Study objective Evaluation of emergency department (ED) patients with chest pain who are at low risk for acute coronary syndrome is resource intensive and may lead to false-positive test results and ...unnecessary downstream procedures. We seek to identify patients at low short-term risk for a cardiac event for whom additional ED investigations might be unnecessary. Methods We prospectively enrolled patients older than 24 years and with a primary complaint of chest pain from 3 academic EDs. Physicians completed standardized data collection forms before diagnostic testing. The primary adjudicated outcome was acute myocardial infarction, revascularization, or death of cardiac or unknown cause within 30 days. We used recursive partitioning to derive the rule and validated the model with 5,000 bootstrap replications. Results Of 2,718 patients enrolled, 336 (12%) experienced a cardiac event within 30 days (6% acute myocardial infarction, 10% revascularization, 0.2% death). We developed a rule consisting of the absence of 5 predictors: ischemic ECG changes not known to be old, history of coronary artery disease, pain typical for acute coronary syndrome, initial or 6-hour troponin level greater than the 99th percentile, and age greater than 50 years. Patients aged 40 years or younger required only a single troponin evaluation. The rule was 100% sensitive (95% confidence interval 97.2% to 100.0%) and 20.9% specific (95% confidence interval 16.9% to 24.9%) for a cardiac event within 30 days. Conclusion This clinical prediction rule identifies ED chest pain patients at very low risk for a cardiac event who may be suitable for discharge. A prospective multicenter study is needed to validate the rule and determine its effect on practice.
OBJECTIVE To estimate the association between antioxidant use and primary cancer incidence and mortality and to evaluate these effects across specific antioxidant compounds, target organs, and ...participant subgroups. METHODS Multiple electronic databases (MEDLINE, Cochrane Controlled Clinical Trials Register, EMBASE, Science Citation Index) were searched from their dates of inception until August 2005 to identify eligible randomized clinical trials. Random effects meta-analyses estimated pooled relative risks (RRs) and 95% confidence intervals (CIs) that described the effect of antioxidants vs placebo on cancer incidence and cancer mortality. RESULTS Twelve eligible trials, 9 of high methodological quality, were identified (total subject population, 104,196). Antioxidant supplementation did not significantly reduce total cancer incidence (RR, 0.99; 95% CI, 0.94-1.04) or mortality (RR, 1.03; 95% CI, 0.92-1.15) or any site-specific cancer incidence. Beta carotene supplementation was associated with an increase in the incidence of cancer among smokers (RR, 1.10; 95% CI, 1.03-1.10) and with a trend toward increased cancer mortality (RR, 1.16; 95% CI, 0.98-1.37). Selenium supplementation was associated with reduced cancer incidence in men (RR, 0.77; 95% CI, 0.64-0.92) but not in women (RR, 1.00; 95% CI, 0.89-1.13, value for interaction, P <.001) and with reduced cancer mortality (RR, 0.78; 95% CI, 0.65-0.94). Vitamin E supplementation had no apparent effect on overall cancer incidence (RR, 0.99; 95% CI, 0.94-1.04) or cancer mortality (RR, 1.04; 95% CI, 0.97-1.12). CONCLUSION Beta carotene supplementation appeared to increase cancer incidence and cancer mortality among smokers, whereas vitamin E supplementation had no effect. Selenium supplementation might have anticarcinogenic effects in men and thus requires further research. Beta carotene supplementation appeared to increase cancer incidence and mortality among smokers, whereas vitamin E supplementation had no effect; selenium supplementation might have anticarcinogenic effects.
Abstract Background Little is known about the impact of interventions to support shared decision making (SDM) with pediatric patients. Objectives To summarize the efficacy of SDM interventions in ...pediatrics on patient-centered outcomes. Data Sources We searched Ovid Medline, Ovid Embase, Ovid Cochrane Library, Web of Science, Scopus, and Ovid PsycInfo from database inception to December 30, 2013, and performed an environmental scan. Study Eligibility Criteria We included interventions designed to engage pediatric patients, parents, or both in a medical decision, regardless of study design or reported outcomes. Study Appraisal and Synthesis Methods We reviewed all studies in duplicate for inclusion, data extraction, and risk of bias assessment. Meta-analysis was performed on 3 outcomes: knowledge, decisional conflict, and satisfaction. Results Sixty-one citations describing 54 interventions met eligibility criteria. Fifteen studies reported outcomes such that they were eligible for inclusion in meta-analysis. Heterogeneity across studies was high. Meta-analysis revealed SDM interventions significantly improved knowledge (standardized mean difference SMD 1.21, 95% confidence interval CI 0.26 to 2.17, P = .01) and reduced decisional conflict (SMD −1.20, 95% CI −2.01 to −0.40, P = .003). Interventions showed a nonsignificant trend toward increased satisfaction (SMD 0.37, 95% CI −0.04 to 0.78, P = .08). Limitations Included studies were heterogeneous in nature, including their conceptions of SDM. Conclusions and Implications of Key Findings A limited evidence base suggests that pediatric SDM interventions improve knowledge and decisional conflict, but their impact on other outcomes is unclear. Systematic Review Registration Number PROSPERO CRD42013004761 ( http://www.crd.york.ac.uk/PROSPERO/display_record.asp?ID=CRD42013004761 ).
OBJECTIVE To conduct a systematic review and meta-analysis of randomized controlled trials (RCTs) to evaluate the effect of perioperative insulin infusion on outcomes important to patients. PATIENTS ...AND METHODS We used 6 search strategies including an electronic database search of MEDLINE, EMBASE, and Cochrane CENTRAL, from their inception up to May 1, 2006, and included RCTs of perioperative insulin infusion (with or without glucose targets) measuring outcomes in patients undergoing any surgery. Pairs of reviewers working independently assessed the methodological quality and characteristics of included trials and abstracted data on perioperative outcomes (ie, outcomes that occurred during hospitalization or within 30 days of surgery). RESULTS We identified 34 eligible trials. In the 14 trials that assessed mortality, there were 68 deaths among 2192 patients randomized to insulin infusion compared with 98 deaths among 2163 patients randomized to control therapy (random-effects pooled relative risk, 0.69; 95% confidence interval CI, 0.51-0.94; 99% CI, 0.46-1.04; I2 , 0%; 95% CI, 0.0%-47.4%). Hypoglycemia increased in the intensively treated group (20 trials, 119/1470 patients in insulin infusion vs 48/1476 patients in control group; relative risk, 2.07; 95% CI, 1.29-3.32; 99% CI, 1.09-3.88; I2 , 31.5%; 95% CI, 0.0%-59.0%). No significant effect was seen in any other outcomes. The available mortality data represent only 40% of the optimal information size required to reliably detect a plausible treatment effect; potential methodological and reporting biases weaken inferences. CONCLUSION Perioperative insulin infusion may reduce mortality but increases hypoglycemia in patients who are undergoing surgery; however, mortality results require confirmation in large and rigorous RCTs.
Study objective We assess the methodological quality and prognostic accuracy of clinical decision rules in emergency department (ED) syncope patients. Methods We searched 6 electronic databases, ...reviewed reference lists of included studies, and contacted content experts to identify articles for review. Studies that derived or validated clinical decision rules in ED syncope patients were included. Two reviewers independently screened records for relevance, selected studies for inclusion, assessed study quality, and abstracted data. Random-effects meta-analysis was used to pool diagnostic performance estimates across studies that derived or validated the same clinical decision rule. Between-study heterogeneity was assessed with the I2 statistic, and subgroup hypotheses were tested with a test of interaction. Results We identified 18 eligible studies. Deficiencies in outcome (blinding) and interrater reliability assessment were the most common methodological weaknesses. Meta-analysis of the San Francisco Syncope Rule (sensitivity 86% 95% confidence interval {CI} 83% to 89%; specificity 49% 95% CI 48% to 51%) and the Osservatorio Epidemiologico sulla Sincope nel Lazio risk score (sensitivity 95% 95% CI 88% to 98%; specificity 31% 95% CI 29% to 34%). Subgroup analysis identified study design (prospective, diagnostic odds ratio 8.82 95% CI 3.5 to 22 versus retrospective, diagnostic odds ratio 2.45 95% CI 0.96 to 6.21) and ECG determination (by evaluating physician, diagnostic odds ratio 25.5 95% CI 4.41 to 148 versus researcher or cardiologist, diagnostic odds ratio 4 95% CI 2.15 to 7.55) as potential explanations for the variability in San Francisco Syncope Rule performance. Conclusion The methodological quality and prognostic accuracy of clinical decision rules for syncope are limited. Differences in study design and ECG interpretation may account for the variable prognostic performance of the San Francisco Syncope Rule when validated in different practice settings.
Recognizing the impact of the decision making by the dialysis access surgeon on the successful placement of autogenous arteriovenous hemodialysis access, the Society for Vascular Surgery assembled a ...multispecialty panel to develop practice guidelines in arteriovenous access placement and maintenance with the aim of maximizing the percentage and functionality of autogenous arteriovenous accesses that are placed. The Society commissioned the Knowledge and Encounter Research Unit of the Mayo Clinic College of Medicine, Rochester, Minnesota, to systematically review the available evidence in three main areas provided by the panel: timing of referral to access surgeons, type of access placed, and effectiveness of surveillance. The panel then formulated practice guidelines in seven areas: timing of referral to the access surgeon, operative strategies to maximize the placement of autogenous arteriovenous accesses, first choice for the autogenous access, choice of arteriovenous access when a patient is not a suitable candidate for a forearm autogenous access, the role of monitoring and surveillance in arteriovenous access management, conversion of a prosthetic arteriovenous access to a secondary autogenous arteriovenous access, and management of the nonfunctional or failed arteriovenous access. For each of the guidelines, the panel stated the recommendation or suggestion, discussed the evidence or opinion upon which the recommendation or suggestion was made, detailed the values and preferences that influenced the group's decision in formulating the relevant guideline, and discussed technical remarks related to the particular guideline. In addition, detailed information is provided on various configurations of autogenous and prosthetic accesses and technical tips related to their placement.
Objective The objective of this review was to synthesize the available randomized controlled trials (RCTs) estimating the relative efficacy and safety of intensive vs less intensive glycemic control ...in preventing diabetic foot syndrome. Methods We used the umbrella design (systematic review of systematic reviews) to identify eligible RCTs. Two reviewers determined RCT eligibility and extracted descriptive, methodologic, and diabetic foot outcome data. Random-effects meta-analysis was used to pool outcome data across studies, and the I2 statistic was used to quantify heterogeneity. Results Nine RCTs enrolling 10,897 patients with type 2 diabetes were included and deemed to be at moderate risk of bias. Compared with less intensive glycemic control, intensive control (hemoglobin A1c , 6%-7.5%) was associated with a significant decrease in risk of amputation (relative risk RR, 0.65; 95% confidence interval CI, 0.45-0.94; I2 = 0%). Intensive control was significantly associated with slower decline in sensory vibration threshold (mean difference, −8.27; 95% CI, −9.75 to −6.79). There was no effect on other neuropathic changes (RR, 0.89; 95% CI, 0.75-1.05; I2 = 32%) or ischemic changes (RR, 0.92; 95% CI, 0.67-1.26; I2 = 0%). The quality of evidence is likely moderate. Conclusions Compared with less intensive glycemic control therapy, intensive control may decrease the risk of amputation in patients with diabetic foot syndrome. The reported risk reduction is likely overestimated because the trials were open and the decision to proceed with amputation could be influenced by glycemic control.
OBJECTIVE To estimate the association between plasma lipoprotein-associated phospholipase A2 (Lp-PLA2 ) levels and cardiovascular disease (CVD). METHODS We searched MEDLINE (January 1, 1985, through ...September 30, 2006), the Cochrane library (from inception through 2006), conference proceedings, and reference sections of obtained articles and contacted experts for unpublished studies. Eligible studies were cohorts with 1 year or more of follow-up or case-control designs that provided risk estimates for CVD according to blood levels of Lp-PLA2 that were unadjusted or adjusted for conventional CVD risk factors. We used random-effects meta-analysis to estimate the association between Lp-PLA2 and CVD risk and conducted preplanned subgroup analyses to identify risk-subgroup interactions that could explain between-study differences. RESULTS We found 14 eligible studies (N=20,549 patients) that reported either Lp-PLA2 plasma activity (n=5) or an immunoassay that measured the plasma concentration (n=9). The meta-analytic estimate from the unadjusted odds ratio for the association between elevated Lp-PLA2 levels and CVD risk was 1.51 (95% confidence interval, 1.30-1.75) and from the odds ratio adjusted for conventional CVD risk factors was 1.60 (95% confidence interval, 1.36-1.89). Differences in study methods explained differences in results across studies. CONCLUSIONS Lipoprotein-associated phospholipase A2 is significantly associated with CVD. The risk estimate appears to be relatively unaffected by adjustment for conventional CVD risk factors. Measurement of Lp-PLA2 may be useful in CVD risk stratification. In addition, Lp-PLA2 may represent a potential therapeutic target for CVD risk reduction.
Objectives Thoracic endografts (stent grafts) have emerged as a less invasive modality to treat various thoracic aortic lesions. The intentional coverage of the left subclavian artery (LSA) during ...the placement of these endografts is associated with several complications including stroke, spinal cord ischemia, and arm ischemia. In this review, we synthesize the available evidence regarding the complications associated with LSA coverage. Methods We searched electronic databases (MEDLINE and EMBASE) from January 1990 through February 2008 for studies that included patients who received thoracic endografts and had intentional LSA coverage. Eligible studies had a control group that either received the endograft without LSA coverage or had primary revascularization prior to coverage. Two independent reviewers determined trial eligibility and extracted descriptive, methodological and outcome data from each eligible study. Meta-analyses estimated Peto odds ratio (OR) and 95% confidence intervals (CI) to describe the strength of association between coverage and complications; the I2 statistic described the proportion of inconsistency of treatment effect among studies not due to chance. Results We found 51 eligible observational studies. LSA coverage was associated with significant increase in the risk of arm ischemia (OR 47.7; CI, 9.9-229.3; I2 = 72%, 19 studies) and vertebrobasilar ischemia (OR 10.8; CI, 3.17-36.7; I2 = 0%; eight studies); and nonsignificant increase in the risk of spinal cord ischemia (OR 2.69; CI, 0.75-9.68; I2 = 40%; eight studies) and anterior circulation stroke (OR 2.58; CI, 0.82-8.09; I2 = 64%, 13 studies). There were no significant associations between LSA coverage and death, myocardial infarction, or transient ischemic attacks. The incidence of phrenic nerve injury as a complication of primary revascularization was 4.40% (CI, 1.60%-12.20%). Data on perioperative infection were sparse and rarely reported. Conclusions Very low quality evidence suggests that LSA coverage increases the risk of arm ischemia, vertebrobasilar ischemia, and possibly spinal cord ischemia and anterior circulation stroke.
OBJECTIVE To determine the prevalence and characteristics of endocrinopathies at diagnosis of POEMS ( p olyneuropathy, o rganomegaly, e ndocrinopathy, M protein, and skin changes) syndrome. PATIENTS ...AND METHODS From January 1, 1960, through June 30, 2006, we identified 170 patients with POEMS syndrome in the Mayo Clinic dysproteinemia database. We abstracted information about endocrine abnormalities from their medical records. RESULTS Of the 170 patients with POEMS syndrome during the entire study period, the 64 patients seen after 2000 had more complete endocrine evaluations; of these 64 patients, 54 (84%) had a recognized endocrinopathy (38 men; median age, 50 years; interquartile range, 43-59 years). Hypogonadism was the most common endocrine abnormality; 26 (79%) of 33 men had subnormal total testosterone levels, and 10 men had gynecomastia. Among the 35 patients with measured prolactin levels, 7 men and 3 women had elevated levels. Hypothyroidism was noted in 17 men and 11 women. Abnormalities in glucose metabolism were present in 24 (48%) of 50 patients; 16 patients had impaired fasting glucose levels, and 8 were diagnosed as having diabetes. Adrenal insufficiency (defined by an abnormal response of cortisol to stimulation with standard high-dose 250 μg synthetic adrenocorticotropic hormone) was noted in 6 of 9 patients tested. Fourteen (27%) of 51 patients tested had hypocalcemia. Twenty-nine (54%) of 54 patients had evidence of multiple endocrinopathies in the 4 major endocrine axes (gonadal, thyroid, glucose, and adrenal). CONCLUSION The high prevalence of endocrinopathy in our study, to our knowledge the largest published series of POEMS cases, calls for a thorough endocrine investigation in patients presenting with this syndrome.
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