Healthcare resource utilization and costs in patients with a newly confirmed diagnosis of lupus nephritis in the United States over a 5-year follow-up period.

BACKGROUND: We aimed to describe healthcare resource utilization (HCRU) and healthcare costs in patients with newly confirmed lupus nephritis (LN) in the United States over a 5-year follow-up period. METHODS: This retrospective, longitudinal cohort study (GSK Study 214102) utilized administrative claims data to identify individuals with a newly confirmed diagnosis of LN between August 01, 2011, and July 31, 2018, based on LN-specific International Classification of Diseases diagnosis codes. Index was the date of first LN-related diagnosis code claim. HCRU, healthcare costs, and incidence of systemic lupus erythematosus (SLE) flares were reported annually among eligible patients with at least 5 years continuous enrollment post-index. RESULTS: Of 2,159 patients with a newly confirmed diagnosis of LN meeting inclusion and exclusion criteria, 335 had at least 5 years continuous enrollment post-index. HCRU was greatest in the first year post-LN diagnosis across all categories (inpatient admission, emergency room [ER] visits, ambulatory visits, and pharmacy use), and trended lower, though remained substantial, in the 5-year follow-up period. Among patients with LN and HCRU, the mean (standard deviation [SD]) number of ER visits and inpatient admissions were 3.7 (4.6) and 1.8 (1.5), respectively, in Year 1, which generally remained stable in Years 2-5; the mean (SD) number of ambulatory visits and pharmacy fills were 35.8 (25.1) and 62.9 (43.8), respectively, in Year 1, and remained similar for Years 2-5. Most patients (≥ 91.6%) had ≥ 1 SLE flare in each of the 5 years of follow-up. The proportion of patients who experienced a severe SLE flare was higher in Year 1 (31.6%) than subsequent years (14.3-18.5%). Total costs (medical and pharmacy; mean [SD]) were higher in Year 1 ($44,205 [71,532]) than subsequent years ($29,444 [52,310]-$32,222 [58,216]), driven mainly by inpatient admissions (Year 1: $21,181 [58,886]; subsequent years: $7,406 [23,331]-$9,389 [29,283]). CONCLUSIONS: Patients with a newly confirmed diagnosis of LN have substantial HCRU and healthcare costs, particularly in the year post-diagnosis, largely driven by inpatient costs. This highlights the need for improved disease management to prevent renal damage, improve patient outcomes, and reduce costs among patients with renal involvement.

Validation of a Health-Related Quality of Life Questionnaire in Patients With Recurrent Clostridioides difficile Infection in ECOSPOR III, a Phase 3 Randomized Trial.

BACKGROUND: Debilitating symptoms of recurrent Clostridioides difficile infection (rCDI) often lead to long-term effects on health-related quality-of-life (HRQOL). In ECOSPOR III, SER-109, an investigational oral microbiome therapeutic, was superior to placebo in reducing rCDI. We investigated the validity, reliability, and responsiveness of a 32-item, CDI-specific questionnaire-the Clostridium difficile Quality of Life Survey (Cdiff32)-across mental, physical, and social domains in patients with rCDI. METHODS: In this post hoc analysis of a phase 3 clinical trial, 182 outpatients with rCDI completed Cdiff32 and EQ-5D at baseline and at 1 and 8 weeks. Cdiff32 was evaluated for item performance, internal reliability, and convergent validity. To assess known-groups validity, Cdiff32 scores were compared by disease recurrence status at week 1; internal responsiveness was evaluated in the nonrecurrent disease group by 8 weeks by means of paired t test. RESULTS: All 182 patients (mean age [standard deviation], 65.5 [16.5] years; 59.9% female) completed baseline Cdiff32. Confirmatory factor analysis identified 3 domains (physical, mental, and social relationships) with good item fit. High internal reliability was demonstrated (Cronbach α = 0.94 with all subscales >0.80). Convergent validity was evidenced by significant correlations between Cdiff32 subscales and EQ-5D (r = 0.29-0.37; P < .001). Cdiff32 differentiated patients by disease recurrence status at week 1 (effect sizes, 0.38-0.42; P < .05 overall), with significant improvement from baseline through week 8 in patients with nonrecurrent disease at week 1 (effect sizes, 0.75-1.02; P < .001 overall). CONCLUSIONS: Cdiff32 is a valid, reliable, and responsive disease-specific HRQOL questionnaire that is fit for purpose for interventional treatment trials. The significant improvement in patients with nonrecurrent disease by 8 weeks demonstrates the negative impact of rCDI on HRQOL.

Monkeypox Virus Infection in 22-Year-Old Woman after Sexual Intercourse, New York, USA.

We report a case of a 22-year-old woman in New York, USA, who had painful vulvar and intravaginal lesions after sexual intercourse and tested positive for monkeypox virus. Literature documenting the clinical manifestations of monkeypox in female genitalia remains insufficient.

The cost of flares among patients with systemic lupus erythematosus with and without lupus nephritis in the United States.

OBJECTIVE: Assess healthcare costs associated with systemic lupus erythematosus (SLE) flares among patients with and without lupus nephritis (LN). METHODS: This retrospective cohort study used medical and pharmacy claims data from the United States-based Optum Clinformatics database to identify adults with SLE between 1 January 2016, and 31 December 2018. Index was the date of a patient's earliest SLE diagnosis claim during the identification period. Patients were categorized based on ICD-9/-10 diagnosis codes into one of two cohorts: SLE with LN (LN) and SLE without LN (non-LN). Baseline characteristics were assessed in the 12 months preceding index (baseline period). The presence, severity, and healthcare costs (in 2019 US dollars) of flares were determined in the 12 months following index (follow-up period). RESULTS: Overall, 11,663 patients with SLE were included (LN, n = 2916; non-LN, n = 8747). During the baseline period, a greater proportion of patients in the LN cohort versus non-LN cohort had a Charlson Comorbidity Index score ≥4 (72.5% vs 13.7%) and inpatient stays (41.0% vs 17.0%). A total of 12,190 flares were identified during the follow-up period (LN, 3494; non-LN, 8696). A greater proportion of flares experienced by patients with LN versus those without LN were moderate (61.2% vs 53.6%) and severe (10.6% vs 5.4%). The mean (standard deviation [SD]) number of moderate and severe flares per patient was greater among the LN cohort than the non-LN cohort (moderate: LN, 1.8 [1.2] and non-LN, 1.4 [1.2]; severe: LN, 0.2 [0.6] and non-LN, 0.1 [0.3]). The mean (SD) total healthcare costs associated with SLE flares of any severity were greater for patients with LN (LN, $5842 [9604]; non-LN, $2600 [4249]). The mean (SD) cost per flare increased with severity (mild: LN, $2753 [4640] and non-LN, $1606 [2710]; moderate: LN, $4561 [7156] and non-LN, $2587 [3720]; severe: LN, $29,148 [27,273] and non-LN, $14,829 [19,533]). CONCLUSIONS: Patients with SLE with LN have greater healthcare costs than those without LN. Flares among patients with LN were more frequent, severe, and costly than among patients without LN. This highlights the need for treatments that prevent or reduce flares among patients with SLE, both with and without LN.

Electrolyte melt infiltration for scalable manufacturing of inorganic all-solid-state lithium-ion batteries.

All-solid-state lithium (Li) metal and lithium-ion batteries (ASSLBs) with inorganic solid-state electrolytes offer improved safety for electric vehicles and other applications. However, current inorganic ASSLB manufacturing technology suffers from high cost, excessive amounts of solid-state electrolyte and conductive additives, and low attainable volumetric energy density. Such a fabrication method involves separate fabrications of sintered ceramic solid-state electrolyte membranes and ASSLB electrodes, which are then carefully stacked and sintered together in a precisely controlled environment. Here we report a disruptive manufacturing technology that offers reduced manufacturing costs and improved volumetric energy density in all solid cells. Our approach mimics the low-cost fabrication of commercial Li-ion cells with liquid electrolytes, except that we utilize solid-state electrolytes with low melting points that are infiltrated into dense, thermally stable electrodes at moderately elevated temperatures (~300 °C or below) in a liquid state, and which then solidify during cooling. Nearly the same commercial equipment could be used for electrode and cell manufacturing, which substantially reduces a barrier for industry adoption. This energy-efficient method was used to fabricate inorganic ASSLBs with LiNi0.33Mn0.33Co0.33O2 cathodes and both Li4Ti5O12 and graphite anodes. The promising performance characteristics of such cells open new opportunities for the accelerated adoption of ASSLBs for safer electric transportation.

Development and evaluation of an evidence-based, theory-grounded online Clinical Frailty Scale tutorial.

INTRODUCTION: Frailty is a robust predictor of adverse outcomes in older people. Practice guidelines recommend routine screening for frailty; however, this does not occur regularly. The Clinical Frailty Scale (CFS) is a validated, feasible instrument that can be used in a variety of clinical settings and is associated with many adverse outcomes. Our objective was to develop and evaluate an online training module to guide frailty assessment using the CFS. METHODS: A multidisciplinary team of clinical experts developed an evidence-based, theory-grounded online training module for users who wished to perform frailty assessment using the CFS. The module was prospectively evaluated for user satisfaction, effectiveness and feasibility using a standardised questionnaire. Qualitative feedback was analysed with thematic analysis. RESULTS: Version 1 of the CFS module was used 627 times from 21 October 2019 to 24 March 2020. Satisfaction, effectiveness and feasibility of the module were positively rated (≥4/5 on a 5-point Likert scale n = 582 [93%], n = 507, [81%], n = 575, [91%], respectively). Qualitative feedback highlighted ease of use, likelihood of users to share the module with others and opportunities to increase multimedia content. CONCLUSION: An online tutorial, designed using evidence and theory to guide frailty assessment using the CFS, was positively rated by users. The module's content and structure was rated effective and feasible, and users were satisfied with, and likely to share, the module. Research evaluating the module's impact on the accuracy of frailty assessment is required.

Cuddling very and extremely preterm babies in the delivery room is a positive and normal experience for mothers after the birth.

AIM: Extremely preterm infants are separated from their mothers immediately after birth and not placed skin-to-skin in routine neonatal intensive care unit settings. Visual and physical contact in the delivery room as a first cuddle potentially can facilitate early parent-infant interaction and reduce the trauma of separation. Our aim in this study was to explore mothers' experience of delivery room cuddle by collecting qualitative feedback via emotional mapping. METHODS: Six mothers experiencing delivery room cuddle had been recruited (GA of their babies 24 + 5-29 + 0 weeks, birth weight 540-1019 g). Using a descriptive qualitative approach, semi-structured interviews were performed with six mothers following consent via Zoom or phone between September 2020 and March 2021. Interviews were transcribed using AI Otter and then analysed using thematic analysis. RESULTS: Analysis of the participants' experiences revealed five themes: fears and hopes around delivery; the moment of delivery-recognising uncertainty; reclaiming normalcy; forming connections; and the journey ahead as an empowered parent. CONCLUSION: All mothers reported positive emotions about the cuddle with their baby. They highlighted that this physical contact was often the only positive and 'normal' birth experience they had from the time of delivery.