Despite the central role that patient and community engagement plays in translational science and health equity research, there remain significant institutional barriers for researchers and their community partners to engage in this work meaningfully and sustainably. The goal of this paper is to describe the process and outcomes of Engage for Equity PLUS at Stanford School of Medicine, which was aimed at understanding and addressing institutional barriers and facilitators for community-engaged research (CEnR).

A Stanford champion team of four faculty and two community partners worked with the University of New Mexico team to conduct two workshops (n = 26), focus groups (n = 2), interviews with leaders (n = 4), and an Institutional Multi-Stakeholder Survey (n = 35). These data were employed for action planning to identify strategies to build institutional support for CEnR.

Findings revealed several key institutional barriers to CEnR, such as the need to modify organizational policies and practices to expedite and simplify CEnR administration, silos in collaboration, and the need for capacity building. Facilitators included several offices devoted to and engaging in innovative CEnR efforts. Based on these findings, action planning resulted in three priorities: 1) Addressing IRB barriers, 2) Addressing barriers in post-award policies and procedures, and 3) Increasing training in CEnR within Stanford and for community partners.

Addressing institutional barriers is critical for Academic Medical Centers and their partners to meaningfully and sustainably engage in CEnR. The Engage for Equity PLUS process offers a roadmap for Academic Medical Centers with translational science and health equity goals.

Esketamine nasal spray (ESK) is approved in combination with an oral antidepressant (OAD) for the treatment of adults with treatment-resistant depression (TRD); however, direct comparisons with atypical antipsychotics for TRD are limited. This secondary analysis of the ESCAPE-TRD study compared rates of remission and response, and improvements in depressive symptoms over time, between ESK and quetiapine extended-release (XR) in patients with TRD treated in accordance with US prescribing information (USPI).

ESCAPE-TRD (NCT04338321) was a randomized, open-label, rater-blinded phase 3b trial investigating ESK versus quetiapine XR for acute and maintenance treatment of patients with TRD. This secondary analysis included patients aged 18–64 years who were treated/dosed according to USPI. The primary endpoint was remission, defined as Montgomery–Åsberg Depression Rating Scale (MADRS) total score ≤ 10. Treatment-emergent adverse events (TEAEs) leading to discontinuation were summarized descriptively.

Among 636 patients in this secondary analysis (ESK, n = 316; quetiapine XR, n = 320), significantly more ESK-treated patients achieved remission starting at week 8 (28.3% versus 18.6%; P = 0.005) through week 32 (55.7% versus 36.3%; P < 0.001), compared with quetiapine XR–treated patients. There were clinically and statistically significant improvements in MADRS scores with ESK versus quetiapine XR at each visit from day 8 onwards. Fewer patients discontinued treatment because of TEAEs with ESK (4.5%) versus quetiapine XR (10.1%).

Consistent with the primary analysis, this secondary analysis demonstrated that ESK improves short- and long-term outcomes compared with quetiapine XR in patients with TRD treated according to USPI.

The efficacy and safety of aripiprazole once-monthly 400 mg (AOM 400) as maintenance monotherapy treatment for bipolar I disorder (BP-I) were demonstrated in a double-blind, placebo-controlled, 52-week randomized withdrawal trial (NCT01567527). This post hoc analysis of data from NCT01567527 evaluated the efficacy of AOM 400 in the earlier BP-I population.

Patients within the first quartile of the dataset according to age (18–32 years: AOM 400, n=36; placebo, n=34) or disease duration (≤4.6 years: AOM 400, n=33; placebo, n=34) were considered to be in the earlier stages of BP-I, and were included. The primary outcome was time from randomization to recurrence of any mood episode, defined as meeting any one of several predetermined criteria, including Young Mania Rating Scale (YMRS) total score ≥15 or clinical worsening.

Time to recurrence of any mood episode was significantly delayed with AOM 400 versus placebo in patients aged 18–32 years (hazard ratio [HR]: 2.462 [95% confidence interval (CI): 1.092, 5.547]; p<0.05) and in patients with a disease duration ≤4.6 years (HR: 3.207 [95% CI: 1.346, 7.645]; p<0.01). Further analysis suggested that the benefit of AOM 400 versus placebo was driven by a significantly lower proportion of patients experiencing a YMRS total score ≥15 (18–32 years: 5.60% versus 44.10%, p<0.001; disease duration ≤4.6 years: 6.10% versus 41.20%, p<0.01) or clinical worsening (18–32 years: 8.30% versus 38.20%, p<0.01; disease duration ≤4.6 years: 6.10% versus 38.20%, p<0.01).

The efficacy of AOM 400 was demonstrated in the earlier BP-I population.

Study registration number: NCT01567527 (ClinicalTrials.gov)

The data in this poster were originally presented at Psych Congress, held on 6–10th September 2023 in Nashville, TN, USA.

Otsuka Pharmaceutical Development & Commercialization Inc. (Princeton, NJ, USA) and Lundbeck LLC (Deerfield, IL, USA).

In response to the COVID-19 pandemic, we rapidly implemented a plasma coordination center, within two months, to support transfusion for two outpatient randomized controlled trials. The center design was based on an investigational drug services model and a Food and Drug Administration-compliant database to manage blood product inventory and trial safety.

A core investigational team adapted a cloud-based platform to randomize patient assignments and track inventory distribution of control plasma and high-titer COVID-19 convalescent plasma of different blood groups from 29 donor collection centers directly to blood banks serving 26 transfusion sites.

We performed 1,351 transfusions in 16 months. The transparency of the digital inventory at each site was critical to facilitate qualification, randomization, and overnight shipments of blood group-compatible plasma for transfusions into trial participants. While inventory challenges were heightened with COVID-19 convalescent plasma, the cloud-based system, and the flexible approach of the plasma coordination center staff across the blood bank network enabled decentralized procurement and distribution of investigational products to maintain inventory thresholds and overcome local supply chain restraints at the sites.

The rapid creation of a plasma coordination center for outpatient transfusions is infrequent in the academic setting. Distributing more than 3,100 plasma units to blood banks charged with managing investigational inventory across the U.S. in a decentralized manner posed operational and regulatory challenges while providing opportunities for the plasma coordination center to contribute to research of global importance. This program can serve as a template in subsequent public health emergencies.

The objective of our study was to determine the prevalence of anaemia among 14–19 years school going girls, risk factors for it and profile of micronutrient status among rural girls from western state of India.

Using a cross-sectional design, we obtained information on socio-demography, menstruation, dietary habits, knowledge and daily consumption of the government recommended iron and folic acid (IFA) tablets, and anthropometry. Blood was collected to assess Hb, red blood cell indices, serumFe, folate and vitamin B12 levels.

Nagpur district, Maharashtra, India.

A total of 221 girls aged 14–19 years studying in twenty-four government institutes included.

57 % girls were anaemic, 84 % had deficiency of one or more micronutrients and 60 % were malnourished based on body mass index (BMI). The prevalence of Fe, vitamin B12 and folate deficiency was 37·7 %, 69·8 % and 1·4 %, respectively. Among anaemic girls, Fe and vitamin B12 deficiency was observed in 45·5 % and 67·5 %, respectively, v. among non-anaemic girls it was 27 % and 73 %, respectively. Fe deficiency was a predictor of anaemia and its severity. Girls residing in non-nuclear family were more likely to have anaemia. The consumption of daily non-vegetarian food and green leafy vegetables was 3 % and 3·6 %, respectively. Only 9 % consumed IFA tablets in the past 2 weeks.

Anaemia is common in adolescent girls, particularly associated with Fe and vitamin B12 deficiency. There is need to reconsider the approach to prevention of anaemia in adolescent girls, particularly before they become pregnant.

Chronic pain patients often contend with insomnia symptoms, creating a reciprocal relationship that adds complexity to their condition. Evaluating interventions targeting insomnia in this population becomes paramount, given the intertwined nature of pain and sleep disturbances.

This retrospective pretest design aimed to assess the efficacy of an Internet-delivered sound healing intervention in reducing insomnia severity and addressing sleep- and pain-related parameters among individuals with chronic pain.

Conducted as a community-based project, Tuning for Health provided support to individuals grappling with long-term illnesses. The intervention involved the virtual delivery of a specially crafted sound track using tuning forks over a 6-week period, supervised by an experienced therapist and administered weekly for an hour. Participants were instructed to play the track daily at a time convenient for them. A total of 68 participants (mean age 59.3 years) completed the intervention. Outcome measures, including the Insomnia Severity Index (ISI), a sleep diary, and assessments for anxiety, depression, and pain-related parameters, were collected at the end of the 6-week intervention and repeated after a 6-month follow-up. Negative effects were monitored and reported.

Significant immediate interaction effects (time by treatment) were observed for the pain severity, ISI and various sleep parameters, such as sleep efficiency, sleep onset latency, early morning awakenings, and wake time after sleep onset. A time effect for anxiety and depression was noted at the 6-month follow-up. The group exhibited highly significant improvements in pain-related parameters. At the 6-month follow-up, sustained enhancements in sleep parameters and mental health were reported, with no reported side effects.

These unique results suggest the potential efficacy of sound healing in alleviating chronic pain and associated insomnia. Further research with a larger sample size is warranted to validate these findings. Combining sound healing with other treatments may offer enhanced outcomes for individuals dealing with both chronic pain and comorbid insomnia. This study lays the groundwork for future investigations into the promising intersection of sound healing, chronic pain management, and sleep improvement.

None Declared

The use of smart technology in supporting older adults is a growing field of research. However, there is little qualitative research on the experiences of patients utilizing this technology, particularly those attending psychiatry services.

To explore the experiences of staff and patients utilizing smart-hubs implemented during the Covid-19 pandemic to provide remote audio/visual communication and smart AI personal assistant technology for the management of patients in a rural Psychiatry of Old Age service.

Smart hubs were installed in patient homes and in the Psychiatry of Old Age base during the Covid-19 pandemic when lockdown restrictions limited in-person service provision. Patients and staff utilized the smart hubs for its assistive technology and to engage with each other. Semi-structured qualitative interviews were conducted of 10 staff and 15 patients at 6-12 months following the introduction of the smart hubs and thematic analysis was conducted to generate themes.

Three themes were generated from the thematic analysis: 1) Openness to SMART hub technology, 2) Getting set-up and 3) Keeping SMART. The majority of participants did not have much experience using smart technology prior to the intervention. However, many participants reported that they would be comfortable using technology. The Covid-19 pandemic contributed to the rapid adoption of this intervention within the service with mixed views regarding the smart hub prior to implementation. The role of key individuals such as staff and family was highlighted in supporting older persons with setting-up the smart hub. Technical needs included the need for a strong internet connection and technical limitations were driven by privacy, cost and regional considerations. Many patients were able to utilize the smart hub independently to access interests, therapeutic activities and as a memory aid. The smart hub offered a novel way to connect to services and families and was also seen as a companion by some patients and staff to help address loneliness and isolation. The majority of participants found the use of smart hubs acceptable and were willing to utilize the smart hub in the future as an adjunct to face to face psychiatric interventions. However, suggestions for future use included the need for additional training as users felt that there was more they could do with the smart hub, continued support to manage any challenges and improved information leaflets to better engage users.

Smart hub technology offers an alternate means of providing remote and inclusive psychiatric care to older patients unable to access services in person and at risk of deterioration without intervention in the community.

None Declared

Generalized anxiety disorder (GAD) is one of the most common mental disorders in adults. Psychotherapies are among the most recommended treatment choices for GAD, but which should be considered as first-line treatment still needs to be clarified.

To examine the most effective and accepted psychotherapy for GAD both in the short and long-term, via a network meta-analysis.

We searched MEDLINE, Embase, PsycINFO, and the Cochrane Register of Controlled Trials – CENTRAL, from database inception to January 1st, 2023, to find randomized controlled trials (RCTs) of psychotherapies for GAD. Eight psychotherapies (behaviour therapy, cognitive-behaviour therapy, cognitive restructuring, psychoeducation, psychodynamic therapy, relaxation therapy, supportive psychotherapy, and third-wave CBTs) were compared with each other and two control conditions (treatment as usual, waiting list). We followed Cochrane standards when extracting data and assessing data quality and used PRISMA guidelines for the reporting. We conducted random-effects model pairwise and network meta-analyses. We assessed risk of bias of individual studies through the second version of the Cochrane’s Risk of Bias tool and used the Confidence in Network Meta-Analysis (CINeMA) to rate certainty of evidence for meta-analytical results. Severity of GAD symptoms and acceptability of the psychotherapies were our outcomes of interest.

We analysed data from 66 RCTs. Effect size estimates on data from 5,597 participants suggest third wave cognitive-behavioural therapies (standardized mean differences [SMDs] =-0.78; 95%CI=-1.19 to -0.37; certainty=moderate), cognitive-behavioural therapy (CBT) (SMD=-0.68; 95%CI=-1.05 to -0.32 certainty=moderate), and relaxation therapy (SMD=-0.54; 95%CI=-1.04 to -0.05; certainty=low) reduced generalized anxiety symptoms more than treatment as usual (TAU). Relative risks for all-cause discontinuation signalled no differences compared with TAU for all psychotherapies. When excluding studies at high risk of bias, relaxation therapy lost its superiority over TAU. When considering anxiety severity at three to twelve months after completion of the intervention only CBT remained significantly more efficacious than TAU (SMD=-0.58; 95%CI=-0.93 to -0.23).

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Given the evidence for both acute and long-term efficacy, CBT may represent the reasonable first-line psychological treatment for GAD. Third-wave CBT and relaxation therapy have short-term efficacy and may also be offered. Results from this investigation should inform patients, clinicians, and guidelines. This project is funded by the European Union’s HORIZON EUROPE research programme under grant agreement No 101061648.

None Declared

The Stricker Learning Span (SLS) is a computer-adaptive word list memory test specifically designed for remote assessment and self-administration on a web-based multi-device platform (Mayo Test Drive). Given recent evidence suggesting the prominence of learning impairment in preclinical Alzheimer’s disease (AD), the SLS places greater emphasis on learning than delayed memory compared to traditional word list memory tests (see Stricker et al., Neuropsychology in press for review and test details). The primary study aim was to establish criterion validity of the SLS by comparing the ability of the remotely-administered SLS and inperson administered Rey Auditory Verbal Learning Test (AVLT) to differentiate biomarkerdefined groups in cognitively unimpaired (CU) individuals on the Alzheimer’s continuum.

Mayo Clinic Study of Aging CU participants (N=319; mean age=71, SD=11; mean education=16, SD=2; 47% female) completed a brief remote cognitive assessment (∼0.5 months from in-person visit). Brain amyloid and brain tau PET scans were available within 3 years. Overlapping groups were formed for 1) those on the Alzheimer’s disease (AD) continuum (A+, n=110) or not (A-, n=209), and for 2) those with biological AD (A+T+, n=43) vs no evidence of AD pathology (A-T-, n=181). Primary neuropsychological outcome variables were sum of trials for both the SLS and AVLT. Secondary outcome variables examined comparability of learning (1-5 total) and delay performances. Linear model ANOVAs were used to investigate biomarker subgroup differences and Hedge’s G effect sizes were derived, with and without adjusting for demographic variables (age, education, sex).

Both SLS and AVLT performances were worse in the biomarker positive relative to biomarker negative groups (unadjusted p’s<.05). Because biomarker positive groups were significantly older than biomarker negative groups, group differences were attenuated after adjusting for demographic variables, but SLS remained significant for A+ vs A- and for A+T+ vs A-T- comparisons (adjusted p’s<.05) and AVLT approached significance (p’s .05-.10). The effect sizes for the SLS were slightly better (qualitatively, no statistical comparison) for separating biomarker-defined CU groups in comparison to AVLT. For A+ vs A- and A+T+ vs A-T- comparisons, unadjusted effect sizes for SLS were -0.53 and -0.81 and for AVLT were -0.47 and -0.61, respectively; adjusted effect sizes for SLS were -0.25 and -0.42 and for AVLT were -0.19 and -0.26, respectively. In secondary analyses, learning and delay variables were similar in terms of ability to separate biomarker groups. For example, unadjusted effect sizes for SLS learning (-.80) was similar to SLS delay (.76), and AVLT learning (-.58) was similar to AVLT 30-minute delay (-.55) for the A+T+ vs AT- comparison.

Remotely administered SLS performed similarly to the in-person-administered AVLT in its ability to separate biomarker-defined groups in CU individuals, providing evidence of criterion validity. The SLS showed significantly worse performance in A+ and A+T+ groups (relative to A- and A-T-groups) in this CU sample after demographic adjustment, suggesting potential sensitivity to detecting transitional cognitive decline in preclinical AD. Measures emphasizing learning should be given equal consideration as measures of delayed memory in AD-focused studies, particularly in the preclinical phase.

The Beta-lactam Comprehensive Allergy Management Program (CAMP) was implemented to facilitate complete beta-lactam allergy history documentation in the electronic medical record (EMR) and increase beta-lactam utilization. The study objective was to assess the rate of complete allergy histories and days of antimicrobial therapy (DOT) before versus after CAMP implementation.

Quasi-experimental study with interrupted time-series analysis.

Non-teaching, urban, and community medical center within a multi-hospital health system.

Adult inpatients with a beta-lactam allergy receiving antimicrobial therapy.

The multidisciplinary CAMP team screened, interviewed, and collected allergy history details of adult inpatients with a beta-lactam allergy receiving antimicrobial therapy starting January 4, 2021. Patients were stratified as high, moderate, or low risk of IgE-mediated allergy and referred to an allergist for skin testing or drug challenge. The EMR was updated with interview details and drug challenge or skin test results. The primary endpoint was rate of complete allergy history documentation before (12/1/18–4/1/19) compared to after (1/4/21–5/1/21) program implementation. The secondary endpoint was days of inpatient beta-lactam therapy. Implementation logistics, de-labeling rate, and antimicrobial therapy changes were evaluated.

The program evaluated 392 individuals, with 184 and 208 patients comprising the pre- and post-intervention groups, respectively. The post-intervention period was associated with an increase of 19.8% in complete allergy histories (0.359 PPc; R2 0.26; p = 0.002) and 9.34 beta-lactam DOT per 1,000-days-present (1.106 PPc; R2 0.194; p = 0.009).

Implementation of a comprehensive beta-lactam allergy management program was associated with higher rates of complete beta-lactam allergy history and beta-lactam use.

Assess turnaround time (TAT) and cost-benefit of on-site C. auris screening and its impact on length of stay (LOS) and costs compared to reference laboratories.

Before-and-after retrospective cohort study.

Large-tertiary medical center.

We validated an on-site polymerase chain reaction-based testing platform for C. auris and retrospectively reviewed hospitalized adults who screened negative before and after platform implementation. We constructed multivariable models to assess the association of screening negative with hospital LOS/cost in the pre and postimplementation periods. We adjusted for confounders such as demographics and indwelling device use, and compared TATs for all samples tested.

The sensitivity and specificity of the testing platform were 100% and 98.11%, respectively, compared to send-out testing. The clinical cohort included 287 adults in the pre and 1,266 postimplementation period. The TAT was reduced by more than 2 days (3 (interquartile range (IQR): 2.0, 7.0) vs 0.42 (IQR: 0.24, 0.81), p < 0.001). Median LOS was significantly lower in the postimplementation period; however, this was no longer evident after adjustment. In relation to total cost, the time period had an effect of $6,965 (95% CI: −$481, $14,412); p = 0.067) on reducing the cost. The median adjusted total cost per patient was $7,045 (IQR: $3,805, $13,924) less in the post vs the preimplementation period.

Our assessment did not find a statistically significant change in LOS, nevertheless, on-site testing was not cost-prohibitive for the institution. The value of on-site testing may be supported if an institutional C. auris reduction strategy emphasizes faster TATs.