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Importance Cardiovascular (CV) disease is the leading cause of death globally for both men and women, yet women remain historically underrepresented in CV clinical trials, despite facing a disproportionately high burden of morbidity and mortality in many forms of CV disease. Objective To determine the representation of women across a broad range of CV trials. Evidence Review The participation of women in CV trials registered on ClinicalTrials.gov from 2017 to 2023 was systematically determined through the extraction of publicly available information. Data were extracted to identify the country of study, disease type, trial size, clinical intervention, and age of the participants. The proportion of women and the ratio of number of female to male participants (F:M ratio) were calculated for each trial. The women’s participation:prevalence ratio (PPR) was estimated for each trial based on the relative prevalence of the disease by sex in the specified region. Findings A total of 1079 registered CV trials were identified, including 1 396 104 participants, of whom 571 641 (41.0%) were women. The F:M ratio was significantly lower for studies on arrhythmia (median [IQR], 0.5), coronary heart disease (median [IQR], 0.39 [0.33-0.70]), acute coronary syndrome (median [IQR], 0.32 [0.24-0.51]), and heart failure (median [IQR], 0.51 [0.32-0.87]) but higher for obesity (median [IQR], 1.44 [1.08-4.50]) and pulmonary hypertension (median [IQR], 2.86 [1.50-3.97]) trials. The F:M ratio was higher for trials on lifestyle interventions (median [IQR], 1.51 [0.77-3.24]) than for drug trials. PPRs were low for clinical trials on coronary heart disease (median [IQR], 0.66 [0.50-0.86]), acute coronary syndrome (median [IQR], 0.79 [0.51-0.87]), and stroke (median [IQR], 0.74 [0.61-0.95]). Representation of women in CV trials varied by disease state, region, intervention, and sponsor type. Conclusions and Relevance These findings highlight both progress and persistent challenges in representation of women within CV trials. These gaps not only limit the generalizability of trial outcomes but also perpetuate inequities in evidence-based care for women with CV conditions.

Inflammatory bowel disease (IBD) is associated with significant impacts on patients’ health and quality of life. Chronic inflammation is linked to an increased risk of malignancies, venous thromboembolisms and infections. Chronic diseases are also associated with an increased risk for psychiatric comorbidities, such as anxiety and depression. Consequently, IBD can greatly impact health-related quality of life. While endoscopic healing is a target of therapeutic efficacy in the management of IBD, patients prioritise achieving clinical remission, with symptom control being a primary motivator for IBD management. With the ever-evolving therapeutic landscape in IBD, the need for effective communication and shared decision-making (SDM) is crucial when relaying risks and benefits of treatment options: no treatment, complementary and alternative medicine, surgical resection and medical management. Various visual decision aids, patient-specific activities and predictive tools enhance patients’ understanding of the risks and benefits associated with certain treatments and enable patients to make informed decisions aligned with their personal values. Through SDM, the patient–provider relationship is strengthened, patient satisfaction is enhanced, patient quality of life is improved and better outcomes are achieved.

Due to extensive pathophysiological changes in critically ill patients, standard dosing of antibiotics may lead to inadequate drug exposure. This is concerning, as insufficient plasma drug concentrations may lead to treatment failure, whereas excessive drug exposure may increase the risk of toxic adverse events. The role of inflammation as a factor influencing the pharmacokinetics (PK) and pharmacodynamics (PD) of antibiotics remains largely unknown. PK/PD target attainment of antibiotics can be improved through therapeutic drug monitoring, i.e., measurement of drug concentrations in the blood with subsequent dosage adjustment to reach a certain target. Besides, population PK models may be used to predict drug exposure and tailor dosing in an individual patient (model‐informed precision dosing). Inflammatory biomarkers have been proposed to measure inflammation levels and guide antibiotic treatment. However, their potential to guide antibiotic dosing is unclear. This narrative review describes associations between inflammation and PK/PD of antibiotics in critically ill patients, and the role of biomarkers, therapeutic drug monitoring and model‐informed precision dosing in improving antibiotic dosing. A focus of future research should be on the interplay between inflammation and PK/PD of antibiotics by including inflammatory biomarkers in PK/PD models and using big data to predict antibiotic exposure in critically ill patients.

ABSTRACT Objectives Sarcomas are rare, mesenchymal tumors that require multimodality treatment provided by multidisciplinary teams. This study seeks to better understand sarcoma patient narratives and quality of life in relation to the social determinants of health (SDoH). Methods Eligible patients who were diagnosed with sarcoma, treated by our institution's orthopedic oncology team, and identified with at least one social risk factor were contacted about participating in a semi‐structured interview. SDoH information collected included (1) Economic Stability, (2) Access to Health Care, (3) Neighborhood & Physical Environment, (4) Social & Community Context, and (5) Education Access and Quality. Interviews were then recorded, de‐identified, transcribed, and coded by reviewers. The validated Framework Method for qualitative research was used to summarize themes. Descriptive statistics were used to summarize the percentage of participants that identified with each SDoH concern. Results 100% of patients ( N = 17) discussed how quality and access to healthcare affected their experience. 88.2% of participants expressed the importance of transportation. 29.4% of participants discussed how they thought their educational background affected their cancer care. Other common themes centered around social support, employment, financial security, and insurance. Conclusion Our research elicited ways in which SDoH affected the care experience of patients with sarcoma. The identified domains offer clinicians valuable information into non‐clinical factors, such as employment concerns or transportation issues, that may affect care for patients with sarcoma. Interdisciplinary care providers (social workers, psychologists, financial navigators) may also help promote open dialogues with patients about their social circumstances and actively facilitate connections to institutional resources or community support systems.

Abstract The aim of this international meta-analysis was to quantify the predictive value of BMI for incident fracture and relationship of this risk with age, sex, follow-up time, and BMD. A total of 1 667 922 men and women from 32 countries (63 cohorts), followed for a total of 16.0 million person-years were studied. 293 325 had FN BMD measured (2.2 million person-years follow-up). An extended Poisson model in each cohort was used to investigate relationships between WHO-defined BMI categories (Underweight: <18.5 kg/m2; Normal: 18.5-24.9 kg/m2; Overweight: 25.0-29.9 kg/m2; Obese I: 30.0-34.9 kg/m2; Obese II: ≥35.0 kg/m2) and risk of incident osteoporotic, major osteoporotic and hip fracture (HF). Inverse-variance weighted β-coefficients were used to merge the cohort-specific results. For the subset with BMD available, in models adjusted for age and follow-up time, the hazard ratio (95% CI) for HF comparing underweight with normal weight was 2.35 (2.10-2.60) in women and for men was 2.45 (1.90-3.17). Hip fracture risk was lower in overweight and obese categories compared to normal weight [obese II vs normal: women 0.66 (0.55-0.80); men 0.91 (0.66-1.26)]. Further adjustment for FN BMD T-score attenuated the increased risk associated with underweight [underweight vs normal: women 1.69 (1.47-1.96); men 1.46 (1.00-2.13)]. In these models, the protective effects of overweight and obesity were attenuated, and in both sexes, the direction of association reversed to higher fracture risk in Obese II category [Obese II vs Normal: women 1.24 (0.97-1.58); men 1.70 (1.06-2.75)]. Results were similar for other fracture outcomes. Underweight is a risk factor for fracture in both men and women regardless of adjustment for BMD. However, while overweight/obesity appeared protective in base models, they became risk factors after additional adjustment for FN BMD, particularly in the Obese II category. This effect in the highest BMI categories was of greater magnitude in men than women. These results will inform the second iteration of FRAX®.

Objective: Describe changes in symptoms of velopharyngeal insufficiency (VPI)—hypernasality, audible nasal emission, and VPI-related quality of life—following LeFort I osteotomy in individuals with cleft palate +/- cleft lip. Design: Single-center, retrospective cohort study. Participants: Twenty-one patients with a history of cleft palate repaired in infancy were included in this study. Ten patients had no prior history of VPI surgery and eleven had a pharyngeal flap in place at the time of LeFort I osteotomy. The mean age at time of surgery was 17.2 years. Main Outcome Measure: Pre- and postoperative hypernasality severity, frequency of audible nasal emission, and total score on the VPI Effects on Life Outcomes youth questionnaire (VELO-Y) before and after LeFort osteotomy I. Fischer exact test was used to assess differences between groups for categorical variables and a t test was used for continuous variables. Results: Patients with no prior history of VPI management had a significant increase in hypernasality severity compared with those with a pharyngeal flap in place at the time of surgery ( P =0.004). Patients without a prior history of VPI management also had a significant increase in frequency of audible nasal emission, while patients with a pharyngeal flap had decreased audible nasal emission ( P =0.004). There was not a significant difference between groups for change in the total score on the VELO-Y ( P =0.16). Conclusions: Findings from this study may improve preoperative counseling provided to patients and caregivers on the risk of acquiring VPI after LeFort I osteotomy based on prior VPI surgical history.

Objective Literature is limited regarding the relationship between cochlear magnetic resonance imaging fluid-attenuated inversion recovery (FLAIR) signal and hearing preservation after resection of vestibular schwannoma (VS). We hypothesize that increased preoperative FLAIR signal is associated with decreased odds of hearing preservation. Study Design Retrospective cohort study. Setting Single academic tertiary/quaternary care center. Patients Subjects with histologically confirmed intracanalicular VS (without extension into the cerebellopontine angle). Intervention Microsurgical resection via middle fossa approach. Main Outcome Measures A review of demographic, clinical, radiographic, and audiometric outcomes were performed. Hearing preservation was defined as American Academy of Otolaryngology–Head and Neck Surgery (AAO-HNS) class A or B hearing. Binary logistic regression analysis was performed with SPSS version 29. Results Twenty-seven subjects met inclusion criteria with median age at time of surgery of 47 (interquartile range [IQR]: 38–54) years; 92.60% were White; 66.67% had AAO-HNS class A, and 33.33% had class B hearing. Postoperatively, at median (IQR) of 11.50 (2.10–38.50) months, 44.40% had class A or B hearing. On logistic regression analysis, a ratio of cochlea-to-brainstem FLAIR signal greater than 0.6 was associated with decreased odds of hearing preservation at 11.50 months—odds ratio, 0.13; 95% confidence interval, 0.02–0.84. Age, sex, surgery duration, tumor volume and linear dimension, fundal cap of cerebrospinal fluid, and extent of resection were not associated with hearing preservation. Conclusion Increased cochlear FLAIR signal on preoperative imaging is associated with decreased likelihood of hearing preservation after resection of intracanalicular, sporadic VS via middle fossa approach.

The NCCN Guidelines for Uterine Neoplasms provide recommendations for diagnostic workup, clinical staging, and treatment options for patients with endometrial cancer and uterine sarcoma. The NCCN Cervical Uterine Panel meets at least annually to review comments from reviewers within their institutions; examine relevant new data from publications, abstracts, and recent FDA approvals; and reevaluate and update recommendations. These NCCN Guidelines Insights summarize the panel’s deliberations on the new FIGO 2023 staging system and updates on the new systemic therapy recommendations for the management of endometrial cancer.

Context.— A clinic was created for patients to review their explanted organs with a pathologist. Objective.— To prospectively investigate the benefits of this type of clinic as perceived by both transplant patients and their pathologists. Design.— In this prospective study, patients participated in a videotaped viewing of heart and/or lung explants by the patient and their guest(s) and pathologist (December 2017–August 2022). Patients received a 3D-printed replica of their explant. After viewing the explanted organ, patients and their guests participated in an interview to assess their experiences. Video-reflexive ethnography was used by pathologists for data collection and practice improvement. Results.— Of 143 patients who viewed their explanted organ, 21 patients consented to having the organ-viewing session taped and to participate in a postviewing interview. The study group was comprised of 12 men; the median age was 57.5 years (range, 29–67 years). Five pathologists took part in reflexive sessions. The clinics were viewed positively by patients, providing an opportunity to better understand their disease. Pathologists had a similarly positive experience and gained important insights to patient journeys. Proposals for improvement were brought forward from both patients and pathologists. Conclusions.— Video-reflexive ethnography provided the opportunity for patients and pathologists to reflect on patient-pathology clinic appointments. This work serves as a template to build out pathology-based clinics.