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Blumer I.,Charles st Diabetes Center | Hadar E.,Helen Schneider Hospital for Women | Hadden D.R.,Royal Victoria Hospital | Jovanovic L.,Sansum Diabetes Research Institute | And 3 more authors.
Journal of Clinical Endocrinology and Metabolism | Year: 2013

Objective: Our objective was to formulate a clinical practice guideline for the management of the pregnant woman with diabetes. Participants: The Task Force was composed of a chair, selected by the Clinical Guidelines Subcommittee of The Endocrine Society, 5 additional experts, a methodologist, and a medical writer. Evidence: This evidence-based guideline was developed using the Grading of Recommendations, Assessment, Development, and Evaluation (GRADE) system to describe both the strength of recommendations and the quality of evidence. Consensus Process: One group meeting, several conference calls, and innumerable e-mail communications enabled consensus for all recommendations save one with a majority decision being employed for this single exception. Conclusions: Using an evidence-based approach, this Diabetes and Pregnancy Clinical Practice Guideline addresses important clinical issues in the contemporary management of women with type 1 or type 2 diabetes preconceptionally, during pregnancy, and in the postpartum setting and in the diagnosis and management of women with gestational diabetes during and after pregnancy. Copyright © 2013 by The Endocrine Society.

Singh S.,Mayo Medical School | Garg S.K.,University of Minnesota | Pardi D.S.,Mayo Medical School | Wang Z.,Knowledge and Evaluation Research Unit | And 2 more authors.
Gastroenterology | Year: 2015

BACKGROUND & AIMS: There are several drugs that might decrease the risk of relapse of Crohn's disease (CD) after surgery, but it is unclear whether one is superior to others. We estimated the comparative efficacy of different pharmacologic interventions for postoperative prophylaxis of CD, through a network meta-analysis of randomized controlled trials. METHODS: We conducted a systematic search of the literature through March 2014. We identified randomized controlled trials that compared the abilities of mesalamine, antibiotics, budesonide, immunomodulators, anti-tumor necrosis factor α (anti-TNF) (started within 3 months of surgery), and/or placebo or no intervention to prevent clinical and/or endoscopic relapse of CD in adults after surgical resection. We used Bayesian network meta-analysis to combine direct and indirect evidence and estimate the relative effects of treatment. RESULTS: We identified 21 trials comprising 2006 participants comparing 7 treatment strategies. In a network meta-analysis, compared with placebo, mesalamine (relative risk [RR], 0.60; 95% credible interval [CrI], 0.37-0.88), antibiotics (RR, 0.26; 95% CrI, 0.08-0.61), immunomodulator monotherapy (RR, 0.36; 95% CrI, 0.17-0.63), immunomodulator with antibiotics (RR, 0.11; 95% CrI, 0.02-0.51), and anti-TNF monotherapy (RR, 0.04; 95% CrI, 0.00-0.14), but not budesonide (RR, 0.93; 95% CrI, 0.40-1.84), reduced the risk of clinical relapse. Likewise, compared with placebo, antibiotics (RR, 0.41; 95% CrI, 0.15-0.92), immunomodulator monotherapy (RR, 0.33; 95% CrI, 0.13-0.68), immunomodulator with antibiotics (RR, 0.16; 95% CrI, 0.04-0.48), and anti-TNF monotherapy (RR, 0.01; 95% CrI, 0.00-0.05), but neither mesalamine (RR, 0.67; 95% CrI, 0.39-1.08) nor budesonide (RR, 0.86; 95% CrI, 0.61-1.22), reduced the risk of endoscopic relapse. Anti-TNF monotherapy was the most effective pharmacologic intervention for postoperative prophylaxis, with large effect sizes relative to all other strategies (clinical relapse: RR, 0.02-0.20; endoscopic relapse: RR, 0.005-0.04). CONCLUSIONS: Based on Bayesian network meta-analysis combining direct and indirect treatment comparisons, anti-TNF monotherapy appears to be the most effective strategy for postoperative prophylaxis for CD.

Lebow J.,Mayo Medical School | Sim L.A.,Mayo Medical School | Erwin P.J.,Mayo Clinic Libraries | Murad M.H.,Knowledge and Evaluation Research Unit
International Journal of Eating Disorders | Year: 2013

Objective: Given that atypical antipsychotic medications have been increasingly prescribed for improving weight gain in anorexia nervosa (AN), we conducted a systematic review and meta-analyses to estimate the influence of atypical antipsychotics on BMI, eating disorder, and psychiatric symptoms in individuals with AN. Method: Independent reviewers selected studies and extracted study characteristics, methodologic quality, and outcomes for the intention-to-treat group from randomized clinical trials comparing the effect of atypical antipsychotic use to placebo or an active control treatment on BMI. Results: Compared with placebo, atypical antipsychotics were associated with a nonsignificant increase in BMI (weighted mean difference, WMD = 0.18, 95% CI: -0.36, 0.72; I2 = 26%) and a nonsignificant effect on the drive for thinness and body dissatisfaction. Compared with placebo or active control, these medications led to an increase in anxiety and overall eating disorder symptoms. However, there was a significant reduction over placebo or active control on level of depression. © 2012 by Wiley Periodicals, Inc. (Int J Eat Disord 2013) Copyright © 2012 Wiley Periodicals, Inc.

Chandar A.K.,Case Western Reserve University | Chandar A.K.,University Hospitals Case Medical Center | Singh S.,Mayo Medical School | Murad M.H.,Knowledge and Evaluation Research Unit | And 2 more authors.
Inflammatory Bowel Diseases | Year: 2015

Background: We assessed the risk-benefit profile of anti-α4-integrins, natalizumab (NAT), and vedolizumab (VEDO), in Crohn's disease through a systematic review and meta-analysis of randomized controlled trials. Methods: We searched multiple electronic databases through July 2014 and identified 8 randomized controlled trials in adults with Crohn's disease comparing NAT (5 trials) or VEDO (3 trials) with placebo. Efficacy outcomes were induction of remission, response, and improvement in quality of life; safety outcomes were serious adverse events, infusion reactions, infections, and treatment discontinuation. We performed subgroup analysis based on anti-tumor necrosis factor (TNF)-α exposure and estimated summary relative risk (RR) or mean difference, with 95% confidence intervals (CIs). Results: Anti-α4-integrins were superior to placebo for induction of remission (RR, 0.87; 95% CI, 0.84-0.91), with similar estimates for NAT (RR, 0.86; 95% CI, 0.80-0.93) and VEDO (RR, 0.87; 95% CI, 0.79-0.95). Both NAT and VEDO were equally efficacious for anti-TNF-naive (NAT: RR, 0.87; 95% CI, 0.75-1.00; VEDO: RR, 0.86; 95% CI, 0.79-0.94) and anti-TNF-exposed patients (NAT: RR, 0.86; 95% CI, 0.76-0.99; VEDO: RR, 0.89; 95% CI, 0.78-1.01). Anti-α4-integrins were effective in inducing clinical response and improving quality of life, with no significant difference between NAT and VEDO. Rates of serious adverse events, infusion reactions, infections, and treatment discontinuation were similar for NAT and VEDO. No cases of progressive multifocal leukoencephalopathy have been observed with VEDO to date. Conclusions: NAT and VEDO are effective in inducing remission and response in patients with Crohn's disease, with similar efficacy in anti-TNF-naive and anti-TNF-exposed patients. © 2015 Crohn's & Colitis Foundation of America, Inc.

Successful chronic care self-management requires adherence to healthy lifestyle behaviors, but many healthcare-based health promotion interventions have resulted in small and unsustainable changes in patient behavior. Patients with chronic conditions may already be overwhelmed by burdensome illnesses and treatments, and not have the capacity to respond well to the additional work required of behavior modifications. To explore this phenomenon, we will apply the cumulative complexity model (CCM), a patient-centered model of patient complexity, to a systematic review and meta-analysis of healthcare-based health behavior interventions. This systematic review will include randomized trials published between 2002 and 2012 that compared healthcare-based interventions aimed at improving healthy diet and physical activity in community dwelling adult patients with chronic conditions. After extracting study and risk of bias features from each trial, we will classify the interventions according to the conceptual model. We will then use meta-analysis and subgroup analysis to test hypotheses based on the conceptual model. Healthcare providers need evidence of successful health promoting interventions for patients with chronic conditions who display common behavioral risk factors. To better understand how patients respond to interventions, we will apply the CCM, which accounts for both the capacity of patients with chronic conditions and their treatment-related workload, and posits that a balance between capacity and workload predicts successful enactment of self-care. Analysis will also include whether patients with multiple chronic conditions respond differently to interventions compared to those with single chronic conditions. The results of this review will provide insights as to how patients with chronic conditions respond to health-promoting interventions. PROSPERO registration number: CRD42012003428.

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