Health Care Resource Utilization Following Acute Myocardial Infarction: Findings from the RECORD-MI Registry.

The contemporary health care resource utilization after an acute myocardial infarction (MI) is not well-known. All patients admitted because of MI between January 2015 and December 2021 across 28 hospitals in the Baylor Scott & White Health system were studied. Patient characteristics and outcomes, including all-cause and cardiovascular (CV) rehospitalizations, emergency department (ED) visits, and outpatient visits were evaluated. Of 6,804 patients admitted because of MI, 6,556 were discharged alive. The median age was 69 years, 60% were men, and 77% had non-ST-elevation MI; 17% (1,090) had multivessel disease. The number of patients with first all-cause readmissions within 30 days, 3 months, and 12 months of discharge were 844 (13%), 1,372 (21%), and 2,306 (35%), respectively, with a higher readmission rate in patients with non-ST-elevation MI, previous heart failure (HF), new-onset HF, and left ventricular ejection fraction ≤40%. ED visits at 12 months for any cause were 2,401 (37%), of which 1,321 (55%) were for any CV cause, with a higher incidence in patients with previous HF. Of the 6,556 patients, 4,102 (63%) had at least 1 primary care visit in the past year, 5,009 (76%) had CV specialty visits, and 3,860 (59%) had non-CV visits, with a similar distribution across subgroups. Patients hospitalized with an MI had a high risk of subsequent hospital readmissions and ED and outpatient visits, especially those with a previous HF diagnosis and those discharged with an MI and HF diagnosis.

Factors affecting perceived caregiver burden: caregivers of trauma patients discharged from the intensive care unit.

Background: Caregivers to intensive care unit survivors are vulnerable to caregiver burden, which has been demonstrated to have consequences to patients' and caregivers' mental and physical health. Potentially modifiable factors should be explored so that interventions may be developed. Methods: Ninety-one anticipated caregivers were prospectively assessed both at a southwestern trauma intensive care unit during their patient's admission and at home via remote interview 3 months after intensive care unit admission. Caregiver depression, posttraumatic stress symptoms, experiences, and perceived burden were assessed. Results: At follow up, there was a significant negative correlation between caregiver burden and understanding of their patient's condition (P < 0.001) and intensive care unit events (P = 0.008). Caregivers with lower understanding of their patient's injury/illness had significantly greater depressive symptoms (P = 0.04). Conclusions: Education and knowledge of intensive care unit events regarding their patient may influence perceived burden among caregivers. Interventions to orient caregivers to intensive care unit events are suggested to reduce caregiver and healthcare system burden.

Prolonged exposure for posttraumatic stress disorder following spinal cord injury: A randomized controlled trial.

PURPOSE/OBJECTIVE: Individuals with a spinal cord injury (SCI) may experience posttraumatic stress disorder (PTSD) at a higher rate, which is associated with worse psychiatric comorbidity, decreased quality of life, and greater disability. Yet, effective PTSD interventions remain understudied for individuals with SCI. We conducted the first randomized controlled trial (RCT) of an evidence-based psychotherapy (prolonged exposure [PE]) with survivors of SCI during acute rehabilitation. We examined the efficacy, feasibility, and secondary outcomes. RESEARCH METHOD/DESIGN: Participants (n = 29) were adults recruited from 2018 to 2021 1-month postinjury with PTSD randomized into either PE therapy or treatment as usual. The primary outcome was PTSD assessed at baseline, 6, 10, and 32 weeks postenrollment. RESULTS: An overall group-by-time interaction was not statistically significant (p = .102), but effect sizes demonstrated moderate and large improvements in PTSD for the PE group at 6 (-19.4 vs. -9.7) and 10 (-25.8 vs. -5.7), respectively. Similarly, moderate to large effect sizes were observed for depression, maladaptive posttraumatic cognitions, disruptive nocturnal behaviors, SCI-related quality of life, and risky alcohol consumption. Low rates of enrollment (50%) and treatment completion (25%) suggest feasibility challenges; however, treatment completers did report high satisfaction (100%). CONCLUSIONS/IMPLICATIONS: Results suggest that individuals who received PE had a quicker and clinically meaningful reduction in PTSD symptoms, but delivery during acute rehabilitation is not feasible for many individuals. Future research should examine abbreviated versions of PE for PTSD to enhance the feasibility of treatment in this setting. (PsycInfo Database Record (c) 2024 APA, all rights reserved).

Clinical Delivery of Overground Exoskeleton Gait Training in Persons With Spinal Cord Injury Across the Continuum of Care: A Retrospective Analysis.

Background: After spinal cord injury (SCI), inpatient rehabilitation begins and continues through outpatient therapy. Overground exoskeleton gait training (OEGT) has been shown to be feasible in both settings, yet its use as an intervention across the continuum has not yet been reported. Objectives: This study describes OEGT for patients with SCI across the continuum and its effects on clinical outcomes. Methods: Medical records of patients with SCI who completed at least one OEGT session during inpatient and outpatient rehabilitation from 2018 to 2021 were retrospectively reviewed. Demographic data, Walking Index for Spinal Cord Injury-II (WISCI-II) scores, and OEGT session details (frequency, "walk" time, "up" time, and step count) were extracted. Results: Eighteen patients [male (83%), White (61%), aged 37.4 ± 15 years, with tetraplegia (50%), American Spinal Injury Association Impairment Scale A (28%), B (22%), C (39%), D (11%)] completed OEGT sessions (motor complete, 18.2 ± 10.3; motor incomplete, 16.7 ± 7.7) over approximately 18 weeks (motor complete, 15.1 ± 6.4; motor incomplete, 19.0 ± 8.2). Patients demonstrated improved OEGT session tolerance on device metrics including "walk" time (motor complete, 7:51 ± 4:42 to 24:50 ± 9:35 minutes; motor incomplete, 12:16 ± 6:01 to 20:01 ± 08:05 minutes), "up" time (motor complete, 16:03 ± 7:41 to 29:49 ± 12:44 minutes; motor incomplete, 16:38 ± 4:51 to 23:06 ± 08:50 minutes), and step count (motor complete, 340 ± 295.9 to 840.2 ± 379.4; motor incomplete, 372.3 ± 225.2 to 713.2 ± 272). Across therapy settings, patients with motor complete SCI experienced improvement in WISCI-II scores from 0 ± 0 at inpatient admission to 3 ± 4.6 by outpatient discharge, whereas the motor incomplete group demonstrated a change of 0.2 ± 0.4 to 9.0 ± 6.4. Conclusion: Patients completed OEGT across the therapy continuum. Patients with motor incomplete SCI experienced clinically meaningful improvements in walking function.

Neonatal Intensive Care Unit Resource Use for Infants at 22 Weeks' Gestation in the US, 2008-2021.

Importance: During the past decade, clinical guidance about the provision of intensive care for infants born at 22 weeks' gestation has changed. The impact of these changes on neonatal intensive care unit (NICU) resource utilization is unknown. Objective: To characterize recent trends in NICU resource utilization for infants born at 22 weeks' gestation compared with other extremely preterm infants (≤28 weeks' gestation) and other NICU-admitted infants. Design, Setting, and Participants: This is a serial cross-sectional study of 137 continuously participating NICUs in 29 US states from January 1, 2008, through December 31, 2021. Participants included infants admitted to the NICU. Data analysis was performed from October 2022 to August 2023. Exposures: Year and gestational age at birth. Main Outcomes and Measures: Measures of resource utilization included NICU admissions, NICU bed-days, and ventilator-days. Results: Of 825 112 infants admitted from 2008 to 2021, 60 944 were extremely preterm and 872 (466 [53.4%] male; 18 [2.1%] Asian; 318 [36.5%] Black non-Hispanic; 218 [25.0%] Hispanic; 232 [26.6%] White non-Hispanic; 86 [9.8%] other or unknown) were born at 22 weeks' gestation. NICU admissions at 22 weeks' gestation increased by 388%, from 5.7 per 1000 extremely preterm admissions in 2008 to 2009 to 27.8 per 1000 extremely preterm admissions in 2020 to 2021. The number of NICU admissions remained stable before the publication of updated clinical guidance in 2014 to 2016 and substantially increased thereafter. During the study period, bed-days for infants born at 22 weeks increased by 732%, from 2.5 per 1000 to 20.8 per 1000 extremely preterm NICU bed-days; ventilator-days increased by 946%, from 5.0 per 1000 to 52.3 per 1000 extremely preterm ventilator-days. The proportion of NICUs admitting infants born at 22 weeks increased from 22.6% to 45.3%. Increases in NICU resource utilization during the period were also observed for infants born at less than 22 and at 23 weeks but not for other gestational ages. In 2020 to 2021, infants born at less than or equal to 23 weeks' gestation comprised 1 in 117 NICU admissions, 1 in 34 of all NICU bed-days, and 1 in 6 of all ventilator-days. Conclusions and Relevance: In this serial cross-sectional study of 137 US NICUs from 2008 to 2021, an increasing share of resources in US NICUs was allocated to infants born at 22 weeks' gestation, corresponding with changes in national clinical guidance.

Impact of iodinated contrast shortage on contrast-associated acute kidney injury: a single center experience.

Background: In March 2022, a COVID-19 outbreak disrupted the global supply of iodine contrast media (ICM). Healthcare systems implemented contrast-saving strategies to maintain their remaining ICM supplies. This study sought to determine the impact of contrast shortage on the incidence of contrast-associated acute kidney injury (CA-AKI). Methods: This was a retrospective study of 265 patients undergoing 278 percutaneous coronary interventions (PCI) during 4-month periods prior to (9/1/2021 to 12/31/2021) and during (5/1/2022 to 8/31/2022) contrast shortage at a single center. The primary endpoint was the incidence of CA-AKI between study periods. Results: A total of 148 and 130 PCIs were performed before and during contrast shortage, respectively. The incidence of CA-AKI significantly decreased from 11.5% to 4.6% during contrast shortage (P = 0.04). During the shortage, average contrast volume per PCI was significantly lower (123 ± 62 mL vs 88 ± 46 mL, P < 0.001), while coronary imaging was significantly higher (34.3% vs 50%, P = 0.009) compared to preshortage. All-cause mortality at discharge was comparable between study periods (2.8% vs 3.3%, respectively; P = 0.90). Conclusion: The scarcity of ICM for PCI procedures in this single-center experience was associated with a significant increase in the utilization of intravascular imaging and a significant reduction in CA-AKI.

Linking biomarkers with healthy lifestyle outcomes after stroke: Supplementary results of a 12-month randomized controlled trial.

BACKGROUND AND AIMS: Participation in a healthy lifestyle intervention such as the Diabetes Prevention Program Group Lifestyle Balance-adapted for stroke (GLB-CVA) may reduce stroke burden. Identifying biomarkers associated with lifestyle changes may enhance an individualized approach to stroke recovery. We investigated metabolic biomarkers related to cardiovascular and neurological function in individuals with stroke in the GLB-CVA study and healthy (non-stroke) individuals. METHODS AND RESULTS: Participants with chronic (>12 months) stroke were recruited to this wait-list randomized controlled trial if they were overweight (BMI ≥25 kg/m2). Participants were randomized to (1) the GLB-CVA program to complete 22 educational sessions addressing behavioral principals of dietary and physical activity or (2) a 6 month wait-list control (WLC). Biomarkers [Plasma irisin, vascular endothelial growth factor, lipoprotein-associated phospholipase A2 (Lp-PLA2), insulin-like growth factor 1 and brain-derived neurotrophic factor (BDNF)] were collected at baseline, 3, and 6 months. Age-matched healthy individuals were recruited for biomarker assessment. Compared to healthy adults (n = 19), participants with stroke (GLB-CVA = 24; WLC = 24) at baseline had higher tHcy levels (p < 0.001) and lower PLA2 levels (p = 0.016). No statistically significant interactions were observed for any biomarkers between the GLB-CVA and WLC or between people who achieved 5% weight loss and those who did not. CONCLUSION: Participation in a 6-month healthy lifestyle program did not result in statistically significant changes to select metabolic biomarker levels for our participants with chronic stroke. However, participants with stroke demonstrated a unique biomarker profile compared to age-matched healthy individuals.

Utilization of overground exoskeleton gait training during inpatient rehabilitation: a descriptive analysis.

BACKGROUND: Overground exoskeleton gait training (OEGT) after neurological injury is safe, feasible, and may yield positive outcomes. However, no recommendations exist for initiation, progression, or termination of OEGT. This retrospective study highlights the clinical use and decision-making of OEGT within the physical therapy plan of care for patients after neurological injury during inpatient rehabilitation. METHODS: The records of patients admitted to inpatient rehabilitation after stroke, spinal cord injury, or traumatic brain injury who participated in at least one OEGT session were retrospectively reviewed. Session details were analyzed to illustrate progress and included: "up" time, "walk" time, step count, device assistance required for limb swing, and therapist-determined settings. Surveys were completed by therapists responsible for OEGT sessions to illuminate clinical decision-making. RESULTS: On average, patients demonstrated progressive tolerance for OEGT over successive sessions as shown by increasing time upright and walking, step count, and decreased assistance required by the exoskeleton. Therapists place preference on using OEGT with patients with more functional dependency and assess feedback from the patient and device to determine when to change settings. OEGT is terminated when other gait methods yield higher step repetitions or intensities, or to prepare for discharge. CONCLUSION: Our descriptive retrospective data suggests that patients after neurological injury may benefit from OEGT during inpatient rehabilitation. As no guidelines exist, therapists' clinical decisions are currently based on a combination of knowledge of motor recovery and experience. Future efforts should aim to develop evidence-based recommendations to facilitate functional recovery after neurological injury by leveraging OEGT.

Results of a 12-Month Randomized Controlled Trial Testing the Efficacy of the Diabetes Prevention Program Group Lifestyle Balance (DPP-GLB) for People Post Stroke (GLB-CVA).

BACKGROUND: Experience of stroke is associated with an increased risk for diabetes and metabolic syndrome, yet few interventions exist that have been tailored to the population's unique needs. PURPOSE: To examine adherence and efficacy of the Diabetes Prevention Program Group Lifestyle Balance program (DPP-GLB) modified for individuals post stroke (GLB-CVA) using a randomized controlled trial. METHODS: Adults (18-85 years of age), >12 months post stroke, and body mass index ≥25 kg/m2 were included in this study. Sixty-five individuals were assigned to either the GLB-CVA intervention or a 6-month wait-list control. Participants completed the 12-month GLB-CVA intervention, with attendance and assessment of weight, anthropometric, biomarker, functional, and patient reported outcome data collected at baseline, 3, 6, and 12 months. RESULTS: High attendance (90%) and dietary and activity tracking (71%) suggest high adherence to the 12-month GLB-CVA. Six-month randomized controlled trial data indicate significant weight loss (p = .005) in the GLB-CVA group (7.4 ± 13.6 lbs, 3.65%) compared with the wait-list control (0.1 ± 10.1 lbs, 0%), and improvements in arm circumference (p = .04), high-density lipoprotein (HDL) cholesterol (p = .028), 8-year diabetes risk (p = .011), and pain interference (p < .001). Combined 12-month data showed participants lost 10.1 ± 16.8 lbs (4.88%) and improved waist circumference (p = .001), HbA1c (3.6%), diastolic blood pressure (p < .001), pain (p = .001), social participation (p = .025), and eating practices (p = .01) and habits (p < .001). CONCLUSIONS: Engagement in the GLB-CVA can result in weight loss and improved health for individuals who are overweight or obese following stroke. Future efforts should examine effectiveness in real-world settings and focus on knowledge translation efforts.

Experience of stroke is associated with an added risk for diabetes and metabolic syndrome, yet few interventions exist that have been tailored to the population's unique needs. Our team delivered a health promotion program called the Diabetes Prevention Program Group Lifestyle Balance (DPP-GLB) modified for individuals post stroke (GLB-CVA) living in the community. We enrolled 65 adults (18­85 years of age), who were at least 12 months post stroke, and had body mass index of at least 25 kg/m2. Participants were randomized to either the GLB-CVA intervention or a 6-month wait-list control. Outcome data were collected at baseline, 3, 6, and 12 months. Results showed high participant attendance (90%) and tracking completion (71%). Participants in the GLB-CVA intervention group lost significantly more weight (3.65%) and had greater improvements in arm circumference, HDL cholesterol, 8-year diabetes risk, and pain than participants in the wait-list control. Combined 12-month data showed participants lost 4.88% of their body weight and improved waist circumference, blood sugar (HbA1c), diastolic blood pressure, pain, social participation, eating practices, and habits. Due to these results, we concluded that engagement in the GLB-CVA can result in weight loss and improved health for individuals who are overweight or obese following stroke.

Associations of Mental Health and Experience of the COVID-19 Pandemic with United States Adults' Intentions to Be Vaccinated.

COVID-19 vaccine uptake in the United States has proved challenging. A deeper characterization extending beyond demographics and political ideologies of those hesitating or resisting is needed to guide ongoing conversations. This study examined associations between US adults' vaccination intentions and mental health history, experience of the COVID-19 pandemic, and mental health outcomes. An online population-based cross-sectional survey was administered nationwide during January 4-7, 2021. Participants were questioned about past and current mental health, and completed the Patient Health Questionnaire 8 (PHQ-8), Generalized Anxiety Disorder 7-item (GAD-7), and Posttraumatic Diagnostic Scale (PDS)-5 (to capture symptoms of depression, anxiety, and traumatic stress, respectively). Experience of the pandemic included cumulative county-level COVID case and death rates, self-reported COVID-19 testing/exposure/diagnosis, and self-reported impact on routines, resources, and relationships. Of 936 respondents, 66% intended to be vaccinated, 14.7% responded "maybe," and 19.6% "no." Past diagnosis of obsessive compulsive disorder, less impact on routines or social supports, not having been screened or tested for COVID-19, not knowing someone who tested positive, and not self-isolating were associated with less intention to vaccinate. After controlling for demographic and pandemic experience factors, symptoms of traumatic stress, but not other mental health outcomes, were associated with less intention to vaccinate. The apparent contradiction between less negative impact of the pandemic and symptoms of traumatic stress being associated with less intention to be vaccinated indicates the complex nature of barriers to vaccine uptake. Results from this study contribute to the evidence base needed to improve ongoing and future communications about, and strategies to increase uptake of, vaccination.

A randomized controlled trial protocol for people with traumatic brain injury enrolled in a telehealth delivered diabetes prevention program (tGLB-TBI).

Obesity rates after traumatic brain injury (TBI) are high and are associated with greater risk of morbidity (diabetes, hypertension) and mortality when compared to the general population. Evidence-based interventions for this population are needed and our work modifying and examining the efficacy of the Diabetes Prevention Program Group Lifestyle Balance (GLB-TBI) are promising. Our recent randomized controlled trial included 57 adults with TBI who completed the GLB-TBI in-person and lost 17.8 ± 16.4lbs (7.9% body weight) compared to the attention control (0%). To broaden the accessibility of the intervention we will complete an RCT to assess the efficacy of telehealth delivery (tGLB-TBI) by enrolling 88 participants over a 3 year period. Results will provide a scalable telehealth weight-loss program that clinicians and community workers across the country can use to help people with TBI lose weight and improve health. The long-term goal is to reduce health inequities and broaden program dissemination to people with TBI that lack access due to environmental barriers, including living rurally or lacking transportation.

Efficacy of a group-based education intervention for people with traumatic brain injury: supplementary results from a 12-month randomized controlled trial.

OBJECTIVE: Our team developed an attention control condition, called the Brain Health Group (BHG), for a randomized controlled trial (RCT; NCT03594734). The focus of the BHG was on brain health education and self-management. The objectives of this supplementary analysis are to (1) Describe compliance with the 12-month BHG; (2) Examine efficacy for improving general self-efficacy (GSE, primary) and secondary outcomes; and (3) Describe findings from the program evaluation. DESIGN: English-speaking adults (18-64 years old) who were ≥6 months post a moderate-to-severe TBI were randomized to the BHG (n = 29) or active intervention (n = 28). Data were collected at baseline and 12 months, including GSE, depression, satisfaction with life (SWL), self-rated abilities for health practices (SRAHP), and alcohol use. Program evaluation was conducted at 12 months. RESULTS: Attendance was 89%, and goal tracking was 63%. Within group analysis showed a significant increase in SRAHP scores (p = 0.018). Non-significant increases in GSE and SWL were observed, and participants perceived the BHG as helpful. No significant changes in depression or alcohol use were reported. CONCLUSION: People with TBI can engage in and benefit from the BHG and perceive the program as helpful for improving knowledge about brain health and awareness of self-management skills.

Utilizing psoas muscle cross-sectional area to predict functional outcome.

Background: This study evaluated psoas muscle area (PMA) as a predictor of frailty and functional outcome in trauma patients. Methods: The cohort included 211 trauma patients admitted to an urban level I trauma center from March 2012 to May 2014 who consented to participate in a longitudinal study and underwent abdominal-pelvic computed tomography scans during their initial evaluation. Physical component scores (PCS) of the Veterans RAND 12-Item Health Survey were administered to assess physical functionality at baseline and at 3, 6, and 12 months after injury. PMA in mm2 and Hounsfield units was calculated using the Centricity PACS system. Statistical models were stratified by injury severity score (ISS), <15 or ≥15, and adjusted for age, sex, and baseline PCS. Follow-up PCS were analyzed using general linear regression models. Results: For participants with an ISS <15, increased PMA was significantly associated with higher PCS at 3 (P = 0.008), 6 (P = 0.02), and 12 months (P = 0.002), although this relationship was not statistically significant for ISS ≥15 (P = 0.85, 0.66, 0.61). Conclusion: For mild to moderately injured (but not seriously injured) patients, those with larger psoas muscles experience better functional outcomes after injury.

Longitudinal validation of the Fear of COVID-19 Scale in a nationwide United States sample: An item response theory model across three inflection points of the pandemic.

The COVID-19 pandemic's global emergence/spread caused widespread fear. Measurement/tracking of COVID-19 fear could facilitate remediation. Despite the Fear of COVID-19 Scale (FCV-19S)'s validation in multiple languages/countries, nationwide United States (U.S.) studies are scarce. Cross-sectional classical test theory-based validation studies predominate. Our longitudinal study sampled respondents to a 3-wave, nationwide, online survey. We calibrated the FCV-19S using a unidimensional graded response model. Item/scale monotonicity, discrimination, informativeness, goodness-of-fit, criterion validity, internal consistency, and test-retest reliability were assessed. Items 7, 6, and 3 consistently displayed very high discrimination. Other items had moderate-to-high discrimination. Items 3, 6, and 7 were most (items 1 and 5 the least) informative. [Correction added on 18 May 2023, after first online publication: In the preceding sentence, the term 'items one-fifth least' has been changed to 'items 1 and 5 the least'.] Item scalability was 0.62-0.69; full-scale scalability 0.65-0.67. Ordinal reliability coefficient was 0.94; test-retest intraclass correlation coefficient 0.84. Positive correlations with posttraumatic stress/anxiety/depression, and negative correlations with emotional stability/resilience supported convergent/divergent validity. The FCV-19S validly/reliably captures temporal variation in COVID-19 fear across the U.S.

Relative contribution of acute cognitive and motor functioning on community integration 1 year after moderate-severe TBI.

OBJECTIVES: The objective of this study was to understand the relative contribution of acute motor versus cognitive functioning on community integration 1 year after moderate-severe traumatic brain injury (TBI). METHODS: Secondary data analysis of 779 participants in the TBI Model Systems National Database who experienced a moderate-severe TBI requiring inpatient rehabilitation. Participants were categorized into four groups: low motor/low cognition, low motor/high cognition, high motor/low cognition, or high motor/high cognition. Community integration outcomes measured 1 year post-TBI included the Participation Assessment with Recombined Tools-Objective (PART-O), driving status, Supervision Rating Scale, residence, re-injury, and employment status. RESULTS: Participants with both high motor/high cognition had higher scores on the PART-O total score (p < 0.001), living independently (p = 0.023), living in a private residence (p = 0.002), and being employed (p = 0.026) at 1 year. Participants with high motor/high cognition and high motor/low cognition had higher odds of driving (p = 0.001 and p = 0.034, respectively) when compared to low motor/low cognition. All groups relative to the low motor/low cognition group had higher odds of being re-injured. DISCUSSION AND CONCLUSIONS: High motor and high cognitive function at rehabilitation are associated with favorable community integration outcomes 1 year post-injury, though greater participation afforded by high function may confer elevated risk of re-injury.

Effects of cloth face masks on physical and cognitive performance during maximal exercise testing.

Wearing a cloth face mask has been shown to impair exercise performance; it is essential to understand the impact wearing a cloth face mask may have on cognitive performance. Participants completed two maximal cardiopulmonary exercise tests on a cycle ergometer (with and without a cloth face mask) with a concurrent cognitive task. Blood pressure, heart rate, oxygen saturation, perceived exertion, shortness of breath, accuracy, and reaction time were measured at rest, during each exercise stage, and following a 4-minute recovery period. The final sample included 35 adults (age = 26.1 ± 5.8 years; 12 female/23 male). Wearing a cloth face mask was associated with significant decreases in exercise duration (-2:00 ± 3:40 min, P = 0.003), peak measures of maximal oxygen uptake (-818.9 ± 473.3 mL/min, -19.0 ± 48 mL·min-1·kg-1, P < 0.001), respiratory exchange ratio (-0.04 ± 0.08, P = 0.005), minute ventilation (-36.9 ± 18 L/min), oxygen pulse (-3.9 ± 2.3, P < 0.001), heart rate (-7.9 ± 12.6 bpm, P < 0.001), oxygen saturation (-1.5 ± 2.8%, P = 0.004), and blood lactate (-1.7 ± 2.5 mmol/L, P < 0.001). While wearing a cloth face mask significantly impaired exercise performance during maximal exercise testing, cognitive performance was unaffected in this selected group of young, active adults.

Comparative Expedited Regulatory Programs of U.S Food & Drug Administration and Project Orbis Partners.

Project Orbis was initiated in May 2019 by the Oncology Center of Excellence to facilitate faster patient access to innovative cancer therapies by providing a framework for concurrent submissions and review of oncology products among international partners. Since its inception, Australia's Therapeutic Goods Administration (TGA), Canada's Health Canada (HC), Singapore's Health Sciences Authority (HSA), Switzerland's Swissmedic (SMC), Brazil's National Health Surveillance Agency (ANVISA), United Kingdom's Medicines and Healthcare Products Regulatory Agency (MHRA), and most recently Israel's Ministry of Health (IMoH) Medical Technologies, Health Information, Innovation and Research (MTIIR) Directorate, have joined Project Orbis. While each country has its own expedited review pathways to bring promising therapies to patients, there are some similarities and differences in pathways and timelines. FDA's fast-track designation and MHRA's marketing authorization under exceptional circumstances (MAEC) allow non-clinical and limited clinical evidence to support approval under these programs. HC's Extraordinary Use New Drug (EUND) pathway allows granting exceptional use authorization with limited clinical evidence. ANVISA, HSA, MTIIR, and TGA do not have standard pathways that allow non-clinical evidence and limited clinical evidence. While there is no definite regulatory pathway for HSA, the current framework for approval does allow flexibility in the type of data (non-clinical or clinical) required to demonstrate the benefit-risk profile of a product. HSA may register a product if the agency is satisfied that the overall benefit outweighs the risk. All Project Orbis Partner (POP) countries have similar programs to the FDA accelerated approval program except ANVISA. Although HSA and MTIIR do not have defined pathways for accelerated approval programs, there are opportunities to request accelerated approval per these agencies. All POP countries have pathways like the FDA priority review except MHRA. Priority review timelines for new drugs range from 120 to 264 calendar days (cd). Standard review timelines for new drugs range from 180 to 365 cd.

The risks of attrition bias in longitudinal surveys of the impact of COVID-19.

As the COVID-19 pandemic continues, interest in mental health impacts is shifting from short-term to long-term outcomes. As part of a longitudinal online survey study examining mental health impacts of the pandemic, we assessed the risk of attrition bias related to a history of depression-a condition research shows can increase challenges of recruitment and retention. Among 5023 participants who completed the baseline survey, significantly more reporting a history of depression were lost to follow-up: baseline to 3 months: 497/760 (65.4%) vs 2228/4263 (52.3%), P < 0.001; 3 to 6 months: 179/263 (68.1%) vs 1183/2035 (58.1%), P = 0.002. Participants reporting a history of depression also had greater adjusted odds of a Patient Health Questionnaire-8 score ≥10 (odds ratio [OR] = 3.97, 95% confidence interval [CI] 3.27, 4.84), Generalized Anxiety Disorder-7 score ≥10 (OR = 3.77, 95% CI 3.07, 4.62), and Posttraumatic Diagnostic Scale for DSM V score ≥ 28 (OR = 7.17, 95% CI 4.67, 11.00) at baseline, indicating a need to account for attrition bias when examining these outcomes. Similar considerations likely apply to other longitudinal survey studies and are important to address to ensure accurate evidence is available to support policy decisions regarding resource allocation and funding.

Efficacy of the Diabetes Prevention Program Group Lifestyle Balance Program Modified for Individuals with TBI (GLB-TBI): Results from a 12-month Randomized Controlled Trial.

BACKGROUND: Obesity after traumatic brain injury (TBI) is a public health issue and no evidence-based weight loss interventions exist to meet the unique needs of individuals after TBI. PURPOSE: To (a) examine the efficacy of the Diabetes Prevention Program Group Lifestyle Balance for TBI (GLB-TBI) weight-loss intervention compared to an attention control for primary (weight-loss) and secondary health outcomes; (b) determine participant compliance with the GLB-TBI; and (c) determine if compliance is associated with improved outcomes. METHODS: Individuals with moderate to severe TBI, age 18-64 years, ≥6 months postinjury, and body mass index of ≥25 kg/m2 were randomized to a 12-month, 22-session GLB-TBI intervention or attention control condition. Weight-loss (lbs.), anthropometric, biomarkers, and patient-reported outcomes were collected at baseline, 3, 6, and 12 months. RESULTS: The GLB-TBI group (n = 27) lost 17.8 ± 41.4lbs (7.9%) over the 12-month program and the attention control group (n = 27) lost 0 ± 55.4lbs (0%). The GLB-TBI group had significant improvements in diastolic blood pressure, triglycerides, and HDL cholesterol. GLB-TBI attendance was 89.6% and weekly self-monitoring of diet and activity was 68.8%. Relative to baseline, the GLB-TBI compliant group (≥80% attendance; ≥85% self-monitoring; n = 10) had a statistically significant decrease in weight at each assessment, the noncompliant group had a significant decrease between 6 and 12 months (n = 17), with no change in weight in the attention control group (n = 27). CONCLUSIONS: Findings suggest for adults with TBI who are overweight or obese, participation in the GLB-TBI can significantly reduce weight and metabolic risk factors and increase self-reported habits for diet and exercise.

The experience of COVID-19 among people with depression: Impact on daily life and coping strategies.

BACKGROUND: The prevalence of depression symptoms among U.S. adults increased dramatically during the early months of the COVID-19 pandemic. We sought to understand the impact of the pandemic on people with a history of depression. METHODS: In June 2020, a national sample of 5023 U.S. adults, including 760 reporting past/current diagnoses of depression, completed survey measures related to the COVID experience, coping, anxiety, depression, and PTSD. RESULTS: After adjusting for sociodemographic characteristics, a history of depression increased the odds of negative effects of pandemic on multiple aspects of life: routines, access to mental health treatment, alcohol use, prescription painkiller use, and other drug use. Those with a history of depression also scored significantly higher on the PHQ-8, GAD-7, and PDS-5 (all ps < 0.0001). Greater use of adaptive coping strategies was significantly associated with lower scores, and greater use of maladaptive strategies with higher scores. Individuals reporting a history of depression reported greater use of both adaptive and maladaptive strategies. CONCLUSIONS: Adaptive coping strategies appear to be protective and help regulate symptomatology, suggesting that particular focus during the clinical encounter on developing tools to promote well-being, alleviate stress, and decrease perceptions of helplessness could mitigate the effects.