Trained Research Staff Research Articles

Initial examination of use of the Brief Observation of Social‐Communication Change (BOSCC) across home and school contexts

AbstractThis study investigated the potential influences of administration context on the measurement of child skills. The Brief Observation of Social‐Communication Change (BOSCC) was administered at two time points to preschool‐aged children with autism in two contexts: (1) at school by trained research staff and (2) at home by the parent. Participants were of ages 3–5 years (M = 4.27 years) old with a confirmed diagnosis of Autism Spectrum Disorder. Of the 13 participants (nine male), eight were White, three Asian, one Black and one White/Black; all identified as non‐Hispanic. The social‐communication and Core total scores yield similar information in both contexts, but Restricted and Repetitive Behaviors and Other Abnormal Behavior subscales scores were not related. These results underscore the importance of purposeful selection of measures and their administration context.

The Effectiveness and Safety Analysis of Duloxetine in Treating Comorbid Depression in Parkinson's Disease: A Retrospective Study.

Parkinson's disease (PD) is a neurodegenerative disorder characterized by both motor and non-motor symptoms, including depression, which significantly impacts the quality of life of affected individuals. This study aims to investigate the real-world effectiveness and safety of duloxetine in treating comorbid depression in patients with Parkinson's disease and to compare its outcomes with traditional treatment approaches. This study included adult patients diagnosed with Parkinson's disease combined with depression from December 2020 to December 2023. Based on the use of duloxetine, the cohort was divided into a traditional treatment group and a duloxetine group (traditional treatment combined with duloxetine). Patients with incomplete medical records, concurrent antidepressant therapy, or major psychiatric or neurological disorders were excluded. Retrospective data, including demographic information, treatment adherence, and various assessment scores, were collected from medical records by trained research staff. In total, 106 patients were analyzed, with 50 patients receiving traditional treatment and 56 patients receiving duloxetine. The duloxetine group exhibited significantly lower scores than the traditional treatment group in the Unified PD Rating Scale (p = 0.015), Hamilton Depression Rating Scale (p = 0.013), Beck Depression Inventory (p = 0.031), Parkinson's disease Questionnaire-39 (p = 0.006), and Clinical Global Impression-Improvement (p < 0.001) scores. In motor function assessment, the duloxetine group demonstrated improvements in kinetic tremor scores (p = 0.017), gait speed (p < 0.001), Timed Up and Go Test performance (p < 0.001), dyskinesia severity (p = 0.017), and rigidity (p = 0.019) compared to the traditional treatment group. Additionally, the duloxetine group exhibited better cognitive function across various assessments, including the Symbol Digit Modalities Test (p = 0.024), Stroop Color-Word Test (p = 0.048), and Montreal Cognitive Assessment (p = 0.024). Duloxetine is associated with superior efficacy in improving motor and non-motor symptoms, overall clinical status, and cognitive function. These findings support the potential utility of duloxetine as a comprehensive treatment option for comorbid depression in Parkinson's disease.

Opportunities and Challenges of California’s Fruit and Vegetable Electronic Benefit Transfer Pilot Project at Farmers’ Markets: A Qualitative Study with Supplemental Nutrition Assistance Program Shoppers and Farmers’ Market Staff

Background/Objectives: Nutrition incentive programs can increase access to fresh fruits and vegetables and improve food security among Supplemental Nutrition Assistance Program (SNAP) participants and others in the United States. This qualitative study explored SNAP participants’ and farmers’ market staff’s perceptions of and experiences with a pilot supplemental benefit program offered at seven farmers’ markets in 2023 as part of the California Fruit and Vegetable Electronic Benefit Transfer Pilot Project. The pilot introduced specific characteristics that differ from more traditional nutrition incentive program dollar-for-dollar match incentive models, particularly the traditional model operating in California. Specific differences included the following: (1) offering a monthly USD 60 supplemental benefit that could be redeemed in a single shopping trip; (2) providing the supplemental benefit as a match that could be spent on any SNAP-eligible item in any retail location (rather than solely on fruits and vegetables at the farmers’ market). Methods: We conducted a qualitative, cross-sectional study including seven focus groups with 40 SNAP shoppers and six focus groups with 14 farmers’ market staff at six pilot-participating farmers’ markets in California. All focus groups were conducted by trained research staff and were recorded, transcribed, and analyzed using the immersion crystallization method. Results: Our findings include that shoppers appreciated several features of the pilot, particularly the ability to obtain an entire month’s supplemental benefit during one shopping trip and the ability to spend the benefit earned on any SNAP-eligible item at any SNAP retailer. Farmers’ market staff appreciated that the pilot benefited shoppers but found it difficult to manage due to staff and shopper confusion about the program, increased program utilization, subsequent long lines, and the spending of the earned incentives at other SNAP retailers. Both shoppers and staff reported that the program was difficult to understand. Conclusions: These findings can inform future nutrition incentive program designs to benefit SNAP participants while offering sustainable models for farmers’ markets.

Longitudinal Change in Physical Activity in Children 6 to 36 Months of Age

To describe the developmental pattern for physical activity (PA) in children 6-36 months of age and to identify factors that are longitudinally associated with PA as children transition from infancy to preschool age. The study employed a prospective, longitudinal design with baseline data collected when children were approximately 6 months of age. Mothers and infants (n = 124) were recruited through community and educational settings in South Carolina. Data were collected at 6-month intervals from 6 through 36 months. PA was measured via accelerometry. Mothers completed questionnaires that assessed independent variables, including parent characteristics, the child's sex, race, and ethnicity, birth/delivery type, motor milestones, sleep habits, dietary practices, childcare setting, and home environmental factors. Trained research staff administered anthropometric measures and assessed motor developmental status. Growth curve models described the age-related pattern for PA and evaluated relationships between independent variables and change in PA. PA increased by approximately 45% between 6 and 36 months of age and followed a curvilinear pattern, with most of the increase occurring between 6 and 24 months. The child's exposure to television/electronic media was negatively associated with change in PA, and the presence of older siblings in the home was positively associated with change in PA. As children develop from infancy to early childhood, their PA increases substantially, with most of the increase occurring by 24 months of age.

Abstract C071: Comprehensive genomics-informed prospective older adult (OA) cancer registry: Initial findings from gastrointestinal (GI) malignancy

Abstract The REACH study (Resilience and Equity in Aging, Cancer, and Health) assesses the impact of geriatric consultation on reducing emergency department and/or unplanned hospitalization visits (EDH) for OA age 70+ diagnosed with GI cancer. We sought to develop an OA GI cancer registry (REACH Registry) within the REACH intervention integrating 1) disease and treatment factors from the PRISSMM cancer taxonomy model with 2) patient reported outcomes and 3) geriatric assessment (GA) measures predictive of function, toxicity, and survival. We reviewed GA measures using the modified Rockwood frailty scale, PROMIS-10 global mental and physical scores, Karnofsky performance status, health-related social needs, and disease/treatment factors using PRISSMM cancer taxonomy for OA consented to REACH in the GI Cancer Center at Dana-Farber Cancer Institute (DFCI) from January 2022–April 2024. OA were eligible if age 70+ at initial DFCI consult visit and diagnosed with any GI cancer. The GA stratifies OA by frailty level on a 0-1 scale: Fit/Robust (score range 0–0.19), Pre-Frail (0.2–0.34), and Frail (0.35–1.0). PRISSMM is a cancer data modeling system developed for the American Association for Cancer Research Project Genomics Evidence Neoplasia Information Exchange (GENIE) Biopharma Collaborative; it includes pathology, radiology/imaging, symptoms, and molecular markers curated by trained research staff from unstructured EHR data. From Jan. 2022–Apr. 2024, 50 OA consented to REACH registry (94 eligible). Of those, 44% (n=22) have PRISSMM data available for analysis. Most OA reported white race (90%, n=45) and female gender (52%, n=26). Pancreatic cancer was the most common diagnosis (n=21), followed by colon (9), biliary (5), and esophageal (4). Most OA completed GA (90%, n=45) with 51% screened Fit/Robust (n=23), 47% Pre-Frail (n=21), and 2% Frail (n=1). Type 2 diabetes mellitus was the most commonly reported comorbid condition (26%, n=13), followed by chronic kidney disease (n=6) and congestive heart failure (n=3). Of the 22 OA with available PRISSMM data, 59% (n=13) were diagnosed with stage IV disease and 100% received cancer-directed therapy; 72% (n=16) received standard care, 27% clinical trial (n=6). Most OA consented for tumor somatic genomic testing (77%, n=17). At the time of data curation 24 months from assessment, 20 patients had died, 30 were alive. Evaluation of the REACH intervention geriatric consultation on EDH outcome is forthcoming. REACH registry is the first GI cancer database inclusive of geriatric specific measures alongside curated disease, treatment and genomic data. We observed a higher rate of genomic testing and treatment initiation than reported in the literature. We anticipate that by September 2024, a larger cohort of REACH Registry participants will have completed PRISSMM data available for analysis. Future study will compare EDH for REACH vs. non-REACH OA as well as treatment patterns of this OA cohort evaluated at a large comprehensive cancer center and associated community sites. Citation Format: Tammy T. Hshieh, Rachel L. Weitzner, Siri Rosenberg, Leila Rostamnjad, Lauren K. Brais, Nora Horick, Tamryn Gray, Jiping Wang, Jeffrey Meyerhardt, Nadine J. McCleary. Comprehensive genomics-informed prospective older adult (OA) cancer registry: Initial findings from gastrointestinal (GI) malignancy [abstract]. In: Proceedings of the 17th AACR Conference on the Science of Cancer Health Disparities in Racial/Ethnic Minorities and the Medically Underserved; 2024 Sep 21-24; Los Angeles, CA. Philadelphia (PA): AACR; Cancer Epidemiol Biomarkers Prev 2024;33(9 Suppl):Abstract nr C071.

Sustainability of a PICU Situation Awareness Intervention: A Qualitative Study.

We aimed to investigate facilitators and barriers that impact the sustainability of an interprofessional situation awareness bundle. This is a single-center qualitative study at a tertiary care pediatric center examining the sustainability of an interprofessional situation awareness bundle to reduce in-hospital cardiac arrests. The bundle includes an automated clinical decision support tool, twice-daily safety huddles, and a bedside mitigation plan. A trained research staff member interviewed participants in October 2022. Interviews were audio recorded and transcribed verbatim, and recruitment continued until data saturation. Inductive and deductive analyses were used here. The authors interviewed twelve staff members via individual semistructured interviews: registered nurses (RN, n = 2) and clinicians [(advanced practice providers, n = 2), pediatric critical care fellows, n = 4 and attendings, n = 4)]. Five main themes were identified: (1) the situation awareness bundle is ingrained into daily practice and culture, (2) the bundle has strengthened communication, decision-making, and improved outcomes, (3) standardized processes, stakeholder buy-in, and support of team members are key to adoption and sustainability, (4) variation in processes and fast-changing clinical context remains a challenge for reliable use, and (5) the situation awareness bundle excluded families. The situation awareness bundle has become ingrained, strengthened, and sustained over the last 5 years through integration into daily practice and culture and leveraging standardized processes, tools and technology. It is associated with improved communication and shared decision-making. Understanding the key components for implementation and sustainability is necessary for ongoing spread and improvement in the future.

The VirTra V-100 Is a Test-Retest Reliable Shooting Simulator for Measuring Accuracy/Precision, Decision-Making, and Reaction Time in Civilians, Police/SWAT, and Military Personnel.

Buga, A, Decker, DD, Robinson, BT, Crabtree, CD, Stoner, JT, Arce, LF, El-Shazly, X, Kackley, ML, Sapper, TN, Anders, JPV, Kraemer, WJ, and Volek, JS. The VirTra V-100 is a test-retest reliable shooting simulator for measuring accuracy/precision, decision-making, and reaction time in civilians, police/SWAT, and military personnel. J Strength Cond Res XX(X): 000-000, 2024-Law-enforcement agencies and the military have increasingly used virtual reality (VR) to augment job readiness. However, whether VR technology captures consistent data for shooting performance evaluation has never been explored. We enrolled 30 adults (24 M/6 F) to examine test-retest reliability of the VirTra shooting simulator. Approximately 30% of the sample had a tactical background (PD/SWAT and military). Trained research staff familiarized subjects with how to shoot the infrared-guided M4 rifle at digitally projected targets. Subjects then performed 3 identical experimental shooting sessions (consecutive or separated by 1-2 days) that assessed accuracy/precision, decision-making, and reaction time. Key metrics comprised projectile Cartesian position ( x , y ), score, time, and throughput (score or accuracy divided by time). Test-retest reliability was measured with intraclass correlation coefficients (ICC). After each visit, subjects completed a perceptual survey to self-evaluate their shooting performance and perceived VR realism. The simulator captured 21 ballistic variables with good to excellent test-retest agreement, producing a global ICC of 0.78. Notable metrics were the individual projectile distances to the center of the target (0.81), shot group radius (0.91), time-to-first decision (0.97), decision-making throughput (0.95), and target transition reaction time (0.91). Subjects had positive self-evaluations about their shooting performance, with "confidence" increasing from baseline to the end of the study ( p = 0.014). The VirTra V-100 virtual ballistic shooting simulator captures data with a high degree of test-retest reliability and is easy to familiarize regardless of starting expertise levels, making it appropriate for use as a method to objectively track progress or a tactical research testing tool.

Accuracy of Dysphagia Screening by Non-clinical Research Staff in the Emergency Department.

Although the emergency department (ED) is the initial care setting for the majority of older adults requiring hospital admission, there is a paucity of ED-based dysphagia research in this at-risk population. This is driven by barriers to dysphagia evaluation in this complex care environment. Therefore, we assessed the reliability of trained, non-clinical ED research staff in administering dysphagia screening tools compared to trained speech pathologists (SLPs). We also aimed to determine perceptual screening discrepancies (e.g. voice change) between clinical and non-clinical staff. Forty-two older adults with suspected pneumonia were recruited during an ED visit and underwent dysphagia (Toronto Bedside Swallow Screening Tool; TOR-BSST©) and aspiration (3-oz water swallow test; 3-oz WST) screening by trained non-clinical research staff. Audio-recordings of screenings were re-rated post-hoc by trained, blinded SLPs with discrepancies resolved via consensus. Cohen's kappa (unweighted) revealed moderate agreement in pass/fail ratings between clinical and non-clinical staff for both the TOR-BSST© (k = 0.75) and the 3oz WST (k = 0.66) corresponding to excellent sensitivity and good specificity for both the TOR-BSST (SN = 94%, SP = 85%) and the 3oz WST (SN = 90%, SP = 81%). Further analysis of TOR-BSST perceptual parameters revealed that most discrepancies between clinicians and non-clinicians resulted from over-diagnosis of change in vocal quality (53%). These results support the feasibility of non-clinical research staff administering screening tools for dysphagia and aspiration in the ED. Dysphagia screening may not necessitate clinical staff involvement, which may improve feasibility of large-scale ED research. Future training of research staff should focus on perceptual assessment of vocal quality.

Associated factors of mortality and morbidity in emergency and elective abdominal surgery: a two-year prospective cohort study at lacor hospital, Uganda

BackgroundThe mortality rate associated with open abdominal surgery is a significant concern for patients and healthcare providers. This is particularly worrisome in Africa due to scarce workforce resources and poor early warning systems for detecting physiological deterioration in patients who develop complications.MethodsThis prospective cohort study aimed to follow patients who underwent emergency or elective abdominal surgery at Lacor Hospital in Uganda. The participants were patients who underwent abdominal surgery at the hospital between April 27th, 2019 and July 07th, 2021. Trained research staff collected data using standardized forms, which included demographic information (age, gender, telephone contact, and location), surgical indications, surgical procedures, preoperative health status, postoperative morbidity and mortality, and length of hospital stay.ResultsThe present study involved 124 patients, mostly male, with an average age of 35 years, who presented with abdominal pain and varying underlying comorbidities. Elective cases constituted 60.2% of the total. The common reasons for emergency and elective surgery were gastroduodenal perforation and cholelithiasis respectively. The complication rate was 17.7%, with surgical site infections being the most frequent. The mortality rate was 7.3%, and several factors such as preoperative hypotension, deranged renal function, postoperative use of vasopressors, and postoperative assisted ventilation were associated with it. Elective and emergency-operated patients showed no significant difference in survival (P-value = 0.41) or length of hospital stay (P-value = 0.17). However, there was a significant difference in morbidity (p < 0.001).ConclusionCholelithiasis and gastroduodenal perforation were key surgical indications, with factors like postoperative ventilation and adrenaline infusion linked to mortality. Emergency surgeries had higher complication rates, particularly surgical site infections, despite similar hospital stay and mortality rates compared to elective surgeries.

Exploring the Relationship between Built Environment Attributes and Physical Activity in Lower-Income Aging Adults: Preliminary Insights from a Multi-Level Trial.

The built environment has been linked to physical activity (PA) behaviors, yet there is limited knowledge of this association among lower-income midlife and older adults who are insufficiently active. The present cross-sectional study utilized baseline data collected between October 2017 and November 2019 from a clustered randomized controlled trial to determine how built environment attributes were associated with PA behaviors among midlife and older adults (n = 255) residing in or near affordable housing sites (n = 10). At each site, perceptions of the built environment were collected and scored at the participant level via the abbreviated Neighborhood Environment Walkability Survey (NEWS-A), while objective built environment attributes were measured and scored by trained research staff using the Physical Activity Resource Assessment (PARA). Multiple PA behaviors-walking, total PA, and moderate-to-vigorous PA (MVPA) (min/wk)-were measured using the validated Community Healthy Activities Model Program for Seniors (CHAMPS) questionnaire. Adjusted linear regression models examined associations between NEWS-A measures and PA behaviors, and site-level correlations between PARA measures and PA behaviors were examined using Spearman's rank correlations. At the participant level, adjusted models revealed that a one point increase in the NEWS-A aesthetics score was associated with a 57.37 min/wk increase in walking (β = 57.37 [95% CI: 20.84, 93.91], p = 0.002), with a similar association observed for street connectivity and MVPA (β = 24.31 min/wk [95% CI: 3.22, 45.41], p = 0.02). At the site level, MVPA was positively correlated with the quality of the features of local, PA-supportive environmental resources (ρ = 0.82, p = 0.004). Findings indicate that participant- and site-level measures of the built environment may play a role in promoting PA behavior among this demographic and similar populations. Results also suggest that improvements in aesthetic attributes and street connectivity, along with enhancing the quality of local, PA-supportive environmental resources, may be effective strategies for promoting physical activity among lower-income midlife and older adults.

The Africa non-communicable diseases (NCD) Open Lab: Impact of a portfolio of clinical studies to deepen the understanding of NCDs in sub-Saharan Africa.

Clinical research in sub-Saharan Africa (SSA) has often focussed on communicable diseases. However, with the increasing burden of non-communicable diseases (NCDs), there is a need for Africa-specific NCD research. GSK established the Africa NCD Open Lab in 2014. Three calls for proposals were advertised through various media channels. An external independent scientific advisory board, predominantly representing African scientists and NCD experts, reviewed and selected projects to receive funding. An additional programme in the Africa NCD Open Lab was designed to build statistical capability by supporting training initiatives. We assessed the impact of the Africa NCD Open Lab in three ways: scientific quality with impact; research training and professional development; and research environments. We captured metrics through regular reports/interactions with researchers; via a final report; and through exit interviews with principal investigators. Twenty projects in 11 African countries were funded; reports from 18 completed projects are available (data capture is ongoing). Overall, 139 articles have been published in peer-reviewed journals and other data have been presented at conferences and other forums. Most completed projects led to positive outcomes, such as further research, informing policy, or positively impacting clinical care, including three projects that saw changes to regional or national practice guidelines: the CREOLE study in Nigeria; the African Severe Asthma Program in Uganda; and the African Prospective Study on the Early Detection and Identification of Cardiovascular Disease and Hypertension in South Africa. Participation in the Africa NCD Open Lab led to the award of 34 grants related to or influenced by increased research capacity or experience. Significant professional development related to the projects also occurred with higher-level degrees being awarded, including 30 MScs, 30 PhDs, and nine postdoctoral fellowships. Through these projects, research capacity was strengthened across the region by equipping core research facilities, training research staff, strengthening research support services, and supporting the expansion of investigator networks. The completed Africa NCD Open Lab projects demonstrate high-quality research outcomes addressing important health challenges with potential benefits to African populations. Based on the success of the Africa NCD Open Lab, additional funding has been secured to extend the Open Lab initiative.

520 Johns Hopkins Institute for Clinical and Translational Research (ICTR) - Research Personnel Onboarding Program

OBJECTIVES/GOALS: In Sep 2022, Johns Hopkins Research Coordinator Support Service launched Research Personnel Onboarding Program. The program on board in experienced individuals in 6-8 weeks, tailoring training plans to Investigator and study needs. It also offers Ongoing Support to enhance sustainability and adaptability. METHODS/STUDY POPULATION: * Assess Principal Investigator (PI)’s need Evaluate study’s need Understand trainee’s background Develop a personalized training plan (∼6-8 weeks) Weekly updates Ongoing mentorship Research staff spend 200+ training hours, depending on their need. Training encompasses various modalities: Interactive 1:1 onboarding sessions, Online, and Instructor-led trainings and sessions cover a wide range of topics, including: * Mandatory JHU/Institutional Review Board trainings * Good Clinical Practice * Regulatory submissions * Screening/Consenting * Monitoring/Auditing * Visit conduct * Clinical skills * Soft Skills Figure 1. Chart shows cumulative onboarding hours that focus on “How” to do tasks Figure 2. Chart shows cumulative training hours that focus on regulations, ethics and “Why” for tasks RESULTS/ANTICIPATED RESULTS: * The program contributed nearly 4000 hrs. of research staff training in the past 1 year * The program received 26 requests from investigators; 14 Completed the onboarding program, 1 Active, 5 Projected (Future start date), and 6 Cancelled (HR issues, lack of fund, or hired a trained staff) * 22 requests opted in the “Ongoing Support” * Ongoing Support, is averaged at 1 hr./month for the first 3-6 months. This indicates program success in empowering independent task performance * Developing REDCap request had significantly reduced meetings and paperwork * Web-Based Clockify invoicing has drastically reduced monthly manually invoicing processing time DISCUSSION/SIGNIFICANCE: * Grow the next generation of clinical research professionals * Centralize and standardize expert onboarding throughout the University * Improve outcomes, enhanced productivity, knowledge sharing, collaboration, and innovation * Decrease frustration and enhance satisfaction of trainees and departments

Deaths among Women of Reproductive Age: an Explorative Case Study among Abortion Seekers.

In Nepal, abortion was legalized in 2002. Yet many women are denied abortion services. Women denied abortion services may either continue their pregnancies or find abortion care elsewhere. However, what is not known is the consequences on women, and their children after accessing abortion services or after being denied abortion services. This comment aims to understand the cause of death of women who sought abortion services between 2019 and 2020 and were enrolled in a longitudinal nationwide study of the consequences of legal abortion access in Nepal. Women were interviewed 6 weeks and every 6 months for 3 years after seeking abortion. During the follow-up interviews, the field research assistants were informed about the death of the clients. Once the death was reported, a trained senior research staff visited the deceased persons house and interviewed family members including husbands, maternal parents or in-laws to explore the cause of death. A total of nine deaths were reported between April 2019 and December 2022. Out of nine deceased women, four received abortions while five of them were initially denial abortion services. The majority of the deaths were due to suicide followed by tuberculosis. None of the deaths were caused by abortion or birth. Keywords: Death; Nepal; reproductive ages; womens health.

The mother during pregnancy and the puerperium: Detailed data abstracted from the clinical obstetric records of ALSPAC pregnancies

Background When the Avon Longitudinal Study of Parents and Children (ALSPAC) was planned, it was assumed that the clinical obstetric data would be easily accessible from the newly developed National Health Service computerised ‘STORK’ system. Pilot studies, however, showed that, although fairly accurate in regard to aspects of labour and delivery, it was, at the time (1990-2), inadequate for identifying the full antenatal and postnatal details of clinical complications and treatments of the women in the Study. Methods A scheme was therefore developed to train research staff to find and abstract relevant details from clinical records onto proformas designed for the purpose. Extracting such data proved very time consuming (up to six hours for complicated pregnancies) and consequently expensive. Funding for the enterprise was obtained piecemeal using specific focussed grants to extract data for subsamples of the Study, including a random sample to serve as controls. Results To date, detailed records have been completed for 8369 pregnancies, and a further 5336 (13,705 in total) have complete details on specific prenatal areas, including serial measures of maternal blood pressure, proteinuria and weight. In this Data Note we describe the information abstracted from the obstetric medical records concerning the mother during pregnancy, labour, delivery and the first two weeks of the puerperium. Information abstracted relating to the fetus (including fetal monitoring, presentation, method of delivery) and neonate (signs of asphyxia, resuscitation, treatment and well-being) have been described in a further Data Note. Conclusions These data add depth to ALSPAC concerning ways in which the signs and symptoms, procedures and treatments of the mother prenatally, intrapartum and postnatally, may impact on the long-term health and development of both mother and child. They augment the data collected from the mothers’ questionnaires (described elsewhere) and the ‘STORK’ digital hospital data.

The use of procedural kits may reduce unscheduled central line dressing changes: A matched pre-post intervention study.

Unscheduled dressing changes for central venous lines (CVLs) have been shown to increase the risk of bloodstream infections. The objective of this study is to determine if the use of an innovative dressing change kit reduces the rate of unscheduled dressing changes. This pre-post interventional study took place at a large, academic, tertiary care center in metro Detroit, Michigan, the United States. We assessed the impact of the interventional dressing change procedure kit on the rate of unscheduled dressing changes for adult patients who underwent placement of a CVL inclusive of a central catheter, peripherally inserted central catheter, or hemodialysis catheter. Data was collected for the pre-intervention cohort through electronic health records (EHRs), while data for the post-intervention cohort were collected by direct observation by trained research staff in combination with EHR data. The primary outcome was the rate of unscheduled dressing changes. Secondary outcomes included rate of unscheduled dressing changes based on admission floor type, etiology of unscheduled dressing changes, and central line-associated bloodstream infections (CLABSIs). The study included a convenience sample of 1548 CVLs placed between May 2018 and June 2022 with a matched analysis including 488 catheters in each of the pre- and post-intervention groups. The results showed that the unadjusted rate of unscheduled dressing evaluations was significantly reduced from the pre-intervention group (0.21 per day) to the post-intervention group (0.13 per day) (p < .001). The adjusted rate ratio demonstrated the same trend at 1.00 pre- and 0.60 post-intervention (p < .001). Stratifying the analysis based on the highest level of care showed that the intervention was effective in reducing the unadjusted rate of unscheduled dressing evaluations for both the advanced and regular medical floor subgroups pre- to post-intervention; the advanced subgroup had an reduction from 0.22 to 0.15 per day (p = .001), while the regular medical floor subgroup had a reduction from 0.21 to 0.09 per day (p < .001). CLABSIs were similar in both groups (0.6% vs 0.8%; p = 1.00) in pre- and post-intervention groups, respectively. Procedural kits for central line dressing changes are effective in reducing unscheduled dressing changes and may have a role in reducing CLABSI. Further studies assessing the impact of dressing change kits on cost, procedural compliance, and the precise impact on CLABSI are needed.

The Pregnancy Tele-yoga Module to Combat Stress, Anxiety, and Depression Associated with Pregnancy: An Exploratory Open-label Multicentric Study.

Untreated stress, anxiety, and depression during the perinatal period can lead to adverse maternal and infant outcomes. Yoga, the practice of body-mind-spirit techniques has been shown to reduce stress, anxiety, and depression. The aim of the study was to examine the feasibility and limited efficacy of the 4-week practice of pregnancy tele-yoga module (PTYM) delivered and monitored through an online platform. A multicentric, open-label, exploratory study was conducted in the antenatal clinics (ANCs) of three tertiary care hospitals in India. Pregnant women between 13 and 32 weeks of gestation were invited to participate. PTYM was taught by the trained research staff. A YouTube link demonstrating the PTYM developed by the researchers was shared with consenting participants. Using the Yoga Performance Assessment (YPA), research staff monitored the online performance of the PTYM. Pre- and postintervention, women were assessed using the Depression, Anxiety, and Stress Scale-21 (DASS-21). Preintervention, among 162 consented pregnant women, anxiety (62.34%) was the most common mental health condition, followed by stress (55.55%) and depression (45.67%). YPA at the end of week 1, week 2, week 3, and week 4 was 19.45, 21.35, 24.15, and 28.45, respectively. Postintervention anxiety, stress, and depression persisted in 19.78%, 11.44%, and 10.41% of women. Pregnant women with stress (DASS-21 ≥15; n = 90), anxiety (DASS-21 ≥8; n = 101), and depressive (DASS-21 ≥10; n = 74) symptoms after undergoing 4 weeks of PTYM reported significant reduction in the scores. The current study demonstrated the feasibility and limited efficacy of PTYM in ANCs of a tertiary care hospital in India.

DIFFERENTIAL ASSOCIATIONS OF HAND GRIP STRENGTH AND CHAIR STAND TIME WITH INDOOR AND OUTDOOR FALLS AMONG OLDER ADULTS

Abstract Hand grip strength and chair stand time are physical performance measures that are predictive of frailty and muscle strengths in older age. We examined their associations with indoor and outdoor falls among older adults. The Healthy Aging and Neighborhood Study enrolled 397 community-dwelling older adults aged 65-95 years old in Central Massachusetts (2018-2020). Hand grip strength (in kilograms) and chair stand time (in seconds) were measured at baseline by trained research staff. Falls were reported on monthly falls calendar, and when a fall was reported, the circumstances were collected via telephone interview. Negative binomial regression models were used to estimate the associations of hand grip strength and chair stand time with both indoor and outdoor falls, separately. Models were adjusting for sex, age, BMI, bodily pain, comorbidities, ADL and IADL as appropriate. Overall, annual rates (95% CI) of indoor and outdoor falls were 40.2 (33.7-47.6) and 45.3 (38.4-53.1) per 100 person-years respectively. Stronger hand grip strength was associated with lower rate of indoor falls (IRR (95% CI): 0.94 (0.91-0.98) per kilogram). Longer chair stand time was associated with higher rate of indoor falls (IRR (95% CI): 1.06 (1.03-1.09) per second). There was no significant association of outdoor falls with grip strength (p=0.504) or chair stand time (p=0.430). In conclusion, hand grip strength and chair stand time were predictive of indoor falls but not outdoor falls. Future studies should examine the underlying mechanisms of such differential associations indoor vs. outdoor falls.

Cannabis Exposure and Adverse Pregnancy Outcomes Related to Placental Function

Cannabis use is increasing among reproductive-age individuals and the risks associated with cannabis exposure during pregnancy remain uncertain. To evaluate the association between maternal cannabis use and adverse pregnancy outcomes known to be related to placental function. Ancillary analysis of nulliparous individuals treated at 8 US medical centers with stored urine samples and abstracted pregnancy outcome data available. Participants in the Nulliparous Pregnancy Outcomes Study: Monitoring Mothers-to-Be cohort were recruited from 2010 through 2013; the drug assays and analyses for this ancillary project were completed from June 2020 through April 2023. Cannabis exposure was ascertained by urine immunoassay for 11-nor-9-carboxy-Δ9-tetrahydrocannabinol using frozen stored urine samples from study visits during the pregnancy gestational age windows of 6 weeks and 0 days to 13 weeks and 6 days (visit 1); 16 weeks and 0 days to 21 weeks and 6 days (visit 2); and 22 weeks and 0 days to 29 weeks and 6 days (visit 3). Positive results were confirmed with liquid chromatography tandem mass spectrometry. The timing of cannabis exposure was defined as only during the first trimester or ongoing exposure beyond the first trimester. The dichotomous primary composite outcome included small-for-gestational-age birth, medically indicated preterm birth, stillbirth, or hypertensive disorders of pregnancy ascertained by medical record abstraction by trained perinatal research staff with adjudication of outcomes by site investigators. Of 10 038 participants, 9257 were eligible for this analysis. Of the 610 participants (6.6%) with cannabis use, 32.4% (n = 197) had cannabis exposure only during the first trimester and 67.6% (n = 413) had ongoing exposure beyond the first trimester. Cannabis exposure was associated with the primary composite outcome (25.9% in the cannabis exposure group vs 17.4% in the no exposure group; adjusted relative risk, 1.27 [95% CI, 1.07-1.49]) in the propensity score-weighted analyses after adjustment for sociodemographic characteristics, body mass index, medical comorbidities, and active nicotine use ascertained via urine cotinine assays. In a 3-category cannabis exposure model (no exposure, exposure only during the first trimester, or ongoing exposure), cannabis use during the first trimester only was not associated with the primary composite outcome; however, ongoing cannabis use was associated with the primary composite outcome (adjusted relative risk, 1.32 [95% CI, 1.09-1.60]). In this multicenter cohort, maternal cannabis use ascertained by biological sampling was associated with adverse pregnancy outcomes related to placental dysfunction.

#61 : Frugal Exoscope: A Potential Option for Microsurgery and Training Program in Male Infertility in the Context of Emerging Markets

Background and Aims: Conventional microscopes and exoscopes currently play pivotal roles in the microsurgery or training of male infertility. However, they are expensive and unaffordable in low resource settings which limits training or application of advanced methods. The study aimed to introduce a new, low–cost exoscope system and evaluate its frugal innovation. Method: Using animal models, we evaluated a new frugal exoscope system (called DKTA) in experimental microsurgery of vas deferens repair. Five experts in male infertility surgery undertook an anonymous survey to elucidate their experience with DKTA system use. Three crucial criteria (i.e., substantial cost reduction, concentration on core functionalities, optimised performance level) were evaluated to determine whether the DKTA is effective as frugal innovation. The survey used a 5-point Likert scaling of responses to eight statements investigating surgical, ergonomic, and educational aspects. Results: The DKTA system, including an optical microscope and ultrahigh definition camera (4K), was an exoscope placed between 20–40 cm from the surgical field. It was held in position with a camera support arm on casters and connected to a 65-inches smart TV. DKTA system met the three crucial criteria of frugal innovation, including substantial cost reduction, concentration on core functionalities, and optimised performance level. Five male infertility microsurgeons reported positive evaluations of the DKTA system (use modal scores) when performing experimental vasovasostomy. Conclusions: DKTA system, a frugal innovation, has a valuable contribution to the training programme and performance of male infertility microsurgery in low–resource settings. Acknowledgements: We want to send special thanks to the Centre for Training and Scientific Research staff, Tam Anh General Hospital for their logistics support.

Evaluation of Bleeding Self-Assessments By Patients with Immune Thrombocytopenia (ITP): An Agreement Study

Introduction. Immune thrombocytopenia (ITP) is an autoimmune condition that causes an increase in the risk of bleeding. Bleeding is a patient-important outcome; however, timely and complete assessments of bleeding are time- and labour-intensive. ITP bleeding measurements may be simplified with patient self-assessments. We designed this study to compare the agreement of bleeding assessments done by ITP patients and by trained research staff. Methods. All patients were identified from the McMaster ITP Registry, a longitudinal registry study of consecutive adult patients with thrombocytopenia followed at the McMaster University Medical Centre, a tertiary referral clinic. A modified version of the ITP Bleeding Scale was used for all bleeding assessments, which captured the patients' worst bleeding event at each of 9 anatomical sites - skin, mouth, epistaxis, gastrointestinal, genitourinary, gynecological, pulmonary, ocular or intracranial - graded from 0 (no bleeding) to 2 (severe bleeding) from the time of the last assessment (typically 6 months prior). Patients were provided with instructions on how to use the scale and asked to complete bleeding self-assessments using an online tool. Once the patients completed their self-assessments, a trained research staff member contacted the patient to repeat the bleeding assessment by telephone. Chance-corrected interrater agreement was determined using the kappa statistic for 2-way agreement (Grade 2 vs. Grade 0 or 1 bleeding) and for 3-way agreement (Grade 0 vs. Grade 1 vs. Grade 2). Chance-independent 2-way agreement was also measured using the phi statistic. The primary analysis was the 2-way kappa, since the detection of Grade 2 bleeds is clinically important. Results. We enrolled 108 consecutive patients with ITP from the McMaster ITP Registry who had duplicate bleeding assessments done. The median time between assessments was 3 days (IQR, 2-5). Median age of patients in the study was 53 years (IQR, 38-64), 64% were female. The worst bleeding events, as determined by research staff, were Grade 0 (n=22, 20.4%), Grade 1 (n=34, 31.5%) or Grade 2 (n=52, 48.1%). There was perfect agreement for bleeding assessments at all anatomical sites for 44 patients (40.7%). There were no intracranial hemorrhages and no Grade 2 genitourinary or pulmonary bleeds were reported. Chance-corrected 2-way agreement was excellent for gynecological (k=0.86, 95% CI 0.71-1.02), gastrointestinal (k=1), genitourinary (k=1), pulmonary (k=1) and intracranial (k=1) bleeds ( Table). Agreement was good for skin (k=0.68, 95% CI, 0.54-0.82), oral (k=0.76, 95% CI, 0.53-0.98) and ocular (k=0.66, 95% CI, 0.04-1.28) bleeds, and moderate for epistaxis (k=0.58, 95% CI, 0.21-0.95). Results of chance-independent agreement and 3-way agreement were similar. Conclusions. Bleeding self-assessments by ITP patients yielded comparable results to trained research staff. Agreement for skin and epistaxis was lower than for other sites, suggesting that additional instructions or prompts may be needed for these categories. Bleeding self-assessments could simplify data collection in research and in clinical practice.