RSV Vaccine Effectiveness Against Hospitalization Among US Adults Aged 60 Years or Older During 2 Seasons.

Importance: Respiratory syncytial virus (RSV) vaccines for adults aged 60 years or older became available in 2023. One dose is recommended for all adults aged 75 years or older and those aged 60 to 74 years at increased risk of severe RSV; however, duration of protection is unknown.

Objective: To evaluate RSV vaccine effectiveness against RSV-associated hospitalization among adults aged 60 years or older during 2 RSV seasons.

Association Between Operator Experience and Procedural Outcomes of Tracheal Intubation in the Emergency Department and ICU.

Study Objectives: Complications are common during emergency tracheal intubation. Although graduate medical education in emergency medicine and critical care mandate competency in this procedure, thresholds for proficiency are poorly defined. We evaluated the relationship between the operator performing intubation and complications of emergency tracheal intubation.

Insights from the trial innovation network's initial consultation process.

Multicenter clinical trials are essential for evaluating interventions but often face significant challenges in study design, site coordination, participant recruitment, and regulatory compliance. To address these issues, the National Institutes of Health's National Center for Advancing Translational Sciences established the Trial Innovation Network (TIN). The TIN offers a scientific consultation process, providing access to clinical trial and disease experts who provide input and recommendations throughout the trial's duration, at no cost to investigators.

Multimorbidity Profiles and Severe In-Hospital Outcomes in Adults with Respiratory Syncytial Virus.

Background: Adults hospitalized with acute respiratory infections, including respiratory syncytial virus (RSV), often have multiple underlying conditions. Few data are available on the combined effect of conditions on risk of severe outcomes from RSV disease.

Methods: We enrolled adults hospitalized with RSV at 26 hospitals in 20 US states admitted January 2022-July 2024.

Robotic versus Electromagnetic Bronchoscopy for Peripheral Pulmonary Lesions: A Randomized Trial (RELIANT).

Robotic-assisted bronchoscopy has emerged as an alternative to electromagnetic navigational bronchoscopy for patients undergoing bronchoscopic biopsy of a peripheral pulmonary lesion. Although both platforms are routinely used in clinical practice, comparative effectiveness data are lacking. We sought to compare the effectiveness of robotic-assisted and electromagnetic navigational bronchoscopy for the evaluation of peripheral pulmonary lesions.

Navigational Bronchoscopy or Transthoracic Needle Biopsy for Lung Nodules.

Background: Each year, millions of pulmonary nodules are identified incidentally or through lung cancer screening, and many involve biopsy to distinguish cancer from benign processes. Both navigational bronchoscopy and computed tomography-guided transthoracic needle biopsy are commonly used in patients undergoing biopsies of peripheral pulmonary nodules, but the relative diagnostic accuracy of these two approaches is unclear.

Methods: In this multicenter, randomized, parallel-group, noninferiority trial, we assigned patients with an intermediate-risk or high-risk peripheral pulmonary nodule measuring 10 to 30 mm in diameter to undergo navigational bronchoscopy or transthoracic needle biopsy at seven centers across the United States.

Oxygen Saturation Targets and Neurologic Outcomes Following Cardiac Arrest: A Secondary Analysis of the Pragmatic Investigation of Optimal Oxygen Targets Trial.

Background: More than 600,000 adults in the United States experience an out-of-hospital or in-hospital cardiac arrest each year. Following resuscitation from cardiac arrest, most patients receive mechanical ventilation. The oxygenation target that optimizes neurologic outcomes following cardiac arrest is uncertain.

Evidence-based personalised medicine in critical care: a framework for quantifying and applying individualised treatment effects in patients who are critically ill.

Clinicians aim to provide treatments that will result in the best outcome for each patient. Ideally, treatment decisions are based on evidence from randomised clinical trials. Randomised trials conventionally report an aggregated difference in outcomes between patients in each group, known as an average treatment effect.

Evidence-based Emergency Tracheal Intubation.

Millions of critically ill adults undergo tracheal intubation in an emergency department or ICU each year, nearly 40% of whom experience hypoxemia, hypotension, or cardiac arrest during the procedure. Over the last two decades, a series of randomized trials have examined which of the tools, techniques, devices, and drugs used to perform emergency tracheal intubation improve outcomes and which are ineffective or harmful. Results of these trials have demonstrated that preoxygenation with noninvasive ventilation and administration of positive pressure ventilation between induction and laryngoscopy prevent hypoxemia during intubation, video laryngoscopy facilitates successful intubation on the first attempt and may prevent esophageal intubation, use of a stylet is superior to intubation with an endotracheal tube alone and is comparable with use of a bougie, and administration of a fluid bolus before induction does not prevent hypotension.

Vaccine Effectiveness Against Influenza A(H1N1), A(H3N2), and B-Associated Hospitalizations-United States, September 1, 2023-May 31, 2024.

Background: The 2023-2024 influenza season included sustained elevated activity from December 2023-February 2024 and continued activity through May 2024. Influenza A(H1N1), A(H3N2), and B viruses circulated during the season.

Methods: During September 1, 2023-May 31, 2024, a multistate sentinel surveillance network of 24 medical centers in 20 U.

Effect of Ventilator Mode on Ventilator-Free Days in Critically Ill Adults: A Randomized Clinical Trial.

Background: Whether the choice of ventilator mode affects outcomes for critically ill patients is unknown.

Research Question: What are the effects of 3 common ventilator modes (volume control vs pressure control vs adaptive pressure control) on death and duration of mechanical ventilation among critically ill adults?

Study Design And Methods: We conducted a pragmatic, cluster-randomized, crossover pilot trial among adults receiving invasive mechanical ventilation in a medical ICU between November 1, 2022, and July 31, 2023. Each month, patients in the participating unit were assigned to receive volume control, pressure control, or adaptive pressure control during continuous mandatory ventilation.

Preoxygenation strategies for intubation of patients who are critically ill: a systematic review and network meta-analysis of randomised trials.

Background: Preoxygenation is a crucial preparatory step for intubation. Several strategies for preoxygenation exist, including facemask oxygen, high-flow nasal cannula (HFNC), and non-invasive positive pressure ventilation (NIPPV). However, the comparative efficacy of these strategies remains largely uncertain.

Low-Intensity vs Moderate-Intensity Anticoagulation for Venovenous Extracorporeal Membrane Oxygenation: The Strategies for Anticoagulation During Venovenous Extracorporeal Membrane Oxygenation Pilot Trial.

Background: Bleeding is a common and sometimes fatal complication of venovenous extracorporeal membrane oxygenation (ECMO). Whether lowering the intensity of anticoagulation during venovenous ECMO is safe or effective is unknown.

Research Question: Is a large, multicenter randomized trial of low-intensity vs moderate-intensity anticoagulation during venovenous ECMO feasible?

Study Design And Methods: In a multicenter, parallel-group, randomized pilot trial conducted at 3 centers across the United States, we randomly assigned critically ill adults undergoing venovenous ECMO to low-intensity or moderate-intensity anticoagulation.

Normosol-R vs Lactated Ringers in the Critically Ill: A Randomized Trial.

Background: Balanced crystalloid solutions may improve clinical outcomes compared with saline for some critically ill adults, but it is unclear whether differences in composition between balanced crystalloid solutions affect outcomes.

Research Question: Does the choice of balanced crystalloid solutions (Normosol-R vs lactated Ringers) impact acid-base status, organ function, or outcomes for critically ill adults?

Study Design And Methods: This pragmatic, cluster-randomized, multiple-crossover trial at an academic medical center in the United States compared the use of Normosol-R vs lactated Ringers among critically ill adults. The primary outcome was the plasma bicarbonate (HCO) concentration between enrollment and 7 days.

Protocol and Statistical Analysis Plan for the Randomized Trial of Sedative Choice for Intubation (RSI).

Background: Emergency tracheal intubation is a common and high-risk procedure. Ketamine and etomidate are sedative medicines commonly used to induce anesthesia for emergency tracheal intubation, but whether the induction medication used affects patient outcomes is uncertain.

Research Question: Does the use of ketamine for induction of anesthesia decrease the incidence of death among adults undergoing emergency tracheal intubation, compared to the use of etomidate?

Study Design And Methods: The Randomized trial of Sedative choice for Intubation (RSI) is a pragmatic, multicenter, unblinded, parallel-group, randomized trial being conducted in 14 sites (6 emergency departments and 8 intensive care units) in the United States.

Effect of Oxygen Saturation Targets on Neurologic Outcomes after Cardiac Arrest: A Secondary Analysis of the PILOT Trial.

Background: More than 600,000 adults in the United States experience a cardiac arrest each year. After resuscitation from cardiac arrest, most patients receive mechanical ventilation. The oxygenation target that optimizes neurologic outcomes after cardiac arrest is uncertain.

Video vs Direct Laryngoscopy for Tracheal Intubation After Cardiac Arrest: A Secondary Analysis of the Direct vs Video Laryngoscope Trial.

Background: Airway management is a critical component of the care of patients experiencing cardiac arrest, but data from randomized trials on the use of video vs direct laryngoscopy for intubation in the setting of cardiac arrest are limited. Current American Heart Association guidelines recommend placement of an endotracheal tube either during CPR or shortly after return of spontaneous circulation, but do not provide guidance around intubation methods, including the choice of laryngoscope.

Research Question: Does use of video laryngoscopy improve the incidence of successful intubation on the first attempt, compared with use of direct laryngoscopy, among adults undergoing tracheal intubation after experiencing cardiac arrest?

Study Design And Methods: This secondary analysis of the Direct vs Video Laryngoscope (DEVICE) trial compared video laryngoscopy vs direct laryngoscopy in the subgroup of patients who were intubated after cardiac arrest.

Oxygen Targets for Mechanically Ventilated Adults with Sepsis: Secondary Analysis of the PILOT Trial.

Background: Patients with sepsis frequently require invasive mechanical ventilation. How oxygenation during mechanical ventilation affects clinical outcomes for patients with sepsis remains uncertain. Research Question: To evaluate the effects of different oxygen saturation targets on clinical outcomes for patients with sepsis receiving mechanical ventilation.

Diabetes Mellitus Is Not a Risk Factor for Difficult Intubation Among Critically Ill Adults: A Secondary Analysis of Multicenter Trials.

Objectives: Diabetes mellitus has been associated with greater difficulty of tracheal intubation in the operating room. This relationship has not been examined for tracheal intubation of critically ill adults. We examined whether diabetes mellitus was independently associated with the time from induction of anesthesia to intubation of the trachea among critically ill adults.

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.

Benefit of Early Oseltamivir Therapy for Adults Hospitalized With Influenza A: An Observational Study.

Background: Clinical guidelines recommend initiation of antiviral therapy as soon as possible for patients hospitalized with confirmed or suspected influenza.

Methods: A multicenter US observational sentinel surveillance network prospectively enrolled adults (aged ≥18 years) hospitalized with laboratory-confirmed influenza at 24 hospitals during 1 October 2022-21 July 2023. A multivariable proportional odds model was used to compare peak pulmonary disease severity (no oxygen support, standard supplemental oxygen, high-flow oxygen/non-invasive ventilation, invasive mechanical ventilation, or death) after the day of hospital admission among patients starting oseltamivir treatment on the day of admission (early) versus those who did not (late or not treated), adjusting for baseline (admission day) severity, age, sex, site, and vaccination status.

Keeping Up With Technological Innovation: The Moral Imperative for Pragmatic Clinical Trials in Interventional Pulmonology.

The advances in minimally invasive lung cancer diagnostics of the last decade have transformed patient care but have also raised important concerns about the regulatory processes used to approve new devices and the best way to generate data to support their use. Disruptive technologies, such as robotic bronchoscopy, have been widely adopted by interventional pulmonologists in the absence of robust data demonstrating improved patient outcomes. Comparative research is needed to inform patient care, but traditional methods of conducting clinical trials in which research teams operate separately from clinical teams are ill-suited to testing the safety and effectiveness of technologies being introduced on the market at unprecedented speed.