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Background: Population-based screening to prevent colorectal cancer (CRC) death is effective, but the effectiveness of postpolypectomy surveillance is unclear. Objective: To evaluate the additional benefit in terms of cost-effectiveness of colonoscopy surveillance in a screening setting. Design: Microsimulation using the ASCCA (Adenoma and Serrated pathway to Colorectal CAncer) model. Data Sources: Dutch CRC screening program and published literature. Target Population: Asymptomatic persons aged 55 to 75 years without a prior CRC diagnosis. Time Horizon: Lifetime. Perspective: Health care payer. Intervention: Fecal immunochemical test (FIT) screening with colonoscopy surveillance performed according to the Dutch guideline was simulated. The comparator was no screening or surveillance. FIT screening without colonoscopy surveillance and the effect of extending surveillance intervals were also evaluated. Outcome Measures: CRC burden, colonoscopy demand, life-years, and costs. Results of Base-Case Analysis: FIT screening without surveillance reduced CRC mortality by 50.4% compared with no screening or surveillance. Adding surveillance to FIT screening reduced mortality by an additional 1.7% to 52.1% but increased lifetime colonoscopy demand by 62% (from 335 to 543 colonoscopies per 1000 persons) at an additional cost of €68 000, for an increase of 0.9 life-year. Extending the surveillance intervals to 5 years reduced CRC mortality by 51.8% and increased colonoscopy demand by 42.7% compared with FIT screening without surveillance. In an incremental analysis, incremental cost-effectiveness ratios (ICERs) for screening plus surveillance exceeded the Dutch willingness-to-pay threshold of €36 602 per life-year gained. Results of Sensitivity Analysis: When using a parameter set representing low colorectal lesion prevalence or when colonoscopy costs were halved or colorectal lesion incidence was doubled, screening plus surveillance became cost-effective compared with screening without surveillance. Limitation: Limited data on FIT performance and background CRC risk in the surveillance population. Conclusion: Adding surveillance to FIT screening is not cost-effective based on the Dutch ICER threshold and substantially increases colonoscopy demand. Extending surveillance intervals to 5 years would decrease colonoscopy demand without substantial loss of effectiveness. Primary Funding Source: Alpe d'HuZes, Dutch Cancer Society, and Stand Up To Cancer.

Should We Prescribe Antibiotics to This Patient With Persistent Upper Respiratory Symptoms?: Grand Rounds Discussion From Beth Israel Deaconess Medical Center: Annals of Internal Medicine: Vol 166, No 3

The American College of Physicians (ACP) and the Centers for Disease Control and Prevention (CDC) recently published advice for high-value care on the appropriate use of antibiotics for acute respiratory tract infections. They conducted a narrative literature review of evidence for antibiotic use in this setting that included recent clinical guidelines from professional societies supplemented by randomized, controlled trials; meta-analyses; and systematic reviews. They concluded that clinicians should reserve antibiotic treatment for acute rhinosinusitis in patients with persistent symptoms for more than 10 days, high fever and purulent nasal discharge or facial pain lasting for at least 3 consecutive days, or worsening symptoms after a typical viral illness that lasted 5 days and had initially improved (“double-sickening”). In this Grand Rounds, 2 prominent clinicians debate whether to initiate antibiotic treatment in a 62-year-old man with a history of recurrent sinusitis who presents with persistent upper respiratory symptoms. They review the data on which the ACP/CDC recommendations are based and discuss the potential benefits and risks, as well as the challenges and controversies, of prescribing antibiotic therapy in this setting.

Safety-Net Hospitals, Neighborhood Disadvantage, and Readmissions Under Maryland's All-Payer Program: An Observational Study: Annals of Internal Medicine: Vol 171, No 2

Background: Safety-net hospitals have higher-than-expected readmission rates. The relative roles of the mean disadvantage of neighborhoods the hospitals serve and the disadvantage of individual patients in predicting a patient's readmission are unclear. Objective: To examine the independent contributions of the patient's neighborhood and the hospital's service area to risk for 30-day readmission. Design: Retrospective observational study. Setting: Maryland. Participants: All Maryland residents discharged from a Maryland hospital in 2015. Measurements: Predictors included the disadvantage of neighborhoods for each Maryland resident (area disadvantage index) and the mean disadvantage of each hospital's discharged patients (safety-net index). The primary outcome was unplanned 30-day hospital readmission. Generalized estimating equations and marginal modeling were used to estimate readmission rates. Results were adjusted for clinical readmission risk. Results: 13.4% of discharged patients were readmitted within 30 days. Patients living in neighborhoods at the 90th percentile of disadvantage had a readmission rate of 14.1% (95% CI, 13.6% to 14.5%) compared with 12.5% (CI, 11.8% to 13.2%) for similar patients living in neighborhoods at the 10th percentile. Patients discharged from hospitals at the 90th percentile of safety-net status had a readmission rate of 14.8% (CI, 13.4% to 16.1%) compared with 11.6% (CI, 10.5% to 12.7%) for similar patients discharged from hospitals at the 10th percentile of safety-net status. The association of readmission risk with the hospital's safety-net index was approximately twice the observed association with the patient's neighborhood disadvantage status. Limitations: Generalizability outside Maryland is unknown. Confounding may be present. Conclusion: In Maryland, residing in a disadvantaged neighborhood and being discharged from a hospital serving a large proportion of disadvantaged neighborhoods are independently associated with increased risk for readmission. Primary Funding Source: National Institute on Minority Health and Health Disparities and Maryland Health Services Cost Review Commission.

Bone Health and Bone-Targeted Therapies for Nonmetastatic Prostate Cancer: A Systematic Review and Meta-analysis: Annals of Internal Medicine: Vol 167, No 5

Background: Bone health is a significant concern in men with prostate cancer. Purpose: To evaluate the effectiveness of drug, supplement, and lifestyle interventions aimed at preventing fracture, improving bone mineral density (BMD), or preventing or delaying osteoporosis in men with nonmetastatic prostate cancer. Data Sources: Ovid MEDLINE (1946 to 19 January 2017), EMBASE (1980 to 18 January 2017), and the Cochrane Database of Systematic Reviews (19 January 2017). Study Selection: Randomized trials and systematic reviews of trials that were published in English; involved men with nonmetastatic prostate cancer; and compared bone-targeted therapies with placebo, usual care, or other active treatments. Data Extraction: Two reviewers independently extracted study characteristics and assessed study risk of bias for each outcome. Data Synthesis: Two systematic reviews and 28 reports of 27 trials met inclusion criteria. All trials focused on men with nonmetastatic prostate cancer who were initiating or continuing androgen deprivation therapy (ADT). Bisphosphonates were effective in increasing BMD, but no trial was sufficiently powered to detect reduction in fractures. Denosumab improved BMD and reduced the incidence of new radiographic vertebral fractures in 1 high-quality trial. No trials compared calcium or vitamin D versus placebo. Three lifestyle intervention trials did not show a statistically significant difference in change in BMD between exercise and usual care. Limitations: Most trials were of moderate quality. Only 2 randomized controlled trials were designed to examine fracture outcomes. Potential harms of treatments were not evaluated. Conclusion: Both bisphosphonates and denosumab improve BMD in men with nonmetastatic prostate cancer who are receiving ADT. Denosumab also reduces risk for radiographic vertebral fractures, based on 1 trial. More trials studying fracture outcomes are needed in this population. Primary Funding Source: Program in Evidence-Based Care.

Cytokine Inhibition in Patients With Chronic Fatigue Syndrome: A Randomized Trial: Annals of Internal Medicine: Vol 166, No 8

Background: Interleukin-1 (IL-1), an important proinflammatory cytokine, is suspected to play a role in chronic fatigue syndrome (CFS). Objective: To evaluate the effect of subcutaneous anakinra versus placebo on fatigue severity in female patients with CFS. Design: Randomized, placebo-controlled trial from July 2014 to May 2016. Patients, providers, and researchers were blinded to treatment assignment. (ClinicalTrials.gov: NCT02108210) Setting: University hospital in the Netherlands. Patients: 50 women aged 18 to 59 years with CFS and severe fatigue leading to functional impairment. Intervention: Participants were randomly assigned to daily subcutaneous anakinra, 100 mg (n = 25), or placebo (n = 25) for 4 weeks and were followed for an additional 20 weeks after treatment (n = 50). Measurements: The primary outcome was fatigue severity, measured by the Checklist Individual Strength subscale (CIS-fatigue) at 4 weeks. Secondary outcomes were level of impairment, physical and social functioning, psychological distress, and pain severity at 4 and 24 weeks. Results: At 4 weeks, 8% (2 of 25) of anakinra recipients and 20% (5 of 25) of placebo recipients reached a fatigue level within the range reported by healthy persons. There were no clinically important or statistically significant differences between groups in CIS-fatigue score at 4 weeks (mean difference, 1.5 points [95% CI, −4.1 to 7.2 points]) or the end of follow-up. No statistically significant between-group differences were seen for any secondary outcome at 4 weeks or the end of follow-up. One patient in the anakinra group discontinued treatment because of an adverse event. Patients in the anakinra group had more injection site reactions (68% [17 of 25] vs. 4% [1 of 25]). Limitation: Small sample size and wide variability in symptom duration; inclusion was not limited to patients with postinfectious symptoms. Conclusion: Peripheral IL-1 inhibition using anakinra for 4 weeks does not result in a clinically significant reduction in fatigue severity in women with CFS and severe fatigue. Primary Funding Source: Interleukin Foundation and an independent donor who wishes to remain anonymous.

Missed Opportunities for Measles, Mumps, Rubella Vaccination Among Departing U.S. Adult Travelers Receiving Pretravel Health Consultations

Background: Measles outbreaks continue to occur in the United States and are mostly due to infections in returning travelers. Objective: To describe how providers assessed the measles immunity status of departing U.S. adult travelers seeking pretravel consultation and to assess reasons given for nonvaccination among those considered eligible to receive the measles, mumps, rubella (MMR) vaccine. Design: Observational study in U.S. pretravel clinics. Setting: 24 sites associated with Global TravEpiNet (GTEN), a Centers for Disease Control and Prevention–funded consortium. Patients: Adults (born in or after 1957) attending pretravel consultations at GTEN sites (2009 to 2014). Measurements: Structured questionnaire completed by traveler and provider during pretravel consultation. Results: 40 810 adult travelers were included; providers considered 6612 (16%) to be eligible for MMR vaccine at the time of pretravel consultation. Of the MMR-eligible, 3477 (53%) were not vaccinated at the visit; of these, 1689 (48%) were not vaccinated because of traveler refusal, 966 (28%) because of provider decision, and 822 (24%) because of health systems barriers. Most MMR-eligible travelers who were not vaccinated were evaluated in the South (2262 travelers [65%]) or at nonacademic centers (1777 travelers [51%]). Nonvaccination due to traveler refusal was most frequent in the South (1432 travelers [63%]) and in nonacademic centers (1178 travelers [66%]). Limitation: These estimates could underrepresent the opportunities for MMR vaccination because providers accepted verbal histories of disease and vaccination as evidence of immunity. Conclusion: Of U.S. adult travelers who presented for pretravel consultation at GTEN sites, 16% met criteria for MMR vaccination according to the provider's assessment, but fewer than half of these travelers were vaccinated. An increase in MMR vaccination of eligible U.S. adult travelers could reduce the likelihood of importation and transmission of measles virus. Primary Funding Source: Centers for Disease Control and Prevention, National Institutes of Health, and the Steve and Deborah Gorlin MGH Research Scholars Award.

Historical Perspective on the Rise and Fall and Rise of Antibiotics and Human Weight Gain

In recent medical and popular literature, audiences have been asked to consider whether antibiotics have contributed to the rising obesity epidemic. Prominent magazines have stated that weight may be adversely affected by antibiotics that destroy existing microbiomes and replace them with less helpful ones. However, there is a long history of efforts to investigate the relationship between antibiotics and human weight gain. In the early 1950s, amid initial findings that low doses of antibiotics served as growth promoters in animal livestock, investigators explored the role of antibiotics as magic bullets for human malnutrition. Nevertheless, early enthusiasm was tempered by controlled studies showing that antibiotics did not serve as useful, nonspecific growth promoters for humans. In subsequent decades, against the backdrop of rising concern over antibiotic resistance, investigators studying the role of antibiotics in acute malnutrition have had to navigate a more complicated public health calculus. In a related historical stream, scientists since the 1910s have explored the role of the intestinal microflora in human health. By the 2000s, as increasing resources and more sophisticated tools were devoted to understanding the microbiome (a term coined in 2001), attention would turn to the role of antibiotics and the intestinal microflora in the rising obesity epidemic. Despite scientific and commercial enthusiasm, easy answers (whether about antibiotics or probiotics) have again given way to an appreciation for the complexity of human growth. History encourages caution about our hopes for simplistic answers for presumed “fat drugs” and slimming probiotics alike.

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