A best practices framework for spatial biology studies in drug discovery and development: enabling successful cohort studies using digital spatial profiling.

The discovery of biomarkers, essential for successful drug development, is often hindered by the limited availability of tissue samples, typically obtained through core needle biopsies. Standard 'omics platforms can consume significant amounts of tissue, forcing scientist to trade off spatial context for high-plex assays, such as genome-wide assays. While bulk gene expression approaches and standard single-cell transcriptomics have been valuable in defining various molecular and cellular mechanisms, they do not retain spatial context. As such, they have limited power in resolving tissue heterogeneity and cell-cell interactions. Current spatial transcriptomics platforms offer limited transcriptome coverage and have low throughput, restricting the number of samples that can be analyzed daily or even weekly. While the Digital Spatial Profiling (DSP) method does not provide single-cell resolution, it presents a significant advancement by enabling scalable whole transcriptome and ultrahigh-plex protein analysis from distinct tissue compartments and structures using a single tissue slide. These capabilities overcome significant constraints in biomarker analysis in solid tissue specimens. These advancements in tissue profiling play a crucial role in deepening our understanding of disease biology and in identifying potential therapeutic targets and biomarkers. To enhance the use of spatial biology tools in drug discovery and development, the DSP Scientific Consortium has created best practices guidelines. These guidelines, built on digital spatial profiling data and expertise, offer a practical framework for designing spatial studies and using current and future spatial biology platforms. The aim is to improve tissue analysis in all research areas supporting drug discovery and development.

MIBLood-EV: An Online Reporting Tool to Facilitate the Standardized Reporting of Preanalytical Variables and Quality Control of Plasma and Serum to Enhance Rigor and Reproducibility in Liquid Biopsy Research.

Pre-analytical variability significantly impacts the reproducibility of liquid biopsy research, which is critical for precision medicine and biomedical research. This report highlights the challenges and variability in the pre-analytical processes of liquid biopsies, especially regarding extracellular vesicles (EVs), which are crucial for diagnostics in oncology. The MIBlood-EV initiative aims to standardize the reporting of pre-analytical variables and the quality control of plasma and serum samples to enhance reproducibility in EV research. By providing a comprehensive and flexible reporting framework, MIBlood-EV seeks to improve the reliability of EV studies and facilitate the development of evidence-based protocols, ultimately advancing the field of liquid biopsy research.

The Power of Commitment: Creating an Award-Winning Culture of Health And Well-Being at DTE Energy.

The evidence that a healthy and safe workforce provides a competitive business advantage is increasingly clear. However, how to obtain this may be unclear to many. This article presents a case study showcasing how one large employer worked toward improving its culture of health and well-being. Measuring progress using an established corporate health assessment tool, results improved 75% over a 5-year period. In addition, site scan culture checks showed annual improvement, exceeding best-in-class scores by the fifth year. Building a culture of health and well-being often requires a few years to implement fully and involves a commitment to plan, deploy, improve, and manage over time. Ultimately, by following approaches taken by best-in-class employers, this can be accomplished with some ease and without missteps along the way.

Approaches to the Prevention and Treatment of Postpartum Hemorrhage: A Systematic Review of Past Advances, Recent Developments, and Best Practices.

Postpartum hemorrhage (PPH) remains the leading cause of maternal mortality worldwide, with uterine atony being the most significant contributing factor. Other risk factors for PPH include increased maternal age, coagulation abnormalities, retained placenta, and prolonged third-stage labor. Despite the potential for prevention through early detection and management, PPH can still occur even in the absence of known risk factors. For this reason, adequate preparation and comprehensive management strategies must be implemented. This study, which comprises research from 2006 to 2023, reviews and analyzes various prevention and management techniques for PPH, including surgical and nonsurgical approaches. Key findings indicate that the presence of well-trained critical control teams is essential for the effective management of PPH. In addition, early detection techniques have significantly reduced mortality outcomes associated with PPH, highlighting their importance in patient care.

Primary health care in Nigeria: best practices and quality of care in Nigeria.

INTRODUCTION: The significance of Primary Healthcare Centers (PHCCs) in fostering health equity and enhancing health outcomes cannot be overstated, especially in low and middle-income countries. This paper's primary area of interest is to create evidence and innovation for PHCs, with a particular emphasis on underserved groups. Thus, the study aimed to investigate the state of primary health care in Nigeria, with a particular emphasis on best practices, challenges to best practices, and quality of care. METHODOLOGY: A cross-sectional quantitative study was conducted to collect secondary data from 29 primary healthcare facilities. The data was collected using staff and facility activity indicators over a year (2022). Descriptive statistics and chi-square tests were used to analyze the collected data. RESULT: Our study data showed that all of the PHCCs have service rosters that can be utilized for follow-up with patients. About 85 (84.1%) respondents have reported that deliveries were taken by the reporting midwife, and 55 (54.5%) respondents indicated that their facilities provided on-the-job training to their staff. This is considered as the best practice in the facility. However, the majority of the PHCCs (71.3%) lacked assessment teams, which was found to have a negative impact on the quality of healthcare provided at these facilities (p < 0.05). CONCLUSION: Our study underscores the pressing need for primary healthcare services in Nigeria. Government authorities and healthcare providers must take action to overcome the challenges of limited capacity, service delivery, and quality of care. By adopting effective strategies and ensuring access to primary healthcare, citizens' health outcomes can be greatly enhanced. Thus, it is essential to revamp and optimize healthcare facilities to establish an efficient healthcare system that caters to the needs of all citizens.

Best practices for user consultation in flow cytometry shared resource laboratories.

This "Best Practices in User Consultation" article is the result of a 2022 International Society for the Advancement of Cytometry (ISAC) membership survey that collected valuable insights from the shared research laboratory (SRL) community and of a group discussion at the CYTO 2022 workshop of the same name. One key takeaway is the importance of initiating a consultation at the outset of a flow cytometry project, particularly for trainees. This approach enables the improvement and standardization of every step, from planning experiments to interpreting data. This proactive approach effectively mitigates experimental bias and avoids superfluous trial and error, thereby conserving valuable time and resources. In addition to guidelines, the optimal approaches for user consultation specify communication channels, methods, and critical information, thereby establishing a structure for productive correspondence between SRL and users. This framework functions as an exemplar for establishing robust and autonomous collaborative relationships. User consultation adds value by providing researchers with the necessary information to conduct reproducible flow cytometry experiments that adhere to scientific rigor. By following the steps, instructions, and strategies outlined in these best practices, an SRL can readily tailor them to its own setting, establishing a personalized workflow and formalizing user consultation services. This article provides a pragmatic guide for improving the caliber and efficacy of flow cytometry research and aggregates the flow cytometry SRL community's collective knowledge regarding user consultation.

Recent methodological advances in federated learning for healthcare.

For healthcare datasets, it is often impossible to combine data samples from multiple sites due to ethical, privacy, or logistical concerns. Federated learning allows for the utilization of powerful machine learning algorithms without requiring the pooling of data. Healthcare data have many simultaneous challenges, such as highly siloed data, class imbalance, missing data, distribution shifts, and non-standardized variables, that require new methodologies to address. Federated learning adds significant methodological complexity to conventional centralized machine learning, requiring distributed optimization, communication between nodes, aggregation of models, and redistribution of models. In this systematic review, we consider all papers on Scopus published between January 2015 and February 2023 that describe new federated learning methodologies for addressing challenges with healthcare data. We reviewed 89 papers meeting these criteria. Significant systemic issues were identified throughout the literature, compromising many methodologies reviewed. We give detailed recommendations to help improve methodology development for federated learning in healthcare.

Obtaining informed consent in veterinary clinical trials mini review.

In September 2023 the United States Food and Drug Administration (FDA) released draft guidance for comment about how informed client consent for companion animal clinical trials should be obtained. This guidance has the potential to substantially change how informed consent documents are written and presented to clients in the veterinary community. It provides specifics not only about how to obtain informed consent from owners but also the timeframe within which consent should be obtained, the formatting and language in the consent forms, and details on elements that are required to be in these consent forms. These changes will involve additional efforts by investigators to ensure compliance yet might lead to increased owner compliance and higher enrollment in clinical studies with subsequent benefits for all.

Summary of the National Cancer Institute 2023 Virtual Workshop on Medical Image De-identification-Part 1: Report of the MIDI Task Group - Best Practices and Recommendations, Tools for Conventional Approaches to De-identification, International Approaches to De-identification, and Industry Panel on Image De-identification.

De-identification of medical images intended for research is a core requirement for data-sharing initiatives, particularly as the demand for data for artificial intelligence (AI) applications grows. The Center for Biomedical Informatics and Information Technology (CBIIT) of the US National Cancer Institute (NCI) convened a virtual workshop with the intent of summarizing the state of the art in de-identification technology and processes and exploring interesting aspects of the subject. This paper summarizes the highlights of the first day of the workshop, the recordings, and presentations of which are publicly available for review. The topics covered included the report of the Medical Image De-Identification Initiative (MIDI) Task Group on best practices and recommendations, tools for conventional approaches to de-identification, international approaches to de-identification, and an industry panel.

Ensuring safety and efficacy in combination products: regulatory challenges and best practices.

Combination products, amalgamating drugs, biologics, and medical devices, have revolutionized the healthcare landscape with their potential for innovative therapies. However, the intersection of diverse components within these products presents a complex regulatory environment, demanding rigorous attention to safety and efficacy. This article delves into the intricate landscape of regulatory considerations, safety, and efficacy assessments pertaining to combination products-a category at the intersection of drugs, devices, and biologics. The regulatory framework, primarily governed by the U.S. Food and Drug Administration (FDA), necessitates a nuanced classification determining the regulatory pathway. Collaboration between diverse regulatory centers, such as the Center for Drug Evaluation and Research (CDER) and the Center for Devices and Radiological Health (CDRH), underscores the integrated approach required for these innovative healthcare solutions. Safety considerations unravel the potential risks and adverse events associated with combining diverse components, emphasizing the need for robust risk assessment and mitigation strategies. The evaluation of efficacy involves sophisticated methodologies, clinical trials, and post-market surveillance, with recent advancements incorporating digital technologies. This comprehensive exploration aims to contribute to the evolving understanding and best practices in the regulatory and scientific realms, fostering collaboration and innovation in the development and assessment of combination products.

Considerations for Culturally Congruent Healthcare for Simulation in Bedside Clinical Practice.

This article provides practical recommendations for creating and implementing culturally appropriate and culturally congruent healthcare simulation applications for bedside providers that adhere to best practices and reporting standards. Framed within the 11 criteria for simulation design outlined in the Healthcare Simulation Standards of Best Practice, the article provides a summary of these criteria, highlighting the lessons learned from their application in a Health Resources and Services Administration-sponsored public health grant 6 U4EHP46217-01-01, Public Health Simulation-Infused Program.

Identifying best practices for substance-related intimate partner violence screening and referral: a narrative review.

Introduction: Substance use is strongly associated with intimate partner violence (IPV) and is a modifiable risk factor for IPV. However, lack of comprehensive screening and referral for co-occurring IPV and substance use, along with their psychiatric sequalae, limits the identification and implementation of effective interventions for substance-related IPV. This narrative review (1) investigates the literature on screening and referral practices for IPV, and if these include screening for substance use or other psychiatric comorbidities, (2) provides recommendations for current best practices, and (3) suggests future directions for research and practice aimed at identifying and reducing substance-related IPV. Methods: A narrative literature review examined studies investigating IPV screening and referral programs in clinics. Selected studies were reviewed for: (1) effectiveness, (2) barriers to implementation and sustainability, and (3) responsivity to psychiatric comorbidity, including substance use and substance use disorders (SUD). Results: Findings suggest that effective IPV screening and referral programs have been developed, but disparities in IPV screening exist and many programs only screen for IPV victimization. Barriers to the implementation and sustainability of IPV screening programs include lack of ongoing provider training, funding or institutional support, and direct connection to referral services. Further, many IPV screening programs lack assessment of and referral for comorbid psychiatric conditions, including substance use, and tend not to be routinely implemented in SUD clinics. Discussion: Additional systematic work is needed to develop universal and comprehensive screening and referral programs for substance-related IPV and address issues of long-term sustainability, particularly within SUD treatment settings.

The 2024 International Journal of Exercise Science Position Stand on Inclusion.

The International Journal of Exercise Science (IJES) Working Group for Opportunity, Representation, and Diverse Perspectives was tasked with developing a position stand to provide guidance in critical areas of inclusion. We present to authors, reviewers, and all readership IJES ideals to utilize in practice. Key points are presented, followed by a deeper look with greater explanation into the areas of inclusive language, diversity and inclusion in research, and accessibility. The same approach is presented for the areas of age, disability status, gender identity and sexual orientation, race, and ethnicity with attention to Indigenous Communities, religion, socioeconomic status, and neurodiversity. Person-first language is encouraged, with the acknowledgment that the preference of different community members may vary. IJES is committed to maintaining an environment that is welcoming to all identities so that they feel valued, respected, and included.

Tuberculosis preventive treatment in eight SEAR countries - Current practices, implementation challenges and operations research priorities.

Objectives: Countries in the South East Asian region face similar challenges in control of infectious diseases. There is limited access to experiences and learnings of neighboring countries. The Indian Council - of Medical Research (ICMR) has established a Regional Enabler for the South-East Asia Research Collaboration for Health (RESEARCH) Platform for South East Asian Region (SEAR) countries to address the above issues. This paper discusses about current practices, implementation challenges and operations research priorities of Tuberculosis Preventive therapy (TPT) in eight SEAR countries. Methods: A three day workshop on "Capacity Building for TB Research under Programmatic Settings". was conducted under the aegis of this RESEARCH platform jointly ICMR and the Union which was participated by eight SEAR countries. Data were collected from a semi-structured questionnaire prior to the workshop and open discussions during the workshop. Results: The various challenges faced for TPT implementation were broadly categorized as poor demand and low level of acceptance by the beneficiary, low level of acceptance to provide TPT among the providers, challenges in ruling out active TB, issues with supply and supply chain management of diagnostic tests and drugs. Many operations research priorities like person centric TPT driven models, capacity building for improving cascade of care for latent TB infection, health system strengthening and effective risk communication were identified. Conclusion: Full implementation of the TPT guidelines requires focused attention and coordinated action from all stakeholders of the country to attain the full benefit of TB preventive therapy and the ultimate TB elimination goal.

Establishing Best Practices in Telehealth Care for Adults with Developmental Disabilities in the United States: An e-Delphi Study.

Background: Telehealth care is now a key element of mainstream health care since the COVID-19 pandemic, with all types of health care providers joining the digital revolution. As a population experiencing health care disparities, adults with developmental disabilities and their supporters have described variable experiences with telehealth care that contribute to overall care quality and health outcomes. Methods: This e-Delphi study established consensus on best practices in telehealth care for adults with developmental disabilities in the United States. Online surveys and videoconferencing interviews were conducted with 44 expert panelists with experience with telehealth care and developmental disabilities, including adults with developmental disabilities, family members, direct support professionals, nurses, and health care providers. Results: Three rounds of surveys resulted in a set of 9 guidelines consisting of 42 items. The guidelines addressed 1) appropriate situations for telehealth care, 2) communication needs and preferences, 3) support person collaboration, 4) education and anticipatory guidance, 5) reminders, 6) coordination of care, 7) equitable and fair access, 8) privacy and safety, and 9) evidence-based practice. Conclusion: Health care providers can adopt these best practice guidelines to ensure telehealth care is provided equitably and safely to adults with developmental disabilities. Policy advocacy is needed for the uptake of these guidelines and for health care providers and adults with developmental disabilities to access the resources needed for safe and effective telehealth care use.

Associations between negative patient safety climate and infection prevention practices.

The relationships among positive perceptions of safety climate and better healthcare worker behaviors have been increasingly documented in the literature. The potential influence of negative perceptions is underexplored and has not been examined in relationship to infection prevention practices. We begin to address this gap using data collected as part of a multi-site, cross-sectional study. This brief report describes associations identified between negative perceptions of patient safety climate and standard precaution adherence of hospital-based nurses.

Transparency and reproducibility in the Adolescent Brain Cognitive Development (ABCD) study.

BACKGROUND: Transparency can build trust in the scientific process, but scientific findings can be undermined by poor and obscure data use and reporting practices. The purpose of this work is to report how data from the Adolescent Brain Cognitive Development (ABCD) Study has been used to date, and to provide practical recommendations on how to improve the transparency and reproducibility of findings. METHODS: Articles published from 2017 to 2023 that used ABCD Study data were reviewed using more than 30 data extraction items to gather information on data use practices. Total frequencies were reported for each extraction item, along with computation of a Level of Completeness (LOC) score that represented overall endorsement of extraction items. Univariate linear regression models were used to examine the correlation between LOC scores and individual extraction items. Post hoc analysis included examination of whether LOC scores were correlated with the logged 2-year journal impact factor. RESULTS: There were 549 full-length articles included in the main analysis. Analytic scripts were shared in 30 % of full-length articles. The number of participants excluded due to missing data was reported in 60 % of articles, and information on missing data for individual variables (e.g., household income) was provided in 38 % of articles. A table describing the analytic sample was included in 83 % of articles. A race and/or ethnicity variable was included in 78 % of reviewed articles, while its inclusion was justified in only 41 % of these articles. LOC scores were highly correlated with extraction items related to examination of missing data. A bottom 10 % of LOC score was significantly correlated with a lower logged journal impact factor when compared to the top 10 % of LOC scores (ß=-0.77, 95 % -1.02, -0.51; p-value < 0.0001). CONCLUSION: These findings highlight opportunities for improvement in future papers using ABCD Study data to readily adapt analytic practices for better transparency and reproducibility efforts. A list of recommendations is provided to facilitate adherence in future research.

The Neurostimulation Appropriateness Consensus Committee (NACC)®: Recommendations for the Mitigation of Complications of Neurostimulation.

INTRODUCTION: The International Neuromodulation Society convened a multispecialty group of physicians based on expertise and international representation to establish evidence-based guidance on the mitigation of neuromodulation complications. This Neurostimulation Appropriateness Consensus Committee (NACC)® project intends to update evidence-based guidance and offer expert opinion that will improve efficacy and safety. MATERIALS AND METHODS: Authors were chosen on the basis of their clinical expertise, familiarity with the peer-reviewed literature, research productivity, and contributions to the neuromodulation literature. Section leaders supervised literature searches of MEDLINE, BioMed Central, Current Contents Connect, Embase, International Pharmaceutical Abstracts, Web of Science, Google Scholar, and PubMed from 2017 (when NACC last published guidelines) to October 2023. Identified studies were graded using the United States Preventive Services Task Force criteria for evidence and certainty of net benefit. Recommendations are based on the strength of evidence or consensus when evidence was scant. RESULTS: The NACC examined the published literature and established evidence- and consensus-based recommendations to guide best practices. Additional guidance will occur as new evidence is developed in future iterations of this process. CONCLUSIONS: The NACC recommends best practices regarding the mitigation of complications associated with neurostimulation to improve safety and efficacy. The evidence- and consensus-based recommendations should be used as a guide to assist decision-making when clinically appropriate.

The Neurostimulation Appropriateness Consensus Committee (NACC)®: Recommendations for Spinal Cord Stimulation Long-Term Outcome Optimization and Salvage Therapy.

INTRODUCTION: The International Neuromodulation Society (INS) has recognized a need to establish best practices for optimizing implantable devices and salvage when ideal outcomes are not realized. This group has established the Neurostimulation Appropriateness Consensus Committee (NACC)® to offer guidance on matters needed for both our members and the broader community of those affected by neuromodulation devices. MATERIALS AND METHODS: The executive committee of the INS nominated faculty for this NACC® publication on the basis of expertise, publications, and career work on the issue. In addition, the faculty was chosen in consideration of diversity and inclusion of different career paths and demographic categories. Once chosen, the faculty was asked to grade current evidence and along with expert opinion create consensus recommendations to address the lapses in information on this topic. RESULTS: The NACC® group established informative and authoritative recommendations on the salvage and optimization of care for those with indwelling devices. The recommendations are based on evidence and expert opinion and will be expected to evolve as new data are generated for each topic. CONCLUSIONS: NACC® guidance should be considered for any patient with less-than-optimal outcomes with a stimulation device implanted for treating chronic pain. Consideration should be given to these consensus points to salvage a potentially failed device before explant.

Healthcare providers' perspectives on sustaining respectful maternity care appreciated by mothers in five hospitals of Rwanda.

BACKGROUND: Childbirth reserves respect, as emphasized by the World Health Organization in 2018, and the focus towards the need for positive, dignified delivery experiences has become an integral aspect of Respectful Maternity Care (RMC). It is a known fact that RMC is pivotal for favourable birth outcomes and contributes to the satisfaction of maternity care. The absence of RMC negatively affects women's and newborns' rights. The study aimed to explore healthcare providers' perspectives on sustaining RMC actions that mothers previously reported. METHODOLOGY: This study was conducted in five hospitals in the Eastern province of Rwanda, involving 5 Focus Group Discussions (FGDs) with midwives and nurses. For interviews, we purposively selected 5-unit managers and five physicians. Additionally, 40 midwives and nurses were recruited for the FGDs. The research utilized the Dream phase of Appreciative Inquiry (AI) for interviews and Focus Groups. Data collection aimed to gain insights into Healthcare Providers' perceptions of how RMC is provided and how to establish and sustain RMC in Rwandan health facilities. Nvivo 12 was employed for organizing codes and creating a codebook, and thematic analysis was applied. RESULTS: Four themes with sub-themes emerged. Namely, 1) Women-centered care, with Compassionate care, Privacy and confidentiality maintenance, Information provision and Liberty in decision making, Effective communication, Family involvement, Cleanliness, and Equality care. 2) Professionalism compliance with Motivated staff, Teamwork, Continuous development, Quality work provision, and Community trust. 3) RMC encounters 4) RMC sustenance. CONCLUSION AND RECOMMENDATIONS: The continuous pursuit of high RMC standards in Rwanda involves improving childbirth experiences through utilizing existing resources, ongoing improvement, and sustaining achievements. Key recommended actions in this study for sustaining RMC encompass promoting women-centred care, enhancing healthcare provider attitudes, ensuring professionalism, building community trust, maintaining conducive health facility environments, and involving leadership.