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QI Curriculum Step 1: Establish the What and Why for Change

In Step 1 of ACP’s four-part Quality Improvement (QI) curriculum, you will establish what needs to change and identify the reasons why change is necessary. Developed by physicians for physicians and their clinical teams, this online training series guides you through each stage of the QI journey. It is part of a broader ACP initiative designed to empower and engage physicians in meaningful QI programs that result in meaningful and sustained change.

Putting Adult Vaccine Recommendations Into Action

Vaccinations, as recommended by the Centers for Disease Control and Prevention's (CDC) Advisory Committee on Immunization Practices (ACIP), are an essential component of comprehensive adult health care. Yet, adult vaccination rates in the United States are suboptimal, leaving individuals, and in many cases also others in their communities, at risk for preventable illness.

Pseudogout Syndrome

In this episode of Annals On Call, Dr. Centor discusses pseudogout with Dr. Robert McLean. First, listen to the podcast. After listening, ACP members can take the CME/MOC quiz for free.

Protecting Adults Against Respiratory Syncytial Virus Infection

In this episode of Annals On Call, Dr. Centor discusses respiratory syncytial virus infection in adults and recently approved respiratory syncytial virus vaccines with Dr. Camille Kotton. First, listen to the podcast. After listening, ACP members can take the CME/MOC quiz for free.

These Annals of Internal Medicine results only contain recent articles.

Efficacy and Safety of Ensovibep for Adults Hospitalized With COVID-19: A Randomized Controlled Trial: Annals of Internal Medicine: Vol 175, No 9

Background: Ensovibep (MP0420) is a designed ankyrin repeat protein, a novel class of engineered proteins, under investigation as a treatment of SARS-CoV-2 infection. Objective: To investigate if ensovibep, in addition to remdesivir and other standard care, improves clinical outcomes among patients hospitalized with COVID-19 compared with standard care alone. Design: Double-blind, randomized, placebo-controlled, clinical trial. (ClinicalTrials.gov: NCT04501978) Setting: Multinational, multicenter trial. Participants: Adults hospitalized with COVID-19. Intervention: Intravenous ensovibep, 600 mg, or placebo. Measurements: Ensovibep was assessed for early futility on the basis of pulmonary ordinal scores at day 5. The primary outcome was time to sustained recovery through day 90, defined as 14 consecutive days at home or place of usual residence after hospital discharge. A composite safety outcome that included death, serious adverse events, end-organ disease, and serious infections was assessed through day 90. Results: An independent data and safety monitoring board recommended that enrollment be halted for early futility after 485 patients were randomly assigned and received an infusion of ensovibep (n = 247) or placebo (n = 238). The odds ratio (OR) for a more favorable pulmonary outcome in the ensovibep (vs. placebo) group at day 5 was 0.93 (95% CI, 0.67 to 1.30; P = 0.68; OR > 1 would favor ensovibep). The 90-day cumulative incidence of sustained recovery was 82% for ensovibep and 80% for placebo (subhazard ratio [sHR], 1.06 [CI, 0.88 to 1.28]; sHR > 1 would favor ensovibep). The primary composite safety outcome at day 90 occurred in 78 ensovibep participants (32%) and 70 placebo participants (29%) (HR, 1.07 [CI, 0.77 to 1.47]; HR < 1 would favor ensovibep). Limitation: The trial was prematurely stopped because of futility, limiting power for the primary outcome. Conclusion: Compared with placebo, ensovibep did not improve clinical outcomes for hospitalized participants with COVID-19 receiving standard care, including remdesivir; no safety concerns were identified. Primary Funding Source: National Institutes of Health.

The Fall of the Nation's First Gender-Affirming Surgery Clinic

Johns Hopkins Hospital established the first gender-affirming surgery (GAS) clinic in the United States in 1966. Operating for more than 13 years, the clinic was abruptly closed in 1979. According to the hospital, the decision was made in response to objective evidence claiming that GAS was ineffective. However, this evidence directly contradicted many contemporaneous studies and faced immediate criticism from the scientific community. Despite this resistance, it took the hospital nearly 40 years to resume performing GAS. Scientific evidence—imbued in scandal, bias, and moralism—was instrumentalized to serve broader institutional interests. The burgeoning field of plastic surgery tethered and then untethered GAS from its auspices in response to poor technical outcomes and transphobia. No longer serving surgeons' interests, the clinic was marginalized to “barely minimal facilities” in 1974, five years before GAS was formally banned. Over the next 5 years, the clinic co-inhabited space with the Department of Obstetrics and Gynecology. Simultaneously, the Department of Obstetrics and Gynecology navigated scandals related to reproductive technology (namely, the Dalkon Shield [A.H. Robins] controversy) until the clinic space was demolished in 1979. The study that informed the GAS ban was preferentially funded in keeping with the political economy of biomedical research. This article presents a spatial argument for how the closure of the nation's first GAS clinic was not based in empirical data alone but was manipulated to fuel political and institutional agendas.

Oral ENT-01 Targets Enteric Neurons to Treat Constipation in Parkinson Disease: A Randomized Controlled Trial: Annals of Internal Medicine: Vol 175, No 12

Background: Parkinson disease (PD) is associated with α-synuclein (αS) aggregation within enteric neurons. ENT-01 inhibits the formation of αS aggregates and improved constipation in an open-label study in patients with PD. Objective: To evaluate the safety and efficacy of oral ENT-01 for constipation and neurologic symptoms in patients with PD and constipation. Design: Randomized, placebo-controlled phase 2b study. (ClinicalTrials.gov: NCT03781791) Setting: Outpatient. Patients: 150 patients with PD and constipation. Intervention: ENT-01 or placebo daily for up to 25 days. After baseline assessment of constipation severity, daily dosing was escalated to the prokinetic dose, the maximum dose (250 mg), or the tolerability limit, followed by a washout period. Measurements: The primary efficacy end point was the number of complete spontaneous bowel movements (CSBMs) per week. Neurologic end points included dementia (assessed using the Mini-Mental State Examination [MMSE]) and psychosis (assessed using the Scale for the Assessment of Positive Symptoms adapted for PD [SAPS-PD]). Results: The weekly CSBM rate increased from 0.7 to 3.2 in the ENT-01 group versus 0.7 to 1.2 in the placebo group (P < 0.001). Improvement in secondary end points included SBMs (P = 0.002), stool consistency (P < 0.001), ease of passage (P = 0.006), and laxative use (P = 0.041). In patients with dementia, MMSE scores improved by 3.4 points 6 weeks after treatment in the ENT-01 group (n = 14) versus 2.0 points in the placebo group (n = 14). Among patients with psychosis, SAPS-PD scores improved from 6.5 to 1.7 six weeks after treatment in the ENT-01 group (n = 5) and from 6.3 to 4.4 in the placebo group (n = 6). ENT-01 was well tolerated, with no deaths or drug-related serious adverse events. Adverse events were predominantly gastrointestinal, including nausea (34.4% [ENT-01] vs. 5.3% [placebo]; P < 0.001) and diarrhea (19.4% [ENT-01] vs. 5.3% [placebo]; P = 0.016). Limitation: Longer treatment periods need to be investigated in future studies. Conclusion: ENT-01 was safe and significantly improved constipation. Primary Funding Source: Enterin, Inc.