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Displaying 201 - 210 of 432 in Annals of Internal Medicine
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Antithyroid Drugs and Congenital Malformations: A Nationwide Korean Cohort Study: Annals of Internal Medicine: Vol 168, No 6
Background: Untreated or insufficiently treated Graves disease in pregnancy may pose risks to both mother and fetus. Antithyroid drugs (ATDs) are the treatment mainstay, but the potential teratogenic effect of these drugs has prompted clinicians to question the safe management of this vulnerable population. Objective: To examine the association between maternal prescriptions for ATDs and congenital malformations in live births. Design: Nationwide cohort study. Setting: Korean National Health Insurance database. Participants: A cohort of 2 886 970 completed pregnancies linked to live-born infants in 2 210 253 women between 2008 and 2014. Intervention: Maternal prescriptions for ATDs in the first trimester. Measurements: The risk for overall and organ-specific congenital malformations in offspring, with logistic regression models used to control for potential confounders. Results: 12 891 pregnancies (0.45%) were exposed to ATDs during the first trimester. The prevalence of malformations in exposed offspring was 7.27%, compared with 5.94% in offspring of women who were not prescribed ATDs during pregnancy (P < 0.001) (adjusted odds ratio, 1.19 [95% CI, 1.12 to 1.28]). Absolute increases in the prevalence of congenital malformations per 1000 live births were 8.81 cases (CI, 3.92 to 13.70 cases) for propylthiouracil alone, 17.05 cases (CI, 1.94 to 32.15 cases) for methimazole (MMI) alone, and 16.53 cases (CI, 4.73 to 28.32 cases) for propylthiouracil and MMI, compared with pregnancies without ATD prescriptions. In the MMI group, a high cumulative dose (>495 mg) during the first trimester was associated with an increased risk for malformations compared with a low dose (1 to 126 mg) (adjusted odds ratio, 1.87 [CI, 1.06 to 3.30]). Limitation: The study used a prescription claims database to assess ATD exposure. Conclusion: Exposure to ATDs during the first trimester was associated with increased risk for congenital malformations, particularly for pregnancies in which women received prescriptions for MMI or both ATDs. Primary Funding Source: None.
Should We Screen This Patient for Carotid Artery Stenosis?: Grand Rounds Discussion From Beth Israel Deaconess Medical Center: Annals of Internal Medicine: Vol 167, No 7
In July 2014, the U.S. Preventive Services Task Force (USPSTF) published a clinical guideline on screening for asymptomatic carotid artery stenosis. The guideline recommended against screening in asymptomatic adults, based primarily on the results of 3 large randomized trials (grade D recommendation). The principal screening test was carotid ultrasonography, and the intervention in the 3 trials was carotid endarterectomy for patients with stenosis exceeding 50% to 60%. In a meta-analysis, carotid endarterectomy reduced rates of 1) perioperative stroke, death, or subsequent ipsilateral stroke and 2) perioperative stroke, death, or any subsequent stroke. The corresponding absolute risk differences were –2.0% (95% CI, –3.3% to –0.7%) and –3.5% (CI, –5.1% to –1.8%), respectively. However, perioperative stroke and death were substantially less common among the 3 randomized trials than in contemporaneous cohort studies (1.9% vs. 3.3%). In addition to stroke or death in patients receiving carotid endarterectomy, a harm of screening included the risk for angiography prompted by abnormal results on carotid ultrasonography. In this article, 2 discussants address the risks and benefits of screening for carotid artery disease as well as how to apply the guideline to an individual patient who is deciding whether to be screened.
Death and Cardiac Arrest in U.S. Triathlon Participants, 1985 to 2016: A Case Series: Annals of Internal Medicine: Vol 167, No 8
Background: Reports of race-related triathlon fatalities have raised questions regarding athlete safety. Objective: To describe death and cardiac arrest among triathlon participants. Design: Case series. Setting: United States. Participants: Participants in U.S. triathlon races from 1985 to 2016. Measurements: Data on deaths and cardiac arrests were assembled from such sources as the U.S. National Registry of Sudden Death in Athletes (which uses news media, Internet searches, LexisNexis archival databases, and news clipping services) and USA Triathlon (USAT) records. Incidence of death or cardiac arrest in USAT-sanctioned races from 2006 to 2016 was calculated. Results: A total of 135 sudden deaths, resuscitated cardiac arrests, and trauma-related deaths were compiled; mean (±SE) age of victims was 46.7 ± 12.4 years, and 85% were male. Most sudden deaths and cardiac arrests occurred in the swim segment (n = 90); the others occurred during bicycling (n = 7), running (n = 15), and postrace recovery (n = 8). Fifteen trauma-related deaths occurred during the bike segment. Incidence of death or cardiac arrest among USAT participants (n = 4 776 443) was 1.74 per 100 000 (2.40 in men and 0.74 in women per 100 000; P < 0.001). In men, risk increased substantially with age and was much greater for those aged 60 years and older (18.6 per 100 000 participants). Death or cardiac arrest risk was similar for short, intermediate, and long races (1.61 vs. 1.41 vs. 1.92 per 100 000 participants). At autopsy, 27 of 61 decedents (44%) had clinically relevant cardiovascular abnormalities, most frequently atherosclerotic coronary disease or cardiomyopathy. Limitations: Case identification may be incomplete and may underestimate events, particularly in the early study period. In addition, prerace medical history is unknown in most cases. Conclusion: Deaths and cardiac arrests during the triathlon are not rare; most have occurred in middle-aged and older men. Most sudden deaths in triathletes happened during the swim segment, and clinically silent cardiovascular disease was present in an unexpected proportion of decedents. Primary Funding Source: Minneapolis Heart Institute Foundation.
Percutaneous Ablation Versus Partial and Radical Nephrectomy for T1a Renal Cancer: A Population-Based Analysis: Annals of Internal Medicine: Vol 169, No 2
Background: Stage T1a renal cell carcinoma (RCC) (tumors <4 cm) is usually curable. Nephron-sparing partial nephrectomy (PN) has replaced radical nephrectomy (RN) as the standard of care for these tumors. Radical nephrectomy remains the first alternative treatment option, whereas percutaneous ablation (PA), a newer, nonsurgical treatment, is recommended less strongly because of the relative paucity of comparative PA data. Objective: To compare PA, PN, and RN outcomes. Design: Observational cohort analysis using inverse probability of treatment–weighted propensity scores. Setting: Population-based SEER (Surveillance, Epidemiology, and End Results) cancer registry data linked to Medicare claims. Patients: Persons aged 66 years or older who received treatment for T1a RCC between 2006 and 2011. Interventions: PA versus PN and RN. Measurements: RCC-specific and overall survival, 30- and 365-day postintervention complications. Results: 4310 patients were followed for a median of 52 months for overall survival and 42 months for RCC-specific survival. After PA versus PN, the 5-year RCC-specific survival rate was 95% (95% CI, 93% to 98%) versus 98% (CI, 96% to 99%); after PA versus RN, 96% (CI, 94% to 98%) versus 95% (CI, 93% to 96%). After PA versus PN, the 5-year overall survival rate was 77% (CI, 74% to 81%) versus 86% (CI, 84% to 88%); after PA versus RN, 74% (CI, 71% to 78%) versus 75% (CI, 73% to 77%). Cumulative rates of renal insufficiency 31 to 365 days after PA, PN, and RN were 11% (CI, 8% to 14%), 9% (CI, 8% to 10%), and 18% (CI, 17% to 20%), respectively. Rates of nonurologic complications within 30 days after PA, PN, and RN were 6% (CI, 4% to 9%), 29% (CI, 27% to 30%), and 30% (CI, 28% to 32%), respectively. Ten percent of patients in the PN group had intraoperative conversion to RN. Seven percent of patients in the PA group received additional PA within 1 year of treatment. Limitations: Analysis of observational data may have been affected by residual confounding by provider or from selection bias toward younger, healthier patients in the PN group. Findings from this older study population are probably less applicable to younger patients. Use of SEER–Medicare linked files prevented analysis of patients who received treatment after 2011, possibly reducing generalizability to the newest PA, PN, and RN techniques. Conclusion: For well-selected older adults with T1a RCC, PA may result in oncologic outcomes similar to those of RN, but with less long-term renal insufficiency and markedly fewer periprocedural complications. Compared with PN, PA may be associated with slightly shorter RCC-specific survival but fewer periprocedural complications. Primary Funding Source: Association of University Radiologists GE Radiology Research Academic Fellowship and Society of Interventional Radiology Foundation.
Methods and Reporting Studies Assessing Fecal Microbiota Transplantation: A Systematic Review: Annals of Internal Medicine: Vol 167, No 1
Background: Fecal microbiota transplantation (FMT) could be a novel treatment option for several chronic diseases associated with altered gut microbiota. Purpose: To examine the conduct and reporting of studies assessing FMT. Data Sources: Cochrane Central Register of Controlled Trials, PubMed, EMBASE, and Web of Science from inception to 31 January 2017. Study Selection: Two reviewers independently examined titles and abstracts to identify all English-language reports of human clinical studies assessing the safety or efficacy of FMT. Data Extraction: Three reviewers independently assessed study types and characteristics and the reporting of important methodological components of the FMT intervention. Data Synthesis: Most (84%) of the 85 published reports found addressed the use of FMTs for Clostridium difficile infection or inflammatory bowel disease, and most (87%) were non–randomized controlled trials. Important methodological components that were not reported in published studies included the following: eligibility criteria for donors (47%), materials used for collecting stools and the period of collection (96%), methods used for conservation of stools (76%), the amount and type of stools used (for example, fresh or frozen), and duration of stool conservation (67%). Many (58%) did not report an analysis of microbiota composition. Limitations: Lack of universal consensus regarding the most important methodological components of FMT and inability to assess the actual conduct of studies and whether the publication process affected the completeness of reporting. Conclusion: Key components of FMT interventions, which are necessary to replicate and understand study findings about efficacy and safety, are poorly reported. Primary Funding Source: No specific funding.
Associations Between American Board of Internal Medicine Maintenance of Certification Status and Performance on a Set of Healthcare Effectiveness Data and Information Set (HEDIS) Process Measures
Background: The value of the American Board of Internal Medicine's (ABIM) Maintenance of Certification (MOC) program has been questioned as a marker of physician quality. Objective: To assess whether physician MOC status is associated with performance on selected Healthcare Effectiveness Data and Information Set (HEDIS) process measures. Design: Annual comparisons of HEDIS process measures among physicians who did or did not maintain certification 20 years after initial certification. Setting: Fee-for-service Medicare. Participants: 1260 general internists who were initially certified in 1991 and provided care for 85 931 Medicare patients between 2009 and 2012. Measurements: Annual percentage of a physician's Medicare patients meeting each of 5 HEDIS annual or biennial standards and a composite indicating meeting all 3 HEDIS diabetes standards. Results: Among the 1260 physicians, 786 maintained their certification from 1991 to 2012 and 474 did not. The mean annual percentage of HEDIS-eligible diabetic patients who completed semiannual hemoglobin A1c testing was 58.4% among physicians who maintained certification and 54.4% among those who did not (regression-adjusted difference, 4.2 percentage points [95% CI, 2.0 to 6.5 percentage points]; P < 0.001). Diabetic patients of physicians who maintained certification more frequently met the annual standard for low-density lipoprotein (LDL) cholesterol measurement (83.1% vs. 80.5%; regression-adjusted difference, 2.3 percentage points [CI, 0.6 to 4.1 percentage points]; P = 0.008) and all 3 diabetic standards (46.0% vs. 41.6%; regression-adjusted difference, 3.1 percentage points [CI, 0.5 to 5.7 percentage points]; P = 0.019). The regression-adjusted difference in biennial eye examinations was statistically insignificant (P = 0.112). Measures for LDL cholesterol testing in patients with coronary heart disease and biennial mammography were also met more frequently among physicians who maintained certification (79.4% vs. 77.4% and 72.0% vs. 67.8%, respectively), with regression-adjusted differences of 1.7 percentage points (CI, 0.2 to 3.3 percentage points; P = 0.032) and 4.6 percentage points (CI, 2.9 to 6.3 percentage points; P < 0.001), respectively. Limitation: Potential confounding by unobserved patient, physician, and practice characteristics; inability to determine clinical significance of observed differences. Conclusion: Maintaining certification was positively associated with physician performance scores on a set of HEDIS process measures. Primary Funding Source: American Board of Internal Medicine.
Association of Viral Suppression With Lower AIDS-Defining and Non–AIDS-Defining Cancer Incidence in HIV-Infected Veterans: A Prospective Cohort Study: Annals of Internal Medicine: Vol 169, No 2
Background: Viral suppression is a primary marker of HIV treatment success. Persons with HIV are at increased risk for AIDS-defining cancer (ADC) and several types of non–AIDS-defining cancer (NADC), some of which are caused by oncogenic viruses. Objective: To determine whether viral suppression is associated with decreased cancer risk. Design: Prospective cohort. Setting: Department of Veterans Affairs. Participants: HIV-positive veterans (n = 42 441) and demographically matched uninfected veterans (n = 104 712) from 1999 to 2015. Measurements: Standardized cancer incidence rates and Poisson regression rate ratios (RRs; HIV-positive vs. uninfected persons) by viral suppression status (unsuppressed: person-time with HIV RNA levels ≥500 copies/mL; early suppression: initial 2 years with HIV RNA levels <500 copies/mL; long-term suppression: person-time after early suppression with HIV RNA levels <500 copies/mL). Results: Cancer incidence for HIV-positive versus uninfected persons was highest for unsuppressed persons (RR, 2.35 [95% CI, 2.19 to 2.51]), lower among persons with early suppression (RR, 1.99 [CI, 1.87 to 2.12]), and lowest among persons with long-term suppression (RR, 1.52 [CI, 1.44 to 1.61]). This trend was strongest for ADC (unsuppressed: RR, 22.73 [CI, 19.01 to 27.19]; early suppression: RR, 9.48 [CI, 7.78 to 11.55]; long-term suppression: RR, 2.22 [CI, 1.69 to 2.93]), much weaker for NADC caused by viruses (unsuppressed: RR, 3.82 [CI, 3.24 to 4.49]; early suppression: RR, 3.42 [CI, 2.95 to 3.97]; long-term suppression: RR, 3.17 [CI, 2.78 to 3.62]), and absent for NADC not caused by viruses. Limitation: Lower viral suppression thresholds, duration of long-term suppression, and effects of CD4+ and CD8+ T-cell counts were not thoroughly evaluated. Conclusion: Antiretroviral therapy resulting in long-term viral suppression may contribute to cancer prevention, to a greater degree for ADC than for NADC. Patients with long-term viral suppression still had excess cancer risk. Primary Funding Source: National Cancer Institute and National Institute on Alcohol Abuse and Alcoholism of the National Institutes of Health.
Mindfulness-Based Stress Reduction for Treating Low Back Pain: A Systematic Review and Meta-analysis: Annals of Internal Medicine: Vol 166, No 11
Background: Mindfulness-based stress reduction (MBSR) is frequently used to treat pain-related conditions, but its effects on low back pain are uncertain. Purpose: To assess the efficacy and safety of MBSR in patients with low back pain. Data Sources: Searches of MEDLINE/PubMed, Scopus, the Cochrane Library, and PsycINFO to 15 June 2016. Study Selection: Randomized controlled trials (RCTs) that compared MBSR with usual care or an active comparator and assessed pain intensity or pain-related disability as a primary outcome in patients with low back pain. Data Extraction: Two reviewers independently extracted data on study characteristics, patients, interventions, outcome measures, and results at short- and long-term follow-up. Risk of bias was assessed using the Cochrane risk-of-bias tool. Data Synthesis: Seven RCTs involving 864 patients with low back pain were eligible for review. Compared with usual care, MBSR was associated with short-term improvements in pain intensity (4 RCTs; mean difference [MD], −0.96 point on a numerical rating scale [95% CI, −1.64 to −0.34 point]; standardized mean difference [SMD], −0.48 point [CI, −0.82 to −0.14 point]) and physical functioning (2 RCTs; MD, 2.50 [CI, 0.90 to 4.10 point]; SMD, 0.25 [CI, 0.09 to 0.41 point]) that were not sustained in the long term. Between-group differences in disability, mental health, pain acceptance, and mindfulness were not significant at short- or long-term follow-up. Compared with an active comparator, MBSR was not associated with significant differences in short- or long-term outcomes. No serious adverse events were reported. Limitation: The number of eligible RCTs was limited; only 3 evaluated MBSR against an active comparator. Conclusion: Mindfulness-based stress reduction may be associated with short-term effects on pain intensity and physical functioning. Long-term RCTs that compare MBSR versus active treatments are needed in order to best understand the role of MBSR in the management of low back pain. Primary Funding Source: None.
Comparative Effectiveness of Management Strategies for Renal Artery Stenosis: An Updated Systematic Review: Annals of Internal Medicine: Vol 165, No 9
Background: Atherosclerotic renal artery stenosis (ARAS) is associated with high blood pressure (BP), decreased kidney function, renal replacement therapy (RRT), and death. Purpose: To compare benefits and harms of percutaneous transluminal renal angioplasty with stent placement (PTRAS) versus medical therapy alone in adults with ARAS. Data Sources: MEDLINE, EMBASE, and Cochrane Central Register of Controlled Trials from 1993 to 16 March 2016; gray literature; and prior systematic reviews. Study Selection: Randomized, controlled trials (RCTs); nonrandomized, comparative studies (NRCSs); single-group studies; and selected case reports that reported all-cause and cardiovascular mortality, RRT, kidney function, BP, and adverse events. Data Extraction: Six researchers extracted data on design, interventions, outcomes, and study quality into a Web-based database. Data Synthesis: Eighty-three studies met eligibility criteria. In 5 of 7 RCTs, PTRAS and medical therapy led to similar BP control in patients with ARAS, and no RCTs showed statistically significant differences in kidney function, mortality, RRT, cardiovascular events, or pulmonary edema. Eight NRCSs had more variable results, finding mostly no significant differences in mortality, RRT, or cardiovascular events but heterogeneous effects on kidney function and BP. Procedure-related adverse events were rare, and medication-related adverse events were not reported. Two RCTs found no patient characteristics that were associated with outcomes with either PTRAS or medical therapy. Single-group studies found various but inconsistent factors that predict outcomes. Case reports provided examples of clinical improvement after PTRAS in patients with acute decompensation. Limitation: Limited clinical applicability and power in RCTs, and possible publication bias and lack of adjusted analyses in NRCSs. Conclusion: The strength of evidence regarding the relative benefits and harms of PTRAS versus medical therapy alone for patients with ARAS is low. Studies have generally focused on patients with less severe ARAS. Primary Funding Source: Agency for Healthcare Research and Quality.
Wells Rule and d-Dimer Testing to Rule Out Pulmonary Embolism: A Systematic Review and Individual-Patient Data Meta-analysis: Annals of Internal Medicine: Vol 165, No 4
Background: The performance of different diagnostic strategies for pulmonary embolism (PE) in patient subgroups is unclear. Purpose: To evaluate and compare the efficiency and safety of the Wells rule with fixed or age-adjusted d-dimer testing overall and in inpatients and persons with cancer, chronic obstructive pulmonary disease, previous venous thromboembolism, delayed presentation, and age 75 years or older. Data Sources: MEDLINE and EMBASE from 1 January 1988 to 13 February 2016. Study Selection: 6 prospective studies in which the diagnostic management of PE was guided by the dichotomized Wells rule and quantitative d-dimer testing. Data Extraction: Individual data of 7268 patients; risk of bias assessed by 2 investigators with the QUADAS-2 (Quality Assessment of Diagnostic Accuracy Studies 2) tool. Data Synthesis: The proportion of patients in whom imaging could be withheld based on a “PE-unlikely” Wells score and a negative d-dimer test result (efficiency) was estimated using fixed (≤500 µg/L) and age-adjusted (age × 10 µg/L in patients aged >50 years) d-dimer thresholds; their 3-month incidence of symptomatic venous thromboembolism (failure rate) was also estimated. Overall, efficiency increased from 28% to 33% when the age-adjusted (instead of the fixed) d-dimer threshold was applied. This increase was more prominent in elderly patients (12%) but less so in inpatients (2.6%). The failure rate of age-adjusted d-dimer testing was less than 3% in all examined subgroups. Limitation: Post hoc analysis, between-study differences in patient characteristics, use of various d-dimer assays, and limited statistical power to assess failure rate. Conclusion: Age-adjusted d-dimer testing is associated with a 5% absolute increase in the proportion of patients with suspected PE in whom imaging can be safely withheld compared with fixed d-dimer testing. This strategy seems safe across different high-risk subgroups, but its efficiency varies. Primary Funding Source: None.