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Displaying 451 - 460 of 1907 in Annals of Internal Medicine
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Association of Work Control With Burnout and Career Intentions Among U.S. Physicians: A Multi-institution Study: Annals of Internal Medicine: Vol 178, No 1
Background: Physician control over their clinical work is hypothesized to be associated with both burnout and career intentions. Objective: To assess the association of perceived work control with burnout and career intentions. Design: A multi-institution study. Setting: Cross-sectional survey. Participants: A sample of U.S. physicians between November 2022 and December 2023. Measurements: A novel multicomponent measure of work control, Mini-Z single-item burnout measure, intent to reduce clinical hours (ITR), and intent to leave the current practice. Results: Among respondents, 61.4% (1318 of 2144) reported adequate control over patient load, 60.6% (1301 of 2144) adequate control over membership of their clinical team, and 61.3% (1434 of 2339) adequate control over workload. Adequate control over hiring of staff and clinical schedule were reported by 49.0% (772 of 1574) and 74.6% (1175 of 1574), respectively. Most respondents (58.3% [692 of 1186]) reported that they had sufficient authority/autonomy over that for which they are accountable. On multivariable analyses adjusting for personal and professional characteristics, poor control over patient load, team composition, clinical schedule, domains for which the physician is accountable, and workload were independently associated with burnout. Poor control over patient load and workload were each independently associated with ITR. Limitation: This is a cross-sectional study, so causation cannot be determined, and it is a convenience sample of practices with more than 100 physicians, so it may not be representative of all U.S. physicians. Conclusion: In this large, cross-sectional study, poor control over specific aspects of work was associated with burnout and intentions to reduce clinical effort or leave one’s organization. Efforts to reduce burnout and improve retention should consider how to provide physician control over appropriate aspects of their clinical work environment. Primary Funding Source: American Medical Association.
Ensuring Safe Practice by Late Career Physicians: Institutional Policies and Implementation Experiences
Background: Late career physicians (LCPs; physicians working beyond age 65 to 75 years) may be at higher risk for delivering unsafe care. To oversee LCPs, some health care organizations (HCOs) have adopted LCP policies requiring cognitive, physical, and practice performance screening assessments. Despite recent controversies, little is known about the content and implementation of such policies. Objective: To characterize key features of LCP policies and the perspectives of medical leaders responsible for policy development and implementation. Design: Mixed-methods study using content analysis and key informant interviews. Setting: 29 U.S. HCOs with LCP policies active in 2020. Participants: 21 purposively sampled interviewees in physician leadership roles at 18 HCOs. Measurements: Descriptive statistics of policy features and content analysis of interviews. Results: Although policies had many commonalities—mandatory universal screening at a trigger age around 70 years, a strategy of screening followed by in-depth assessment of positive results, and commitment to patient safety as the key motive—they varied substantially in the testing required, funding, processes after a positive screening result, and decision making around concerning results. Policies prioritized institutional discretion in interpreting and responding to test results; many lacked clear language about appeals or other procedural protections for physicians. Leaders were generally satisfied with policies but reported preemptive retirements as physicians approached the screening age and cautioned that substantial investment in cultivating physicians’ buy-in was required for successful rollout. Limitations: Sampled policies and interviews may not be representative of all HCOs. The analysis excluded the experiences of HCOs that tried and failed to implement LCP screening. Conclusion: Policies about LCPs are considered successful by institutional leaders. Policy variations and early adopters’ implementation experiences highlight opportunities to improve physician acceptance and program rigor. Primary Funding Source: The Greenwall Foundation.
Comparison of Semaglutide or Dulaglutide Versus Empagliflozin for Risk for Death and Cardiovascular Outcomes Among Patients With Type 2 Diabetes: Two Target Trial Emulation Studies: Annals of Internal Medicine: Vol 178, No 7
Background: Reduction of premature death and adverse cardiovascular outcomes is a key goal in type 2 diabetes management. Objective: To compare mortality and cardiovascular event risks in patients treated with semaglutide versus empagliflozin and, secondarily, dulaglutide versus empagliflozin. Design: Target trial emulation studies from observational data comparing semaglutide- or dulaglutide-treated patients with propensity score–matched patients treated with empagliflozin. Setting: Health care system of 703 academic and community clinical practices. Participants: Patients aged 45 years or older with type 2 diabetes treated from 1 January 2019 to 31 December 2024 with semaglutide, dulaglutide, or empagliflozin. Intervention: Initial treatment with semaglutide, dulaglutide, or empagliflozin. At baseline, concomitant treatment with other diabetes medication was permitted, excluding other glucagon-like peptide-1 receptor agonists or sodium–glucose cotransporter-2 inhibitors. Measurements: A composite of death, myocardial infarction (MI), or stroke was the primary outcome, and secondary composite outcomes included death or MI, MI or stroke, and individual cardiac events. Results: Patients treated with semaglutide (n = 7899) versus empagliflozin (n = 7899) were followed for a median of 2.2 years; the respective rates of the composite of death, MI, or stroke were 3.7% versus 4.5% at 2 years and 5.9% versus 6.9% at 3 years. Corresponding incidence rates for the composite outcome were 20.99 versus 23.56 per 1000 person-years, with a hazard ratio (HR) of 0.89 (95% CI, 0.78 to 1.02). The HRs for the individual outcomes were 0.97 (CI, 0.81 to 1.15) for death, 0.85 (CI, 0.68 to 1.05) for MI, and 0.62 (CI, 0.43 to 0.89) for stroke. Risks for dulaglutide- and empagliflozin-treated patients were similar for the composite outcome (HR, 1.03 [CI, 0.90 to 1.16]) and for death, MI, and stroke separately. Limitation: Observational study design, lack of data on cause-specific mortality, and residual confounding. Conclusion: Semaglutide treatment seems to confer some advantage over empagliflozin. This advantage was not observed for dulaglutide. Primary Funding Source: American Heart Association.
Modernizing Medical Device Regulation: Challenges and Opportunities for the 510(k) Clearance Process
Nearly all medical devices reviewed by the U.S. Food and Drug Administration (FDA) are authorized via the 510(k) clearance process. Established in 1976, this review pathway bases authorizations on the comparability of new devices to previously authorized devices (“predicates”). This evaluation usually does not require clinical evidence of safety and effectiveness. Advocates of the 510(k) clearance process tout its support for device innovation and rapid market access, and critics of the 510(k) clearance process express that it may inadequately protect patient safety. In September 2023, the FDA issued 3 guidance documents that, if finalized, would significantly change medical device regulation. This article provides clinical and regulatory context for the proposed guidance documents, which focus on predicate selection, clinical testing requirements, and implantable devices, and identifies opportunities for further reforms that promote transparency and patient safety.
Impact of Genomic Classifiers on Risk Stratification and Treatment Intensity in Patients With Localized Prostate Cancer: A Systematic Review: Annals of Internal Medicine: Vol 178, No 2
Background: Tissue-based genomic classifiers (GCs) have been developed to improve prostate cancer (PCa) risk assessment and treatment recommendations. Purpose: To summarize the impact of the Decipher, Oncotype DX Genomic Prostate Score (GPS), and Prolaris GCs on risk stratification and patient–clinician decisions on treatment choice among patients with localized PCa considering first-line treatment. Data Sources: MEDLINE, EMBASE, and Web of Science published from January 2010 to August 2024. Study Selection: Two investigators independently identified studies on risk classification and treatment choice after GC testing for patients with localized PCa considering first-line treatment. Data Extraction: Relevant data extracted by 1 researcher and overread by a second. Risk of bias (ROB) was assessed in duplicate. Data Synthesis: Ten studies reported risk reclassification after GC testing. In low ROB observational studies, very low- or low-risk patients with PCa were more likely to have their risk levels classified as the same or lower (GPS, 100% to 88.1%; Decipher, 87.2% to 82.9%; Prolaris, 76.9%). However, 1 randomized trial found that GC testing with GPS reclassified 34.5% of very low-risk and 29.4% of low-risk patients to a higher risk category. Twelve observational studies indicated that treatment decisions after GC testing either remained unchanged or slightly favored active surveillance. In contrast, analyses from a single randomized trial found fewer choices for active surveillance after GPS testing. Limitations: Heterogeneity in screening patterns, risk-determination cutoffs, pathology, and clinical practices. Studies on treatment choice were moderate to high ROB. Conclusion: Although GC tests do not consistently influence risk classification or treatment decisions, the differences observed between observational and randomized studies highlight a need for well-designed trials to explore the role of GC tests in patients with newly diagnosed PCa considering first-line treatment. Primary Funding Source: U.S. Department of Veterans Affairs. (PROSPERO: CRD42022347950)
Assessing the Risk for Falls in Older Adults After Initiating Gabapentin Versus Duloxetine
Background: The evidence informing the harms of gabapentin use are at risk of bias from comparing users with nonusers. Objective: To describe the risk for fall-related outcomes in older adults starting treatment with gabapentin versus duloxetine. Design: New user, active comparator study using a target trial emulation framework. Setting: MarketScan (IBM) commercial claims between January 2014 and December 2021. Participants: Adults aged 65 years or older with diabetic neuropathy, postherpetic neuralgia, or fibromyalgia and without depression, anxiety, seizures, or cancer in the 365 days before cohort entry. Intervention: New initiation of treatment with gabapentin or duloxetine (comparator). Measurements: The primary outcome was the hazard of experiencing any fall-related visit in the 6 months after initiating gabapentin or duloxetine until discontinuation of treatment. Secondary outcomes were hazard of severe fall-related events defined as a fall associated with hip fracture or emergency department visit or hospitalization associated with a fall. Stabilized inverse probability of treatment weighting was used to adjust for baseline characteristics. Results: Our analytic cohort included 57 086 older adults with a diagnosis of interest initiating treatment with gabapentin (n = 52 152) or duloxetine (n = 4934). Overall median follow-up duration was 30 days (IQR, 30 to 90 days). Weighted cumulative incidence of a fall-related visit per 1000 person-years at 30, 90, and 180 days was 103.60, 90.44, and 84.44 for gabapentin users and 203.43, 177.73, and 158.21 for duloxetine users, respectively. At 6-month follow-up, incident gabapentin users had lower hazard of falls (hazard ratio, 0.52 [95% CI, 0.43 to 0.64]), but there was no difference in the hazards of experiencing severe falls. Results were similar across sensitivity and subgroup analyses. Limitation: Claims may contain fewer frail adults and undercount falls. Conclusion: Compared with incident use of duloxetine, incident use of gabapentin was not associated with increased fall-related visits. Primary Funding Source: None.
Gastroesophageal Reflux Disease
Gastroesophageal reflux disease (GERD) is a condition that occurs when reflux of gastric contents into the esophagus causes symptoms and/or complications. The prevalence of GERD in Western societies has been estimated at 30%, making it one of the most commonly encountered disorders in primary care. The spectrum of GERD includes typical symptoms of esophageal reflux (heartburn and/or regurgitation); esophageal injury (erosive esophagitis; stricture; Barrett esophagus; and, rarely, adenocarcinoma); and extraesophageal symptoms, such as hoarseness and chronic cough. Proper diagnosis and treatment of GERD includes symptom control, exclusion of other disorders, avoiding overuse of medications and invasive testing, and minimizing complications.
Best Practices in Caring for Seriously Ill Patients
Palliative care (PC) is the art and science of providing goal-concordant care, skillfully managing complex and refractory pain and nonpain symptoms, mitigating suffering, and augmenting quality of life for seriously ill patients throughout the course of the illness trajectory. The primary team should provide generalist PC for all seriously ill patients and know when to refer patients to specialist PC. Specialty-level PC services should be reserved for complex problems beyond the scope of primary PC. This article reviews principles and best practices to support patient-centered PC.
Acute Colonic Diverticulitis
Acute colonic diverticulitis is a gastrointestinal condition that is frequently encountered by primary care and emergency department practitioners, hospitalists, surgeons, and gastroenterologists. Clinical presentation ranges from mild abdominal pain to peritonitis with sepsis. It is often diagnosed on the basis of clinical features alone, but imaging is necessary in more severe presentations to rule out such complications as abscess and perforation. Treatment depends on the severity of the presentation, the presence of complications, and underlying comorbid conditions. Medical and surgical treatment algorithms are evolving. This article provides an evidence-based, clinically relevant overview of the epidemiology, diagnosis, and treatment of acute diverticulitis.
Immune-Related Adverse Events of Immune Checkpoint Inhibitors
Immune-related adverse events (irAEs) are toxicities that arise after the administration of monoclonal antibodies targeting immune checkpoints (immune checkpoint inhibitors [ICIs]) in patients with cancer. They can occur at any time after initiation of ICI treatment, with a broad clinical phenotype that can be organ-specific or systemic. Although most irAEs manifest as mild to moderate signs and symptoms, severe forms of irAEs can lead to irreversible organ failure and have acute life-threatening presentations. Treatment should be tailored to the specific organ involved and the severity. Glucocorticoids are the first-line treatment for most irAEs, with immunosuppressants and biologics mainly used as second-line treatments.