Multisite Prospective Cohort Study Research Articles

Helping ourselves, helping others: the Young Women’s Breast Cancer Study (YWS) – a multisite prospective cohort study to advance the understanding of breast cancer diagnosed in women aged 40 years and younger

PurposeCompared with older women diagnosed with breast cancer, younger women are more likely to die of breast cancer and more likely to suffer psychosocially in both the short-term and long...

An interactive, online decision aid assessing patient goals and preferences for treatment of aortic stenosis to support physician-led shared decision-making: Early feasibility pilot study.

Guidelines recommend shared decision making when choosing treatment for severe aortic stenosis but implementation has lagged. We assessed the feasibility and impact of a novel decision aid for severe aortic stenosis at point-of-care. This prospective multi-site pilot cohort study included adults with severe aortic stenosis and their clinicians. Patients were referred by their heart team when scheduled to discuss treatment options. Outcomes included shared decision-making processes, communication quality, decision-making confidence, decisional conflict, knowledge, stage of decision making, decision quality, and perceptions of the tool. Patients were assessed at baseline (T0), after using the intervention (T1), and after the clinical encounter (T2); clinicians were assessed at T2. Before the encounter, patients reviewed the intervention, Aortic Valve Improved Treatment Approaches (AVITA), an interactive, online decision aid. AVITA presents options, frames decisions, clarifies patient goals and values, and generates a summary to use with clinicians during the encounter. 30 patients (9 women [30.0%]; mean [SD] age 70.4 years [11.0]) and 14 clinicians (4 women [28.6%], 7 cardiothoracic surgeons [50%]) comprised 28 clinical encounters Most patients [85.7%] and clinicians [84.6%] endorsed AVITA. Patients reported AVITA easy to use [89.3%] and helped them choose treatment [95.5%]. Clinicians reported the AVITA summary helped them understand their patients' values [80.8%] and make values-aligned recommendations [61.5%]. Patient knowledge significantly improved at T1 and T2 (p = 0.004). Decisional conflict, decision-making stage, and decision quality improved at T2 (p = 0.0001, 0.0005, and 0.083, respectively). Most patients [60%] changed treatment preference between T0 and T2. Initial treatment preferences were associated with low knowledge, high decisional conflict, and poor decision quality; final preferences were associated with high knowledge, low conflict, and high quality. AVITA was endorsed by patients and clinicians, easy to use, improved shared decision-making quality and helped patients and clinicians arrive at a treatment that reflected patients' values. Trial ID: NCT04755426, Clinicaltrials.gov/ct2/show/NCT04755426.

Abstract 5215: Orphan noncoding RNA (oncRNA) liquid biopsy assay is prognostic for survival in patients with triple-negative breast cancer (TNBC) and residual disease

Abstract Introduction: Residual disease (RD) after neoadjuvant systemic therapy is associated with high recurrence risk in patients with TNBC. oncRNAs are a novel category of small RNAs that are largely absent in healthy tissue but enriched in tumors and can be detected using a blood-based assay. This study investigated impact of an oncRNA recurrence risk model on outcomes in TNBC patients with RD. Methods: Study population included stage I-III TNBC patients with RD and available end-of-treatment (EOT) serum samples who were enrolled in a multisite prospective cohort study. EOT samples were collected after completion of all curative treatment (local/systemic). Small RNAs were isolated from EOT serum, sequenced at average depth of 76.5 ± 12.5 million 50bp single end reads, and annotated using a bespoke bioinformatics pipeline to identify oncRNAs. Cancer risk scores were generated using an oncRNA based tumor detection artificial intelligence model trained on 451 treatment naive breast cancer samples and 470 samples from individuals without known cancer diagnosis. Score cutpoint for high vs low recurrence risk was determined through ROC analysis. Impact of EOT oncRNA risk category on event free survival (EFS) and overall survival (OS) was estimated by Kaplan Meier method and compared by log rank test followed by Cox regression. Residual cancer burden (RCB) was determined according to classification by Symmans et al. Results: oncRNA isolation/score generation was successful for 79 out of 80 TNBC patients with RD and available EOT serum sample. Median age was 48 years and 39% had node positive disease. RCB class distribution was as follows: RCB I=27%, RCB II=49%, RCB III=18%. Training set (n=39) was used to define oncRNA risk score cutpoint. In the testing set (n=40), 38% were classified as oncRNA high-risk and 62% as oncRNA low-risk. oncRNA risk category was not associated with baseline T stage, nodal status, or RCB class. oncRNA high-risk status was associated with lower EFS and OS; 3y EFS was 47% and 73% (HR 2.76, 95% CI 0.92-9.24, p=0.058) and OS 53% and 76% (HR 3.78, 95% CI 1.19-12.00, p=0.016) in high and low risk groups, respectively. In multivariable analysis including oncRNA risk status, T stage, nodal status, and RCB class, oncRNA high risk status retained significant association with lower EFS (HR 7.70, 95% CI 1.33-44.64, p=0.023) and OS (HR 7.99, 95% CI 1.36-47.00, p=0.022). Conclusion: EOT oncRNA liquid biopsy assay was independently prognostic for outcomes in TNBC patients with RD. More than half of patients in the oncRNA high-risk group suffered an EFS event by 3 years. oncRNA risk score has potential to provide prognostic utility complementary to clinicopathologic characteristics in patients with TNBC. These findings should be confirmed in other TNBC studies and may provide insights for patient stratification/selection in RD adjuvant therapy intensification trials. Citation Format: Rachel Yoder, Jennifer Yen, Mehran Karimzadeh, Joshua M. Staley, India Fernandez, Adam C. Heinrich, Fereydoun Hormozdiari, Jeffrey Gregg, Andrew K. Godwin, Irene Acerbi, Raaj Trivedi, Babak Alipanahi, Shane R. Stecklein, Priyanka Sharma. Orphan noncoding RNA (oncRNA) liquid biopsy assay is prognostic for survival in patients with triple-negative breast cancer (TNBC) and residual disease [abstract]. In: Proceedings of the American Association for Cancer Research Annual Meeting 2024; Part 1 (Regular Abstracts); 2024 Apr 5-10; San Diego, CA. Philadelphia (PA): AACR; Cancer Res 2024;84(6_Suppl):Abstract nr 5215.

Healthcare Burden and Resource Utilization After Pediatric Acute Respiratory Distress Syndrome: A Secondary Analysis of the Collaborative Pediatric Critical Care Research Network Acute Respiratory Distress Syndrome Study.

To describe family healthcare burden and health resource utilization in pediatric survivors of acute respiratory distress syndrome (ARDS) at 3 and 9 months. Secondary analysis of a prospective multisite cohort study. Eight academic PICUs in the United States (2019-2020). Critically ill children with ARDS and follow-up survey data collected at 3 and/or 9 months after the event. None. We evaluated family healthcare burden, a measure of healthcare provided by families at home, and child health resource use including medication use and emergency department (ED) and hospital readmissions during the initial 3- and 9-month post-ARDS using proxy-report. Using multivariable logistic regression, we evaluated patient characteristics associated with family healthcare burden at 3 months. Of 109 eligible patients, 74 (68%) and 63 patients (58%) had follow-up at 3- and 9-month post-ARDS. At 3 months, 46 families (62%) reported healthcare burden including (22%) with unmet care coordination needs. At 9 months, 33 families (52%) reported healthcare burden including 10 families (16%) with unmet care coordination needs. At month 3, 61 patients (82%) required prescription medications, 13 patients (18%) had ED visits and 16 patients (22%) required hospital readmission. At month 9, 41 patients (65%) required prescription medications, 19 patients (30%) had ED visits, and 16 (25%) required hospital readmission were reported. Medication use was associated with family healthcare burden at both 3 and 9 months. In a multivariable analysis, preillness functional status and chronic conditions were associated with healthcare burden at month 3 but illness characteristics were not. Pediatric ARDS survivors report high rates of healthcare burden and health resource utilization at 3- and 9-month post-ARDS. Future studies should assess the impact of improved care coordination to simplify care (e.g., medication management) and improve family burden.

Predictors of increasing disability in activities of daily living among people with advanced respiratory disease: a multi-site prospective cohort study, England UK

Purpose Disability in activities of daily living (ADL) is a common unmet need among people with advanced respiratory disease. Rehabilitation could help prolong independence, but indicators for timely intervention in this population are lacking. This study aimed to identify trajectories of disability in ADLs over time, and predicting factors, in advanced respiratory disease. Method Multi-site prospective cohort study in people with advanced non-small cell lung cancer (NSCLC), chronic obstructive pulmonary disease (COPD) or interstitial lung disease (ILD), recruited from hospital or community services, throughout England. Disability in basic (Barthel Index) and instrumental (Lawton–Brody IADL Scale) ADLs were assessed monthly over six months. Visual graphical analysis determined individual trajectories. Multivariate logistic regression examined predictors of increasing disability in basic and instrumental ADLs. Findings Between March 2020 and January 2021, we recruited participants with a diagnosis of NSCLC (n = 110), COPD (n = 72), and ILD (n = 19). 151 participants completed ≥3 timepoints and were included in the longitudinal analysis. Mobility limitation was an independent predictor of increasing disability in instrumental ADLs (odds ratio, 1⋅41 [CI: 1⋅14–1⋅74], p = 0⋅002). Conclusion Mobility limitation could be used as a simple referral criterion across people with advanced respiratory disease to ensure timely rehabilitation that targets independence in ADLs.

Evaluating Open Dialogue in Italian mental health services: evidence from a multisite prospective cohort study.

This longitudinal study aimed to quantitatively document and evaluate the implementation and outcomes of the Open Dialogue (OD) approach within Italian Mental Health Departments (MHDs), focusing on the ratings of OD-network meetings by patients and their families and assessing the clinical outcomes over a span of 12 months. Over the course of the study, 58 patients participated in 517 OD-network meetings, demonstrating a high level of satisfaction with the care received, as evidenced by the Session Rating Scale (SRS) and Outcome Rating Scale (ORS). Clinically, significant improvements were observed in the Global Assessment of Functioning (GAF), Clinical Outcomes in Routine Evaluation (CORE-OM), and the Lubben Social Network Scale (LSNS), indicating enhanced psychological and social functioning. The SRS scores showed that satisfaction with the meetings increased over time, while the ORS indicated that both patients and their social networks perceived gradual improvements throughout the therapy. The OD approach within Italian MHDs was successfully implemented and well-received by patients and their social networks, yielding significant clinical improvements. These findings suggest the feasibility and effectiveness of integrating the OD model into the Italian public mental health system, supporting its potential for broader application in diverse healthcare settings. The study highlights the importance of continuous engagement and evaluation to maintain high standards of practice and suggests that OD can be a valuable addition to existing mental health care practices, promoting recovery through inclusive, dialogue-based interventions.

Perceived stress and depressive symptoms during pregnancy and postpartum in Turkish-origin women living in Germany

ObjectivePeople of Turkish origin (also referred to as “with a Turkish migrant background”) are one of the largest migrant groups in Germany and show disparities across different stress-related health outcomes. Specifically, women of Turkish origin in Germany have a greater risk for some mental health issues and adverse pregnancy and birth outcomes compared to women without migrant background. We tested differences between women of Turkish origin and women without migrant background in self-reported pregnancy and postpartum stress experiences and depressive symptoms. Methods32 women of Turkish origin (mean age 29.7 years) and 77 women without migrant background (mean age 32 years) participated in a multi-site prospective cohort study with two study visits during pregnancy and one month postpartum. Women provided sociodemographic data and completed the Perceived Stress Scale (PSS) and the Center for Epidemiology – Depression (CESD) scale at each study visit. ResultsUsing hierarchical linear models, we found that women of Turkish origin (both first and second generation) reported more perceived stress (b = 0.57, CI: 0.29–0.84, p < 0.001) and depressive symptoms (b = 0.32, CI = 0.14–0.49, p < 0.001) compared to women without migrant background across gestation. A linear regression analysis showed that there was also a significant difference in depressive symptoms at one month postpartum (b = 0.35, CI = 0.03–0.66, p < 0.05). ConclusionTailored psychosocial interventions are needed to address mental health needs of pregnant Turkish origin women and to intervene on the possible transmission of stress-related health disadvantages to their offspring.

Loss to Follow-up and Death Among Individuals With Newly Diagnosed Human Immunodeficiency Virus Receiving Dolutegravir-Based First-Line Antiretroviral Treatment in Eastern Ethiopia: Implications for 95% United Nations Targets.

Loss to follow-up (LTFU) and death are unfavorable outcomes of human immunodeficiency virus (HIV) treatment. This study aimed to identify the predictors of LTFU and death among individuals with newly diagnosed HIV receiving dolutegravir (DTG)-based first-line antiretroviral treatment (ART) in eastern Ethiopia. A multisite prospective cohort study was carried out between October 2020 and July 2022. New case patients who started ART were enrolled consecutively and then followed up for the next 6 months. A structured questionnaire and checklists were used to collect data. HIV viral load was determined using the Abbott RealTime HIV-1 assay. Bivariable and multivariable logistic regression models were used to identify baseline factors associated with the outcomes. A total of 235 people with newly diagnosed HIV were enrolled; 16.6% (95% confidence interval, 12.3%-21.9%) were lost to follow-up, and 5.9% (3.5%-9.8%) died within 6 months of follow-up. Baseline World Health Organization clinical stage I (adjusted odds ratio, 3.93 [95% confidence interval, 1.34-11.57]), low viral load (3.67 [1.09-12.36]), and body weight (1.04 [1.01-1.07]) were predictors of LTFU, whereas nonfunctional status (10.02 [1.9-51.3]) was the only factor associated with death. LTFU and death rates among patients with DTG were relatively high, accounting for roughly a quarter of the attrition of people with newly diagnosed HIV from ART care and services. Thus, targeted interventions are required to reduce LTFU and death among individuals with HIV on ART. Further investigation is necessary to evaluate the long-term effects of DTG-based regimens on LTFU and its impact on HIV mortality rates, and qualitative research, specifically tracing LTFU, is recommended.

Telehealth and In-Person Behavioral Health Services in Rural Communities Before and During the COVID-19 Pandemic: Multisite Prospective Cohort Study.

The COVID-19 pandemic triggered widespread adjustments across the US health care system. Telehealth use showed a substantial increase in mental health conditions and services due to acute public health emergency (PHE) behavioral health needs on top of long-standing gaps in access to behavioral health services. How health systems that were already providing behavioral telehealth services adjusted services and staffing during this period has not been well documented, particularly in rural areas with chronic shortages of behavioral health providers and services. This study investigates patient and treatment characteristic changes from before the COVID-19 PHE to during the PHE within both telehealth and in-person behavioral health services provided in 95 rural communities across the United States. We used a nonrandomized, prospective, multisite research design involving 2 active treatment groups. The telehealth cohort included all patients who initiated telehealth treatment regimens during the data collection period. A comparison group included a cohort of patients who initiated in-person treatment regimen. Patient enrollment occurred on a rolling basis, and data collection was extended for 3 months after treatment initiation for each patient. Chi-square tests compared changes from pre-PHE to PHE time periods within telehealth and in-person treatment cohorts. The dependent measures included patient diagnosis, clinicians providing treatment services, and type of treatment services provided at each encounter. The 4780 patients in the telehealth cohort and the 6457 patients in the in-person cohort had an average of 3.5 encounters during the 3-month follow-up period. The encounters involving anxiety, dissociative, and stress-related disorders in the telehealth cohort increased from 30% (698/2352) in the pre-PHE period to 35% (4632/12,853) in the PHE period (P<.001), and encounters involving substance use disorders in the in-person cohort increased from 11% (468/4249) in the pre-PHE period to 18% (3048/17,047) in the PHE period (P<.001). The encounters involving treatment service codes for alcohol, drug, and medication-assisted therapy in the telehealth cohort increased from 1% (22/2352) in the pre-PHE period to 11% (1470/13,387) in the PHE period (P<.001); likewise, encounters for this type of service in the in-person cohort increased from 0% (0/4249) in the pre-PHE period to 16% (2687/17,047) in the PHE period (P<.001). From the pre-PHE to the PHE period, encounters involving 60-minute psychotherapy in the telehealth cohort increased from 8% (190/2352) to 14% (1802/13,387; P<.001), while encounters involving group therapy in the in-person cohort decreased from 12% (502/4249) to 4% (739/17,047; P<.001). The COVID-19 pandemic challenged health service providers, and they adjusted the way both telehealth and in-person behavioral therapy services were delivered. Looking forward, future research is needed to explicate the interaction of patient, provider, setting, and intervention factors that influenced the patterns observed as a result of the COVID-19 pandemic.

Clinic presentation delay and tuberculosis treatment outcomes in the Lake Victoria region of East Africa: A multi-site prospective cohort study.

In the Lake Victoria region of East Africa, little is known about delays between tuberculosis (TB) symptom onset and presentation at a clinic. Associations between clinic presentation delay and TB treatment outcomes are also poorly understood. In 2019, we abstracted data from routine TB treatment records for all adults (n = 776) initiating TB treatment in a 6-month period across 12 health facilities near Lake Victoria. We interviewed 301 cohort members and assessed whether they experienced a clinic presentation delay longer than 6 weeks. We investigated potential clinical and demographic correlates of clinic presentation delay and examined the association between clinic presentation delay and an unfavorable TB treatment outcome (death, loss to follow-up, or treatment failure). Clinic presentation delay was common, occurring among an estimated 54.7% (95% CI: 48.9%, 61.2%) of cohort members, though no specific correlates were identified. Clinic presentation delay was slightly associated with unfavorable TB treatment outcomes. The 180-day risk of an unfavorable outcome was 14.2% (95% CI: 8.0%, 20.4%) among those with clinic presentation delay, compared to 12.7% (95% CI: 5.1%, 20.3%) among those presenting earlier. Multi-level community-based interventions may be necessary to reduce clinic presentation delays in communities near Lake Victoria.

Humoral Immune Response to Messenger RNA Coronavirus Disease 2019 Vaccination Among Children Aged 5-11 Years in a Multisite Prospective Cohort Study, September 2021-September 2022.

The PROTECT study is a longitudinal cohort study initiated in July 2021 with weekly testing for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in 4 states: Arizona, Florida, exas, and Utah. This study aims to examine vaccine-elicited antibody response against postvaccination SARS-CoV-2 infections. Children aged 5-11 years had serum collected 14-59 days after their second dose of monovalent Pfizer-BioNTech coronavirus disease 2019 messenger RNA vaccine. Vaccine-elicited antibodies were measured using the area under the curve (AUC) and end-point titer using enzyme-linked immunosorbent assay (receptor-binding domain [RBD] and S2) and surrogate neutralization assays against ancestral (WA1) and Omicron (BA.2). 79 vaccinated participants (33 [41.7%] female; median age, 8.8 years [standard deviation, 1.9 years]), 48 (60.8%) were from Tucson, Arizona; 64 (81.0%) were non-Hispanic white; 63 (80.8%) attended school in person; 68 (86.1%) did not have any chronic conditions; and 47 (59.5%) were infected after vaccination. Uninfected children had higher AUCs against WA1 (P = .009) and Omicron (P = .02). The geometric mean and surrogate neutralization titer above the limit of detection was 346.0 for WA1 and 39.7 for Omicron, an 8.7-fold decrease (P < .001). After adjustment of covariates in the WA1-specific model, we observed a 47% reduction in the odds of postvaccination infection for every standard deviation increase in RBD AUC (aOR, 0.53 [95% confidence interval, .29-.97) and a 69% reduction in the odds of infection for every 3-fold increase in RBD end titer (0.31 [.06-1.57]). Children with higher antibody levels experienced a lower incidence of postvaccination SARS-CoV-2 infection.

Day-of-the-Week and Time-of-the-Day Patterns of Sedentary Behavior in the Hispanic Community Health Study/Study of Latinos.

Existing sedentary behavior interventions have largely achieved mixed results. Conventionally, interventions have attempted to reduce sedentary behavior using a full-day approach. An alternative strategy may be to target specific periods during the day and/or week. This study examined the day-of-the-week (Monday to Sunday) and time-of-the-day patterns (3-and 6-h periods) of sedentary behavior among U.S. Hispanics/Latinos adults. Participants ( n = 12,241) from the Hispanic Community Health Study/Study of Latinos, a multisite community-based prospective cohort study of Hispanic/Latino adults, were studied. Sedentary behavior was assessed for 1 wk using a hip-mounted accelerometer through total sedentary time, sedentary time in bouts ≥60 min, and total number of sedentary breaks. The temporal patterns of sedentary behavior metrics were evaluated using linear mixed effect models accounting for the Hispanic Community Health Study/Study of Latinos complex survey design. There were statistically significant variations in temporal patterns across day-of-the-week and time-of-the-day periods for all three metrics ( P < 0.001). Adults were more sedentary on weekends than on weekdays and most sedentary on Sundays. The time-of-the-day patterns had a U-curve pattern wherein adults were most sedentary late at night, became less sedentary throughout the day, reached peak activeness around noon, then gradually became more sedentary into the evening. These patterns were largely robust across seasonality and most sociodemographic characteristics, including age, employment status, work shift schedule, acculturation, and field center. Our findings suggest that early mornings, evenings, and weekends were the more sedentary periods in this cohort of Hispanic/Latino adults, characterized by higher volumes of sedentary time, higher volumes of time in prolonged sedentary bouts, and fewer number of sedentary breaks than other time periods, highlighting important windows of opportunity to reduce sedentary behavior.

Left Ventricular Dysfunction Associated With Brain Death: Results From the Donor Heart Study.

Left ventricular dysfunction in potential donors meeting brain death criteria often results in nonuse of donor hearts for transplantation, yet little is known about its incidence or pathophysiology. Resolving these unknowns was a primary aim of the DHS (Donor Heart Study), a multisite prospective cohort study. The DHS enrolled potential donors by neurologic determination of death (n=4333) at 8 organ procurement organizations across the United States between February 2015 and May 2020. Data included medications administered, serial diagnostic tests, and transthoracic echocardiograms (TTEs) performed: (1) within 48 hours after brain death was formally diagnosed; and (2) 24±6 hours later if left ventricular (LV) dysfunction was initially present. LV dysfunction was defined as an LV ejection fraction <50% and was considered reversible if LV ejection fraction was >50% on the second TTE. TTEs were also examined for presence of LV regional wall motion abnormalities and their reversibility. We assessed associations between LV dysfunction, donor heart acceptance for transplantation, and recipient 1-year survival. An initial TTE was interpreted for 3794 of the 4333 potential donors by neurologic determination of death. A total of 493 (13%) of these TTEs showed LV dysfunction. Among those donors with an initial TTE, LV dysfunction was associated with younger age, underweight, and higher NT-proBNP (N-terminal pro-B-type natriuretic peptide) and troponin levels. A second TTE was performed within 24±6 hours for a subset of donors (n=224) with initial LV dysfunction; within this subset, 130 (58%) demonstrated reversibility. Sixty percent of donor hearts with normal LV function were accepted for transplant compared with 56% of hearts with reversible LV dysfunction and 24% of hearts with nonreversible LV dysfunction. Donor LV dysfunction, whether reversible or not, was not associated with recipient 1-year survival. LV dysfunction associated with brain death occurs in many potential heart donors and is sometimes reversible. These findings can inform decisions made during donor evaluation and help guide donor heart acceptance for transplantation.

Increased Levels of Psychological Stress and Alterations in Stress Biology during Pregnancy among Women of Turkish-Origin in Germany

People of Turkish origin constitute one of the biggest migrant groups in Germany. They have an increased risk to develop stress-related health disadvantages, and this risk is also prevalent in the offspring generation from early ages on. We have conducted a multi-site prospective cohort study to examine the role of stress and stress biology in this intergenerational perpetuation of health disparities. 140 pregnant women (33 of Turkish origin) participated in a prospective cohort study with two study visits during pregnancy and one after birth (T1: 20-25 weeks of gestation, T2: 30-35 weeks of gestation, T3: four weeks after birth). At T1 and T2, women completed the Perceived Stress Scale and Center for Epidemiologic Studies Depression Scale and collected saliva samples after awakening, 30 minutes after awakening, and in the evening, and venous blood samples were collected for analysis of CRP and IL-6 concentrations. Multilevel models showed that Turkish-origin women exhibited higher levels of perceived stress and depressive symptoms, had increased inflammatory levels (Spallek et al., 2021), a blunted cortisol awakening response and flatter diurnal cortisol slope during pregnancy compared to non-migrant women after adjustment for socioeconomic factors.Some of the effects were mainly driven by 2nd generation migrants. Increased levels of psychosocial stress and stress-related biological alterations among Turkish-origin pregnant women may contribute to the intergenerational transmission of health disadvantages in this group.

Use of Infrared Thermometry to Observe Temperature Variation Associated with the Healing Process in Wounds and Ulcers: TIHUAP Cohort Study Protocol.

We are interested in observing how temperature differences between the wound bed and perilesional skin are related to the healing process in primary care patients with wounds. Multisite prospective cohort study with one-year follow-up in the Metropolitan North area of Barcelona. Recruitment of patients over 18 years with an open wound will take place from January 2023 to September 2023. Temperature checks will be conducted on a weekly basis at control visits and wound care. The following variables will be measured: Percentage reduction of wound area over time, thermal index, the Kundin Wound Gauge, and the Resvech 2.0 Scale. The temperature will be measured weekly using a handheld thermometer and mesh grid to frame the temperature points. The healing trajectory will also be monitored on a monthly basis via photographic imaging, the Resvech Scale, calculation of wound size, percentage reduction of wound area over time, and thermal index for one year of follow-up or until the wound is cured. This study may represent a turning point for its introduction into primary care. Early diagnosis of wound complications would facilitate treatment decision-making for healthcare professionals, thus improving the management of resources related to chronic wounds.

Geographic mobility and treatment outcomes among people in care for tuberculosis in the Lake Victoria region of East Africa: A multi-site prospective cohort study.

Geographic mobility may disrupt continuity of care and contribute to poor clinical outcomes among people receiving treatment for tuberculosis (TB). This may occur especially where health services are not well coordinated across international borders, particularly in lower and middle income country settings. In this work, we describe mobility and the relationship between mobility and unfavorable TB treatment outcomes (i.e., death, loss to follow-up, or treatment failure) among a cohort of adults who initiated TB treatment at one of 12 health facilities near Lake Victoria. We abstracted data from health facility records for all 776 adults initiating TB treatment during a 6-month period at the selected facilities in Kenya, Tanzania, and Uganda. We interviewed 301 cohort members to assess overnight travel outside one's residential district/sub-county. In our analyses, we estimated the proportion of cohort members traveling in 2 and 6 months following initiation of TB treatment, explored correlates of mobility, and examined the association between mobility and an unfavorable TB treatment outcome. We estimated that 40.7% (95% CI: 33.3%, 49.6%) of people on treatment for TB traveled overnight at least once in the 6 months following treatment initiation. Mobility was more common among people who worked in the fishing industry and among those with extra-pulmonary TB. Mobility was not strongly associated with other characteristics examined, however, suggesting that efforts to improve TB care for mobile populations should be broad ranging. We found that in this cohort, people who were mobile were not at increased risk of an unfavorable TB treatment outcome. Findings from this study can help inform development and implementation of mobility-competent health services for people with TB in East Africa.

The human connection: Oncologist characteristics that facilitate therapeutic bonding among Latino patients with advanced cancer.

e18676 Background: Therapeutic alliances (TA) are bonds between patients and their oncologists characterized by mutual caring, trust, understanding, and respect. They lay the foundation for the provision of high-quality cancer care. We here relate oncologist characteristics to TA in Latino vs. non-Latino advanced cancer patients. Results will inform the development of an intervention to train oncologists in how to develop a strong TA with their Latino patients. Methods: The study population included non-Latino oncologists (n = 41) and their Latino (n = 67) and non-Latino white (n = 90) patients with advanced cancers who participated in Coping with Cancer III, a multi-site prospective cohort study designed to examine Latino/non-Latino disparities in advance care planning and end-of-life cancer care, conducted at U.S. medical centers from 2015-2019. Oncologist characteristics included age, sex, race, institution type, Spanish language proficiency and practice style behaviors (e.g., “familismo”— embracing dedication, commitment, and loyalty to family), addressing patients by their first name, and personal disclosure (e.g., “personalismo”), among others. The average score of 6 items from The Human Connection scale was used to assess the patients’ TA with their oncologists. Hierarchical linear modeling (HLM) was used to evaluate the effects of oncologist characteristics on TA in the full patient sample and stratified by patient ethnicity. Results: Of the 157 patients, 67 (42.7%) were Latino; most were female (n = 92, 58.6%) and &lt; 65 years old (n = 95, 60.5%). Most oncologists were male (n = 24, 58.5%), non-Latino? white (n = 25, 61%), and ≥ 40 years (n = 25, 61%). There were no significant associations between patient age, sex, Medicaid recipient status, education level, marital status, and geographic region with TA. An adjusted HLM in the full sample showed that Latino ethnicity was associated with significantly lower TA (b = −0.16, p = 0.037). In an adjusted HLM for TA stratified by ethnicity, oncologist preference to address patients by their first names (b = 0.34, p = 0.001) and a “familismo” practice style (b = 0.46, p = 0.001) were positively associated with TA among Latino patients. In contrast, “familismo” had no impact on TA for the non-Latino white patients. Conclusions: In this study, Latino patients with advanced cancer had a worse therapeutic alliance with their oncologists compared to non-Latino patients. Cultural differences between Latino and non-Latino white patients may be leveraged in an intervention designed to improve the therapeutic bonding and patient-clinician relationship between oncologists and their Latino patients with advanced cancer, thus potentially mitigating cancer care disparities in this important, often underserved, patient population.

Associations of frailty with overall survival (OS) and functional decline among older adults with non–small-cell lung cancer (NSCLC) receiving chemotherapy, immunotherapy, and/or targeted therapy.

12040 Background: Among older adults with cancer receiving chemotherapy, frailty indices can predict poor outcomes including survival and toxicity. Given the increasing use of immunotherapy and targeted therapy to treat NSCLC, we assessed the prognostic importance of frailty among older adults with NSCLC receiving systemic therapy. Methods: This multi-site prospective cohort study enrolled adults age ≥65 with advanced NSCLC starting chemotherapy, immunotherapy, and/or targeted therapy with non-curative intent. Patients completed geriatric assessments pretreatment and at 1, 2, 4, and 6 months. We constructed a 47-item deficit-accumulation frailty index including pretreatment demographic, geriatric assessment, and clinical factors using established methodology. Frailty scores ranged from 0 (no frailty deficits) to 1 (all frailty deficits present). We categorized patients as robust ( &lt; 0.2), pre-frail (0.2-0.34), or frail (≥0.35). The primary outcome was OS. Secondary outcomes included treatment-related grade ≥3 adverse events (AE), unplanned hospitalization, and functional decline in instrumental activities of daily living (IADL). We conducted a Kaplan-Meier survival analysis to estimate OS by frailty group and Cox proportional hazards models adjusting for treatment type. We used logistic regression models to evaluate the association of frailty with secondary outcomes adjusting for treatment type. Results: Among 149 patients, median age was 73 (range 65-94). During the study, 32% received targeted therapy, 29% immunotherapy, 27% chemoimmunotherapy, and 12% chemotherapy. Overall 43% of patients were robust, 38% pre-frail, and 19% frail. Frailty was associated with Asian race, lower education, Medicaid insurance, and no prior NSCLC surgery. Notably, frailty was not associated with age or treatment type. Median OS was 18.7 months overall: not reached for robust patients, 8.9 months for pre-frail, and 5.6 months for frail patients. Adjusting for treatment type, pre-frail (HR 2.11, 95% CI 1.24-3.60; p = 0.006) and frail (HR 2.86, 95% CI 1.52-5.39; p = 0.001) patients had worse OS compared to robust patients. During treatment, 29% developed a grade ≥3 AE, 31% had an unplanned hospitalization, and 41% developed IADL decline. Pre-frail/frail patients were more likely to develop IADL decline (HR 2.18, 95% CI 1.02-4.68; p = 0.04) than robust patients, but there were no differences in toxicity or hospitalization. Conclusions: Frailty is prognostic for OS among older adults with advanced NSCLC receiving systemic therapy across treatment types and predicted IADL decline. Frailty assessment before initiation of systemic therapy may help identify older adults with advanced NSCLC at higher risk of poor outcomes to inform decision making, individualize anticipatory guidance, and optimize supportive care.

Main Street, USA Enrollment: Community Hospital Recruitment Strategies for Diverse and Equitable Selection of Pregnant Participants in a Prospective Cohort Study [ID: 1377833

INTRODUCTION: The same factors contributing to disproportionately worse health outcomes are also barriers to inclusion in research for Black, Hispanic, and Indigenous patients. In this subanalysis of a large, multisite prospective cohort study of maternal plasma mRNA signatures and adverse pregnancy outcomes (APOs), we sought to determine whether equitable representation was aided by the inclusion of a large community hospital as an enrollment site. METHODS: Pregnant persons between 18 and 45 year old with a singleton pregnancy eligible to enroll in this IRB-approved prospective cohort study at Woman’s Hospital (Baton Rouge, Louisiana). A hybrid of indirect and direct recruitment strategies, bolstered by text message communication and gift card compensation, were deployed to facilitate enrollment that mirrored the community’s diversity. RESULTS: Two thousand five hundred twenty-two participants have been enrolled over 22 months (18% of the hospital’s eligible patient population): 41% of participants are Black, 9% are of Hispanic origin, 50% are White, and 9% Other race. This identically mirrors the demographics of the hospital obstetric patient population (38% Black, 7% Hispanic, 49% White, and 13% Other). CONCLUSION: Participants overall mirrored the diverse population served. Inclusion of study sites outside of the traditional academic setting is an effective strategy for promoting equitable access to clinical research, combating barriers to inclusion in research faced by the populations that are disproportionately affected by APOs.

Assessment of Neurodevelopment in Infants With and Without Exposure to Asymptomatic or Mild Maternal SARS-CoV-2 Infection During Pregnancy

Associations between prenatal SARS-CoV-2 exposure and neurodevelopmental outcomes have substantial public health relevance. A previous study found no association between prenatal SARS-CoV-2 infection and parent-reported infant neurodevelopmental outcomes, but standardized observational assessments are needed to confirm this finding. To assess whether mild or asymptomatic maternal SARS-CoV-2 infection vs no infection during pregnancy is associated with infant neurodevelopmental differences at ages 5 to 11 months. This cohort study included infants of mothers from a single-site prospective cross-sectional study (COVID-19 Mother Baby Outcomes [COMBO] Initiative) of mother-infant dyads and a multisite prospective cohort study (Epidemiology of Severe Acute Respiratory Syndrome Coronavirus 2 in Pregnancy and Infancy [ESPI]) of pregnant individuals. A subset of ESPI participants was subsequently enrolled in the ESPI COMBO substudy. Participants in the ongoing COMBO study were enrolled beginning on May 26, 2020; participants in the ESPI study were enrolled from May 7 to November 3, 2021; and participants in the ESPI COMBO substudy were enrolled from August 2020 to March 2021. For the current analysis, infant neurodevelopment was assessed between March 2021 and June 2022. A total of 407 infants born to 403 mothers were enrolled (204 from Columbia University Irving Medical Center in New York, New York; 167 from the University of Utah in Salt Lake City; and 36 from the University of Alabama in Birmingham). Mothers of unexposed infants were approached for participation based on similar infant gestational age at birth, date of birth, sex, and mode of delivery to exposed infants. Maternal symptomatic or asymptomatic SARS-CoV-2 infection. Infant neurodevelopment was assessed using the Developmental Assessment of Young Children, second edition (DAYC-2), adapted for telehealth assessment. The primary outcome was age-adjusted standard scores on 5 DAYC-2 subdomains: cognitive, gross motor, fine motor, expressive language, and receptive language. Among 403 mothers, the mean (SD) maternal age at delivery was 32.1 (5.4) years; most mothers were of White race (240 [59.6%]) and non-Hispanic ethnicity (253 [62.8%]). Among 407 infants, 367 (90.2%) were born full term and 212 (52.1%) were male. Overall, 258 infants (63.4%) had no documented prenatal exposure to SARS-CoV-2 infection, 112 (27.5%) had confirmed prenatal exposure, and 37 (9.1%) had exposure before pregnancy or at an indeterminate time. In adjusted models, maternal SARS-CoV-2 infection during pregnancy was not associated with differences in cognitive (β = 0.31; 95% CI, -2.97 to 3.58), gross motor (β = 0.82; 95% CI, -1.34 to 2.99), fine motor (β = 0.36; 95% CI, -0.74 to 1.47), expressive language (β = -1.00; 95% CI, -4.02 to 2.02), or receptive language (β = 0.45; 95% CI, -2.15 to 3.04) DAYC-2 subdomain scores. Trimester of exposure and maternal symptom status were not associated with DAYC-2 subdomain scores. In this study, results of a novel telehealth-adapted observational neurodevelopmental assessment extended a previous finding of no association between prenatal exposure to maternal SARS-CoV-2 infection and infant neurodevelopment. Given the widespread and continued high prevalence of COVID-19, these data offer information that may be helpful for pregnant individuals who experience asymptomatic or mild SARS-CoV-2 infections.