Evolving Real-World Effectiveness of Monoclonal Antibodies for Treatment of COVID-19 : A Cohort Study.

BACKGROUND: Treatment guidelines and U.S. Food and Drug Administration emergency use authorizations (EUAs) of monoclonal antibodies (mAbs) for treatment of high-risk outpatients with mild to moderate COVID-19 changed frequently as different SARS-CoV-2 variants emerged. OBJECTIVE: To evaluate whether early outpatient treatment with mAbs, overall and by mAb product, presumed SARS-CoV-2 variant, and immunocompromised status, is associated with reduced risk for hospitalization or death at 28 days. DESIGN: Hypothetical pragmatic randomized trial from observational data comparing mAb-treated patients with a propensity score-matched, nontreated control group. SETTING: Large U.S. health care system. PARTICIPANTS: High-risk outpatients eligible for mAb treatment under any EUA with a positive SARS-CoV-2 test result from 8 December 2020 to 31 August 2022. INTERVENTION: Single-dose intravenous mAb treatment with bamlanivimab, bamlanivimab-etesevimab, sotrovimab, bebtelovimab, or intravenous or subcutaneous casirivimab-imdevimab administered within 2 days of a positive SARS-CoV-2 test result. MEASUREMENTS: The primary outcome was hospitalization or death at 28 days among treated patients versus a nontreated control group (no treatment or treatment ≥3 days after SARS-CoV-2 test date). RESULTS: The risk for hospitalization or death at 28 days was 4.6% in 2571 treated patients and 7.6% in 5135 nontreated control patients (risk ratio [RR], 0.61 [95% CI, 0.50 to 0.74]). In sensitivity analyses, the corresponding RRs for 1- and 3-day treatment grace periods were 0.59 and 0.49, respectively. In subgroup analyses, those receiving mAbs when the Alpha and Delta variants were presumed to be predominant had estimated RRs of 0.55 and 0.53, respectively, compared with 0.71 for the Omicron variant period. Relative risk estimates for individual mAb products all suggested lower risk for hospitalization or death. Among immunocompromised patients, the RR was 0.45 (CI, 0.28 to 0.71). LIMITATIONS: Observational study design, SARS-CoV-2 variant presumed by date rather than genotyping, no data on symptom severity, and partial data on vaccination status. CONCLUSION: Early mAb treatment among outpatients with COVID-19 is associated with lower risk for hospitalization or death for various mAb products and SARS-CoV-2 variants. PRIMARY FUNDING SOURCE: None.

Complicated Grief With Post-Traumatic Stress Disorder Addressed With Accelerated Resolution Therapy: Case Discussions.

Complicated grief is a significant health concern for older adults, resulting in significant psychological and physical morbidity. Elements of post traumatic stress disorder (PTSD) are often present in individuals with complicated grief. Accelerated Resolution Therapy (ART) is a brief form of psychotherapy that utilizes the techniques of imaginal exposure, rescripting of events, and lateral eye movements that may be useful in complicated grief with PTSD symptoms. Two cases where ART was used for complicated grief with PTSD are presented. Both individuals had attempted to come to terms with their loss through traditional grief therapy with an inadequate response and substantial residual grief symptoms. These cases illustrate how ART can be used to address CG and PTSD and describe situations where it may be appropriate. Clinical and research implications are also discussed.

Factors associated with pediatric drowning admissions and outcomes at a trauma center, 2010-2017.

BACKGROUND: Drowning is a leading cause of preventable mortality and morbidity in children. Its high fatality rate and frequent severe sequelae (e.g. brain damage and permanent loss of functioning) place a premium on preventive efforts. METHODS: A retrospective analysis of patients ≤21 years of age admitted between 2010 and 2017 to a pediatric trauma center was conducted to identify factors associated with drowning admissions, fatal drowning, and severe outcome (ventilator use, ICU admission, or death). Outcomes were modeled and estimated by use of logistic regression and Poisson regression. RESULTS: Drowning accounted for 153/4931 (3.1%) trauma admissions between 2010 and 2017. The risk of death (13.1% vs. 1.5%, p < .01), and severe outcome (24.8% vs. 7.8%, p < .01) was significantly higher for drownings vs. other causes. All 20 drowning deaths occurred among children left unattended. In Poisson regression analysis, weekends, summer breaks, and hotter days were independently associated with a higher probability of drowning admissions. Additionally, in analyses excluding indicators of severity, the odds of severe outcome were higher for children age ≤ 2 years [adjusted odds ratio (AOR) = 3.88 95% CI (1.58, 9.53)], and injury downtime of >5 min or unknown length [AOR = 6.66 95% CI (2.74-16.15)]. Immediate intervention after the discovery was associated with ~70% lower odds of a severe outcome. CONCLUSIONS: Drowning admissions were both more severe and more often fatal compared to other pediatric injury causes of admission. Enhanced and targeted educational messages for parents of young children, focused on prevention behaviors on high-risk days and immediate bystander intervention, may reduce the occurrence and severity of these tragic accidents. TABLE OF CONTENTS SUMMARY: A retrospective multi-year cohort study to identify modifiable factors associated with drowning admissions, severe complications, and death from a large trauma registry database. WHAT'S KNOWN ON THIS SUBJECT: Drowning is a leading cause of unintentional injury that results in severe morbidity and a high rate of mortality. Children are disproportionately affected by drowning and have a higher risk of long term sequelae and death. WHAT THIS STUDY ADDS: This study identified high-risk populations and periods for drowning, the importance of supervision, and the effectiveness of immediate intervention in reducing unfavorable outcomes after drowning. It also highlights a need for heightened local intervention for drowning prevention.

Mindfulness-based stress reduction for breast cancer survivors (MBSR(BC)): evaluating mediators of psychological and physical outcomes in a large randomized controlled trial.

MBSR(BC) is known to have a positive impact on psychological and physical symptoms among breast cancer survivors (BCS). The cognitive mechanisms of "how" MBSR(BC) works was addressed in a recent study that found that there was strong consistent evidence that reduced emotional reactivity is a mediator and moderate consistent evidence that mindfulness, rumination, and worry were mediators. The purpose of this study, as part of a larger R01 trial, was to test whether positive effects achieved from the MBSR(BC) program were mediated through changes in increased mindfulness, decreased fear of breast cancer recurrence, and perceived stress. Female BCS > 21 years diagnosed with Stage 0-III breast cancer were randomly assigned to a 6-week MBSR(BC) or a Usual Care (UC)regimen. Potential mediators of 6- and 12-week outcomes were identified by analysis of covariance (ANCOVA), followed by formal mediational analyses of main effects of MBSR(BC) on 6- and 12-week outcomes, including percentage of total effects explained. Among 322 BCS (167 MBSR(BC) and 155 UC), fear of recurrence and perceived stress, but not mindfulness, mediated reductions in anxiety and fatigue at weeks 6 and 12, partially supporting our hypothesis of cognitive mechanisms of MBSR(BC). TRIAL REGISTRATION: Registration Number: NCT01177124 http://www.ClinicalTrials.gov.

Particulate Matter Air Pollution and Racial Differences in Cardiovascular Disease Risk.

OBJECTIVE: We aimed to assess racial differences in air pollution exposures to ambient fine particulate matter (particles with median aerodynamic diameter <2.5 µm [PM2.5]) and black carbon (BC) and their association with cardiovascular disease (CVD) risk factors, arterial endothelial function, incident CVD events, and all-cause mortality. APPROACH AND RESULTS: Data from the HeartSCORE study (Heart Strategies Concentrating on Risk Evaluation) were used to estimate 1-year average air pollution exposure to PM2.5 and BC using land use regression models. Correlates of PM2.5 and BC were assessed using linear regression models. Associations with clinical outcomes were determined using Cox proportional hazards models, adjusting for traditional CVD risk factors. Data were available on 1717 participants (66% women; 45% blacks; 59±8 years). Blacks had significantly higher exposure to PM2.5 (mean 16.1±0.75 versus 15.7±0.73µg/m3; P=0.001) and BC (1.19±0.11 versus 1.16±0.13abs; P=0.001) compared with whites. Exposure to PM2.5, but not BC, was independently associated with higher blood glucose and worse arterial endothelial function. PM2.5 was associated with a higher risk of incident CVD events and all-cause mortality combined for median follow-up of 8.3 years. Blacks had 1.45 (95% CI, 1.00-2.09) higher risk of combined CVD events and all-cause mortality than whites in models adjusted for relevant covariates. This association was modestly attenuated with adjustment for PM2.5. CONCLUSIONS: PM2.5 exposure was associated with elevated blood glucose, worse endothelial function, and incident CVD events and all-cause mortality. Blacks had a higher rate of incident CVD events and all-cause mortality than whites that was only partly explained by higher exposure to PM2.5.

Post-traumatic stress disorder and hypertensive disorders of pregnancy among military women.

BACKGROUND: Women are more likely to develop post-traumatic stress disorder (PTSD) than men. Limited research exists evaluating the risk of hypertensive disorders of pregnancy (HDP) among military women with PTSD. METHODS: We conducted a retrospective cohort study using US Department of Defense (DoD) data comprised of all active-duty women giving birth to their first, liveborn singleton infant using DoD-sponsored health insurance from 1 January 2004 to 31 December 2008 (n = 34 176). Birth hospitalisation records, maternal mental health visits, and Post-Deployment Health Assessment (PDHA) and Reassessment (PDHRA) screenings were included. The HDP outcome (yes vs no) was defined using ICD-9-CM codes in the maternal birth hospitalisation record. Women fit into one of four PTSD exposure categories (confirmed, probable, possible, none). Confirmed cases had a PTSD ICD-9-CM diagnosis code. Probable/possible cases were classified using PDHA screening items. We used multiple log-linear regression to assess PTSD (confirmed, any vs none) and the risk of HDP overall, and then explored effect modification by military service and demographic variables. We assessed the risk of HDP among deployed mothers with PTSD (confirmed, probable/possible vs none) who completed a PDHA, and explored effect modification by race/ethnicity. We also assessed risk of HDP with differing PTSD lead times. RESULTS: Overall, PTSD was not associated with HDP except among mothers whose PTSD was diagnosed ≥1 year prior to conception (RR 1.42, 95% CI 1.06, 1.90). CONCLUSIONS: Post-traumatic stress disorder preceding conception by at least a year appeared to confer an increased risk of HDP, but further research is needed using more thorough PTSD assessment.

Feasibility of the mobile mindfulness-based stress reduction for breast cancer (mMBSR(BC)) program for symptom improvement among breast cancer survivors.

OBJECTIVE: The purpose of this pilot study was to test the feasibility of delivering the mobile mindfulness-based stress reduction for breast cancer (mMBSR(BC)) program using an iPad and to evaluate its impact on symptom improvement. METHODS: A single group, pre-posttest design was implemented among female stages 0-III breast cancer survivors (BCS) who completed treatment. Data were collected at baseline and week 6 on measures of psychological and physical symptoms and quality of life. The mMBSR(BC) program is a standardized, stress-reducing intervention that combines sitting and walking meditation, body scan, and yoga and is designed to deliver weekly 2-hour sessions for 6 weeks using an iPad. RESULTS: The mean age of the 15 enrolled BCS was 57 years; one participant was non-Hispanic black, and 14 were non-Hispanic white. Of the 13 who completed the study, there were significant improvements from baseline to 6 weeks post-mMBSR(BC) in psychological and physical symptoms of depression, state anxiety, stress, fear of recurrence, sleep quality, fatigue, and quality of life (P's < .05). Effect sizes for improvements of multiple symptoms ranged from medium to large. CONCLUSIONS: These results provide preliminary support that the mMBSR(BC) program may be feasible and acceptable, showing a clinical impact on decreasing psychological and physical symptoms. This mobile-based program offers a delivery of a standardized MBSR(BC) intervention to BCS that is convenient for their own schedule while decreasing symptom burden in the survivorship phase after treatment for breast cancer.

Association of obstructive sleep apnea with microvascular endothelial dysfunction and subclinical coronary artery disease in a community-based population.

Studies have reported an association between obstructive sleep apnea (OSA) and cardiovascular disease (CVD) morbidity and mortality. Proposed mechanisms include endothelial dysfunction and atherosclerosis. We aimed to investigate the associations of OSA with endothelial dysfunction and subclinical atherosclerotic coronary artery disease (CAD), and assess the impact of race on these associations. We used data from the Heart Strategies Concentrating on Risk Evaluation (Heart SCORE) study, a community-based prospective cohort with approximately equal representation of black and white participants. OSA severity was measured in 765 individuals using the apnea-hypopnea index (AHI). Endothelial dysfunction was measured using the Endo-PAT device, expressed as Framingham reactive hyperemia index (F_RHI). Coronary artery calcium (CAC), a marker of subclinical CAD, was quantified by electron beam computed tomography. There were 498 (65%) female participants, 282 (37%) black individuals, and 204 (26%) participants with moderate/severe OSA (AHI ≥15). In univariate models, moderate/severe OSA was associated with lower F_RHI and higher CAC, as well as several traditional CVD risk factors including older age, male sex, hypertension, diabetes, higher body mass index, and lower high-density lipoprotein cholesterol levels. In a multivariable model, individuals with moderate/severe OSA had 10% lower F_RHI and 35% higher CAC, which did not reach statistical significance ( p=0.08 for both comparisons). There was no significant interaction of race on the association of OSA with F_RHI or CAC ( p-value >0.1 for all comparisons). In a community-based cohort comprised of black and white participants, moderate/severe OSA was modestly associated with endothelial dysfunction and subclinical atherosclerotic CAD. These associations did not vary by race.

Association of cumulative social risk with mortality and adverse cardiovascular disease outcomes.

BACKGROUND: Quantifying the cumulative effect of social risk factors on cardiovascular disease (CVD) risk can help to better understand the sources of disparities in health outcomes. METHOD AND RESULTS: Data from the Heart Strategies Concentrating on Risk Evaluation (HeartSCORE) study were used to create an index of cumulative social risk (CSR) and quantify its association with incident CVD and all-cause mortality. CSR was defined by assigning a score of 1 for the presence of each of 4 social factors: i) racial minority status (Black race), ii) single living status, iii) low income, and iv) low educational level. Hazard ratios (HRs) were computed using Cox-regression models, adjusted for CVD risk factors. Over a median follow-up period of 8.3 years, 127 incident events were observed. The incidence of the primary outcome for subgroups of participants with 0, 1, and ≥2 CSR scores was 5.31 (95% CI, 3.40-7.22), 10.32 (7.16-13.49) and 17.80 (12.94-22.67) per 1000 person-years, respectively. Individuals with CSR score of 1 had an adjusted HR of 1.85 (1.15-2.97) for incident primary outcomes, compared to those with score of 0. The corresponding HR for individuals with CSR score of 2 or more was 2.58 (1.60-4.17). CONCLUSION: An accumulation of social risk factors independently increased the likelihood of CVD events and deaths in a cohort of White and Black individuals.

Airflow Limitation and Endothelial Dysfunction. Unrelated and Independent Predictors of Atherosclerosis.

RATIONALE: Lower FEV1 is associated with increased prevalence of atherosclerosis; however, causal mechanisms remain elusive. OBJECTIVES: To determine if systemic endothelial dysfunction mediates the association between reduced FEV1 and increased atherosclerosis. METHODS: Brachial artery endothelial function, pulmonary function, coronary artery calcium, and carotid plaque were assessed in 231 Pittsburgh SCCOR (Specialized Centers for Clinically Oriented Research) study participants; peripheral arterial endothelial function, pulmonary function, and coronary artery calcium were assessed in 328 HeartSCORE (Heart Strategies Concentrating on Risk Evaluation) study participants. MEASUREMENTS AND MAIN RESULTS: Lower FEV1 was independently associated with increased atherosclerosis in both cohorts (per 25% lower % predicted FEV1: odds ratio [OR], 1.76; 95% confidence interval [CI], 1.30-2.40; P < 0.001 for carotid plaque in SCCOR participants) (per 25% lower % predicted FEV1: OR, 1.35; 95% CI, 1.02-1.77; P = 0.03 for coronary artery calcium in HeartSCORE participants). Similarly, reduced endothelial function was independently associated with increased atherosclerosis in both cohorts (per SD lower endothelial function: OR, 1.30; 95% CI, 1.01-1.67; P = 0.04 for carotid plaque in SCCOR participants) (per SD lower endothelial function: OR, 1.38; 95% CI, 1.09-1.76; P = 0.008 and OR, 1.41; 95% CI, 1.07-1.86; P = 0.01 for coronary artery calcium in SCCOR and HeartSCORE participants, respectively). However, there was no association between endothelial dysfunction and FEV1, FEV1/FVC, low-attenuation area/visual emphysema, and diffusing capacity in SCCOR participants, and between endothelial dysfunction and FEV1 or FEV1/FVC in HeartSCORE participants (all P > 0.05). Adjusting the association between FEV1 and atherosclerosis for endothelial dysfunction had no impact. CONCLUSIONS: Endothelial dysfunction does not mediate the association between airflow limitation and atherosclerosis. Instead, airflow limitation and endothelial dysfunction seem to be unrelated and mutually independent predictors of atherosclerosis.

Usability and Acceptability of a Web-Based Program for Chemotherapy-Induced Peripheral Neuropathy.

Chemotherapy-induced neuropathy is a painful and debilitating adverse effect of certain chemotherapy drugs. There have not been any patient-centered, easily accessible Web-based interventions to assist with self-management of chemotherapy-induced neuropathy. The aims of this study were to evaluate usability and acceptability and to estimate an effect size of a Web-based intervention for assessing and managing chemotherapy-induced neuropathy. Participants (N = 14) were instructed to complete the Creativity, Optimism, Planning, and Expert Information for Chemotherapy-Induced Peripheral Neuropathy program and provide verbal responses to the program. Participants completed the Chemotherapy Induced Peripheral Neuropathy Assessment Tool and Post-Study System Usability Questionnaire. Iterative changes were made to the COPE-CIPN. Participants were asked to provide feedback on the revised COPE-CIPN, repeat the Chemotherapy Induced Peripheral Neuropathy Assessment Tool, and evaluate acceptability using the Acceptability e-Scale. The COPE-CIPN demonstrated high usability (mean, 1.98 [SD, 1.12]) and acceptability (mean, 4.40 [SD, 0.52]). Comments indicated that the interface was easy to use, and the information was helpful. While neuropathy symptoms continued to increase in this group of patients receiving neurotoxic chemotherapy, there was a decrease in mean level of interference with activities from 53.71 to 39.29 over 3 to 4 months, which indicated a moderate effect (d = 0.39) size. The COPE-CIPN may be a useful intervention to support self-management of chemotherapy-induced neuropathy.

Evaluation of brief treatment of symptoms of psychological trauma among veterans residing in a homeless shelter by use of Accelerated Resolution Therapy.

BACKGROUND: Posttraumatic stress disorder (PTSD) is prevalent in both homeless and nonhomeless veterans. PURPOSE: To examine unique characteristics of being homeless that may influence PTSD treatment completion and clinical success. METHODS: Twenty-three veterans who were homeless and residing in a homeless shelter, along with 94 veterans from the community, were enrolled to receive one to five sessions of Accelerated Resolution Therapy (ART), an emerging trauma-focused therapy for symptoms of PTSD. Rates of treatment completion with ART and acute and 6-month change in symptoms of PTSD were compared in an observational (nonrandomized) manner by housing status. FINDINGS: Compared to veterans recruited from the community, veterans residing in the homeless shelter were older and presented with more extensive psychopathology yet had less combat exposure while being more likely to have experienced sexual assault. Rates of treatment completion were 52.2% (12 of 23) among homeless veterans compared to 81.9% (77 of 94) among veterans from the community (p = .005). Among treatment completers, both groups received an average of four sessions of ART. Reduction of symptoms of PTSD was substantial and nonsignificantly greater among homeless veterans vs. those treated from the community (p = .14), as were comorbidity reductions in depression, anxiety, sleep quality, pain, and improved quality of life. Results at 6-month posttreatment follow-up were similar. CONCLUSIONS: Although limited by small sample size and a nonrandomized design, ART appears to be an effective, brief treatment for symptoms of PTSD among veterans residing in a homeless shelter. However, development of effective strategies to maximize treatment completion among homeless veterans is needed.

The effects of mindfulness-based stress reduction on objective and subjective sleep parameters in women with breast cancer: a randomized controlled trial.

OBJECTIVE: The purpose of this study was to investigate the effects of mindfulness-based stress reduction for breast cancer survivors (MBSR(BC)) on multiple measures of objective and subjective sleep parameters among breast cancer survivors (BCS). METHODS: Data were collected using a two-armed randomized controlled design among BCS enrolled in either a 6-week MBSR(BC) program or a usual care (UC) group with a 12-week follow-up. The present analysis is a subset of the larger parent trial (ClinicalTrials.gov Identifier: NCT01177124). Seventy-nine BCS participants (mean age 57 years), stages 0-III, were randomly assigned to either the formal (in-class) 6-week MBSR(BC) program or UC. Subjective sleep parameters (SSP) (i.e., sleep diaries and the Pittsburgh Sleep Quality Index (PSQI)) and objective sleep parameters (OSP) (i.e., actigraphy) were measured at baseline, 6 weeks, and 12 weeks after completing the MBSR(BC) or UC program. RESULTS: Results showed indications of a positive effect of MBSR(BC) on OSP at 12 weeks on sleep efficiency (78.2% MBSR(BC) group versus 74.6% UC group, p = 0.04), percent of sleep time (81.0% MBSR(BC) group versus 77.4% UC group, p = 0.02), and less number waking bouts (93.5 in MBSR(BC) group versus 118.6 in the UC group, p < 0.01). Small nonsignificant improvements were found in SSP in the MBSR(BC) group from baseline to 6 weeks (PSQI total score, p = 0.09). No significant relationship was observed between minutes of MBSR(BC) practice and SSP or OSP. CONCLUSIONS: These data suggest that MBSR(BC) may be an efficacious treatment to improve objective and subjective sleep parameters in BCS.

A Cost-Effective Mindfulness Stress Reduction Program: A Randomized Control Trial for Breast Cancer Survivors.

Many breast cancer survivors continue to experience residual symptoms including anxiety, cognitive impairment, depression, fatigue, and pain. In this study, the cost-effectiveness of a Mindfulness-Based Stress Reduction intervention for breast cancer survivors was examined. The cost of the program was assessed from the societal perspective, accounting for both direct medical and patient opportunity costs. The cost per quality-adjusted life year was relatively low compared to the cost-utility findings of other published breast cancer interventions. The program appears to provide for significantly improved health-related quality of life at a comparativelv low cost.

Postoperative therapy with infliximab prevents long-term Crohn's disease recurrence.

BACKGROUND & AIMS: A previous randomized, placebo-controlled study showed that infliximab maintenance therapy prevented recurrence of Crohn's disease 1 year after an ileocolonic resection. We evaluated recurrence of Crohn's disease, on the basis of endoscopic examination and/or the need for additional surgical resection, beyond the first postoperative year. METHODS: In a prospective, open-label, long-term follow-up study, 24 patients previously randomly assigned to receive infliximab for 1 year after an ileocolonic resection were given the option to continue, stop, or start infliximab therapy. The primary end point was the time to recurrence of Crohn's disease, on the basis of endoscopic evidence (endoscopic recurrence), from the initial assignment to postoperative infliximab or placebo. Secondary end points were rate of endoscopic recurrence, time to reoperation, and rate of surgical recurrence in relation to the total time on infliximab. RESULTS: All patients were followed for at least 5 years after surgery. Patients assigned to the infliximab group in the first year after surgery had a longer mean time to first endoscopic recurrence (1231 ± 747 days) than patients originally assigned to the placebo group (460 ± 121 days, P = .003). Colonoscopies identified Crohn's disease recurrence in 22.2% of patients who received long-term infliximab and in 93.9% of those not on infliximab (P < .0001). Compared with no infliximab, the adjusted rate ratio for being in endoscopic remission while on infliximab was 13.47 (95% confidence interval, 3.52-61.53; P = .0001). Patients originally assigned to the infliximab group had a mean longer time to surgery (1798 ± 359 days) than patients originally assigned to the placebo group (1058 ± 529 days, P = .04). The rate of surgical recurrence (required additional surgical resection) was significantly lower among patients who received infliximab for most of the follow-up period than patients who received it for shorter periods (20.0% vs 64.3%, P = .047). CONCLUSIONS: Postoperative infliximab maintenance beyond 1 year prevents recurrence of Crohn's disease.

Mindfulness based stress reduction (MBSR(BC)) in breast cancer: evaluating fear of recurrence (FOR) as a mediator of psychological and physical symptoms in a randomized control trial (RCT).

To investigate the mechanism(s) of action of mindfulness based stress reduction (MBSR(BC)) including reductions in fear of recurrence and other potential mediators. Eighty-two post-treatment breast cancer survivors (stages 0-III) were randomly assigned to a 6-week MBSR(BC) program (n = 40) or to usual care group (UC) (n = 42). Psychological and physical variables were assessed as potential mediators at baseline and at 6 weeks. MBSR(BC) compared to UC experienced favorable changes for five potential mediators: (1) change in fear of recurrence problems mediated the effect of MBSR(BC) on 6-week change in perceived stress (z = 2.12, p = 0.03) and state anxiety (z = 2.03, p = 0.04); and (2) change in physical functioning mediated the effect of MBSR(BC) on 6-week change in perceived stress (z = 2.27, p = 0.02) and trait anxiety (z = 1.98, p = 0.05). MBSR(BC) reduces fear of recurrence and improves physical functioning which reduces perceived stress and anxiety. Findings support the beneficial effects of MBSR(BC) and provide insight into the possible cognitive mechanism of action.

Improvements in heart rate recovery among women after cardiac rehabilitation completion.

BACKGROUND: Heart rate recovery (HRR) after exercise cessation is thought to reflect the rate of reestablishment of parasympathetic tone. Relatively little research has focused on improved HRR in women after completing cardiac rehabilitation (CR) exercise training. OBJECTIVE: We examined the influence of exercise training on HRR in women completing a traditional CR program and in women completing a CR program tailored for women. METHODS: A 2-group randomized clinical trial compared HRR between 99 women completing a traditional 12-week CR program and 137 women completing a tailored CR program. Immediately upon completion of a symptom-limited graded exercise test, HRR was measured at 1 through 6 minutes. RESULTS: Compared with baseline, improvement in 1-minute HRR (HRR1) was similar (P = 0.777) between the tailored (mean [SD], 17.5 [11] to 19.1 [12]) and the traditional CR program (15.7 [9.0] to 16.9 [9.5]). The amount of change in the 2-minute HRR (HRR2) for the tailored (30 [13] to 32.8 [14.6]) and traditional programs (28.3 [12.8] to 31.2 [13.7]) also was not different (P = 0.391). Similar results were observed for HRR at 3 through 6 minutes. Given these comparable improvements of the 2 programs, in the full cohort, the factors independently predictive of post-CR HRR1, in rank order, were baseline HRR1 (part correlation, 0.35; P < 0.001); peak exercise capacity, estimated as metabolic equivalents (METs; 0.24, P < 0.001); anxiety (-0.17, P = 0.001); and age (-0.13, P = 0.016). The factors independently associated with post-CR HRR2 were baseline HRR2 (0.44, P < 0.001), peak METs (0.21, P < 0.001), and insulin use (-0.10, P = 0.041). CONCLUSIONS: One to 6 minutes after exercise cessation, HRR was significantly improved among the women completing both CR programs. The modifiable factors positively associated with HRR1 included peak METs and lower anxiety, whereas HRR2 was associated with insulin administration and peak METs. Additional research on HRR after exercise training in women is warranted.

Is LDL cholesterol associated with long-term mortality among primary prevention adults? A retrospective cohort study from a large healthcare system.

OBJECTIVES: Among primary prevention-type adults not on lipid-lowering therapy, conflicting results exist on the relationship between low-density lipoprotein cholesterol (LDL-C) and long-term mortality. We evaluated this relationship in a real-world evidence population of adults. DESIGN: Retrospective cohort study. SETTING: Electronic medical record data for adults, from 4 January 2000 through 31 December 2022, were extracted from the University of Pittsburgh Medical Center healthcare system. PARTICIPANTS: Adults without diabetes aged 50-89 years not on statin therapy at baseline or within 1 year and classified as primary prevention-type patients. To mitigate potential reverse causation, patients who died within 1 year or had baseline total cholesterol (T-C) ≤120 mg/dL or LDL-C <30 mg/dL were excluded. MAIN EXPOSURE MEASURE: Baseline LDL-C categories of 30-79, 80-99, 100-129, 130-159, 160-189 or ≥190 mg/dL. MAIN OUTCOME MEASURE: All-cause mortality with follow-up starting 365 days after baseline cholesterol measurement. RESULTS: 177 860 patients with a mean (SD) age of 61.1 (8.8) years and mean (SD) LDL-C of 119 (31) mg/dL were evaluated over a mean of 6.1 years of follow-up. A U-shaped relationship was observed between the six LDL-C categories and mortality with crude 10-year mortality rates of 19.8%, 14.7%, 11.7%, 10.7%, 10.1% and 14.0%, respectively. Adjusted mortality HRs as compared with the referent group of LDL-C 80-99 mg/dL were: 30-79 mg/dL (HR 1.23, 95% CI 1.17 to 1.30), 100-129 mg/dL (0.87, 0.83-0.91), 130-159 mg/dL (0.88, 0.84-0.93), 160-189 mg/dL (0.91, 0.84-0.98) and ≥190 mg/dL (1.19, 1.06-1.34), respectively. Unlike LDL-C, both T-C/HDL cholesterol (high-density lipoprotein cholesterol) and triglycerides/HDL cholesterol ratios were independently associated with long-term mortality. CONCLUSIONS: Among primary prevention-type patients aged 50-89 years without diabetes and not on statin therapy, the lowest risk for long-term mortality appears to exist in the wide LDL-C range of 100-189 mg/dL, which is much higher than current recommendations. For counselling these patients, minimal consideration should be given to LDL-C concentration.

Comparison of Accelerated Resolution Therapy for PTSD Between Veterans With and Without Prior PTSD Treatment.

INTRODUCTION: Post-traumatic stress disorder (PTSD) is a psychiatric disorder commonly caused by a traumatic event(s) and prevalent among service members and veterans. Accelerated Resolution Therapy (ART) is an emerging "mind-body" psychotherapy for PTSD that is generally briefer and less expensive than current first-line treatments, such as cognitive processing therapy (CPT) and prolonged exposure (PE) therapy. This study examined the results of ART for treatment of military-related PTSD, with stratification by prior PTSD treatment types, including service members/veterans with reported residual PTSD symptoms following receipt of first-line recommended psychotherapy. MATERIALS AND METHODS: Four groups were constructed and compared based on self-reported prior PTSD treatment history: treatment-naïve (n = 33), pharmacotherapy only (n = 40), first-line psychotherapy (CPT and/or PE) (n = 33), and other psychotherapy (n = 42). Participants were assessed for PTSD symptoms at baseline, post-treatment, and 6-month follow-up using the 17-item Military PTSD Checklist (PCL-M), as well as assessment of depressive, anxiety, and sleep symptoms. The study was approved by the Institutional Review Board at University of South Florida. RESULTS: Among 148 veterans/service members who enrolled and started treatment with ART, 106 (71.6%) completed treatment in a mean of 3.5 treatment sessions, and 55 (51.9%) provided 6-month follow-up data. Mean age was 43.8 years, 95% were male, and 84% were of white race. Within-group standardized effect sizes for pre-to-post changes in PTSD scores (PCL-M) were large at 1.48, 1.11, 1.88, and 1.03 for the treatment-naïve, pharmacotherapy only, first-line psychotherapy, and other psychotherapy groups, respectively. Among treatment completers, the clinically significant treatment response rate (reduction of ≥10 points on the PCL-M) was highest in the treatment-naïve (83%) and first-line psychotherapy (88%) groups. Similar significant symptom reductions were observed for measures of depression and anxiety, and favorable treatment effects were generally sustained at 6-month follow-up. CONCLUSION: In a brief treatment period, ART appears to result in substantial reductions in symptoms of PTSD among veterans, including those with residual PTSD symptoms after prior treatment with first-line psychotherapies endorsed by the U.S. Department of Defense and Veterans Affairs. These results suggest that ART be considered as a potential first-line treatment modality for veterans with PTSD.

Changes in body weight and glycemic control in association with COVID-19 Shutdown among 23,000 adults with type 2 diabetes.

AIMS: To examine the association between COVID-19 Shutdown and within-subjects changes in body weight, body mass index (BMI), and glycemic parameters using electronic health record (EHR) data from 23,000 adults with type 2 diabetes (T2DM). METHODS: Patients with T2DM with outpatient visit data on body weight, BMI, hemoglobin A1c (HbA1c), and blood glucose (≥ 2 measures before and after 3/16/2020) recorded in the EHR at the University of Pittsburgh Medical Center were included. A within-subjects analysis compared average and clinically significant changes in weight, BMI, HbA1c, and blood glucose during the year POST-Shutdown (Time 2-3) compared to the same interval during the PRE-Shutdown year (Time 0-1) using paired samples t-tests and the McNemar-Bowker test. RESULTS: We studied 23,697 adults with T2DM (51% female; 89% White; mean age = 66 ± 13 years; mean BMI = 34 ± 7 kg/m2; mean HbA1c = 7 ± 2% [53 ± 21.9 mmol/mol]). Weight and BMI decreased during both the PRE- and POST-Shutdown intervals, but the changes were statistically smaller during the year POST-Shutdown relative to PRE (0.32 kg and 0.11 units, p < 0.0001). HbA1c showed statistically greater improvements during the POST-Shutdown interval compared to PRE (- 0.18% [-2 mmol/mol], p < 0.0001), but changes in glucose did not differ for the two intervals. CONCLUSIONS: Despite widespread discussion of weight gain in association with the COVID-19 Shutdown, study data showed no evidence of adverse effects of Shutdown on body weight, BMI, HbA1C, or blood glucose in a large sample of adults with T2DM. This information may help to inform future public health decision-making.