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Displaying 651 - 660 of 7510 in ACP Online
ACP Medical Student Member Winning Presentations for the 2021 National Abstracts Competition
ACP highlights 2021 virtual presentations for winning abstracts.
Quality Improvement-Patient Safety: Medical Student Oral Presentations
Social Isolation within an Urban Safety Net Hospital Patient Population Agnes Premkumar, ACP California Southern 1 Chapter
High Value Care: Medical Student Oral Presentations
Influence of Default Order Sentence Standardization on the Prescribing Patterns of Hydrocodone-Acetaminophen Combination Products Andrew Mudreac, ACP Illinois Northern Chapter
Basic Research: Medical Student Oral Presentations
Imposter Syndrome Among Minority Medical Students Martha Gallegos, ACP New Mexico Chapter
ACP Medical Student Member Winning Presentations for the 2020 National Abstracts Competition
ACP highlights virtual presentations for winning abstracts originally selected for an oral Podium Presentation at the now canceled Internal Medicine Meeting 2020.
Early Career Physicians: Physician Leadership Capstone Projects
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Early Career Physicians: Oral Presentations
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ACP Early Career Physician 2021 Winning Presentations
ACP highlights 2021 virtual presentations for winning abstracts and ACP Leadership Academy Physician Leadership Capstones.
Displaying 651 - 660 of 6736 in Annals of Internal Medicine
These Annals of Internal Medicine results only contain recent articles.
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The Regulatory Repercussions of Approving Muscular Dystrophy Medications on the Basis of Limited Evidence
The U.S. Food and Drug Administration (FDA) approved eteplirsen (Exondys 51) for Duchenne muscular dystrophy in 2016 via its accelerated approval program on the basis of a study of 12 boys. After a contentious review process and a high-profile meeting of an external advisory committee, FDA leaders concluded that very small increases in treated patients’ levels of dystrophin, a muscle protein, were reasonably likely to predict clinical benefit. The eteplirsen approval, which was followed by approvals of other drugs in the same class via the same pathway, has been controversial because of the questionable evidence underlying these decisions, delays in mandated postapproval testing, and high U.S. prices. Questions remain about the effectiveness and long-term safety of these products. Although the FDA initially set a November 2020 deadline for eteplirsen’s manufacturer to complete a clinical trial determining whether the drug has clinical benefit, the company will not complete the trial until 2024 or later. The relationship between levels of truncated dystrophin, the muscle protein studied in eteplirsen’s pivotal trial, and clinical outcomes remains uncertain. Despite recent legislative and regulatory changes to the FDA’s accelerated approval pathway, the history of eteplirsen and similar drugs points to the need for additional reforms to better balance evidence generation with patient safety and access to promising medications. Lawmakers and regulators should take further action to limit excessive spending on unproven therapies and ensure that drug sponsors conduct robust and timely confirmatory trials after receiving accelerated approval.
Efficacy of Acupuncture for Chronic Spontaneous Urticaria: A Randomized Controlled Trial: Annals of Internal Medicine: Vol 176, No 12
Background: The effectiveness of acupuncture for patients with chronic spontaneous urticaria (CSU), reported in a few small-scale studies, is not convincing. Objective: To investigate whether acupuncture leads to better effects on CSU than sham acupuncture or waitlist control. Design: A multicenter, randomized, sham-controlled trial. (Chinese Clinical Trial Registry: ChiCTR1900022994) Setting: Three teaching hospitals in China from 27 May 2019 to 30 July 2022. Participants: 330 participants diagnosed with CSU. Intervention: Participants were randomly assigned in a 1:1:1 ratio to receive acupuncture, sham acupuncture, or waitlist control over an 8-week study period (4 weeks for treatment and another 4 weeks for follow-up). Measurements: The primary outcome was the mean change from baseline in the Weekly Urticaria Activity Score (UAS7) at week 4. Secondary outcomes included itch severity scores, self-rated improvement, and Dermatology Life Quality Index scores. Results: The mean change in UAS7 (range, 0 to 42) for acupuncture from baseline (mean score, 23.5 [95% CI, 21.8 to 25.2]) to week 4 (mean score, 15.3 [CI, 13.6 to 16.9]) was −8.2 (CI, −9.9 to −6.6). The mean changes in UAS7 for sham acupuncture and waitlist control from baseline (mean scores, 21.9 [CI, 20.2 to 23.6] and 22.1 [CI, 20.4 to 23.8], respectively) to week 4 (mean scores, 17.8 [CI, 16.1 to 19.5] and 20.0 [CI, 18.3 to 21.6], respectively) were −4.1 (CI, −5.8 to −2.4) and −2.2 (CI, −3.8 to −0.5), respectively. The mean differences between acupuncture and sham acupuncture and waitlist control were −4.1 (CI, −6.5 to −1.8) and −6.1 (CI, −8.4 to −3.7), respectively, which did not meet the threshold for minimal clinically important difference. Fifteen participants (13.6%) in the acupuncture group and none in the other groups reported adverse events. Adverse events were mild or transient. Limitation: Lack of complete blinding, self-reported outcomes, limited generalizability because antihistamine use was disallowed, and short follow-up period. Conclusion: Compared with sham acupuncture and waitlist control, acupuncture produced a greater improvement in UAS7, although the difference from control was not clinically significant. Increased adverse events were mild or transient. Primary Funding Source: The National Key R&D Program of China and the Science and Technology Department of Sichuan Province.
Impact of Finerenone-Induced Albuminuria Reduction on Chronic Kidney Disease Outcomes in Type 2 Diabetes: A Mediation Analysis: Annals of Internal Medicine: Vol 176, No 12
Background: In patients with chronic kidney disease (CKD) and type 2 diabetes (T2D), finerenone, a nonsteroidal mineralocorticoid receptor antagonist, reduces cardiovascular and kidney failure outcomes. Finerenone also lowers the urine albumin-to-creatinine ratio (UACR). Whether finerenone-induced change in UACR mediates cardiovascular and kidney failure outcomes is unknown. Objective: To quantify the proportion of kidney and cardiovascular risk reductions seen over a 4-year period mediated by a change in kidney injury, as measured by the change in log UACR between baseline and month 4. Design: Post hoc mediation analysis using pooled data from 2 phase 3, double-blind trials of finerenone. (ClinicalTrials.gov: NCT02540993 and NCT02545049) Setting: Several clinical sites in 48 countries. Patients: 12 512 patients with CKD and T2D. Intervention: Finerenone and placebo (1:1). Measurements: Separate mediation analyses were done for the composite kidney (kidney failure, sustained ≥57% decrease in estimated glomerular filtration rate from baseline [approximately a doubling of serum creatinine], or kidney disease death) and cardiovascular (cardiovascular death, nonfatal myocardial infarction, nonfatal stroke, or hospitalization for heart failure) outcomes. Results: At baseline, median UACR was 514 mg/g. A 30% or greater reduction in UACR was seen in 3338 (53.2%) patients in the finerenone group and 1684 (27.0%) patients in the placebo group. Reduction in UACR (analyzed as a continuous variable) mediated 84% and 37% of the treatment effect on the kidney and cardiovascular outcomes, respectively. When change in UACR was analyzed as a binary variable (that is, whether the guideline-recommended 30% reduction threshold was met), the proportions mediated for each outcome were 64% and 26%, respectively. Limitation: The current findings are not readily extendable to other drugs. Conclusion: In patients with CKD and T2D, early albuminuria reduction accounted for a large proportion of the treatment effect against CKD progression and a modest proportion of the effect against cardiovascular outcomes. Primary Funding Source: Bayer AG.
Effect of Complementary Interventions to Redesign Care on Teamwork and Quality for Hospitalized Medical Patients: A Pragmatic Controlled Trial: Annals of Internal Medicine: Vol 176, No 11
Background: Multiple challenges impede interprofessional teamwork and the provision of high-quality care to hospitalized patients. Objective: To evaluate the effect of interventions to redesign hospital care delivery on teamwork and patient outcomes. Design: Pragmatic controlled trial. Hospitals selected 1 unit for implementation of interventions and a second to serve as a control. (ClinicalTrials.gov: NCT03745677) Setting: Medical units at 4 U.S. hospitals. Participants: Health care professionals and hospitalized medical patients. Intervention: Mentored implementation of unit-based physician teams, unit nurse–physician coleadership, enhanced interprofessional rounds, unit-level performance reports, and patient engagement activities. Measurements: Primary outcomes were teamwork climate among health care professionals and adverse events experienced by patients. Secondary outcomes were length of stay (LOS), 30-day readmissions, and patient experience. Difference-in-differences (DID) analyses of patient outcomes compared intervention versus control units before and after implementation of interventions. Results: Among 155 professionals who completed pre- and postintervention surveys, the median teamwork climate score was higher after than before the intervention only for nurses (n = 77) (median score, 88.0 [IQR, 77.0 to 91.0] vs. 80.0 [IQR, 70.0 to 89.0]; P = 0.022). Among 3773 patients, a greater percentage had at least 1 adverse event after compared with before the intervention on control units (change, 1.61 percentage points [95% CI, 0.01 to 3.22 percentage points]). A similar percentage of patients had at least 1 adverse event after compared with before the intervention on intervention units (change, 0.43 percentage point [CI, −1.25 to 2.12 percentage points]). A DID analysis of adverse events did not show a significant difference in change (adjusted DID, −0.92 percentage point [CI, −2.49 to 0.64 percentage point]; P = 0.25). Similarly, there were no differences in LOS, readmissions, or patient experience. Limitation: Adverse events occurred less frequently than anticipated, limiting statistical power. Conclusion: Despite improved teamwork climate among nurses, interventions to redesign care for hospitalized patients were not associated with improved patient outcomes. Primary Funding Source: Agency for Healthcare Research and Quality.