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Cases in Precision Medicine: APOL1 and Genetic Testing in the Evaluation of Chronic Kidney Disease and Potential Transplant
This article discusses potential indications for genetic testing in an African American patient with chronic kidney disease who is being evaluated for a kidney transplant. Two known risk variants in the APOL1 (apolipoprotein L1) gene predispose to kidney disease and are found almost exclusively in persons of African ancestry. APOL1 risk variants are considered, including whether clinicians should incorporate genetic testing in the screening process for living kidney donors. In addition to APOL1 testing, the role of diagnostic exome sequencing in evaluating potential transplant recipients and donors with a positive family history of kidney disease is discussed.
Treatments for the Prevention and Management of Suicide: A Systematic Review: Annals of Internal Medicine: Vol 171, No 5
Background: Suicide is a growing public health problem, with the national rate in the United States increasing by 30% from 2000 to 2016. Purpose: To assess the benefits and harms of nonpharmacologic and pharmacologic interventions to prevent suicide and reduce suicide behaviors in at-risk adults. Data Sources: MEDLINE, EMBASE, PsycINFO, and other databases from November 2011 through May 2018. Study Selection: Systematic reviews (SRs) and randomized controlled trials (RCTs) that assessed nonpharmacologic or pharmacologic therapies for adults at risk for suicide. Data Extraction: One investigator abstracted data and assessed study quality, and a second investigator checked abstractions and assessments for accuracy. Data Synthesis: Eight SRs and 15 RCTs were included. The evidence for psychological interventions suggests that cognitive behavioral therapy (CBT) reduces suicide attempts, suicidal ideation, and hopelessness compared with treatment as usual (TAU). Limited evidence suggests that dialectical behavior therapy (DBT) reduces suicidal ideation compared with wait-list control or crisis planning. The evidence for pharmacologic treatments suggests that ketamine reduces suicidal ideation with minimal adverse events compared with placebo or midazolam. Lithium reduces rates of suicide among patients with unipolar or bipolar mood disorders compared with placebo. However, no differences were observed between lithium and other medications in reducing suicide. Limitation: Qualitative synthesis of new evidence with existing meta-analyses, methodological shortcomings of studies, heterogeneity of nonpharmacologic interventions, and limited evidence for pharmacologic treatments and harms. Conclusion: Both CBT and DBT showed modest benefit in reducing suicidal ideation compared with TAU or wait-list control, and CBT also reduced suicide attempts compared with TAU. Ketamine and lithium reduced the rate of suicide compared with placebo, but there was limited information on harms. Limited data are available to support the efficacy of other nonpharmacologic or pharmacologic interventions. Primary Funding Source: U.S. Department of Veterans Affairs Veterans Health Administration. (PROSPERO: CRD42018104978)
Menopausal Estrogen-Alone Therapy and Health Outcomes in Women With and Without Bilateral Oophorectomy: A Randomized Trial: Annals of Internal Medicine: Vol 171, No 6
Background: Whether health outcomes of menopausal estrogen therapy differ between women with and without bilateral salpingo-oophorectomy (BSO) is unknown. Objective: To examine estrogen therapy outcomes by BSO status, with additional stratification by 10-year age groups. Design: Subgroup analyses of the randomized Women's Health Initiative Estrogen-Alone Trial. (ClinicalTrials.gov: NCT00000611) Setting: 40 U.S. clinical centers. Participants: 9939 women aged 50 to 79 years with prior hysterectomy and known oophorectomy status. Intervention: Conjugated equine estrogens (CEE) (0.625 mg/d) or placebo for a median of 7.2 years. Measurements: Incidence of coronary heart disease and invasive breast cancer (the trial's 2 primary end points), all-cause mortality, and a “global index” (these end points plus stroke, pulmonary embolism, colorectal cancer, and hip fracture) during the intervention phase and 18-year cumulative follow-up. Results: The effects of CEE alone did not differ significantly according to BSO status. However, age modified the effect of CEE in women with prior BSO. During the intervention phase, CEE was significantly associated with a net adverse effect (hazard ratio for global index, 1.42 [95% CI, 1.09 to 1.86]) in older women (aged ≥70 years), but the global index was not elevated in younger women (P trend by age = 0.016). During cumulative follow-up, women aged 50 to 59 years with BSO had a treatment-associated reduction in all-cause mortality (hazard ratio, 0.68 [CI, 0.48 to 0.96]), whereas older women with BSO had no reduction (P trend by age = 0.034). There was no significant association between CEE and outcomes among women with conserved ovaries, regardless of age. Limitations: The timing of CEE in relation to BSO varied; several comparisons were made without adjustment for multiple testing. Conclusion: The effects of CEE did not differ by BSO status in the overall cohort, but some findings varied by age. Among women with prior BSO, in those aged 70 years or older, CEE led to adverse effects during the treatment period, whereas women randomly assigned to CEE before age 60 seemed to derive mortality benefit over the long term. Primary Funding Source: The WHI program is funded by the National Heart, Lung, and Blood Institute; National Institutes of Health; and U.S. Department of Health and Human Services. Wyeth Ayerst donated the study drugs.
Use of Peripherally Inserted Central Catheters in Patients With Advanced Chronic Kidney Disease: A Prospective Cohort Study: Annals of Internal Medicine: Vol 171, No 1
Background: Existing guidelines, including Choosing Wisely recommendations, endorse avoiding placement of peripherally inserted central catheters (PICCs) in patients with chronic kidney disease (CKD). Objective: To describe the frequency of and characteristics associated with PICC use in hospitalized patients with stage 3b or greater CKD (glomerular filtration rate [GFR] <45 mL/min/1.73 m2). Design: Prospective cohort study. Setting: 52 hospitals participating in the Michigan Hospital Medicine Safety Consortium. Participants: Hospitalized medical patients who received a PICC between November 2013 and September 2016. Measurements: Percentage of patients receiving PICCs who had CKD, frequency of PICC-related complications, and variation in the proportion of PICCs placed in patients with CKD. Results: Of 20 545 patients who had PICCs placed, 4743 (23.1% [95% CI, 20.9% to 25.3%]) had an estimated GFR (eGFR) less than 45 mL/min/1.73 m2 and 699 (3.4%) were receiving hemodialysis. In the intensive care unit (ICU), 30.9% (CI, 29.7% to 32.2%) of patients receiving PICCs had an eGFR less than 45 mL/min/1.73 m2; the corresponding percentage in wards was 19.3% (CI, 18.8% to 19.9%). Among patients with an eGFR less than 45 mL/min/1.73 m2, multilumen PICCs were placed more frequently than single-lumen PICCs. In wards, PICC-related complications occurred in 15.3% of patients with an eGFR less than 45 mL/min/1.73 m2 and in 15.2% of those with an eGFR of 45 mL/min/1.73 m2 or higher. The corresponding percentages in ICU settings were 22.4% and 23.9%. In patients with an eGFR less than 45 mL/min/1.73 m2, PICC placement varied widely across hospitals (interquartile range, 23.7% to 37.8% in ICUs and 12.8% to 23.7% in wards). Limitation: Nephrologist approval for placement could not be determined, and 2.7% of eGFR values were unknown and excluded. Conclusion: In this sample of hospitalized patients who received PICCs, placement in those with CKD was common and not concordant with clinical guidelines. Primary Funding Source: Blue Cross Blue Shield of Michigan and Blue Care Network.
Lipophilic Statins and Risk for Hepatocellular Carcinoma and Death in Patients With Chronic Viral Hepatitis: Results From a Nationwide Swedish Population
Background: Whether statin type influences hepatocellular carcinoma (HCC) incidence or mortality in chronic hepatitis B or C virus infection is unknown. Objective: To assess the relationship between lipophilic or hydrophilic statin use and HCC incidence and mortality in a nationwide population with viral hepatitis. Design: Prospective propensity score (PS)–matched cohort. Setting: Swedish registers, 2005 to 2013. Participants: A PS-matched cohort of 16 668 adults (8334 who initiated statin use [6554 lipophilic and 1780 hydrophilic] and 8334 nonusers) among 63 279 eligible adults. Measurements: Time to incident HCC, ascertained from validated registers. Statin use was defined from filled prescriptions as 30 or more cumulative defined daily doses (cDDDs). Results: Compared with matched nonusers, 10-year HCC risk was significantly lower among lipophilic statin users (8.1% vs. 3.3%; absolute risk difference [RD], −4.8 percentage points [95% CI, −6.2 to −3.3 percentage points]; adjusted subdistribution hazard ratio [aHR], 0.56 [CI, 0.41 to 0.79]) but not hydrophilic statin users (8.0% vs. 6.8%; RD, −1.2 percentage points [CI, −2.6 to 0.4 percentage points]; aHR, 0.95 [CI, 0.86 to 1.08]). The inverse association between lipophilic statins and HCC risk seemed to be dose-dependent. Compared with nonusers, 10-year HCC risk was lowest with 600 or more lipophilic statin cDDDs (8.4% vs. 2.5%; RD, −5.9 percentage points [CI, −7.6 to −4.2 percentage points]; aHR, 0.41 [CI, 0.32 to 0.61]), and 10-year mortality was significantly lower among both lipophilic (15.2% vs. 7.3%; RD, −7.9 percentage points [CI, −9.6 to −6.2 percentage points]) and hydrophilic (16.0% vs. 11.5%; RD, −4.5 percentage points [CI, −6.0 to −3.0 percentage points]) statin users. Limitation: Lack of lipid, fibrosis, or HCC surveillance data. Conclusion: In a nationwide viral hepatitis cohort, lipophilic statins were associated with significantly reduced HCC incidence and mortality. An association between hydrophilic statins and reduced risk for HCC was not found. Further research is needed to determine whether lipophilic statin therapy is feasible for prevention of HCC. Primary Funding Source: None.
The Cost-Effectiveness of Cognitive Behavioral Therapy Versus Second-Generation Antidepressants for Initial Treatment of Major Depressive Disorder in the United States: A Decision Analytic Model: Annals of Internal Medicine: Vol 171, No 11
Background: Most guidelines for major depressive disorder recommend initial treatment with either a second-generation antidepressant (SGA) or cognitive behavioral therapy (CBT). Although most trials suggest that these treatments have similar efficacy, their health economic implications are uncertain. Objective: To quantify the cost-effectiveness of CBT versus SGA for initial treatment of depression. Design: Decision analytic model. Data Sources: Relative effectiveness data from a meta-analysis of randomized controlled trials; additional clinical and economic data from other publications. Target Population: Adults with newly diagnosed major depressive disorder in the United States. Time Horizon: 1 to 5 years. Perspectives: Health care sector and societal. Intervention: Initial treatment with either an SGA or group and individual CBT. Outcome Measures: Costs in 2014 U.S. dollars, quality-adjusted life-years (QALYs), and incremental cost-effectiveness ratios. Results of Base-Case Analysis: In model projections, CBT produced higher QALYs (3 days more at 1 year and 20 days more at 5 years) with higher costs at 1 year (health care sector, $900; societal, $1500) but lower costs at 5 years (health care sector, −$1800; societal, −$2500). Results of Sensitivity Analysis: In probabilistic sensitivity analyses, SGA had a 64% to 77% likelihood of having an incremental cost-effectiveness ratio of $100 000 or less per QALY at 1 year; CBT had a 73% to 77% likelihood at 5 years. Uncertainty in the relative risk for relapse of depression contributed the most to overall uncertainty in the optimal treatment. Limitation: Long-term trials comparing CBT and SGA are lacking. Conclusion: Neither SGAs nor CBT provides consistently superior cost-effectiveness relative to the other. Given many patients' preference for psychotherapy over pharmacotherapy, increasing patient access to CBT may be warranted. Primary Funding Source: Department of Veterans Affairs, National Institute of Mental Health
On-Demand Sildenafil as a Treatment for Raynaud Phenomenon: A Series of n-of-1 Trials: Annals of Internal Medicine: Vol 169, No 10
Background: Treatment of Raynaud phenomenon (RP) with phosphodiesterase-5 inhibitors has shown moderate efficacy. Adverse effects decrease the risk–benefit profile of these drugs, and patients may not be willing to receive long-term treatment. On-demand single doses before or during exposure to cold may be a good alternative. Objective: To assess the efficacy and safety of on-demand sildenafil in RP. Design: Series of randomized, double-blind, n-of-1 trials. (ClinicalTrials.gov: NCT02050360) Setting: Outpatients at a French university hospital. Participants: Patients with primary or secondary RP. Intervention: Each trial consisted of a multiple crossover study in a single patient. Repeated blocks of 3 periods of on-demand treatment were evaluated: 1 week of placebo, 1 week of sildenafil at 40 mg per dose, and 1 week of sildenafil at 80 mg per dose, with a maximum of 2 doses daily. Measurements: Raynaud Condition Score (RCS) and frequency and daily duration of attacks. Skin blood flow in response to cooling also was assessed with laser speckle contrast imaging. Mixed-effects models were used and parameters were estimated in a Bayesian framework to determine individual and aggregated efficacy. Results: 38 patients completed 2 to 5 treatment blocks. On the basis of aggregated data, the probability that sildenafil at 40 mg or 80 mg was more effective than placebo was greater than 90% for all outcomes (except for RCS with sildenafil, 80 mg). However, the aggregated effect size was not clinically relevant. Yet, substantial heterogeneity in sildenafil's efficacy was observed among participants, with clinically relevant efficacy in some patients. Limitation: The response to sildenafil was substantially heterogeneous among patients. Conclusion: Despite a high probability that sildenafil is superior to placebo, substantial heterogeneity was observed in patient response and aggregated results did not show that on-demand sildenafil has clinically relevant efficacy. In this context, the use of n-of-1 trials may be an original and relevant approach in RP. Primary Funding Source: GIRCI (Groupement Interrégional de Recherche Clinique et d'Innovation) Auvergne Rhône-Alpes (academic funding) and Pfizer.
Cardiovascular Disease and Risk Management: Review of the American Diabetes Association Standards of Medical Care in Diabetes 2018
Description: The American Diabetes Association (ADA) annually updates its Standards of Medical Care in Diabetes to provide clinicians, patients, researchers, payers, and other interested parties with evidence-based recommendations for the diagnosis and management of patients with diabetes. Methods: For the 2018 standards, the ADA Professional Practice Committee searched MEDLINE through November 2017 to add, clarify, or revise recommendations on the basis of new evidence. The committee rated the recommendations as A, B, or C depending on the quality of evidence or E for expert consensus or clinical experience. The standards were reviewed and approved by the Executive Committee of the ADA Board of Directors, which includes health care professionals, scientists, and laypersons. Feedback from the larger clinical community informed revisions. Recommendations: This synopsis focuses on guidance relating to cardiovascular disease and risk management in nonpregnant adults with diabetes. Recommendations address diagnosis and treatment of cardiovascular risk factors (hypertension and dyslipidemia), aspirin use, screening for and treatment of coronary heart disease, and lifestyle interventions.
Percutaneous Closure Versus Medical Treatment in Stroke Patients With Patent Foramen Ovale: A Systematic Review and Meta-analysis: Annals of Internal Medicine: Vol 168, No 5
Background: New evidence emerged recently regarding the percutaneous closure of patent foramen ovale (PFO) to prevent recurrent stroke in patients with cryptogenic stroke. Purpose: To compare risks for recurrent cerebrovascular events in adults with PFO and cryptogenic stroke who underwent PFO closure versus those who received medical therapy alone. Data Sources: PubMed, Scopus, and Google Scholar from 1 December 2004 through 14 September 2017; references of eligible studies; relevant scientific session abstracts; and cardiology Web sites. Study Selection: Randomized controlled trials, published in English, that compared PFO closure using a currently available device with medical treatment alone and that reported, at minimum, the rates of stroke or transient ischemic attack (TIA) or of new-onset atrial fibrillation (AF) or atrial flutter (AFL). Data Extraction: 2 investigators independently extracted study data and assessed study quality. Data Synthesis: 4 of 5 trials comparing PFO closure with medical therapy used commercially available devices. These 4 trials, involving 2531 patients, found that PFO closure reduced the risk for the main outcome of stroke or TIA (risk difference [RD], −0.029 [95% CI, −0.050 to −0.007]) and increased the risk for new-onset AF or AFL (RD, 0.033 [CI, 0.012 to 0.054]). The beneficial effect of PFO closure was associated with larger interatrial shunts (P = 0.034). Limitation: Trials were not double-blind, and inclusion criteria were heterogeneous. Conclusion: Compared with medical treatment, PFO closure prevents recurrent stroke and TIA but increases the incidence of AF or AFL in PFO carriers with cryptogenic stroke. Primary Funding Source: Italian Ministry of Education, University and Research (MIUR). (PROSPERO: CRD42017074686)
Comparison of Rates of Firearm and Nonfirearm Homicide and Suicide in Black and White Non-Hispanic Men, by U.S. State
Background: The extent to which differences in homicide and suicide rates in black versus white men vary by U.S. state is unknown. Objective: To compare the rates of firearm and nonfirearm homicide and suicide in black and white non-Hispanic men by U.S. state and to examine whether these deaths are associated with state prevalence of gun ownership. Design: Surveillance study. Setting: 50 states and the District of Columbia, 2008 to 2016. Cause-of-death data were abstracted by using the Centers for Disease Control and Prevention's WONDER (Wide-ranging Online Data for Epidemiologic Research) database. Participants: Non-Hispanic black and non-Hispanic white males, all ages. Measurements: Absolute rates of and rate differences in firearm and nonfirearm homicide and suicide in black and white men. Results: During the 9-year study period, 84 113 homicides and 251 772 suicides occurred. Black–white differences in rates of firearm homicide and suicide varied widely across states. Relative to white men, black men had between 9 and 57 additional firearm homicides per 100 000 per year, with black men in Missouri, Michigan, Illinois, Indiana, and Pennsylvania having more than 40 additional firearm homicides per 100 000 per year. White men had between 2 fewer and 16 more firearm suicides per 100 000 per year, with the largest inequalities observed in southern and western states and the smallest in the District of Columbia and densely populated northeastern states. Limitations: Some homicides and suicides may have been misclassified as deaths due to unintentional injury. Survey data on state household gun ownership were collected in 2004 and may have shifted during the past decade. Conclusion: The large state-to-state variation in firearm homicide and suicide rates, as well as the racial inequalities in these numbers, highlights states where policies may be most beneficial in reducing homicide and suicide deaths and the racial disparities in their rates. Primary Funding Source: McGill University and the National Institutes of Health.