Improving family-centered outcomes is a priority in oncologic critical care. As part of the Intensive Care Unit (ICU) Patient-Centered Outcomes Research Collaborative, we implemented patient- and family-centered initiatives in a comprehensive cancer center.

A multidisciplinary team was created to implement the initiatives. We instituted an open visitation policy (OVP) that revamped the use of the two-way communication boards and enhanced the waiting room experience by hosting ICU family-centered events. To assess the initiatives’ effects, we carried out pre-intervention (PRE) and post-intervention (POST) family/caregiver and ICU practitioner surveys.

A total of 159 (PRE = 79, POST = 80) family members and 147 (PRE = 95, POST = 52) ICU practitioners participated. Regarding the decision-making process, family members felt more included (40.5% vs. 68.8%, p < 0.001) and more supported (29.1% vs. 48.8%, p = 0.011) after the implementation of the initiatives. The caregivers also felt more control over the decision-making process in the POST survey (34.2% vs. 56.3%, p = 0.005). Although 33% of the ICU staff considered OVP was beneficial for the ICU, 41% disagreed and 26% were neutral. Only half of them responded that OVP was beneficial for patients and 63% agreed that OVP was beneficial for families. Half of the practitioners agreed that OVP resulted in additional work for staff.

Our project effectively promoted patient- and family-centered care. The families expressed satisfaction with the communication of information and the decision-making process. However, the ICU staff felt that the initiatives increased their work load. Further research is needed to understand whether making this project universal or introducing additional novel practices would significantly benefit patients admitted to the ICU and their family.

To describe the cumulative seroprevalence of severe acute respiratory coronavirus virus 2 (SARS-CoV-2) antibodies during the coronavirus disease 2019 (COVID-19) pandemic among employees of a large pediatric healthcare system.

Prospective observational cohort study open to adult employees at the Children’s Hospital of Philadelphia, conducted April 20–December 17, 2020.

Employees were recruited starting with high-risk exposure groups, utilizing e-mails, flyers, and announcements at virtual town hall meetings. At baseline, 1 month, 2 months, and 6 months, participants reported occupational and community exposures and gave a blood sample for SARS-CoV-2 antibody measurement by enzyme-linked immunosorbent assays (ELISAs). A post hoc Cox proportional hazards regression model was performed to identify factors associated with increased risk for seropositivity.

In total, 1,740 employees were enrolled. At 6 months, the cumulative seroprevalence was 5.3%, which was below estimated community point seroprevalence. Seroprevalence was 5.8% among employees who provided direct care and was 3.4% among employees who did not perform direct patient care. Most participants who were seropositive at baseline remained positive at follow-up assessments. In a post hoc analysis, direct patient care (hazard ratio [HR], 1.95; 95% confidence interval [CI], 1.03–3.68), Black race (HR, 2.70; 95% CI, 1.24–5.87), and exposure to a confirmed case in a nonhealthcare setting (HR, 4.32; 95% CI, 2.71–6.88) were associated with statistically significant increased risk for seropositivity.

Employee SARS-CoV-2 seroprevalence rates remained below the point-prevalence rates of the surrounding community. Provision of direct patient care, Black race, and exposure to a confirmed case in a nonhealthcare setting conferred increased risk. These data can inform occupational protection measures to maximize protection of employees within the workplace during future COVID-19 waves or other epidemics.

Vortioxetine has demonstrated sustained efficacy and favorable safety profile in multiple clinical trials.

This study aims to describe the effectiveness and safety of vortioxetine in real-world clinical practice.

RELIEVE is a prospective, multi-national, observational cohort study of outpatients initiating vortioxetine treatment for MDD at physician’s discretion and followed for 6 months. Data were collected at routine clinical visits. The primary outcome was functioning measured by Sheehan Disability Scale (SDS). Depressive symptoms measured by Patient Health Questionnaire 9-item (PHQ-9), cognitive symptoms measured by PDQ-5 and DSST were key secondary outcomes. Safety outcomes including adverse events were reported. This interim analysis presents results of 527 patients who completed the study and were followed for 6 months. Mixed models of repeated measures were used to assess improvements between baseline and month 6, adjusted for relevant confounders.

A total of 527 patients (mean age, 50.2 years, 65% female) were enrolled from US, Canada, France and Italy, and included in the analysis. Mean SDS total score, PHQ-9, PDQ-5 scores decreased by 8.6, 7.4 and 4.7 respectively from baseline to last visit. Mean DSST score improved by 6.5 from baseline to last visit. Patients’ overall functioning and quality of life significantly improved, sick leave days and underproductive days (both absenteeism and presenteeism) decreased over the entire follow up period. The overall incidence of adverse events(AE) was 25%, with the most common AEs being nausea and headache.

The results confirm the effectiveness and good tolerability of vortioxetine in a broad range of patients in routine clinical practice.

Dr. Mattingly has served as researcher, consultant or speaker for Akili, Alcobra, Alkermes, Allergan, Axsome, Boehringer, Forum, Genentech, Jansen, Lundbeck, Medgenics, Merck, Neos, NLS Pharma, Otsuka, Reckitt Benckiser, Roche, Sage, Shire, Sunovion, Supe

Improved survival has led to a growing population of adults with congenital heart disease (CHD), followed by numerous reports of late complications. Liver disease is a known complication in some patients, with most studies focusing on Fontan associated liver disease. Whether liver disease also exists in other patients with CHD is not fully investigated. Elevated central venous pressure is considered pivotal in the development of liver disease in Fontan associated liver disease, and other patients with alterations in central venous pressure may also be at risk for developing liver fibrosis. We wanted to see if liver fibrosis is present in patients with tetralogy of Fallot. Many patients with tetralogy of Fallot have severe pulmonary regurgitation, which can lead to elevated central venous pressure. Patients with tetralogy of Fallot may be at risk of developing liver fibrosis.

Ten patients (24–56 years) with tetralogy of Fallot and pulmonary regurgitation were investigated for liver fibrosis. All patients were examined with magnetic resonance elastography of liver, hepatobiliary iminodiacetic acid scan, indocyanine green elimination by pulse spectrophotometry, elastography via FibroScan, abdominal ultrasound including liver elastography, and blood samples including liver markers.

Three out of ten patients had findings indicating possible liver fibrosis. Two of these had a liver biopsy performed, which revealed fibrosis stage 1 and 2, respectively. The same three patients had an estimated elevated central venous pressure in previous echocardiograms.

Mild liver fibrosis was present in selected patients with tetralogy of Fallot and may be related to elevated central venous pressure.

In March 2020, academic medical center (AMC) pharmacies were compelled to implement practice changes in response to the COVID-19 pandemic. These changes were described by survey data collected by the Clinical and Translational Science Awards (CTSA) program which were interpreted by a multi-institutional team of AMC pharmacists and physician investigators.

The CTSA program surveyed 60 AMC pharmacy departments. The survey included event timing, impact on pharmacy services, and corrective actions taken.

Almost all departments (98.4%) reported at least one disruption. Shortages of personal protective equipment (PPE) were common (91.5%) as were drug shortages (66.0%). To manage drug shortages, drug prioritization protocols were utilized, new drug supply vendors were identified (79.3%), and onsite compounding was initiated. PPE shortages were managed by incorporating the risk mitigation strategies recommended by FDA and others. Research pharmacists supported new clinical research initiatives at most institutions (84.0%), introduced use of virtual site visits, and shipped investigational drugs directly to patients. Some pharmacies formulated novel investigational products for clinical trial use. Those AMC pharmacies within networked health systems assisted partner rural and inner-city hospitals by sourcing commercial and investigational drugs to alleviate local disease outbreaks and shortages in underserved populations. Pharmacy-based vaccination practice was expanded to include a wider range of pediatric and adult vaccines.

The COVID-19 pandemic radically altered hospital pharmacy practice. By adopting innovative methods and adapting to regulatory imperatives, pharmacies at CTSA sites played an extremely important role supporting continuity of care and collaborating on critical clinical research initiatives.

High-quality diets, characterised by nutrient-rich foods, are one of the foundations for health and well-being. Indicators of diet quality, antioxidants, are associated with protection against cardiometabolic diseases. The current study explores relationships between plasma antioxidants and cardiometabolic risk among Aboriginal people in Australia.

As part of a community-driven health promotion programme, we conducted a cross-sectional study including a health-behaviour questionnaire, plasma antioxidants and cardiometabolic risk markers (anthropometric, blood pressure measurements, fasting glucose, glycated Hb (HbA1c), lipids, C-reactive protein and albumin-creatinine-ratio) continuous and categorised into population-specific cut-offs. Antioxidants (β-carotene, β-cryptoxanthin, lycopene, lutein-zeaxanthin, retinol and α-tocopherol measured using HPLC) were applied to a principal component analysis, which aggregated these into a single component. Linear regression models were applied to investigate associations between the antioxidant component and cardiometabolic risk markers.

Community in a remote area in Northern Territory, Australia.

A total of 324 Aboriginal people, mean age 35·5 (range 15–75) years.

Antioxidant component levels were higher among individuals with higher self-reported vegetable intake (P < 0·01), higher among individuals with higher self-reported fruit intake (P = 0·05) and lower among current smokers (P = 0·06). Linear regression revealed an inverse association between the antioxidant component and C-reactive protein (β = –0·01, P < 0·01) after adjusting for confounders.

Higher plasma antioxidant levels, indicators of diet quality, were associated with lower levels of high-sensitivity C-reactive protein in this Aboriginal population in remote Australia. This association suggests plasma antioxidants may be protective against inflammation; however, longitudinal studies are needed to examine this potentially protective relationship.

Leukocyte telomere length (LTL) is a widely hypothesized biomarker of biological aging. Persons with shorter LTL may have a greater likelihood of developing dementia. We investigate whether LTL is associated with cognitive function, differently for individuals without cognitive impairment versus individuals with dementia or incipient dementia.

Enrolled subjects belong to the Long Life Family Study (LLFS), a multi-generational cohort study, where enrollment was predicated upon exceptional family longevity. Included subjects had valid cognitive and telomere data at baseline. Exclusion criteria were age ≤ 60 years, outlying LTL, and missing sociodemographic/clinical information. Analyses were performed using linear regression with generalized estimating equations, adjusting for sex, age, education, country, generation, and lymphocyte percentage.

Older age and male gender were associated with shorter LTL, and LTL was significantly longer in family members than spouse controls (p < 0.005). LTL was not associated with working or episodic memory, semantic processing, and information processing speed for 1613 cognitively unimpaired individuals as well as 597 individuals with dementia or incipient dementia (p < 0.005), who scored significantly lower on all cognitive domains (p < 0.005).

Within this unique LLFS cohort, a group of families assembled on the basis of exceptional survival, LTL is unrelated to cognitive ability for individuals with and without cognitive impairment. LTL does not change in the context of degenerative disease for these individuals who are biologically younger than the general population.

Only a few randomized clinical trials have tested the effect on transition rates of intervention programs for patients with sub-threshold psychosis-like symptoms.

To examine whether integrated treatment reduced transition to psychosis for first-contact patients diagnosed with schizotypal disorder.

Seventy-nine patients were randomized to integrated treatment or standard treatment. Survival analysis with multivariate Cox-regression was used to identify factors determinant for transition to psychotic disorder.

In the multivariate model, male gender increased risk for transition to psychotic disorder (relative risk = 4.47, (confidence interval 1.30-15.33)), while integrated treatment reduced the risk (relative risk = 0.36 (confidence interval 0.16-0.85)). At two-year follow-up, the proportion diagnosed with a psychotic disorder was 25.0 percent for patients randomized to integrated treatment compared to 48.3 percent for patients randomized to standard treatment.

Integrated treatment postponed or inhibited onset of psychosis in significantly more cases than standard treatment.

Only a few randomized clinical trials have tested the effect on transition rates of intervention programs for patients with sub-threshold psychosis-like symptoms.

To examine whether integrated treatment reduced transition to psychosis for first-contact patients diagnosed with schizotypal disorder.

Seventy-nine patients were randomized to integrated treatment or standard treatment. Survival analysis with multivariate Cox-regression was used to identify factors determinant for transition to psychotic disorder.

In the multivariate model, male gender increased risk for transition to psychotic disorder (relative risk = 4.47, (confidence interval 1.30-15.33)), while integrated treatment reduced the risk (relative risk = 0.36 (confidence interval 0.16-0.85)). At two-year follow-up, the proportion diagnosed with a psychotic disorder was 25.0 percent for patients randomized to integrated treatment compared to 48.3 percent for patients randomized to standard treatment.

Integrated treatment postponed or inhibited onset of psychosis in significantly more cases than standard treatment.

To evaluate the effects of integrated treatment for first-episode psychotic patients.

In a randomised clinical trial of 547 first-episode patients with schizophrenia spectrum disorders, effects of integrated treatment and standard treatment was compared. The integrated treatment lasted for two years and consisted of assertive community treatment with programmes for family-involvement and social skills training. Standard treatment offered contact with a community mental health centre. Patients were assessed at entry and after one, two and five years by investigators that were not involved in treatment.

At the one-year and two-year follow-up psychotic and negative symptoms changed in favour of integrated treatment. Patients in integrated treatment had significantly less co-morbid substance abuse, better adherence to treatment, and more satisfaction with treatment. Use of bed days was 22 percent less in integrated treatment than in standard treatment. Results of five-year follow-up will be presented.

Integrated treatment improved clinical outcome and adherence to treatment. The improvement in clinical outcome was consistent in the one-year and two-year follow-ups.

South Africa (SA) is a developing country with an ageing population. Adequate nutrition and physical activity (PA) protect against the loss of muscle mass and physical function, both of which are important components of sarcopenia. This study aimed to measure the prevalence of sarcopenia in older black SA women and investigate its associations with PA and protein intake.

Older black SA women (age, 68 (range; 60–85 years) n = 122) completed sociodemographic questionnaires, 24 h urine collection (estimate protein intake), venous blood (hs-C-reactive protein (hs-CRP) and ferritin), functional tests (grip strength, 3 m timed-up-and-go (TUG), 10 m walk test) and PA monitoring (activPAL). Dual-energy x-ray absorptiometry whole-body scans assessed fat and fat-free soft tissue mass (FFSTM).

According to the European Working group on Sarcopenia in Older People (EWGSOP)2, 2.5% (n = 3) had confirmed sarcopenia of a low severity based on normal physical function. Of the total cohort, 9% (n = 11) had low grip strength, 22.1% (n = 27) had a low appendicular skeletal muscle index (ASMI), and no women had low TUG (s) or gait speed (m/s). Higher ASMI was associated with lower hs-CRP (p = 0.05; Rho = -0.209) and higher ferritin (Rho = 0.252; p = 0.019), grip strength (kg, Rho = 0.223; p = 0.015), and gait speed (m/s, Rho = 0.180; p = 0.050). Protein intake suggested intake of 41.8g/day/ or 0.51 g/kg of body mass/day. Higher total protein intake (g/24h), was associated with higher FFSTM (kg) and ASMI (p < 0.001). PA outcomes were not correlated with FFSTM or ASMI (p > 0.05), however, there was a strong positive correlation of TUG (s) and gait speed (m/s) with time spent: 1) stepping per day (min) and; 2) at a high cadence (> 100 steps/min) (all p < 0.01). Daily step count was 7137 ± 3233 (mean ± Standard deviation), with 97.9 ± 38.7 min of total time spent stepping and 12.6 ± 16.8 min spent stepping at a high cadence (> 100 steps/min). Of note, 13.9% (n = 17) of women were completing > 10,000 steps/day.

Based on the EWGSOP2 criteria, there is a low prevalence of sarcopenia in older black SA women, explained by the maintenance of strength and physical function that directly related to PA, especially that performed at higher intensities. In contrast, low muscle mass was relatively prevalent (22.1%) and was associated with low dietary protein and not PA. Notably, it may be important to review the cut-points of EWGSOP2 criteria to be specific to the older SA women from disadvantaged communities.

Osteoporosis was not a public health concern in black South African (SA) women, until recently when it was reported that the prevalence of vertebral fractures was 9.1% in black compared to 5.0% in white SA women. Accordingly, this study aimed to measure bone mineral density (BMD) of older black SA women and to investigate its association with risk factors for osteoporosis, including strength, muscle and fat mass, dietary intake and objectively measured physical activity (PA).

Older black SA women (age, 68 (range; 60–85 years) n = 122) completed sociodemographic and quantitative food frequency questionnaires (QFFQ), fasting venous blood samples (25-hydroxycholecalciferol: Vitamin D-25), 24 h urine collection (estimate protein intake), grip strength and PA monitoring (activPAL). Dual-energy x-ray absorptiometry (DXA) scans of the hip (femoral neck and total) and lumbar spine determined BMD and whole-body scans for fat and fat-free soft tissue mass (FFSTM). WHO classifications were used to determine osteopenia (t-score -2.5 to -1), and osteoporosis (t-score < -2.5).

At the lumbar spine 34.4% of the women (n = 42) had osteopenia and 19.7% (n = 24) had osteoporosis. Osteopenia at the left femoral neck was 32% (n = 40) and osteoporosis was 13.1% (n = 16) of participants. The total left hip BMD indicated osteopenia in 27.9% (n = 34) and osteoporosis in 13.1% (n = 16) of participants. Multinomial regression revealed no differences in age (y) or frequency of falls in the past year between all groups (p = 0.727). Compared to those with normal BMD, participants with osteoporosis at the hip neck and lumbar spine were shorter, weighed less and had a lower body mass index (BMI) (all p < 0.05). When adjusted for height, the osteoporotic group (hip neck and lumbar spine) had lower trunk fat (% whole body), FFSTM (kg) and grip strength (kg), compared to those with normal BMD (p < 0.05). Only protein intake (g; 24 h urine analyses) was lower in women with osteoporosis (all sites) compared to those with normal BMD. Fat, carbohydrate and micronutrient intakes (relative to total daily energy intake), and vitamin D concentrations were not associated with BMD (all sites). Number of daily step count and stepping time (min) were inversely associated with BMI (p < 0.05), but not with BMD (all sites; p > 0.05).

A high prevalence of osteopenia and osteoporosis was evident at the lumbar spine and hip in older black SA women. This study highlights the importance of strength, body composition, and protein intake in maintaining BMD and preventing the development of osteoporosis in older women.