In this cluster-randomized trial involving medical inpatients, the use of a shared decision-making approach that incorporated a decision-making checklist and a visual decision aid, compared with usual care, had strong effects on patients’ decisions regarding code status.
Goals-of-care conversations are among the most sensitive aspects of medical practice. They are fraught with complexity — medical, emotional, cultural, and ethical — and shaped by numerous factors that influence not only their content but also how the conversation is delivered and received. Shared decision-making is the standard process for conducting such conversations: a collaborative process where clinicians engage with the patient or their substitute decision-maker to determine the most appropriate treatment plan, guided by the clinical context, perceived prognosis, and the patient’s values and preferences.1,2
The ability of a single intravitreal injection of UBX1325, a novel senolytic small molecule inhibitor, or placebo to mitigate the impact of diabetic macular edema was tested in 65 patients with diabetic macular edema with prior suboptimal response to anti–vascular endothelial growth factor treatment. The primary trial objective was safety, with similar profiles seen in both groups. The secondary objective showed encouraging changes from baseline for UBX1325 versus sham in best corrected visual acuity.
Diabetic macular edema, a manifestation of diabetic retinopathy that impairs central vision, is a leading cause of vision loss in working-age adults.1,2 In the United States, 9.6 million people have diabetic retinopathy; this is 26% of all patients with diabetes. Of those with diabetic retinopathy, 1.84 million have a form of vision-threatening diabetic retinopathy, which includes diabetic macular edema.3 The current Food and Drug Administration–approved treatment for diabetic retinopathy consists of intravitreous injection of anti–vascular endothelial growth factor (VEGF) antibodies for treatment.1
Neuroinflammation has been shown to play a role in the functional decline associated with amyotrophic lateral sclerosis (ALS), and regulatory T cells (Tregs) have been shown to resolve neuroinflammation. Shneider and colleagues describe a preliminary safety study of Treg infusion for ALS.
Tension-free vaginal tape has been the standard treatment for female stress urinary incontinence. Transurethral injection of polyacrylamide hydrogel is an alternative. This article reports the 5-year follow-up of a trial comparing the two.
Amyotrophic lateral sclerosis (ALS) remains one of the most challenging neurological diseases for researchers, and clinicians, both for its still obscure pathogenesis and for the lack of therapies able to alter its relentless progression. The study by Shneider and colleagues, published in this issue of NEJM Evidence, investigating regulatory T cells (Tregs) as a potential therapy offers an intriguing window into an approach that warrants careful consideration and allows for cautious optimism.1
In this randomized, open-label, phase 3, noninferiority trial, Huang et al. treated patients with stage T1-4N2-3 or T3-4N0-1 locoregionally advanced nasopharyngeal carcinoma with either induction gemcitabine and cisplatin followed by intensity-modulated radiation therapy or concurrent cisplatin and radiation. The trial met its primary end point of 2-year failure-free survival of the experimental induction arm compared with the concurrent chemotherapy arm.
When an effective treatment exists, sometimes the motivation to develop a new treatment is not to produce a more effective (superior) intervention than the current standard, but instead to produce a treatment with some advantage other than effectiveness. For example, a new drug is developed that needs to be taken only once per day, unlike the current drug, which is to be taken multiple times per day.
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Patients with an acute exacerbation of chronic obstructive pulmonary disease and blood eosinophil counts of greater than or equal to 300 cells/μl in the prior year were randomly assigned to receive mepolizumab, an anti–interleukin-5 antibody, or placebo, every 4 weeks for 48 weeks, in addition to exacerbation treatment. The median time to hospitalization or death due to any cause was 25.4 weeks and 26.1 weeks in the mepolizumab and placebo groups, respectively, with Kaplan–Meier estimates of 33.9% and 31.0%, respectively. Over 48 weeks, the number of moderate or severe exacerbations was 2.80 with mepolizumab and 3.45 with placebo.
Chronic obstructive pulmonary disease (COPD) remains a complex and persistent medical challenge with major public health implications and a substantial economic burden worldwide.1 Among patients hospitalized with acute exacerbations, the 1-year mortality is more than 25%, and the 5-year mortality is more than 50%; a substantial percentage continue to have exacerbations despite the use of triple therapy, which includes an inhaled glucocorticoid, a long-acting β2 agonist, and a long-acting muscarinic bronchodilator.2,3
See also in NEJM: Mepolizumab to Prevent Exacerbations of COPD with an Eosinophilic Phenotype
See also in NEJM: Mepolizumab in COPD — If at First You Don’t Succeed
The authors review natural experiments, an increasingly common study design. Overall, while natural experiments have become popular in health policy, the widespread application of these approaches to specific clinical questions faces several challenges.
A 7-year-old boy presented with 10 days of fever after travel to Bangladesh. How do you approach the evaluation, and what is the diagnosis?
