The Role of the Clinical Laboratory in Diagnostic Stewardship and Population Health.

Background: As healthcare identifies new opportunities to provide patient services and moves from volume to value payment models, the clinical laboratory is in an ideal position to serve as a catalyst for these changes. In 2017, the Project Santa Fe Foundation (PSFF) was founded to support the clinical laboratory's role to promote the objectives of population health and value-based healthcare. The initiative, known as Clinical Lab 2.

Efficacy, Safety, and Immunogenicity of the MATISSE (Maternal Immunization Study for Safety and Efficacy) Maternal Respiratory Syncytial Virus Prefusion F Protein Vaccine Trial.

Objective: To evaluate descriptive efficacy data, exploratory immunogenicity data, and safety follow-up through study completion from the global, phase 3 MATISSE (Maternal Immunization Study for Safety and Efficacy) maternal vaccination trial of bivalent respiratory syncytial virus (RSV) prefusion F protein vaccine (RSVpreF).

Methods: MATISSE was a phase 3, randomized, double-blinded, placebo-controlled trial. Healthy pregnant participants aged 49 years or younger at 24-36 weeks of gestation were randomized (1:1) to receive a single RSVpreF 120 micrograms or placebo dose.

Preterm Birth Frequency and Associated Outcomes From the MATISSE (Maternal Immunization Study for Safety and Efficacy) Maternal Trial of the Bivalent Respiratory Syncytial Virus Prefusion F Protein Vaccine.

Objective: To describe preterm birth frequency and newborn and infant outcomes overall and among preterm children in the MATISSE (Maternal Immunization Study for Safety and Efficacy) trial of maternal vaccination with bivalent respiratory syncytial virus (RSV) prefusion F protein-based vaccine (RSVpreF) to protect infants against severe RSV-associated illness.

Methods: MATISSE was a global, phase 3, randomized, double-blind trial. Pregnant individuals received single injections of RSVpreF or placebo.

TB or not TB? Development and validation of a clinical decision support system to inform airborne isolation requirements in the evaluation of suspected tuberculosis.

Background: The study objective was to develop and validate a clinical decision support system (CDSS) to guide clinicians through the diagnostic evaluation of hospitalized individuals with suspected pulmonary tuberculosis (TB) in low-prevalence settings.

Methods: The "TBorNotTB" CDSS was developed using a modified Delphi method. The CDSS assigns points based on epidemiologic risk factors, TB history, symptoms, chest imaging, and sputum/bronchoscopy results.

Best Practice & Research clinical obstetrics & gynaecology.

Screening for fetal genetic disorders is a focus of prenatal care. Cell free DNA (cfDNA) screening for aneuploidies became available in 2011. Initially available only to high-risk individuals, this test is now standard of care in many settings.