The Space Omics and Medical Atlas (SOMA) and international astronaut biobank.

Spaceflight induces molecular, cellular and physiological shifts in astronauts and poses myriad biomedical challenges to the human body, which are becoming increasingly relevant as more humans venture into space1-6. Yet current frameworks for aerospace medicine are nascent and lag far behind advancements in precision medicine on Earth, underscoring the need for rapid development of space medicine databases, tools and protocols. Here we present the Space Omics and Medical Atlas (SOMA), an integrated data and sample repository for clinical, cellular and multi-omic research profiles from a diverse range of missions, including the NASA Twins Study7, JAXA CFE study8,9, SpaceX Inspiration4 crew10-12, Axiom and Polaris. The SOMA resource represents a more than tenfold increase in publicly available human space omics data, with matched samples available from the Cornell Aerospace Medicine Biobank. The Atlas includes extensive molecular and physiological profiles encompassing genomics, epigenomics, transcriptomics, proteomics, metabolomics and microbiome datasets, which reveal some consistent features across missions, including cytokine shifts, telomere elongation and gene expression changes, as well as mission-specific molecular responses and links to orthologous, tissue-specific mouse datasets. Leveraging the datasets, tools and resources in SOMA can help to accelerate precision aerospace medicine, bringing needed health monitoring, risk mitigation and countermeasure data for upcoming lunar, Mars and exploration-class missions.

Molecular and physiological changes in the SpaceX Inspiration4 civilian crew.

Human spaceflight has historically been managed by government agencies, such as in the NASA Twins Study1, but new commercial spaceflight opportunities have opened spaceflight to a broader population. In 2021, the SpaceX Inspiration4 mission launched the first all-civilian crew to low Earth orbit, which included the youngest American astronaut (aged 29), new in-flight experimental technologies (handheld ultrasound imaging, smartwatch wearables and immune profiling), ocular alignment measurements and new protocols for in-depth, multi-omic molecular and cellular profiling. Here we report the primary findings from the 3-day spaceflight mission, which induced a broad range of physiological and stress responses, neurovestibular changes indexed by ocular misalignment, and altered neurocognitive functioning, some of which match those of long-term spaceflight2, but almost all of which did not differ from baseline (pre-flight) after return to Earth. Overall, these preliminary civilian spaceflight data suggest that short-duration missions do not pose a significant health risk, and moreover present a rich opportunity to measure the earliest phases of adaptation to spaceflight in the human body at anatomical, cellular, physiological and cognitive levels. Finally, these methods and results lay the foundation for an open, rapidly expanding biomedical database for astronauts3, which can inform countermeasure development for both private and government-sponsored space missions.

Efficient Lignin Fractionation from Scots Pine (Pinus sylvestris) Using Ammonium-Based Protic Ionic Liquid: Process Optimization and Characterization of Recovered Lignin.

Lignin-based chemicals and biomaterials will be feasible alternatives to their fossil-fuel-based counterparts once their breakdown into constituents is economically viable. The existing commercial market for lignin remains limited due to its complex heterogenous structure and lack of extraction/depolymerization techniques. Hence, in the present study, a novel low-cost ammonium-based protic ionic liquid (PIL), 2-hydroxyethyl ammonium lactate [N11H(2OH)][LAC], is used for the selective fractionation and improved extraction of lignin from Scots pine (Pinus sylvestris) softwood biomass (PWB). The optimization of three process parameters, viz., the incubation time, temperature, and biomass:PIL (BM:PIL) ratio, was performed to determine the best pretreatment conditions for lignin extraction. Under the optimal pretreatment conditions (180 °C, 3 h, and 1:3 BM:PIL ratio), [N11H(2OH)][LAC] yielded 61% delignification with a lignin recovery of 56%; the cellulose content of the recovered pulp was approximately 45%. Further, the biochemical composition of the recovered lignin and pulp was determined and the recovered lignin was characterized using 1H-13C heteronuclear single quantum coherence (HSQC) nuclear magnetic resonance (NMR) spectroscopy, quantitative 31P NMR, gel permeation chromatography (GPC), attenuated total reflectance (ATF)-Fourier transform infrared spectroscopy (ATR-FTIR), and thermal gravimetric analysis (TGA) analysis. Our results reveal that [N11H(2OH)][LAC] is significantly involved in the cleavage of predominant ß-O-4' linkages for the generation of aromatic monomers followed by the in situ depolymerization of PWB lignin. The simultaneous extraction and depolymerization of PWB lignin favors the utilization of recalcitrant pine biomass as feedstock for biorefinery schemes.

Treatment of Small Cell Lung Cancer with Lurbinectedin: A Review.

BACKGROUND: Lurbinectedin was approved on June 15, 2020 by the Food and Drug Administration with the brand name ZEPZELCA as the first systematic approved therapy for patients having Small Cell Lung Cancer (SCLC). OBJECTIVES: In this review, an attempt is made to summarize different aspects of Lurbinectedin, including the pathophysiology, chemistry, chemical synthesis, mechanism of action, adverse reactions, and pharmacokinetics. Special attention is given to various reported clinical trials of lurbinectedin. METHODS: A comprehensive literature search was conducted in the relevant databases like ScienceDirect, PubMed, ResearchGate and Google Scholar to identify studies. After a thorough study of these reports, significant findings/data were collected and compiled under suitable headings. Important findings related to clinical trials have been tabulated. CONCLUSION: Lurbinectedin is known to act by inhibiting the active transcription of encoding genes, thereby suppressing tumor-related macrophages with an impact on tumour atmosphere. Lurbinectedin has emerged as a potential drug candidate for the treatment of Small-Cell Lung Cancer (SCLC).

Understanding facilitators and barriers to reengineering the clinical research enterprise in community-based practice settings.

Solutions are employed to support clinical research trial tasks in community-based practice settings. Using the IT Implementation Framework (ITIF), an integrative framework intended to guide the synthesis of theoretical perspectives for planning multi-level interventions to enhance IT use, we sought to understand the barriers and facilitators to clinical research in community-based practice settings preliminary to implementing new informatics solutions for improving clinical research infrastructure. The studies were conducted in practices within the Columbia University Clinical Trials Network. A mixed-method approach, including surveys, interviews, time-motion studies, and observations was used. The data collected, which incorporates predisposing, enabling, and reinforcing factors in IT use, were analyzed according to each phase of ITIF. Themes identified in the first phase of ITIF were 1) processes and tools to support clinical trial research and 2) clinical research peripheral to patient care processes. Not all of the problems under these themes were found to be amenable to IT solutions. Using the multi-level orientation of the ITIF, we set forth strategies beyond IT solutions that can have an impact on reengineering clinical research tasks in practice-based settings. Developing strategies to target enabling and reinforcing factors, which focus on organizational factors, and the motivation of the practice at large to use IT solutions to integrate clinical research tasks with patient care processes, is most challenging. The ITIF should be used to consider both IT and non-IT solutions concurrently for reengineering of clinical research in community-based practice settings.

Using design principles to foster understanding of complex health concepts in consumer informatics tools.

Consumer health informatics tools can only be effective if patients comprehend their content. Optimal design may foster better patient comprehension and health literacy, which can improve health outcomes. We developed a patient-centric decision aid, Tailored Lifestyle Conversations (TLC), to help patients comprehend behavioral risks and set behavior change priorities for reducing risk of cardiovascular disease. The TLC decision aid was developed using a design framework based on Gestalt Principles of Perception. Further iteration was informed by qualitative user feedback. Preliminary analysis showed that the TLC decision aid helped patients understand their risk and supported their decisions on health behavior change. We identified design elements that supported patient comprehension, and other elements that were not effective, to inform iterative revision. This paper describes an effective methodology for the development of consumer health informatics tools that includes grounding in design principles complemented by iterative revision based on user testing and feedback.

What do patients search for when seeking clinical trial information online?

The Internet has become a common source for consumers to seek health information across a wide range of topics including searching for clinical trials. However, not much is known about what consumers search for in relation to clinical trials and how they formulate their search queries. In this study, we use log file data from TrialX.com, a consumer-centric website that provides clinical trial information to ascertain patterns in consumer queries. We analyzed semantic patterns in the queries by mapping query keywords to the UMLS Semantic Types and performed a manual evaluation of user paths. We found that the queries can be grouped into combinations of information needs related to condition, location and treatment. The results also suggested that the consumers using longer search queries with multiple Semantic Types are more likely to take action to participate in clinical trials. The study provides early insights that can be used to inform changes in website content and information display to improve clinical trials information seeking.

GetHealthyHarlem.org: developing a web platform for health promotion and wellness driven by and for the Harlem community.

GetHealthyHarlem.org is a community website developed on an open-source platform to facilitate collaborative development of health content through participatory action research (PAR) principles. The website was developed to enable the Harlem community to create a shared health and wellness knowledgebase, to enable discourse about local and culturally relevant health information, and to foster social connections between community members and health promotion organizations. The site is gaining active use with more than 9,500 unique site visits in the six months since going live in November, 2008. In ongoing research studies, we are using the website to explore how the PAR model can be applied to the development of a community health website.

An evidence-based decision aid to help patients set priorities for selecting among multiple health behaviors.

To explore how patients and providers respond to Tailored Lifestyle Conversations (TLC), an evidence-based decision aid to help patients set priorities for selecting among multiple health behavior change goals, we conducted a study utilizing key informant interviews. Based on patient level assessment data, TLC presents tailored outputs that include 1) behavioral and clinical risk; 2) readiness and confidence scores for changing each of four behaviors; and 3) qualitative equations to elicit patient priorities for change. Patient priorities are documented in an action plan to be discussed with their provider during a clinical encounter. Interview questions probed how patients and providers responded to this output, and how heavily they valued the chance of success versus health benefit in deciding which behavior to work on first. The interviews also revealed how TLC might mediate the conversation around behavior change between patients and providers. TLC has potential to drive a more evidence based and patient centric approach to behavioral counseling in clinical settings.

TLC: an informatics approach to enable patients to initiate tailored lifestyle conversations with providers at the point of care.

Chronic illness including cardiovascular disease (CVD) is a major burden on the healthcare system. Behavioral and lifestyle changes could significantly reduce the burden of CVD, but provider counseling for behavior change is a very challenging, and often ineffective task. We have developed a patient-centric decision support tool to be incorporated into an Electronic Health Record system (EHR). The tool provides tailored feedback on behavioral risk, readiness and confidence in an effort to empower patients to make decisions about improving health behaviors. In turn, the tool will facilitate an informed and balanced discussion between patients and their providers about behavioral changes, incorporating both the clinical view and the individual's preferences for choosing among multiple behavior change goals based on their psychosocial characteristics, and evaluation of benefits and barriers.

Building a collaborative global health informatics website.

Information technology is playing an increasing role in managing the challenges of global public health issues. The emergence of Web 2.0 technologies provides a tremendous avenue to foster connections among diverse health professionals engaged in the development and implementation of informatics-based solutions for global health. Our website, www.globalhealthinformatics.org, leverages an open source platform that employs Web 2.0 functionalities to create such a global community with the objective of fostering collaboration and knowledge sharing.

Selecting data elements to build a patient-centric electronic health record that will support adherence to therapeutic lifestyle change.

Cardiovascular disease (CVD) remains the leading cause of death in the US. Therapeutic lifestyle change (TLC) is an effective intervention to reduce the risk of CVD. In developing a patient-centric electronic health record (PC-EHR), our project aims to build an evidence-based support system to facilitate patient-provider interaction, foster cooperative chronic disease management, and promote adherence to TLC guidelines by both providers and patients. In this paper we report on the findings of a modified Delphi method (MDM) study to determine the behavioral and psychosocial elements needed to extend the clinical data model and support the TLC decision support algorithm. An eight-member expert advisory committee reviewed a list of 83 proposed data elements including those from the National Cholesterol Education Program Adult Treatment Panel III guidelines and finalized a set of 30 data elements for inclusion. The MDM proved to be an effective approach for prioritizing data elements.

A tag based recommendation engine to suggest information resources in an online community for health promotion.

WEB 2.0 or the "social web" has created a new paradigm of collaborative information creation, organization and consumption. Among these, the social process of "tagging" has emerged as a bottom-up user-driven method to index content. We describe the use of tags as a way to connect users to resources in an online community that we are developing which utilizes social content creation and collaboration to promote health. Such connections are the basis of a recommendation engine that will suggest users a) other users who have similar health profiles, b) relevant information resources such as articles or blogs on health promotion and c) community resources such as local health facilities.

Re-engineering opportunities in clinical research using workflow analysis in community practice settings.

In this paper we examine frequently performed clinical research activities with the objective of identifying aspects of workflow that could be amenable to informatics-based re-engineering. This paper is part of a series of studies under the NIH Roadmap initiative, which examines workflow of clinical research in community practices. We describe three common work activities, detailing the main actors involved, the tools used and the challenges faced. These activities illustrate inefficiencies in the clinical research workflow which include: a) lack of supporting tools to perform routine work activities, b) redundancy, low reuse of data and poor interoperability between systems and c) the fragmented and distributed nature of the workflow. We identify opportunities for re-engineering at both a micro (activity) and macro level (organization).

A day in the life of a clinical research coordinator: observations from community practice settings.

One of the goals of the NIH Roadmap Initiative is to re-engineer the national clinical research enterprise, with an emphasis on information technology solutions. Understanding end-users' workflow is critical to developing technology systems that are grounded in the context of the users' environment and are designed to fulfill their needs. Community practices are becoming the prevailing setting for conducting clinical research. Few studies have assessed clinical research workflow in such settings. We have conducted a series of investigations to model the workflow and have previously reported on some basic aspects of it, like the lack of information systems to support the workflow. In this paper we describe finer details of the workflow, using results of observational studies. These findings highlight the needs and inefficiencies that suggest the kind of information system that must be developed to enhance collaboration, communication and improve efficiency. This preliminary investigation also opens ground for more extensive studies to further elucidate the workflow.

Redesigning electronic health record systems to support public health.

Current electronic health record systems are primarily clinical in focus, designed to provide patient-level data and provider-level decision support. Adapting EHR systems to serve public health needs provides the possibility of enormous advances for public health practice and policy. In this review, we evaluate EHR functionality and map it to the three core functions of public health: assessment, policy development, and assurance. In doing so, we identify and discuss important design, implementation, and methodological issues with current systems. For example, in order to support public health's traditional focus on preventive health and socio-behavioral factors, EHR data models would need to be expanded to incorporate environmental, psychosocial, and other non-medical data elements, and workflow would have to be examined to determine the optimal way of collecting these data. We also argue that redesigning EHR systems to support public health offers benefits not only to the public health system but also to consumers, health-care institutions, and individual providers.

Extending electronic health records to improve adolescent health.

Electronic health records have been recognized as essential for improving clinical documentation, coordination, and management of health care in addition to lowering costs and improving patient safety. In recent years, there has been a significant impetus for promoting the adoption of electronic health records, as evidenced by the numerous public and private initiatives across the United States. However, currently available electronic health records have not focused on the unique clinical, psychosocial, and health educational needs and requirements of the adolescent age group. In this chapter we discuss briefly the history, development, and adoption of electronic health records and provide examples of how electronic health records can be extended to focus on the needs of adolescents and those who care for them.

Digital partnerships for health: steps to develop a community-specific health portal aimed at promoting health and well-being.

We describe the steps taken by the Harlem Health Promotion Center to develop a community-specific health web portal aimed at promoting health and well-being in Harlem. Methods and results that begin with data collection and move onto elucidating requirements for the web portal are discussed. Sentiments of distrust in medical institutions, and the desire for community specific content and resources were among the needs emanating from our data analysis. These findings guided our decision to customize social software designed to foster connections, collaborations, flexibility, and interactivity; an "architecture of participation". While, we maintain that the leveraging of social software may indeed be the way to build healthy communities and support learning and engagement in underserved communities, our conclusion calls for careful thinking, testing and evaluation research to establish best practice models for leveraging these emerging technologies to support health improvements in the community.