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.

Corrigendum Supports Therapeutic Contribution of Acupoint Tapping to EFTs' Observed Effects: Response to Spielmans (2021).

ABSTRACT: We published a meta-analysis of studies that examined the various components of an evidence-based therapy called emotional freedom techniques (EFTs). EFT uses elements of conventional therapies such as exposure and cognitive processing but includes the unique ingredient of acupoint stimulation using fingertip tapping. Six studies were identified, and three of these met the quality control criteria of the American Psychological Association's Division 12 Task Force for Empirically Validated Therapies. Meta-analysis found that the acupoint component of EFT was not an inert ingredient or inactive placebo but made an active contribution to the therapeutic effects noted in a research literature that now numbers over 100 clinical trials of EFT. Subsequent to publication, errors in the original analysis were identified, primarily incorrect standard deviations. A new analysis was performed by an independent statistician and found slightly greater effects than the original investigation. The results were published as a corrigendum, which was subsequently challenged by Spielmans. Here we examine the critiques of the corrigendum and original article. We find that although they may be of academic interest, they are irrelevant to the central research question of whether the acupoint component of EFT is inert or active. We reaffirm that the evidence clearly validates the contribution made by acupoint tapping to EFT's observed clinical effects.

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.

Early Apixaban Use Following Stroke in Patients With Atrial Fibrillation: Results of the AREST Trial.

BACKGROUND AND PURPOSE: It is unknown when to start anticoagulation after acute ischemic stroke (AIS) from atrial fibrillation (AF). Early anticoagulation may prevent recurrent infarctions but may provoke hemorrhagic transformation as AF strokes are typically larger and hemorrhagic transformation-prone. Later anticoagulation may prevent hemorrhagic transformation but increases risk of secondary stroke in this time frame. Our aim was to compare early anticoagulation with apixaban in AF patients with stroke or transient ischemic attack (TIA) versus warfarin administration at later intervals. METHODS: AREST (Apixaban for Early Prevention of Recurrent Embolic Stroke and Hemorrhagic Transformation) was an open-label, randomized controlled trial comparing the safety of early use of apixaban at day 0 to 3 for TIA, day 3 to 5 for small-sized AIS (<1.5 cm), and day 7 to 9 for medium-sized AIS (≥1.5 cm, excluding full cortical territory), to warfarin, in a 1:1 ratio at 1 week post-TIA, or 2 weeks post-AIS. RESULTS: Although AREST ended prematurely after a national guideline focused update recommended direct oral anticoagulants over warfarin for AF, it revealed that apixaban had statistically similar yet generally numerically lower rates of recurrent strokes/TIA (14.6% versus 19.2%, P=0.78), death (4.9% versus 8.5%, P=0.68), fatal strokes (2.4% versus 8.5%, P=0.37), symptomatic hemorrhages (0% versus 2.1%), and the primary composite outcome of fatal stroke, recurrent ischemic stroke, or TIA (17.1% versus 25.5%, P=0.44). One symptomatic intracerebral hemorrhage occurred on warfarin, none on apixaban. Five asymptomatic hemorrhagic transformation occurred in each arm. CONCLUSIONS: Early initiation of anticoagulation after TIA, small-, or medium-sized AIS from AF does not appear to compromise patient safety. Potential efficacy of early initiation of anticoagulation remains to be determined from larger pivotal trials. Registration: URL: https://www.clinicaltrials.gov/; Unique identifier: NCT02283294.

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.

Adverse Childhood Experiences (ACEs) and Headaches Among Children: A Cross-Sectional Analysis.

OBJECTIVES: This cross-sectional study examined the association between adverse childhood experiences (ACEs) and history of frequent headaches (including migraine) among children 3-17 years old using data from the 2016 and 2017 U.S. National Survey of Children's Health (NSCH). BACKGROUND: ACEs include abuse (physical, emotional, or sexual), parental divorce, death, mental illness, or addiction, and are linked to higher morbidity and mortality in adulthood. A relationship between ACEs and headaches exists among adults, but studies examining the relationship among children are lacking. To our knowledge, no studies have examined the link among children using NSCH data. METHODS: The NSCH is a nationally representative survey of U.S. children's physical and emotional well-being aimed at understanding their health needs. Parental-reported information was collected on child history of headaches and 9 ACEs for the selected child. The survey collected information on 71,881 children in 2016 and 2017 out of which 61,565 were eligible for the study (age ≥3 years and not missing data on history headaches). Children with missing values for headache, ACEs, or covariates (n = 58,958) were excluded from the final analysis. We used multivariable logistic regression with survey weighting and adjusted for demographics and comorbidities (anxiety, depression, epilepsy, and brain injury) to examine the association between ACEs and headaches overall and stratified by gender. We further assessed the independent relationship between each ACE and headaches. RESULTS: In the current study, out of 61,656 children, 26,884 (48.6%) experienced at least 1 ACE and 3426 (6.5%) experienced 4+ ACEs. Overall, compared with children with no ACEs, the adjusted odds of headache were 1.34 times higher among children with 1 reported ACE (95% CI: 1.07, 1.68), 2.15 times higher among children with 2 ACEs (95% CI: 1.66, 2.80), 1.89 times higher among children with 3 ACEs (95% CI: 1.40, 2.53), and 3.40 times higher among children with 4+ ACEs (95% CI: 2.61, 4.43). Females with 3 and 4+ ACEs were somewhat more likely to report headaches compared to males with the same number of ACEs. Individually, no ACE was independently associated with history of headaches except for difficulty due to family's income (aOR = 2.46, 95% CI: 1.98, 3.06). CONCLUSION: Experiencing one or more ACEs vs none was associated with higher risk of headaches in children, and difficulty due to family's income was the only ACE independently associated with headaches. Our findings support results of other studies on ACEs and headache in young adults and suggest that adverse ACE-related health outcomes begin earlier than previously recognized. Additionally, struggling due to low income may represent a constellation of chronic stressors that independently contribute to poor health outcomes in childhood as compared to other individual ACEs. Future research should examine the importance of specific ACE clusters and stressors during childhood.

Corrigendum to: Is Tapping on Acupuncture Points an Active Ingredient in Emotional Freedom Techniques: A Systematic Review and Meta-Analysis of Comparative Studies.

We published a meta-analysis of component trials of emotional freedom techniques (EFT) in this journal. EFT is an evidence-based method, validated in over 100 clinical trials, that uses fingertip tapping on acupressure points in conjunction with techniques from exposure and cognitive therapy. The meta-analysis examined six studies in which an active control, such as diaphragmatic breathing or sham acupoints, was used in place of tapping on actual acupoints. The purpose of the meta-analysis was to determine whether tapping was an inert or an active ingredient in EFTs observed treatment effects. Subsequent to publication, errors in the statistical analysis were identified, primarily incorrect standard deviation values, and our methodological approach was questioned by others. We therefore had the meta-analysis rerun by an independent senior statistician who compared pre- to follow-up results to determine the sustained effects of treatment. The cumulative fixed effects Hedge's g-value was found to be 0.73 (95% confidence interval = 0.42-1.04, p < 0.0001). The corresponding random effects Hedge's g-value is 0.74 (95% confidence interval = 0.34-1.13, p < 0.0001). We also reviewed and clarified our methodology. In conclusion, despite computational errors in our original publication, the present revised analysis supports the original conclusion that the acupressure component of the EFT protocol is an active ingredient that contributes to the method's favorable health effects.

Feasibility and acceptability of a self-managed exercise to rhythmic music intervention for ICU survivors.

BACKGROUND: Post-ICU rehabilitation is a challenging clinical issue for patients discharged from an Intensive Care Unit ("ICU survivors"). Our exercise to rhythmic music intervention was designed to allow ICU survivors to self-manage their exercise by following a personalized, recorded exercise playlist. AIM: Our study reports the feasibility and acceptability of an innovative music intervention among ICU survivors enrolled in a randomized controlled pilot study. METHODS: ICU survivors, admitted in ICU for at least 5 days and cognitively intact, were randomly assigned to an exercise to rhythmic music group (n = 10) or an active control group (n = 10). Participants in the music group were taught to self-manage exercise by listening to a recorded playlist of instructions and music-facilitated movements tailored to their musical preference and exercise ability. Participants in the control group were provided a brochure with exercise instructions. After 5 days or at hospital discharge, participants completed an 8-item acceptability questionnaire and were interviewed. Content analysis was conducted. RESULTS: 18 Participants were included for final analysis. Participants were 61.8 ± 14.7 years old, predominantly male (66.7%), and Caucasian (55.6%). Results demonstrated feasibility, as the study team was able to meet the enrollment goal of 5-6 participants per month. Three themes related to general, physical, and psychosocial benefits were identified. Based on positive feedback, the exercise to rhythmic music intervention was deemed acceptable. CONCLUSION: The exercise to rhythmic music intervention was feasible and acceptable, suggesting that clinical trials with larger sample sizes should investigate the effects of the intervention on outcomes among ICU survivors.

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.

Optimal frequency of tooth brushing in mechanically ventilated adults: Study protocol for a randomized controlled trial.

The optimal frequency of tooth brushing in the critically ill has not been experimentally determined. For mechanically ventilated patients, optimal frequency of tooth brushing is an important unresolved issue as there is little evidence to judge the benefits or associated risks of tooth brushing. Given this knowledge gap, the project's overall goal is to determine the optimal frequency of tooth brushing (once, twice, or three times daily) for mechanically ventilated adults. A prospective, randomized, experimental design is used. Specifically, 345 subjects, with 207 expected to complete the study, are randomly assigned within 36 hr of intubation to one of three groups (once, twice, or three times tooth brushing daily). Tooth brushing with a soft compact-head toothbrush takes approximately 2 min. Dental plaque assessment, gingival crevicular fluid (GCF) determination for IL-1ß, and data regarding healthcare-acquired infection (HAI) and clinical status are collected at baseline and daily in-hospital. The clinical impact of daily frequency of tooth brushing in relation to extent of dental plaque and inflammation reflected by GCF analysis will be compared by the three treatment arms. In addition, evaluation of safety for HAIs will be compared based on calculation of the number needed to harm. The trial will empirically determine the optimal frequency of tooth brushing in mechanically ventilated adults, balancing benefits and risks. This contribution is significant because it will have immediate impact on bedside nursing practice, and is a final component necessary for specific evidence-based guidelines for the common nursing intervention of oral care in mechanically ventilated adults.

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.