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Background: In the EPIC-HR (Evaluation of Protease Inhibition for Covid-19 in High-Risk Patients) trial, nirmatrelvir plus ritonavir led to an 89% reduction in hospitalization or death among unvaccinated outpatients with early COVID-19. The clinical impact of nirmatrelvir plus ritonavir among vaccinated populations is uncertain. Objective: To assess whether nirmatrelvir plus ritonavir reduces risk for hospitalization or death among outpatients with early COVID-19 in the setting of prevalent SARS-CoV-2 immunity and immune-evasive SARS-CoV-2 lineages. Design: Population-based cohort study analyzed to emulate a clinical trial using inverse probability–weighted models to account for anticipated bias in treatment. Setting: A large health care system providing care for 1.5 million patients in Massachusetts and New Hampshire during the Omicron wave (1 January to 17 July 2022). Patients: 44 551 nonhospitalized adults (90.3% with ≥3 vaccine doses) aged 50 years or older with COVID-19 and no contraindications for nirmatrelvir plus ritonavir. Measurements: The primary outcome was a composite of hospitalization within 14 days or death within 28 days of a COVID-19 diagnosis. Results: During the study period, 12 541 (28.1%) patients were prescribed nirmatrelvir plus ritonavir, and 32 010 (71.9%) were not. Patients prescribed nirmatrelvir plus ritonavir were more likely to be older, have more comorbidities, and be vaccinated. The composite outcome of hospitalization or death occurred in 69 (0.55%) patients who were prescribed nirmatrelvir plus ritonavir and 310 (0.97%) who were not (adjusted risk ratio, 0.56 [95% CI, 0.42 to 0.75]). Recipients of nirmatrelvir plus ritonavir had lower risk for hospitalization (adjusted risk ratio, 0.60 [CI, 0.44 to 0.81]) and death (adjusted risk ratio, 0.29 [CI, 0.12 to 0.71]). Limitation: Potential residual confounding due to differential access to COVID-19 vaccines, diagnostic tests, and treatment. Conclusion: The overall risk for hospitalization or death was already low (1%) after an outpatient diagnosis of COVID-19, but nirmatrelvir plus ritonavir reduced this risk further. Primary Funding Source: National Institutes of Health.

Temporal Improvements in COVID-19 Outcomes for Hospitalized Adults: A Post Hoc Observational Study of Remdesivir Group Participants in the Adaptive COVID-19 Treatment Trial

Background: The COVID-19 standard of care (SOC) evolved rapidly during 2020 and 2021, but its cumulative effect over time is unclear. Objective: To evaluate whether recovery and mortality improved as SOC evolved, using data from ACTT (Adaptive COVID-19 Treatment Trial). Design: ACTT is a series of phase 3, randomized, double-blind, placebo-controlled trials that evaluated COVID-19 therapeutics from February 2020 through May 2021. ACTT-1 compared remdesivir plus SOC to placebo plus SOC, and in ACTT-2 and ACTT-3, remdesivir plus SOC was the control group. This post hoc analysis compared recovery and mortality between these comparable sequential cohorts of patients who received remdesivir plus SOC, adjusting for baseline characteristics with propensity score weighting. The analysis was repeated for participants in ACTT-3 and ACTT-4 who received remdesivir plus dexamethasone plus SOC. Trends in SOC that could explain outcome improvements were analyzed. (ClinicalTrials.gov: NCT04280705 [ACTT-1], NCT04401579 [ACTT-2], NCT04492475 [ACTT-3], and NCT04640168 [ACTT-4]) Setting: 94 hospitals in 10 countries (86% U.S. participants). Participants: Adults hospitalized with COVID-19. Intervention: SOC. Measurements: 28-day mortality and recovery. Results: Although outcomes were better in ACTT-2 than in ACTT-1, adjusted hazard ratios (HRs) were close to 1 (HR for recovery, 1.04 [95% CI, 0.92 to 1.17]; HR for mortality, 0.90 [CI, 0.56 to 1.40]). Comparable patients were less likely to be intubated in ACTT-2 than in ACTT-1 (odds ratio, 0.75 [CI, 0.53 to 0.97]), and hydroxychloroquine use decreased. Outcomes improved from ACTT-2 to ACTT-3 (HR for recovery, 1.43 [CI, 1.24 to 1.64]; HR for mortality, 0.45 [CI, 0.21 to 0.97]). Potential explanatory factors (SOC trends, case surges, and variant trends) were similar between ACTT-2 and ACTT-3, except for increased dexamethasone use (11% to 77%). Outcomes were similar in ACTT-3 and ACTT-4. Antibiotic use decreased gradually across all stages. Limitation: Unmeasured confounding. Conclusion: Changes in patient composition explained improved outcomes from ACTT-1 to ACTT-2 but not from ACTT-2 to ACTT-3, suggesting improved SOC. These results support excluding nonconcurrent controls from analysis of platform trials in rapidly changing therapeutic areas. Primary Funding Source: National Institute of Allergy and Infectious Diseases.

Prevalence and Characteristics of Adrenal Tumors in an Unselected Screening Population: A Cross-Sectional Study: Annals of Internal Medicine: Vol 175, No 10

Background: With the widespread use of advanced imaging technology, adrenal tumors are increasingly being identified. Objective: To investigate the prevalence and characteristics of adrenal tumors in an unselected screening population in China. Design: Cross-sectional study. (ClinicalTrials.gov: NCT04682938) Setting: A health examination center in China. Patients: Adults having an annual checkup were invited to be screened for adrenal tumors by adrenal computed tomography. Measurements: The participants with adrenal tumors had further evaluation for malignancy risk and adrenal function. Results: A total of 25 356 participants were screened, 351 of whom were found to have adrenal tumors, for a prevalence of 1.4%. The prevalence increased with age, from 0.2% in participants aged 18 to 25 years to 3.2% in those older than 65 years. Among 351 participants with adrenal tumors, 337 were diagnosed with an adrenocortical adenoma, 14 with another benign nodule, and none with a malignant mass. In 212 participants with an adenoma who completed endocrine testing, 69.3% were diagnosed with a nonfunctioning adenoma, 18.9% with cortisol autonomy, 11.8% with primary aldosteronism, and none with pheochromocytoma. Proportions of nonfunctioning adenomas were similarly high in various age groups (72.2%, 67.8%, and 72.2% in those aged <46, 46 to 65, and ≥66 years, respectively). Limitation: Only 212 of 337 participants with an adrenocortical adenoma had endocrine testing. Conclusion: The prevalence of adrenal tumors in the general adult screening population is 1.4%, and most of these tumors are nonfunctioning regardless of patient age. Cortisol and aldosterone secretion are the main causes of functional adenomas. Primary Funding Source: National Key Research and Development Program of China and National Natural Science Foundation of China.

From Individualized Interactions to Standardized Schedules: A History of Time Organization in U.S. Outpatient Medicine

Many outpatient physicians and patients feel that current scheduling systems do not afford enough time for direct patient–physician interaction, leaving patients feeling unheard and physicians feeling demoralized. This dissatisfaction degrades patients' trust in the health care system and contributes to workforce moral injury and burnout. In the hopes of understanding the roots of this time stress and helping to guide future decisions about how to organize physicians' time, this article describes changes in the organization of U.S. outpatient physicians' time, starting from care at home in the late 19th century. It discusses the origins of the appointment system, which was invented to be highly personalized, with assistants adjusting appointment durations to accommodate clinical activities, specific patient needs, and individual physician proclivities. The article then describes how centralization of appointment scheduling became more common as U.S. medicine became increasingly consolidated into larger and larger groups and health systems. This distanced schedulers from the people and care they were organizing and necessitated standardized appointment durations, which did not accommodate individual patient and physician needs. With the rise of managerialism, schedulers became increasingly accountable to administrators rather than patients and physicians. Whereas early appointment systems depended on personal connection between schedulers and the physicians and patients they supported, today's schedulers have few such interactions. The widespread shift to centralized scheduling and standardized time slots has contributed to misalignment among time allocation, patient care, and health care workforce well-being and is likely exacerbating ongoing tensions among patients, physicians, and administrators.

Effectiveness of an Intervention to Improve Decision Making for Older Patients With Advanced Chronic Kidney Disease: A Randomized Controlled Trial: Annals of Internal Medicine: Vol 176, No 1

Background: Older patients with advanced chronic kidney disease (CKD) face difficult decisions about managing kidney failure, frequently experiencing decisional conflict, regret, and treatment misaligned with preferences. Objective: To assess whether a decision aid about kidney replacement therapy improved decisional quality compared with usual care. Design: Multicenter, randomized, controlled trial. (ClinicalTrials.gov: NCT03522740) Setting: 8 outpatient nephrology clinics associated with 4 U.S. centers. Participants: English-fluent patients, 70 years and older with nondialysis CKD stages 4 to 5 recruited from 2018 to 2020. Intervention: DART (Decision-Aid for Renal Therapy) is an interactive, web-based decision aid for older adults with CKD. Both groups received written education about treatments. Measurements: Change in the decisional conflict scale (DCS) score from baseline to 3, 6, 12, and 18 months. Secondary outcomes included change in prognostic and treatment knowledge and change in uncertainty. Results: Among 400 participants, 363 were randomly assigned: 180 to usual care, 183 to DART. Decisional quality improved with DART with mean DCS declining compared with control (mean difference, −8.5 [95% CI, −12.0 to −5.0]; P < 0.001), with similar findings at 6 months, attenuating thereafter. At 3 months, knowledge improved with DART versus usual care (mean difference, 7.2 [CI, 3.7 to 10.7]; P < 0.001); similar findings at 6 months were modestly attenuated at 18 months (mean difference, 5.9 [CI, 1.4 to 10.3]; P = 0.010). Treatment preferences changed from 58% “unsure” at baseline to 28%, 20%, 23%, and 14% at 3, 6, 12, and 18 months, respectively, with DART, versus 51% to 38%, 35%, 32%, and 18% with usual care. Limitation: Latinx patients were underrepresented. Conclusion: DART improved decision quality and clarified treatment preferences among older adults with advanced CKD for 6 months after the DART intervention. Primary Funding Source: Patient-Centered Outcomes Research Institute (PCORI).

Contraceptive Counseling: An Essential Component of Preventive Health Care

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.

Severe Pain After Hip Fracture Repair in Older Adults: Challenging a Dominant Narrative

Characteristics of Persons Screened for Lung Cancer in the United States: A Cohort Study: Annals of Internal Medicine: Vol 175, No 11

Background: Lung cancer screening (LCS) with low-dose computed tomography (LDCT) was recommended by the U.S. Preventive Services Task Force (USPSTF) in 2013, making approximately 8 million Americans eligible for screening. The demographic characteristics and adherence of persons screened in the United States have not been reported at the population level. Objective: To define sociodemographic characteristics and adherence among persons screened and entered into the American College of Radiology's Lung Cancer Screening Registry (LCSR). Design: Cohort study. Setting: United States, 2015 to 2019. Participants: Persons receiving a baseline LDCT for LCS from 3625 facilities reporting to the LCSR. Measurements: Age, sex, and smoking status distributions (percentages) were computed among persons who were screened and among respondents in the 2015 National Health Interview Survey (NHIS) who were eligible for screening. The prevalence between the LCSR and the NHIS was compared with prevalence ratios (PRs) and 95% CIs. Adherence to annual screening was defined as having a follow-up test within 11 to 15 months of an initial LDCT. Results: Among 1 159 092 persons who were screened, 90.8% (n = 1 052 591) met the USPSTF eligibility criteria. Compared with adults from the NHIS who met the criteria (n = 1257), screening recipients in the LCSR were older (34.7% vs. 44.8% were aged 65 to 74 years; PR, 1.29 [95% CI, 1.20 to 1.39]), more likely to be female (41.8% vs. 48.1%; PR, 1.15 [CI, 1.08 to 1.23]), and more likely to currently smoke (52.3% vs. 61.4%; PR, 1.17 [CI, 1.11 to 1.23]). Only 22.3% had a repeated annual LDCT. If follow-up was extended to 24 months and more than 24 months, 34.3% and 40.3% were adherent, respectively. Limitations: Underreporting of LCS and missing data may skew demographic characteristics of persons reported to be screened. Underreporting of adherence may result in underestimates of follow-up. Conclusion: Approximately 91% of persons who had LCS met USPSTF eligibility criteria. In addition to continuing to target all eligible adults, men, those who formerly smoked, and younger eligible patients may be less likely to be screened. Adherence to annual follow-up screening was poor, potentially limiting screening effectiveness. Primary Funding Source: None.

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