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ROCHESTER, Minn. -- Using a shared decision-making aid to involve patients more in their own care decisions can prevent unnecessary hospitalization or advanced cardiac tests for patients reporting low-risk chest pain -- for the cost of about 1 minute of time. So says a study from Mayo Clinic researchers, published online today in The BMJ. MULTIMEDIA ALERT: Video and audio are available for download on the Mayo Clinic News Network. According to the Centers for Disease Control and Prevention, the second highest cause of emergency department visits is chest pain. "Chest pain can be caused by a wide variety of problems," says Erik Hess, M.D., study lead author and emergency medicine physician at Mayo Clinic. "While we recommend that people seek immediate medical help when experiencing chest pain, the next steps can vary - and be unnecessarily costly." Patients at low risk for acute coronary syndrome - a range of conditions that includes a heart attack and is associated with sudden, reduced blood flow to the heart - are frequently admitted for observation and cardiac testing. Dr. Hess and his colleagues say this is because, "Given the potential for missing a diagnosis of acute coronary syndrome, clinicians have a very low risk threshold to admit patients for observation and advanced cardiac testing." "Despite little possibility that these low-risk patients are experiencing acute coronary syndrome, emergency physicians are more likely to default to admission for observation and additional testing," says Dr. Hess. "This presents a substantial unnecessary burden and cost to the patient and the health care system." The research team felt that introducing a shared decision-making approach might not only increase patients' understanding of their symptoms and risks, but also allow them to participate more actively in deciding whether hospital admission and advanced cardiac testing were necessary. Using the Chest Pain Choice decision aid, emergency department physicians and patients with low-risk chest pain can estimate the risk for acute coronary syndrome within the next 45 days. Based on that risk, they can then have a joint discussion on whether hospital admission and advanced cardiac testing is warranted, or whether a follow-up appointment with primary care or cardiology is a more appropriate step. In a randomized clinical trial across six emergency departments in five states, the researchers compared usual care for 447 patients to 451 patients receiving the Chest Pain Choice decision aid intervention. The primary outcome, selected by patient and caregiver representatives, was patient knowledge. Secondary outcomes were involvement in the decision to be admitted, proportion of patients admitted for cardiac testing, and the 30-day rate of major adverse cardiac events. The team showed that using the decision aid resulted in: Both patients and physicians were satisfied with the decision aid and its use, which, according to the study authors, "took an average of one additional minute of clinician time." Shared decision-making resulted in significantly less overuse of hospitalization and advanced cardiac testing, thereby reducing the overall burden on the health care system, as well as potential costs for patients. "When patients are involved with their care decisions, it is more likely they will get the right care for their concerns," says Dr. Hess. "We believe that the Chest Pain Choice decision aid will make it easier for patients and physicians to have a thoughtful discussion and make an individualized care plan that is less likely to overuse unnecessary services." Dr. Hess first presented the Chest Pain Choice decision aid at the American College of Cardiology's 65th Annual Scientific Session (Read news release.). The study was funded by the Patient-Centered Outcomes Research Institute and the Mayo Clinic Robert D. and Patricia E. Kern Center for the Science of Health Care Delivery. It was conducted in collaboration with the Knowledge and Evaluation Research Unit. This unit focuses much of its efforts on developing and validating shared decision aids across health care. Mayo Clinic is a nonprofit organization committed to clinical practice, education and research, providing expert, whole-person care to everyone who needs healing. For more information, visit and

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.

Singh S.,Mayo Medical School | Allen A.M.,Mayo Medical School | Wang Z.,Knowledge and Evaluation Research Unit | Prokop L.J.,Knowledge and Evaluation Research Unit | And 2 more authors.
Clinical Gastroenterology and Hepatology | Year: 2015

Background and Aims: Little is known about differences in rates of fibrosis progression between patients with nonalcoholic fatty liver (NAFL) vs nonalcoholic steatohepatitis (NASH). We conducted a systematic review and meta-analysis of all studies that assessed paired liver biopsy specimens to estimate the rates of fibrosis progression in patients with nonalcoholic fatty liver disease (NAFLD) including NAFL and NASH. Methods: Through a systematic search of multiple databases and author contact, up to June 2013, we identified studies of adults with NAFLD that collected paired liver biopsy specimens at least 1year apart. From these, we calculated a pooled-weighted annual fibrosis progression rate (number of stages changed between the 2 biopsy samples) with 95% confidence intervals (CIs), and identified clinical risk factors associated with progression. Results: We identified 11 cohort studies including 411 patients with biopsy-proven NAFLD (150 with NAFL and 261 with NASH). At baseline, the distribution of fibrosis for stages 0, 1, 2, 3, and 4 was 35.8%, 32.5%, 16.7%, 9.3%, and 5.7%, respectively. Over 2145.5 person-years of follow-up evaluation, 33.6% had fibrosis progression, 43.1% had stable fibrosis, and 22.3% had an improvement in fibrosis stage. The annual fibrosis progression rate in patients with NAFL who had stage 0 fibrosis at baseline was 0.07 stages (95% CI, 0.02-0.11 stages), compared with 0.14 stages in patients with NASH (95% CI, 0.07-0.21 stages). These findings correspond to 1 stage of progression over 14.3 years for patients with NAFL (95% CI, 9.1-50.0 y) and 7.1 years for patients with NASH (95% CI, 4.8-14.3 y). Conclusions: Based on a meta-analysis of studies of paired liver biopsy studies, liver fibrosis progresses in patients with NAFL and NASH. © 2015 AGA Institute.

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.

Prutsky G.,Knowledge and Evaluation Research Unit
Cochrane database of systematic reviews (Online) | Year: 2012

Haemoptysis is a common pathology around the world, occurring with more frequency in low-income countries. It has different etiologies, many of which have infectious characteristics. Antifibrinolytic agents are commonly used to manage bleeding from different sources, but their usefulness in pulmonology is unclear. To evaluate the effectiveness and safety of antifibrinolytic agents in reducing the volume and duration of haemoptysis in adult and paediatric patients. We searched the Cochrane Central Register of Controlled Trials (CENTRAL) and the Database of Abstracts of Reviews of Effects (DARE) in The Cochrane Library, EMBASE and LILACS for publications that describe randomized controlled trials (RCTs) of antifibrinolytic therapy in patients presenting with haemoptysis. We also performed an independent search in MEDLINE for relevant trials not yet included in CENTRAL or DARE.We conducted electronic and manual searches of relevant national and international journals.We reviewed the reference lists of included studies to locate relevant randomized controlled trials (RCTs). An additional search was carried out to find unpublished RCTs. We included RCTs designed to evaluate the effectiveness and safety of antifibrinolytic agents in reducing haemoptysis in adult and paediatric patients of both genders presenting with haemoptysis of any etiology and severity. The intervention of interest was the administration of antifibrinolytic agents compared with placebo or no treatment. All reviewers independently assessed methodological quality and extracted data tables pre-designed for this review. We found two randomized controlled trials which met the inclusion criteria: Tscheikuna 2002 (via electronic searches) and Ruiz 1994 (via manual searches). We did not exclude any of the relevant studies we found.Tscheikuna 2002, a double-blind RCT performed in Thailand, evaluated the effectiveness of tranexamic acid (TXA, an antifibrinolytic agent) administered orally in 46 hospital in- and outpatients with haemoptysis of various etiologies. Ruiz 1994, a double-blind RCT performed in Peru, evaluated the effectiveness of intravenous TXA in 24 hospitalised patients presenting with haemoptysis secondary to tuberculosis.Pooled together, results demonstrated a significant reduction in bleeding time between patients receiving TXA and patients receiving placebo with a weighted mean difference (WMD) of -19.47 (95% CI -26.90 to -12.03 hours), but with high heterogeneity (I 2 = 52%). TXA did not affect remission of haemoptysis evaluated at seven days after the start of treatment. Adverse effects caused by the drug's mechanism of action were not reported. There was no significant difference in the incidence of mild side effects between active and placebo groups (OR 3.13, 95% CI 0.80 to 12.24). There is insufficient evidence to judge whether antifibrinolytics should be used to treat haemoptysis from any cause, though limited evidence suggests they may reduce the duration of bleeding.

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.

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.

Goff S.L.,Tufts University | Mazor K.M.,University of Massachusetts Medical School | Ting H.H.,Knowledge and Evaluation Research Unit | Kleppel R.,Tufts University | Rothberg M.B.,Cleveland Clinic
JAMA Internal Medicine | Year: 2014

Importance: Patients with stable coronary artery disease (CAD) attribute greater benefit to percutaneous coronary interventions (PCI) than indicated in clinical trials. Little is known about how cardiologists' presentation of the benefits and risks may influence patients' perceptions.Objectives: To broadly describe the content of discussions between patients and cardiologists regarding angiogram and PCI for stable CAD, and to describe elements that may affect patients' understanding.Design, Setting, and Participants: Qualitative content analysis of encounters between cardiologists and patients with stable CAD who participated in the Verilogue Point-of-Practice Database between March 1, 2008, and August 31, 2012. Transcripts in which angiogram and PCI were discussed were retrieved from the database. Patients were aged 44 to 88 years (median, 64 years); 25%were women; 50% reported symptoms of angina; and 6%were taking more than 1 medication to treat angina.Main Outcomes and Measures: Results of conventional and directed qualitative content analysis.Results: Forty encounters were analyzed. Five major categories and subcategories of factors that may affect patients' understanding of benefit were identified: (1) rationale for recommending angiogram and PCI (eg, stress test results, symptoms, and cardiologist's preferences); (2) discussion of benefits (eg, accurate discussion of benefit [5%], explicitly overstated benefit [13%], and implicitly overstated benefit [35%]); (3) discussion of risks (eg, minimization of risk); (4) cardiologist's communication style (eg, humor, teach-back, message framing, and failure to respond to patient questions); and (5) patient and family member contributions to the discussion.Conclusions and Relevance: Fewcardiologists discussed the evidence-based benefits of angiogram and PCI for stable CAD, and some implicitly or explicitly overstated the benefits. The etiology of patient misunderstanding is likely multifactorial, but if future quantitative studies support the findings of this hypothesis-generating analysis, modifications to cardiologists' approach to describing the risks and benefits of the procedure may improve patient understanding. Copyright © 2014 American Medical Association. All rights reserved.

Brito J.P.,Mayo Medical School | Brito J.P.,Knowledge and Evaluation Research Unit | Hay I.D.,Mayo Medical School | Morris J.C.,Mayo Medical School
BMJ (Online) | Year: 2014

Thyroid cancer is one of the fastest growing diagnoses; more cases of thyroid cancer are found every year than all leukemias and cancers of the liver, pancreas, and stomach. Most of these incident cases are papillary in origin and are both small and localized. Patients with these small localized papillary thyroid cancers have a 99% survival rate at 20 years. In view of the excellent prognosis of these tumors, they have been denoted as low risk. The incidence of these low risk thyroid cancers is growing, probably because of the use of imaging technologies capable of exposing a large reservoir of subclinical disease. Despite their excellent prognosis, these subclinical low risk cancers are often treated aggressively. Although surgery is traditionally viewed as the cornerstone treatment for these tumors, there is less agreement about the extent of surgery (lobectomy v near total thyroidectomy) and whether prophylactic central neck dissection for removal of lymph nodes is needed. Many of these tumors are treated with radioactive iodine ablation and thyrotropin suppressive therapy, which - although effective for more aggressive forms of thyroid cancer - have not been shown to be of benefit in the management of these lesions. This review offers an evidence based approach to managing low risk papillary thyroid cancer. It also looks at the future of promising alternative surgical techniques, non-surgical minimally localized invasive therapies (ethanol ablation and laser ablation), and active surveillance, all of which form part of a more individualized treatment approach for low risk papillary thyroid tumors.

Gionfriddo M.R.,Knowledge and Evaluation Research Unit
Current diabetes reports | Year: 2014

Clinicians and patients with type 2 diabetes enjoy an expanding list of medications to improve glycemic control. With this expansion has come a flurry of concerns about the safety of these antihyperglycemic agents, concerns that affect judgments about the risk/benefit balance of therapy. Some of these safety signals have been identified through the synthesis of existing research evidence. Thus, it has become important for clinicians and clinical policymakers to understand the strengths and limitations of systematic reviews and meta-analyses in determining the safety of diabetes medications. In this paper, we highlight key safety concerns with diabetes medications and discuss the role evidence synthesis plays in each, with special attention to its strengths and limitations.

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