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BackgroundCognitive behavioral therapy (CBT) can be delivered efficaciously through various modalities, including telephone (T-CBT) and face-to-face (FtF-CBT). The purpose of this study was to explore predictors of outcome in T-CBT and FtF-CBT for depression.MethodA total of 325 depressed participants were randomized to receive eighteen 45-min sessions of T-CBT or FtF-CBT. Depression severity was measured using the Hamilton Depression Rating Scale (HAMD) and the Patient Health Questionnaire-9 (PHQ-9). Classification and regression tree (CART) analyses were conducted with baseline participant demographics and psychological characteristics predicting depression outcomes, HAMD and PHQ-9, at end of treatment (week 18).ResultsThe demographic and psychological characteristics accurately identified 85.3% and 85.0% of treatment responders and 85.7% and 85.0% of treatment non-responders on the HAMD and PHQ-9, respectively. The Coping self-efficacy (CSE) scale predicted outcome on both the HAMD and PHQ-9; those with moderate to high CSE were likely to respond with no other variable influencing that prediction. Among those with low CSE, depression severity influenced response. Social support, physical functioning, and employment emerged as predictors only for the HAMD, and sex predicted response on the PHQ-9. Treatment delivery method (i.e. telephone or face-to-face) did not impact the prediction of outcome.ConclusionsFindings suggest that the predictors of improved depression are similar across treatment modalities. Most importantly, a moderate to high level of CSE significantly increases the chance of responding in both T-CBT and FtF-CBT. Among patients with low CSE, those with lower depressive symptom severity are more likely to do well in treatment.

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., (© 2024 The Authors.)

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., Competing Interests: Conflict of Interest RNK is a consultant for Boston Scientific, Medtronic, and Neptune Medical. SK is a consultant for Boston Scientific, Endogastric Solutions, Ethicon, and Castle Biosciences. The remaining authors have no conflicts of interest to disclose., (The Author(s). This is an open access article published by Thieme under the terms of the Creative Commons Attribution-NonDerivative-NonCommercial-License, permitting copying and reproduction so long as the original work is given appropriate credit. Contents may not be used for commercial purposes, or adapted, remixed, transformed or built upon. (https://creativecommons.org/licenses/by-nc-nd/4.0/).)

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., Competing Interests: Declaration of interests K.M.B. has nothing to disclose. O.B. has nothing to disclose. A.S.K. has nothing to disclose. M.J.K. has nothing to disclose. E.C.F. has nothing to disclose., (Copyright © 2023 American Society for Reproductive Medicine. Published by Elsevier Inc. All rights reserved.)

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., Competing Interests: Competing interests: SCB reports grants from the NIH, Merck, Pfizer, Gordon and Betty Moore Foundation, Retirement Research Foundation for Aging, Lundbeck, Gilead, and Eli Lilly via her institution and personal fees from Sanofi, Pfizer, University of Westminster, Lundbeck, Gilead, and Luto UK outside the submitted work. PCZ reports grants from the NIH and Vanda via her institution and personal consulting fees from Jazz, Eisai, Harmony and Sleep Number that are outside the submitted work. MW reports grants from the NIH, Gordon and Betty Moore Foundation, and Eli Lilly, and personal fees from Pfizer, Sanofi, Luto UK, University of Westminster, and Lundbeck outside the submitted work. RO’C is supported by a training grant from the National Institute on Aging (K01AG070107). All the other authors report no conflict of interest., (© Author(s) (or their employer(s)) 2023. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

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.

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., Competing Interests: The authors declare that they have no conflict of interest., (Thieme. All rights reserved.)

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., Competing Interests: SCB reports grants from the NIH, Merck, Pfizer, Gordon and Betty Moore Foundation, RRF Foundation for Aging, Lundbeck, and Eli Lilly through her institution; and personal fees from Gilead, Sanofi, Pfizer, University of Westminster, Lundbeck, and Luto outside the submitted work. All other authors report no conflict of interest., (Copyright © 2022 the Author(s). Published by Wolters Kluwer Health, Inc.)

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., Competing Interests: MSW reports grants from the NIH during the conduct of the study; grants from Merck, the Gordon and Betty Moore Foundation, the NIH, and Eli Lilly outside the submitted work; and personal fees from Sanofi, Pfizer, and Luto outside the submitted work. SCB reports grants from the NIH during the conduct of the study; grants from Merck, the NIH, and Eli Lilly outside the submitted work; grants and personal fees from the Gordon and Betty Moore Foundation outside the submitted work; and personal fees from Sanofi, Pfizer, and Luto outside the submitted work. LAO, LMC, MJK, RO, GAW, JYB, RML, MRE, and AMZ have no conflicts of interest to disclose., (Copyright © 2022 the Author(s). Published by Wolters Kluwer Health, Inc.)

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., (© 2022. The Author(s), under exclusive licence to Springer-Verlag GmbH Germany, part of Springer Nature.)

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., (©Evan H Goulding, Cynthia A Dopke, Rebecca C Rossom, Tania Michaels, Clair R Martin, Chloe Ryan, Geneva Jonathan, Alyssa McBride, Pamela Babington, Mary Bernstein, Andrew Bank, C Spencer Garborg, Jennifer M Dinh, Mark Begale, Mary J Kwasny, David C Mohr. Originally published in JMIR Research Protocols (https://www.researchprotocols.org), 21.02.2022.)

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., (Copyright © 2021 Elsevier Ltd. All rights reserved.)

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., (Copyright © 2021 Elsevier Inc. All rights reserved.)

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., (Copyright © 2021 Society for Adolescent Health and Medicine. Published by Elsevier Inc. All rights reserved.)

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., Competing Interests: DCM has an ownership interest in Adaptive Health, Inc., which has a license from Northwestern University to commercialize IntelliCare. AKG, MKJ, & EGL have received consulting fees from Actualize Therapy, LLC. DCM also has received consulting fees from Apple Inc., (© 2021 The Authors.)

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., Competing Interests: MJK has received honoraria from KAI Research in conjunction with the National Institutes of Health Award R01-AR071057, and consulting fees from AbbVie and Actualize Therapy, LLC. DMO and JZ are full-time employees of AbbVie and may hold stock and/or stock options in AbbVie. RD is a contractor with AbbVie. GUH has ongoing research collaborations with Prothena; has served as a consultant for AbbVie, Alzprotect, Asceneuron, Biogen, Biohaven, Lundbeck, Novartis, Roche, Sanofi, and UCB; has received honoraria for scientific presentations from AbbVie, Biogen, Bristol Myers Squibb, Roche, Teva, UCB, and Zambon; has received research support from CurePSP, the German Academic Exchange Service (DAAD), the German Ministry of Education and Research (BMBF), the German Parkinson's Disease Foundation (DPG), the German PSP Association (PSP Gesellschaft), the German Research Foundation (DFG), International Parkinson's Funds (IPF), VolkswagenStiftung/Lower Saxony Ministry for Science/Petermax-Müller Foundation (Etiology and Therapy of Synucleinopathies and Tauopathies); and has received institutional support from the German Center for Neurodegenerative Diseases (DZNE). The authors declare that this study received funding from AbbVie Inc. The funder contributed to the study design, research, and interpretation of the data, and to the writing, review, and approval of the publication. AbbVie also provided funding to IQVIA for licensing of the electronic medical records database sourced by the IMS® Disease Analyzer and funding for editorial support., (Copyright © 2021 Kwasny, Oleske, Zamudio, Diegidio and Höglinger.)

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., (Copyright © 2021 Elsevier Inc. All rights reserved.)

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.

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., (Copyright © 2020. Published by Elsevier B.V.)

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.

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.

Background: The US outbreak of coronavirus disease 2019 (COVID-19) accelerated rapidly over a short time to become a public health crisis., Objective: To assess how high-risk adults' COVID-19 knowledge, beliefs, behaviors, and sense of preparedness changed from the onset of the US outbreak (March 13-20, 2020) to the acceleration phase (March 27-April 7, 2020)., Design: Longitudinal, two-wave telephone survey., Participants: 588 predominately older adults with ≥ 1 chronic condition recruited from 4 active, federally funded studies in Chicago., Main Measures: Self-reported knowledge of COVID-19 symptoms and prevention, related beliefs, behaviors, and sense of preparedness., Key Results: From the onset to the acceleration phase, participants increasingly perceived COVID-19 to be a serious public health threat, reported more changes to their daily routine and plans, and reported greater preparedness. The proportion of respondents who believed they were "not at all likely" to get the virus decreased slightly (24.9 to 22.4%; p = 0.04), but there was no significant change in the proportion of those who were unable to accurately identify ways to prevent infection (29.2 to 25.7%; p 0.14). In multivariable analyses, black adults and those with lower health literacy were more likely to report less perceived susceptibility to COVID-19 (black adults: relative risk (RR) 1.62, 95% confidence interval (CI) 1.07-2.44, p = 0.02; marginal health literacy: RR 1.96, 95% CI 1.26-3.07, p < 0.01). Individuals with low health literacy remained more likely to feel unprepared for the outbreak (RR 1.80, 95% CI 1.11-2.92, p = 0.02) and to express confidence in the federal government response (RR 2.11, 95% CI 1.49-3.00, p < 0.001) CONCLUSIONS: Adults at higher risk for COVID-19 continue to lack critical knowledge about prevention. While participants reported greater changes to daily routines and plans, disparities continued to exist in perceived susceptibility to COVID-19 and in preparedness. Public health messaging to date may not be effectively reaching vulnerable communities.

Importance: Depression and anxiety are common and disabling. Primary care is the de facto site for treating these mental health problems but is typically underresourced to meet the burden of these demands., Objective: To evaluate the efficacy of a mobile intervention platform, IntelliCare, for addressing depression and anxiety among primary care patients., Design, Setting, and Participants: Two-arm randomized clinical trial at internal medicine clinics at the University of Arkansas for Medical Sciences. Adult primary care patients (N = 146) who screened positive for depression on the Patient Health Questionnaire-8 (PHQ; score  ≥ 10) or anxiety on the Generalized Anxiety Disorder-7 (GAD-7; score ≥ 8) were recruited between July 17, 2018, and December 14, 2018., Interventions: The coach-supported platform composed of a suite of apps, was delivered over 8 weeks. Wait list control participants received treatment as usual for 8 weeks, then the mobile platform., Main Outcomes and Measures: Primary outcomes were changes in depression (PHQ-9) and anxiety (GAD-7) during the intervention period. Secondary outcomes were differences in the proportion of patients who achieved recovery (PHQ-9/GAD-7 <5 or 50% improvement from baseline), sustainment of intervention effects during 2-month follow-up, and app use during the intervention period., Results: One hundred forty-six patients were included (119 of 146 were women [81.5%]; mean [SD] age, 42.3 [13.8] years). Of the 146 patients, 122 (83.6%) were diagnosed as having depression and 131 (89.7%) were diagnosed as having anxiety. A greater proportion of intervention vs wait list control participants achieved recovery from depression (n = 38 of 64 [59%] vs n = 18 of 58 [31%]; odds ratio, 3.25; 95% CI, 1.54-6.86) and anxiety (n = 37 of 65 [57%] vs n = 25 of 66 [38%]; odds ratio, 2.17; 95% CI, 1.08-4.36). Sustained effects were observed for depression (slope, 0.01; 95% CI, -0.09 to 0.10; P = .92) and anxiety scores (slope, 0.02; 95% CI, -0.08 to 0.12; P = .67) during follow-up. App use was high, with a median of 93 and 98 sessions among participants with depression and anxiety, respectively., Conclusions and Relevance: In this trial, a mobile intervention app was effective for depression and anxiety among primary care patients. Findings also support designing digital mental health interventions as platforms containing simple, brief apps that can be bundled by users to meet their needs., Trial Registration: ClinicalTrials.gov Identifier: NCT03500536.

Background: Aneurysm recurrence after coiling has been associated with aneurysm growth, (re)hemorrhage, and a greater need for follow-up. The second-generation HydroCoil Embolic System (HES; MicroVention, Inc) consists of a platinum core with integrated hydrogel and was developed to reduce recurrence through enhancing packing density and healing within the aneurysm., Objective: To compare recurrence between the second-generation HES and bare platinum coil (BPC) in the new-generation Hydrogel Endovascular Aneurysm Treatment Trial (HEAT)., Methods: HEAT is a randomized, controlled trial that enrolled subjects with ruptured or unruptured 3- to 14-mm intracranial aneurysms amenable to coiling. The primary endpoint was aneurysm recurrence using the Raymond-Roy scale. Secondary endpoints included minor and major recurrence, packing density, adverse events related to the procedure and/or device, mortality, initial complete occlusion, aneurysm retreatment, hemorrhage from target aneurysm during follow-up, aneurysm occlusion stability, and clinical outcome at final follow-up., Results: A total of 600 patients were randomized (HES, n = 297 and BPC, n = 303), including 28% with ruptured aneurysms. Recurrence occurred in 11 (4.4%) subjects in the HES arm and 44 (15.4%) subjects in the BPC arm (P = .002). While the initial occlusion rate was higher with BPC, the packing density and both major and minor recurrence rates were in favor of HES. Secondary endpoints including adverse events, retreatment, hemorrhage, mortality, and clinical outcome did not differ between arms., Conclusion: Coiling of small-to-medium aneurysms with second-generation HES resulted in less recurrence when compared to BPC, without increased harm. These data further support the use of the second-generation HES for the embolization of intracranial aneurysms., (© Congress of Neurological Surgeons 2020.)

Background: User engagement is key to the effectiveness of digital mental health interventions. Considerable research has examined the clinical outcomes of overall engagement with mental health apps (eg, frequency and duration of app use). However, few studies have examined how specific app use behaviors can drive change in outcomes. Understanding the clinical outcomes of more nuanced app use could inform the design of mental health apps that are more clinically effective to users., Objective: This study aimed to classify user behaviors in a suite of mental health apps and examine how different types of app use are related to depression and anxiety outcomes. We also compare the clinical outcomes of specific types of app use with those of generic app use (ie, intensity and duration of app use) to understand what aspects of app use may drive symptom improvement., Methods: We conducted a secondary analysis of system use data from an 8-week randomized trial of a suite of 13 mental health apps. We categorized app use behaviors through a mixed methods analysis combining qualitative content analysis and principal component analysis. Regression analyses were used to assess the association between app use and levels of depression and anxiety at the end of treatment., Results: A total of 3 distinct clusters of app use behaviors were identified: learning, goal setting, and self-tracking. Each specific behavior had varied effects on outcomes. Participants who engaged in self-tracking experienced reduced depression symptoms, and those who engaged with learning and goal setting at a moderate level (ie, not too much or not too little) also had an improvement in depression. Notably, the combination of these 3 types of behaviors, what we termed "clinically meaningful use," accounted for roughly the same amount of variance as explained by the overall intensity of app use (ie, total number of app use sessions). This suggests that our categorization of app use behaviors succeeded in capturing app use associated with better outcomes. However, anxiety outcomes were neither associated with specific behaviors nor generic app use., Conclusions: This study presents the first granular examination of user interactions with mental health apps and their effects on mental health outcomes. It has important implications for the design of mobile health interventions that aim to achieve greater user engagement and improved clinical efficacy., (©Renwen Zhang, Jennifer Nicholas, Ashley A Knapp, Andrea K Graham, Elizabeth Gray, Mary J Kwasny, Madhu Reddy, David C Mohr. Originally published in the Journal of Medical Internet Research (http://www.jmir.org), 20.12.2019.)

Whiplash injury is a common consequence of motor vehicle crashes (MVC), yet it is also one of the most poorly understood. While more than 50% of those injured should expect to rapidly recover, others are not as fortunate with approximately 25% of those exposed to and injured in an MVC transitioning from acute to chronic pain and disability. The purpose of this prospective study was to determine if the severity and direction of collisions involving participants enrolled in a longitudinal study of recovery from whiplash are able to differentiate between different recovery groups based on the neck disability index (NDI) percentage scores at 3-months, and if these crash specific parameters are associated with known risk factors for recovery. Here, we examined objective collision data, repair invoices, and characteristics of the crash for 37 acutely injured participants consented and enrolled at their emergency department visit and further assessed at three time points; < 1 week, 2-weeks, and 3-months post MVC. Collision data were used to reconstruct and estimate the severity of the crash and determine if they aligned with the heterogeneity of whiplash injury recovery. Wilcoxon rank sum tests were used to determine if % scores on the Neck Disability Index (NDI) at 3-months post MVC were associated with the following variables: sex, head turned at time of impact, seatbelt use, whether or not airbags deployed, if the vehicle was struck while stopped or while turning, or the principle direction of force (PDOF). Spearman's correlation coefficients were used to determine if NDI at 3-months post MVC was associated with age, Body Mass Index, pain-related disability at baseline, signs of post-traumatic distress, intrusion/hyperarousal, negative affect, pain intensity, estimated speed change from the impact, and damage estimates (in US$). There was a significant positive association between self-reported neck disability at 3-months post MVC, post-traumatic distress, negative affect and uncontrolled pain. There was no direct effect of participant characteristics, arousal, intrusion/hyperarousal sub-score, damage, PDOF, speed change, or other crash characteristics. Established crash parameters were not associated with the heterogeneity of whiplash injury recovery in a small sample of injured participants., Competing Interests: Elliott, Parrish, Smith, Courtney, Kwasny, Wasieliewski report funding from NIH; Elliott reports Advisory member for the Board of Directors, JOSPT; Editorial board member for JOSPT, Musculoskeletal Science & Practice; Advisory Board member the journal, Spine. Honoraria, conference travel, and accommodation for speaking engagements. Walton reports funding for research projects not related to the material presented herein, coming from arm's length public funders: the Canadian Pain Society, the Ontario Ministry of Research and Innovation, and the Canadian Chronic Pain Network, and one industry sector arm's length funder: Focus on Therapeutic Outcomes Inc. He also reports a role as Associate Editor for the journal Musculoskeletal Science and Practice, and receives honoraria and travel expenses for national and international speaking engagements. Heinrichs reports funding from NIH; owner and employee of a forensic consulting firm (MEA Forensic); reconstructs car crashes for lawyers and insurance companies; Siegmund reports funding from NIH; director, owner and employee of a forensic consulting firm (MEA Forensic); investigates injury claims for lawyers and insurance companies. This does not alter our adherence to PLOS ONE policies on sharing data and materials.

This trial examined whether a stepped care program for depression, which initiated treatment with internet cognitive behavioral therapy, including telephone and messaging support, and stepped up non-responders to telephone-administered cognitive behavioral therapy (tCBT), was noninferior, less costly to deliver, and as acceptable to patients compared to tCBT alone. Adults with a diagnosis of major depressive episode (MDE) were randomized to receive up to 20 weeks of stepped care or tCBT. Stepped care (n = 134) was noninferior to tCBT (n = 136) with an end-of-treatment effect size of d = 0.03 and a 6-month post-treatment effect size of d = -0.07 [90% CI 0.29 to 0.14]. Therapist time in stepped care was 5.26 (SD = 3.08) hours versus 10.16 (SD 4.01) for tCBT (p < 0.0001), with a delivery cost difference of $-364.32 [95% CI $-423.68 to $-304.96]. There was no significant difference in pre-treatment preferences (p = 0.10) or treatment dropout (39 in stepped care; 27 in tCBT; p = 0.14). tCBT patients were significantly more satisfied than stepped care patients with the treatment they received (p < 0.0001). These findings indicate that stepped care was less costly to deliver, but no less effective than tCBT. There was no significant difference in treatment preference or completion, however satisfaction with treatment was higher in tCBT than stepped care. TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT01906476., (Copyright © 2019 Elsevier Ltd. All rights reserved.)

Internet-based cognitive behavioral therapy (iCBT) may overcome barriers to mental health care and has proven efficacious. However, this approach currently exists outside the existing mental health care delivery system. Stepped care is a proposed framework for integrating digital mental health (DMH) into health systems by initiating iCBT and "stepping up" care to a more intensive intervention should iCBT prove ineffective. This study explores pre-treatment factors associated with reaching stepping criteria among patients receiving iCBT. This exploratory analysis of a stepped care arm of a larger randomized trial examined participants who were stepped to a more intensive intervention if they did not respond to iCBT. The association of pre-treatment factors on stepping were examined using Kruskal-Wallis and Chi-square tests. One-fifth of the 151 participants met criteria for stepping within the 20-week treatment period. Only pre-treatment depression severity and treatment preference were associated with increased likelihood of stepping ( p = 0.049 and 0.048, respectively). The low number of individuals who stepped provides support for iCBT as an effective, low intensity treatment for depression. The modest association of pre-treatment depression and preference to not receive iCBT may be useful in identifying patients who are less likely to respond.

Background and Objectives: Chronically ill older adults must integrate self-care behaviors into their daily routine to promote health and reduce urgent health care utilization. Individuals of lower socioeconomic position (SEP) experience a disproportionate burden of stressors that challenge the formation of regular routines. We examined associations between the presence of a daily routine and older adults' health status and urgent health care utilization, to determine whether higher levels of daily routine mediates associations between SEP and health outcomes., Research Design and Methods: We used data from a cohort of older adult primary care patients in Chicago. Daily routine was measured using a brief, validated scale. A single factor score of SEP was created with measures of education, income, homeownership, and insurance status. Health status was assessed by Patient Reported Outcomes Measurement Information Service physical function, depression, and anxiety. Urgent health care utilization was patient reported. Multivariable models were used to assess the effect of routine and SEP on health status and urgent health care utilization., Results: Individuals reporting low levels of daily routine reported worse physical function (β = -2.34; 95% CI -4.18, -0.50), more anxiety (β = 2.73; 95% CI 0.68, 4.78) and depressive symptoms (β = 2.83; 95% CI 0.94, 4.74) than those with greater daily routine. No differences in urgent health care utilization were observed by daily routine. Daily routine varied by SEP (p < .001); routine partially mediated the relationship between SEP and physical function and anxiety symptoms (ps < .05)., Discussion and Implications: A daily routine may be an under recognized modifiable factor that could promote health outcomes among older adults., (© The Author(s) 2018. Published by Oxford University Press on behalf of The Gerontological Society of America. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.)

Background: IntelliCare is a modular platform that includes 12 simple apps targeting specific psychological strategies for common mental health problems., Objective: This study aimed to examine the effect of 2 methods of maintaining engagement with the IntelliCare platform, coaching, and receipt of weekly recommendations to try different apps on depression, anxiety, and app use., Methods: A total of 301 participants with depression or anxiety were randomized to 1 of 4 treatments lasting 8 weeks and were followed for 6 months posttreatment. The trial used a 2X2 factorial design (coached vs self-guided treatment and weekly app recommendations vs no recommendations) to compare engagement metrics., Results: The median time to last use of any app during treatment was 56 days (interquartile range 54-57), with 253 participants (84.0%, 253/301) continuing to use the apps over a median of 92 days posttreatment. Receipt of weekly recommendations resulted in a significantly higher number of app use sessions during treatment (overall median=216; P=.04) but only marginal effects for time to last use (P=.06) and number of app downloads (P=.08). Coaching resulted in significantly more app downloads (P<.001), but there were no significant effects for time to last download or number of app sessions (P=.36) or time to last download (P=.08). Participants showed significant reductions in the Patient Health Questionnaire-9 (PHQ-9) and Generalized Anxiety Disorder-7 (GAD-7) across all treatment arms (P s<.001). Coached treatment led to larger GAD-7 reductions than those observed for self-guided treatment (P=.03), but the effects for the PHQ-9 did not reach significance (P=.06). Significant interaction was observed between receiving recommendations and time for the PHQ-9 (P=.04), but there were no significant effects for GAD-7 (P=.58)., Conclusions: IntelliCare produced strong engagement with apps across all treatment arms. Coaching was associated with stronger anxiety outcomes, and receipt of recommendations enhanced depression outcomes., Trial Registration: ClinicalTrials.gov NCT02801877; https://clinicaltrials.gov/ct2/show/NCT02801877., (©David C Mohr, Stephen M Schueller, Kathryn Noth Tomasino, Susan M Kaiser, Nameyeh Alam, Chris Karr, Jessica L Vergara, Elizabeth L Gray, Mary J Kwasny, Emily G Lattie. Originally published in the Journal of Medical Internet Research (http://www.jmir.org), 28.08.2019.)

Background: Individuals with type 2 diabetes manage complex multi-drug regimens, but nearly half of all patients do not consistently take the dose prescribed for them, and therefore may not receive the full potential therapeutic benefit. Both patient and health system factors contribute to achieving and maintaining medication adherence. To determine if patients with type 2 diabetes who are concurrently managing other chronic conditions could improve their adherence, we devised and are testing a multifaceted, primary care-based strategy to provide health literacy-appropriate and language concordant regimen information, guidance and reminders., Objective: We are testing the effectiveness of an electronic health record (EHR) based strategy and short message service (SMS) text reminders to help patients with type 2 diabetes adhere to their medications., Methods: We are conducting a 3-arm, multi-site trial to test and compare the effectiveness of the EHR, and EHR + SMS text reminder strategies compared to usual care on medication adherence. Our goal is to enroll a total of 900 English or Spanish-speaking patients with type 2 diabetes and hemoglobin A1C value ≥7.5%. Enrolled participants will complete interviews at baseline and 3 and 6 months following their baseline interview., Conclusions: Our trial is evaluating practical, clinic-based, scalable, evidence-based solutions for patients with type 2 diabetes managing complex medication regimens. Our findings will evaluate strategies that can be implemented broadly in primary care practices, and programmed as defaults within EHRs to support appropriate medication adherence to allow the widespread implementation of those strategies., (Copyright © 2019 Elsevier Inc. All rights reserved.)

Depression is common in primary care settings, but barriers prevent many primary care patients from initiating treatment. Smartphone apps stand as a possible means to overcome such barriers. However, there is limited evidence to understand the use and efficacy of these apps. The purpose of the current study was to pilot an evaluation of the usage and efficacy of apps for depression based upon behavioral or cognitive intervention skills, compared to a wait-list control. Thirty adults with depression were randomized to the use of either a behavioral app (Boost Me) or a cognitive app (Thought Challenger) or to a wait-list control. Boost Me and Thought Challenger participants received 6 weeks of the respective intervention along with weekly coaching sessions, with a 4-week follow-up period; wait-list control participants received no interventions for 10 weeks. A repeated-measures analysis of variance was conducted to examine depression over time and across treatment groups; t tests compared app usage across groups. Depression scores changed significantly over time (p < .001), with group differences occurring between Thought Challenger and wait-list control participants (p = .03). Boost Me was used significantly more than was Thought Challenger (p = .02); however, there was no evidence to suggest correlations between usage and changes in depression (ps > .05). The present study provides initial support that intervention strategies for depression delivered via apps with human support can impact symptoms and may promote continued use over 6 weeks. This pilot also demonstrates the feasibility of future research regarding the delivery of behavioral and cognitive intervention strategies via apps. (PsycINFO Database Record (c) 2019 APA, all rights reserved).

Background: The growing field of personal sensing harnesses sensor data collected from individuals' smartphones to understand their behaviors and experiences. Such data could be a powerful tool within mental health care. However, it is important to note that the nature of these data differs from the information usually available to, or discussed with, health care professionals. To design digital mental health tools that are acceptable to users, understanding how personal sensing data can be used and shared is critical., Objective: This study aimed to investigate individuals' perspectives about sharing different types of sensor data beyond the research context, specifically with doctors, electronic health record (EHR) systems, and family members., Methods: A questionnaire assessed participants' comfort with sharing six types of sensed data: physical activity, mood, sleep, communication logs, location, and social activity. Participants were asked about their comfort with sharing these data with three different recipients: doctors, EHR systems, and family members. A series of principal component analyses (one for each data recipient) was performed to identify clusters of sensor data types according to participants' comfort with sharing them. Relationships between recipients and sensor clusters were then explored using generalized estimating equation logistic regression models., Results: A total of 211 participants completed the questionnaire. The majority were female (171/211, 81.0%), and the mean age was 38 years (SD 10.32). Principal component analyses consistently identified two clusters of sensed data across the three data recipients: "health information," including sleep, mood, and physical activity, and "personal data," including communication logs, location, and social activity. Overall, participants were significantly more comfortable sharing any type of sensed data with their doctor than with the EHR system or family members (P<.001) and more comfortable sharing "health information" than "personal data" (P<.001). Participant characteristics such as age or presence of depression or anxiety did not influence participants' comfort with sharing sensed data., Conclusions: The comfort level in sharing sensed data was dependent on both data type and recipient, but not individual characteristics. Given the identified differences in comfort with sensed data sharing, contextual factors of data type and recipient appear to be critically important as we design systems that harness sensor data for mental health treatment and support., (©Jennifer Nicholas, Katie Shilton, Stephen M Schueller, Elizabeth L Gray, Mary J Kwasny, David C Mohr. Originally published in JMIR Mhealth and Uhealth (http://mhealth.jmir.org), 05.04.2019.)

Background: IntelliCare is a mental health app platform with 14 apps that are elemental, simple and brief to use, and eclectic. Although a variety of apps may improve engagement, leading to better outcomes, they may require navigation aids such as recommender systems that can quickly direct a person to a useful app., Objective: As the first step toward developing navigation and recommender tools, this study explored app-use patterns across the IntelliCare platform and their relationship with depression and anxiety outcomes., Methods: This is a secondary analysis of the IntelliCare Field Trial, which recruited people with depression or anxiety. Participants of the trial received 8 weeks of coaching, primarily by text, and weekly random recommendations for apps. App-use metrics included frequency and lifetime use. Depression and anxiety, measured using the Patient Health Questionnaire-9 and Generalized Anxiety Disorder-7, respectively, were assessed at baseline and end of treatment. Cluster analysis was utilized to determine patterns of app use; ordinal logistic regression models and log-rank tests were used to determine if these use metrics alone, or in combination, predicted improvement or remission in depression or anxiety., Results: The analysis included 96 people who generally followed recommendations to download and try new apps each week. Apps were clustered into 5 groups: Thinking (apps that targeted or relied on thinking), Calming (relaxation and insomnia), Checklists (apps that used checklists), Activity (behavioral activation and activity), and Other. Both overall frequency of use and lifetime use predicted response for depression and anxiety. The Thinking, Calming, and Checklist clusters were associated with improvement in depression and anxiety, and the Activity cluster was associated with improvement in Anxiety only. However, the use of clusters was less strongly associated with improvement than individual app use., Conclusions: Participants in the field trial remained engaged with a suite of apps for the full 8 weeks of the trial. App-use patterns did fall into clusters, suggesting that some knowledge about the use of one app may be useful in selecting another app that the person is more likely to use and may help suggest apps based on baseline symptomology and personal preference., (©Mary J Kwasny, Stephen M Schueller, Emily Lattie, Elizabeth L Gray, David C Mohr. Originally published in JMIR Mental Health (http://mental.jmir.org), 21.03.2019.)

Background: Elevated body mass index (BMI) is considered a risk factor for complications after THA and TKA. Stakeholders have proposed BMI cutoffs for those seeking arthroplasty. The research that might substantiate BMI cutoffs is sensitive to the statistical methods used, but the impact of the statistical methods used to model BMI has not been defined., Questions/purposes: (1) How does the estimated postarthroplasty risk of minor and major complications vary as a function of the statistical method used to model BMI? (2) What is the prognostic value of BMI for predicting complications with each statistical method?, Methods: Using the American College of Surgeons National Surgical Quality Improvement Program from 2005 to 2012, we investigated the impact of BMI on major and minor complication risk for THA and TKA. Analyses were weighted with covariate-balancing propensity scores to account for the differential rate of comorbidities across the range of BMI. We specified BMI in two ways: (1) categorically by World Health Organization (WHO) BMI classes; and (2) as a smooth, continuous variable using splines. Models of risk for major complications (deep surgical site infection [SSI], pulmonary embolism, stroke, cardiac arrest, myocardial infarction, wound disruption, implant failure, unplanned intubation, > 48 hours on a ventilator, acute renal insufficiency, coma, sepsis, reoperation, or mortality) and minor complications (superficial SSI, pneumonia, urinary tract infection, deep vein thrombosis, or peripheral nerve injury) were constructed and were adjusted for confounding variables known to correlate with complications (eg, American Society of Anesthesiologists classification). Results were compared for different specifications of BMI. Receiver operating characteristic (ROC) curves were compared to determine the additive prognostic value of BMI., Results: The type of BMI parameterization leads to different assessments of risk of postarthroplasty complications for BMIs > 30 kg/m and < 20 kg/m with the spline specification showing better fit in all adjusted models (Akaike Information Criteria favors spline). Modeling BMI categorically using WHO classes indicates that BMI cut points of 40 kg/m for TKA or 35 kg/m for THA are associated with higher risks of major complications. Modeling BMI continuously as a spline suggests that risk of major complications is elevated at a cut point of 44 kg/m for TKA and 35 kg/m for THA. Additionally, in these models, risk does not uniformly increase with increasing BMI. Regardless of the method of modeling, BMI is a poor prognosticator for complications with area under the ROC curves between 0.51 and 0.56, false-positive rates of 96% to 97%, and false-negative rates of 2% to 3%., Conclusions: The statistical assumptions made when modeling the effect of BMI on postarthroplasty complications dictate the results. Simple categorical handling of BMI creates arbitrary cutoff points that should not be used to inform larger policy decisions. Spline modeling of BMI avoids arbitrary cut points and provides a better model fit at extremes of BMI. Regardless of statistical management, BMI is an inadequate independent prognosticator of risk for individual patients considering total joint arthroplasty. Stakeholders should instead perform comprehensive risk assessment and avoid use of BMI as an isolated indicator of risk., Level of Evidence: Level III, diagnostic study.

Purpose: Aneurysm recanalization constitutes a limitation in the endovascular treatment of intracranial aneurysms using conventional bare platinum coils. The development of platinum coils coupled with hydrogel polymers aimed at decreasing the rates of recurrence by way of enhanced coil packing density and biological healing within the aneurysm. While enhanced occlusion and durability has been shown for the first generation hydrogel coils, their use was limited by technical challenges. Less data is available regarding the second-generation hydrogel coils which have been designed to perform like bare platinum coils., Methods: The new generation Hydrogel Endovascular Aneurysm Treatment Trial (HEAT) is a multicenter, randomized controlled trial that compares the health outcomes of the second-generation HydroCoil Embolic System with bare platinum coils in the endovascular intracranial aneurysms. The primary endpoint is aneurysm recurrence, defined as any progression on the Raymond aneurysm scale, over a 24-month follow-up period. Secondary endpoints include packing density, functional independence, procedural adverse events, mortality rate, initial complete occlusion, aneurysm retreatment, hemorrhage from treated aneurysm, and any aneurysm recurrence., Results: Patient recruitment initiated in June 2011 and ended in January 2016 in 46 centers. Six hundred eligible patients diagnosed with an intracranial aneurysm, ruptured or unruptured were randomly assigned to one of the two treatment arms., Conclusion: The HEAT trial compares the durability, imaging, and clinical outcomes of the second-generation hydrogel versus bare platinum coils in the endovascular treatment of ruptured or unruptured intracranial aneurysms. The results of this trial may further inform current endovascular treatment guidelines based on observed long-term outcomes.

Proper diabetes self-care requires patients to have considerable knowledge, a range of skills, and to sustain multiple health behaviors. Self-management interventions are needed that can be readily implemented and sustained in rural clinics with limited resources that disproportionately care for patients with limited literacy. Researchers on our team developed an evidence-based, patient-centered, low literacy intervention promoting diabetes self-care that includes: 1) the American College of Physicians (ACP) Diabetes Guide that uses plain language and descriptive photographs to teach core diabetes concepts and empower patients to initiate behavior change; 2) a brief counseling strategy to assist patients in developing short-term, explicit and attainable goals for behavior change ('action plans'); and 3) a training module for health coaches that prepares them to assume educator/counselor roles with the Diabetes Guide as a teaching tool. While the intervention has previously been field tested and found to significantly improve patient knowledge, self-efficacy, and engagement in related health behaviors, its optimal implementation is not known. This project took advantage of a unique opportunity to modify and disseminate the ACP health literacy intervention among patients with type 2 diabetes cared for at rural clinics in Arkansas that are Patient-Centered Medical Homes (PCMH). These practices all had health coaches that could be leveraged to provide chronic disease self-management mostly via phone, but also at the point-of-care. Hence we conducted a patient-randomized, pragmatic clinical trial in 6 rural PCMHs in Arkansas, targeting individuals with uncontrolled type 2 diabetes., (Published by Elsevier Inc.)

The morbidity and mortality after hip fracture in the elderly are influenced by non-modifiable comorbidities. Time-to-surgery is a modifiable factor that may play a role in postoperative morbidity. This study investigates the outcomes and complications in the elderly hip fracture surgery as a function of time-to-surgery. Using the American College of Surgeons-National Surgical Quality Improvement Program data from 2011 to 2012, a study population was generated using the Current Procedural Terminology codes for percutaneous or open treatment of femoral neck fractures (27235, 27236) and fixation with a screw and side plate or intramedullary fixation (27244, 27245) for peritrochanteric fractures. Three time-to-surgery groups (<24 hours to surgical intervention, 24-48 hours, and >48 hours) were created and matched for surgery type, sex, age, and American Society of Anesthesiologists class. Time-to-surgery was then studied for its effect on the post-surgical outcomes using the adjusted regression modeling. A study population of 6036 hip fractures was created, and 2012 patients were assigned to each matched time-to-surgery group. The unadjusted models showed that the earlier surgical intervention groups (<24 hours and 24-48 hours) exhibited a lower overall complication rate (P = .034) compared with the group waiting for surgery >48 hours. The unadjusted mortality rates increased with delay to surgical intervention (P = .039). Time-to-surgery caused no effect on the return to the operating room rate (P = .554) nor readmission rate (P = .285). Compared with other time-to-surgeries, the time-to-surgery of >48 hours was associated with prolonged total hospital length of stay (10.9 days) (P < .001) and a longer surgery-to-discharge time (hazard ratio, 95% confidence interval: 0.74, 0.69-0.79) (P < .001). Adjusted analyses showed no time-to-surgery related difference in complications (P = .143) but presented an increase in the total length of stay (P < .001) and surgery-to-discharge time (P < .001). Timeliness of surgical intervention in a comorbidity-adjusted population of elderly hip fracture patients causes no effect on the overall complications, readmissions, nor 30-day mortality. However, time-to-surgery of >48 hours is associated with costly increase in the total length of stay, including an increased post-surgery-to-discharge time., Competing Interests: Authors’ Disclosure Statement: The authors report no actual or potential conflict of interest in relation to this article.

Background: Patients with chronic conditions are often responsible for self-managing complex, multi-drug regimens with minimal professional clinical support. While numerous interventions to promote and support medication adherence have been tested, most have had limited success or have been too resource-intensive for real-world implementation., Objective: To compare the effectiveness of multiple low-cost, technology-enabled strategies, alone and in combination, for promoting medication regimen adherence among older adults., Methods: Older, English or Spanish-speaking patients on complex drug regimens (N=1505) will be recruited from a community health system in Chicago, IL. Enrolled patients will be randomized to one of four study arms, receiving either: 1) enhanced usual care alone; 2) daily medication reminders via SMS text messages; 3) medication monitoring via a patient portal-based assessment; or 4) both SMS text message reminders and portal-based medication monitoring. The primary outcome of the study is medication adherence, which will be assessed via multiple measures at baseline, 2months, and 6months. The effect of intervention strategies on clinical markers (hemoglobin A1c, blood pressure, cholesterol level), as well as intervention fidelity and the barriers and costs of implementation will also be evaluated., Conclusions: This randomized controlled trial will evaluate the impact of various low-cost intervention strategies on adherence to complex medication regimens and will explore barriers to implementation. If the studied intervention strategies are shown to be effective, then these approaches could be effectively deployed across a diverse range of clinical settings and patient populations., Clinical Trial Registration: This trial is registered on clinicaltrials.govNCT02820753., (Copyright © 2017 Elsevier Inc. All rights reserved.)

Background: Investigation into the role of vitamin D in fractures in the pediatric population has been limited despite estimates that as many as 70% of American children have inadequate vitamin D levels (measured as 25-hydroxyvitamin D, 25(OH)D). The purpose of this study was to evaluate vitamin D's role in pediatric fracture risk by comparing 25(OH)D between fractured and nonfractured cohorts., Methods: A 12-month prospective case-control study was completed in children aged 2 to 14 years in an urban, academic hospital. Sixty fractured children requiring conscious sedation or general anesthesia for management were compared with 60 nonfractured controls. All participants and their guardians were surveyed for low bone density risk factors, and total serum 25(OH)D was measured. Statistical analysis was completed using Student t tests, χ tests, analysis of variance, and logistic regression models., Results: After controlling for age and daily sun exposure, lower total serum 25(OH)D was associated with higher fracture risk (odds ratio=0.94; 95% confidence interval, 0.90-0.99; P=0.023). In the fractured cohort, 6 (10%) patients were deficient (25(OH)D<20 ng/mL) and 33 (55%) were insufficient (25(OH)D, 20 to 30 ng/mL). Of the nonfractured population, 8 (13%) were deficient and 19 (32%) were insufficient. There were more insufficient patients in the fractured than in the nonfractured cohort (odds ratio=2.99; 95% confidence interval, 1.27-7.0; P=0.037)., Conclusions: Higher fracture incidence is associated with serum 25(OH)D insufficiency. Hypovitaminosis D may place the pediatric population at increased risk for fracture. Consideration should be given to routine assessment of vitamin D in fractured children., Level of Evidence: Prognostic level III-prospective case-control study.

Background: Mental health apps tend to be narrow in their functioning, with their focus mostly being on tracking, management, or psychoeducation. It is unclear what capability such apps have to facilitate a change in users, particularly in terms of learning key constructs relating to behavioral interventions. Thought Challenger (CBITs, Chicago) is a skill-building app that engages users in cognitive restructuring, a core component of cognitive therapy (CT) for depression., Objective: The purpose of this study was to evaluate the learnability and learning performance of users following initial use of Thought Challenger., Methods: Twenty adults completed in-lab usability testing of Thought Challenger, which comprised two interactions with the app. Learnability was measured via completion times, error rates, and psychologist ratings of user entries in the app; learning performance was measured via a test of CT knowledge and skills. Nonparametric tests were conducted to evaluate the difference between individuals with no or mild depression to those with moderate to severe depression, as well as differences in completion times and pre- and posttests., Results: Across the two interactions, the majority of completion times were found to be acceptable (5 min or less), with minimal errors (1.2%, 10/840) and successful completion of CT thought records. Furthermore, CT knowledge and skills significantly improved after the initial use of Thought Challenger (P=.009)., Conclusions: The learning objectives for Thought Challenger during initial uses were successfully met in an evaluation with likely end users. The findings therefore suggest that apps are capable of providing users with opportunities for learning of intervention skills., (©Colleen Stiles-Shields, Enid Montague, Emily G Lattie, Stephen M Schueller, Mary J Kwasny, David C Mohr. Originally published in JMIR Human Factors (http://humanfactors.jmir.org), 11.08.2017.)

Objective: Smartphones are being used with increasing frequency to deliver behavioral interventions for depression via apps. However, barriers specific to using an app for depression are poorly defined. The purpose of the current study is to identify barriers to the use of a mobile app to deliver treatment for depression. Secondarily, design implications will be provided based upon identified barriers., Method: A card sorting task that ranked and grouped barriers to the use of apps for depression was completed. Participants first completed a card sorting task identifying barriers to face-to-face treatment, as a primer to identification of treatment barriers. The sample consisted of those above ( n  = 9) and below ( n  = 11) the threshold for a referral to psychotherapy, to capture anticipated barriers for likely end users. Cluster analyses were conducted to analyze the card sorting data. Multiple analyses were conducted to identify: 1) the most important barriers, and 2) how consistently barriers were ranked as important., Result: The card sorting task identified a number of primary barriers to the use of apps for depression treatment, including concerns over intervention efficacy, app functioning, privacy, cost, and lack of guidance and tailored feedback. The top face-to-face treatment barrier was cost, overlapping with mobile barriers., Conclusion: This study identified perceived barriers to the use of mobile treatment apps. Identification of barriers implicates design recommendations for apps for depression., Competing Interests: The author(s) declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article.

Background: Digital mental health tools have tended to use psychoeducational strategies based on treatment orientations developed and validated outside of digital health. These features do not map well to the brief but frequent ways that people use mobile phones and mobile phone apps today. To address these challenges, we developed a suite of apps for depression and anxiety called IntelliCare, each developed with a focused goal and interactional style. IntelliCare apps prioritize interactive skills training over education and are designed for frequent but short interactions., Objective: The overall objective of this study was to pilot a coach-assisted version of IntelliCare and evaluate its use and efficacy at reducing symptoms of depression and anxiety., Methods: Participants, recruited through a health care system, Web-based and community advertising, and clinical research registries, were included in this single-arm trial if they had elevated symptoms of depression or anxiety. Participants had access to the 14 IntelliCare apps from Google Play and received 8 weeks of coaching on the use of IntelliCare. Coaching included an initial phone call plus 2 or more texts per week over the 8 weeks, with some participants receiving an additional brief phone call. Primary outcomes included the Patient Health Questionnaire-9 (PHQ-9) for depression and the Generalized Anxiety Disorder-7 (GAD-7) for anxiety. Participants were compensated up to US $90 for completing all assessments; compensation was not for app use or treatment engagement., Results: Of the 99 participants who initiated treatment, 90.1% (90/99) completed 8 weeks. Participants showed substantial reductions in the PHQ-9 and GAD-7 (P<.001). Participants used the apps an average of 195.4 (SD 141) times over the 8 weeks. The average length of use was 1.1 (SD 2.1) minutes, and 95% of participants downloaded 5 or more of the IntelliCare apps., Conclusions: This study supports the IntelliCare framework of providing a suite of skills-focused apps that can be used frequently and briefly to reduce symptoms of depression and anxiety. The IntelliCare system is elemental, allowing individual apps to be used or not used based on their effectiveness and utility, and it is eclectic, viewing treatment strategies as elements that can be applied as needed rather than adhering to a singular, overarching, theoretical model., Trial Registration: Clinicaltrials.gov NCT02176226; http://clinicaltrials.gov/ct2/show/NCT02176226 (Archived by WebCite at http://www.webcitation/6mQZuBGk1)., Competing Interests: Conflicts of Interest: None declared., (©David C Mohr, Kathryn Noth Tomasino, Emily G. Lattie, Hannah L Palac, Mary J Kwasny, Kenneth Weingardt, Chris J Karr, Susan M Kaiser, Rebecca C Rossom, Leland R Bardsley, Lauren Caccamo, Colleen Stiles-Shields, Stephen M Schueller. Originally published in the Journal of Medical Internet Research (http://www.jmir.org), 05.01.2017.)

Background: Expressive therapies are increasingly incorporated into the management of Parkinson's disease (PD), although there are little objective data assessing their benefits., Objective: Develop and study a novel community Improvisation Theater (IT) program for PD in order to improve quality of life., Methods: A prospective, rater-blinded, modified cross-over design study of IT for PD. 22 subjects were randomized 1:1 to active-start (AS) or control-start (CS) groups, controlling for age and Hoehn and Yahr stage. Participants were recruited from the Northwestern PD and Movement Disorders Center. 60 min IT sessions were led by The Second City ® faculty weekly for 12 weeks. The primary aim was to assess feasibility, determined as 70% of participants attending at least 75% of the classes. Exploratory data were obtained comparing pre- and post-intervention outcomes using Wilcoxon signed rank test for UPDRS parts I-IV, PDQ-39, and 5 neuro-QoL measures (communication, anxiety, stigma, depression, and wellbeing)., Results: All 22 participants completed the study. 21/22 (95%) participants attended at least 80% of the classes. All participants indicated that they would recommend the class to others with PD. 21/22 participants enjoyed the class and felt it was beneficial for their symptoms. A significant improvement pre-to-post intervention was seen with the UPDRS part II ADL measure (mean -1.5, p = 0.019)., Conclusion: A novel improvisation program can be well-attended, enjoyable, and improve ADL measures among patients with PD of varying ages and disease severity., (Copyright © 2016 Elsevier Ltd. All rights reserved.)

Background: Adverse drug events (ADEs) affect millions of patients annually and place a significant burden on the healthcare system. The Food and Drug Administration (FDA) has developed patient safety information for high-risk medications that pose serious public health concerns. However, there are currently few assurances that patients receive this information or are able to identify or respond correctly to ADEs., Objective: To evaluate the effectiveness of the Electronic Medication Complete Communication (EMC 2 ) Strategy to promote safe medication use and reporting of ADEs in comparison to usual care., Methods: The automated EMC 2 Strategy consists of: 1) provider alerts to counsel patients on medication risks, 2) the delivery of patient-friendly medication information via the electronic health record, and 3) an automated telephone assessment to identify potential medication concerns or ADEs. The study will take place in two community health centers in Chicago, IL. Adult, English or Spanish-speaking patients (N=1200) who have been prescribed a high-risk medication will be enrolled and randomized to the intervention arm or usual care based upon practice location. The primary outcomes of the study are medication knowledge, proper medication use, and reporting of ADEs; these will be measured at baseline, 4weeks, and three months. Intervention fidelity as well as barriers and costs of implementation will be evaluated., Conclusions: The EMC 2 Strategy automates a patient-friendly risk communication and surveillance process to promote safe medication use while minimizing clinic burden. This trial seeks to evaluate the effectiveness and feasibility of this strategy in comparison to usual care., (Copyright © 2016 Elsevier Inc. All rights reserved.)

Objective: Acute respiratory distress syndrome trials powered for mortality require significant resources, limiting the number of evaluable therapies. Validation of intermediate endpoints would enhance the feasibility of testing novel acute respiratory distress syndrome therapies in pilot studies and potentially reduce the frequency of failed large clinical trials. We sought to determine whether a change in the oxygenation index over the first 7 days of acute respiratory distress syndrome could discriminate between therapies likely or unlikely to show benefit in larger clinical trials., Design: A derivation cohort from three acute respiratory distress syndrome studies was used to estimate the 7-day change in oxygenation index. Receiver operating characteristic curves were used to calculate optimal thresholds and predictability of the change in oxygenation index for 28-day mortality and ventilator-free days. The thresholds were then validated in two cohorts. Then, for each individual acute respiratory distress syndrome study, the threshold 7-day oxygenation index change was tested as an outcome measure and compared with mortality and ventilator-free days as reported in the original study., Setting: Medical ICUs., Patients: Acute respiratory distress syndrome patients., Interventions: Various., Measurements and Main Results: Change in oxygenation index, 28-day mortality, and ventilator-free days. In the derivation cohort, the mean 7-day oxygenation index improved by 4.2 (± 11.7) in 28-day survivors compared with an increase of 2.4 (± 11.6) in 28-day nonsurvivors (p < 0.001). The mean 7-day oxygenation index decreased by 5.9 (± 8.4) in patients with more than 14 ventilator-free days, compared with a decrease of 1.9 (± 12.4) among those with less than 14 ventilator-free days (p = 0.001). The optimal 7-day oxygenation index threshold for predicting mortality was an increase of 1.71 and for predicting less than 14 ventilator-free days, a decrease of 2.34. When used as a surrogate endpoint, the optimal 7-day oxygenation index change closely approximated mortality and ventilator-free day outcomes in three Acute Respiratory Distress Syndrome Network studies used for the derivation cohort and a distinct study used for validation. The change in oxygenation index was a poor predictor of individual patient outcome., Conclusions: Failure to meet a threshold improvement in the oxygenation index over the first 7 days of therapy can be used to identify therapies unlikely to succeed in subsequent trials powered for mortality and ventilator-free days. By reducing trial time and costs, use of the 7-day oxygenation index change as an intermediate endpoint could increase the number of clinical trials of promising therapies for acute respiratory distress syndrome and reduce the number of large-scale trials of therapies unlikely to be of benefit., Competing Interests: The remaining authors have disclosed that they do not have any potential conflicts of interest.