OBJECTIVE: The burden of major depressive disorder is compounded by a limited understanding of its risk factors, the limited efficacy of treatments, and the lack of precision approaches to guide treatment selection. The Texas Resilience Against Depression (T-RAD) study was designed to explore the etiology of depression by collecting comprehensive socio-demographic, clinical, behavioral, neurophysiological/neuroimaging, and biological data from depressed individuals (D2K) and youth at risk for depression (RAD).
METHODS: This report details the baseline sociodemographic, clinical, and functional features from the initial cohort (D2K N = 1040, RAD N = 365).
RESULTS: Of the total T-RAD sample, n = 1078 (76.73 %) attended ≥2 in-person visits, and n = 845 (60.14 %) attended ≥4 in-person visits. Most D2K (84.82 %) had a primary diagnosis of any depressive disorder, with a bipolar disorder diagnosis being prevalent (13.49 %). RAD participants (75.89 %) did not have a psychiatric diagnosis, but other non-depressive diagnoses were present. D2K participants had 9-item Patient Health Questionnaire scores at or near the moderate range (10.58 ± 6.42 > 24 yrs.; 9.73 ± 6.12 10-24 yrs). RAD participants were in the non-depressed range (2.19 ± 2.65). While the age ranges in D2K and RAD differ, the potential to conduct analyses that compare at-risk and depressed youth is a strength of the study. The opportunity to examine the trajectory of depressive symptoms in the D2K cohort over the lifespan is unique.
CONCLUSIONS: As a longitudinal study, missing data were common.
CONCLUSIONS: T-RAD will allow data to be collected from multiple modalities on a clinically well-characterized sample. These data will drive important discoveries on diagnosis, treatment, and prevention of depression.

UNASSIGNED: The objective of the analysis presented is to assess the efficacy of a fast-track pathway for elective hip and knee arthroplasty, compared to the traditional approach, adopted within a research hospital located in Milan (Italy), in terms of length of stay reduction and related direct medical costs.
UNASSIGNED: A monocentric observational retrospective study was implemented considering adult subjects who underwent elective primary total hip or knee replacement, with a diagnosis of primary or secondary osteoarthritis. Exclusion criteria were subjects admitted via emergency department, subjects undergoing knee or hip replacement because of fractures or prosthesis revision. The analysis compared the length of stay and the direct medical costs, assuming the hospital perspective, of subjects admitted in the pre-fast-track period (years 2016/2017) and during the fast-track period (years 2018/2019).
UNASSIGNED: Knee replacement mean costs are 5,599 € (±1,158.3 €) in the pre-fast-track period and 4,487 € (±978.4 €) in the fast-track period (-1,112 €; -19.9%). Hip replacement mean costs in the pre-fast-track period are 5,364 € (±1,037.2 €) and 4,450 € (±843.7 €) in the fast-track period (-914 €; -17.0%). The adoption of fast-track pathway led to a statistically significant decrease of days of hospitalization of -2.8 (-37.6%) in knee replacement and of -2.9 (-39.2%) in hip replacement.
UNASSIGNED: The fast-track pathway adopted proved to be effective, reducing patients\' length of stay, and sustainable and efficient, reducing direct medical costs, for both elective hip and knee replacement surgeries.

BACKGROUND: Prepubertal transgender, nonbinary, and gender-diverse (TGD) children (ie, those asserting gender identity, expressing gender-role behavior outside of culturally defined norms for their sex registered at birth, or both) are presenting in greater numbers to pediatric gender clinics across the United States and abroad. A large subset of TGD children experiences gender dysphoria, that is, distress that arises from the incongruence between gender identity and sex registered at birth. A lack of consensus exists regarding care for prepubertal TGD children due, in part, to a dearth of empirical research on longitudinal developmental trajectories of gender identity, role behavior, and gender dysphoria (when present).
OBJECTIVE: The objective of this National Institutes of Health-funded study is to provide evidence to inform clinical care for prepubertal TGD children by establishing a US longitudinal cohort (N=248) of prepubertal TGD children and their caregivers that is followed prospectively at 6-month intervals across 18 months.
METHODS: At each timepoint, clinical and behavioral data are collected via web-based visit from child and caregiver reporters. Latent class analysis, among other methods, is used to identify subgroups and longitudinally characterize the gender identity and gender-role behavior of TGD children. These models will define longitudinal patterns of gender identity stability and characterize the relationship between TGD classes and mental and behavioral health outcomes, including the moderating role of social gender transition (when present), on these associations.
RESULTS: Baseline data collection (N=248) is complete, and the identification of TGD subgroups based on gender identity and expression using latent class analysis is anticipated in 2024. The completion of all 4 waves of data collection is anticipated in July 2024, coinciding with the start of a no-cost study extension period. We anticipate longitudinal analyses to be completed by winter 2024.
CONCLUSIONS: Through a longitudinal observational design, this research involving prepubertal TGD children and their caregivers aims to provide empirical knowledge on gender development in a US sample of TGD children, their mental health symptomology and functioning over time, and how family initiated social gender transition may predict or alleviate mental health symptoms or diagnoses. The research findings have promise for clinicians and families aiming to ensure the best developmental outcome for these children as they develop into adolescents.
UNASSIGNED: DERR1-10.2196/55558.

BACKGROUND: This study demonstrates that digital maturity contributes to strengthened quality and safety performance outcomes in US hospitals. Advanced digital maturity is associated with more digitally enabled work environments with automated flow of data across information systems to enable clinicians and leaders to track quality and safety outcomes. This research illustrates that an advanced digitally enabled workforce is associated with strong safety leadership and culture and better patient health and safety outcomes.
OBJECTIVE: This study aimed to examine the relationship between digital maturity and quality and safety outcomes in US hospitals.
METHODS: The data sources were hospital safety letter grades as well as quality and safety scores on a continuous scale published by The Leapfrog Group. We used the digital maturity level (measured using the Electronic Medical Record Assessment Model [EMRAM]) of 1026 US hospitals. This was a cross-sectional, observational study. Logistic, linear, and Tweedie regression analyses were used to explore the relationships among The Leapfrog Group\'s Hospital Safety Grades, individual Leapfrog safety scores, and digital maturity levels classified as advanced or fully developed digital maturity (EMRAM levels 6 and 7) or underdeveloped maturity (EMRAM level 0). Digital maturity was a predictor while controlling for hospital characteristics including teaching status, urban or rural location, hospital size measured by number of beds, whether the hospital was a referral center, and type of hospital ownership as confounding variables. Hospitals were divided into the following 2 groups to compare safety and quality outcomes: hospitals that were digitally advanced and hospitals with underdeveloped digital maturity. Data from The Leapfrog Group\'s Hospital Safety Grades report published in spring 2019 were matched to the hospitals with completed EMRAM assessments in 2019. Hospital characteristics such as number of hospital beds were obtained from the CMS database.
RESULTS: The results revealed that the odds of achieving a higher Leapfrog Group Hospital Safety Grade was statistically significantly higher, by 3.25 times, for hospitals with advanced digital maturity (EMRAM maturity of 6 or 7; odds ratio 3.25, 95% CI 2.33-4.55).
CONCLUSIONS: Hospitals with advanced digital maturity had statistically significantly reduced infection rates, reduced adverse events, and improved surgical safety outcomes. The study findings suggest a significant difference in quality and safety outcomes among hospitals with advanced digital maturity compared with hospitals with underdeveloped digital maturity.

UNASSIGNED: We sought to characterize the clinical prognostic factors in veterans with amyotrophic lateral sclerosis (ALS) followed in our ALS clinic.
UNASSIGNED: ALS is a rare, progressive neurodegenerative condition associated with decreased survival compared to that in the normal population.
UNASSIGNED: The electronic medical records of 105 veterans diagnosed with ALS who are followed in our ALS clinic between 2010 and 2021 were reviewed. Approval from the institutional review board was obtained from the study protocol. Demographic and clinical variables included age at symptom onset, age at initial evaluation, survival (from symptom onset to death), gender, site of onset (appendicular, bulbar, and respiratory), initial amyotrophic lateral sclerosis functional-related score-revised (ALSFRS-R), total functional independence measure (TFIM) scores, initial forced vital capacity (FVC), and interventions (Riluzole, gastrostomy, noninvasive ventilation [NIV], and tracheostomy). Normally distributed data was expressed as mean ± standard deviation. Fischer\'s exact analysis of the distribution differences of categorical data. The Kaplan-Meier plot analyzed the time-to-event.
UNASSIGNED: The mean (SD) age at symptom onset was 62.0 (11.1) years, age at diagnosis was 65 (11) years, with 72% of the patients being over 60 years at diagnosis. The median survival time from symptom onset was 4.12 (3) years. Limb-onset ALS (appendicular) was the most frequent (52%) followed by bulbar-onset ALS (43%). The mean ALSFRS-R and TFIM scores were 31 (8) and 91 (25), respectively. Family history (familial), bulbar, and respiratory presentation at diagnosis were associated with shorter survival times.
UNASSIGNED: This study suggests that of the clinical prognostic factors veterans with familial ALS, bulbar, and respiratory onset at presentations had shorter survival. The presence of Agent Orange, PEG placement, and NIV did not affect survival.

BACKGROUND: Eculizumab, a complement active antibody, and efgartigimod, an Fc fragment that blocks neonatal Fc receptor, are both approved to treat generalized myasthenia gravis (gMG) patients. The objective of this study is to describe the clinical response to both treatments in a real-life setting.
METHODS: We collected baseline and follow-up clinical data using the Myasthenia Gravis-Activities of Daily Living (MG-ADL), and Quantitative Myasthenia Gravis (QMG). We included 63 patients, 32 treated with eculizumab and 31 with efgartigimod. Of the efgartigimod-treated patients, 22 were anti-acetylcholine receptor antibody-positive (AChR-Ab +) and 9 were AChR-Ab- (3 MuSK-Ab + and 6 seronegative).
RESULTS: Both treatments showed similar efficacy relative to the MG-ADL scale reduction (p = 0.237). Efgartigimod had a similar effect on both AChR-Ab + and AChR-Ab- (p = 0.280). Eculizumab was superior to efgartigimod relative to the QMG score reduction for the entire dataset (p = 0.003) and was more likely to achieve a clinical response at the QMG compared to efgartigimod (OR 1.373; p = 0.016). Steroid-sparing effect was higher for eculizumab than efgartigimod ( - 16.7 vs  - 5.2 mg of the baseline daily dose at follow-up; p = 0.001). Mean speed of prednisone reduction was  - 13.1 mg of the daily dose for each month of follow-up for eculizumab-treated patients and  - 3.2 for efgartigimod (p = 0.001). We found three serious events, all not related to treatment in the investigator\'s opinion. One eculizumab-treated patient experienced a severe pneumonia and died despite treatment.
CONCLUSIONS: Our study provides evidence that eculizumab and efgartigimod can be used in clinical practice to reduce disability in gMG patients. Eculizumab-treated patients had a higher QMG response and steroid sparing effect. Efgartigimod may offer a more flexible schedule due to its cyclical use, no need for vaccination, and efficacy in AChR-Ab- patients.

(There is no abstract) for this article type.

UNASSIGNED: The Hispanic community represents a sizeable community that experiences inequities in the US health care system. As the system has moved toward digital health platforms, evaluating the potential impact on Hispanic communities is critical.
UNASSIGNED: The study aimed to investigate demographic, socioeconomic, and behavioral factors contributing to low telehealth use in Hispanic communities.
UNASSIGNED: We used a retrospective observation study design to examine the study objectives. The COVID-19 Research Database Consortium provided the Analytics IQ PeopleCore consumer data and Office Alley claims data. The study period was from March 2020 to April 2021. Multiple logistic regression was used to determine the odds of using telehealth services.
UNASSIGNED: We examined 3,478,287 unique Hispanic patients, 16.6% (577,396) of whom used telehealth. Results suggested that patients aged between 18 and 44 years were more likely to use telehealth (odds ratio [OR] 1.07, 95% CI 1.05-1.1; P<.001) than patients aged older than 65 years. Across all age groups, patients with high incomes were at least 20% more likely to use telehealth than patients with lower incomes (P<.001); patients who had a primary care physician (P=.01), exhibited high medical usage (P<.001), or were interested in exercise (P=.03) were more likely to use telehealth; patients who had unhealthy behaviors such as smoking and alcohol consumption were less likely to use telehealth (P<.001). Male patients were less likely than female patients to use telehealth among patients aged 65 years and older (OR 0.94, 95% CI 0.93-0.95; P<.001), while male patients aged between 18 and 44 years were more likely to use telehealth (OR 1.05, 95% CI 1.03-1.07; P<.001). Among patients younger than 65 years, full-time employment was positively associated with telehealth use (P<.001). Patients aged between 18 and 44 years with high school or less education were 2% less likely to use telehealth (OR 0.98, 95% CI 0.97-0.99; P=.005). Results also revealed a positive association with using WebMD (WebMD LLC) among patients aged older than 44 years (P<.001), while there was a negative association with electronic prescriptions among those who were aged between 18 and 44 years (P=.009) and aged between 45 and 64 years (P=.004).
UNASSIGNED: This study demonstrates that telehealth use among Hispanic communities is dependent upon factors such as age, gender, education, socioeconomic status, current health care engagement, and health behaviors. To address these challenges, we advocate for interdisciplinary approaches that involve medical professionals, insurance providers, and community-based services actively engaging with Hispanic communities and promoting telehealth use. We propose the following recommendations: enhance access to health insurance, improve access to primary care providers, and allocate fiscal and educational resources to support telehealth use. As telehealth increasingly shapes health care delivery, it is vital for professionals to facilitate the use of all available avenues for accessing care.

OBJECTIVE: This study aimed to investigate cross-sectional associations of total, animal, and plant-based protein intake and depressive symptoms in Dutch adults with type 2 diabetes (T2D).
METHODS: We included 1137 individuals with T2D (aged 68.6 ± 9.0) from the Hoorn Diabetes Care System cohort. Energy-adjusted protein intake was assessed using a validated Food Frequency Questionnaire. The nine-item Patient Health Questionnaire (PHQ-9) was used to assess the prevalence of depressive symptoms (PHQ-9 ≥ 10 and/or anti-depressant use) and the severity of depressive symptoms (continuous PHQ-9 score). Associations between total, animal, and plant-based protein (quartiles) with depressive symptoms were assessed using multiple logistic and linear regression.
RESULTS: Highest intake of total, animal, and plant-based protein was not associated with the prevalence of depressive symptoms, compared to lowest intake (e.g., total protein, ORQ4vsQ1:0.75, 95%CI 0.42;1.32). For the severity of depressive symptoms, highest total protein intake was significantly associated with lower PHQ-9 scores (ORQ4vsQ1:0.87, 95%CI 0.75;1.00), compared to lowest intake. Animal protein was not associated with the severity of depressive symptoms (β ∼ 1), while the association for plant-based protein was marginally non-significant (βQ4vsQ1:0.88, 95%CI 0.76;1.02).
CONCLUSIONS: In individuals with T2D, higher total protein intake was associated with reduced severity of depressive symptoms, but not with the prevalence of depressive symptoms. Further prospective research with a larger sample size is needed to confirm these associations.

BACKGROUND: Currently, no reporting guidelines exist for observational and qualitative study protocols. In an effort to enhance the quality of research protocols, we introduce two study protocol reporting checklists that we have developed.
CONCLUSIONS: These checklists include educational components and examples intended to assist novice researchers. Through the analysis of 333 study protocols submitted for ethical review, our checklists have been developed and validated, demonstrating their applicability across various observational and qualitative study designs.
UNASSIGNED: We provide insights into the systematic implementation of these checklists alongside complementary elements that support their effectiveness. We recommend longitudinal monitoring and evaluation of checklist utilization.