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Monoclonal Antibodies for Treatment of SARS-CoV-2 Infection During Pregnancy: A Cohort Study: Annals of Internal Medicine: Vol 175, No 12
Background: Monoclonal antibody (mAb) treatment decreases hospitalization and death in high-risk outpatients with mild to moderate COVID-19. However, no studies have evaluated adverse events and effectiveness of mAbs in pregnant persons compared with no mAb treatment. Objective: To determine the frequency of drug-related adverse events and obstetric-associated safety outcomes after treatment with mAb compared with no mAb treatment of pregnant persons, and the association between mAb treatment and a composite of 28-day COVID-19–related hospital admission or emergency department (ED) visit, COVID-19–associated delivery, or mortality. Design: Retrospective, propensity score–matched, cohort study. Setting: UPMC Health System from 30 April 2021 to 21 January 2022. Participants: Persons aged 12 years or older with a pregnancy episode and any documented positive SARS-CoV-2 test (polymerase chain reaction or antigen test). Intervention: Bamlanivimab and etesevimab, casirivimab and imdevimab, or sotrovimab treatment compared with no mAb treatment. Measurements: Drug-related adverse events, obstetric-associated safety outcomes among persons who delivered, and a risk-adjusted composite of 28-day COVID-19–related hospital admission or ED visit, COVID-19–associated delivery, or mortality. Results: Among 944 pregnant persons (median age [interquartile range (IQR)], 30 years [26 to 33 years]; White (79.5%; n = 750); median Charlson Comorbidity Index score [IQR], 0 [0 to 0]), 552 received mAb treatment (58%). Median gestational age at COVID-19 diagnosis or treatment was 179 days (IQR, 123 to 227), and most persons received sotrovimab (69%; n = 382). Of those with known vaccination status, 392 (62%) were fully vaccinated. Drug-related adverse events were uncommon (n = 8; 1.4%), and there were no differences in any obstetric-associated outcome among 778 persons who delivered. In the total population, the risk ratio for mAb treatment of the composite 28-day COVID-19–associated outcome was 0.71 (95% CI, 0.37 to 1.4). The propensity score–matched risk ratio was 0.61 (95% CI, 0.34 to 1.1). There were no deaths among mAb-treated patients compared with 1 death in the nontreated control patients. There were more non-COVID-19–related hospital admissions in the mAb-treated persons in the unmatched cohort (14 [2.5%] vs. 2 [0.5%]; risk ratio, 5.0; 95% CI, 1.1 to 21.7); however, there was no difference in the propensity score–matched rates, which were 2.5% mAb-treated vs. 2% untreated (risk ratio, 1.3; 95% CI, 0.58% to 2.8%). Limitations: Drug-related adverse events were patient and provider reported and potentially underrepresented. Symptom severity at the time of SARS-CoV-2 testing was not available for nontreated patients. Conclusion: In pregnant persons with mild to moderate COVID-19, adverse events after mAb treatment were mild and rare. There was no difference in obstetric-associated safety outcomes between mAb treatment and no treatment among persons who delivered. There was no difference in 28-day COVID-19–associated outcomes and non-COVID-19–related hospital admissions for mAb treatment compared with no mAb treatment in a propensity score–matched cohort. Primary Funding Source: No funding was received for this study.
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.
Long-Term Stability of Coverage Among Michigan Medicaid Beneficiaries: A Cohort Study: Annals of Internal Medicine: Vol 176, No 1
Background: Medicaid, the primary source of insurance coverage for disadvantaged Americans, was originally designed as a temporary safety-net program. No studies have used long-run data to assess the recent use of the program by beneficiaries. Objective: To assess patterns of short- and long-term enrollment among beneficiaries, using a 10-year longitudinal panel of Michigan Medicaid eligibility data. Design: Primary analyses assessing trends in Medicaid enrollment among cohorts of existing and new beneficiaries. Setting: Administrative records from Michigan Medicaid for the period 2011 to 2020. Participants: 3.97 million Medicaid beneficiaries. Measurements: Short- and long-term enrollment in the program. Results: The sample includes 3.97 million unique beneficiaries enrolled at some point between 2011 and 2020. Among a cohort of 1.23 million beneficiaries enrolled in 2011, over half (53%) were also enrolled in Medicaid in June 2020, spending, on average, two-thirds of that period (67%) on Medicaid. These beneficiaries, however, experienced substantial lapses in coverage, as only 25% were continuously enrolled throughout the period. Enrollment was less stable when assessed from the perspective of newly enrolled beneficiaries, of whom only 37% remained enrolled at the end of the study period. Limitation: Primary estimates from a single state. Conclusion: For many beneficiaries, Medicaid has served as their primary source of coverage for at least a decade. This pattern would justify increasing investments in the program to improve long-term health outcomes. Primary Funding Source: Self-funded.
Evolving Real-World Effectiveness of Monoclonal Antibodies for Treatment of COVID-19: A Cohort Study: Annals of Internal Medicine: Vol 176, No 4
Background: Treatment guidelines and U.S. Food and Drug Administration emergency use authorizations (EUAs) of monoclonal antibodies (mAbs) for treatment of high-risk outpatients with mild to moderate COVID-19 changed frequently as different SARS-CoV-2 variants emerged. Objective: To evaluate whether early outpatient treatment with mAbs, overall and by mAb product, presumed SARS-CoV-2 variant, and immunocompromised status, is associated with reduced risk for hospitalization or death at 28 days. Design: Hypothetical pragmatic randomized trial from observational data comparing mAb-treated patients with a propensity score–matched, nontreated control group. Setting: Large U.S. health care system. Participants: High-risk outpatients eligible for mAb treatment under any EUA with a positive SARS-CoV-2 test result from 8 December 2020 to 31 August 2022. Intervention: Single-dose intravenous mAb treatment with bamlanivimab, bamlanivimab–etesevimab, sotrovimab, bebtelovimab, or intravenous or subcutaneous casirivimab–imdevimab administered within 2 days of a positive SARS-CoV-2 test result. Measurements: The primary outcome was hospitalization or death at 28 days among treated patients versus a nontreated control group (no treatment or treatment ≥3 days after SARS-CoV-2 test date). Results: The risk for hospitalization or death at 28 days was 4.6% in 2571 treated patients and 7.6% in 5135 nontreated control patients (risk ratio [RR], 0.61 [95% CI, 0.50 to 0.74]). In sensitivity analyses, the corresponding RRs for 1- and 3-day treatment grace periods were 0.59 and 0.49, respectively. In subgroup analyses, those receiving mAbs when the Alpha and Delta variants were presumed to be predominant had estimated RRs of 0.55 and 0.53, respectively, compared with 0.71 for the Omicron variant period. Relative risk estimates for individual mAb products all suggested lower risk for hospitalization or death. Among immunocompromised patients, the RR was 0.45 (CI, 0.28 to 0.71). Limitations: Observational study design, SARS-CoV-2 variant presumed by date rather than genotyping, no data on symptom severity, and partial data on vaccination status. Conclusion: Early mAb treatment among outpatients with COVID-19 is associated with lower risk for hospitalization or death for various mAb products and SARS-CoV-2 variants. Primary Funding Source: None.
Anticoagulant Therapy for Cancer-Associated Thrombosis: A Cost-Effectiveness Analysis: Annals of Internal Medicine: Vol 176, No 1
Background: Direct oral anticoagulants (DOACs) offer an alternative to low-molecular-weight heparin (LMWH) and warfarin for treating cancer-associated thrombosis (CAT). Objective: To determine the cost and effectiveness of DOACs versus LMWH. Design: Cohort-state transition decision analytic model. Data Sources: Network meta-analysis comparing DOACs versus LMWH. Target Population: Adult patients with cancer at the time they develop thrombosis. Time Horizon: Lifetime. Perspective: Health care sector. Intervention: Strategies of 1) enoxaparin, 2) apixaban, 3) edoxaban, and 4) rivaroxaban for treatment of CAT. Outcome Measures: Incremental cost-effectiveness ratio (ICER) in 2022 U.S. dollars per quality-adjusted life-year (QALY) gained. Results of Base-Case Analysis: In the base-case scenario, using drug prices from the U.S. Department of Veterans Affairs Federal Supply Schedule, apixaban dominated enoxaparin and edoxaban by being less costly and more effective. Rivaroxaban was slightly more effective than apixaban, with an ICER of $493 246. In a scenario analysis using “real-world” drug prices from GoodRx, rivaroxaban was cost-effective with an ICER of $50 053 per QALY. Results of Sensitivity Analysis: Results were highly sensitive to monthly drug costs. Probabilistic sensitivity analyses showed that at a willingness-to-pay threshold of $50 000 per QALY, apixaban was preferred in 80% of simulations. However, sensitivity analyses also demonstrated that apixaban only remained cost-effective if monthly medication costs were below $530. Above this, rivaroxaban became cost-effective. Limitations: An assumption was made that patients would continue anticoagulation indefinitely unless they suffered a major bleed. Nonmedical costs such as patient and caregiver loss of productivity were not accounted for, and long-term thrombotic complications were not explicitly modeled. Conclusion: The 3 DOACs are more effective and more cost-effective than LMWH. The most cost-effective DOAC depends on the relative cost of each of these agents. These are important considerations for treating physicians and health policymakers. Primary Funding Source: None.