RTI Health Solutions

The COVID-19 pandemic severely disrupted healthcare systems, placing immense physical, emotional, and organizational strain onfront linenursing staff, including registered nurses and nursing assistants. These professionals faced heightened stress due to increased virus exposure, global personal protective equipment (PPE) shortages, and rapidly changing protocols. This study sought to explore the experiences of registered nurses and nursing assistants working in inpatient care during the COVID-19 pandemic, focusing on workplace stressors and available or recommended resources to mitigate these challenges. Despite extensive documentation of elevated stress and burnout among nurses during COVID-19, little is known about how registered nurses and nursing assistants appraised specific workplace stressors and evaluated the adequacy of available organizational resources during the pandemic. Using a qualitative descriptive design, semi-structured interviews were conducted with 14 registered nurses and six nursing assistants from COVID-19 and non COVIDunits at a large academic medical center. Guided by Lazarus and Folkman's Stress and Coping Model, the analysis identified a range of personal, interpersonal, organizational, and societal stressors. Personal stressors included long work hours, loss of loved ones to COVID-19, and feelings of isolation. Interpersonal stressors involved exposure risk, emotional strain from coworkers' stress, and shifts in bedside roles. Organizational stressors encompassed staffing shortages, changes in protocols, and being called off shifts. Societal stressors included inconsistent public health messaging and concerns about protecting vulnerable family members. Participants emphasized the importance of authentic leadership and nursing-centered delivery of resources in addressing these stressors. Six key resource categories emerged: emotional support, staffing, safety, compensation, communication, and stress management. Findings highlight the critical role of nurse managers, effective communication, and staffing policies in mitigating workplace challenges. While rooted in a U.S. context, these insights may inform strategies to support nursing staff globally in future crises, reinforcing the need for tailored, sustainable approaches tofront linecaregiver well-being.

Abstract Background: Maintenance endocrine therapy (mET) is increasingly used as part of the post-chemotherapy treatment for HER2-positive, hormone receptor-positive metastatic breast cancer (HER2+, HR+ mBC). However, the impact of mET on delaying brain metastases (BM) and other clinical outcomes is unclear. As the time from taxane completion to mET initiation can vary considerably, standard cohort methods with fixed index dates can lead to immortal time and selection bias. This study estimates the effect of different mET treatment strategies (TS) on BM-free survival (BMFS), overall survival (OS), and real-world progression-free survival (rwPFS) in patients (pts) with HER2+, HR+ mBC without BM. Methods: The study used the Flatiron Health database (January 2011-September 2024). mET included aromatase inhibitors, selective estrogen receptor degraders or modulators, and ovarian function suppression. Our target trial compared four TS in pts with HER2+, HR+ mBC who had completed ≥5 cycles of 1L HER2-targeted therapy + taxane (baseline was last taxane administration): Arm 1: mET initiation within 3 months (mo) of baseline; Arm 2: no mET initiation within 3 mo of baseline (initiation was possible afterwards); Arm 3: no mET initiation within 60 mo of baseline; and Arm 4: mET initiation between 4-6 mo of baseline. In all TS, CDK4/6 inhibitor use was not permitted and pts who initiated 2L treatment/had a BMFS/OS/rwPFS event were excluded from the TS. In the target trial emulation (TTE), pts were assigned to all TS with which their baseline data were compatible, creating four clones (TS were not distinguishable at baseline), and were censored upon deviation from the assigned TS. BMFS, OS, rwPFS were measured up to 60 mo from last taxane administration (LTA); risk differences and risk ratios were estimated via pooled logistic regression adjusted for baseline confounders (de novo vs. recurrent disease, disease-free interval, treatment at an academic center, Roche Prognostic Score, last HR test being negative despite prior positive tests). Estimates were bounded with percentile-based 95% confidence intervals (CI) estimated via bootstrapping. Sensitivity analyses included changes in grace period, time discretization, functional form of time, censoring of early death events, and simulation of uniform initiation of TS. Results: The TTE (N = 784) evaluated 391 pts who received ET within 3 mo and 393 pts who did not receive ET within 3 mo. At the time of taxane completion, baseline characteristics were generally balanced between pt groups, except ET pts were more likely to be treated in an academic center (25.8% vs. 17.3%) and less likely to have a negative latest HR test (3.6% vs. 12.7%). The difference in the risk of death (95% CI) comparing Arm 1 vs. Arm 3 was -3.2% (-5.6, -0.8) at 12 mo and -6.5% (-10.9, -1.7) at 24 mo (negative estimates favor Arm 1). The corresponding risk differences for rwPFS were -6.8% (-16.0, 0.9) and -10.1% (-20.3, -1.9), and for BMFS, -2.0% (-8.9, 4.7) and -4.7% (-13.0, 2.8). Treatment effect estimates were less precise beyond 36 mo due to loss to follow-up. Similar estimates were found against other TS, although the limited number of pts with data compatible with Arm 4 yielded imprecise estimates. Conclusions: Early mET within 3 mo of LTA was associated with improved clinical outcomes in pts with HER2+, HR+ mBC (although the limited number of BMFS events and modest estimates prevent making any firm conclusions). The TTE framework for comparative effectiveness studies with flexible treatment initiation helps align real-world data with randomized clinical trials, supporting better design of real-world data studies including comparisons of TS that can inform clinical practice. Citation Format: T. Sanglier, I. Gravestock, J. Leone, M. Secrest, C. Tchakoute, E. Restuccia, F. Montemurro, M. Shivhare, A. Knott, P. Lambert, D. Martinez, P. Luhn, X. Garcia de Albeniz Martinez, S. Tolaney, N. Lin, S. Sammons. Estimating the effect of initiating early maintenance endocrine therapy on brain metastases-free survival and other clinical outcomes in patients with HER2+/HR+ mBC without brain metastases: A target trial emulation [abstract]. In: Proceedings of the San Antonio Breast Cancer Symposium 2025; 2025 Dec 9-12; San Antonio, TX. Philadelphia (PA): AACR; Clin Cancer Res 2026;32(4 Suppl):Abstract nr PS5-01-10.

PurposeValidated patient-reported outcome measures (PROMs) are required for use in clinical trials of celiac disease (CeD) therapies. The Celiac Disease Symptom Diary 2.1© (CDSD 2.1©), which measures the daily severity of core CeD symptoms (abdominal pain, bloating, diarrhea, nausea, tiredness), was developed according to the latest regulatory guidelines for fit-for-purpose PROMs. This study evaluated the psychometric properties of CDSD 2.1.MethodsPsychometric properties of CDSD 2.1 were evaluated using data from a 12-week US observational study, the Virtual Celiac Symptoms Study (NCT05309330), in patients with CeD maintaining a gluten-free diet. Participants completed CDSD 2.1 daily and other PROMs (Patient Global Impression of Severity [PGIS], Gastrointestinal Symptom Rating Scale [GSRS], and Celiac Symptom Index [CSI]) at specified time points to evaluate the reliability, validity, and responsiveness of CDSD 2.1.ResultsOverall, 480 participants (338 adults, 142 adolescents) completed the study. Cronbach’s alpha (baseline = 0.77 adults/adolescents) indicated high internal consistency reliability of weekly average gastrointestinal (GI; abdominal pain, bloating, nausea, diarrhea) CDSD 2.1 scores. An intraclass correlation coefficient of 0.89 (adults)/0.88 (adolescents) demonstrated high test-retest reliability among stable patients on PGIS. Moderate-to-strong correlations between weekly average GI CDSD 2.1 scores and GSRS domains at baseline and CSI at Week 3 confirmed construct validity (r = 0.44–0.76; p<0.05). Weekly average GI CDSD 2.1 score changes followed expected patterns based on PGIS change groups, demonstrating responsiveness.ConclusionThis evaluation provides evidence to support the use of CDSD 2.1 in clinical trials as a reliable and responsive measure of CeD symptom severity.

Congenital cytomegalovirus (cCMV) is the most common congenital infection worldwide. cCMV can result in long-term impairments such as hearing loss and developmental delay. The study objective was to understand the caregiver experience of cCMV and caregiver-reported perceptions of the experience for cCMV patients. This non-interventional, cross-sectional study interviewed 25 caregivers of patients (aged 4 months to 17 years) with confirmed cCMV in the United States. Semi-structured qualitative interviewing methods were used to elicit descriptions of cCMV symptoms and their impact on the patient as perceived by the caregiver. Separate questions assessed the caregiver burden of a patient with cCMV. Transcripts were analyzed using an iterative coding process to identify key concepts. All caregivers reported increased healthcare needs for their child with cCMV. Other caregiver-reported patient impacts spanned multiple domains including emotional, physical and social functioning, education and communication. For example, a child with cCMV-related communication/hearing difficulties experiencing sadness or social isolation, or with cCMV-related seizures resulting in worry or apprehension. The caregiver impacts of caring for a child with cCMV also covered multiple domains including emotional, role and social functioning, work, sleep, and family planning. Emotional functioning was considered the greatest impact by approximately half of caregivers. These results advance understanding of experiences related to cCMV for caregivers and caregiver-reported perceptions of the patient experience. This may help healthcare professionals improve routine clinical practice for families affected by cCMV. The results and conceptual model may also support the development of a disease-specific clinical outcome assessment tool. Cytomegalovirus is a common virus, usually mild in healthy adults, that can be passed to an unborn baby during pregnancy (congenital cytomegalovirus). Some babies born with congenital cytomegalovirus have long-term health problems, such as hearing loss or learning disabilities. This study interviewed 25 parents caring for children with congenital cytomegalovirus in the United States to explore the impact of the disease on the lives of patients and caregivers. Impacts of congenital cytomegalovirus on the children, as reported by the caregivers, included emotional (e.g., anxiety, fear, worry), physical (e.g., needing devices to assist hearing) or social effects (e.g., social withdrawal), or difficulties with education or communication. All caregivers reported emotional impacts such as feelings of shock, anxiety, and fear, sometimes lasting a long time as parents worried about potential future impacts of congenital cytomegalovirus on their child. These results help to understand the impacts of congenital cytomegalovirus on the lives of patients and their families.

Limited evidence exists on prevailing treatments, disease characteristics and real-world outcomes of patients with alopecia areata (AA), particularly for those with ≥ 50% scalp hair loss (SHL) managed in clinical settings outside the USA. To provide evidence on disease characteristics, clinical management and outcomes of patients with AA with ≥ 50% SHL from real-world practice settings in Europe. The Assessment of real-world Disease characteristics and outcomes in Alopecia Areata in a Global non-Interventional Observational cohort (ADAAGIO) study was a retrospective chart review study in the UK, France, Spain and Germany. Adults and adolescents with ≥ 50% SHL were included. The first clinical observation of ≥ 50% SHL defined the study index date (2015-2019). Patients had ≥ 6 months of follow-up from index. Analyses were descriptive. The primary endpoint was the absolute Severity of Alopecia Tool (SALT) score, assessed longitudinally. Other endpoints included change in SALT score from baseline, and sustained SALT ≤ 20, defined as time to achieving SALT ≤ 20 without regression to SALT > 30 within 6 months, and sustained SALT ≤ 20 was assessed via inverse probability of censoring weighting (IPCW)-adjusted Kaplan-Meier estimation. In total, 741 patients were included [median age at index: 27 years (range 12-81); 52.6% (390/741) female]. The mean SALT score at index was 63.5 (SD 15.6); 80.2% (594/741) had patchy AA and 19.8% (147/741) had alopecia totalis or universalis. Topical corticosteroids were the most common treatment post-index, with 55.6% (412/741) receiving ≥ 1 course with a median cumulative exposure of 4 months. Systemic and intralesional corticosteroids [44.1% (327/741) and 22.5% (167/741), respectively], Systemic and intralesional corticosteroids [44.1% (327/741) and 22.5% (167/741), respectively], systemic were also common. The mean absolute SALT reduction at 12 months post-index was -44.6% (SD 37.3%). However, at 12 months, based on IPCW-adjusted estimation, few patients (10.6%) achieved SALT ≤ 20 that was sustained for ≥ 6 months. Although patients in this study experienced substantial absolute SALT score reductions, few achieved and sustained SALT ≤ 20. These findings highlight the potential suboptimal effectiveness of the varied treatments.

Type 2 diabetes is a leading cause of chronic kidney disease (CKD). Individuals with both conditions have increased risk of poor cardiorenal outcomes and mortality. The rapidly evolving landscape for CKD-protective therapies in type 2 diabetes currently includes sodium-glucose cotransporter 2 inhibitors (SGLT2i) and glucagon-like peptide-1 receptor agonists (GLP-1 RA), both of which demonstrate cardiorenal outcome benefits. As part of the FOUNTAIN platform (ClinicalTrials.gov ID: NCT05526157; EUPAS ID: EUPAS48148), this study aimed to better understand changes in patient characteristics and treatment patterns corresponding with updates toclinical guideline recommendations and drug labeling and the emergence of new CKD-protective therapies such as finerenone in the US in 2021-2022. An observational real-world data study assessed patient characteristics and drug utilization in separate SGLT2i and GLP-1 RA new-user cohorts of adults with CKD and type 2 diabetes in an earlier (1 January 2012-30 June 2021) and a later (9 July 2021-30 September 2023) period using Optum's de-identified Clinformatics® Data Mart Database (Optum® CDM). Compared with the earlier period new users, later period new users in both cohorts were older, had more severe CKD, used less intensive type 2 diabetes medication, and had better metabolic control; SGLT2i new users more frequently had no type 2 diabetes therapy before the index date and greater congestive heart failure prevalence; and GLP-1 RA new users had increased SGLT2i use and decreased insulin use. These findings inform and contextualize future studies assessing cardiorenal outcomes for these and additional treatments, including finerenone, for individuals with CKD and type 2 diabetes.