Exploratory Assessment Research Articles

Integrated early-stage environmental and economic assessment of emerging technologies and its applicability to the case of plasma gasification

Economic and environmental impact assessments are increasingly being adopted in the design and implementation of emerging systems. However, their emerging nature leads to several assessment challenges that need to be addressed to ensure the validity and usefulness of results in understanding their potential performance and supporting their development. There is the need to (i) account for spatial and temporal variability to allow a broader perspective at an early stage of development; (ii) handle uncertainties to systematically identify the critical factors and their interrelations that drive the results; (iii) integrate environmental and economic results to support sound decision-making based on two sustainability aspects. To address these assessment challenges, this study presents an alternative approach with the following corresponding features: (i) multiple scenario development to conduct an exploratory assessment of the systems under varying conditions and settings, (ii) global sensitivity analysis to identify the main critical factors and their interrelations, and (iii) trade-off and eco-efficiency analysis to integrate the economic and environmental results. The integrated approach is applied to a case study on plasma gasification for solid waste management. The results of the study highlight how the approach allows the identification of the dynamic relations between project settings and surrounding conditions. For example, the choice of gasifying agent largely depends on the background energy system, which dictates the impacts of the process energy requirement and the savings from the substituted energy of the syngas output. Based on these findings, the usefulness and validity of the proposed integrated approach are discussed in terms of how the key assessment challenges are addressed and how it can provide guidance for the development of emerging systems.

Bamboo: A Source of Multiple Uses for Adoption as an Alternative Livelihood in Odisha, India

Despite becoming one of the most valuable resources, the role of bamboo in livelihoods and rural development is poorly understood. The present study documents the indigenous utilization pattern of bamboo (Bambusa vulgaris Schrad ex Wendl.) and its significance in the social, cultural and religious life of the people of Bhadrak district, Odisha, India. An exploratory assessment was made from 71 informants through field surveys, literature consultations and key informant interviews. Plant parts such as culms are used for various purposes including construction, handicraft, fencing, musical instruments, as well as in rituals and ceremonies. Leaves are mostly used as fodder. This plant has been instrumental for indigenous people by providing them substantial livelihood through their own indigenous wisdom, from collection to the processing of products. Proper training with modern technology, financial assistance to develop infrastructure, as well as proper marketing of products will encourage more earning opportunities among rural people of the said district.

Integrated interventions and supporting activities to increase uptake of multiple cancer screenings: conceptual framework, determinants of implementation success, measurement challenges, and research priorities

BackgroundScreening for colorectal, breast, and cervical cancer has been shown to reduce mortality; however, not all men and women are screened in the USA. Further, there are disparities in screening uptake by people from racial and ethnic minority groups, people with low income, people who lack health insurance, and those who lack access to care. The Centers for Disease Control and Prevention funds two programs—the Colorectal Cancer Control Program and the National Breast and Cervical Cancer Early Detection Program—to help increase cancer screenings among groups that have been economically and socially marginalized. The goal of this manuscript is to describe how programs and their partners integrate evidence-based interventions (e.g., patient reminders) and supporting activities (e.g., practice facilitation to optimize electronic medical records) across colorectal, breast, and cervical cancer screenings, and we suggest research areas based on implementation science.MethodsWe conducted an exploratory assessment using qualitative and quantitative data to describe implementation of integrated interventions and supporting activities for cancer screening. We conducted 10 site visits and follow-up telephone interviews with health systems and their partners to inform the integration processes. We developed a conceptual model to describe the integration processes and reviewed screening recommendations of the United States Preventive Services Task Force to illustrate challenges in integration. To identify factors important in program implementation, we asked program implementers to rank domains and constructs of the Consolidated Framework for Implementation Research.ResultsHealth systems integrated interventions for all screenings across single and multiple levels. Although potentially efficient, there were challenges due to differing eligibility of screenings by age, gender, frequency, and location of services. Program implementers ranked complexity, cost, implementation climate, and engagement of appropriate staff in implementation among the most important factors to success.ConclusionIntegrating interventions and supporting activities to increase uptake of cancer screenings could be an effective and efficient approach, but we currently do not have the evidence to recommend widescale adoption. Detailed multilevel measures related to process, screening, and implementation outcomes, and cost are required to evaluate integrated programs. Systematic studies can help to ascertain the benefits of integrating interventions and supporting activities for multiple cancer screenings, and we suggest research areas that might address current gaps in the literature.

The perceived value of human-AI collaboration in early shape exploration: An exploratory assessment.

As a vital element of early shape exploration, divergence can be time-consuming and challenging, with iterative cycles where idea fixation and creative blocks must be overcome for fuzzy ideas to be fully expanded and understood. Despite interesting tools that have been developed for this purpose, some important challenges remain, as it appears that many designers still prefer simple freehand sketching and tend to defer the use of computational tools to later stages. This work presents an exploratory assessment of the perceived value of a new tool, Shapi, developed to assist early shape exploration by addressing some of the pitfalls reported in the literature. Shapi is envisioned as an autonomous assistant that provides local and global shape variations in the form of rough sketches based on an initial human sketch and interactive cycles. These shape variations are What-If scenarios and cognitive facilitators that may spark new ideas or enable a deeper understanding of the shape and the identification of interesting patterns. Shapi’s capabilities are explored in a diverse set of case studies with different purposes: nine implementations in industrial design, three in graphic design, and five with open-ended artistic purposes. These implementations are then used in a survey about initial perceived value in which the majority gave high ratings in terms of exploration (75.5% ≥ 4 out of 5), interpretation (83.7% ≥ 4), adaptation (77.6% ≥ 4), value (73.5% ≥ 4), creativity (69.4% ≥ 4), and general interest in the tool (79.6% ≥ 4). This work brings insight into promising functionalities, opportunities, and risks in the intersection between artificial intelligence, design, and art.

Planning toward sustainable food systems: An exploratory assessment of local U.S. food system plans

National planning and health organizations agree that to achieve healthy and sustainable food systems, planners must balance goals across a spectrum of sustainability issues that include economic vitality, public health, ecological sustainability, social equity, and cultural diversity. This research is an assessment of government-adopted food system plans in the U.S. that examines which topics, across the three dimensions of sustainability (social, environmental, and economic), are included in local food system plans and conducts an exploratory analysis that asks whether the community capitals (built, cultural, social, financial, human, and natural) available in a community are associated with the content of food system plans. The research team first developed a Sustainable Food System Policy Index made up of 26 policy areas across the three dimensions that, in aggregate, define and operationalize sustainable food systems. With this index we evaluated a sample of 28 food system plans for inclusion of these policy impact areas. We then performed an exploratory regression analysis to examine whether the availability of community capitals was associated with the content of food system plans. Findings indicated that jurisdictions integrated a broad range of issues into their food system plans; however, there are certain issues across every dimension of sustainability that are much less frequently included in plans, such as strategies related to participation in decision-making, financial infrastructure, and the stewardship of natural resources. Regression analysis identified statistically significant linear relationships between particular capitals and the proportion of policy areas included in plans. In particular, higher metrics associated with poverty were associated with the inclusion of fewer policy areas and with a potentially narrower policy agenda. This study adds to the plan evaluation literature as one of the first attempts to document the content of a sample of U.S. food system plans through a sustainability lens, contributing to the knowledge of what types of issues are advanced by local food system plans and the policy implications of current gaps in planning agendas.

Impacts of truck platooning on the multimodal freight transport market: An exploratory assessment on a case study in Italy

• Exploratory analysis of system-wide competition between existing freight modes and truck platooning. • Cost of various freight modes compared, leveraging a multimodal nationwide freight supply model. • Forty different scenarios modelled, with different assumptions on the input variables including three levels of automation. • Truck platooning could be convenient in medium to large distances, with competition mainly with traditional road and rail freight transport. • It would be appropriate to consider track platooning as a new freight transport mode. Truck platooning is expected to significantly affect road freight transport performances, although in the long term due to technological and operational issues still to address. Furthermore, truck platooning could be introduced with increasing levels of automation, corresponding to different technologies and operational costs. In parallel, various Countries promote freight-related infrastructural plans pursuing a modal shift from the road towards more sustainable modes (railways, sea shipping, inland waterways). The planning horizon of such infrastructures probably overlaps, at least partially, with a non-negligible market penetration of truck platooning. In this framework, the paper aims to explore the extent of a system-wide competition between existing freight modes and truck platooning, through an exploratory analysis of the potential market of truck platooning in Italy. The study is based on a comparative analysis of the cost of various freight modes, leveraging a multimodal nationwide freight supply model. Forty different scenarios have been modelled, with different assumptions on the input variables including three levels of automation. Results show that truck platooning could be highly competitive with respect to rail transport for medium to large distances. Competition with conventional road transport is significant as well, with a large contestable market share between truck platooning and traditional road freight, especially on medium to long distances, whilst maritime transport starts competing with truck platooning only in the case of (at least partially) unmanned truck platooning operations. The size of truck platoons impacts appreciably on results only with a manned leader truck and unmanned followers. Based on the above results it would be appropriate to consider track platooning as a new freight transport mode.

Use of multibiomarker disease activity scores in biosimilarity studies for the treatment of patients with rheumatoid arthritis

ObjectivesThis exploratory analysis investigated the potential use of the multibiomarker disease activity (MBDA) score to support biosimilarity assessments using data from two randomised controlled trials (RCTs) of biosimilar infliximab (IFX-qbtx)...

Adapting and pilot testing an HIV and intersectional stigma reducing intervention for Dominican Republic healthcare contexts: Protocol for translational research

BackgroundThis protocol details the adaptation and pilot testing of the Finding Respect and Ending Stigma around HIV (FRESH) intervention in Dominican Republic. FRESH is a healthcare setting stigma-reduction intervention designed to reduce stigmas affecting people living with HIV (PLHIV), focusing on HIV and intersectional stigmas experienced by sexual and gender minority (SGM) people living with HIV. After the successful adaptation of the FRESH intervention, it will be pilot-tested through the conduct of a pilot stepped wedge cluster randomized controlled trial. MethodsThree aims are included in this study; Aim 1 includes exploratory qualitative assessment, specifically the conduct four focus groups with men who have sex with men (MSM) living with HIV (n = 24–32) and in-depth interviews with transgender women living with HIV to explore their experiences with stigma in clinics (n = 9–12). In-depth interviews will also be held with HIV healthcare workers to elucidate their perceptions and behaviors towards their SGM clients (n = 9–12). In Aim 2, informed by Aim 1 data, we will use the sequential phases of the ADAPT-ITT framework to iteratively adapt the FRESH intervention for the Dominican Republic. In Aim 3, the adapted intervention will be pilot-tested via a cluster stepped wedge randomized controlled trial to assess feasibility and acceptability of the intervention and study protocols. ConclusionsIf this pilot trial is successful, next steps will include testing the adapted intervention across Dominican Republic or in similar Spanish-speaking Caribbean nations in a larger trial to assess effectiveness in reducing stigma in clinical settings towards PLHIV.

An exploratory assessment of the management of pediatric traumatic brain injury in three centers in Africa.

PurposeTraumatic brain injury (TBI) is a leading cause of morbidity and mortality in low- and middle-income countries (LMICs). Hospital care practices of pediatric TBI patients in LMICs are unknown. Our objective was to report on hospital management and outcomes of children with TBI in three centers in LMICs.MethodsWe completed a secondary analysis of a prospective observational study in children (<18 years) over a 4-week period. Outcome was determined by Pediatric Cerebral Performance Category (PCPC) score; an unfavorable score was defined as PCPC > 2 or an increase of two points from baseline. Data were compared using Chi-square and Wilcoxon rank sum tests.ResultsFifty-six children presented with TBI (age 0–17 y), most commonly due to falls (43%, n = 24). Emergency department Glasgow Coma Scale scores were ≤ 8 in 21% (n = 12). Head computed tomography was performed in 79% (n = 44) of patients. Forty (71%) children were admitted to the hospital, 25 (63%) of whom were treated for suspected intracranial hypertension. Intracranial pressure monitoring was unavailable. Five (9%, n = 5) children died and 10 (28%, n = 36) inpatient survivors had a newly diagnosed unfavorable outcome on discharge.ConclusionInpatient management and monitoring capability of pediatric TBI patients in 3 LMIC-based tertiary hospitals was varied. Results support the need for prospective studies to inform development of evidence-based TBI management guidelines tailored to the unique needs and resources in LMICs.

Individual differences in habituation: Innate covariation between habituation, exploration, and body size in naïve chicks (Gallus gallus)

Habituation to novel stimuli has been associated with behavioural differences among individuals in numerous animal species. Because the habituation mechanisms depend on previous experiences with a stimulus, one would expect individuals to develop their habituation capacity based on the life experiences that also shape their behavioural traits. And indeed, in adult lizards, exploratory behaviour and body size correlates with habituation. However, here we show that the same factors correlate with habituation of domestic chicks reared under controlled laboratory conditions and tested in the first 3 days after hatching. This result indicates that the covariation between habituation, exploration, and body size does not necessarily depend on experience. Rather, it represents an innate association between exploratory behaviour and risk assessment, which may provide an immediate survival advantage to new-borns of this precocial avian species.

How much infrastructure is required to support decent mobility for all? An exploratory assessment

Decarbonizing transport is crucial for achieving climate targets, which is challenging because mobility is growing rapidly. Personal mobility is a key societal service and basic need, but currently not available to everyone with sufficient quality and quantity. The basis for mobility and accessibility of desired destinations is infrastructure, but its build-up and maintenance require a substantial fraction of global resource use. The question arises, how much mobility and how much infrastructure are required to deliver decent, sustainable mobility.We explore the relations between mobility levels, mobility infrastructure and well-being. We synthesize definitions of decent mobility and assess mobility measurements and provide a novel estimate of mobility infrastructure stocks for 172 countries in the year ~2021. We then explore the relations between infrastructure, travelled distances, accessibility, economic activity and several ‘beyond GDP’ well-being indicators.We find that travelled distances and mobility infrastructure levels are significantly correlated. Above levels of ~92–207 t/cap of mobility infrastructure no further significant gains in well-being can be expected from a further increase of infrastructure. We conclude that high mobility in terms of distances travelled as well as building up mobility infrastructure is only beneficial for well-being up to a certain point.

An Exploratory Assessment of Factors with Which Influenza Vaccine Uptake Is Associated in Hungarian Adults 65 Years Old and Older: Findings from European Health Interview Surveys.

Influenza vaccination is an imperative public health task for elderly people due to a higher risk of developing more severe complications. The main aim of our study was to determine the influencing factors of being vaccinated against influenza among subjects aged 65 and above. Data were from the Hungarian implementations of the European Health Interview Survey 2009, 2014 and 2019 studies with a final sample size of 3355. A multivariate logistic regression model with interactions was used to identify the possible factors associated with vaccination. Approximately 32% of the participants were vaccinated for the most recent influenza season. The most important factors were identified that contributed to influenza vaccination among individuals, which were the following: educational attainment, having a partner, the annual frequency of specialist and doctor visits, and having comorbidities. Respondents who thought that they could do a lot for their health had higher odds of being immunized. Being obese seemed to be a risk factor. According to our findings, the current influenza vaccination coverage was considered as low in Hungary; hence, the implementation of minor reformulations in the field of health policy is suggested.

Environmental and health outcomes of single-use versus reusable duodenoscopes

The large-scale effects of duodenoscopes on the environment and public health have not been quantified. Our aim was to perform an exploratory life cycle assessment comparing environmental and human health effects of single-use duodenoscopes (SDs) and reusable duodenoscopes (RDs). We evaluated 3 duodenoscopes: conventional RDs, RDs with disposable endcaps, and SDs. The primary outcomes were impacts on climate change and human health, complemented by multiple environmental impacts. Performing ERCP with SDs releases between 36.3 and 71.5 kg of CO2 equivalent, which is 24 to 47 times greater than using an RD (1.53 kg CO2) or an RD with disposable endcaps (1.54 kg CO2). Most of the impact of SDs comes from its manufacturing, which accounts for 91% to 96% of its greenhouse gas emission. The human health impact of RDs becomes comparable with the SD lower bound if disposable endcaps or other design modifications can reduce serious infection rates below a target rate of 23 cases per year (.0046%). Although SDs may provide incremental public health benefit compared with RDs, it comes at a substantially higher cost to the environment. As infection rates continue to decrease from more regimented cleaning protocols and enhanced designs such as disposable endcaps to facilitate cleaning, the negative impact to human health from contaminated RDs could be comparable with SDs.

Exploring Fear of Crime for Those Targeted by Romance Fraud

ABSTRACT This article assesses 3,259 romance fraud reports made by individuals to Scamwatch (Australian online reporting portal for fraud), between July 2018 – July 2019 (inclusive). It seeks to highlight experiences of fear of crime as articulated by the complainants. Drawing on frameworks used to analyze fear of crime (specifically the affective, behavioral and cognitive aspects of fear) the article is an exploratory assessment of how fear of crime is evident in those targeted by romance fraud. It builds a model for better understanding differing victim responses to romance fraud and the often-hidden harms involved around the anxieties of victims which importantly, can manifest in both online and offline environments.

Abstract CT211: A phase 1 dose-escalation and dose-expansion study to evaluate the safety, pharmacokinetics, and anti- tumor activity of ARX517 in subjects with advanced solid tumors resistant or refractory to standard therapies (APEX-01 trial, NCT04662580)

Abstract Background: Novel anti-PSMA (prostate-specific membrane antigen) targeted therapies have exhibited encouraging antitumor activity in prostate cancer and most non-prostate solid tumors express PSMA in tumor neovasculature. ARX517 is an antibody drug conjugate composed of a fully humanized anti-PSMA monoclonal antibody linked to pAF-AS269, a potent microtubule inhibitor. Upon binding to PSMA on the surface of cancer cells, ARX517 is internalized and pAF-AS269 is released following lysosomal metabolism. Methods: This Phase 1, dose-escalation and dose-expansion study is evaluating the safety, pharmacokinetics, and preliminary anti-tumor activity of ARX517 in adults with prostate cancer or other solid tumors whose disease is resistant or refractory to standard therapies. Patients must have metastatic castration-resistant prostate cancer refractory to standard therapies, including abiraterone, darolutamide, apalutamide or enzalutamide and progression by Prostate Cancer Working Group criteria. Non-prostate advanced solid tumors must be pathologically confirmed, metastatic, or unresectable solid tumors that have disease progression despite at least 1 prior standard of care systemic treatment and have no satisfactory treatment alternatives. All patients must have adequate organ function and any brain metastasis must demonstrate radiographic stability. Exploratory pharmacodynamic assessment includes PSMA-PET/CT imaging, which is optional for low dose cohorts but required starting at 1.4 mg/kg dose. Dose-escalation will consist of ascending dose levels of ARX517 administered as a single agent and will use a i3+3 design. The number of subjects in the dose-expansion will be based on the number of doses to be expanded for further evaluation of safety, PK, and clinical activity. Through dose levels one and two, no dose limiting toxicities have been observed. Ascending dose levels of ARX517 as a single agent will be administered until the recommended Phase 2 dose or maximum tolerated dose is determined. Status: ARX517-2011 began recruiting patients in July 2021 and as of January 2022 has completed enrollment in the 3rd cohort of dose-escalation. Citation Format: Russell K. Pachynski, Luke Nordquist, Michael T. Schweizer, John Shen, Nabil Adra, Mehmet A. Bilen, Zachery R. Reichert, Rahul Aggarwal, Bilal A. Siddiqui, Matt Li, Dong Xu, Richard Huhn, Darryl Z. L'Heureux, Jinchun Yan, Ying Buechler, Sulan Yao, John Simitzi, Wenge Shi, Shawn Zhang, Scott T. Tagawa. A phase 1 dose-escalation and dose-expansion study to evaluate the safety, pharmacokinetics, and anti- tumor activity of ARX517 in subjects with advanced solid tumors resistant or refractory to standard therapies (APEX-01 trial, NCT04662580) [abstract]. In: Proceedings of the American Association for Cancer Research Annual Meeting 2022; 2022 Apr 8-13. Philadelphia (PA): AACR; Cancer Res 2022;82(12_Suppl):Abstract nr CT211.

Representing Diet in a Tree-Based Format for Interactive and Exploratory Assessment of Dietary Intake Data

ObjectivesWe assessed the utility of representing dietary intake data in hierarchical tree structures that consider relationships among foods.MethodsDietary intake was collected from 1909 adults (≥18 years) using a food frequency questionnaire (FFQ; VioScreen) from the American Gut Project. FFQ food items were formatted into hierarchical tree structures based on 1) USDA's Food Nutrient and Database for Dietary Studies (FNDDS) classifications, 2) nutrient content, and 3) molecular compound information detected via mass spectrometry to capture the non-nutrient composition of foods. Next, we compared how well representing dissimilarities (or distances) between individuals based on their diet corresponded with indices such as the Healthy Eating Index (HEI-2015), when those distances are calculated using tree-based versus non-tree-based metrics. We performed an Adonis test (PERMANOVA) to measure the amount of variation explained (R2) in these diet-based distances by HEI-2015.ResultsWe observed that dietary ordinations generated using tree-based relationships between foods have better agreement with HEI than ordinations generated without considering relatedness between foods. The variation explained by HEI-2015 increased by 35% when using the FNDDS tree compared to using a non-tree based quantitative metric (Bray-Curtis (not tree-based) R2 = 0.02931 vs. Weighted UniFrac (tree-based) R2 = 0.03969), by >20% when using the nutrient tree (vs. Weighted UniFrac R2 = 0.03627), and only marginally (6%) when using the molecular compound tree (vs. Weighted UniFrac R2 = 0.03116).ConclusionsWe show that tree-based measurements of dietary similarity lead to better agreement with diet indices (e.g., HEI) than when relationships among foods are not considered. We also show that representing dietary intake in a tree-like structure can offer interactive visualizations of data that can be used to inform hypotheses regarding dietary characteristics.Funding SourcesDanone Nutricia Research.

The implementation of fertility guidelines and impact on the rate of pre-therapy fertility risk discussions in pediatric oncology: A retrospective cohort study.

e22027 Background: Pediatric cancer patients undergoing treatment are often at risk for infertility or subfertility. Healthcare providers do not consistently deliver fertility information prior to therapy. Our objective was to assess if development and implementation of a fertility guideline improves the frequency of pre-treatment fertility discussions with pediatric cancer families. Methods: This retrospective cohort study analyzed all consecutively eligible patients over two time periods. The pre-guideline time period was 18 months prior to implementation and the post-guideline time period was 12 months after implementation. Guideline implementation included an education session with oncology staff. Eligible patients were &lt; 19 years old at cancer diagnosis and received chemotherapy and/or radiation therapy. Patients treated with palliative intent were excluded. Pre-guideline rate of pre-treatment fertility discussions was estimated at 40%. An estimated 40 participants in the post-guideline cohort can detect a 30% increase in fertility discussions with β 0.8 and α 0.05. Exploratory analysis assessed factors associated with the frequency of fertility risk discussions. Results: Ninety-five patients were included. Fifty-seven percent were &lt; 10, 26% were 10-15, and 17% were ≥ 16 years old. Pre- and post-guideline cohorts are compared in table. In the pre-guideline cohort, 41% of patients had a discussion about risks of fertility impairment documented, while post-guideline cohort had 49% documented ( p = 0.531). Exploratory assessment of combined cohorts found males (OR 0.2.7, 95% CI 0.1.2-6.3-0.87) and patients ≥ 10 years old (OR 5.0, CI 2.1-12.1) were more likely to receive fertility discussions prior to therapy. Radiation and cancer type did not influence whether fertility discussions occurred. Conclusions: Implementation of a fertility guideline did not increase discussions of fertility risk, and less than half of patients had a documented fertility risk discussion. Male patients and age ≥ 10 years old were more likely to have documented discussions about risks to future fertility. Effective strategies are needed to improve the rate of discussions regarding fertility risk to ensure families receive this information prior to therapy. [Table: see text]

Multiassay nutritional metabolomics profiling of low vitamin A status versus adequacy is characterized by reduced plasma lipid mediators among lactating women in the Philippines: A pilot study

Low vitamin A (VA) status is common among lactating women in low-income countries. Lactation has substantial effects on mother's metabolism and VA is required in multiple biological processes, including growth, vision, immunity, and reproduction. The objective of this pilot study was to use metabolomics profiling to conduct a broad, exploratory assessment of differences in plasma metabolites associated with low VA status versus VA adequacy in lactating women. Plasma samples from lactating women who participated in a survey in Samar, Philippines, were selected from a cross-sectional study based on plasma retinol concentrations indicating low (VA–; n = 5) or adequate (VA+; n = 5) VA status (plasma retinol <0.8 or >1.05 µmol/L). The plasma results collected from 6 metabolomics assays (oxylipins, endocannabinoids, bile acids, primary metabolomics, biogenic amines, and lipidomics) were compared by group using liquid chromatography mass spectrometry. Twenty-eight metabolites were altered in the VA– versus VA+ status groups, with 24 being lipid mediators (P < .05). These lipid mediators included lower concentrations of arachidonic acid- and eicosapentaenoic acid-derived oxylipins, as well as lysophospholipids and sphingolipids, in the VA– group (P < .05). Chemical similarity enrichment analysis identified hydroxy-eicosatetraenoic acids, hydroxy-eicosapentaenoic acids, and dihydroxy-eicosatetraenoic acids as significantly altered oxylipin clusters (P < .0001, false discovery rate [FDR] P < .0001), as well as sphingomyelins, saturated lysophosphatidylcholines, phosphatidylcholines, and phosphatidylethanolamines (P < .001, FDR P < .01). The multiassay nutritional metabolomics profiling of low VA status compared with adequacy in lactating women was characterized by reduced lipid mediator concentrations. Future studies with stronger study designs and larger sample size are needed to confirm and validate these preliminary results.

Replication of Overall Survival, Progression-Free Survival, and Overall Response in Chemotherapy Arms of Non-Small Cell Lung Cancer Trials Using Real-World Data.

The utility of real-world data (RWD) for use as external controls in drug development is informed by studies that replicate trial control arms for different endpoints. The purpose of this study was to replicate control arms from four non-small cell lung cancer (NSCLC) randomized controlled trials (RCT) to analyze overall survival (OS), progression-free survival (PFS), and overall response rate (ORR) using RWD. This study used RWD from a nationwide de-identified database and a clinico-genomic database to replicate OS, PFS, and ORR endpoints in the chemotherapy control arms of four first-line NSCLC RCTs evaluating atezolizumab [IMpower150-wild-type (WT), IMpower130-WT, IMpower131, and IMpower132]. Additional objectives were to develop a definition of real-world PFS (rwPFS) and to evaluate the real-world response rate (rwRR) endpoint. Baseline demographic and clinical characteristics were balanced after application of propensity score weighting methods. For rwPFS and OS, RWD external controls were generally similar to their RCT control counterparts. Across all four trials, the hazard ratio (HR) point estimates comparing trial controls with external controls were closer to 1.0 for the PFS endpoint than for the OS endpoint. An exploratory assessment of rwRR in RWD revealed a slight but nonsignificant overestimation of RCT ORR, which was unconfounded by baseline characteristics. RWD can be used to reasonably replicate the OS and PFS of chemotherapy control arms of first-line NSCLC RCTs. Additional studies can provide greater insight into the utility of RWD in drug development.

Qualitative assessment of caregiver experiences when navigating childhood immunisation in urban communities in Sierra Leone

ObjectiveTo gain in-depth understanding of the caregiver experience when navigating urban immunisation services for their children.DesignAn exploratory qualitative assessment comprising 16 in-depth interviews using an interpretative phenomenology approach.SettingCaregivers were purposively...