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ABSTRACT Introduction Postoperative mortality commonly follows complications that are not prevented, recognised or managed effectively. Ward‐based nursing care is central to surveillance, escalation and rescue, but population‐level evidence using shift‐level staffing data is limited. This national population‐based cohort study examined the association between surgical ward nurse staffing and postoperative outcomes. Methods Adults aged 18 years or older undergoing inpatient surgery under general or neuraxial anaesthesia in public hospitals in Aotearoa New Zealand between 2022 and 2024 were included. Prospectively recorded TrendCare staffing data were linked to administrative health datasets. The exposure was shift‐level staffing variance, defined as the difference between required and available nursing care hours on surgical wards in the treating hospital during admission. The primary outcome was 90‐day postoperative mortality. Secondary outcomes were postoperative complications and failure to rescue. Results The cohort included 202 428 patients undergoing 223 415 surgical admissions. Within 90 days, 6296 admissions resulted in death (2.8%). Complications occurred in 41 722 admissions (18.7%), with failure to rescue in 15.1%. Of 281 147 surgical ward shifts, 122 186 (43.5%) were understaffed. After adjustment, each one‐nurse reduction in staffing per shift was associated with higher odds of mortality (aOR: 1.13, 95% CI: 1.07–1.18), complications (aOR: 1.07, 95% CI: 1.05–1.10) and failure to rescue (aOR: 1.07, 95% CI: 1.00–1.14). Modelling estimated that correcting observed staffing deficits was associated with 182 fewer deaths annually. Conclusion Lower surgical ward nurse staffing was associated with increased postoperative mortality, complications and failure to rescue. Nurse staffing is a modifiable system factor associated with postoperative safety and should be prioritised to improve surgical outcomes.

OBJECTIVE Dysphagia has been shown to have an adverse effect on patient quality of life following cervical spine surgery, but its impact on patients’ ability to return to work (RTW) and return to physical activities (RTA) has never been investigated. This study aimed to evaluate the impact of postoperative dysphagia on patients’ ability to RTW and RTA after surgery. METHODS A prospectively maintained multi-institutional spine registry of patients who underwent cervical spine surgery between 2016 and 2023 was retrospectively reviewed. An Eating Assessment Tool-10 (EAT-10) score ≥ 3 was used to quantify preoperative and 12-month postoperative dysphagia. Prolonged dysphagia was defined as new dysphagia present at 12 months among patients without baseline dysphagia. RTW and RTA were assessed at baseline and 12 months postoperatively. Mixed-effects logistic regressions were used to evaluate the effect of dysphagia on RTW and RTA. RESULTS Of the 1208 patients meeting inclusion criteria, 240 (20%) experienced prolonged dysphagia, of whom 208 (87%) underwent anterior surgery. Preoperatively, 709 (59%) patients were fully employed or on short-term leave, 307 (25%) were retired, and 191 (16%) were otherwise unemployed. At the 12-month follow-up, RTW and RTA status were collected for 629 (95%) of the 664 employed patients who planned to RTW after surgery and 1127 (93%) of the total cohort, respectively. Significantly lower rates of RTW (86% vs 96%, p < 0.001) and RTA (62% vs 79%, p < 0.001) were observed in patients with prolonged dysphagia. Multivariable analysis identified dysphagia as being independently associated with lower odds of RTW (OR 0.35, 95% CI 0.14–0.86; p = 0.022) and RTA (OR 0.44, 95% CI 0.31–0.63; p < 0.001). CONCLUSIONS Prolonged postoperative dysphagia—defined as a new EAT-10 score ≥ 3 at 12 months—was associated with substantially lower odds of returning to work and physical activities after cervical spine surgery, underscoring the importance of dysphagia prevention and management in postoperative care.

Abstract Objectives Embedded pragmatic clinical trials (ePCTs) are conducted as part of routine clinical care and therefore use data collected from real-world data sources, such as electronic health record systems and administrative claims. A common approach for using these types of data across all phases of trial conduct is to create a computable phenotype (an explicitly defined data query data, including specified data types, data codes, and logical parameters) to capture patients with a clinical condition, exposure, symptom, characteristic, treatment, or outcome of interest. Materials and Methods The Electronic Health Record (EHR) Core Working Group of the NIH Pragmatic Trials Collaboratory captured the experiences of investigators in developing, adapting, and applying computable phenotype definitions in their studies. Results Four case studies describe different approaches to developing and using computable phenotypes in pragmatic trials. Discussion We recommend: (1) developing computable phenotypes as part of a team with multiple areas of expertise; (2) appropriate validation; (3) dissemination of salient details regarding phenotype creation; and (4) capturing and reporting any modifications made to phenotypes during the conduct of the trial. Conclusion A range of issues and decisions influence how computable phenotypes are developed and used in pragmatic clinical trials. Multidisciplinary teams that understand the context of the data, including the reason the data are collected and potential sources of bias, are best suited for the development and validation of phenotypes for ePCTs.

OBJECTIVE This study examines the recovery rates of patients who experience postoperative dysphagia within 1 month following cervical spine surgery. METHODS Data from a prospectively maintained multi-institutional quality registry were retrospectively analyzed. Eating Assessment Tool-10 (EAT-10) questionnaire scores were collected at baseline and 1, 3, and 12 months postoperatively, with total scores ≥ 3 indicating dysphagia. Patients were grouped by whether they reported baseline dysphagia to assess the impact of baseline dysphagia on recovery. Recovery was defined as resolution of postoperative dysphagia and not reporting the condition at any follow-up time point. Patients were excluded from the recovery model if they did not report dysphagia within 1 month of surgery. Recovery to baseline was defined as reporting a postoperative EAT-10 score equal to or less than the baseline score at subsequent time points. Patients were excluded from the recovery-to-baseline model if they did not report EAT-10 scores within 1 month of surgery that were worse than their baseline score. Survival curves were generated for both models. RESULTS Of the 2003 patients in the registry, 627 met inclusion criteria for the recovery curve and 714 for the recovery-to-baseline curve. Of the patients without baseline dysphagia, 498 developed new postoperative dysphagia within 1 month, with cumulative recovery probabilities of 39.5% by 3 months and 59.1% by 12 months after cervical spine surgery. Furthermore, of the patients without baseline dysphagia, 73.5% (175/238) who reported no dysphagia at 3 months and 32.5% (68/209) who reported no dysphagia at 12 months experienced long-term recovery. Eighty patients with baseline dysphagia reported worse EAT-10 scores within 1 month, with cumulative probabilities of improvement to baseline or below of 37.7% by 3 months and 54.1% by 12 months. Patients with baseline dysphagia were significantly less likely to recover than patients without baseline dysphagia (hazard ratio [HR] 0.37, 95% CI 0.26–0.53; p < 0.001) but significantly more likely to recover to baseline (HR 1.45, 95% CI 1.05–2.00; p = 0.025). CONCLUSIONS Patients who develop postoperative dysphagia within 1 month of cervical spine surgery generally see symptomatic improvement over time. This analysis may aid in clinical decision-making when informing patients about the risk of developing postoperative dysphagia and the recovery rate of this surgical complication.

BACKGROUND AND OBJECTIVES: This study proposes and assesses the validity of postoperative dysphagia severity categories based on patients' Eating Assessment Tool-10 (EAT-10) scores and quality-of-life patient-reported outcome measures (PROMs) collected before and after cervical spine surgery. METHODS: A prospectively collected multi-institutional quality registry including 2003 patients was retrospectively reviewed. Patients were categorized based on EAT-10 score severities, with thresholds determined by existing literature and significant differences in PROMs: none (0-2), mild (3-4), moderate (5-15), and severe (16-40). Correlations between EAT-10 severity and established PROMs were assessed at baseline, 3-, and 12-month follow-ups. The Dunn test using Bonferroni adjustment was used to identify differences in PROMs between EAT-10 severities. Multivariate linear regression assessed how EAT-10 severity affects PROMs at baseline, 3-, and 12-month follow-ups. RESULTS: Among 1659 patients with 3-month EAT-10 data, there were 1183 no, 149 mild, 245 moderate, and 82 severe dysphagia patients. Neck Disability Index and EuroQol 5-Dimension scores were significantly different between none vs mild ( P < .001; P = .001), mild vs moderate ( P < .001; P < .001), and moderate vs severe ( P = .035; P = .024) at 3 months. Among 1405 patients with 12-month EAT-10 data, there were 1044 no, 100 mild, 194 moderate, and 67 severe dysphagia patients. Neck Disability Index scores were significantly different between none vs mild ( P < .001) and moderate vs severe ( P = .004) but not for mild vs moderate ( P > .9) at 12 months. EuroQol 5-Dimension scores were significantly different between none vs mild ( P = .004) and mild vs moderate ( P = .005) but not for moderate vs severe ( P = .08). In multivariate regression, EAT-10 severity categories independently predicted worse PROMs at all time points. CONCLUSION: We propose none (0-2), mild (3-4), moderate (5-15), and severe (16-40) dysphagia categories based on EAT-10 scores. Evidence from univariate and multivariate analyses strengthens the validity of our proposed EAT-10 severity categories, providing statistical justification for their incorporation into clinical practice.

Abstract Background Breast cancer is etiologically heterogeneous, but which risk factors differ in their associations across tumor subtypes remains unclear. We conducted a large, pooled analysis to evaluate independent, dose-response associations between breast cancer risk factors and quantitative tumor features. Methods Analyses of 15,731 invasive breast cancers from 24 studies evaluated associations (p-trend) between reproductive and hormonal factors, body mass index (BMI), alcohol, smoking, and family history in relation to quantitative immunohistochemistry measures on tissue microarrays (ER, PR, HER2, KI67, TP53) and tumor grade. Analyses in a subset of 10 population-based studies estimated subtype-specific odds ratios (ORs) comparing cases to controls. A Bayesian False Discovery Probability (BFDP) &lt;0.2 was used to identify associations with strong statistical evidence. Results Nulliparity and later age at menopause were associated with higher ER-positivity (p-trend=0.021 and 0.001, respectively), with corresponding OR[ER+] (95% CI) = 1.49 (1.16-1.90) for nulliparous vs. parous and 1.07 (1.03-1.11) per 5 years. Current combined menopausal hormone therapy (MHT) use was associated with lower grade (p-trend&lt;0.001), with OR [grade1] = 3.37 (2.69-4.21) for current vs. never users. Higher BMI was associated with lower ER-positivity and higher grade in premenopausal women (p-trend&lt;0.001 and &lt;0.001), with OR[ER+] = 0.80 (0.74-0.87) and OR[grade1] = 0.75 (0.63-0.88) per 5 units, and with higher PR-positivity and higher grade in postmenopausal women (p-trend&lt;0.001 and &lt;0.001), with OR[PR+] = 1.08 (1.03-1.14) and OR[grade 3] = 1.10 (1.04-1.17) per 5 units. Conclusion This pooled analysis of 15,731 cases showed that nulliparity, age at menopause, MHT, and BMI have independent, dose-response associations with ER, PR, and grade, clarifying patterns of etiologic heterogeneity. Associations with HER2, KI67 and TP53, or other risk factors did not meet our threshold for strong evidence.

Abstract Improved understanding of how chimeric antigen receptor (CAR) and endogenous T‐cell phenotypes associate with progression‐free survival (PFS) is needed to individualize and improve immunotherapy outcomes in multiple myeloma (MM). We characterized and investigated the prognostic value of immune dynamics defined with multidimensional and computational flow cytometry in 258 bone marrow aspirates from 107 MM patients treated with idecabtagene vicleucel in the KarMMa trial. At screening, there was an association between longer PFS and increased percentages of PD1 + cytotoxic T cells and ICOS − TIGIT + Tregs. At Month 1 after infusion, the presence of >1% CAR‐T cells, a CD4/CD8 CAR‐T‐cell ratio >0.09, and greater abundance of non‐activated non‐cytolytic CAR‐T cells identified patients with longer PFS. Notably, 47 of the 115 endogenous T‐cell clusters were prognostic at the latest assessment performed after CAR‐T infusion. Lower percentages of ICOS + TIGIT − Tregs showed the strongest association with longer PFS. Altogether, this large dataset of dynamic immune profiling throughout treatment with anti‐B‐cell maturation antigen (anti‐BCMA) CAR‐T cells uncovered that the T‐cell composition prior to apheresis as well as CAR‐T and endogenous T‐cell phenotypes after infusion associates with PFS. These findings have potential for translation into routine laboratory practice for improved understanding of response and resistance to CAR‐T cells in relapsed/refractory MM.

Abstract Importance Respiratory syncytial virus (RSV) hospitalization rates are highest among children <2 years of age. RSV immunization with infant monoclonal antibody or maternal vaccine is recommended to protect all U.S. infants in their first RSV season. For certain high-risk children aged 8−19 months entering their second RSV season, the monoclonal antibody nirsevimab is recommended. Little is known regarding preexisting health conditions as risk factors for RSV-associated respiratory failure in children during their second season. Objectives To describe children admitted to the pediatric intensive care unit (PICU) for RSV during their second RSV season by preexisting health conditions, and to compare demographic and clinical characteristics across groups. Design, Setting, and Participants Surveillance registry of children 8-<24 months old admitted to the PICU in 30 pediatric hospitals in the 2023-2024/2024-2025 RSV seasons. All children had an RSV-positive respiratory sample and received respiratory support with high flow nasal cannula, noninvasive ventilation, or invasive mechanical ventilation (IMV). Exposure Preexisting health conditions potentially increasing risk of severe RSV disease. Main Outcomes and Measures Patients were classified into four mutually exclusive groups by preexisting health conditions: 1) U.S. nirsevimab eligible criteria, 2) other identified RSV risk conditions (with some evidence of increased risk for severe RSV), 3) other preexisting conditions, and 4) no preexisting conditions. Patient demographic characteristics and level of respiratory support received were compared. Results Among 574 children: 47 (8.2%) had U.S. nirsevimab eligibility criteria, 76 (13.2%) had other RSV risk conditions, 96 (16.7%) had other preexisting conditions, and 355 (61.8%) had none. A higher proportion of children with nirsevimab eligibility factors (40.4%) than those with other identified RSV risk conditions (17.1%) required IMV, which was higher than other (10.4%) or no (5.9%) preexisting health conditions (p trend <0.001). Conclusions and Relevance Approximately 20% of children admitted to the PICU with severe RSV were in the defined groups that met U.S. nirsevimab-eligibility criteria or that had an identified RSV risk condition associated with known risk for severe RSV. A considerable proportion of both groups of children required IMV for respiratory support. These findings may help inform future deliberations regarding U.S. second season nirsevimab-eligibility recommendations. Key Points Question What preexisting health conditions are present in children aged 8–<24 months admitted to the pediatric intensive care unit for severe RSV disease in their second RSV season and how do clinical outcomes differ? Findings Among 574 children, 8% were eligible for nirsevimab in the U.S. and 13% had other preexisting conditions with known risk for severe RSV. Children with preexisting conditions, particularly those eligible for nirsevimab, were more likely to require invasive mechanical ventilation than those without. Meaning These findings may inform future deliberations regarding which children in their second RSV season might benefit from RSV preventive products.