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Displaying 71 - 80 of 430 in Annals of Internal Medicine
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The Incidence of SARS-CoV-2 Reinfection in Persons With Naturally Acquired Immunity With and Without Subsequent Receipt of a Single Dose of BNT162b2 Vaccine: A Retrospective Cohort Study: Annals of Internal Medicine: Vol 175, No 5
Background: There is insufficient evidence regarding the magnitude and durability of protection conferred by a combined effect of naturally acquired immunity after SARS-CoV-2 infection and vaccine-induced immunity. Objective: To compare the incidence rate of SARS-CoV-2 reinfection in previously infected persons to that of previously infected persons who subsequently received a single dose of BNT162b2 messenger RNA vaccine. Design: A retrospective cohort study emulating a randomized controlled target trial through a series of nested trials. Setting: Nationally centralized database of Maccabi Healthcare Services, Israel. Participants: Persons with documented SARS-CoV-2 infection who did not receive subsequent SARS-CoV-2 vaccination were compared with persons with documented SARS-CoV-2 infection who received a single dose of the BNT162b2 vaccine at least 3 months after infection. Intervention: Forty-one randomized controlled trials were emulated, in which 107 413 Maccabi Healthcare Services' members aged 16 years and older were eligible for at least 1 trial. Measurements: SARS-CoV-2–related outcomes of infection, symptomatic disease, hospitalization, and death, between 2 March and 13 December 2021. Results: A statistically significant decreased risk (hazard ratio, 0.18 [95% CI, 0.15 to 0.20]) for reinfection was found among persons who were previously infected and then vaccinated versus those who were previously infected but remained unvaccinated. In addition, there was a decreased risk for symptomatic disease (hazard ratio, 0.24 [CI, 0.20 to 0.29]) among previously infected and vaccinated persons compared with those who were not vaccinated after infection. No COVID-19–related mortality cases were found. Limitation: Hybrid protection against non-Delta variants could not be inferred. Conclusion: Persons previously infected with SARS-CoV-2 gained additional protection against reinfection and COVID-19 from a subsequent single dose of the BNT162b2 vaccine. Nonetheless, even without a subsequent vaccination, reinfection appeared relatively rare. Primary Funding Source: None.
Video Teleconferencing for Disease Prevention, Diagnosis, and Treatment: A Rapid Review: Annals of Internal Medicine: Vol 175, No 2
Background: Video teleconferencing (VTC) as a substitute for in-person health care or as an adjunct to usual care has increased in recent years. Purpose: To assess the benefits and harms of VTC visits for disease prevention, diagnosis, and treatment and to develop an evidence map describing gaps in the evidence. Data Sources: Systematically searched PubMed, EMBASE, Web of Science, and the Cochrane Library from 1 January 2013 to 3 March 2021. Study Selection: Two investigators independently screened the literature and identified 38 randomized controlled trials (RCTs) meeting inclusion criteria. Data Extraction: Data abstraction by a single investigator was confirmed by a second investigator; 2 investigators independently rated risk of bias. Data Synthesis: Results from 20 RCTs rated low risk of bias or some concerns of bias show that the use of VTC for the treatment and management of specific diseases produces largely similar outcomes when used to replace or augment usual care. Nine of 12 studies where VTC was intended to replace usual care and 5 of 8 studies where VTC was intended to augment usual care found similar effects between the intervention and control groups. The remaining 6 included studies (3 intended to replace usual care and 3 intended to augment usual care) found 1 or more primary outcomes that favored the VTC group over the usual care group. Studies comparing VTC with usual care that did not involve in-person care were more likely to favor the VTC group. No studies evaluated the use of VTC for diagnosis or prevention of disease. Studies that reported harms found no differences between the intervention and control groups; however, many studies did not report harms. No studies evaluated the effect of VTC on health equity or disparities. Limitations: Studies that focused on mental health, substance use disorders, maternal care, and weight management were excluded. Included studies were limited to RCTs with sample sizes of 50 patients or greater. Component analyses were not conducted in the studies. Conclusion: Replacing or augmenting aspects of usual care with VTC generally results in similar clinical effectiveness, health care use, patient satisfaction, and quality of life as usual care for areas studied. However, included trials were limited to a handful of disease categories, with patients seeking care for a limited set of purposes. Primary Funding Source: Patient-Centered Outcomes Research Institute.
Trends in Depressive Symptoms and Associated Factors During Residency, 2007 to 2019: A Repeated Annual Cohort Study: Annals of Internal Medicine: Vol 175, No 1
Background: Efforts to address the high depression rates among training physicians have been implemented at various levels of the U.S. medical education system. The cumulative effect of these efforts is unknown. Objective: To assess how the increase in depressive symptoms with residency has shifted over time and to identify parallel trends in factors that have previously been associated with resident physician depression. Design: Repeated annual cohort study. Setting: U.S. health care organizations. Participants: First-year resident physicians (interns) who started training between 2007 and 2019. Measurements: Depressive symptoms (9-item Patient Health Questionnaire [PHQ-9]) assessed at baseline and quarterly throughout internship. Results: Among 16 965 interns, baseline depressive symptoms increased from 2007 to 2019 (PHQ-9 score, 2.3 to 2.9; difference, 0.6 [95% CI, 0.3 to 0.8]). The prevalence of baseline predictors of greater increase in depressive symptoms with internship also increased across cohorts. Despite the higher prevalence of baseline risk factors, the average change in depressive symptoms with internship decreased 24.4% from 2007 to 2019 (change in PHQ-9 score, 4.1 to 3.0; difference, −1.0 [CI, −1.5 to −0.6]). This change across cohorts was greater among women (4.7 to 3.3; difference, −1.4 [CI, −1.9 to −0.9]) than men (3.5 to 2.9; difference, −0.6 [CI, −1.2 to −0.05]) and greater among nonsurgical interns (4.1 to 3.0; difference, −1.1 [CI, −1.6 to −0.6]) than surgical interns (4.0 to 3.2; difference, −0.8 [CI, −1.2 to −0.4]). In parallel to the decrease in depressive symptom change, there were increases in sleep hours, quality of faculty feedback, and use of mental health services and a decrease in work hours across cohorts. The decrease in work hours was greater for nonsurgical than surgical interns. Further, the increase in mental health treatment across cohorts was greater for women than men. Limitation: Data are observational and subject to biases due to nonrandom sampling, missing data, and unmeasured confounders, limiting causal conclusions. Conclusion: Although depression during physician training remains high, the average increase in depressive symptoms associated with internship decreased between 2007 and 2019. Primary Funding Source: National Institute of Mental Health.
Effects of Tai Chi or Conventional Exercise on Central Obesity in Middle-Aged and Older Adults: A Three-Group Randomized Controlled Trial: Annals of Internal Medicine: Vol 174, No 8
Background: Central obesity is a major manifestation of metabolic syndrome, which is a common health problem in middle-aged and older adults. Objective: To examine the therapeutic efficacy of tai chi for management of central obesity. Design: Randomized, controlled, assessor-blinded trial. (ClinicalTrials.gov: NCT03107741) Setting: A single research site in Hong Kong between 27 February 2016 and 28 February 2019. Participants: Adults aged 50 years or older with central obesity. Intervention: 543 participants were randomly assigned in a 1:1:1 ratio to a control group with no exercise intervention (n = 181), conventional exercise consisting of aerobic exercise and strength training (EX group) (n = 181), and a tai chi group (TC group) (n = 181). Interventions lasted 12 weeks. Measurements: Outcomes were assessed at baseline, week 12, and week 38. The primary outcome was waist circumference (WC). Secondary outcomes were body weight; body mass index; high-density lipoprotein cholesterol (HDL-C), triglyceride, and fasting plasma glucose levels; blood pressure; and incidence of remission of central obesity. Results: The adjusted mean difference in WC from baseline to week 12 in the control group was 0.8 cm (95% CI, −4.1 to 5.7 cm). Both intervention groups showed reductions in WC relative to control (adjusted mean differences: TC group vs. control, −1.8 cm [CI, −2.3 to −1.4 cm]; P < 0.001; EX group vs. control: −1.3 cm [CI, −1.8 to −0.9 cm]; P < 0.001); both intervention groups also showed reductions in body weight (P < 0.05) and attenuation of the decrease in HDL-C level relative to the control group. The favorable changes in WC and body weight were maintained in both the TC and EX groups, whereas the beneficial effect on HDL-C was only maintained in the TC group at week 38. Limitations: High attrition and no dietary intervention. Conclusion: Tai chi is an effective approach to reduce WC in adults with central obesity aged 50 years or older. Primary Funding Source: Health and Medical Research Fund.
Changes in Dialysis Center Quality Associated With the End-Stage Renal Disease Quality Incentive Program: An Observational Study With a Regression Discontinuity Design: Annals of Internal Medicine: Vol 174, No 8
Background: In 2012, the Centers for Medicare & Medicaid Services started levying performance-based financial penalties against outpatient dialysis centers under the mandatory End-Stage Renal Disease Quality Incentive Program. Objective: To determine whether penalization was associated with improvement in dialysis center quality. Design: Leveraging the threshold for penalization (total performance score < 60), a regression discontinuity design was used to examine the effect of penalization on quality over 2 years. Publicly available Medicare data from 2015–2018 were used. The effect of penalization at dialysis centers with different characteristics (for example, size or chain affiliation) was also examined. Setting: United States. Participants: Outpatient dialysis centers (n = 5830). Measurements: Dialysis center total performance scores (a composite metric ranging from 0 to 100 based on clinical quality and adherence to reporting requirements) and individual measures that contribute to the total performance score. Results: There were 1109 (19.0%) outpatient dialysis centers that received penalties in 2017 on the basis of performance in 2015. Penalized centers were located in ZIP codes with a higher average proportion of non-White residents (36.4% vs. 31.2%; P < 0.001) and residents with lower median income ($49 290 vs. $51 686; P < 0.001). Penalization was not associated with improvement in total performance scores in 2017 (0.4 point [95% CI, −2.5 to 3.2 points]) or 2018 (0.3 point [CI, −2.8 to 3.4 points]). This was consistent across dialysis centers with different characteristics. There was also no association between penalization and improvement in specific measures. Limitation: The study could not account for how centers respond to penalization. Conclusion: Penalization under the End-Stage Renal Disease Quality Incentive Program was not associated with improvement in the quality of outpatient dialysis centers. Primary Funding Source: None.
Comparison of Knowledge and Information-Seeking Behavior After General COVID-19 Public Health Messages and Messages Tailored for Black and Latinx Communities: A Randomized Controlled Trial: Annals of Internal Medicine: Vol 174, No 4
Background: The paucity of public health messages that directly address communities of color might contribute to racial and ethnic disparities in knowledge and behavior related to coronavirus disease 2019 (COVID-19). Objective: To determine whether physician-delivered prevention messages affect knowledge and information-seeking behavior of Black and Latinx individuals and whether this differs according to the race/ethnicity of the physician and tailored content. Design: Randomized controlled trial. (Registration: ClinicalTrials.gov, NCT04371419; American Economic Association RCT Registry, AEARCTR-0005789) Setting: United States, 13 May 2020 to 26 May 2020. Participants: 14 267 self-identified Black or Latinx adults recruited via Lucid survey platform. Intervention: Participants viewed 3 video messages regarding COVID-19 that varied by physician race/ethnicity, acknowledgment of racism/inequality, and community perceptions of mask wearing. Measurements: Knowledge gaps (number of errors on 7 facts on COVID-19 symptoms and prevention) and information-seeking behavior (number of web links demanded out of 10 proposed). Results: 7174 Black (61.3%) and 4520 Latinx (38.7%) participants were included in the analysis. The intervention reduced the knowledge gap incidence from 0.085 to 0.065 (incidence rate ratio [IRR], 0.737 [95% CI, 0.600 to 0.874]) but did not significantly change information-seeking incidence. For Black participants, messages from race/ethnicity-concordant physicians increased information-seeking incidence from 0.329 (for discordant physicians) to 0.357 (IRR, 1.085 [CI, 1.026 to 1.145]). Limitations: Participants' behavior was not directly observed, outcomes were measured immediately postintervention in May 2020, and online recruitment may not be representative. Conclusion: Physician-delivered messages increased knowledge of COVID-19 symptoms and prevention methods for Black and Latinx respondents. The desire for additional information increased with race-concordant messages for Black but not Latinx respondents. Other tailoring of the content did not make a significant difference. Primary Funding Source: National Science Foundation; Massachusetts General Hospital; and National Institutes of Health, National Institute of Diabetes and Digestive and Kidney Diseases.
Residual Shunt After Patent Foramen Ovale Closure and Long-Term Stroke Recurrence: A Prospective Cohort Study: Annals of Internal Medicine: Vol 172, No 11
Background: Residual shunt is observed in up to 25% of patients after patent foramen ovale (PFO) closure, but its long-term influence on stroke recurrence currently is unknown. Objective: To investigate the association of residual shunt after PFO closure with the incidence of recurrent stroke and transient ischemic attack (TIA). Design: Prospective cohort study comparing stroke or TIA recurrence in patients with and without residual shunt after PFO closure. Setting: Single hospital center. Participants: 1078 consecutive patients (mean age, 49.3 years) with PFO-attributable cryptogenic stroke who were undergoing percutaneous PFO closure were followed for up to 11 years. Measurements: Residual shunt was evaluated by transthoracic echocardiography with saline contrast. Primary outcome was a composite of the first recurrent ischemic stroke or TIA after PFO closure. Results: Compared with complete closure, the presence of residual shunt after PFO closure was associated with an increased incidence of recurrent stroke or TIA: 2.32 versus 0.75 events per 100 patient-years (hazard ratio [HR], 3.05 [95% CI, 1.65 to 5.62]; P < 0.001). This result remained robust after adjustment for important covariates, namely age; study period; device; presence of atrial septal aneurysm, hypertension, hyperlipidemia, diabetes, hypercoagulability, or hypermobile septum; and medication use (HR, 3.01 [CI, 1.59 to 5.69]; P < 0.001). Further stratification based on shunt size revealed that moderate or large residual shunts were associated with a higher risk for stroke or TIA recurrence (HR, 4.50 [CI, 2.20 to 9.20]; P < 0.001); the result for small residual shunts was indeterminate (HR, 2.02 [CI, 0.87 to 4.69]; P = 0.102). Limitation: Nonrandomized study with potential unmeasured confounding. Conclusion: Among patients undergoing PFO closure to prevent future stroke, the presence of residual shunt, particularly a moderate or large residual shunt, was associated with an increased risk for stroke or TIA recurrence. Primary Funding Source: National Institutes of Health.
Comparative Pricing of Branded Tenofovir Alafenamide–Emtricitabine Relative to Generic Tenofovir Disoproxil Fumarate–Emtricitabine for HIV Preexposure Prophylaxis: A Cost-Effectiveness Analysis: Annals of Internal Medicine: Vol 172, No 9
Background: Tenofovir alafenamide–emtricitabine (F/TAF) was recently approved as a noninferior and potentially safer option than tenofovir disoproxil fumarate–emtricitabine (F/TDF) for HIV preexposure prophylaxis (PrEP) in the United States. Objective: To estimate the greatest possible clinical benefits and economic savings attributable to the improved safety profile of F/TAF and the maximum price payers should be willing to pay for F/TAF over generic F/TDF. Design: Cost-effectiveness analysis. Data Sources: Published literature on F/TDF safety (in persons with and those without HIV) and the cost and quality-of-life effects of fractures and end-stage renal disease (ESRD). Target Population: Age-stratified U.S. men who have sex with men (MSM) using PrEP. Time Horizon: Five years. Perspective: Health care sector. Intervention: Preexposure prophylaxis with F/TAF versus F/TDF. Outcome Measures: Fractures averted, cases of ESRD averted, quality-adjusted life-years (QALYs) saved, costs, incremental cost-effectiveness ratios (ICERs), and maximum justifiable price for F/TAF compared with generic F/TDF. Results of Base-Case Analysis: Over a 5-year horizon, compared with F/TDF, F/TAF averted 2101 fractures and 25 cases of ESRD for the 123 610 MSM receiving PrEP, with an ICER of more than $7 million per QALY. At a 50% discount for generic F/TDF ($8300 per year) and a societal willingness to pay up to $100 000 per QALY, the maximum fair price for F/TAF was $8670 per year. Results of Sensitivity Analysis: Among persons older than 55 years, the ICER for F/TAF remained more than $3 million per QALY and the maximum permissible fair price for F/TAF was $8970 per year. Results were robust to alternative time horizons and PrEP-using population sizes. Limitation: Intermittent use and on-demand PrEP were not considered. Conclusion: In the presence of a generic F/TDF alternative, the improved safety of F/TAF is worth no more than an additional $370 per person per year. Primary Funding Source: National Institute of Allergy and Infectious Diseases, National Institute on Drug Abuse, National Institute of Mental Health, and Massachusetts General Hospital Executive Committee on Research.
Altered Risk for Cardiovascular Events With Changes in the Metabolic Syndrome Status: A Nationwide Population-Based Study of Approximately 10 Million Persons: Annals of Internal Medicine: Vol 171, No 12
Background: Population-scale evidence for the association between dynamic changes in metabolic syndrome (MetS) status and alterations in the risk for major adverse cardiovascular events (MACE) is lacking. Objective: To investigate whether recovery from or development of MetS in a population is associated with an altered risk for MACE. Design: Nationwide cohort study. Setting: An analysis based on the National Health Insurance Database of Korea. Participants: A total of 27 161 051 persons who received national health screenings from 2009 to 2014 were screened. Those with a history of MACE were excluded. We determined the MetS status of 9 553 042 persons using the following harmonizing criteria: MetS-chronic (n = 1 486 485), MetS-developed (n = 587 088), MetS-recovery (n = 538 806), and MetS-free (n = 6 940 663). Measurements: The outcome was the occurrence of MACE, including acute myocardial infarction, revascularization, and acute ischemic stroke, identified from the claims database. The incidence rate ratios (IRRs) were calculated with adjustments for body mass index, comorbidity scores, previous metabolic variables, and other clinical or demographic variables. Results: At a median follow-up of 3.54 years, the MetS-recovery group (incidence rate, 4.55 per 1000 person-years) had a significantly lower MACE risk (adjusted IRR, 0.85 [95% CI, 0.83 to 0.87]) than that of the MetS-chronic group (incidence rate, 8.52 per 1000 person-years). The MetS-developed group (incidence rate, 6.05 per 1000 person-years) had a significantly higher MACE risk (adjusted IRR, 1.36 [CI, 1.33 to 1.39]) than that of the MetS-free group (incidence rate, 1.92 per 1000 person-years). Among the MetS components, change in hypertension was associated with the largest difference in MACE risk. Limitation: Limited assessment of mortality and short follow-up. Conclusion: Recovery from MetS was significantly associated with decreased risk for MACE, whereas development of MetS was associated with increased risk. Primary Funding Source: Korea Healthcare Technology R&D Project, Ministry of Health and Welfare, Republic of Korea.
High-Intensity Versus Low-Intensity Surveillance for Patients With Colorectal Adenomas: A Cost-Effectiveness Analysis: Annals of Internal Medicine: Vol 171, No 9
Background: Surveillance of patients with colorectal adenomas has limited long-term evidence to support current practice. Objective: To compare the lifetime benefits and costs of high- versus low-intensity surveillance. Design: Microsimulation model. Data Sources: U.S. cancer registry, cost data, and published literature. Target Population: U.S. patients aged 50, 60, or 70 years with low-risk adenomas (LRAs) (1 to 2 small adenomas) or high-risk adenomas (HRAs) (3 to 10 small adenomas or ≥1 large adenoma) removed after screening with colonoscopy or fecal immunochemical testing (FIT). Time Horizon: Lifetime. Perspective: Societal. Intervention: No further screening or surveillance, routine screening after 10 years, low-intensity surveillance (10 years after LRA removal and 5 years after HRA removal), and high-intensity surveillance (5 years after LRA removal and 3 years after HRA removal). Outcome Measures: Colorectal cancer (CRC) incidence and incremental cost-effectiveness. Results of Base-Case Analysis: Without surveillance or screening, lifetime CRC incidence for patients aged 50 years was 10.9% after LRA removal and 17.2% after HRA removal at screening colonoscopy. Subsequent colonoscopic screening, low-intensity surveillance, or high-intensity surveillance decreased incidence by 39%, 46% to 48%, and 55% to 56%, respectively. Incidence of CRC and surveillance benefits were higher for adenomas detected at FIT screening and lower for older patients. High-intensity surveillance cost less than $30 000 per quality-adjusted life-year (QALY) gained compared with low-intensity surveillance. Results of Sensitivity Analysis: High-intensity surveillance cost less than $100 000 per QALY gained in most alternative scenarios for adenoma recurrence, CRC incidence, longevity, quality of life, screening ages, surveillance ages, test performance, disutilities, and cost. Limitation: Few surveillance outcome data exist. Conclusion: The model suggests that high-intensity surveillance as recommended in the United States provides modest but clinically relevant benefits over low-intensity surveillance at acceptable cost. Primary Funding Source: National Cancer Institute.