We employed Innovation Corps (I-Corps™) methods to adaptation of a mobile health  short-message-system (SMS) -based interactive obesity treatment approach (iOTA) for adults with severe mentall illness receiving care in community settings.N = 29) were recorded and transcribed ver batim and coded based on pragmatic-variant grounded theory methods.We hypothesized “jobs to be done” in three broad stakeholder groups: “decision makers” (DM = state and community clinic administrators), “clinician consumers”  and “service consumers” . Semistructured interviews (Four themes emerged across groups: education, inertia, resources and ownership. Sub-themes in education and ownership differed between DM and CC groups on implementation ownership, intersecting with professional development, suggesting the importance of training and supervision in scalability. Sub-themes in resources and intertia differed between CC and SC groups, suggesting illness severity and access to healthy food as major barriers to engagement, whereas the SC group identified the need for enhanced emotional support, in addition to pragmatic skills like menu planning and cooking, to promote health behavior change. Although SMS was percieved as a viable education and support tool, CC and DM groups had limited familiarity with use in clinical care delivery.Based on customer discovery, the characteristics of a minimum viable iOTA for implementation, scalability and sustainability include population- and context-specific adaptations to treatment content, interventionist training and delivery mechanism. Successful implementation of an SMS-based intervention will likely require micro-adaptations to fit specific clinical settings. Obesity is two to three times more prevalent in people with severe mental illness (SMI), contributing to higher rates of obesity-related conditions like type 2 diabetes and cardiovascular disease (CVD) compared to the general population . This buCommunity-based mental health care is associated with better medical monitoring and treatment engagement in people with SMI –11. ManyEach CMHC and Clubhouse ecosystem is unique, meaning health promotion programs must be tailored both to the clinical population and treatment setting in order to be successful . Thus, mIn the present study, we employed I-Corps methods to identify challenges or “pains” associated with wellness program implementation in CMHC and Clubhouse settings. In general, the project team hypothesized that some areas of concern would be thematically unified across stakeholder groups. We also expected that certain barriers faced by each group would be unique, with overlap between stakeholders with similar roles. In order to allow for a broader interview framework, we formed our hypotheses based on stakeholder groups condensed into three broad categories: decision makers , clinician consumers  and service consumers (SC), related to successful implementation of hybrid health coaching interventions targeting weight management via lifestyle change. We hypothesized that barriers for the DM groups would include limited resources to support implementation, while CC groups would experience barriers relative to burnout and mismatch between administrative expectations and clinician reality. Lastly, we expected barriers at the SC level to include illness-related difficulties managing the increased cognitive load associated with learning and practicing new health behaviors, leading to reduced motivation and engagement.status quo, (3) create testable and pliable “value proposition” hypotheses for the proposed products or services solutions based on these unmet needs, and (4) conduct customer-stakeholder interviews to identify and validate which problems resonate as the most critical or most important to solve (I-Corps methodology consists of four steps: (1) identify the relevant target consumers and decision-makers as key stakeholders, (2) identify potential unmet needs or issues in the existing services or products relative to available alternatives, including the to solve .Five settings in Missouri and Florida were identified for discovery—two CMHCs treating children, adolescents and adults, one Clubhouse, and two ambulatory academic teaching clinics, one treating children and adolescents, and one treating adults. Purposive sampling methods were used to identify relevant stakeholders with diverse perspectives on technology, community mental health care and healthy lifestyle interventions . Specifin = 4); “Clinician Consumers,” included nurses (n = 4), psychosocial rehabilitation (PSR) counselors, community support workers, case mangers, social workers (n = 5), and prescribing clinicians  (n = 8); “Decision Makers,” included local clinic and clubhouse administrators (n = 5), and state administrators (n = 3).Based on the clinical structure and hierarchy in most community clinical settings, and in consultation with clinical leadership in each setting, we identified 6 broad stakeholder groups across the three categories: “Service Consumers,” included ambulatory outpatients, CMHC and Clubhouse members,  delivered by staff with limited training or programmatic structure.”We hypothesized that each stakeholder group would have unique jobs and associated barriers when engaging clinical service consumers in health behavior change related to weight management, but that the use of simple technology to provide reminders and reinforce goal-oriented health behavior change would be viewed favorably as a tool for providing enhanced support to clinical service consumers compared to existing practices thereby extending the clinician's impact without increasing work burden or cost. From this hypothesis, we generated an initial value proposition statement: “We then created a brief semi-structured interview  to identInterviews were continued until thematic saturation was achieved and were recorded and transcribed verbatim. Transcripts were analyzed using an inductive coding approach based on pragmatic-variant grounded theory . The firFour broad themes emerged across stakeholders. These included Education, with sub-themes of existing knowledge and awareness, professional training, and clinicians as educators; Inertia, with sub-themes of symptom severity, readiness for change, motivation, avoidance and overwhelm; Resources, with sub-themes of scarcity in financial resources, social support, referral resources, access to psychological support and consideration of mobile technology as a resource; and Ownership, with sub-themes of accountability, preference for individual vs. shared process ownership, and staff empowerment. Unique jobs to be done, pains and gains were identified in each stakeholder group. Representative quotes and number of mentions within each sub-theme, by stakeholder group are listed in Twenty-nine stakeholder participants were identified within the selected clinical settings and consented to participate in the study. The breakdown of characteristics by stakeholder group can be found in State administrators considered physical and mental health to be of equal importance, and viewed their primary jobs related to physical health and weight management of clinical consumers as (1) selecting physical health and wellness programs for statewide implementation based on needs identified by local clinical administration, (2) providing staff training for dissemination, and (3) ensuring sustainability of implementation with ongoing fidelity monitoring.Local clinic administrators acknowledged the importance of addressing SC physical health in balance with acute SC care needs and staff workload, and perceived their primary responsibilities as promoting clinician accountability for professional development, fostering a workplace culture of team-based clinical care, and protecting clinician time for SC care.Prescribing clinicians felt a responsibility to help treatment teams prioritize the often competing physical and mental health demands in order to determine which SCs would benefit from or be likely to engage in an intervention, support the clinician providing health coaching and reduce health risks by optimizing medical monitoring and management.Nurses embraced responsibility for supporting physical health of SCs, and considered themselves as process owners who prioritize organizational values regarding physical health and wellness. Among their primary job functions, nurses supported medical recommendations via education and coaching to promote health behavior change.PSR counselors were the clinicians most likely to be assigned health coacing roles in each setting. They viewed themselves as process owners for implementation of the treatment plan, focused on optimizing psychosocial functioning and quality of life, and addressing acute psychosocial concerns . However, this group did not believe they were best suited to own the process of addressing physical health, including the implementation of weight management programming, which was viewed as separate from the overall treatment plan.SCs indicated that their greatest needs were in accountability, particularly in staying engaged with self-monitoring. Thus, as physicians noted engagement as a reason for their inertia in delivering behavioral lifestyle counseling, SCs also noted this as a problem—one they wanted help with.State administrators noted that many available health and wellness programs required financial commitments for ongoing training or licensing . Inconsistent program implementation at the local level was attributed to turnover or attrition of staff trained as trainers, and to limited time to participate in ongoing training to ensure fidelity of intervention delivery . Digital and mobile health  interventions were perceived as potential barriers to adoption of new interventions due to variability in use of technology from setting to setting, with equally varied attitudes toward technology within each unique clinical setting.Local clinic administrators noted that although training offered by the state was free, clinics were still responsible for covering the time away from SC care to accommodate training and trainer activities. In absence of resources to make up for loss of revenue-generating activities, directors were tasked with identifying existing resources to support program implementation and sustainability.Prescribing clinicians in teaching roles expressed confidence in the use of motivational interviewing for promoting healthier behaviors, while physician trainees were less confident, indicating limited didactic or experiential learning on the subject. Both groups acknowledged implementation challenges related to process ownership and SC engagement.Nurses were most likely to either create resource lists or design their own coaching approach with SC in settings where internally available programs were not available. Limited time and competing clinical demands posed the biggest challenges to implementation.PSR counselors, though trained as health coaches in many settings, felt less secure in their medical knowledge, and were reluctant to accept ownership of this role. Attrition of staff who led original trainings lead to degradation of treatment delivery over time.SCs noted that lack of emotion regulation skills and social supports reduced their resolve to make healthy choices. They indicated a need for problem-solving help with pragmatic issues such as where to buy fresh produce with limited money, how to cook healthier foods and how to make healthy selections when not eating at home .State administration considered successful training and program implementation in terms of SC-level health outcomes, as well as in workforce development. Employing a “train the trainer” model was seen as a way to reduce training costs while empowering local organizations and staff, increasing uptake and organizational culture change. The use of semi-automated SMS texting was seen as a possible augmentation to existing care to extend clinician reach and increase SC engagement.Local clinic administration viewed collaboration with academic researchers as a career development opportunity for staff and an opportunity to enhance clinical care. Administrators considered mobile technology as useful in concept, but saw potential barriers to implementation in terms of integration with the current work flow for clinicians. Subthemes under ownership also involved protection—of SCs (safety) and of staff .Prescribing clinicians identified SC engagement as a major contributor to successful treatment outcomes, impacted by intrinsic motivation or incentive, shame/avoidance, and previous negative experiences—both from the perspective of the physician  and the SC/family . In general, physicians viewed mobile technology as a potential solution to the additional work burden and to SC engagement in wellness programming.Nurses noted they could fill in gaps when case managers were dealing with competing psychosocial clinical priorities that took precedence over health prevention measures. In settings where wellness programming was available, nurses consistently refered SCs to those programs and seemed to have the most knowledge about them. Nurses cautiously perceived mobile technology as a way to increase engagement in wellness programming, but did not feel this could take the place of education or clinical care.PSR counselors preferred a team approach to delivering health interventions with their SCs, and perceived the use of technology to extend their reach to SCs as potentially helpful as long as this respected therapeutic boundaries or safety of personal data.SCs indicated an openness to the use of mHealth technology to increase their sense of external support and accountability, indicating that they would be most comfortable with a case manager in the role as health coach.Enhancement of existing wellness programming with low-cost text messaging support can promote health behavior change in SCs with SMI better than the current leading alternative of counseling on energy balance delivered by staff with limited training.”Similarities in priorities across groups were observed . AdminisUsing I-Corps, a novel stakeholder-centered method for designing health intervention for dissemination and sustainabilitys, our results suggest adjustments to the current health coaching delivery model are needed for successful implementation in community setting. In particular, case manager time constraints and challenges to successful SC engagement were cited as significant barriers to implementation, with most respondents expressing a belief that technology could be used to simplify treatment delivery and improve engagement. Additional barriers to uptake included role confusion , fragmented communication between providers, and low motivation for change among SCs. This study provides critically-needed information for the successful adaptation of obesity treatment for the SMI population, addressing contextual factors relevant to the CMHC and Clubhouse settings.The four major “barrier” themes , while similar across groups, were interpreted differently based on stakeholder “jobs to be done.” A final fifth barrier was identified, involving discrepancy in who should function as the health coach. Decision makers identified PSR counselors and/or case managers as being the best positioned to function as health coaches, given their proximity and rapport with SCs. Nonetheless, this group was reluctant to accept ownership of this role. These results extend previous work suggesting that barriers to successful treatment engagement are multifactorial, involving specific challenges at the SC, provider and organizational levels . HoweverThe use of technology to extend the reach of health coaches was seen as promising by both clinicians and SCs. Our results suggest adaptations to traditional health coaching delivery models, where existing clinical staff are trained and responsible for implementation, may benefit from the introduction of technology. These results are consistent with previous reports in SMI populations suggesting openness to the use of technology for delivering health behavior change interventions, which have been shown to boost treatment engagement in non-mentally ill obese adults , 35, 36.The present study is subject to strengths and limitations. First, the I-Corps approach is a proven methodology consistent with best practices for designing for dissemination and diffusion of health innovations , 38. ThoThe raw data supporting the conclusions of this article will be made available by the authors, without undue reservation.The studies involving human participants were reviewed and approved by Washington University Institutional Review Board. The patients/participants provided their written informed consent to participate in this study.All authors listed have made a substantial, direct, and intellectual contribution to the work and approved it for publication.Research reported in this publication was supported by the National Center for Advancing Translational Sciences of the National Institutes of Health under Award Numbers UL1TR002535, UL1TR003096, UL1TR001417, and the National Institute of Mental Health Grant Numbers MH112473 and MH118395. This work was also made possible by Public Health Cubed seed funding via the Washington University School of Medicine Institute for Public Health.The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health.BE has received funding from the National Institutes of Health (NIH) and the Centers for Disease Control and Prevention (CDC). EM has received grant support from the National Institutes of Health (NIH) and the CDC and has consulted for the U.S. Food and Drug Administration (FDA) and Eli Lilly and Company. JP has participated in Advisory panels or consulted with Merck, Boehringer-Ingelheim, Lundbeck, Otsuka, and Janssen. JN has participated in advisory panels or consulted with Merck, Boehringer-Ingelheim, Lundbeck, Otsuka, and Janssen; has received grant support from the NIH and the Substance Abuse and Mental Health Services Administration (SAMHSA); has served as a consultant for Alkermes, Inc., Intra-cellular Therapies, Inc., Sunovion and Merck; and served on a Data Safety Monitoring Board for Amgen. GN has received grant support from the NIH, the Barnes Jewish Hospital Foundation, the McDonnell Center for Systems Neuroscience, and Usona Institute (drug only), and has served as a consultant for Alkermes, Inc., Otsuka and Sunovion. The remaining 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.All claims expressed in this article are solely those of the authors and do not necessarily represent those of their affiliated organizations, or those of the publisher, the editors and the reviewers. Any product that may be evaluated in this article, or claim that may be made by its manufacturer, is not guaranteed or endorsed by the publisher.


Pulmonary hypertension (PH) is a progressive disease that arises from multiple etiologies and ultimately leads to right heart failure as the predominant cause of morbidity and mortality. In patients, distinct inflammatory responses are a prominent feature in different types of PH, and various immunomodulatory interventions have been shown to modulate disease development and progression in animal models. Specifically, PH-associated inflammation comprises infiltration of both innate and adaptive immune cells into the vascular wall of the pulmonary vasculature—specifically in pulmonary vascular lesions—as well as increased levels of cytokines and chemokines in circulating blood and in the perivascular tissue of pulmonary arteries (PAs). Previous studies suggest that altered hemodynamic forces cause lung endothelial dysfunction and, in turn, adherence of immune cells and release of inflammatory mediators, while the resulting perivascular inflammation, in turn, promotes vascular remodeling and the progression of PH. As such, a vicious cycle of endothelial activation, inflammation, and vascular remodeling may develop and drive the disease process. PA stiffening constitutes an emerging research area in PH, with relevance in PH diagnostics, prognostics, and as a therapeutic target. With respect to its prognostic value, PA stiffness rivals the well-established measurement of pulmonary vascular resistance as a predictor of disease outcome. Vascular remodeling of the arterial extracellular matrix (ECM) as well as vascular calcification, smooth muscle cell stiffening, vascular wall thickening, and tissue fibrosis contribute to PA stiffening. While associations between inflammation and vascular stiffening are well-established in systemic vascular diseases such as atherosclerosis or the vascular manifestations of systemic sclerosis, a similar connection between inflammatory processes and PA stiffening has so far not been addressed in the context of PH. In this review, we discuss potential links between inflammation and PA stiffening with a specific focus on vascular calcification and ECM remodeling in PH. Pulmonary hypertension (PH) comprises a group of diseases in which the mean pulmonary artery pressure (mPAP) exceeds 25 mmHg at rest according to current guidelines . RecentlLately, pulmonary perivascular inflammation has gradually gained increased attention as an early common hallmark across different PH groups. In the early stage of the disease, PAH patients and corresponding animal models not only display an accumulation of immune cells such as macrophages , 7 and mvia the Windkessel effect into the nearly laminar flow at the level of the distal pulmonary vascular tree. As such, PAC reduces right ventricular (RV) afterload and maintains near-constant lung perfusion over the cardiac cycle. In line with the impact of PAC for RV function, invasive or non-invasive assessment of PAC (or capacitance) has revealed PA stiffening in PAH patients as a sensitive predictor of pathological RV remodeling and mortality  and/or calcification within the arterial wall –42 Fig, which uVascular stiffening has also been attributed to vascular calcification , a pathovice versa. Proposed links and relevant literature are summarized in Stiffening of proximal PAs in PAH patients , 57 incrPA stiffening and inflammatory responses are both paramount characteristics of PH. While inflammation is commonly associated with PH in both animal models and clinical scenarios, little is known about the role of inflammation in inducing vascular remodeling in PH. Only a limited number of studies have so far addressed the role of inflammation in promoting the production of ECM components , namely,In PH, elevated pressure and high pulsatile flow as a consequence of reduced vascular compliance can be sensed by ECs of the pulmonary vascular bed. Specifically in hypoxia-induced PH, ECs produce elevated levels of the inflammatory cytokines IL-1β  and IL-6via SMC proliferation and muscularization of the distal pulmonary arterial tree due to migration of SMCs into precapillary arterioles , activator protein 1 (AP1), and cAMP-responsive element-binding protein (CREB) ignaling . Likewisin vitro . Interesin vitro , which min vitro , which iin vitro , providiin vitro  as well in vitro , suggestin vitro , 200.Although studies linking calcification and inflammation in PH are scarce, cytokines have been implicated in the regulation of calcification in the extra-pulmonary vasculature. Importantly, vascular calcification also seems to be closely interconnected with ECM remodeling and stiffening , as SMC in vitro, the extent and relevance of EndoMT in vivo in recent studies using lineage tracing technologies remains controversial: By use of double transgenic mice stably expressing green fluorescent protein (GFP) in all ECs, Suzuki and colleagues detected GFP in 14.3 ± 1.8% of mesenchymal (CD144-CD45-CD326-) cells, indicating substantial EndoMT  focus primarily on alleviating vasoconstriction as a symptomatic approach , the lon4Cl) as a potential treatment for inflammation in PH was able to prevent SMC dedifferentiation and proliferation in a Sugen5416/hypoxia rat model  and the German Center for Cardiovascular Research partner site Berlin, CK was supported by the German Centre for Cardiovascular Research partner site Berlin and by the German Ministry of Education and Research (BMBF), NNV was supported by the Doctoral Scholarship from the German Centre for Cardiovascular Research and the German Cardiology Association (DGK), MK was supported by the German Foundation for Heart Research (F23/20), and S-FL and QL were supported by the China Scholarship Council (No. 202008350142 and No.202108080221).Parts of the figures were generated with the help of BioRender.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.All claims expressed in this article are solely those of the authors and do not necessarily represent those of their affiliated organizations, or those of the publisher, the editors and the reviewers. Any product that may be evaluated in this article, or claim that may be made by its manufacturer, is not guaranteed or endorsed by the publisher.


In the United States, science shapes federal health and safety protections, but political officials can and do politicize federal science and science-based safeguards. Many presidential administrations have politicized science, but under the administration of President Trump, these attacks on science—such as buried research, censored scientists, halted data collection—increased in number to unprecedented levels. Underserved communities bore the brunt of the harms. Such attacks disproportionately harm Black, Indigenous, low-income communities, and communities of color, all of whom have long been burdened by pollution exposure and other stressors. We analyze the effects on underserved communities of the Trump administration’s anti-science environmental and public health policy actions and offer policy recommendations for current and future administrations. Our goal is to strengthen scientific integrity, prioritize health disparity research, and meaningfully engage affected communities in federal rulemaking. Political and financial motivations of United States (US) presidential administrations are unfortunately a perennial threat to science-based decisionmaking.We analyze how anti-science actions under the Trump administration particularly impacted Black, Indigenous, low-income communities, and communities of color.Current and future administrations should create policy infrastructure that promotes independent science and ensures decisions have equitable benefits.The US Congress, by enacting legislation, has charged federal agencies with protecting public health and the environment , 2. ManyUnderserved communities  are those faced with significant barriers to accessing the benefits associated with environmental and public health protections, and often experience the brunt of harms when policymakers sideline science. This, in turn, exacerbates long-standing health inequities. Since at least the 1980s, a growing body of research has shown that members of underserved communities face disproportionately high exposure to pollution and other stressors –8. ResidFor decades, environmental justice advocates, scientists, and members of underserved communities have advocated for policymakers to use a framework for analyzing environmental justice centered on a right of all individuals to be protected from environmental degradation; adopt a public health strategy based on scientific evidence to identify threats to underserved communities, particularly before these threats result in harm; shift the burden of scientific proof to polluters to show that their activities are not resulting in harm to underserved communities; and target resources toward communities experiencing disproportionate adverse health effects from environmental hazards , 5.Implicit in this framework is the role of robust and independent science to identify health disparities and for policymakers to rely on the best available science to carry out policy actions equitably. Science-based and science-informed decision making can help counteract implicit bias and systemic racism in policy decisions, and, in turn, help protect underserved communities from these health threats –13. WhenThis connection is particularly prominent at science-based federal agencies that employ thousands of scientists to carry out robust and independent data collection and analyses. These same agencies employ political appointees in high-level positions who may sideline science. Within the federal government, this tension is usually described in reference to scientific integrity, a set of principles, guidelines, and policy documents adopted by federal agencies to ensure that rigorous scientific research is free from politically motivated suppression or distortion , 20–23. While every administration since at least the 1950s has sidelined science to advance a political agenda , the TruThe relationship between the Trump administration’s diminution of scientific integrity and related harms on underserved communities has not yet been discussed in the literature. Several universities, law firms, newspapers, and non-profit organizations tracked and documented the Trump administration’s anti-science actions and deregulatory rulemakings in real time, but none of these efforts examined the effect of the actions on underserved communities , 19.To understand the role of science in decision making and environmental justice, we examined the effects of the Trump administration’s anti-science actions using two approaches. First, to understand the scope, breadth, and frequency, we analyzed the data and documented incidents of attacks on science by the Trump administration Figs. , 2. We aWe collected information to allow us to analyze patterns in how the Trump administration attacked science. To examine the effects on underserved communities, we conducted a sub-analysis on anti-science actions that had an equity component. After examining publicly available sources from January 2017 to November 2022, we created an online database that tracked instances of when the Trump administration attacked science.The publicly available information came from agency websites, the federal register, newspaper articles, academic journals, congressional websites, agency inspector general reports, and Government Accountability Office (GAO) reports. To assess whether an action undermined science with intention to further a political goal, we often relied on documents (emails and unpublished reports) that we obtained through requests under the US Freedom of Information Act or other ‘sunshine laws’ that require governments to make staff communications, data, documents, and other information publicly available upon request. As details of the Trump administration’s treatment of science continued to emerge in 2021 and 2022 from responses to our document requests and interviews with former government staff, we continued tracking these attacks on science until November 2022.We defined our study time period to coincide with presence of the Trump administration. It started on January 21, 2017 (his first full day in office) to January 20, 2021 (the day his term ended). We used rigorous criteria to assess whether an action carried out by the Trump administration constituted an attack on science  and Barack Obama 19) . Commonl9 . CommoAttacks on science commonly fell into the six issue areas we chose, with the highest counts as follows: environmental (79), public health (58), climate change (34), equity 27), COVID-19 (29), and endangered species (20). Sixty-nine attacks encompassed one or more issue areas, with the three most prevalent combinations being public health and environmental (34), endangered species and environmental (8), and public health and equity (6). The combination of public health and environmental mostly involved chemical safety issues. Of the 206 attacks, 33 did not fit into any of these 6 issue areas, and involved administrative procedures, communication with the media, data and research accessibility, scientific advisory committees, scientific grants, or other scientific topic areas . We also categorized all 206 attacks by type—the three most common were political appointees issuing anti-science rules (61), suppressing studies (52), or censoring federal scientists (43)  occurred during this year.In 2020, the 55 attacks mostly dealt with the COVID-19 pandemic and the CDC was an especially frequent target. With two exceptions, all 22 attacks on science involving the CDC occurred during the first year of the COVID-19 pandemic and involved this disease.In 2021, 10 out of 22 attacks occurred before the end of the Trump presidency on January 20, 2021 and mostly involved the issuing of anti-science rules or regulations. Attacks reported after this date in 2021 or in 2022 (3) surfaced due to investigatory actions by the federal government, Congress, and the media.Over time, the Trump administration shifted some patterns of attack on science:We took a closer look at the 27 attacks on science that had an equity component—attacks that likely affected underserved communities. Of the 14 agencies involved in these, the top 5 included HHS (6), DOI (4), EPA (3), Census Bureau (3), White House (2), Department of Justice (DOJ) (2), Occupational Safety and Health Administration (OSHA) (2), Department of Homeland Security (DHS) (2), and CDC (2). The greatest number of attacks fell into three of the categories: anti-science rules, regulations, and orders (10), studies halted, edited, or suppressed (7), and rolling back data collection or data accessibility (6). We determined that perpetrators of some of these attacks clearly meant to undermine science to disenfranchise underserved communities.Policymaking occurs in stages—identifying a problem, creating a policy with public input, then implementing and enforcing it. In practice, policymakers sometimes skip stages or complete them out of order . NeverthFederal agencies collect scientific data and conduct scientific research to identify, monitor, and address public health and safety risks, evaluate policy effectiveness, and identify inequities in public services. When limited or no data are available, science agencies may not take policy action. Thus, the federal government’s ability to identify and address environmental justice issues relies on robust research and data collection.In August 2017, Hurricane Harvey damaged over 40 petrochemical facilities around a City, Houston, in the State of Texas. These facilities released pollutants that quickly concentrated in underserved communities , 36, 37 By preventing comprehensive data collection in an emergency, the administration deliberately restricted the body of available data on pollutants known to cause adverse health effects. Consequently, people affected by the crisis could not make decisions based on the best available science to keep themselves and their loved ones safe. Decision makers could have used such data to assess the health effects of the crisis, inform emergency response, and shape policies to better protect the public—and especially underserved communities—from disasters in future.The US Government is beholden to its people, and public participation in evidence-based policymaking is central to the Constitution’s stated vision of self-governance. Public participation  gives people a voice in policy decisions , 42. For, and abandoned uranium mines can increase the risk of kidney disease and hypertension in Indigenous residents [In April 2017, DOI leaders began to identify national monument sites from which to strip federal protections and opened this review to a public comment process . One sucesidents , 50. By Because alleviating health inequities depends upon strong science-based protections, the implementation and enforcement of these policies play major roles in the health and safety of communities.In November 2020, the EPA issued a final rule eliminating a 1995 once in, always in guidance for major sources under the Clean Air Act . Before As a result of long-standing, systemic inequities and resulting zoning and land use laws industrial sources of hazardous air pollutants are more likely to locate their facilities near communities with higher proportions of low-income individuals and people of color . ExposurDecisions informed by science are especially important to address the health inequities faced by underserved communities. To strengthen scientific integrity and incorporate equity and environmental justice into decision making, federal agencies can implement several recommendations , 21, 54.Agencies should carry out cumulative impact analyses to provide a holistic view of health and safety risks faced by communities and adequately account for all sources of pollution, including those from fugitive releases from refineries, chemical plants, and other industrial facilities during startups, shutdowns, and malfunctions .Prioritize grant solicitations for, and otherwise encourage research on efforts that can highlight health disparities in underserved communities.Agencies should disaggregate and make publicly available to the greatest extent possible, environmental data on human health risks and exposures by race, ethnicity, gender, age, income, and geographic location .Agencies should amend existing practices on public participation to require outreach to identify and meaningfully engage with communities, including by actively working to address barriers to participation (language barriers or Internet inaccessibility).Agencies should carry out research to identity effective strategies for engaging the public during rulemaking, particularly for communities most affected by proposed rules.Agencies should ensure that the public can comment early and effectively in the rulemaking process to promote a deliberative model of public engagement that encourages two-way dialogue between agencies and the public .To strengthen the implementation of Executive Order 12898, issued in 1994 by President Bill Clinton to focus federal attention on the environmental and human health effects in underserved communities, each federal agency, to the maximum extent permitted by law, should include diverse segments of the population in epidemiological and clinical studies, identify multiple and cumulative exposures, and actively encourage and solicit community-based science and Tribal ecological knowledge .When the EPA’s Integrated Risk Information System—a database of chemical safety assessments—updates a risk value for a chemical and it poses an adverse public health risk, the EPA should notify communities and prioritize enforcement and cleanup efforts. EPA should intervene most rapidly where facilities near underserved communities emit that contaminant.Agencies must fill all safety inspector positions and expand the workforce responsible for health and safety investigations.Science-based agencies have limited capacity for enforcement of environmental regulations due to inadequate funding. This limits their ability to enforce, ensure compliance with, and impose meaningful penalties for violations of health-protecting environmental laws. Agencies must request and advocate for well-funded budgets to implement these regulatory and enforcement programs.By examining how actions taken under the Trump administration undermined scientific integrity and harmed underserved communities, we can better understand how current and future administrations can safeguard science and its role in protecting underserved communities. Science conducted and funded by the federal government represents a powerful tool for the public good, particularly in pollution-burdened communities. It is imperative that federal scientists do their jobs without political interference. To protect the health and safety of the country’s most disenfranchised, government decision makers must safeguard the scientific process and ensure that science and equity inform policy at every stage. Further, the examples provided in this study show the breadth of ways in which sidelining science in decisionmaking can take shape, with lessons and solutions that can be applied at other levels of government in the US as well as in other countries facing similar threats.


Normal spermatogenesis and sperm function are crucial for male fertility. The effects of healthy testicular aging and testicular premature aging on spermatogenesis, sperm function, and the spermatogenesis microenvironment cannot be ignored. Compared with younger men, the testis of older men tends to have disturbed spermatogenic processes, sperm abnormalities, sperm dysfunction, and impaired Sertoli and Leydig cells, which ultimately results in male infertility. Various exogenous and endogenous factors also contribute to pathological testicular premature aging, such as adverse environmental stressors and gene mutations. Mechanistically, Y-chromosomal microdeletions, increase in telomere length and oxidative stress, accumulation of DNA damage with decreased repair ability, alterations in epigenetic modifications, miRNA and lncRNA expression abnormalities, have been associated with impaired male fertility due to aging. In recent years, the key molecules and signaling pathways that regulate testicular aging and premature aging have been identified, thereby providing new strategies for diagnosis and treatment. This review provides a comprehensive overview of the underlying mechanisms of aging on spermatogenesis. Furthermore, potential rescue measures for reproductive aging have been discussed. Finally, the inadequacy of testicular aging research and future directions for research have been envisaged to aid in the diagnosis and treatment of testicular aging and premature aging. The arrival of the information era and the rise in socioeconomic levels have exacerbated the life pressures and childbearing costs, and it has become increasingly common for both men and women to voluntarily delay having children . Not onlvia mitosis, then form spermatids via meiosis, and are finally transformed into highly differentiated haploid spermatozoa. The continued production of motile spermatozoa poses several requirements for spermatogenesis. First, the organism must be able to maintain a normal reproductive cycle, and have a thriving population of spermatogonia. Second, to produce sufficient haploid gametes, ongoing meiosis and the generation of spermatids are needed. Finally, the generation of elongated spermatozoa necessitates the specific transformation of spermatid morphology and the expression of key genes  and Adark without nuclear vacuole (AdNoVac). AdVac does not undergo mitosis and is viewed as a spermatogonial stem cell for spermatogenesis, whereas AdNoVac and Apale spermatogonia differentiate and proliferate into B spermatogonia, which enters the spermatogenesis process  spermatozoa, whole-genome bisulfite sequencing was used to compare DNA methylation in young and aged spermatozoa. The researchers found an increase in DNA methylation in the aged spermatozoa, which was inversely correlated with sperm quality and fertilization rate in the aged common carp   and antioxidant levels, which tends to enhance oxidation. Oxidative stress plays a pertinent role in the etiology of male infertility in humans and other mammals . High le (8OHdG) , and the (8OHdG) . In addi (8OHdG) .Sperm DNA fragmentation index (DFI) is a common parameter used to assess the quality of semen samples . Many stLitopenaeus vannamei has been reported to result in reduced sperm quality and abnormal acrosome reaction  extract can increase sperm motility and improve reproductive performance in aging mice by upregulating the expression of CatSper channel proteins (Prdx6) mice have been observed to exhibit an age-dependent reduction in sperm count, activity, motility, and fertility. The older mice displayed increased sperm DNA fragmentation, more oxidative damage, enhanced sperm DNA compaction, and decreased sperm proteins, which indicate the protective role of Prdx6 in male reproductive premature aging , LIM and cysteine-rich domains 1 (Lmcd1), and insulin-like 3 (insl3), can relieve damage due to Sertoli cell aging. Icariin alleviates the damage to the Sertoli cells caused by aging mainly by upregulating the ERα/NRF2 signaling pathway  and p21 expression. Compared with the control group, the positive staining of SA-βgal in the Leydig cells has been reported to increase with age . The chomalities . CDGSH imalities . These iAstragalus membranaceus and Punica granatum are long-lived Chinese herbal medicines in ancient China. Studies on rats of different age groups have shown that Astragalus membranaceus telomerase activator-65 and pomegranate supplements could rebuild hormonal balance and testicular structure, exhibit antioxidant activity, and prevent male sterility caused by aging  Novel-specific biomarkers should be explored for the early clinical diagnosis of reproductive aging. 3) The feasibility of applying the findings from animal models to human testicular premature aging must be explored. 4) Efficacy should be tracked in intervention outcomes for reproductive aging. 5) Relevant research should be conducted in large-scale clinical cohort to examine the association between reproductive aging and multiple reproductive outcomes. 6) The use of animal models for targeted gene therapy provides references for the prevention and treatment of human testicular premature aging. Systematic and intensive studies are likely to aid in enhancing the reproductive health of men. It is hoped that in the future, it would be possible to treat premature or aging-dependent infertility caused by specific etiologies or genetic mutations via precisely targeted therapies.The phenotypes of physiological and pathological testicular aging have been well studied; however, the related causes, mechanisms, and rescue measures remain largely unknown. Furthermore, studies on senescence mechanisms in humans are not only limited by ethical requirements but also by the long experimental cycles. Also, because of the discrepancies in the regulation of the reproductive system between different species, the findings on testicular premature aging in animal models are not necessarily appropriate for humans. Therefore, we propose that the next research directions regarding testicular aging and premature aging should be focused on the following aspects: 1) Clinical samples of human testicular aging and premature aging should be directly used to explore the causes and mechanisms SD contributed to literature searching and wrote the manuscript. CC, JZ, and YG designed figures and a table. XHZ and XNZ supervised the study and revised the manuscript. All authors contributed to the article and approved the submitted version.This research was supported by the National Natural Science Foundation of China (81871201), Jiangsu Innovation and Entrepreneurship Talent Plan (JSSCRC2021543), and Large Instruments Open Foundation of Nantong University (KFJN2249).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.All claims expressed in this article are solely those of the authors and do not necessarily represent those of their affiliated organizations, or those of the publisher, the editors and the reviewers. Any product that may be evaluated in this article, or claim that may be made by its manufacturer, is not guaranteed or endorsed by the publisher.


Achondroplasia is associated with disproportionate short stature and significant and potentially severe medical complications. Vosoritide is the first medicine to treat the underlying cause of achondroplasia and data from phase 3 and phase 2 extension studies showed effects on growth and body proportions. However, there are currently no long-term data available on the direct impact on endpoints such as medical complications and health-related quality of life (HRQoL). This study explored the perceived impact of achondroplasia on medical complications, HRQoL, healthcare resource use and mortality, and potential modifying effects of vosoritide, based on published evidence and expert opinion. Structured expert opinion was obtained by an international modified Delphi study among 14 experts in managing achondroplasia performed on a virtual platform and consisting of an explorative phase followed by an anonymous individual rating round.Overall, the panelists expect that in individuals starting long-term treatment between 2 years of age and puberty, growth velocity increases observed in the clinical trials will be maintained until final height is reached (92% agreement) and will likely result in clinically meaningful improvements in upper-to-lower body segment ratio (85%). Earlier treatment initiation will likely result in a greater final height (100%) and more likely improve proportionality (92%) than later treatment. Although current data are limited, ≥ 75% of panelists find it conceivable that the earlier long-term treatment is started, the greater the probability of a positive effect on the lifetime incidence of symptomatic spinal stenosis, kyphosis, obstructive sleep apnea, and foramen magnum stenosis. These are among the most clinically important complications of achondroplasia because of their high impact on comorbidity, mortality, and/or HRQoL. A positive effect of vosoritide on the incidence of surgeries through lifetime was considered more likely with earlier long-term treatment (90%).This explorative study, based on international expert opinion, provides further insight into the medical and functional impacts of achondroplasia and how these might be modified through long-term use of vosoritide. The results can be used to guide the direction and design of future research to validate the assumptions and to discuss potential treatment outcomes with disease modifying therapies with families and clinicians.The online version contains supplementary material available at 10.1186/s13023-022-02372-z. FGFR3), resulting in impaired endochondral ossification. The most apparent clinical manifestations of the disorder are disproportionate short stature with shortening of the upper and lower limbs, macrocephaly with frontal bossing, and midface hypoplasia. In addition, several complications can arise throughout lifetime, including life-threatening foramen magnum stenosis in infants, symptomatic spinal stenosis, thoracolumbar kyphosis, upper airway obstruction, sleep disordered breathing, genu varum/tibial bowing, recurrent otitis media, conductive hearing loss, dental malocclusion, and cardiovascular disease [With an incidence estimated around 1 in 20,000–30,000 live births, achondroplasia is the most common disorder associated with disproportionate growth and short stature [ disease . The med disease , 6.Vosoritide is the first medicine to treat the underlying cause of achondroplasia. It is a biological analogue of C-type natriuretic peptide, a potent stimulator of endochondral ossification that works through downregulation of the intracellular signaling pathway of the FGFR3 receptor . VosoritData from the phase 3 and phase 2 extension studies showing the effects of vosoritide on growth and body proportions beyond 60 months of treatment are not yet available . In addition, there are no long-term data currently available on the direct impact of treatment on medical complications, physical function , and HRQoL. To address this knowledge gap until long-term data become available, this paper explores and discusses how achondroplasia can affect medical complications, HRQoL healthcare resource use, and mortality and how vosoritide-related increases in height and improvements in other anthropometric measures such as upper-to-lower body segment ratio may impact on medical complications, physical function and HRQoL. The resulting assumptions are based on extrapolation of existing data and structured expert opinion obtained by an international modified Delphi study.A modified Delphi study was performed to explore the potential impact of achondroplasia on medical complications / comorbidities  and the potential modifying effects of vosoritide based on published evidence and clinical opinion and expertise, and to identify evidence gaps for future clinical research.The expert panel consisted of a Core Committee of two (RS and SF), and twelve additional clinicians from a wide geographic spread  and covering multiple medical specialties, including clinical genetics, pediatrics, pediatric endocrinology, pediatric neurosurgery, and pediatric orthopedics. All panelists had relevant expertise in managing achondroplasia; seven (50%) are principal investigators in vosoritide clinical trials.The Delphi technique is a widely used and accepted interactive research method for measuring and/or obtaining consensus of opinion from experts . The tecIn an initial preparatory virtual video conference meeting, the study approach, expert panel composition, and draft clinical assumptions and questions for the explorative panel discussion were discussed by the Core Committee. The subsequent explorative panel discussion was held using the Within3 platform  to discuss and refine draft clinical assumptions and to gauge the opinion of the panel on topics for which no or limited data was available. The assumptions and questions were grouped in six major topics: anthropometrics, medical complications in general, skeletal complications, non-skeletal complications, quality of life, and mortality. For each assumption and question, a literature review of existing data was performed and summarized as background material for the panel discussion by a professional medical communication agency . The panelists were asked to answer questions based on published data (if available) and their own clinical experience or opinion and to explain reasons underlying their answers. Assumptions were rated on a 5-point Likert scale . Additional questions had varying answer options ; 13 participated in the rating round    and infants aged 0 to 12 months  , 15.There is currently no available evidence for a direct effect of vosoritide on medical complications of achondroplasia. Animal studies have shown an effect of vosoritide on skull morphology (mice) and on neural foraminal area of lumbar vertebrae (cynomolgus monkeys) , 17, butAbout one third of the panel members felt unable to judge a potential effect of treatment on cardiovascular disease, since the mechanism for increased cardiovascular mortality in patients with achondroplasia, or whether there is an increased risk at all, is not well understood. Also, the term cardiovascular disease was perceived as ‘too vague’ as it can encompass a range of different diseases. In addition, the experts noted that ‘true’ hydrocephalus, requiring neurosurgical intervention, is nowadays considered an unusual complication of achondroplasia.It has been well established that individuals with achondroplasia have a reduced HRQoL compared with the healthy population , 19–21. Studies have shown that short stature and skeletal dysplasia negatively impact on the ability of individuals to perform activities of daily living and on independence of adults , 22. LitIn addition to disproportionate short stature, medical complications may impact on the HRQoL of individuals with achondroplasia. Complications may result in frequent surgeries such as ear-nose-throat (mainly in children) and orthopedic procedures , 23, chrThe impact of foramen magnum stenosis not requiring decompression surgery on healthcare resources was considered high due to the need for monitoring and non-surgical management. In addition, 54% of panel members believe that obstructive sleep apnea can still have an impact on HRQoL when it is considered resolved after treatment, due to the recurrence risk later in life and the need for ongoing surveillance  and healthcare resources. Table S3. Rating results of additional questions. Table S4. Questions eliminated after the explorative phase and reason for elimination


Lesbian, gay, bisexual, transgender, queer, intersex, and/or asexual and other sexual and gender diverse persons (LGBTQIA+ or SGD persons) experience barriers to equitable health care. The purpose of this article is to describe a collaborative process that resulted in core cultural competency recommendations addressing training for those who provide health care and/or social services to LGBTQIA+ patients.In 2018 and 2019, Whitman-Walker Health, a Federally Qualified Community Health Center in Washington, DC, and the National LGBT Cancer Network purposively selected leaders of community clinics and community-based organizations, cultural competency trainers, and clinicians and researchers with expertise in SGD health with diverse lived experiences to develop consensus-based cultural competency recommendations. Recommendations were developed through a synthesis of peer-reviewed studies, publicly accessible curricula, and evaluations of SGD cultural competency trainings; two in-person convenings; and iterative feedback from diverse stakeholders.Five anchoring recommendations emerged: (1) know your audience; (2) develop and fine-tune the curriculum; (3) employ both adult and transformational learning theories; (4) choose multiple effective trainers; and (5) evaluate impact of training. These recommendations promote an ongoing process of individual and organizational improvement and a stance of humility rather than competence to be mastered.By setting core cultural competency standards for all persons involved in health care and social services, these recommendations complement existing clinical competency recommendations to advance SGD health equity. Many SGD people are multiply minoritized based on race, ethnicity, economic status, and other social factors.3 The impact of multiplied stigma can be exponential. Due to these intersectional disparities, more jurisdictions and schools require health professionals to undergo SGD cultural competency training5; however, no national standard for such training currently exists.In the past 15 years, awareness has broadened regarding the importance of tailored health care for individuals minoritized based on sexual orientation, sexual attraction, gender identity, gender expression, and differences in sex development.6–8; yet early models were theoretically flawed.9 First, models suggesting that a provider can have “mastery” over another person's lived experiences is patriarchal, racist, and classist.11 Second, competence focused at the individual level does not adequately address the interdisciplinary way that care is delivered.12 Cultural competence must include all levels of employees within institutions and move beyond individual competence to organizational culture, protocols, and policies. Third, models of competence have prioritized the role of providers over other employees; however, barriers to accessing care encompass factors that precede clinical interactions ,13 suggesting a need for competence across all roles in health care. Finally, solely focusing on common processes impacting health equity across diverse groups  is insufficient.14Cultural competence in health care initially aimed to address health disparities15 This is particularly important for understanding how health inequity might influence those who are minoritized based on intersectional demographics or lived experiences.Because different identity groups experience challenges to health equity in unique ways, affirming care must be adaptable.process over outcome. Cultural and narrative humility are processes that are grounded in the acknowledgement that each patient's story is different and requires health care provider self-reflection, self-evaluation, and self-critique.16 While cultural humility is often discussed with cultural competence, policy and legislative mandates often use the term “cultural competence.”4The concept of cultural competence has evolved because of these critiques, with a specific focus on outcome mandates with the use of processes known to be effective. We use the term “cultural competence” to align with mandates, given that they are the vehicle that requires SGD cultural competency training; however, we endorse a stance of cultural humility. Indeed, we support the use of the term cultural humility and encourage mandates to embrace this more appropriate term in the future.The difference between assumed competence and humility is critical and highlights the importance of trainers who must balance 17 The Joint Commission released recommendations for health care organizations to create an inclusive climate for SGD patients.18Numerous national organizations have created standards for culturally responsive health care. Since 2008, the Human Rights Campaign's Healthcare Equality Index has assessed hospitals' provision of services for SGD patients and families and support for SGD employees.2 with position statements from the American Medical Association (AMA)19 and American Nurses Association (ANA)20 following suit. The American Psychological Association (APA) has a long history of developing SGD-affirming policies, and the APA Task Force on Psychological Practice with Sexual Minority Persons published SGD guidelines, approved by the APA Council of Representatives.21 The authors also examined the role of gender identity and expression as a key aspect of intersectionality. Furthermore, the American Counseling Association's Society for Sexual, Affectional, Intersex, and Gender Expansive Identities published LGBQIA22 and transgender23 competencies.The Association of American Medical Colleges defined clinical competency recommendations for medical doctors,24 and that people access social services outside the health care setting, it is essential that all health care and social service staff receive high-quality cultural competency training to effectively address basic SGD health needs.SGD clinical competency recommendations are appropriately related to the clinical scope of the discipline for which the recommendations are made. Yet given that nonclinical employees encompass over 30% of health care jobs,25 The goal of these recommendations is to increase knowledge, skills, and positive attitudes of health care personnel when providing services to SGD patients, partners, and their families. This article describes the methods used to develop these standards to ensure transparency and credibility for those considering use of the recommendations.This article describes a national collaborative process that resulted in a set of core cultural competency recommendations to inform training practices that focus on health care services to SGD patients.We acknowledge that people with intersex conditions and asexual persons do not always identify as part of the LGBTQ+ community; however, we have included these communities to raise awareness of shared experiences of stigma and barriers to health care. We focused specific attention on including perspectives of those with intersex conditions and persons with asexual lived experience; yet engagement of persons within both of these communities could have been greater. We use the term SGD to be as inclusive as possible, acknowledging that many people do not identify with the terms represented in the LGBTQIA+ abbreviation.Our aim is to be inclusive and highlight the role of power in stigmatizing persons minoritized in multiple and overlapping ways. While we know our recommendations will need refinement, they are built on processes that require humility in understanding various lived experiences and engaging community members to improve the health of SGD persons in their own community.In 2018 and 2019, Whitman-Walker Health and the National LGBT Cancer Network purposively selected leaders of community clinics and community-based organizations, cultural competency trainers, and clinicians and researchers with expertise in SGD health from across the United States from both rural and urban settings and with lived experience to develop consensus-based SGD cultural competency recommendations. Per Whitman-Walker Health policies, no institutional review board approval was sought for this project as it was considered quality improvement.N = 30), 6 uniquely participated in the first summit, 8 uniquely in the second summit, and 16 attended both summits.Participants were selected based on lived experience as an SGD person, with intentionality of including SGD people of color, as well as professional leadership in developing cultural competency curricula, education, and trainings. We attempted to optimize participant diversity in professional role, race/ethnicity, gender identity, and sexual orientation. Of the summit participants  health care is interdisciplinary and cultural competence recommendations must address the range of personnel engaged in health care systems; (2) there is a “core” to SGD cultural competence; (3) cultural humility is fundamental and a lifelong goal—not an achievement at a point in time; (4) community engagement is critical; and (5) qualified, diverse trainers are crucial.Multiple theoretical frameworks guided the intersectionality and minority stress theory.26 Intersectionality examines the ways in which individuals are impacted by intersecting processes of power imbalances that influence inequity either positively or negatively.14 Minority stress theory specifically explores distal  and proximal  forces related to one's identity and/or minoritized status that create stress for an individual.28Development of these recommendations was guided by 29 Transformational learning theories seek to understand the processes by which learners interpret new information in the context of past ideas and understandings to shift their worldview through critical reflection.30 As we recognize the diversity of health care employees' professions, ages, and experience, adult and transformational learning theories are paramount to considering how to support all employees in building SGD cultural competence. Such diversity also supports selection of multiple trainers who represent intersectional experiences of SGD persons.Regarding implementation of recommendations, adult and transformational learning theories are suggested pedagogic strategies. Adult learning theories describe processes and conditions by which adults effectively engage in lifelong learning.n = 22 in 2018; n = 24 in 2019; N = 30) convened on two occasions, in person, for a 2-day summit . At the first summit, participants reviewed a synthesis of peer-reviewed studies, publicly accessible curricula, and evaluations of trainings, while sharing their own experiences. Participants recommended best and promising practices. Then feedback was gathered from diverse additional stakeholders (n = 63). Recommendations were refined at the second summit, which included additional participants who represented greater racial and ethnic diversity than those in the first summit, and highlighted lived experiences of intersex and asexual persons.Recommendations were developed through four phases. Participants  on which they have not previously reflected.Transformational learning theory leans into uncomfortable emotional responses to challenges and critically explores habituated thinking patterns. Trainers should verbally acknowledge to trainees the role of discomfort during the learning process, help prepare them for potential reactions, and invite them to embrace their curiosity around these reactions.Fourth, organizations should be thoughtful about the fit of trainers to organizational and employee needs. Multiple trainers with maximum variation of lived experiences can inform the broader diversity of SGD lived experiences. Choosing trainers with experiences that might mirror patients seen within the organization can optimize relevance of lessons learned. Acknowledging limitations of trainers—both in terms of experiences and expertise—is important. In addition, coordinating with multiple trainers can provide important respite for trainers when emotions are distressing and curricula are challenging to facilitate. Inclusion of community voices that are not academic or professional is especially encouraged and important.Inclusion of local community-based organizations that serve SGD clients can create and strengthen long-term relationships to reinforce affirming care for SGD patients for a particular organization. In addition, local organizations are likely to be attuned to the nuances of SGD persons' needs in the context of their specific geography, political landscape, and local mandates. Providing fair compensation of trainers and community members participating in training is important to convey the value of their expertise and appreciation for the time and emotional labor of sharing knowledge that could benefit the organization and improve learners' professional behaviors.33 Evaluating training sessions can help organizations model the regular collection of data for quality improvement to support their commitment to providing SGD-affirming care and striving for culturally competent care. Understanding the impact of training on learner knowledge, attitudes, skills, intention to change, motivation to change, and actual behavior change can refine ongoing professional development approaches and add to the evidence base in the literature. The Transforming Healthcare: A Guide to Best Practices in LGBTQIA+ Cultural Competency Training25 offers detailed support for the high-level recommendations presented in Fifth, evaluate the training. There are few extant evaluations of SGD cultural competency training.34 and the QUeering Individual and Relational Knowledge Scale (QUIRKS).35 Other methods of evaluation could include role play with feedback, use of standardized patient scenarios, and nonvalidated measures that ask learners to rate their confidence in performing learning outcomes before and after training and/or motivation to change behaviors.33For those interested in rigorous evaluation, two examples of SGD-specific validated scales that could be used to evaluate trainings include the Lesbian, Gay, Bisexual, Transgender Development of Clinical Skills Scale (LGBT-DOCSS)Transforming Healthcare: A Guide to Best Practices in LGBTQIA+ Cultural Competency Training25 intends to fill this gap. This guide provides recommendations from experienced trainers, employees, providers, and community members. The core of high-quality SGD cultural competence includes the following: using current knowledge, skills, and attitudes of learners; reasons for training being prioritized; the organizational environment; and the amount of time available. The guide does not mandate specific content to be covered in training, but rather provides a guide to optimize SGD cultural competency training decisions from planning through implementation and evaluation.Although a growing number of educational programs and health systems offer SGD training, there is a dearth of standards for such training. 25 and this overview of its development suggest processes and recommendations to maximize impact of SGD-specific training. We recommend instructors use these recommendations when designing their trainings. Leaders can consider processes before, during, and after training to ensure maximum benefit.While we believe these recommendations to be useful to any who are involved in the process of developing, disseminating, and evaluating training, they are particularly important for those leading training from start to finish. The guide37 In addition to setting a standard for core LGBTQIA+ cultural competence, they are intended to aid organizations in selecting trainers and to assist trainers in encouraging learner reflection, stereotype negation, and depathologizing minoritized identities. Organizations should reference complementary clinical competency work, position statements from discipline-specific membership organizations, and organizational baseline standards when using these recommendations (37These recommendations are complementary to existing discipline-specific and organizational standards.ndations .2,17,18,cultural competence are distinct from recommendations for clinical competence that delineate the clinical care needs for SGD populations.Specifically, the current recommendations form a core of cultural competence from which existing discipline-specific and organizational standards can build. Importantly, the current recommendations for SGD all employees in health care systems and social service organizations should be competent in with respect to SGD populations. Setting uniform standards is critical for shared accountability, confidence in co-workers, and establishing what is unacceptable in health care spaces. The latter allows for any individual in the health care system to be able to recognize inappropriate behaviors and intervene accordingly. Finally, our recommendations set core competency standards that include the processes inherent to cultural humility. This approach allows a framework for improving the competence of health care systems to better serve SGD colleagues and patients.Importantly, these recommendations are distinct in several ways. First, the current recommendations recognize the importance of and set criteria for how to select a trainer for SGD cultural competency training. These include recommendations for using multiple trainers with diverse identities and lived experiences, and compensating trainers fairly. Second, these recommendations set a standard for what 38 To our knowledge, the present standards are the first to embody this commitment for SGD communities.A particular strength of these recommendations is the commitment to nonclinical SGD community engagement. These recommendations include critical feedback from nonclinical members across SGD communities. Recently, numerous calls have been made for more community engagement in clinical education.We are acutely aware of the historic, social, and political context for this work. These recommendations cannot adequately address the experiences of every SGD person. They offer an approach to training, which includes learning about unique experiences of SGD people. Attempts were made to be inclusive of SGD subpopulations; however, we were limited by those who were publicly visible and willing and able to provide feedback. The recommendations require strengthening in perspectives from asexual individuals; those who are intersex; First Nations/Two Spirit people; and those from other cultural backgrounds. We support and acknowledge that ongoing and iterative refinements are necessary to reduce disparities faced by SGD people.Skills building takes multiple sessions. These recommendations are not meant to produce rapid change; however, they can help guide individuals and organizations toward meaningful and sustainable change. Understanding equity, and compassionately and effectively serving the needs of SGD persons and families, requires an ongoing commitment not only by providers but also by health care systems. System-level interventions are necessary to truly create an inclusive health care environment. It is helpful for organizations to develop a long-term relationship with trainers that encompasses a series of training sessions over a period of time and identify staff champions to optimize advancements in implementing and improving SGD-affirming organizational policies and practices.Transforming Healthcare: A Guide to Best Practices in LGBTQIA+ Cultural Competency Training25 complements existing guidelines on SGD cultural competency training by highlighting core components and their application to all individuals within health systems. Alongside clinical and organizational SGD competency frameworks, these recommendations can strengthen delivery of health care and, ultimately, improve health care experiences and outcomes for SGD patients.


Telecommunications systems emit radiofrequency, which is an invisible electromagnetic radiation. Mobile phones operate with microwaves  very close to the user's ear. The skin, inner ear, cochlear nerve and the temporal lobe surface absorb the radiofrequency energy.literature review on the influence of cellular phones on hearing and balance.systematic review.We reviewed papers on the influence of mobile phones on auditory and vestibular systems from Lilacs and Medline databases, published from 2000 to 2005, and also materials available in the Internet.Studies concerning mobile phone radiation and risk of developing an acoustic neuroma have controversial results. Some authors did not see evidences of a higher risk of tumor development in mobile phone users, while others report that usage of analog cellular phones for ten or more years increase the risk of developing the tumor. Acute exposure to mobile phone microwaves do not influence the cochlear outer hair cells function in vivo and in vitro, the cochlear nerve electrical properties nor the vestibular system physiology in humans. Analog hearing aids are more susceptible to the electromagnetic interference caused by digital mobile phones.there is no evidence of cochleo-vestibular lesion caused by cellular phones The radiation spectrum includes microwaves (frequencies between 300 MHz and 300 GHZ) and reaches close to infrared radiation.,RF is also used daily in microwave ovens and diathermy medical devices (thermoablation); the latter are used in treating cardiac arrhythmias, tumors and other conditions.,Since the 1970s, the World Health Organization, governments of various countries, researchers, and manufacturers of telecom equipment have studied the effects of RF on human health. The large number of radio transmitters and telecom antennae installed close to residential areas and the growing use of mobile phones justify these efforts.There are still, however, concerns about the possibility of lymphatic cancer, central nervous system tumors (including acoustic neuromas), choroidal melanomas, and other conditions in subjects chronically exposed to RF, which have motivated epidemiological and experimental studies.8One of the most frequently discussed themes currently is the effect of mobile phone use on human health, given that these devices transmit microwaves This review presents themes of interest for otorhinolaryngologists, such as the biological effect of RF, the relation between mobile phone use and central nervous system tumors, and the effects of mobile phone electromagnetic radiation on the auditory system, on the vestibular labyrinth, and on hearing aids.Lilacs and Medline database indexed papers were reviewed. We selected papers published from 2000 to 2005. We also reviewed published matter from the National Telecommunications Agency  - ANATEL, and Internet website materials from mobile phone manufacturers.,,RF is a non-ionizing radiation, as opposed to X-rays and gama radiation; it does not, therefore, have enough energy to destabilize electrons or break chemical bonds in DNA.1)thermal effects: these are the best known effects. They result from water molecule polarization as electromagnetic waves course through tissues and produce heat (temperature variation over 1oC).Devices that generate RF between 350 and 500 kHz or microwaves over 2 GHz are used for thermoablation surgery. Tissue temperatures reach 50–100oC, resulting in local necrosis and coagulation. Temperatures over 100oC vaporize and carbonize tissues.,Telecom workers that are accidentally exposed to high RF loads absorb this energy, which produces heat. They may have skin burns and injury to heat-sensitive tissues, such as the lens of the eye, the testicles and the brain, leading respectively to cataract, male infertility and seizures.,,,The power of radio and television transmitters may reach many kilowatts; mobile phone base stations may reach over 100 W.2)non-thermal effects: these take place with no temperature change in biological tissues. These effects have not yet been fully clarified, and are the reason for many debates among scientists.The effect of RF on living organisms may be didactically divided into the following:These effects include electrical force induction and possibly an increase in heat shock protein synthesis in cells.,No study thus far has demonstrated that exposure to RF without thermal effects produces genetic mutations or chromosomal aberrations in mammal cells, which suggests that RF cannot initiate tumors.D'Andrea et al. (2003),The specific absorption rate (SAR) is used to measure the energy dose that subjects exposed to RF absorb. The SAR is expressed in power (Watts) by tissue mass (kilograms).The full body SAR in human beings depends on various factors, such as: the nature of an electromagnetic field (low or high frequency); the distance and spatial orientation of the field relative to a subject; the subject's geometry ; and the water content of different tissues.The SAR also varies according to the mobile phone handset model, the transmission system technology , the distance between a user's head and the handset antenna, and the distance between a mobile phone and its base station.,Digital handsets  expose a user's head to a SAR almost always below 1 W/kg, well below the recommended maximum safe exposure limits.While using a mobile phone, the skin around the ear, the inner ear, the vestibulocochlear nerve, and a small surface area of the temporal lobe absorb RF and microwave energy.A number of case-control studies have investigated the relation between mobile phone use and CNS tumors .Table 1CMuscat et al. (2000)17 analyzed 469 cases of cerebral neoplasms and 422 controls. The mobile phone use profile was similar in both groups; males aged 30 to 49 years predominated, most of which worked as salespersons. No association between exposure to mobile phone-generated RF and neoplasms was found. Furthermore, temporal lobe tumors were more likely to arise on the opposite side to that where mobile phones were habitually used.Inskip et al. (2001)18 and Muscat et al. (2002)19 reported similar results. No relation was found between tumor diagnosis, the duration of handset use (in years) and the frequency of telephone calls.These three studies collected data from the 1990s, when most of the handsets were analog. These have been replaced by digital technology, where microwave emissions have a lower output power at higher frequencies.Christensen et al. (2004)Lönn et al. (2004)Hardell et al. (2005)Johansen et al. (2001)An important point to consider when interpreting this data is that the duration of use (in years) and frequency of use  of mobile phone are imprecise measures of microwave exposure. As we saw in the section on biological effects cause by RF, the SAR will vary significantly depending on many factors.1)Ozturan et al. (2002)Oysu et al. (2005)Sievert et al. (2005)Aran et al. (2004)2)Kizilay et al. (2003)Aran et al. (2004)8 conducted an experimental model using guinea pigs exposed to GSM microwaves at 900 MHz in one ear only for one hour each day, five days a week, during two months,. The guinea pigs were divided into four groups: exposure to a SAR of 1 W/kg, of 2 W/kg, of 4 W/kg, and non-exposed (controls). Distortion product otoacoustic emissions and BERA thresholds were assessed before, during and after the experiment. Finally, the animals were sacrificed for histological studies of the cochlea.No dose-response effects of radiation on otoacoustic emissions were found. BERA revealed a significant mean threshold increase in both ears of every animal (exposed to microwaves and controls) during the two months that the experiment lasted. The authors explained these findings describing that as the animals grew, their heads increased, and so did the distance between central auditory pathways and the auditory evoked potential recording electrodes. There were no threshold differences between the radiation-exposed and the contralateral ear (non-exposed) in microwave-irradiated animals.Histology revealed complete ossification of an irradiated cochlea in only one guinea pig (in the SAR 2 W/kg group) out of 32 animals. According to the authors, unilateral ossifying labyrinthitis is common in guinea pigs due to otitis media and bacterial meningitis; so this finding cannot be attributed exclusively to radiation.Pau et al. (2005)The authors also conducted an infrared thermography experiment on bone and soft tissues to assess any eventual thermal effect produced by mobile phones on the lateral semicircular canal. No temperature variations were found at a depth that corresponded to that of the labyrinth, suggesting that mobile phone microwave transmitting power is not sufficient to cause heating.,Older hearing aids - particularly analog devices - may be susceptible to electromagnetic interference. Pulsed microwaves, used in digital handsets, may be demodulated by hearing aid electric circuit semiconductors, resulting in noise.A mobile phone handset manufacturer offers an accessory that may be used by subjects using analog prostheses. It is a loop used around the neck that transmits mobile phone signals to the hearing aid by induction. According to this manufacturer, the induction loop improves the user's acoustic comfort.Technological developments in telecommunications systems have brought undeniable benefits; possible harmful effects of RF and microwaves, however, are still a controversial issue.,Published papers are based on North-American and European research - particularly from Scandinavian countries - the home of major world manufacturers of mobile telecommunication handsets and base stations. No evidence has shown any causal relation between RF exposure and the occurrence of cancer, CNS tumors, or other diseases.,The International Commission on Non-Ionizing Radiation Protection has stated that nearly all of the epidemiological surveys have focused on adults.,,,,,,,There is no evidence supporting the influence of mobile phone use on the occurrence of benign or malignant CNS tumors, especially those located in the temporal lobe.,21,,Muscat et al. 2002)02,20, 21,,,,Various papers have suggested that exposure to mobile phone microwaves has no influence on the activity of cochlear outer hair cells or of cochlear nerve electrical conduction, both in vivo and in vitro.Notwithstanding the evidence, Ozturan et al. (2002)Apparently, mobile phone microwaves have no short-term effects on the vestibular system of normal subjects.These unresolved issues justify future studies to better understand the effect of mobile phone electromagnetic radiation on the auditory and vestibular systems; this includes the risk of tumors in the eighth cranial nerve. Any adverse effect that may eventually be found should be promptly reported; it is a health issue of interest to billions of users worldwide.Currently manufactured digital hearing aids include effective protective features against mobile phone electromagnetic interference.There is no scientific evidence suggesting that RF/microwaves emitted by mobile phones cause thermal harm to users.Acute exposure to microwaves transmitted by mobile phone handsets does not affect the cochlear outer hair cell activity, the cochlear nerve electric conduction or vestibular labyrinth function in vivo or in vitro.There are controversial data about an increased risk of acoustic neuroma in chronic mobile phone users.Analog hearing aids are more prone to electromagnetic interference caused by digital mobile phone handsets.Finally, the mobile phone electromagnetic interference on implanted cardiac pacemakers and medical/hospital equipment  should be noted. Just as mobile phones are required to be switched off in aircraft, it is highly recommended that doctors refrain from using mobile phones in operating rooms and intensive care units, for the safety of patients. In certain situations, mobile phone electrical fields may overwhelm the shielding capability of electrical medical devices, causing them to switch off, setting off alarms irregularly or yielding incorrect vital sign measurements.We wish to acknowledge Mr. Jose Amaro O. Balbani for kindly clarifying the technical aspects and for strongly encouraging this study.