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To assess the consistency of return to sport and occupation recommendations following EHI provided in published clinical practice guidelines, consensus statements, position statements, and practice alerts. The agreement between medical policies governing the return to duty following EHI between the branches of the United States Armed Forces and published recommendations was assessed. Ovid MEDLINE, Web of Science, and CINAHL databases were searched for clinical practice guidelines and position statements published at any time that guided return to activity in individuals with EHI. Methodological quality was assessed, and the specific recommendations for clinical management were extracted. Consistency of recommendations was evaluated. Agreement between published guidelines and the policies governing return to activity in military tactical athletes with heat injury were also evaluated. Guidelines developed by two civilian sports medicine societies in the United States detailing recommendations for return to function following EHI were identified. There was consistency between guidelines regarding recommendations that addressed abstinence from activity; medical follow-up; graded resumption of activity; and return to function. Pertaining military policy, contemporary regulations published in recent years reflected the recommendations provided in the professional guidelines. The greatest incongruence was noted in older military policies. This systematic review highlights the need for consistent recommendations across all branches of the military and medical specialties pertaining to returning servicemembers to duty after EHI. [ABSTRACT FROM AUTHOR]

Regulatory studies have revolutionised over time. Today, the focus has shifted from animal toxicity testing to non-animal for regulatory safety testing. This move is in line with the international 3Rs (Replacement, Reduction, and Refinement) principle and has also changed the regulator's perspective. The 3R principle has stimulated changes in policy, regulations, and new approaches to safety assessment in drug development in many countries. The 3Rs approach has led to the discovery and application of new technologies and more human-relevant in vitro approaches that minimise the use of animals including non-human primates, in research and improve animal welfare. In 2016, the European Medicines Agency published the Guidelines on the principles of regulatory acceptance of 3Rs testing approaches, followed by a conceptual paper in 2023 to align with current 3R standards. Additionally, the United States Food and Drug Administration passed new legislation in 2023 that no longer requires all new human drugs to be tested on animals, which will change the current testing paradigm. This review paper provides the adoption of the 3Rs and the current regulatory perspective regarding their implementation., Competing Interests: Declaration of competing interest The authors declare the following financial interests/personal relationships which may be considered as potential competing interests:Johnson Stanslas reports administrative support was provided by PutraMalaysia University. Johnson Stanslas reports a relationship with Putra Malaysia University that includes: employment. Johnson Stanslas has patent pending to Not applicable. The authors declare that there are no conflicts of interest. If there are other authors, they declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper., (Copyright © 2024 Elsevier Inc. All rights reserved.)

Approval of drug products for market registration warrants, among other data, evidence to support their safety and effectiveness in the target populations. The extent of investigations to provide the supporting evidence varies between the new innovator products and their follow-on versions generally referred to as Generic Drugs Products in the United States and Hybrids in the Europe. The new drug applications entail large data sets encompassing both nonclinical and clinical product developments. Safety and effectiveness in man is studied in sequentially phased clinical trials, including post marketing evaluations (Where applicable). However, for the generic/hybrid products the safety and effectiveness are established through determination of bioequivalence in head-to-head comparison between the originator and the follow-ons. Methods for documentation of bioequivalence for drug products that reach target site(s) through systemic circulation are aligned worldwide. However, establishing bioequivalence of orally inhaled drug products is complex as drug delivery to the local site(s) of action is independent of the systemic circulation. Documentation of bioequivalence gets further complicated due to the Drug-Device combination nature of these products. The guidelines for establishment of BE of locally acting orally inhaled drugs products vary among certain geographies. This article examines the scientific underpinning of distinctions and similarities between the US and EU guidelines., (Copyright © 2024. Published by Elsevier B.V.)

Nonhuman animals used in biomedical research frequently suffer and are harmed as part of their use as experimental models. The Institutional Animal Care and Use Committee (IACUC) of a given institution is meant to ensure that research protocols follow federal guidelines, but research protocols such as those described in this case can generate unnecessary suffering; this problem suggests limitations of IACUCs' capacity to protect nonhuman animals' welfare. This commentary on the case considers how to more fully protect nonhuman animals used in scientific research and identifies barriers to more comprehensive protection of nonhuman animals' welfare., (Copyright 2024 American Medical Association. All Rights Reserved.)

In 1992, the American Society of Anesthesiologists Committee on Ethics was formed primarily to address the rights of patients with existing Do-Not-Resuscitate orders presenting for anesthesia. Guidelines written for the ethical management of these patients stated that such orders should be reconsidered-not rescinded-thus respecting patient self-determination. The Committee also rewrote the reigning Guidelines for the Ethical Practice of Anesthesiology by expanding its ethical foundations to reflect the evolving climate of ethical opinions. These Guidelines described ethically appropriate conduct and behavior, including anesthesiologists' ethical responsibilities to patients, themselves, colleagues, health-care institutions, and community and society., Competing Interests: Disclosure The authors have nothing to disclose., (Copyright © 2023 Elsevier Inc. All rights reserved.)

Force Health Protection programs in the U.S. Air Force endeavor to sustain the operational readiness of the warfighters. We have previously identified hundreds of chemical substances of interest and toxicity reference value (TRV) knowledge gaps that constrain risk based-decision-making for potential exposures. Multiple approaches to occupational TRV estimation were used to generate possible guideline values for 84 compounds (18% of the substances of interest). These candidate TRVs included values from international databases, chemical similarity (nearest neighbor) approaches, empirical adjustments to account for duration differences, quantitative activity relationships, and thresholds of toxicological concern. This present work describes derivation of provisional TRVs from these candidate values. Rodent bioassay-derived long-term worker Derived No-Effect Levels (DNELs) were deemed presumptively the most reliable, but only 19 such DNELs were available for the 84 substances with TRV gaps. In the absence of DNELs, the quality of the approaches and consistency among candidate values were key elements of the weight of evidence used to select the most suitable guideline values. The use of novel nearest-neighbor approaches, empirical adjustment of short term TRVs, and occupational exposure bands were found to be options that would allow occupational TRV estimation with reasonable confidence for nearly all substances evaluated., Competing Interests: Declaration of competing interest The authors declare the following financial interests/personal relationships which may be considered as potential competing interests: Lisa M. Sweeney reports financial support was provided by Air Force Research Laboratory. Teresa R. Sterner reports financial support was provided by Air Force Research Laboratory. If there are other authors, they declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper., (Copyright © 2024 Elsevier Inc. All rights reserved.)

The Association of Professors of Gynecology and Obstetrics created the Diversity, Equity, and Inclusion Guidelines Task Force to develop best practices to establish a diverse physician workforce and eliminate racism in medical education. Using the guidelines, educators are impacting their communities and, in some areas, leading their institutions toward greater diversity and inclusion. The guidelines are organized by 4 domains: learning environment, grading and assessment, pathway programs, and metrics. This manuscript uses that framework to highlight the work of individual educators who are moving the needle towards racism-free health care and aims to inspire others contemplating incorporation into their programs., (Copyright © 2024 Wolters Kluwer Health, Inc. All rights reserved.)

The US Environmental Protection Agency (USEPA) considers sediment toxicity tests as conditional registration requirements for pesticides with soil Kd ≥50 L/kg-solid, Koc ≥1000 L/kg-organic carbon, or log Kow ≥3. The hydrophobicity of these compounds often necessitates use of solvents to ensure accurate and homogeneous dosing of spiked-sediment studies. For sediment tests, a volatile solvent (e.g., acetone) is generally used as a transient carrier. Due to low water solubility, test material is dissolved in a volatile solvent to create stock solutions. A measured aliquot of stock solution is then mixed with sand substrate, after which the solvent is evaporated. This spiking process results in negligible solvent exposure to organisms. In 2016, USEPA released final ecotoxicity test guidelines for subchronic freshwater (850.1735) and marine (850.1740) sediment test. These methods provide an option for conducting experiments with only a solvent control and no negative control. To adopt this testing strategy, functional equivalency between the negative and solvent control must be demonstrated. These test guidelines describe specific factors that should be considered for evaluating functional equivalency, including (a) the concentration of solvent in the test sediment after evaporation, (b) the levels of solvent that are known to affect organism health, (c) the known impurities in the solvent and their potential impact on organism health, and (d) the historical organism performance of solvent versus negative controls. Our analysis considers these factors and overall supports the elimination of the negative control requirement because this change is unlikely to impact the robustness or interpretability of spiked-sediment toxicity tests. Environ Toxicol Chem 2024;43:1740-1746. © 2023 CropLife America. Environmental Toxicology and Chemistry published by Wiley Periodicals LLC on behalf of SETAC., (© 2023 CropLife America. Environmental Toxicology and Chemistry published by Wiley Periodicals LLC on behalf of SETAC.)

The Physical Activity Guidelines for Americans , second edition, recommends older adults participate in ≥150 minutes per week of moderate-intensity equivalent aerobic activity and ≥2 days per week of muscle-strengthening activity. We estimated prevalence and trends of meeting the guidelines among US adults aged ≥65 years from 1998 to 2018. Using the 1998-2018 National Health Interview Survey, we estimated the prevalence of meeting aerobic, muscle-strengthening, and combined physical activity guidelines stratified by age group, sex, race and ethnicity, and education level. Within age groups, we calculated prevalence differences by sociodemographic categories. Prevalence of meeting each guideline increased for all age groups and most sociodemographic subgroups. The increased magnitude of meeting the combined guideline from 1998-2000 to 2016-2018 differed across levels of educational attainment for most age groups. Despite increasing over time, the prevalence among older adults of meeting physical activity guidelines remains low (range for combined guideline: 7.2%-17.2%)., Competing Interests: Declaration of Conflicting InterestsThe author(s) declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article.

This study presented a narrative review of the six latest sets of guidelines on physical activity for children and adolescents from Australia, Canada, China, the United Kingdom, the United States and WHO, and analysed the history of the development of the guidelines; the policy context in which the guidelines were developed; and the main subjects of the guidelines. The core elements of the latest guidelines were identified and compared, including frequency, intensity, duration (time), and type of physical activity, assessment intensity of physical activity, and risk prevention for physical activity participation. There is an urgent need for obtaining the latest scientific evidence to support and update the contents of the Chinese guidelines. We therefore make the following recommendations for future revisions of the Chinese guidelines based on the findings of this study: (1) to update the recommended frequency, intensity, duration, and type of physical activities that meet the needs for Chinese children and adolescents; (2) to update the methods for assessing physical activity intensity, and identifying and managing the risk factors in participating in physical activity; and (3) to incorporate analyses and reviews of school physical education curriculum for effectively achieving the adequate levels of physical activity., Competing Interests: The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest., (Copyright © 2024 Hu, Zhou, Crowley-McHattan and Liu.)

This article examines the ethics of research design and the initiation of a study (e.g., recruitment of participants) involving refugee participants. We aim to equip investigators and members of IRBs with a set of ethical considerations and pragmatic recommendations to address challenges in refugee-focused research as it is developed and prepared for IRB review. We discuss challenges including how refugees are being defined and identified; their vulnerabilities before, during, and following resettlement that impacts their research participation; recruitment; consent practices including assent and unaccompanied minors; and conflicts of interest. Ethical guidance and regulatory oversight provided by international bodies, federal governments, and IRBs are important for enforcing the protection of participants. We describe the need for additional ethical guidance and awareness, if not special protections for refugee populations as guided by the National Institutes of Health (NIH) Guiding Principles for Ethical Research., (© 2024 The Authors. Ethics & Human Research published by Wiley Periodicals LLC on behalf of The Hastings Center.)

Although platform trials have many benefits, the complexity of these designs may result not only in increased methodological but also regulatory and ethical challenges. These aspects were addressed as part of the IMI project EU Patient-Centric Clinical Trial Platforms (EU-PEARL). We reviewed the available guidelines on platform trials in the European Union and the United States. This is supported and complemented by feedback received from regulatory interactions with the European Medicines Agency and the US Food and Drug Administration. Throughout the project we collected the needs of all relevant stakeholders including ethics committees, regulators, and health technology assessment bodies through active dialog and dedicated stakeholder workshops. Furthermore, we focused on methodological aspects and where applicable identified the corresponding guidance. Learnings from the guideline review, regulatory interactions, and workshops are provided. Based on these, a master protocol template was developed. Issues that still need harmonization or clarification in guidelines or where further methodological research is needed are also presented. These include questions around clinical trial submissions in Europe, the need for multiplicity control across the whole master protocol, the use of non-concurrent controls, and the impact of different randomization schemes. Master protocols are an efficient and patient-centered clinical trial design that can expedite drug development. However, they can also introduce additional operational and regulatory complexities. It is important to understand the different requirements of stakeholders upfront and address them in the trial. While relevant guidance is increasing, early dialog with relevant stakeholders can help to further support such designs., (© 2024 The Authors, Johnson & Johnson Innovative Medicines and Sanofi. Clinical Pharmacology & Therapeutics published by Wiley Periodicals LLC on behalf of American Society for Clinical Pharmacology and Therapeutics.)

Group supervision is an extensively used format across many training agencies, yet it has been largely disregarded in theory and research within the supervision literature. In fact, the Guidelines for Clinical Supervision in Health Service Psychology (American Psychological Association, 2015a) mentions group supervision only one time, despite the fact that supervision within a group context includes competencies and considerations that are both unique and essential to the effective and ethical practice of group supervision. Because supervision conducted with multiple supervisees is multilayered and-as a result-more complex, group supervisors need to develop special skills that go beyond the supervision dyad. This article looks to the literature on supervision-both individual and group modalities-and on group psychotherapy to highlight the practices and processes that set group supervision apart. Building upon the seven supervision competencies outlined by the American Psychological Association (Supervisor Competence; Diversity; Supervisory Relationship; Professionalism; Assessment/Evaluation/Feedback; Professional Competence Problems; and Ethical, Legal and Regulatory Considerations), which currently concentrate exclusively on individual supervision, we extend each area to include distinct features of group supervision. We include recommendations for supervisor training and for the application of effective group supervision practices, as well as ideas on how best to approach the formal adoption of group supervision guidelines for psychotherapists. Our hope is that, either in a revision of the Guidelines for Clinical Supervision in Health Service Psychology or in a freestanding supplement to the Guidelines, guidance for group supervision will be more explicitly included. (PsycInfo Database Record (c) 2024 APA, all rights reserved).

Introduction: Limited data on 24-hour movement behaviors of children aged 5-8 years exist globally. We describe the prevalence and sociodemographic associations of meeting physical activity (PA), sedentary recreational screen time (ST), and sleep guidelines among children from 11 jurisdictions in the US-Affiliated Pacific region., Methods: Cross-sectional representative data from 1192 children aged 5-8 years living in the US-Affiliated Pacific region were drawn from the baseline 2012-2014 Children's Healthy Living Program. Sleep and moderate- to vigorous-intensity PA were calculated from accelerometry. ST and sociodemographic data were collected from caregiver surveys. The percentage of children meeting the Asia-Pacific 24-hour movement guidelines for PA (≥60 min/d of moderate- to vigorous-intensity PA), sleep (≥9 and ≤ 11 h/d) and ST (≤2 h/d) were calculated. Generalized linear mixed models were used to examine associations with adiposity and sociodemographic variables., Results: Twenty-seven percent (95% confidence interval, 24.6-30.0) of children met integrated guidelines; 98% (96.2-98.0) met PA, 78% (75.4-80.0) met sleep, and 35% (32.6-38.0) met ST guidelines. Females (adjusted odds ratio = 1.40 [95% confidence interval, 1.03-1.91]) and those living in lower-middle-income jurisdictions (2.29 [1.49-3.54]) were more likely to meet ST guidelines. Overweight children (0.62 [0.40-0.96]), those aged 8 years (0.39 [0.22-0.69]), and children with caregivers of an education level of high school or beyond (0.44 [0.29-0.68]) were less likely to achieve ST guidelines. Children from midrange annual household incomes were less likely to meet combined guidelines (0.60 [0.39-0.92])., Conclusions: Three-quarters of children are not meeting integrated Asia-Pacific 24-hour movement guidelines. Future strategies for reducing ST and increasing integrated guidelines compliance are needed.

Objective: In 2006 the Association of American Medical Colleges recommended standardization of documentation of the contributions of medical educators and guidelines for their academic promotion. The authors characterized current United States (US) medical school promotion guidelines for medical educators., Methods: Authors collected publicly available data from medical school promotion websites from March through July 2022 after determining categories by traditional-set domains as well as peer-reviewed standards. Extracted data were analyzed using descriptive and inferential statistics, and frequencies were calculated for nominal and categorical data., Results: Of 155 medical schools identified, promotion criteria were publicly available for 143 (92%) schools. Ninety-one (64%) schools identified a distinct educator track. Of those with a defined educator track, 44 (48%) schools consider workshops or other media when evaluating candidates for promotion, and only 52 (57%) of schools with a specified educational track require additional documentation of teaching or education as part of their promotion process. Notably, 34 (37%) of the 91 schools with an educator track specifically require an Educational Portfolio, compared to 27 (52%) of the 52 schools that do not have a specific educator track for promotion., Conclusion: This study describes the current lack of clarity and consistency of the promotion criteria for medical educators and indicates that the guidelines proposed by the Association of American Medical Colleges over 15 years ago have not been widely adopted. These data amplify previous calls for a more objective set of criteria for evaluating and recognizing the contributions of medical educators., Competing Interests: Declaration of Competing Interest The authors have no conflicts of interest to disclose., (Copyright © 2024 Academic Pediatric Association. Published by Elsevier Inc. All rights reserved.)

Oocyte donation has greatly expanded in the past several decades since the first procedure was performed in 1983. According to the Centers for Disease Control, the number of cycles using donor oocytes increased from 18,011 cycles in 2010 to 27,131 cycles in 2019. Oocyte donation has become an important reproductive option for women with diminished ovarian reserve, recurrent failed in vitro fertilization, or heritable genetic conditions. It is also particularly important for single men, same-sex male couples, and men with a transgender woman partner. More recently, societal changes accompanying the expansion of social media and broader access to direct-to-consumer DNA testing have raised concerns about privacy and anonymity. In this article, we review two specific aspects of donor privacy: privacy related to personal identifiers provided by clinics or donor egg bank websites and privacy related to direct-to-consumer genetic testing. We also provide clinical recommendations specific to the United States for working with oocyte donors and donor oocyte recipients., Competing Interests: Financial Disclosure The authors did not report any potential conflicts of interest., (Copyright © 2024 by the American College of Obstetricians and Gynecologists. Published by Wolters Kluwer Health, Inc. All rights reserved.)

In December 2021, the United States Food and Drug Administration (FDA) issued the final guidance for industry titled Pathology Peer Review in Nonclinical Toxicology Studies: Questions and Answers . The stated purpose of the FDA guidance is to provide information to sponsors, applicants, and nonclinical laboratory personnel regarding the management and conduct of histopathology peer review as part of nonclinical toxicology studies conducted in compliance with good laboratory practice (GLP) regulations. On behalf of and in collaboration with global societies of toxicologic pathology and the Society of Quality Assurance, the Scientific and Regulatory Policy Committee (SRPC) of the Society of Toxicologic Pathology (STP) initiated a review of this FDA guidance. The STP has previously published multiple papers related to the scientific conduct of a pathology peer review of nonclinical toxicology studies and appropriate documentation practices. The objectives of this review are to provide an in-depth analysis and summary interpretation of the FDA recommendations and share considerations for the conduct of pathology peer review in nonclinical toxicology studies that claim compliance to GLP regulations. In general, this working group is in agreement with the recommendations from the FDA guidance that has added clear expectations for pathology peer review preparation, conduct, and documentation., Competing Interests: Declaration of Conflicting InterestsThe author(s) declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article.

Recent decades have seen advancements in the management and treatment of difficultto- treat diseases such as cancer. A special class of therapeutics called cell and gene therapy has been introduced in the past 10 years. Cell and gene therapy products have strengthened the treatment options for life-threatening diseases with unmet clinical needs and also provided the possibility of a potential cure for the disease in some of the patients. Cell and gene therapy products are gaining recognition, and the interest in clinical development of cell and gene therapy products is increasing. Moreover, as the class of cell and gene therapy products is relatively new, there is a limited regulatory experience in the development, and the developers of the cell and gene therapy products can often be puzzled with an array of questions on regulations. The current review intends to provide a basic understanding of regulatory guidelines from the FDA and EMA that are applicable to cell and gene therapy products. Essentials such as which office is responsible for the evaluation of applications, which regulatory class/pathway is appropriate for development, and what are the quality, nonclinical and clinical studies that are needed to support the application are discussed in the article. In addition, a summary of regulatory designations and the post-approval requirements, such as Risk Evaluation and Mitigation Strategies (REMS) and long-term follow- up, is included in the article. Developers (referred to as 'sponsors' in this article) of cell and gene therapies can use the respective guidance documents and other specific review articles cited in this review for detailed information on the topics., (Copyright© Bentham Science Publishers; For any queries, please email at epub@benthamscience.net.)

The Tumor Combination Guide was created at the request of the U. S. Food and Drug Administration (FDA) by a Working Group of biopharmaceutical experts from international societies of toxicologic pathology, the Food and Drug Administration (FDA), and members of the Standard for Exchange of Nonclinical Data (SEND) initiative, to assist pharmacology/toxicology reviewers and biostatisticians in statistical analysis of nonclinical tumor data. The guide will also be useful to study and peer review pathologists in interpreting the tumor data. This guide provides a higher-level hierarchy of tumor types or categories correlating the tumor names from the International Harmonization of Nomenclature and Diagnostic Criteria (INHAND) publications with those available in the NEOPLASM controlled terminology (CT) code list in SEND. The version of CT used in a study should be referenced in the nonclinical study data reviewer's guide (SDRG) (section 3.1) of electronic submissions to the FDA. The tumor combination guide instructions and examples are in a tabular format to make informed decisions for combining tumor data for statistical analysis. The strategy for combining tumor types for statistical analysis is based on scientific criteria gleaned from the current scientific literature; as SEND and INHAND terminology and information evolve, this guide will be updated., Competing Interests: Declaration of Conflicting InterestsThe author(s) declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article.

Background: The 2009 Institute of Medicine (IOM) gestational weight gain (GWG) guidelines were initially developed for pregnant women in the United States., Objective: This study aimed to investigate whether the IOM guidelines were suitable for pregnant Chinese women., Methods: A retrospective cohort study comprising 20,593 singleton pregnant women was conducted at the Beijing Obstetrics and Gynaecology Hospital (1 January 2018 to 31 December 2019). Applicability was evaluated by comparing the GWG corresponding to the lowest point of the predicted composite risk curve with the 2009 IOM GWG Guidelines. The IOM Guidelines serve as the standard for the GWG categories and the pre-pregnancy body mass index. An exponential function model was used to fit the weight gain during pregnancy and the probability of caesarean section, preterm birth, small for gestational age, and large for gestational age. A quadratic function model was used to fit the combined probability of the above-mentioned adverse pregnancy outcomes. The applicability of the IOM guidelines was evaluated by comparing the weights corresponding to the lowest predicted probability with the GWG range recommended by the IOM guidelines., Results: According to the 2009 IOM GWG Guidelines, 43% of the women achieved adequate weight, almost 32% gained excessive weight, and 25% gained inadequate weight. The GWG range proposed by the IOM included the lowest predicted probability value for underweight women and exceeded the lowest predicted probability for normal weight, overweight, and obese women., Conclusions: The 2009 IOM guidelines were suitable for Chinese women whose pre-pregnancy body mass index was classified as underweight. The guidelines were not suitable for normal, overweight, or obese pre-pregnancy body mass index classifications. Therefore, based on the above evidence, the 2009 IOM guidelines are not suitable for all Chinese women.

Although air quality has gradually improved in recent years, as shown by the decrease in PM 2.5 concentration, the problem of rising ambient ozone has become increasingly serious. To reduce hazards to human health and environmental welfare exposure to ozone, scientists and government regulators have developed ozone guidelines and standards. These answer the questions of which levels of exposure are hazardous to human health and the environment, and how can ambient ozone exposure be guaranteed, respectively. So what are the basis for the ozone guidelines and standards? This paper reviews in detail the process of revising ozone guidelines and standards by the World Health Organization (WHO) and the United States Environmental Protection Agency (EPA). The present study attempts to explore and analyze the scientific basis and empirical methods for updating guidelines and standards, in a view to guide the future revision process and provide directions for further scientific research. We found many epidemiological and toxicological studies and exposure-response relationships provided strong support for developing and revising the ozone guidelines. When setting standards, ozone exposure has been effectively considered, and the economic costs, health, and indirect economic benefits of standard compliance were reasonably estimated. Accordingly, epidemiological and toxicological studies and the establishment of exposure-response relationships, as well as exposure and risk assessment and benefit-cost estimates of standards compliance should be strengthened for the further update of guidelines and standards. In addition, with the increasing prominence of combined air pollution led by ozone and PM 2.5 , more joint exposure scientific research related to ozone guidelines and standards should be undertaken., Competing Interests: The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest., (Copyright © 2023 Xue and Zhang.)

Guidelines for screening and management of congenital hypothyroidism in neonates have been recently updated by the American Academy of Pediatrics (AAP). This article compares new AAP guideline with the Indian Society for Pediatric and Adolescent Endocrinology (ISPAE) Guidelines, 2018 and lists the changes in screening, diagnosis, and management of congenital hypothyroidism suggested in the new guidelines, along with clinical utilization in the Indian scenario.

Adult moyamoya disease and syndrome are rare disorders with significant morbidity and mortality. A writing group of experts was selected to conduct a literature search, summarize the current knowledge on the topic, and provide a road map for future investigation. The document presents an update in the definitions of moyamoya disease and syndrome, modern methods for diagnosis, and updated information on pathophysiology, epidemiology, and both medical and surgical treatment. Despite recent advancements, there are still many unresolved questions about moyamoya disease and syndrome, including lack of unified diagnostic criteria, reliable biomarkers, better understanding of the underlying pathophysiology, and stronger evidence for treatment guidelines. To advance progress in this area, it is crucial to acknowledge the limitations and weaknesses of current studies and explore new approaches, which are outlined in this scientific statement for future research strategies.

Background: Chiari malformation type I (CIM) diagnoses have increased in recent years. Controversy regarding the best operative management prompted a review of the literature to offer guidance on surgical interventions., Objective: To assess the literature to determine (1) whether posterior fossa decompression or posterior fossa decompression with duraplasty is more effective in preoperative symptom resolution; (2) whether there is benefit from cerebellar tonsillar resection/reduction; (3) the role of intraoperative neuromonitoring; (4) in patients with a syrinx, how long should a syrinx be observed for improvement before additional surgery is performed; and 5) what is the optimal duration of follow-up care after preoperative symptom resolution., Methods: A systematic review was performed using the National Library of Medicine/PubMed and Embase databases for studies on CIM in children and adults. The most appropriate surgical interventions, the use of neuromonitoring, and clinical improvement during follow-up were reviewed for studies published between 1946 and January 23, 2021., Results: A total of 80 studies met inclusion criteria. Posterior fossa decompression with or without duraplasty or cerebellar tonsil reduction all appeared to show some benefit for symptom relief and syrinx reduction. There was insufficient evidence to determine whether duraplasty or cerebellar tonsil reduction was needed for specific patient groups. There was no strong correlation between symptom relief and syringomyelia resolution. Many surgeons follow patients for 6-12 months before considering reoperation for persistent syringomyelia. No benefit or harm was seen with the use of neuromonitoring., Conclusion: This evidence-based clinical guidelines for the treatment of CIM provide 1 Class II and 4 Class III recommendations. In patients with CIM with or without syringomyelia, treatment options include bone decompression with or without duraplasty or cerebellar tonsil reduction. Improved syrinx resolution may potentially be seen with dural patch grafting. Symptom resolution and syrinx resolution did not correlate directly. Reoperation for a persistent syrinx was potentially beneficial if the syrinx had not improved 6 to 12 months after the initial operation. The full guidelines can be seen online at https://www.cns.org/guidelines/browse-guidelines-detail/3-surgical-interventions ., (Copyright © Congress of Neurological Surgeons 2023. All rights reserved.)

Clinical practice guidelines provide a framework against which quality of care is measured. Recommendations contained within guidelines are used for decision-making not only within the clinical domain but also other related issues within the health systems. As such the use of research evidence for formulating recommendations contained in a guideline is a global standard to ensure guideline quality. The paper briefly reviews how the need for and use of evidence in guideline development shaped up historically and then provides an overview of the four typologies of guideline development mechanisms at the country level. [ABSTRACT FROM AUTHOR]

Abstract: In October 2022, the European Commission released a draft of a new Directive aimed at securing more effective control and prevention of outdoor air pollution in Europe through the recasting and update of previous European legislation. The proposal is intended to reshape the current regulations in the field within the EU and its implementation at the Member State level and achieve lower air pollution in light of the recent advancements in environmental health and novel indications in the field from the World Health Organization. In addition, the proposed Directive provides a legal framework for air pollution control that falls within the wider legal context of the EU Green Deal and NextGenerationEU initiatives. The new rules are also remarkably consistent with corresponding and updated US regulations, though stricter in terms of air pollution control and more open to interactions with local authorities. In sum, the proposed EU Directive appears to take better stock of the emerging scientific evidence on the adverse effects of air pollution and may provide an effective legal instrument for adequate public health protection.

Pediatric cardiac arrest presents an infrequent but high-stakes event for emergency clinicians, who need to maintain expertise in this area. Evidence regarding pediatric resuscitations has been accumulating substantially over the past decade and highlights the unique considerations and challenges when resuscitating children. This issue reviews resuscitation principles of children in cardiac arrest while addressing the newest evidence-based and best-practice recommendations by the American Heart Association.

Since 1986, the American Association of Colleges of Nursing (AACN) has published its Essentials, a framework to guide all levels of nursing education and practice. This brief overview will describe the latest AACN Essentials.

Background: Most professional spine societies have enacted formal guidelines for spine surgeons providing expert witness services. However, there is significant heterogeneity in existing recommendations, with most societies providing information that is limited in detail and scope., Objective: To provide a review of guidelines published by professional spine societies for spine surgeons serving as expert witnesses., Methods: The Gale Directory Library, PubMed, and the grey literature were queried for national or international professional societies related to spine surgery. The search was focused on societies in the United States and North America, but also included well recognized international organizations in the field of spine surgery. Included societies with publicly available guidelines regarding expert witness services were extracted for 4 domains: (1) qualifications, (2) preparations, (3) testimony, and (4) compensation as well as the presence of a professional compliance program, defined as any official subcommittee aimed toward investigating claims of unethical behavior., Results: Although most professional spine societies share general themes with respect to expert witness guidelines, important differences exist. Of the 26 societies included, 10 included publicly available guidelines: 4 of which were general neurosurgery societies, 2 general orthopedic surgery, and 4 spine specific. Three societies included the guidelines on all 4 domains (ie, qualifications, preparations, testimony, and compensation), and 2 societies included only 1 of the 4 domains. Eight societies possess a professional compliance program., Conclusion: There remains a paucity in expert witness guidelines provided by professional spine societies. Although existing recommendations are useful, there is a lack of standardized and comprehensive materials for spine surgeons providing expert witness testimony to reference. Moving forward, joint committees comprising surgeons, attorneys, and patient stakeholders may help improve the guidelines., (Copyright © Congress of Neurological Surgeons 2022. All rights reserved.)

Abstract: Objective: To analyze the level of agreement between recommendations on preventive services developed by Canada, France and the USA. Methods: We gathered recommendations on primary and secondary preventive services to adults up to November 3rd, 2011 from Canadian and US Task Forces, and equivalent French agencies. We excluded recommendations on immunization, long-term diseases or pregnancy. Results: Among 250 recommendations, 84 (34%) issued by a single country could not be compared; 43 (26%) of the remaining 166 were in strong agreement (strictly identical grades between advising countries); 25 of 43 resulted in a proposal to be implemented in clinical practice, two others not to be implemented in clinical practice and 16 were indeterminate about implementation. Strong agreement was more frequent for recommendations concerning history-taking and physical examination than for those concerning interventions (odds ratio (OR)=11.3, 95%CI: 1.6–241.2; p =0.04), and for recommendations concerning a high-risk population than for those concerning the general population (OR=3.1, 95%CI: 1.4–7.0; p =0.006). Agreement did not differ either according to maximum time range between recommendations' publication or according to the advising country. Conclusion: Agreement between recommendations is low particularly on those concerning non-clinical preventive services or non-high-risk individuals. [Copyright &y& Elsevier]

The article discusses the association of obesity and sedentary behavior with cardiovascular disease (CVD) risk among women. Data from the U.S. Centers for Disease Control (CDC) revealed the link of obesity and physical inactivity to CVD death. Several studies also provided evidence that obesity is an independent risk factor for CVD in men and women. It concluded that weight loss and physical activity can help prevent CVD in women.

Introduction: Early Feasibility Studies (EFS) are among the pre-market clinical investigations allowed by the International Standard for Clinical investigation of medical devices (MD) for human subjects. The Food and Drug Administration (FDA) introduced an EFS program in the US in 2013. The European Union (EU) MD Regulation, that entered into force in May 2021, opened the possibility of EFS in the EU. However, European countries at present have no standardized procedural framework for EFS. In this paper, we address the desirability of a European EFS program., Areas Covered: Characteristics of EFS conducted so far are reviewed, and perceptions of an expert, multidisciplinary panel of key stakeholders are explored regarding desirability and feasibility of a European EFS program and critical factors favoring or hampering its implementation., Expert Opinion: Implementing an EFS program in the EU would contribute to creating a favorable environment for early-stage clinical investigations, with positive effects on the quality and timeliness of clinical evidence for novel MDs, and attractiveness of the European system for pre- and post-market clinical research. Based on discussion with experts, also leveraging on the US experience, three dimensions should be considered for effective design and implementation: process, resources, and ethical issues.

Objective: Surgeon scientists bring to bear highly specialized talent and innovative and impactful solutions for complicated clinical problems. Our objective is to inform and provide framework for early stage surgeon scientist training and support., Summary of Background Data: Undergraduate, medical student, and residency experiences impact the career trajectory of surgeon scientists. To combat the attrition of the surgeon scientist pipeline, interventions are needed to engage trainees and to increase the likelihood of success of future surgeon scientists., Methods: A surgery resident writing group at an academic medical center, with guidance from faculty, prepared this guidance document for early stage surgeon scientist trainees with integration of the published literature to provide context. The publicly available National Institutes of Health RePORTER tool was queried to provide data salient to early stage surgeon scientist training., Results: The educational path of surgeons and the potential research career entry points are outlined. Challenges and critical supportive elements needed to inspire and sustain progress along the surgeon scientist training path are detailed. Funding mechanisms available to support formal scientific training of early stage surgeon scientists are identified and obstacles specific to surgical careers are discussed., Conclusions: This guidance enhances awareness of essential education, communication, infrastructure, resources, and advocacy by surgery leaders and other stakeholders to promote quality research training in residency and to re-invigorate the surgeon scientist pipeline., Competing Interests: The authors report no conflicts of interest., (Copyright © 2021 Wolters Kluwer Health, Inc. All rights reserved.)

Black Americans and other racially and ethnically minoritized individuals are disproportionately burdened by higher morbidity and mortality from kidney disease when compared with their White peers. Yet, kidney researchers and clinicians have struggled to fully explain or rectify causes of these inequalities. Many studies have sought to identify hypothesized genetic and/or ancestral origins of biologic or behavioral deficits as singular explanations for racial and ethnic inequalities in kidney health. However, these approaches reinforce essentialist beliefs that racial groups are inherently biologically and behaviorally different. These approaches also often conflate the complex interactions of individual-level biologic differences with aggregated population-level disparities that are due to structural racism ( i.e. , sociopolitical policies and practices that created and perpetuate harmful health outcomes through inequities of opportunities and resources). We review foundational misconceptions about race, racism, genetics, and ancestry that shape research and clinical practice with a focus on kidney disease and related health outcomes. We also provide recommendations on how to embed key equity-enhancing concepts, terms, and principles into research, clinical practice, and medical publishing standards., (Copyright © 2022 by the American Society of Nephrology.)

Drug-drug interaction (DDI) data for small molecular drugs approved by the US Food and Drug Administration in 2020 ( N = 40) were analyzed using the University of Washington Drug Interaction Database. The mechanism(s) and clinical relevance of these interactions were characterized based on information available in the new drug application reviews. About 180 positive clinical studies defined as mean area under the curve ratios (AUCRs) ≥1.25 for inhibition DDIs or pharmacogenetic studies and ≤0.8 for induction DDIs were then fully analyzed. Oncology was the most represented therapeutic area, including 30% of 2020 approvals. As victim drugs, inhibition and induction of CYP3A explained most of all observed clinical interactions. Three sensitive substrates were identified: avapritinib (CYP3A), lonafarnib (CYP3A), and relugolix (P-glycoprotein), with AUCRs of 7.00, 5.07, and 6.25 when coadministered with itraconazole, ketoconazole, and erythromycin, respectively. As precipitants, three drugs were considered strong inhibitors of enzymes (AUCR ≥ 5): cedazuridine for cytidine deaminase and lonafarnib and tucatinib for CYP3A. No drug showed strong inhibition of transporters. No strong inducer of enzymes or transporters was identified. As expected, all DDIs with AUCRs ≥5 or ≤0.2 and almost all those with AUCRs of 2-5 and 0.2-0.5 triggered dosing recommendations in the drug label. Overall, all 2020 drugs found to be either sensitive substrates or strong inhibitors of enzymes or transporters were oncology treatments, underscoring the need for effective DDI management strategies in patients with cancer often receiving polytherapy. SIGNIFICANCE STATEMENT: This minireview provides a thorough and specific overview of the most significant pharmacokinetic-based DDI data observed (or expected) with small molecular drugs approved by the US Food and Drug Administration in 2020. It will help to better understand mitigation strategies to manage the DDI risks in the clinic., (Copyright © 2021 by The American Society for Pharmacology and Experimental Therapeutics.)

Objectives. To assess the association between individual-level adherence to social-distancing and personal hygiene behaviors recommended by public health experts and subsequent risk of COVID-19 diagnosis in the United States. Methods. Data are from waves 7 through 26 (June 10, 2020-April 26, 2021) of the Understanding America Study COVID-19 survey. We used Cox models to assess the relationship between engaging in behaviors considered high risk and risk of COVID-19 diagnosis. Results. Individuals engaging in behaviors indicating lack of adherence to social-distancing guidelines, especially those related to large gatherings or public interactions, had a significantly higher risk of COVID-19 diagnosis than did those who did not engage in these behaviors. Each additional risk behavior was associated with a 9% higher risk of COVID-19 diagnosis (hazard ratio [HR] = 1.09; 95% confidence interval [CI] = 1.05, 1.13). Results were similar after adjustment for sociodemographic characteristics and local infection rates. Conclusions. Personal mitigation behaviors appear to influence the risk of COVID-19, even in the presence of social factors related to infection risk. Public Health Implications. Our findings emphasize the importance of individual behaviors for preventing COVID-19, which may be relevant in contexts with low vaccination. ( Am J Public Health . 2022;112(1):169-178. https://doi.org/10.2105/AJPH.2021.306565).

More than a year after the first domestic COVID-19 cases, the United States does not have national standards for COVID-19 surveillance data analysis and public reporting. This has led to dramatic variations in surveillance practices among public health agencies, which analyze and present newly confirmed cases by a wide variety of dates. The choice of which date to use should be guided by a balance between interpretability and epidemiological relevance. Report date is easily interpretable, generally representative of outbreak trends, and available in surveillance data sets. These features make it a preferred date for public reporting and visualization of surveillance data, although it is not appropriate for epidemiological analyses of outbreak dynamics. Symptom onset date is better suited for such analyses because of its clinical and epidemiological relevance. However, using symptom onset for public reporting of new confirmed cases can cause confusion because reporting lags result in an artificial decline in recent cases. We hope this discussion is a starting point toward a more standardized approach to date-based surveillance. Such standardization could improve public comprehension, policymaking, and outbreak response. ( Am J Public Health . 2021;111(12):2127-2132. https://doi.org/10.2105/AJPH.2021.306520).

The National Center for Health Statistics' (NCHS's) National Vital Statistics System (NVSS) collects, processes, codes, and reviews death certificate data and disseminates the data in annual data files and reports. With the global rise of COVID-19 in early 2020, the NCHS mobilized to rapidly respond to the growing need for reliable, accurate, and complete real-time data on COVID-19 deaths. Within weeks of the first reported US cases, NCHS developed certification guidance, adjusted internal data processing systems, and stood up a surveillance system to release daily updates of COVID-19 deaths to track the impact of the COVID-19 pandemic on US mortality. This report describes the processes that NCHS took to produce timely mortality data in response to the COVID-19 pandemic. ( Am J Public Health . 2021;111(12):2133-2140. https://doi.org/10.2105/AJPH.2021.306519).

The growth in drug development over the past years reflects significant advancements in basic sciences and a greater understanding of molecular pathways of disease. Benchmarking industry practices has been important to enable a critical reflection on the path to evolve pharmaceutical testing, and the outcome of past industry surveys has had some impact on best practices in testing. A survey was provided to members of SPS, ACT, and STP. The survey consisted of 37 questions and was provided to 2550 participants with a response rate of 24%. Most respondents (∼75%) came from the US and Europe. The survey encompassed multiple topics encountered in nonclinical testing of pharmaceuticals. The most frequent target indications were oncology (69%), inflammation (55%), neurology/psychiatry/pain (46%), cardiovascular (44%), and metabolic diseases (39%). The most frequent drug-induced toxicology issues confronted were hepatic, hematopoietic, and gastrointestinal. Toxicological effects that impacted the no observed adverse effect level (NOAEL) were most frequently based on histopathology findings. The survey comprised topics encountered in the use of biomarkers in nonclinical safety assessment, most commonly those used to assess inflammation, cardiac/vascular, renal, and hepatic toxicity as well as common practices related to the assessment of endocrine effects, carcinogenicity, genotoxicity, juvenile and male-mediated developmental and female reproductive toxicity. The survey explored the impact of regulatory meetings on program design, application of the 3 Rs, and reasons for program delays. Overall, the survey results provide a broad perspective of current practices based on the experience of the scientific community engaged in nonclinical safety assessment.