Bronchodilators in Tobacco-Exposed Persons with Symptoms and Preserved Lung Function.

BACKGROUND: Many persons with a history of smoking tobacco have clinically significant respiratory symptoms despite an absence of airflow obstruction as assessed by spirometry. They are often treated with medications for chronic obstructive pulmonary disease (COPD), but supporting evidence for this treatment is lacking. METHODS: We randomly assigned persons who had a tobacco-smoking history of at least 10 pack-years, respiratory symptoms as defined by a COPD Assessment Test score of at least 10 (scores range from 0 to 40, with higher scores indicating worse symptoms), and preserved lung function on spirometry (ratio of forced expiratory volume in 1 second [FEV1] to forced vital capacity [FVC] ≥0.70 and FVC ≥70% of the predicted value after bronchodilator use) to receive either indacaterol (27.5 µg) plus glycopyrrolate (15.6 µg) or placebo twice daily for 12 weeks. The primary outcome was at least a 4-point decrease (i.e., improvement) in the St. George's Respiratory Questionnaire (SGRQ) score (scores range from 0 to 100, with higher scores indicating worse health status) after 12 weeks without treatment failure (defined as an increase in lower respiratory symptoms treated with a long-acting inhaled bronchodilator, glucocorticoid, or antibiotic agent). RESULTS: A total of 535 participants underwent randomization. In the modified intention-to-treat population (471 participants), 128 of 227 participants (56.4%) in the treatment group and 144 of 244 (59.0%) in the placebo group had at least a 4-point decrease in the SGRQ score (difference, -2.6 percentage points; 95% confidence interval [CI], -11.6 to 6.3; adjusted odds ratio, 0.91; 95% CI, 0.60 to 1.37; P = 0.65). The mean change in the percent of predicted FEV1 was 2.48 percentage points (95% CI, 1.49 to 3.47) in the treatment group and -0.09 percentage points (95% CI, -1.06 to 0.89) in the placebo group, and the mean change in the inspiratory capacity was 0.12 liters (95% CI, 0.07 to 0.18) in the treatment group and 0.02 liters (95% CI, -0.03 to 0.08) in the placebo group. Four serious adverse events occurred in the treatment group, and 11 occurred in the placebo group; none were deemed potentially related to the treatment or placebo. CONCLUSIONS: Inhaled dual bronchodilator therapy did not decrease respiratory symptoms in symptomatic, tobacco-exposed persons with preserved lung function as assessed by spirometry. (Funded by the National Heart, Lung, and Blood Institute and others; RETHINC ClinicalTrials.gov number, NCT02867761.).

Comparative effectiveness of individual pneumococcal vaccines with dual pneumococcal vaccination in older United States Veterans.

INTRODUCTION: Pneumococcal vaccination recommendations are constantly evolving. Recent pneumococcal vaccination guidelines have been updated to recommend pneumococcal conjugate vaccines in older adults. However, the clinical benefits of protein conjugate vaccine (PCV 13), pneumococcal polysaccharide vaccine (PPSV 23) and dual vaccination when compared to each other remain unclear. METHODS: A retrospective cohort study conducted between 2014 and 2016 conducted at the Veterans Health administration (VHA) (N = 1,277,575). Primary outcomes were pneumococcal pneumonia and pneumococcal meningitis. Secondary outcomes were "other" pneumonia and "other" meningitis. "Other" referred to episodes of pneumonia and meningitis without an identified etiological agent. RESULTS: PCV 13 was associated with decreased risk of pneumococcal pneumonia (Adjusted HR 0.69; 95 % CI 0.51 to 0.93) and "other" pneumonia (Adjusted HR 0.74; 95 % CI 0.64 to 0.86) when compared to PPSV 23. No significant difference was found between PCV 13 and PPSV 23 in terms of pneumococcal meningitis (Adjusted HR 3.98; 95 % CI 0.74 to 21.32; P = 0.12) and "other" meningitis (Adjusted HR 0.81; 95 % CI 0.33 to 2.03; P = 0.66). Dual vaccination was also associated with a decrease in the rate of pneumococcal pneumonia (Adjusted HR 0.88; 95 % CI 0.77 to 0.99; P = 0.03) and "other" pneumonia (Adjusted HR 0.90; 95 % CI 0.85 to 0.95; P < 0.01) in comparison to PPSV 23. CONCLUSIONS: PCV 13 was associated with a 31% decrease in the rate of pneumococcal pneumonia in comparison to PPSV 23 in older adult Veterans. Our results demonstrating clinical benefit with PCV 13 vaccination are in alignment with the latest pneumococcal vaccination guidelines that recommend routine vaccination with pneumococcal conjugate vaccines in all older adults.

Aspirin versus anticoagulation for prevention of venous thromboembolism major lower extremity orthopedic surgery: a systematic review and meta-analysis.

BACKGROUND: Hip fracture surgery and lower extremity arthroplasty are associated with increased risk of both venous thromboembolism and bleeding. The best pharmacologic strategy for reducing these opposing risks is uncertain. PURPOSE: To compare venous thromboembolism (VTE) and bleeding rates in adult patients receiving aspirin versus anticoagulants after major lower extremity orthopedic surgery. DATA SOURCES: Medline, Cumulative Index to Nursing and Allied Health Literature, and the Cochrane Library through June 2013; reference lists, ClinicalTrials.gov, and scientific meeting abstracts. STUDY SELECTION: Randomized trials comparing aspirin to anticoagulants for prevention of VTE following major lower extremity orthopedic surgery. DATA EXTRACTION: Two reviewers independently extracted data on rates of VTE, bleeding, and mortality. DATA SYNTHESIS: Of 298 studies screened, 8 trials including 1408 participants met inclusion criteria; all trials screened participants for deep venous thrombosis (DVT). Overall rates of DVT did not differ statistically between aspirin and anticoagulants (relative risk [RR]: 1.15 [95% confidence interval {CI}: 0.68-1.96]). Subgrouped by type of surgery, there was a nonsignificant trend favoring anticoagulation following hip fracture repair but not knee or hip arthroplasty (hip fracture RR: 1.60 [95% CI: 0.80-3.20], 2 trials; arthroplasty RR: 1.00 [95% CI: 0.49-2.05], 5 trials). The risk of bleeding was lower with aspirin than anticoagulants following hip fracture repair (RR: 0.32 [95% CI: 0.13-0.77], 2 trials), with a nonsignificant trend favoring aspirin after arthroplasty (RR: 0.63 [95% CI: 0.33-1.21], 5 trials). Rates of pulmonary embolism were too low to provide reliable estimates. CONCLUSION: Compared with anticoagulation, aspirin may be associated with higher risk of DVT following hip fracture repair, although bleeding rates were substantially lower. Aspirin was similarly effective after lower extremity arthroplasty and may be associated with lower bleeding risk. Journal of Hospital Medicine 2014;9:579-585. © 2014 Society of Hospital Medicine.

Effectiveness and acceptability of a computerized decision support system using modified Wells criteria for evaluation of suspected pulmonary embolism.

STUDY OBJECTIVE: Ready availability of computed tomography (CT) angiography for evaluation of pulmonary embolism in emergency departments (EDs) is associated with a dramatic increase in the number of CT angiography tests. The aims of this study are to determine whether a validated prediction algorithm embedded in a computerized decision support system improves the positive yield rate of CT angiography for pulmonary embolism and is acceptable to emergency physicians. METHODS: This study was conducted as a prospective interventional study with a retrospective preinterventional comparison group. RESULTS: The implementation of the computerized physician order entry-based computerized decision support system was associated with an overall increase in the positivity rate of from 8.3% (95% confidence interval [CI] 4.9% to 12.9%) preintervention to 12.7% (95% CI 8.6% to 17.7%) postintervention, with a difference of 4.4% (95% CI -1.4% to 10.1%). A total of 404 patients were eligible for inclusion. Physician nonadherence to the computerized decision support system occurred in 105 (26.7%) cases. Fifteen patients underwent CT angiography despite low Wells score and negative D-dimer result, all of whose results were negative for pulmonary embolism. Emergency physicians did not order CT angiography for 44 patients despite high pretest probability, with one receiving a diagnosis of pulmonary embolism on a subsequent visit and another, of DVT. When emergency physicians adhered to the computerized decision support system for the evaluation of suspected pulmonary embolism, a higher yield of CT angiography for pulmonary embolism occurred, with 28 positive results of 168 CT angiography tests (16.7%; 95% CI 11.4% to 23.2%) and a difference compared with preintervention of 8.4% (95% CI 1.7% to 15.4%). Physicians cited the time required to apply the computerized decision support system and a preference for intuitive judgment as reasons for not adhering to the computerized decision support system. CONCLUSION: Use of an evidence-based computerized physician order entry-based computerized decision support system for the evaluation of suspected pulmonary embolism was associated with a higher yield of CT angiography for pulmonary embolism. The computerized decision support system, however, was poorly accepted by emergency physicians (partly because of increased computer time), leading to possibly selective use, reducing the effect on overall yield, and leading to removal of the computerized decision support system from the computer order entry. These findings emphasize the importance of facilitation of rule-based decisionmaking in the ED and attentiveness to the complex demands placed on emergency physicians.

Trends in use and yield of chest computed tomography with angiography for diagnosis of pulmonary embolism in a Connecticut hospital emergency department.

RATIONALE: We hypothesize that the ready availability of chest computed tomography (CT) scan, with angiography (CTA), for pulmonary embolism (PE) has resulted in its increased use in the emergency department (ED) with an associated decrease in positive studies. RESULTS: CTA for diagnosis of PE increased over 13-fold from 2000 to 2005. The diagnostic yield of CTA for PE decreased from 14% in 2000 to a mean (SD) of 7.2 (.91)% during subsequent years (P =.007). No significant change in yield occurred after 2001 (P = 0.51). Significantly more segmental and subsegmental embolisms were observed with the 16-slice CT in years 2004-2005 when compared to the single-slice CT used in years 2000-2003. CONCLUSIONS: CTA for PE in our hospital ED has a low-positive yield rate, suggesting overutilization. However, the positive-yield rate remained steady despite increasing numbers of CTA, suggesting increased detection of PE and/or false-positive CTA.

Granulosa cell tumor of the ovary: 10 years follow-up data of 65 patients.

BACKGROUND: Granulosa cell tumor of the ovary is an uncommon neoplasm. The majority of patients are diagnosed in early stages of disease and overall prognosis is favorable. The stage at time of diagnosis is the only prognostic factor that is unequivocally related to survival. Other prognostic factors have not been well defined and are discussed in the literature controversially. MATERIALS AND METHODS: In a multi-institutional retrospective study we analyzed all relevant clinical data of patients with histologically proven granulosa cell tumor of the ovary. We applied the Kaplan-Meier method in order to estimate overall survival rates and evaluate prognostic factors. RESULTS: The median follow-up was 75 months (range, 6-315 months). Overall survival was 87% and 76% after 5 and 10 years, respectively. Eighty percent of granulosa cell tumors were diagnosed stage I (FIGO). The survival rate after recurrence was 56.8% after 10 years. Mitotic rate (p=0.003), tumor stage (p<0.001) and residual tumor disease (p<0.001) were associated with a poor prognosis (p<0.001). Age and rupture of the tumor could not be confirmed to be of prognostic value. CONCLUSION: The results of our study showed that the mitotic index may be a valuable prognostic factor. Complete tumor resection should always be attempted, since residual tumor disease is associated with a poor prognosis. Prospective studies are needed in order to confirm our findings.