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Representativeness in randomized clinical trials remains a critical concern, affecting the external validity of trial results, equitable access to the risks and benefits of research participation, and public trust in clinical research. Although representative participation by members of groups traditionally underrepresented in clinical trials is just a surrogate for true diversity, equity, inclusion, and belonging in clinical trials, it can be quantified, allowing stakeholders to add empirical rigor to diversity, equity, inclusion, and belonging efforts. Multiple ways to measure representativeness have been proposed, including the participation-to-prevalence ratio, raw participation proportions or numbers for relevant subgroups, and enrollment fraction for relevant subgroups. These methods have strengths and weaknesses and may be appropriate to report in certain circumstances, depending on why stakeholders seek to assess representativeness. Stakeholders—including regulatory agencies, journal editors, clinical trial investigators, and trial sponsors—may use quantitative measures of representativeness to establish trial enrollment standards, monitor equitable participation in ongoing trials, and condition funding or drug or device approval on achieving specific representativeness targets. However, using quantitative measures of representativeness in this way could have unintended consequences, including researchers "gaming" recruitment strategies to meet target numbers, overlooking nuanced variations within communities, and potentially incentivizing problematic and exploitative recruitment strategies. Although no single method of measuring representativeness offers a comprehensive solution for increasing diversity, equity, inclusion, and belonging in all randomized clinical trials, a carefully designed, multifaceted approach to measuring representativeness may provide stakeholders with useful perspectives for measuring progress in increasing the diversity of clinical trial participation. For stakeholders seeking a single number to assess the representativeness of a trial enrolling patients with a disease state with well-delineated demographics, the participation-to-prevalence ratio is ideal; however, for a more nuanced view of representativeness, the combination of enrollment fraction in subgroups of relevance plus a full report of the demographics of patients approached for enrollment may be more appropriate. [ABSTRACT FROM AUTHOR]

Background: Much enthusiasm has been generated around vertebral body tethering (VBT) as an alternative to fusion treatment. However, the majority of studies have shown little difference between coronal curve magnitude on the first postoperative erect radiograph and that at final follow-up, suggesting that VBT is not consistently modulating spine growth in a manner that substantially affects coronal curve magnitude. Methods: All patients with adolescent idiopathic scoliosis (AIS) who underwent VBT between December 2013 and June 2020 and subsequently had at least 2 years of follow-up in a multicenter registry were reviewed. The change in coronal curve magnitude was calculated by subtracting the magnitude at the time of final follow-up from that on the first postoperative erect radiograph. A change of <5° was considered to be within normal measurement variability. Results: One hundred and ten patients met the inclusion criteria (racial breakdown: 94 White, 6 Black/African American, 3 Asian, 2 Middle Eastern, 1 mixed race, and 4 uncertain/unspecified; ethnicity: 87 not Hispanic or Latino, 1 Hispanic/Latino, and 22 did not report their ethnicity). Their mean age was 12.9 years (standard deviation [SD], 1.3 years) and the mean follow-up was 3.7 years (range, 2.0 to 6.9 years). A mean of 6.6 levels were tethered. The preoperative mean coronal curve magnitude was 51.0° (range, 32° to 75°), which corrected to a mean of 27.3° (range, 10° to 53°) on the first postoperative erect radiograph. At the time of final follow-up, the mean coronal curve magnitude was 30.9° (range, −50° to 69°), and 49.1% (54) of the 110 curves were stable (the coronal curve magnitude at final follow-up was within 5° of that on the first postoperative erect radiograph). A total of 42.7% (47) had >5° of increase in coronal curve magnitude following the initial postoperative erect radiograph, whereas 8.2% (9) showed a >5° increase during the follow-up period. Five of the 9 patients (4.5% of the series) had a >10° decrease, with 2 of the 5 having overcorrection, ending up with 31° and 50° curves in the opposite direction. Conclusions: Although VBT holds promise and many (49.1%) of the 110 curves in this series remained stable from the first postoperative erect to the final follow-up radiograph, only 9 demonstrated a decrease in coronal curve magnitude over time, including 2 that overcorrected. Further research is needed to identify the factors differentiating among patients who had curve progression, did not have progression, or had overcorrection to determine which patients are more likely to benefit from VBT. Level of Evidence: Therapeutic Level IV. See Instructions for Authors for a complete description of levels of evidence. [ABSTRACT FROM AUTHOR]

Background: Rates of severe retinopathy of prematurity (ROP) continue to rise globally despite advances in healthcare. Differences in practices related to optimizing oxygenation is among key factors that increase the risk of severe ROP. A recent increase in severe ROP rates at 2 local neonatal intensive care units (NICUs) prompted further investigation into potential preventative practices. Purpose: The project team's goal was to reduce rates of severe ROP by 20% in the 2 participating units. Methods: A level IV and level III NICU were targeted, including 255 infants at risk for ROP. Interventions included staff education, implementation of new established oxygen guidelines, as well as use of order sets, and alarm limits. Compliance rates and severe ROP rates before and after new guideline implementation were assessed. Results: After implementing the new guidelines, average alarm limit compliance met project goals of 90% at both sites. Severe ROP rates declined from 10% to 7% in the level IV NICU site and from 6% to 0% in the level III NICU site during the 24-month study period from 2022 to 2023. Implications for practice and research: Education and increased understanding regarding risk factors for ROP patients are crucial to successfully implementing and sustaining standardized oxygenation guidelines. Including the entire healthcare team and patient families is key to successful QI initiatives and improving patient outcomes. Further research is needed for optimal standardized oxygen alarm limits for this patient population. One of the leading causes of childhood blindness is retinopathy of prematurity (ROP).1 ROP is a disease of the retina that affects premature infants, with the highest risk to very low birthweight (VLBW) infants born with a gestational age of less than 30 to 32 weeks or infants weighing less than 1500 grams.2 There are 5 stages of ROP. Stages 1 and 2 are considered mild and resolve on their own. Stage 3 is considered moderate-severe and sometimes resolves independently, with many cases requiring treatment. Stages 4 and 5 ROP are deemed severe and require treatment. Video 1 Eyedealistic Vision: Optimizing Oxygenation to Reduce Severe Retinopathy of Prematurity in the Neonatal Intensive Care Unit Video 1. Eyedealistic Vision: Optimizing Oxygenation to Reduce Severe Retinopathy of Prematurity in the Neonatal Intensive Care Unit 1_a39blria Kaltura [ABSTRACT FROM AUTHOR]

The landmine rotation is a multipurpose, total body, strength and power exercise that bridges the gap between traditional resistance exercise and rotational sport specificity. This article describes proper landmine rotation technique, outlines several variations, and offers programming recommendations. [ABSTRACT FROM AUTHOR]

Background: Pain catastrophizing, or the interpretation of pain as unbearable or intolerable, can increase pain-related anxiety and severity. High levels of pain catastrophizing have also been linked to substance use, particularly for substances with analgesic properties. Importantly, behavioral treatments can reduce pain catastrophizing, making them promising interventions for mitigating pain-related substance use. The aim of this scoping review is to summarize literature investigating the relationship between pain catastrophizing and substance use in adults. Methods:We performed a scoping review of peer-reviewed literature. Included articles had both a measurement of pain catastrophizing and substance use, and reported analyses characterizing the relationship between the two. Results: Of the 341 abstracts identified, 47 articles met eligibility criteria. Most studies focused on people with chronic pain. Some studies also considered samples with substance use disorders (with and without chronic pain) or acute pain, and general population samples. There was generally a positive association between pain catastrophizing and substance misuse; this association was consistent across multiple samples and substances. Most studies were cross-sectional, although associations were also detected in longitudinal studies. The magnitude of associations tended to be stronger for higher severity substance use and more proximal tests of association. More longitudinal and experimental studies are needed, however, to better delineate these effects. Discussion: Findings indicate a consistent positive association between pain catastrophizing and substance use, highlighting the potential for interventions targeting pain catastrophizing to reduce negative substance-related consequences. [ABSTRACT FROM AUTHOR]

Goal: Excessively lengthy wait times for appointments with clinicians are a major source of frustration for patients, and difficulties with access represent a public health problem facing populations across all societies. As delays in care have been associated with inferior outcomes, same-day appointments have been proposed as a patient-centric means of improving healthcare delivery. However, this paradigm represents a radical shift from conventional scheduling tactics, and skepticism has long existed regarding its feasibility and real-world applicability to clinical practice. Given the limited data available about same-day access and the lack of guidance on this strategy, the need to evaluate experiences and engage in introspective reflection (i.e., examine thoughts, emotions, judgments, and perceptions) for quality improvement are paramount. Thus, the purpose of this study was to review a single-institutional practice with same-day access, focusing on lessons learned over a two-year period. Methods: From March 2021 to March 2023, a total of 4,301 consecutive patients with newly diagnosed cancer were offered same-day appointments as part of a prospective pilot initiative conducted in the outpatient setting at a tertiary-based academic medical center. Systematic analysis demonstrated the positive impact of this initiative on access-related benchmarks. A retrospective review was conducted to identify core themes pertaining to the feasibility of the initiative with respect to its design and implementation. An interpretive synthesis was then presented in descriptive fashion. Principal Findings: Of the 3,414 patients scheduled, 477 (14%) opted for same-day appointments. While same-day appointments significantly reduced the time to consultation and treatment for patients with newly diagnosed cancer, the initiative presented new challenges—both expected and unexpected—that could have hindered its development, acceptance, and adoption. These challenges related to scheduling capacity, logistical coordination, workflow efficiency, resource allocation, and cultural change. A consistent, proactive management approach, coupled with an unwavering commitment to communication, was required to overcome these operational barriers. Practical Applications: Same-day appointments in the ambulatory setting has the potential to improve health outcomes and care quality, while fundamentally changing the way healthcare is delivered for the betterment of patients. However, thoughtful preparation and team-based planning are imperative to establish a methodical approach that will optimize the likelihood of success. Given the potentially disruptive nature of this paradigm, the need for steady leadership, accompanied by the consistent promotion of standardized guidelines, is critical to ensure engagement among all stakeholders. Lastly, the importance of promoting positive cultural change and creating an environment of shared purpose, trust, and transparency cannot be overemphasized. [ABSTRACT FROM AUTHOR]

Supplemental Digital Content is Available in the Text. Compound 194 inhibits CRMP2 SUMOylation, indirectly regulating NaV1.7 to alleviate osteoarthritic pain. Osteoarthritis (OA) is a highly prevalent and disabling joint disease, characterized by pathological progressive joint deformation and clinical symptoms of pain. Disease-modifying treatments remain unavailable, and pain-mitigation is often suboptimal, but recent studies suggest beneficial effects by inhibition of the voltage-gated sodium channel NaV1.7. We previously identified compound 194 as an indirect inhibitor of NaV1.7 by preventing SUMOylation of the NaV1.7-trafficking protein, collapsin response mediator protein 2. Compound 194 reduces the functional activity of NaV1.7 channels and produces effective analgesia in a variety of acute and neuropathic pain models. However, its effectiveness has not yet been evaluated in models of OA. Here, we explore the effects of 194 on pain-related outcomes in the OA-like monoiodoacetate model using behavioral assessment, biochemistry, novel in vivo fiber photometry, and patch clamp electrophysiology. We found that the monoiodoacetate model induced (1) increased pain-like behaviors and calcium responses of glutamatergic neurons in the parabrachial nucleus after evoked cold and mechanical stimuli, (2) conditioned place aversion to mechanical stimulation, (3) functional weight bearing asymmetry, (4) increased sodium currents in dorsal root ganglia neurons, and (5) increased calcitonin gene–related peptide-release in the spinal cord. Crucially, administration of 194 improved all these pain-related outcomes. Collectively, these findings support indirect inhibition of NaV1.7 as an effective treatment of OA-related pain through the inhibition of collapsin response mediator protein 2-SUMOylation via compound 194. [ABSTRACT FROM AUTHOR]

Background: Nonuse and inconsistent use of contraception in young adults can result in undesired pregnancies. Prior research on contraceptive use has primarily focused on individual influences such as attitudes, beliefs, and skills related to contraceptive use, with little consideration of the social and economic determinants. Objective: This study explored domains from the Healthy People 2030 Social Determinants of Health (SDH) framework and examined their cross-sectional associations with young adults' self-reported contraceptive use (ie, any use in the past year and consistent use of contraception). Methods: Eleven measures related to 5 SDH domains were extracted from the Add Health dataset collected from 2001 to 2002 (Wave III). The final sample included 11,172 youth with a mean age of 21.88 years (SD: 1.84) and was 53.8% female. Results: Measures associated with the past year's use of contraceptives included non-poverty status, employment, housing instability, high school graduation, enrollment in higher education, English language spoken at home, experience of civic participation, and access to primary care. For consistent use of contraception, associated measures were participants' non-poverty status, employment, high school graduation, enrollment in higher education, English language spoken at home, experience of civic participation, incarceration, and access to health care. Conclusions: Interventions that address social determinants of health can potentially promote contraceptive use. [ABSTRACT FROM AUTHOR]

Background: Restoration of hand function after traumatic brachial plexus injury (BPI) remains a formidable challenge. Traditional methods such as nerve or free muscle transfers yield suboptimal results. Advancements in myoelectric prostheses, characterized by novel signal acquisition and improved material technology, show promise in restoring functional grasp. This study evaluated the ability of adults with a BPI injury to control an externally powered prosthetic hand using nonintuitive signals, simulating the restoration of grasp with a myoelectric prosthesis. It also assessed the effectiveness of a comprehensive multidisciplinary evaluation in guiding treatment decisions. Methods: A multidisciplinary brachial plexus team assessed adults with compromised hand function due to BPI. The feasibility of amputation coupled with fitting of a myoelectric prosthesis for grasp reconstruction was evaluated. Participants' ability to control a virtual or model prosthetic hand using surface electromyography (EMG) as well as with contralateral shoulder motion-activated linear transducer signals was tested. The patient's input and injury type, along with the information from the prosthetic evaluation, were used to determine the reconstructive plan. The study also reviewed the number of participants opting for amputation and a myoelectric prosthetic hand for grasp restoration, and a follow-up survey was conducted to assess the impact of the initial evaluation on decision-making. Results: Of 58 subjects evaluated, 47 (81%) had pan-plexus BPI and 42 (72%) received their initial assessment within 1 year post-injury. Forty-seven patients (81%) could control the virtual or model prosthetic hand using nonintuitive surface EMG signals, and all 58 could control it with contralateral uniscapular motion via a linear transducer and harness. Thirty patients (52%) chose and pursued amputation, and 20 (34%) actively used a myoelectric prosthesis for grasp. The initial evaluation was informative and beneficial for the majority of the patients, especially in demonstrating the functionality of the myoelectric prosthesis. Conclusions: The study indicates that adults with traumatic BPI can effectively operate a virtual or model myoelectric prosthesis using nonintuitive control signals. The simulation and multidisciplinary evaluation influenced informed treatment choices, with a high percentage of patients continuing to use the myoelectric prostheses post-amputation, highlighting its long-term acceptance and viability. Level of Evidence: Therapeutic Level IV. See Instructions for Authors for a complete description of levels of evidence. [ABSTRACT FROM AUTHOR]

Background: We assessed access to pre-exposure prophylaxis (PrEP) and interest in integration of PrEP with gender-affirmative care in a global sample of transmasculine persons. Methods: Transmasculine persons (N = 590) aged 18 years and above from 57 countries completed a brief online survey from April to July 2022 about sexual behavior, knowledge, and interest in PrEP, current access to PrEP and gender-affirmative care, and preferred context for accessing PrEP. Descriptive analyses were stratified by country income group. Results: Most participants (54.4%) lived near a health center offering care to trans people. Overall, 1.9% of respondents reported ever receiving a positive HIV test result. Among those who had not (n = 579), more than a third reported engaging in receptive sex in the past year (35.2%) or anticipated doing so in the next year (41.5%), 86.9% had never received information about HIV prevention specific to transmasculine people, and 76.3% had heard of PrEP. Among those who had heard of PrEP (n = 440), only 18.9% had discussed or been offered it by a provider, and only 3.6% were currently taking it—yet 67.9% who had heard of it but were not using it would "definitely" (28.5%) or "maybe" (39.4%) be interested in taking it were it available for free. Out of these participants, the majority (60.5%) preferred the idea of accessing PrEP from the same clinic where they received gender-affirming care. Conclusions: Interventions are needed to improve PrEP access for transmasculine people globally. Clinics already providing gender-affirming care to trans people are acceptable clinical contexts to integrate such interventions. [ABSTRACT FROM AUTHOR]

Supplemental Digital Content is Available in the Text. Chaize, C, Allen, M, and Beato, M. Physical performance is affected by players' position, game location, and substitutions during official competitions in professional Championship English football. J Strength Cond Res 38(12): e744–e753, 2024—This study aimed to verify, first, if physical parameters were different between positions during official matches in the English Football League Championship. Second, whether game location (home vs. away games) and playing status (full match vs. substitute) affected players' physical performance. Twenty-six, male, professional, football players of the same club were included in this data analysis during the 2023–24 season. STATSports 10 Hz global navigation satellite systems Apex units (Northern Ireland, United Kingdom) were used to monitor official matches (21 games). The metrics recorded were distance covered (m·min−1), high-speed running distance (>19.8 km·h−1), sprint distance (>25.2 km·h−1), the number of accelerations (>3 m·s−2), decelerations (<−3 m·s−2), and high-metabolic-load distance (HMLD) measured in meters (>25.5 w·kg−1). Significant differences were found between positions and game location for distance covered and high-speed running (HSR; p < 0.05) as well as between game location (p = 0.020) for sprinting distance. Differences were found between game location (p = 0.034) for decelerations. Differences were found between positions and game location for HMLD (p < 0.05). Significant difference between full-match players vs. substitutes were found for distance covered (p < 0.001), HSR (p = 0.002), accelerations (p = 0.017), decelerations (p = 0.023), and HMLD (p = 0.008). In conclusion, this study found that physical performance was influenced by players' positions and player status, whereas it found that game location affected a minor number of physical metrics. Therefore, practitioners should be aware that training should be tailored based on the physical demands of the players' positions. Moreover, practitioners and managers need to be aware of the positive impact of substitutions on match intensity. [ABSTRACT FROM AUTHOR]

Studies have found that blood flow to the renal medulla is an important determinant of pressure-natriuresis and the long-term regulation of arterial pressure. First, a brief review of methods developed enabling the study of the medullary circulation is presented. Second, studies performed in rats are presented showing medullary blood flow plays a vital role in the pressure-natriuresis relationship and thereby in hypertension. Third, it is shown that chronic reduction of medullary blood flow results in hypertension and that enhancement of medullary blood flow reduces hypertension hereditary models of both salt-sensitive rats and salt-resistant forms of hypertension. The key role that medullary nitric oxide production plays in protecting this region from ischemic injury associated with circulating vasoconstrictor agents and reactive oxygen species is presented. The studies cited are largely the work of my students, research fellows, and colleagues with whom I have performed these studies dating from the late 1980s to more recent years. [ABSTRACT FROM AUTHOR]

Dual-energy X-ray absorptiometry (DXA) is commonly used for testing athlete's body composition, but many athletes are too tall. The first aim was to assess the viability of combining upper- and lower-body regions of interest (ROI), creating a combined scan for tall athletes who do not fit on the table and second, to provide practical solutions to DXA users who routinely scan tall athletes. Sixty subjects (34.8 ± 11.9 years; 1719 cm) completed 2 total-body DXA scans for baseline precision testing, using GE Lunar Prodigy (LP) or Hologic Horizon A (HA) models. Next, an upper body ROI from the skull to the distal femoral condyles was combined with a flipped scan (feet-to-head) ROI encompassing the proximal tibial plateau to the distal foot. Soft and bone tissue coefficient of variance (CV%) were calculated between the baseline scans and for the newly combined ROI scan. The combined ROI scan added 0.25-0.63% and 0.01-4.35% error rates for the LP and HA, respectively. An exploratory assessment of a GE Lunar iDXA demonstrated results similar to the HA with 4%+ error. The combined ROI scan is a user-friendly and precise method for older LP systems adding less than 1% error; however, newer DXA systems cannot use the stitched scan technique. Coaches and practitioners who use newer DXAs must prioritize consistently using the same boney landmarks (head, jaw, or feet) and ROI heights to provide precise longitudinal assessments of tall athletes' bone and body composition, until larger DXA tables become available. [ABSTRACT FROM AUTHOR]

Background and Objectives: This qualitative study explored perceived community strengths and health issues among 3 underserved and under-studied populations in the Atlanta, Georgia—older adults, Black or African American persons, and refugees/immigrants/migrants. Methods: Eight focus groups were conducted with 92 participants who were members of the 3 populations in Atlanta between November 2022 and March 2023. Results: Although there were variations among groups, all groups emphasized diversity within their community as the foundation of community strength. Elements of the built environment such as parks, convenience stores, the Atlanta Beltline, and food outlets bolstered community strength. Furthermore, community members being able to voice concerns and the responsiveness of governmental institutions helped form strong relationships to build a strong community. Regarding health issues, common physical health concerns included hypertension and obesity, with varied mental health issues. Accessibility and affordability of healthy foods were significant social concerns, alongside challenges in healthcare access such as navigating complex systems and high medical costs. Conclusion: Tailored interventions recognizing community strengths and addressing specific health issues are crucial for improving outcomes in marginalized communities, necessitating a health-in-all policies approach considering social, cultural, and structural determinants of health. [ABSTRACT FROM AUTHOR]

BACKGROUND: Hypertension or elevated blood pressure (BP) is a worldwide clinical challenge and the leading primary risk factor for kidney dysfunctions, heart failure, and cerebrovascular disease. The kidney is a central regulator of BP by maintaining sodium-water balance. Multiple genome-wide association studies revealed that BP is a heritable quantitative trait, modulated by several genetic, epigenetic, and environmental factors. The SNPs identified in genome-wide association studies predominantly (>95%) reside within noncoding genomic regions, making it difficult to understand how they regulate BP. Given the central role of the kidney in regulating BP, we hypothesized that chromatin-accessible regions in renal tissue would be enriched for BP-associated single nucleotide polymorphisms. METHODS: We manually dissected 2 important kidney segments that maintain the sodium-water balance: proximal tubules and medullary thick ascending limbs from the human and rat kidneys. To delineate their chromatin and transcriptomic profiles, we performed the assay for transposase-accessible chromatin and RNA sequencing, respectively. RESULTS: The chromatin accessibility maps revealed the shared and unique cis -regulatory elements that modulate the chromatin accessibility in proximal tubule and medullary thick ascending limbs of humans and rats. We developed a visualization tool to compare the cross-species epigenomic maps to identify potential regulatory targets for hypertension pathogenesis. We also identified a significant enrichment of BP-associated single nucleotide polymorphisms (1064 for human proximal tubule and 1172 for human medullary thick ascending limbs) within accessible chromatin regions of both segments, including rs1173771 and rs1421811 at the NPR3 locus and rs1800470 at the TGFb1 locus. CONCLUSIONS: Collectively, this study lays a foundation for interrogating how intergenic single nucleotide polymorphisms may regulate polygenic traits such as BP. [ABSTRACT FROM AUTHOR]