treatment options aimed at alleviating chest dysphoria should be made accessible to adolescents and tailored to individual needs.

Change in Health Literacy over a Decade in a Prospective Cohort of Community-Dwelling Older Adults.

BACKGROUND: Health literacy is often viewed as a static trait in longitudinal studies, which may over or underestimate an individual's ability to manage one's health. OBJECTIVES: We sought to examine health literacy over time among older adults using three widely used measures. DESIGN: A prospective cohort study. PARTICIPANTS: Community-dwelling adults ages 55 to 74 at baseline with at least one follow-up visit (N = 656) recruited from one academic internal medicine clinic and six community health centers in Chicago, IL. MEASURES: Health literacy was measured using the Test of Functional Health Literacy in Adults (TOFHLA), Newest Vital Sign (NVS), and Rapid Estimate of Adult Literacy in Medicine (REALM) at baseline and up to three follow-up time points. RESULTS: In unadjusted analyses, significant changes since baseline were found beginning at the second follow-up (mean (M) = 6.0 years, SD = 0.6) for the TOFHLA (M = - 0.9, SD = 0.95, p = 0.049) and the REALM (M = 0.3, SD = 2.5, p = 0.004) and at the last follow-up (M = 8.6 years, SD = 0.5) for the NVS (M = - 0.2, SD = 1.4, p = 0.02). There were non-linear effects of baseline age on TOFHLA and NVS scores over time (piecewise cubic spline p = 0.01 and p < 0.001, respectively) and no effect on REALM scores (B = 0.02, 95% CI - 0.01 to 0.04, p = 0.17) using multivariable mixed-effects linear regression models, controlling for race, education, income, and comorbidity. CONCLUSION: We found a negative relationship between age and health literacy over time as measured by the TOFHLA and NVS. Health literacy barriers appear to be more prevalent among individuals in later life, when self-care demands are similarly increasing. Clinicians might consider strategies to assess and respond to limited health literacy, particularly among patients 70 and older. REALM performance remained stable over 10 years of follow-up. This questions whether health literacy tools measure the same attribute. Prospective health literacy studies should carefully consider what measures to use, depending on their objective.

Transplant regimen adherence for kidney recipients by engaging information technologies (TAKE IT): Rationale and methods for a randomized controlled trial of a strategy to promote medication adherence among transplant recipients.

BACKGROUND: Several studies report a high prevalence of non-adherence to prescribed immunosuppressive (IS) medications among kidney transplant recipients (KTRs), yet few interventions have been effective for helping patients sustain appropriate post-transplant adherence. We describe a multifaceted, evidence-based, medication adherence monitoring strategy ('TAKE IT') that leverages available transplant center resources to identify potential medication non-adherence and other concerns earlier to prevent complications that could result from inadequate IS adherence. METHODS: The TAKE IT strategy includes: 1) medication adherence mobile application; 2) routine, online patient self-reported adherence assessments; 3) care alert notifications via the electronic health record (EHR) directed to transplant coordinators; 4) quarterly adherence reports to monitor IS values and summarize adherence trends; 5) deployment of adherence support tools tailored to specific adherence concerns. To test the TAKE IT intervention, we will conduct a two-arm, patient-randomized controlled trial at two large, diverse transplant centers (Northwestern University, Mayo Clinic, AZ) with planned recruitment of 450 KTRs (n = 225 per site) within 2 years of transplantation and 2 years of follow-up. Study assessments will take place at baseline, 6 weeks, 6, 12, 18 and 24 months. The primary effectiveness outcome is medication adherence via pill count, secondary outcomes include self-reported adherence and clinical outcomes. Process outcomes and cost-effectiveness will also be examined. CONCLUSION: The TAKE IT trial presents an innovative approach to monitoring and optimizing medication adherence among a population taking complex medication regimens. This trial seeks to evaluate the effectiveness and feasibility of this strategy compared to usual care.

An Exploratory Brief Head-To-Head Non-Inferiority Comparison of an Internet-Based and a Telephone-Delivered CBT Intervention for Adults with Depression.

BACKGROUND: Telephone-administered psychotherapy (tCBT) and internet-based treatments (iCBT) may overcome barriers to mental health treatment. TCBT has demonstrated efficacy similar to traditional psychotherapy, however, few studies have compared iCBT to efficacious interventions. This exploratory study examined the noninferiority of iCBT relative to tCBT. We also explored pretreatment moderators of outcome and assessed treatment dropout. METHODS: As a secondary exploratory analysis of a 304-participant randomized noninferiority trial, we compared iCBT, the first level of a stepped-care intervention, with tCBT on depression outcome after 5 weeks of treatment (prior to stepping). Multiple linear regression models were fit to examine moderators of 5-week depression. Differences in dropout were examined using Kaplan-Meier survival analysis. RESULTS: After 5 weeks of treatment, both interventions significantly reduced depression severity. The effect size difference between the two interventions was d=0.004 [90% CI=-0.19 to 0.19]; the CI did not cross the non-inferiority margin. Pretreatment depression was significantly associated with depression at week 5. The relationship between cognitive strategy usefulness and depression at week 5 differed between interventions, controlling for pretreatment depression. There was no significant difference in dropout between interventions. LIMITATIONS: Given the stepped-care trial design, iCBT and tCBT could not be compared at the end of treatment or follow-up. Analyses were exploratory and should be interpreted with caution. CONCLUSIONS: A large sample, powered for noninferiority, found iCBT no less efficacious than tCBT at reducing depression symptoms after five weeks of treatment.

Macromolecular changes in spinal cord white matter characterize whiplash outcome at 1-year post motor vehicle collision.

Each year, whiplash injuries from motor vehicle collisions (MVC) affect millions worldwide, with no strong evidence of pathology. While the majority recover soon after the injury, the same is not true for roughly 20% reporting higher levels of pain and distress, without diagnostic options. This study used magnetization transfer (MT) imaging to quantify white matter integrity in 78 subjects with varying levels of pain, 1 year after MVC. MT images of the cervical spinal cord were collected parallel to the intervertebral disks. MT ratios (MTR) were calculated in select white matter tracts along with MTR homogeneity (MTRh) at each level. Significant differences were observed between clinical outcome groups in the left and right spinothalamic tracts (p = 0.003 and 0.020) and MTRh (p = 0.009). MTRh was elevated in females with poor recovery versus females reporting recovery (p < 0.001) or milder symptoms (p < 0.001), and in males reporting recovery (p = 0.007) or no recovery (p < 0.001). There was a significant interaction between recovery status and sex (p = 0.015). MT imaging identified tract specific and regional changes in white matter integrity suggesting potential insults to the cord. Additionally, significant MTRh differences between sexes were observed, characterizing the heterogeneity of whiplash recovery and worse outcomes in females.