Sexual Exposures Associated With Mpox Infection: California, November 2022 to June 2023.

BACKGROUND: Exposures associated with mpox infection remain imperfectly understood. METHODS: We conducted a case-control study enrolling participants who received molecular tests for mpox/orthopoxvirus in California from November 2022 through June 2023. We collected data on behaviors during a 21-day risk period before symptom onset or testing among mpox case patients and test-negative controls. RESULTS: Thirteen of 54 case patients (24.1%) and 5 of 117 controls (4.3%) reported sexual exposure to individuals they identified as potential mpox case patients ("index contacts"; odds ratio [OR], 7.7 [95% confidence interval (CI), 2.5-19.3] relative to individuals who did not report exposure to potential mpox case patients). Among these participants, 10 of 13 case patients (76.9%) and 2 of 5 controls (40.0%) reported that their index contacts were not experiencing symptoms visible to participants during sex (OR, 14.9 [95% CI, 3.6-101.8]). Only 3 of 54 case patients (5.6%) reported exposure to symptomatic index contacts. Case patients reported more anal/vaginal sex partners than did controls (adjusted OR, 2.2 [95% CI, 1.0-4.8] for 2-3 partners and 3.8 [1.7-8.8] for ≥4 partners). Male case patients with penile lesions more commonly reported insertive anal/vaginal sex than those without penile lesions (adjusted OR, 9.3 [95% CI, 1.6-54.8]). Case patients with anorectal lesions more commonly reported receptive anal sex than those without anorectal lesions (adjusted OR, 14.4 [95% CI, 1.0-207.3]). CONCLUSIONS: Sexual exposure to contacts known or suspected to have experienced mpox was associated with increased risk of infection, often when index contacts lacked apparent symptoms. Exposure to more sex partners, including those whom participants did not identify as index contacts, was associated with increased risk of infection in a site-specific manner. While participants' assessment of symptoms in partners may be imperfect, these findings suggest that individuals without visibly prominent mpox symptoms transmit infection.

Association of Chemotherapy-Induced Peripheral Neuropathy with Diet Quality Among Post-Treatment Cancer Survivors.

Nutrition is essential for peripheral nerve function, yet dietary factors associated with chronic chemotherapy-induced peripheral neuropathy (CIPN) remain poorly characterized. The purpose of this cross-sectional study was to determine differences in diet quality and macronutrients for cancer survivors with and without CIPN. Cancer survivors (e.g., ≥3 months post platinum and/or taxane-based neurotoxic chemotherapy) with (i.e., ≥1/4 PRO-CTACE™ Numbness and Tingling Severity) and without CIPN completed the VioScreen Research Graphical Food Frequency Questionnaire. The association among diet (Healthy Eating Index [HEI]), macronutrient intake (average percent caloric intake), and CIPN severity were analyzed using generalized linear regression models, adjusting for caloric intake, body mass index, age, and sex. Results revealed that for each one-point increase in diet quality, PRO-CTCAE severity decreased by -0.06 (95% CI: -0.10, -0.02, P < 0.01). Participants without CIPN reported higher diet quality than those with CIPN (HEI mean: 70.11 vs 68.45) (OR = 0.94, P = 0.03, 95% CI: 0.89, 0.99). Participants with CIPN had significantly higher carbohydrate consumption than participants without CIPN (OR = 1.11, P = 0.04, 95% CI: 1.01, 1.22). There were no significant differences in consumption of proteins or fats between groups. Further research should be pursued to discover the potential benefits of dietary interventions for CIPN management among cancers survivors.

Long-term outcome of percutaneous endovascular stenting in external iliac artery endofibrosis.

BACKGROUND: External iliac artery endofibrosis (EIAE) is a rare vascular disease which has been traditionally seen in avid cyclists. The conventional approach has been surgery, although no high-quality evidence suggests superiority of surgery over percutaneous endovascular intervention. There are limited data on the efficacy of stenting in EIAE. METHODS: Over a 14-year period, we treated 10 patients (13 limbs) with EIAE with stents. These patients had declined surgery. The mean follow up was 8.4 ± 3.3 years. There were eight women. Five patients were competitive runners, three were cyclists, and two were triathletes. The mean age was 40.7 ± 2.9 years and body mass index was 19.46 ± 1.6. Intravascular ultrasound (IVUS) was used in eight limbs. RESULTS: Procedural success was achieved in all. The recurrence of symptoms occurred in three patients at a mean of 9.3 ± 2.1 months postindex intervention. The other seven patients remained symptom free. IVUS revealed a pathognomonic finding which we termed 'perfect circle appearance'. It results from symmetric or asymmetric hypertrophy of one or more layers of the arterial wall leading to negative remodeling, which creates a distinct echo dense structure contrasting itself from the luminal blood's echoluscent appearance. It is identical to IVUS images of diffuse venous stenosis with important implications in the treatment technique. CONCLUSIONS: We conclude that stenting in EIAE is safe and effective with a good long-term outcome. It can be an alternative to surgery, particularly in those patients who refuse a surgical approach. The IVUS image is pathognomonic and 'sine qua non' of EIAE.

Reaching Populations to Address Disparities in Cancer Care Delivery: Results From a Six-Site Initiative.

BACKGROUND: Large segments of the US population do not receive quality cancer care due to pervasive and systemic inequities, which can increase morbidity and mortality. Multicomponent, multilevel interventions can address inequities and improve care, but only if they reach communities with suboptimal access. Intervention studies often underenroll individuals from historically excluded groups. METHODS: The Alliance to Advance Patient-Centered Cancer Care includes 6 grantees across the United States who implemented unique multicomponent, multilevel intervention programs with common goals of reducing disparities, increasing engagement, and improving the quality of care for targeted populations. The Reach, Effectiveness, Adoption, Implementation, and Maintenance (RE-AIM) framework informed the evaluation efforts across sites. Each Alliance site identified their intended populations, which included underrepresented minorities (eg, Black and Latinx persons), individuals who prefer a language other than English, and rural residents. We evaluated the demographic characteristics of participants to determine program reach. RESULTS: Between 2018 and 2020, a total of 2,390 of 5,309 potentially eligible participants were enrolled across the 6 sites. The proportion of enrolled individuals with selected characteristics included 38% (n=908) Black adults, 24% (n=574) Latinx adults, 19% (n=454) preferring a language other than English, and 30% (n=717) rural residents. The proportion of those enrolled who were the intended population was commensurate to the proportion with desired characteristics in those identified as potentially eligible. CONCLUSIONS: The grantees met or exceeded enrollments from their intended populations who have been underserved by quality cancer care into patient-centered intervention programs. Intentional application of recruitment/engagement strategies is needed to reach individuals from historically underserved communities.

Reduced Odds of Mpox-Associated Hospitalization Among Persons Who Received JYNNEOS Vaccine - California, May 2022-May 2023.

The effectiveness of 1 dose of JYNNEOS vaccine (modified vaccinia Ankara vaccine, Bavarian Nordic) against hospitalization for mpox (caused by Monkeypox virus), has been demonstrated; however, the impact of 2 doses on hospitalization risk, especially among persons infected with HIV, who are at higher risk for severe disease, is an important factor in evaluating vaccine effectiveness against mpox disease severity and Monkeypox virus infection. Surveillance data collected by the California Department of Public Health were used to evaluate whether receipt of 2 doses of JYNNEOS vaccine reduced the odds of hospitalization among persons with mpox. The odds of hospitalization among persons with mpox who had received 1 or 2 JYNNEOS doses were 0.27 (95% CI = 0.08-0.65) and 0.20 (95% CI = 0.01-0.90), respectively, compared with unvaccinated mpox patients. In mpox patients with HIV infection, the odds of hospitalization among those who had received 1 JYNNEOS vaccine dose was 0.28 (95% CI = 0.05-0.91) times that of those who were unvaccinated. No mpox-associated hospitalizations were identified among persons infected with HIV who had received 2 JYNNEOS vaccine doses. To optimize durable immunity, all eligible persons at risk for mpox, especially those infected with HIV, should complete the 2-dose JYNNEOS series.

Psychometric Evaluation of the Modes of Health Information Acquisition, Sharing, and Use Questionnaire: Prospective Cross-Sectional Observational Study.

BACKGROUND: Health information is a critical resource for individuals with health concerns and conditions, such as hypertension. Enhancing health information behaviors may help individuals to better manage chronic illness. The Modes of Health Information Acquisition, Sharing, and Use (MHIASU) is a 23-item questionnaire that measures how individuals with health risks or chronic illness acquire, share, and use health information. Yet this measure has not been psychometrically evaluated in a large national sample. OBJECTIVE: The objective of this study was to evaluate the psychometric properties of the self-administered MHIASU in a large, diverse cohort of individuals living with a chronic illness. METHODS: Sharing Information, a prospective, observational study, was launched in August 2018 and used social media campaigns to advertise to Black women. Individuals who were interested in participating clicked on the advertisements and were redirected to a Qualtrics eligibility screener. To meet eligibility criteria individuals had to self-identify as a Black woman, be diagnosed with hypertension by a health care provider, and live in the United States. A total of 320 Black women with hypertension successfully completed the eligibility screener and then completed a web-based version of the MHIASU questionnaire. We conducted a psychometric evaluation of the MHIASU using exploratory factor analysis. The evaluation included item review, construct validity, and reliability. RESULTS: Construct validity was established using exploratory factor analysis with principal axis factoring. The analysis was constricted to the expected domains. Interitem correlations were examined for possible item extraction. There were no improvements in factor structure with the removal of items with high interitem correlation (n=3), so all items of the MHIASU were retained. As anticipated, the instrument was found to have 3 subscales: acquisition, sharing, and use. Reliability was high for all 3 subscales, as evidenced by Cronbach α scores of .81 (acquisition), .81 (sharing), and .93 (use). Factor 3 (use of health information) explained the maximum variance (74%). CONCLUSIONS: Construct validity and reliability of the web-based, self-administered MHIASU was demonstrated in a large national cohort of Black women with hypertension. Although this sample was highly educated and may have had higher digital literacy compared to other samples not recruited via social media, the population captured (Black women living with hypertension) are often underrepresented in research and are particularly vulnerable to this chronic condition. Future studies can use the MHIASU to examine health information behavior in other diverse populations managing health concerns and conditions.

A Preliminary Look at the Macrovascular System for Transmetatarsal Amputation Success.

OBJECTIVE: Transmetatarsal amputation (TMA) is a commonly used level of amputation that preserves most of the foot's function and independence. However, many TMAs fail, and patients go onto higher amputations. The primary endpoint of this study is to determine if source artery occlusions are correlated with TMA flap failure. METHODS: A total of 82 patients with TMAs were retrospectively reviewed for healing rates between 2009 and 2019 at a single center. Forty-five of the patients had an angiogram, which was analyzed for source artery and overall TMA failure. Of the initial 82 patients, a cohort of 12 had documentation of specific flap failure and an angiogram performed. This cohort of 12 patients was used for correlation of flap failure with source artery occlusion. RESULTS: Overall, the TMA healing rate was 45.28%. No correlation was noted between a specific source artery occlusion and overall TMA failure. However, a moderate positive correlation was seen with dorsalis pedis artery and peroneal artery occlusions and dorsal flap failure. No correlation was seen with the posterior tibial artery and plantar flap failure. A moderate negative correlation was seen with peroneal artery occlusion and plantar flap failure. CONCLUSIONS: The authors concluded that retrograde flow through the angiosome principle is what allowed for successful outcomes in TMAs. Physicians are urged to carefully plan, dissect, and preserve these vessels to help prevent TMA flap failure, especially in patients with vascular risk or disease.

A multicenter, randomized controlled clinical trial evaluating the effects of a novel autologous heterogeneous skin construct in the treatment of Wagner one diabetic foot ulcers: Final analysis.

A novel autologous heterogeneous skin construct (AHSC) was previously shown to be effective versus standard of care (SOC) treatment in facilitating complete wound healing of Wagner 1 diabetic foot ulcers in an interim analysis of 50 patients previously published. We now report the final analysis of 100 patients (50 per group), which further supports the interim analysis findings. Forty-five subjects in the AHSC treatment group received only one application of the autologous heterogeneous skin construct, and five received two applications. For the primary endpoint at 12 weeks, there were significantly more diabetic wounds closed in the AHSC treatment group (35/50, 70%) than in the SOC control group (17/50, 34%) (p = 0.00032). A significant difference in percentage area reduction between groups was also demonstrated over 8 weeks (p = 0.009). Forty-nine subjects experienced 148 adverse events: 66 occurred in 21 subjects (42%) in the AHSC treatment group versus 82 in 28 SOC control group subjects (56.0%). Eight subjects were withdrawn due to serious adverse events. Autologous heterogeneous skin construct was shown to be an effective adjunctive therapy for healing Wagner 1 diabetic foot ulcers.

HIV and Sexually Transmitted Infections Among Persons with Monkeypox - Eight U.S. Jurisdictions, May 17-July 22, 2022.

High prevalences of HIV and other sexually transmitted infections (STIs) have been reported in the current global monkeypox outbreak, which has affected primarily gay, bisexual, and other men who have sex with men (MSM) (1-5). In previous monkeypox outbreaks in Nigeria, concurrent HIV infection was associated with poor monkeypox clinical outcomes (6,7). Monkeypox, HIV, and STI surveillance data from eight U.S. jurisdictions* were matched and analyzed to examine HIV and STI diagnoses among persons with monkeypox and assess differences in monkeypox clinical features according to HIV infection status. Among 1,969 persons with monkeypox during May 17-July 22, 2022, HIV prevalence was 38%, and 41% had received a diagnosis of one or more other reportable STIs in the preceding year. Among persons with monkeypox and diagnosed HIV infection, 94% had received HIV care in the preceding year, and 82% had an HIV viral load of <200 copies/mL, indicating HIV viral suppression. Compared with persons without HIV infection, a higher proportion of persons with HIV infection were hospitalized (8% versus 3%). Persons with HIV infection or STIs are disproportionately represented among persons with monkeypox. It is important that public health officials leverage systems for delivering HIV and STI care and prevention to reduce monkeypox incidence in this population. Consideration should be given to prioritizing persons with HIV infection and STIs for vaccination against monkeypox. HIV and STI screening and other recommended preventive care should be routinely offered to persons evaluated for monkeypox, with linkage to HIV care or HIV preexposure prophylaxis (PrEP) as appropriate.

The impact of the SARS-CoV-2 pandemic on the management of chronic limb-threatening ischemia and wound care.

In the wake of the coronavirus pandemic, the critical limb ischemia (CLI) Global Society aims to develop improved clinical guidance that will inform better care standards to reduce tissue loss and amputations during and following the new SARS-CoV-2 era. This will include developing standards of practice, improve gaps in care, and design improved research protocols to study new chronic limb-threatening ischemia treatment and diagnostic options. Following a round table discussion that identified hypotheses and suppositions the wound care community had during the SARS-CoV-2 pandemic, the CLI Global Society undertook a critical review of literature using PubMed to confirm or rebut these hypotheses, identify knowledge gaps, and analyse the findings in terms of what in wound care has changed due to the pandemic and what wound care providers need to do differently as a result of these changes. Evidence was graded using the Oxford Centre for Evidence-Based Medicine scheme. The majority of hypotheses and related suppositions were confirmed, but there is noticeable heterogeneity, so the experiences reported herein are not universal for wound care providers and centres. Moreover, the effects of the dynamic pandemic vary over time in geographic areas. Wound care will unlikely return to prepandemic practices. Importantly, Levels 2-5 evidence reveals a paradigm shift in wound care towards a hybrid telemedicine and home healthcare model to keep patients at home to minimize the number of in-person visits at clinics and hospitalizations, with the exception of severe cases such as chronic limb-threatening ischemia. The use of telemedicine and home care will likely continue and improve in the postpandemic era.

Toward rational use of cognitive training in those with mild cognitive impairment.

The term cognitive training includes a range of techniques that hold potential for treating cognitive impairment caused by neurologic injury and disease. Our central premise is that these techniques differ in their mechanisms of action and therefore engage distinct brain regions (or neural networks). We support this premise using data from a single-blind randomized-controlled trial in which patients with mild cognitive impairment were randomized to either mnemonic strategy training (MST) or spaced retrieval training (SRT) as they learned ecologically relevant object-location associations. Both training approaches were highly effective in the short term, but MST demonstrated a clear advantage after days to weeks. MST also increased activation in and functional connectivity between frontal, temporal, and parietal regions as well as the hippocampus. In contrast, patterns of reduced activation and functional connectivity were evident following SRT. These findings support the rational development of cognitive training techniques.

Trauma History as a Significant Predictor of Posttraumatic Growth Beyond Mental Health Symptoms in Women-Identifying Survivors of Undergraduate Non-Consensual Sexual Experiences.

There is little data on what influences posttraumatic growth for women who experienced non-consensual sexual contact (NCSC) as an undergraduate college student. The purpose of this study is to garner a better understanding of posttraumatic growth among women-identifying survivors of undergraduate NCSC by addressing the following aims: 1) evaluate the mediating role of NCSC-related shame on the relationship between perceived peer rape myth acceptance and posttraumatic growth (n = 174); and 2) evaluate the shared and independent variance contributions of mental health symptoms and trauma history clusters on posttraumatic growth (n = 151).NCSC-related shame did not mediate the relationship between perceived peer rape myth acceptance and posttraumatic growth. Mental health symptoms and trauma history significantly contributed to 35.27% of posttraumatic growth variance, with the trauma history cluster significantly influencing posttraumatic growth scores beyond mental health symptoms. Based on these findings, it is important that clinicians assess for a history of trauma and the impact of that trauma in addition to mental health symptoms when trying to understand posttraumatic growth after campus sexual violence.

A multicentre, randomised controlled clinical trial evaluating the effects of a novel autologous, heterogeneous skin construct in the treatment of Wagner one diabetic foot ulcers: Interim analysis.

We desired to carefully evaluate a novel autologous heterogeneous skin construct in a prospective randomised clinical trial comparing this to a standard-of-care treatment in diabetic foot ulcers (DFUs). This study reports the interim analysis after the first half of the subjects have been analysed. Fifty patients (25 per group) with Wagner 1 ulcers were enrolled at 13 wound centres in the United States. Twenty-three subjects underwent the autologous heterogeneous skin construct harvest and application procedure once; two subjects required two applications due to loss of the first application. The primary endpoint was the proportion of wounds closed at 12 weeks. There were significantly more wounds closed in the treatment group (18/25; 72%) vs controls (8/25; 32%) at 12 weeks. The treatment group achieved significantly greater percent area reduction compared to the control group at every prespecified timepoint of 4, 6, 8, and 12 weeks. Thirty-eight adverse events occurred in 11 subjects (44%) in the treatment group vs 48 in 14 controls (56%), 6 of which required study removal. In the treatment group, there were no serious adverse events related to the index ulcer. Two adverse events (index ulcer cellulitis and bleeding) were possibly related to the autologous heterogeneous skin construct. Data from this planned interim analysis support that application of autologous heterogeneous skin construct may be potentially effective therapy for DFUs and provide supportive data to complete the planned study.

West Nile Virus-Associated Hospitalizations, California, 2004-2017.

BACKGROUND: West Nile virus (WNV) is the most commonly reported mosquito-borne disease in the USA. California reports more WNV disease than any other state. METHODS: We identified WNV-associated hospitalizations from 2004 through 2017 in California and estimated hospitalization incidence using Patient Discharge Data. We described demographic, geographic, and clinical characteristics of WNV hospitalizations; identified risk factors for in-hospital death; and tabulated hospitalization charges. RESULTS: From 2004 through 2017, 3109 Californians were hospitalized with WNV (median, 214 patients/year; range, 72-449). The majority were male (1983; 63.8%) and aged ≥60 years (1766; 56.8%). The highest median annual hospitalization rate (0.88 hospitalizations/100 000 persons) was in the Central Valley, followed by southern California (0.59 hospitalizations/100 000 persons). Most patients (2469; 79.4%) had ≥1 underlying condition, including hypertension, cardiovascular disease, diabetes, chronic kidney disease, or immunosuppression due to medications or disease. Median hospitalization length of stay was 12 days (interquartile range, 6-23 days). During hospitalization, 1317 (42%) patients had acute respiratory failure and/or sepsis/septic shock, 772 (24.8%) experienced acute kidney failure, and 470 (15.1%) had paralysis; 272 (8.8%) patients died. Nearly 47% (1444) of patients were discharged for additional care. During these 14 years, $838 680 664 (mean $59.9 million/year) was charged for WNV hospitalizations, 73.9% through government payers at a median charge of $142 321/patient. CONCLUSIONS: WNV-associated hospitalizations were substantial and costly in California. Hospitalization incidence was higher in males, elderly persons, and patients with underlying conditions. WNV persists as a costly and severe public health threat in California.

Adaptation without Specialization Early in a Host Shift.

AbstractStudents of speciation debate the role of performance trade-offs across different environments early in speciation. We tested for early performance trade-offs with a host shift experiment using a member of the Enchenopa binotata species complex of treehoppers (Hemiptera: Membracidae). In this clade of plant-feeding insects, different species live on different host plants and exhibit strong behavioral and physiological host specialization. After five generations, the experimental host shifts resulted either in no adaptation or in adaptation without specialization. The latter result was more likely in sympatry; in allopatry, populations on novel host plants were more likely to become extinct. We conclude that in the early stages of speciation, adaptation to novel host plants does not necessarily bring about performance trade-offs on ancestral environments. Adaptation may be facilitated rather than hindered by gene flow, which prevents extinction. Additional causes of specialization and assortative mating may be required if colonization of novel environments is to result in speciation.

Recovery opioid overdose team (ROOT) pilot program evaluation: A community-wide post-overdose response strategy.

Background: Effective interventions for overdose survivors are needed in the emergency departments (EDs). One promising model is the use of peer recovery coaches to engage with survivors in EDs, followed by partnering with community case management navigators to connect survivors to recovery support and treatment services. This paper describes the evaluation of a pilot program, the Recovery Opioid Overdose Team (ROOT), a warm hand-off system that links survivors to treatment services post-ED discharge. Methods: The ROOT program is composed of a peer recovery coach who is in long-term recovery, and a case management navigator who specializes in mental health care and provides guidance for accessing community services. After an overdose reversal, law enforcement contacts a county 24/7 Crisis Team, who then notifies ROOT. The peer recovery coach engages with the survivor in the ED, and then follow up continues with the case management navigator and the peer recovery coach for up to 90 days post-ED discharge. Retrospective chart reviews were conducted to evaluate ROOT in two Midwest EDs from September 2017 through March 2019. Results: Of the 122 referrals, 77.0% (n = 94) of the survivors initially engaged with ROOT in the ED or in the community. The remaining 23.0% (n = 28) left the ED against medical advice or were unengaged. The majority of overdose survivors were male (63.9%; n = 78), White (43.4%; n = 53), had housing (80.2%; n = 48), and access to transportation (48.4%; n = 59). From the 122 referrals, 33.6% (n = 41) received ongoing treatment services (n = 20 outpatient, n = 17 residential, n = 2 detoxification facility, n = 1 recovery housing, n = 1 medication treatment for opioid use disorder), 2.5% (n = 3) were incarcerated, 2.5% (n = 3) died, and 61.5% (n = 75) declined services. Conclusions: The ROOT, a community-wide coordinated program in the EDs, shows promise in linking overdose survivors to recovery support and treatment services post-overdose.

Quality of life improvement in patients with hard-to-heal leg wounds treated with Prontosan wound irrigation solution and wound gel.

OBJECTIVE: This study evaluated the impact of four weeks of treatment with Prontosan Wound Irrigation Solution and Prontosan Wound Gel (B. Braun Medical Inc., US) on adults with hard-to-heal leg wounds. Overall change (weeks 1-5) in the Global Quality of Life scale (GQOL), changes in body, psyche and everyday life (EDL) quality of life (QoL) subscores, and changes in wound appearance and size after treatment were assessed. METHOD: In this prospective, open-label, single-arm, five-centre study, non-hospitalised patients with no more than two wounds below the knee were recruited into the study; wounds were ≥5cm2 and ≤50cm2 and present for ≥4 weeks. The investigator or a designee applied the wound solution and gel to the wounds at clinic visits, and patients/caregivers applied the wound solution and gel at home. Wound-QoL questionnaires were completed at the initial screening and at each week of treatment. Wound size and photographs were obtained at pre- and post-treatment during clinic visits. RESULTS: A total of 43 patients were enrolled in the study. Mean GQOL scores decreased by 1.11 (46.1%). Body, psyche and EDL decreased by 1.17 (60.0%), 1.26 (41.8%) and 1.00 (42.2%), respectively. Wounds also showed improvement in odour, appearance and size. Adverse events were mild in intensity and transient in nature. CONCLUSION: This study demonstrated marked improvement in the QoL of patients with hard-to-heal leg wounds below the knee during four weeks of treatment with the wound solution and gel. Wounds also showed improvement in odour, appearance and size, and the treatment solution and gel were well tolerated. DECLARATION OF INTEREST: B. Braun Medical Inc. funded the research and preparation of this article. AK, DV, CRC and WC are employees of B. Braun Medical Inc. AO and RS declare no conflict of interest.

Fetal bovine acellular dermal matrix for the closure of diabetic foot ulcers: a prospective randomised controlled trial.

AIM: The purpose of this clinical trial was to evaluate the safety and efficacy of a fetal bovine acellular dermal matrix (FBADM) plus standard of care (SOC) for treating hard-to-heal diabetic foot ulcers (DFUs). METHOD: A prospective, multi-centre, randomised controlled trial was carried out. The study included a 2-week run-in period, a 12-week treatment phase and a 4-week follow-up phase. The primary endpoint was complete wound closure at 12 weeks. RESULTS: Twenty-one US sites enrolled and randomised 226 patients with hard-to-heal DFUs. The study was terminated early due to the COVID-19 pandemic, which led to a modified intent-to-treat (mITT) population of 207 patients, with 103 in the FBADM group and 104 in the SOC group. Of these participants, 161 completed the study per protocol (mPP population), with 79 receiving FBADM, and 82 without. At the first analysis point, patients treated with FBADM were found to be significantly more likely to achieve complete wound closure compared with SOC alone (mITT: 45.6% versus 27.9% p=0.008; mPP: 59.5% versus 35.6% p=0.002). The difference in outcome yielded an odds ratio of 2.2 (95% confidence interval (CI): 1.2, 3.9; p=0.008). Median time to closure within 12 weeks was 43 days for the FBADM group compared to 57 days for the SOC group (p=0.36). The median number of applications of FBADM to achieve closure was one. Adverse events were similar between groups and no product-related serious adverse events occurred. CONCLUSIONS: These results indicate that in many cases a single application of FBADM in conjunction with SOC offers a safe, faster and more effective treatment of DFUs than SOC alone.

Intracranial Effects of Microgravity: A Prospective Longitudinal MRI Study.

Background Astronauts on long-duration spaceflight missions may develop changes in ocular structure and function, which can persist for years after the return to normal gravity. Chronic exposure to elevated intracranial pressure during spaceflight is hypothesized to be a contributing factor, however, the etiologic causes remain unknown. Purpose To investigate the intracranial effects of microgravity by measuring combined changes in intracranial volumetric parameters, pituitary morphologic structure, and aqueductal cerebrospinal fluid (CSF) hydrodynamics relative to spaceflight and to establish a comprehensive model of recovery after return to Earth. Materials and Methods This prospective longitudinal MRI study enrolled astronauts with planned long-duration spaceflight. Measures were conducted before spaceflight followed by 1, 30, 90, 180, and 360 days after landing. Intracranial volumetry and aqueductal CSF hydrodynamics (CSF peak-to-peak velocity amplitude and aqueductal stroke volume) were quantified for each phase. Qualitative and quantitative changes in pre- to postflight (day 1) pituitary morphologic structure were determined. Statistical analysis included separate mixed-effects models per dependent variable with repeated observations over time. Results Eleven astronauts (mean age, 45 years ± 5 [standard deviation]; 10 men) showed increased mean volumes in the brain (28 mL; P < .001), white matter (26 mL; P < .001), mean lateral ventricles (2.2 mL; P < .001), and mean summated brain and CSF (33 mL; P < .001) at postflight day 1 with corresponding increases in mean aqueductal stroke volume (14.6 µL; P = .045) and mean CSF peak-to-peak velocity magnitude (2.2 cm/sec; P = .01). Summated mean brain and CSF volumes remained increased at 360 days after spaceflight (28 mL; P < .001). Qualitatively, six of 11 (55%) astronauts developed or showed exacerbated pituitary dome depression compared with baseline. Average midline pituitary height decreased from 5.9 to 5.3 mm (P < .001). Conclusion Long-duration spaceflight was associated with increased pituitary deformation, augmented aqueductal cerebrospinal fluid (CSF) hydrodynamics, and expansion of summated brain and CSF volumes. Summated brain and CSF volumetric expansion persisted up to 1 year into recovery, suggesting permanent alteration. © RSNA, 2020 Online supplemental material is available for this article. See also the editorial by Lev in this issue.

Thermal thresholds heighten sensitivity of West Nile virus transmission to changing temperatures in coastal California.

Temperature is widely known to influence the spatio-temporal dynamics of vector-borne disease transmission, particularly as temperatures vary across critical thermal thresholds. When temperature conditions exhibit such 'transcritical variation', abrupt spatial or temporal discontinuities may result, generating sharp geographical or seasonal boundaries in transmission. Here, we develop a spatio-temporal machine learning algorithm to examine the implications of transcritical variation for West Nile virus (WNV) transmission in the Los Angeles metropolitan area (LA). Analysing a large vector and WNV surveillance dataset spanning 2006-2016, we found that mean temperatures in the previous month strongly predicted the probability of WNV presence in pools of Culex quinquefasciatus mosquitoes, forming distinctive inhibitory (10.0-21.0°C) and favourable (22.7-30.2°C) mean temperature ranges that bound a narrow 1.7°C transitional zone (21-22.7°C). Temperatures during the most intense months of WNV transmission (August/September) were more strongly associated with infection probability in Cx. quinquefasciatus pools in coastal LA, where temperature variation more frequently traversed the narrow transitional temperature range compared to warmer inland locations. This contributed to a pronounced expansion in the geographical distribution of human cases near the coast during warmer-than-average periods. Our findings suggest that transcritical variation may influence the sensitivity of transmission to climate warming, and that especially vulnerable locations may occur where present climatic fluctuations traverse critical temperature thresholds.