International consensus statement on microbiome testing in clinical practice.

There is growing interest in the potential exploitation of the gut microbiome as a diagnostic tool in medicine, but evidence supporting its clinical usefulness is scarce. An increasing number of commercial providers offer direct-to-consumer microbiome diagnostic tests without any consensus on their regulation or any proven value in clinical practice, which could result in considerable waste of individual and health-care resources and potential drawbacks in the clinical management of patients. We convened an international multidisciplinary expert panel to standardise best practices of microbiome testing for clinical implementation, including recommendations on general principles and minimum requirements for their provision, indications, pre-testing protocols, method of analyses, reporting of results, and potential clinical value.

Addressing pain in people living with cystic fibrosis: Cystic fibrosis foundation evidence-informed guidelines.

Even as many outcomes for people living with cystic fibrosis (PLwCF) improve, individuals still experience extensive symptom burdens. From birth, many PLwCF experience both pain as a symptom of their CF disease and procedural pain, posing detriments to health, functioning, and quality of life. Despite its prevalence and impact, there is no CF-specific guidance for the assessment and management of pain.

Safety and efficacy of mitapivat in sickle cell disease (RISE UP): results from the phase 2 portion of a global, double-blind, randomised, placebo-controlled trial.

Background: Sickle cell disease, a debilitating, inherited haemolytic anaemia with premature morbidity and mortality, affects millions globally. Mitapivat, a first-in-class, oral, allosteric activator of pyruvate kinase, improves red blood cell survival by increasing ATP and diminishes sickling by decreasing 2,3-diphosphoglycerate. We aimed to evaluate the efficacy and safety of mitapivat in patients with sickle cell disease.

Phase II study of MEK inhibitor trametinib alone and in combination with AKT inhibitor GSK2141795/uprosertib in patients with metastatic triple negative breast cancer.

Purpose: While MEK inhibitors demonstrated activity in metastatic triple negative breast cancer (mTNBC) preclinical studies, preclinical, and clinical studies implicate rapid development of resistance limiting clinical benefit. The purpose of this study was to determine response rate for Trametinib alone and in combination with Uprosertib in patients with mTNBC previously treated with chemotherapy.

Methods: This was an open-label, two-part, phase II, single-arm, multicenter study.

Approaches to management of HIT in complex scenarios, including cardiac surgery.

Although heparin-induced thrombocytopenia (HIT) presents management challenges for any population, it adds complexity to the management of certain patient populations, including those undergoing cardiac surgery and those with refractory HIT and/or acute bleeding. For each of these scenarios, we review alternative management strategies when standard therapies-heparin cessation and the initiation of a nonheparin anticoagulant-are either insufficient or not practicable. In patients with HIT undergoing cardiac surgery, we review the clinical experience for heparin reexposure using therapeutic plasma exchange (TPE) or antiplatelet therapy.

Local control and patient survival after stereotactic radiosurgery for esophageal cancer brain metastases: an international multicenter analysis.

Objective: This study aimed to evaluate local control (LC) of tumors, patient overall survival (OS), and the safety of stereotactic radiosurgery (SRS) for esophageal cancer brain metastases (EBMs).

Methods: This retrospective cohort study used data from 15 International Radiosurgery Research Foundation facilities encompassing 67 patients with 185 EBMs managed using SRS between January 2000 and May 2022. The median patient age was 63 years, with a male predominance (92.

Interleukin-1 Blockade With RPH-104 (Goflikicept) in Patients With ST-Segment Elevation Myocardial Infarction: Secondary End Points From an International, Double-Blind, Randomized, Placebo-Controlled, Phase 2a Study.

In a randomized double-blinded clinical trial of patients with ST segment elevation myocardial infarction (STEMI), goflikicept, an interleukin-1 blocker, significantly reduced systemic inflammation, measured as the area under the curve (AUC) for high-sensitivity C reactive protein at 14 days. We report secondary analyses of biomarkers at 28 days, and cardiac function and clinical end points at 1 year. Patients received a single administration of goflikicept 80 mg (n = 34), goflikicept 160 mg (n = 34), or placebo (n = 34).

Innovation in Medical Education on Intellectual/Developmental Disabilities: Report on the National Inclusive Curriculum for Health Education-Medical Initiative.

The lack of physician training in serving patients with intellectual and developmental disabilities (IDDs) has been highlighted as a key modifiable root cause of health disparities experienced by this high-priority public health population. To address gaps in medical education regarding the lack of IDD curriculum, lack of evaluation/assessment, and lack of coordination across institutions, the American Academy of Developmental Medicine and Dentistry created the National Inclusive Curriculum for Health Education-Medical (NICHE-MED) Initiative in 2016. The aims of NICHE-MED are to: (1) impact medical students' attitudes and/or knowledge to address underlying ableism and address how future physicians think about disability; (2) apply a lens of health equity and intersectionality, centering people with IDD, but fostering conversation and learning about issues faced by other disability and minoritized populations; and (3) support community-engaged scholarship within medical education.

Religious and Spiritual Experiences, Discrimination, and Stress Among Midlife Women in the USA: The Study of Women's Health Across the Nation.

The harmful effects of perceived discrimination for physical and mental health are well documented. Evidence identifies how dimensions of religious/spiritual (R/S) involvement may reduce these harmful effects. This study examined how R/S experiences are associated with the effects of discrimination on perceived stress.

Proteomics in Acute Heart Transplant Rejection, On Behalf of the GRAfT Investigators.

Background: Proteomic phenotyping can provide insights into rejection pathophysiology, novel biomarkers, and therapeutic targets.

Methods: Within the prospective, multicenter Genomic Research Alliance for Transplantation study, 181 proteins were evaluated from blood drawn at the time of endomyocardial biopsy; protein fold change, logistic regression, and pathway analyses were conducted, with protein discovery adjusted for a 5% false discovery rate.

Results: Among 104 adult heart transplant patients (31% female sex, 53% Black race, median age 52 y), 74 had no rejection, 18 developed acute cellular rejection (ACR), and 12 developed antibody-mediated rejection (AMR).

Assessment of Inter-Laboratory Variability for Flow Cytometric Crossmatch Testing: Lessons Learned from Proficiency Surveys.

Detection of antibody directed against human leukocyte antigens (HLA) using a combination of flow cytometric crossmatch (FCXM) and antibody tests, is an important responsibility of Histocompatibility laboratories. Proficiency testing surveys utilize the results of these assays to assess concordance across multiple laboratories. In this study, we reviewed the ASHI Proficiency Testing (PT) antibody and crossmatching (AC) survey results obtained over a 6-year period, to evaluate the degree and nature of inter-laboratory FCXM and antibody assay variability.

Fostamatinib for Hospitalized Adults With COVID-19 and Hypoxemia: A Randomized Clinical Trial.

Importance: Fostamatinib, a spleen tyrosine kinase inhibitor, has been reported to improve outcomes of COVID-19.

Objective: To evaluate the efficacy and safety of fostamatinib in adults hospitalized with COVID-19 and hypoxemia.

Design, Setting, And Participants: This multicenter, phase 3, placebo-controlled, double-blinded randomized clinical trial was conducted at 41 US sites and 21 international sites between November 17, 2021, and September 27, 2023; the last follow-up visit was December 31, 2023.

What you believe is what you get? A systematic review examining how beliefs and attitudes about sleep are associated with sleep duration in non-clinical samples.

A burgeoning area of research is investigating whether beliefs and attitudes about sleep are associated with sleep duration in individuals without clinical conditions (e.g., insomnia, depression, anxiety, chronic pain).

Sexual orientation discrimination and eating disorder symptoms in early adolescence: a prospective cohort study.

Background: Sexual orientation discrimination increases the risks of negative health outcomes for sexual minorities. Previous studies have found increased rates of eating disorder symptoms in sexual minority individuals, which is attributable to minority stress and discrimination that they experience. Emerging research suggests relationships between sexual orientation discrimination and eating disorder symptoms.

Metabolic dysfunction and alcohol-related liver disease (MetALD): Position statement by an expert panel on alcohol-related liver disease.

In this position statement, we explore the intricate relationship between alcohol intake and metabolic dysfunction in the context of the 2023 nomenclature update for steatotic liver disease (SLD). Recent and lifetime alcohol use should be accurately assessed in all patients with SLD to facilitate classification of alcohol use in grams of alcohol per week. Alcohol biomarkers (i.