A Pivotal Study on the Safety and Effectiveness of a Targeted Alkali Thermolysis Patch for Treatment of Primary Axillary Hyperhidrosis or Excessive Axillary Sweating.

BACKGROUND: One-third of US adults are bothered by excessive sweating, approximately 5% are diagnosed with hyperhidrosis. A topical patch using targeted alkali thermolysis (TAT) was developed for treatment of this condition. OBJECTIVE: This study was intended to assess the efficacy and safety of the TAT-Patch for axillary sweat reduction. MATERIALS AND METHODS: A randomized, multicenter, double-blind, sham-controlled, pivotal trial enrolled 120 subjects to a bilateral axillary treatment with a TAT patch (63 subjects) or sham patch (57 subjects). RESULTS: The primary end point was achieved; 64% of TAT-treated versus 44% of sham-treated subjects (p = .0332) improved from Hyperhidrosis Disease Severity Scale (HDSS) 3/4 to HDDS 1/2 at 4 weeks. Targeted alkali thermolysis treatment also showed a statistically significant improvement over sham treatment for all secondary end points, including gravimetric sweat production and subject-reported quality-of-life (QoL) assessments. The duration of effect is approximately 3 months, determined by the time to return to baseline HDSS. Mild-to-moderate treatment-site adverse events (AEs) were reported in 22% of TAT patch subjects. No serious or severe AEs were reported. CONCLUSION: HDSS, GSP, and QoL findings confirm clinically meaningful sweat reduction and a significant improvement in quality of life following a single TAT patch treatment. This device has potential to offer a new, noninvasive treatment option that is well tolerated with minimal downtime.

Status and perceptions of work from home in three academic musculoskeletal radiology divisions.

OBJECTIVE: The objective of this study is to assess the status and perception of work from home (WFH) in three academic musculoskeletal radiology divisions. MATERIALS AND METHODS: A 17-item anonymous online survey related to WFH was administered to all musculoskeletal (MSK) faculty (n = 27) of three academic radiology divisions between April and July 2023. Survey items included demographics, clinical work environment, presence of a WFH policy, number of days WFH and desired WFH days, commute, perceived benefits and drawbacks of WFH, and symptoms of burnout. Statistical analysis included the Cochrane-Armitage trend test and Fisher exact test. The study was exempt from IRB approval. RESULTS: The survey response rate was 85% (57% men, 57% white, 57% established career, defined by > 10 years in practice). In 47%, an informal policy allowed WHF on certain rotations including moonlighting/call. Seventeen percent had no opportunity to WFH. WFH 1-2 days/week was reported in 73% of respondents while 27% did not WFH. None of the respondents worked from home more than 2 days/week. Women worked from home more compared to men (p = 0.02). Perceived advantages of WFH included efficiency (no commute/parking) (76%), flexibility (52%), autonomy (33%), and increased productivity (29%). Fifty-seven percent preferred in-person read out particularly for first year trainees, with 52% preferring a virtual or hybrid model. CONCLUSION: WFH is common in academic MSK practices and perceived to be beneficial to MSK faculty. These findings should be taken into consideration when designing WFH policies.

Prevalence of Clinically Relevant Findings on Magnetic Resonance Imaging in Middle-Aged Adults With Knee Pain and Suspected Meniscal Tear: A Follow-Up.

OBJECTIVE: Radiographs are frequently obtained for patients with knee osteoarthritis (KOA), with magnetic resonance imaging (MRI) reserved for those with complex KOA. There are few data on how often subsequent MRI reveals clinically actionable but unanticipated findings. The purpose of this study is to estimate the prevalence of these findings on MRI for patients managed nonoperatively for suspected meniscal tears. METHODS: The Treatment of Meniscal Problems and Osteoarthritis (TeMPO) study enrolled patients aged 45 to 85 years with knee pain, osteoarthritis (Kellgren-Lawrence [KL] grades 0-3), and suspected meniscal tear. We reviewed baseline MRI and recorded notable findings, including subchondral insufficiency fractures of the knee (SIFKs), avascular necrosis (AVN), tumors, and nonsubchondral fractures. Other baseline data included demographic characteristics, Knee Injury and Osteoarthritis Outcome Score, duration of knee symptoms, and KL grade. RESULTS: Study-ordered MRI was performed on 760 patients, with 61 concerning findings identified (8.03%, 95% confidence interval 6.09%-9.96%). A total of 25 participants had SIFKs, 10 had nonsubchondral fractures, 4 had AVN, 8 had benign tumors, and 14 had other clinically relevant findings. CONCLUSION: We estimated the prevalence of clinically relevant incidental findings on MRI to be 8.03% in middle-aged adults with mild to moderate KOA and suspected meniscal tear. These data may prompt clinicians to be more aware of the range of findings that can underlie knee symptoms, some of which could change management but may require different modalities of imaging to detect. Future research is needed to pinpoint factors associated with these concerning findings so that patients who are at risk can be identified and referred for advanced imaging.

The natural history of marginal erosions in hands with and without osteoarthritis.

INTRODUCTION/OBJECTIVES: Among people with or without hand osteoarthritis, we aimed to identify characteristics of people (e.g., age and gender) with marginal erosions (MEs). We also examined changes in MEs during 48 months. We described radiographic severity and progression among joints with MEs, changes in MEs, or central erosions (CEs). DESIGN: We studied participants from the Osteoarthritis Initiative with baseline and 48-month hand radiographs. A radiologist and rheumatologist evaluated the radiographs for disease severity (Kellgren-Lawrence grades) and erosions (central or marginal), respectively. We used descriptive statistics to characterize participants and calculated frequencies at the joint level. RESULTS: Of the 3558 participants, 89 had a ME at baseline. People with MEs were more often male, older, and ever (former and current) smokers than those without a ME. There was no difference in inflammatory biomarkers or the presence of hand pain between individuals with and without a baseline ME. Almost all hands had only one ME (80%), whereas only 50% of individuals with CEs had only one CE at baseline. Compared to CEs, MEs appeared more frequently in joints without osteoarthritis (54% vs. < 1%). Approximately 18% of joints with an ME progressed in Kellgren-Lawrence grade versus 4% without ME. Among the joints with an ME at baseline, 10% resolved by 48 months. Less than 0.1% of joints developed a new ME. CONCLUSION: MEs appear to be distinct from CEs. MEs are predominantly present in males, isolated to one specific joint without osteoarthritis within a hand, and possibly predictive of radiographic progression. Key Points • Marginal erosions appear to be distinct from central erosions. • Most marginal erosions occur in joints without radiographic osteoarthritis. • Radiographic progression but not hand pain is more common in joints with a marginal erosion than without one.

Gender and age differences in the associations between cortical thickness and hand osteoarthritis severity: data from the Osteoarthritis Initiative.

OBJECTIVE: To evaluate gender differences in the association between metacarpal cortical thickness (Tcort)-a surrogate for bone density-and severity of radiographic hand osteoarthritis (HOA) in a longitudinal observational study. METHOD: Hand radiographs of 3575 participants (2039 F/1536 M) from the Osteoarthritis Initiative were assessed at baseline and 48 months. A reader used a semi-automated software tool to calculate Tcort, a measurement of the cortical thickness, for metacarpals 2-4. Average Tcort at baseline and change in Tcort from baseline to 48 months was determined and stratified by gender and age for 7 5-year age groups. Spearman's rank correlation coefficients were calculated for the association of baseline Tcort and 2 measures of baseline HOA severity: the sum of Kellgren-Lawrence (KL) grade and total number of joints with radiographic HOA. Longitudinally, logistic regression was used to assess the relationship of Tcort loss to new finger joint radiographic HOA, increase in KL grades, and incident hand pain. RESULTS: Male Tcort was higher than females. Significant correlations between Tcort and radiographic severity were noted for women but not men, with stronger associations among women >60 years (rho = -0.25; 95% confidence interval (CI) = -0.31 to -0.19). Statistically significant associations were seen between Tcort change and radiographic osteoarthritis change among women but not men, with substantial gender differences for Tcort change, particularly ages 50 to 70 years (p < 0.01; e.g., Tcort change ages 55 to <60: males = -0.182 (0.118), females = -0.219 (0.124)). CONCLUSION: We found significant HOA-related gender differences in Tcort, suggesting the involvement of female bone loss during and after menopause.

Chronic Nonspinal Osteomyelitis in Adults: Consensus Recommendations on Percutaneous Bone Biopsies from the Society of Academic Bone Radiologists.

The diagnosis and management of chronic nonspinal osteomyelitis can be challenging, and guidelines regarding the appropriateness of performing percutaneous image-guided biopsies to acquire bone samples for microbiological analysis remain limited. An expert panel convened by the Society of Academic Bone Radiologists developed and endorsed consensus statements on the various indications for percutaneous image-guided biopsies to standardize care and eliminate inconsistencies across institutions. The issued statements pertain to several commonly encountered clinical presentations of chronic osteomyelitis and were supported by a literature review. For most patients, MRI can help guide management and effectively rule out osteomyelitis when performed soon after presentation. Additionally, in the appropriate clinical setting, open wounds such as sinus tracts and ulcers, as well as joint fluid aspirates, can be used for microbiological culture to determine the causative microorganism. If MRI findings are positive, surgery is not needed, and alternative sites for microbiological culture are not available, then percutaneous image-guided biopsies can be performed. The expert panel recommends that antibiotics be avoided or discontinued for an optimal period of 2 weeks prior to a biopsy whenever possible. Patients with extensive necrotic decubitus ulcers or other surgical emergencies should not undergo percutaneous image-guided biopsies but rather should be admitted for surgical debridement and intraoperative cultures. Multidisciplinary discussion and approach are crucial to ensure optimal diagnosis and care of patients diagnosed with chronic osteomyelitis.

Associations of inflammatory and metabolic biomarkers with incident erosive hand osteoarthritis in the osteoarthritis initiative cohort.

OBJECTIVE: Erosive hand osteoarthritis (eHOA) is a subtype of hand osteoarthritis (OA) that develops in finger joints with pre-existing OA and is differentiated by clinical characteristics (hand pain/disability, inflammation, and erosions) that suggest inflammatory or metabolic processes. METHOD: This was a longitudinal nested case-cohort design among Osteoarthritis Initiative participants who had hand radiographs at baseline and 48-months, and biospecimens collected at baseline. We classified incident radiographic eHOA in individuals with ≥1 joint with Kellgren-Lawrence ≥2 and a central erosion present at 48-months but not at baseline. We used a random representative sample (n = 1282) for comparison. We measured serum biomarkers of inflammation, insulin resistance and dysglycemia, and adipokines using immunoassays and enzymatic colorimetric procedures, blinded to case status. RESULTS: Eighty-six participants developed incident radiographic eHOA. In the multivariate analyses adjusted for age, gender, race, smoking, and body mass index, and after adjustment for multiple analyses, incident radiographic eHOA was associated with elevated levels of interleukin-7 (risk ratio (RR) per SD = 1.30 [95% confidence interval (CI) 1.09, 1.55] p trend 0.01). CONCLUSION: This exploratory study suggests an association of elevated interleukin-7, an inflammatory cytokine, with incident eHOA, while other cytokines or biomarkers of metabolic inflammation were not associated. Interleukin-7 may mediate inflammation and tissue damage in susceptible osteoarthritic finger joints and participate in erosive progression.

Validating the Reliability and Clinical Relevance of a Nasolabial Fold Photonumeric Scale.

BACKGROUND: The use of tissue fillers to treat age-related deepening of the nasolabial fold (NLF) has increased and become the standard clinical approach, creating a need for evidence-based, objective evaluation for pre- and post-procedure assessment of the NLF. METHODS: A 5-point rating scale was developed to assess the NLF, specifically the presence of depression and shadowing. Live validation of the scale was performed with a total of 73 participants representing the full range of NLF severities. Physicians board-certified in a core aesthetic specialty (3 trained raters) performed the scale validation over 2 rounds, 2 weeks apart. Training was carried out, and test-retest reliability was quantitated through the determination of intra- and inter-rater reliability by percentage of agreement, weighted kappa statistic with 95% confidence interval (CI), and intraclass correlation coefficient with 95% CI. To evaluate the clinical relevance of a 1-grade difference, rater assessments of 90 photo pairs were compared with previous designations of clinically different or not clinically different. RESULTS: The NLF scale achieved near-perfect intra- and inter-rater reliability when utilized by trained raters to assess a diverse group of live participants. Furthermore, clinically relevant differences between grades were established, and a 1-point difference was detectable by trained evaluators using the NLF scale. CONCLUSION: The clinically relevant and highly reliable validated NLF scale provides a standardized grading system with a user-friendly design for objectively assessing NLF in clinical practice and as a research tool for clinical approval studies of new aesthetic products and technologies. J Drugs Dermatol. 2024;23(1):1284-1291.   doi:10.36849/JDD.7316.

Identifying predictors of translocation success in rare plant species.

The fundamental goal of a rare plant translocation is to create self-sustaining populations with the evolutionary resilience to persist in the long term. Yet, most plant translocation syntheses focus on a few factors influencing short-term benchmarks of success (e.g., survival and reproduction). Short-term benchmarks can be misleading when trying to infer future growth and viability because the factors that promote establishment may differ from those required for long-term persistence. We assembled a large (n = 275) and broadly representative data set of well-documented and monitored (7.9 years on average) at-risk plant translocations to identify the most important site attributes, management techniques, and species' traits for six life-cycle benchmarks and population metrics of translocation success. We used the random forest algorithm to quantify the relative importance of 29 predictor variables for each metric of success. Drivers of translocation outcomes varied across time frames and success metrics. Management techniques had the greatest relative influence on the attainment of life-cycle benchmarks and short-term population trends, whereas site attributes and species' traits were more important for population persistence and long-term trends. Specifically, large founder sizes increased the potential for reproduction and recruitment into the next generation, whereas declining habitat quality and the outplanting of species with low seed production led to increased extinction risks and a reduction in potential reproductive output in the long-term, respectively. We also detected novel interactions between some of the most important drivers, such as an increased probability of next-generation recruitment in species with greater seed production rates, but only when coupled with large founder sizes. Because most significant barriers to plant translocation success can be overcome by improving techniques or resolving site-level issues through early intervention and management, we suggest that by combining long-term monitoring with adaptive management, translocation programs can enhance the prospects of achieving long-term success.

Identificación de pronosticadores del éxito de reubicación en especies raras de plantas Resumen El objetivo fundamental de la reubicación de plantas raras es la creación de poblaciones autosuficientes con resiliencia evolutiva que persistan a la larga. De todas maneras, la mayoría de las síntesis de estas reubicaciones se enfocan en unos cuantos factores que influyen sobre los parámetros a corto plazo del éxito (supervivencia y reproducción). Los parámetros a corto plazo pueden ser engañosos si se intenta inferir el crecimiento y la viabilidad en el futuro ya que los factores que promueven el establecimiento pueden diferir de aquellos requeridos para la persistencia a largo plazo. Ensamblamos un conjunto grande de datos representativos en general (n = 275) de las reubicaciones de plantas en riesgo bien documentadas y monitoreadas (7.9 años en promedio) para identificar los atributos de sitio más importantes, las técnicas de manejo y los rasgos de las especies para seis parámetros de ciclos de vida y medidas poblacionales del éxito de reubicación. Usamos el algoritmo de bosque aleatorio para cuantificar la importancia relativa de las 29 variables de pronosticadores para cada medida del éxito. Los factores en los resultados de las reubicaciones variaron con los marcos temporales y las medidas de éxito. Las técnicas de manejo tuvieron la mayor influencia relativa sobre la obtención de parámetros de ciclos de vida y tendencias poblacionales a corto plazo, mientras que los atributos de sitio y los rasgos de la especie fueron más importantes para la persistencia poblacional y las tendencias a largo plazo. En específico, las grandes cantidades de fundadores incrementaron el potencial de reproducción y reclutamiento de la siguiente generación, mientras que la declinación de la calidad del hábitat incrementó el riesgo de extinción y el trasplante de especies con baja producción de semillas redujo el rendimiento del potencial reproductivo a la larga. También detectamos interacciones novedosas entre algunos de los factores más importantes, como el aumento en la probabilidad del reclutamiento en la siguiente generación en especies con tasas mayores de producción de semillas, pero sólo cuando se emparejó con grandes cantidades de fundadores. Ya que las barreras más significativas para el éxito de la reubicación de plantas pueden superarse al mejorar las técnicas o resolver los temas a nivel de sitio por medio de un manejo y una intervención temprana, sugerimos que con la combinación del monitoreo a largo plazo con el manejo adaptativo los programas de reubicación pueden aumentar el prospecto de lograr el éxito a largo plazo.

Health Equity and Access to Health Care as a Social Determinant of Health: The Role of the Primary Care Provider.

Populations of people who suffer poorer health outcomes and increased disease burden, particularly preventable diseases, injury, and violence are experiencing health inequity. Achieving greater health equity by addressing social determinants of health and access to health care is the goal of many primary care physicians, health care advocates, and policy makers. Race, geographic location, age, poverty, disabilities, gender, and mental health are common examples of factors that determine health equity. Access to health care, by itself is a predictor of health outcomes and is influenced by many of the same factors.

Femoral Head Osteonecrosis: Computed Tomography Not Needed to Identify Collapse When Using the Association Research Circulation Osseous Staging System.

Background: The 2019 Revised Association Research Circulation Osseous (ARCO) Staging Criteria for Osteonecrosis of the Femoral Head (ONFH) only requires plain radiographs and magnetic resonance imaging (MRI) to diagnose and stage ONFH; however, the effectiveness of the 2019 ARCO criteria in the absence of computed tomography (CT) scans has not been investigated. Therefore, the purpose of this study was to evaluate whether CT scanning is a necessary modality for diagnosing/staging ONFH using the ARCO staging system. More specifically, do CT scans help differentiate pre- and post-collapse lesions more than MRI scans? Methods: A study was conducted on 228 ONFH patients diagnosed between January 1, 2008, and December 31, 2018, at a single academic medical center. CT and MRI scans were reviewed by the senior author and other contributors. The ONFH classification was compared between the 2 scans to determine if CT scans were able to further differentiate staging of collapsed lesions vs MRI scans. Results: A diagnosis of ONFH was made by MRI first in 57% (129/228) while 21% (48/228) used MRI and CT simultaneously. Only 22% (51/228) of cases were diagnosed by CT scans first. There were no cases where collapse was found by a CT scan that were not diagnosed by standard x-rays and/or MRIs. Conclusions: CT scans are not a useful adjunct for diagnosing or treating ONFH and are not necessary if MRI is ordered when using the Revised ARCO Staging System for ONFH diagnosis.

Subchondral Insufficiency Fractures of the Knee: A Clinical Narrative Review.

¼ Subchondral insufficiency fractures of the knee (SIFKs) are subchondral plate fractures with a prevalence of 2% to 4% of all knee injuries.¼ Magnetic resonance imaging is the gold standard for evaluating SIFK, while plain radiographs have limited the use in the diagnosis of SIFK.¼ Among patients with SIFK, 50% to 100% have meniscal pathology.¼ Medical therapies and standard treatments traditionally used in the management of knee osteoarthritis differ from recommended management of SIFK patients.¼ Randomized controlled trials and cohort studies with long-term follow-up are needed to determine the optimal rehabilitation protocol, interventional therapy, and prognosis of SIFK patients.

Validating the Reliability and Clinical Relevance of an Infraorbital Hollow Photonumeric Scale.

Background: Infraorbital hollowing is a facial aesthetic issue for which a broad age range of patients seek treatment. Expanding treatment options for this region warrants the development of validated tools to objectively assess infraorbital hollow (IOH) severity before and after treatment. Objectives: To validate a 4-point rating scale to assess depression of IOH, depression relative to the mid-pupillary line, and visibility of the lateral orbital rim. Methods: The IOH scale described herein was developed and subjected to live validation with a total of 73 patients representing the full range of IOH severities. Scale validation was performed by board-certified plastic surgeons and dermatologists (3 raters) over 2 rounds, 2 weeks apart. Intrarater and interrater reliabilities were used to demonstrate test-retest reliability as quantitated with percentage of agreement, weighted kappa statistic with 95% confidence interval (CI), and intraclass correlation coefficient with 95% CI. The clinical relevance of a 1-grade difference was evaluated by comparing rater assessments of 77 photo pairs with their previously determined designation as "clinically different" or "not clinically different." Results: The IOH scale demonstrated substantial to near-perfect intrarater and interrater reliabilities when utilized by trained raters to assess a diverse group of live patients. Furthermore, clinically relevant differences between grades were established, and detection of a 1-point difference could be achieved by trained evaluators using the IOH scale. Conclusions: This highly reliable, clinically relevant, and validated IOH scale provides a user-friendly, standardized grading system to objectively evaluate and track changes in infraorbital hollowing in clinical practice and research.

Increased Effusion Synovitis for Those With a Dysregulated Inflammatory Response After an Anterior Cruciate Ligament Injury.

Introduction The progression to posttraumatic osteoarthritis (PTOA) after an anterior cruciate ligament (ACL) injury is likely multifactorial, involving biological, mechanical, and psychosocial factors. Following acute joint trauma, there appears to be a subset of patients that demonstrate a dysregulated inflammatory response. This pro-inflammatory phenotype, or "Inflamma-type," is characterized by an amplified pro-inflammatory response combined with a lack of attendant anti-inflammatory response and has been observed following both an ACL injury and an intra-articular fracture. The aims of this study were to: 1) compare magnetic resonance imaging (MRI)-measured effusion synovitis between those with vs. without a dysregulated inflammatory response, and 2) assess the correlations between effusion synovitis and synovial fluid concentrations of proinflammatory cytokines, degradative enzymes, and synovial fluid biomarkers of cartilage degradation. Methods A cluster analysis was previously performed with synovial fluid concentrations of biomarkers of inflammation and cartilage degradation from 35 patients with acute ACL injuries. Patients were then categorized into two groups: a pro-inflammatory phenotype ("Inflamma-type") and those with a more normal inflammatory response to injury (NORM). Effusion synovitis measured from each patient's preoperative clinical MRI scan was compared between the Inflamma-type and NORM groups using an independent, two-tailed t-test. In addition, Spearman's rho non-parametric correlations were calculated to evaluate the relationship between effusion synovitis and each of the synovial fluid concentrations of pro-inflammatory cytokines, degradative enzymes, and biomarkers of cartilage degradation and bony remodeling. Results Effusion synovitis was significantly greater for the Inflamma-type (10.9±3.8 mm) than the NORM group (7.4±4.4 mm, p=0.04, Cohen's d=0.82). Effusion synovitis significantly correlated with matrix metalloproteinase-3 (rho=0.63, p<0.001), matrix metalloproteinase-1 (rho=0.50, p=0.003), and sulfated glycosaminoglycan (rho=0.42, p=0.01). No other significant correlations were present. Conclusion Effusion synovitis was significantly greater for those that demonstrated a dysregulated inflammatory response after acute ACL injury than those with a more normal response to injury. Effusion synovitis was also found to significantly correlate with synovial fluid concentrations of degradative enzymes and a biomarker of early cartilage degradation. Future work is needed to determine if non-invasive methods, such as MRI or ultrasound, may accurately identify patients within this pro-inflammatory phenotype and whether this subset is more prone to more rapid PTOA changes after injury.

Efficacy and Safety of Resilient Hyaluronic Acid Fillers Injected with a Cannula: A Randomized, Evaluator-Blinded, Split-Face Controlled Study.

Purpose: Cannulas are increasingly used for injecting hyaluronic acid fillers, as they are thought to improve patient comfort safety and treatment tolerability. This study aimed to demonstrate the non-inferiority of a Resilient Hyaluronic Acid 4 (RHA 4) filler injected with a cannula versus a needle for the treatment of moderate to severe nasolabial folds (NLF). Patients and Methods: A total of 50 subjects were included in a randomized, evaluator-blinded, split-face trial. The NLF were injected with RHA 4 using a cannula on one side of the face and using a needle on the other side on Day 0. A touch-up could be performed 4 weeks later. The subjects were followed up for 12 weeks after the last injection, ie, injection on Day 0 or touch-up. Efficacy was evaluated using a Wrinkle Severity Rating Scale (WSRS), the Global Aesthetic Improvement Scale (GAIS), and patient-reported outcomes. Safety assessments included the injection-site pain, common treatment reactions (CTRs), and adverse events (AEs). Results: Twelve weeks after the last injection, the efficacy of the cannula treatment was found to be non-inferior to that of the needle treatment, based on the WSRS score improvements. The other study endpoints showed the equivalent efficacy and safety of the two methods. No serious or unexpected AEs were reported. Conclusion: RHA 4 may be effectively and safely injected into the NLF using a cannula or a needle, provided it is administrated by a trained practitioner.

Fit with Faith: An Exploratory Study Examining a Behavior Change Intervention for African-American Clergy and Their Spouses.

Fit with Faith is a 10-week, diet, physical activity, and stress reduction intervention for African-American clergy and spouses, which included: meetings, phone calls, a behavior tracking app. Survey, 24-h recall, accelerometer, anthropometric, and blood pressure data were collected. Wilcoxon signed ranked tests were used for analyses. In this one-arm study, clergy and spouses (n = 20) attended most meetings and calls, but only half posted daily goals or tracked behaviors using the app. Spouses' body mass index (BMI) decreased and physical activity self-regulation cognitive scores increased pre-post intervention. Statistically significant changes in BMI, systolic blood pressure, and self-regulations scores also were seen among younger (< 51 years) participants (n = 8). As positive changes were seen mostly among women and younger participants, more research is needed on how to engage all clergy in behavior change programs.

Efficacy and safety of topical brepocitinib cream for mild-to-moderate chronic plaque psoriasis: a phase IIb randomized double-blind vehicle-controlled parallel-group study.

BACKGROUND: Plaque psoriasis (PsO) is an inflammatory skin disease driven, in part, by the activation of Janus kinase (JAK) signalling pathways. OBJECTIVES: To assess the efficacy and safety of multiple doses of topical brepocitinib, a tyrosine kinase 2/JAK1 inhibitor, in participants with mild-to-moderate PsO. METHODS: This phase IIb multicentre randomized double-blind study was conducted in two stages. In stage 1, participants received one of eight treatments for 12 weeks: brepocitinib 0.1% once daily, 0.3% once or twice daily, 1.0% once or twice daily, 3.0% once daily, or vehicle once or twice daily. In stage 2, participants received brepocitinib 3.0% twice daily or vehicle twice daily. The primary endpoint was the change from baseline in Psoriasis Area and Severity Index (PASI) score at week 12, analysed using analysis of covariance. The key secondary endpoint was the proportion of participants who achieved a Physician Global Assessment response [score of clear (0) or almost clear (1) and an improvement of ≥ 2 points from baseline] at week 12. Additional secondary endpoints included the difference vs. vehicle in change from baseline in PASI, using mixed-model repeated measures, and the change from baseline in Peak Pruritus Numerical Rating Scale at week 12. Safety was monitored. RESULTS: Overall, 344 participants were randomized. Topical brepocitinib did not result in statistically significant changes compared with respective vehicle controls in the primary or key secondary efficacy endpoints for any dose group. At week 12, least squares mean change from baseline in PASI score ranged from -1.4 to -2.4 for the brepocitinib once-daily groups vs. -1.6 for vehicle once daily, and from -2.5 to -3.0 for the brepocitinib twice-daily groups vs. -2.2 for vehicle twice daily. From week 8, change from baseline in PASI score separated from vehicle in all brepocitinib twice daily groups. Brepocitinib was well tolerated, with adverse events (AEs) occurring at similar rates across groups. One participant in the brepocitinib 1.0% once-daily group developed a treatment-related AE of herpes zoster in the neck area. CONCLUSIONS: Topical brepocitinib was well tolerated but did not result in statistically significant changes compared with vehicle when administered at the doses evaluated to treat signs and symptoms of mild-to-moderate PsO.

Quantitative bone marrow lesion, meniscus, and synovitis measurement: current status.

Imaging plays a pivotal role in osteoarthritis research, particularly in epidemiological and clinical trials of knee osteoarthritis (KOA), with the ultimate goal being the development of an effective drug treatment for future prevention or cessation of disease. Imaging assessment methods can be semi-quantitative, quantitative, or a combination, with quantitative methods usually relying on software to assist. The software generally attempts image segmentation (outlining of relevant structures). New techniques using artificial intelligence (AI) or deep learning (DL) are currently a frequent topic of research. This review article provides an overview of the literature to date, focusing primarily on the current status of quantitative software-based assessment techniques of KOA using magnetic resonance (MR) imaging. We will concentrate on the imaging evaluation of three specific structural imaging biomarkers: bone marrow lesions (BMLs), meniscus, and synovitis consisting of effusion synovitis (ES) and Hoffa's synovitis (HS). A brief clinical and imaging background review of osteoarthritis evaluation, particularly relating to these three structural markers, is provided as well as a general summary of the software methods. A summary of the literature with respect to each KOA assessment method will be presented overall as well as with respect to each specific biomarker individually. Novel techniques, as well as future goals and directions using quantitative imaging assessment, will be discussed.

Imaging Features of Calcium Pyrophosphate Deposition Disease: Consensus Definitions From an International Multidisciplinary Working Group.

OBJECTIVE: To develop definitions for imaging features being considered as potential classification criteria for calcium pyrophosphate deposition (CPPD) disease, additional to clinical and laboratory criteria, and to compile example images of CPPD on different imaging modalities. METHODS: The American College of Rheumatology and European Alliance of Associations for Rheumatology CPPD classification criteria Imaging Advisory Group (IAG) and Steering Committee drafted definitions of imaging features that are characteristic of CPPD on conventional radiography (CR), conventional computed tomography (CT), dual-energy CT (DECT), and magnetic resonance imaging (MRI). An anonymous expert survey was undertaken by a 35-member Combined Expert Committee, including all IAG members. The IAG and 5 external musculoskeletal radiologists with expertise in CPPD convened virtually to further refine item definitions and voted on example images illustrating CR, CT, and DECT item definitions, with ≥90% agreement required to deem them acceptable. RESULTS: The Combined Expert Committee survey indicated consensus on all CR definitions. The IAG and external radiologists reached consensus on CT and DECT item definitions, which specify that calcium pyrophosphate deposits appear less dense than cortical bone. The group developed an MRI definition and acknowledged limitations of this modality for CPPD. Ten example images for CPPD were voted acceptable (4 CR, 4 CT, and 2 DECT), and 3 images of basic calcium phosphate deposition were voted acceptable to serve as contrast against imaging features of CPPD. CONCLUSION: An international group of rheumatologists and musculoskeletal radiologists defined imaging features characteristic of CPPD on CR, CT, and DECT and assembled a set of example images as a reference for future clinical research studies.

Patient Comfort, Safety, and Effectiveness of Resilient Hyaluronic Acid Fillers Formulated With Different Local Anesthetics.

BACKGROUND: Maximizing patient comfort during hyaluronic acid gel injection is a common concern that is usually addressed by selecting fillers with lidocaine. OBJECTIVE: Two randomized, double-blinded, split-face trials aimed to demonstrate noninferiority of specific hyaluronic acid fillers incorporating mepivacaine (RHA-M) versus their lidocaine controls, at providing pain relief. METHODS: Thirty subjects per trial received injections of RHA R -M versus RHA R , and RHA4-M versus RHA4, respectively, in the perioral rhytids (PR) and nasolabial folds (NLF). Pain was assessed on a visual analog scale; aesthetic effectiveness was evaluated with validated scales, and safety was monitored based on common treatment responses (CTRs) and adverse events (AEs). RESULTS: RHA-M fillers proved as effective as their lidocaine counterparts at reducing pain (noninferior, p < .0002 and p < .0001). Bilateral wrinkle improvement was measured both in the PR (-1.5 ± 0.6 points on each side) and in the NLF (-1.8 ± 0.6 and -1.9 ± 0.5 points) trials at one month, with virtually identical responder rates (≥96.7%). Common treatment responses and AEs were similar between treated sides, and none was clinically significant. CONCLUSION: Resilient hyaluronic acid fillers with either mepivacaine or lidocaine are equally effective at reducing pain during treatment and equally performant and safe for correction of dynamic facial wrinkles and folds.