Minnesota Evidence Based Practice Center

Minneapolis, MN, United States

Minnesota Evidence Based Practice Center

Minneapolis, MN, United States
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Kane R.L.,University of Minnesota | Kane R.L.,Minnesota Evidence Based Practice Center | Shamliyan T.,University of Minnesota | Shamliyan T.,Minnesota Evidence Based Practice Center | Pacala J.,University of Minnesota
Journal of the American Geriatrics Society | Year: 2012

Objectives To ascertain the effect on survival of eight common geriatric syndromes (multiple comorbidities, cognitive impairment, frailty, disability, sarcopenia, malnutrition, homeostenosis, and chronic inflammation), identified by an expert panel of academic geriatricians. Design A systematic literature review sought studies from a variety of sources to compare survival and life expectancy of individuals with geriatric syndromes with those of the general population. Setting Studies used reflected the general population. Participants Community-dwelling persons aged 65 and older. Measurements Eight geriatric syndromes (multiple definitions) and survival. Results Two thousand three hundred seventy-four publications were retrieved, and 509 publications of 123 studies were included. Seven geriatric syndromes (multiple comorbidities, cognitive impairment, frailty, disability, malnutrition, impaired homeostasis, and chronic inflammation) were associated with poor survival. In each case, the prevalence of a syndrome was negatively associated with mortality. Malnutrition and impaired homeostasis exerted twice the influence of factors such as multiple comorbidities and frailty. From age 65 to 74, only those who are very ill or frail (e.g., impaired homeostasis, low body mass index, or advanced dementia) have a higher risk of mortality than average older adults. In the old-old, particularly aged 90 and older, the added value of predicting survival beyond 1 year is minimal. Conclusion Geriatric syndrome information is helpful to understanding survival for younger old persons but provides little information about survival for the very old. Complex survival models add comparatively little benefit to more simply measured and calculated models. © 2012, Copyright the Authors Journal compilation © 2012, The American Geriatrics Society.

Chou R.,Oregon Health And Science University | Aronson N.,Blue Cross Blue Shield Evidence based Practice Center | Atkins D.,Office of Research Development | Ismaila A.S.,McMaster University | And 5 more authors.
Journal of Clinical Epidemiology | Year: 2010

Comparative effectiveness reviews (CERs) are systematic reviews that evaluate evidence on alternative interventions to help clinicians, policy makers, and patients make informed treatment choices. Reviews should assess harms and benefits to provide balanced assessments of alternative interventions. Identifying important harms of treatment and quantifying the magnitude of any risks require CER authors to consider a broad range of data sources, including randomized controlled trials (RCTs) and observational studies. This may require evaluation of unpublished data in addition to published reports. Appropriate synthesis of harms data must also consider issues related to evaluation of rare or uncommon events, assessments of equivalence or noninferiority, and use of indirect comparisons. This article presents guidance for evaluating harms when conducting and reporting CERs. We include suggestions for prioritizing harms to be evaluated, use of terminology related to reporting of harms, selection of sources of evidence on harms, assessment of risk of bias (quality) of harms reporting, synthesis of evidence on harms, and reporting of evidence on harms. © 2010 Elsevier Inc.

Wilt T.J.,Center for Chronic Disease Outcomes Research | Wilt T.J.,Minnesota Evidence Based Practice Center | Wilt T.J.,University of Minnesota | MacDonald R.,Center for Chronic Disease Outcomes Research | And 13 more authors.
JAMA Internal Medicine | Year: 2013

Importance: Restless legs syndrome (RLS) is a neurological disorder characterized by unpleasant sensations in the legs and a distressing, irresistible urge to move them. We conducted a systematic review to evaluate efficacy, safety, and comparative effectiveness of pharmacologic treatments for primary RLS. Evidence Acquisition: We included randomized controlled trials (RCTs), published in English, reporting efficacy outcomes and harms of pharmacologic treatments for primary RLS of at least 4 weeks' duration. MEDLINE and other databases were searched through June 2012. Reviewers extracted outcomes and adverse events and rated the strength of evidence. Results: We identified 29 eligible RCTs. We found highstrength evidence that the proportion of patients who had a clinically important response (International Restless Legs Syndrome [IRLS] responders), defined as a 50% or greater reduction from baseline in mean IRLS symptom scale scores, was greater with dopamine agonist therapy compared with placebo (61% vs 41% ) (risk ratio, 1.60 [95% CI, 1.38-1.86]; 7 trials). Dopamine agonists also improved patient-reported sleep scale scores and qualityof- life measures. High-strength evidence demonstrated that calcium channel alpha-2-delta ligands increased the proportion of IRLS responders compared with placebo (61% vs 37%) (risk ratio, 1.66 [95% CI, 1.33-2.09]; 3 trials). Adverse events associated with dopamine agonists included nausea, vomiting, and somnolence. Alpha- 2-delta ligands adverse events included somnolence and unsteadiness or dizziness. Conclusions and Relevance: On the basis of shortterm RCTs that enrolled highly selected populations with long-term high-moderate to very severe symptoms, dopamine agonists and calcium channel alpha-2-delta ligands reduced RLS symptoms and improved sleep outcomes and disease-specific quality of life. Adverse effects and treatment withdrawals due to adverse effects were common. © 2013 American Medical Association. All rights reserved.

Shamliyan T.,University of Minnesota | Shamliyan T.,Minnesota Evidence based Practice Center | Talley K.M.C.,University of Minnesota | Ramakrishnan R.,University of Minnesota | And 2 more authors.
Ageing Research Reviews | Year: 2013

Frailty is a known risk factor for those aged 65 and over, and its prevalence increases with age. Definitions of frailty vary widely, and prevalence estimates are affected by the way frailty is defined. Systematic reviews have yet to examine the literature on the association between definitions of frailty and mortality. We examined the definitions and prevalence of frailty and its association with survival in older community-dwelling adults. We conducted a systematic review of observational population-based studies published in English. We calculated pooled prevalence of frailty with a random effects model. We identified 24 population-based studies that examined frailty in community-dwelling older adults. The pooled prevalence was 14% when frailty was defined as a phenotype exhibiting three or more of the following: weight loss, fatigue/exhaustion, weakness, low physical activity/slowness, and mobility impairment. The pooled prevalence was 24% when frailty was defined by accumulation of deficits indices that included up to 75 diseases and impairments. The prevalence of frailty increased with age and was greater in women and in African Americans. Frailty in older adults was associated with poor survival with a dose-responsive reduction in survival per increasing number of frailty criteria. Taking into account population prevalence and multivariate adjusted relative risks, we estimated that 3-5% of deaths among older adults could be delayed if frailty was prevented. Frailty is a prevalent and important geriatric syndrome associated with decreased survival. Geriatric assessment of frailty provides clinically important information about functional status and survival of older adults. © 2012 Elsevier B.V.

Swanson E.,University of Minnesota | Mahgoub A.,University of Minnesota | MacDonald R.,Minnesota Evidence based Practice Center | Shaukat A.,University of Minnesota
Clinical Gastroenterology and Hepatology | Year: 2014

Background & Aims: Few studies have compared the efficacy and complications of endoscopic or medical therapies for bleeding angiodysplasias or gastric antral vascular ectasias (GAVE). We conducted a systematic review to evaluate therapies. Methods: We performed a PubMed search for studies (written in English from January 1, 1980, through January 1, 2013) of medical or endoscopic treatment of bleeding angiodysplasias and GAVE. Measured outcomes included levels of hemoglobin, transfusion requirements, rebleeding rates, complications, treatment failures, and overall mortality. Results: We analyzed data from 63 studies that met inclusion criteria; 50 evaluated endoscopic treatment (1790 patients), 13 evaluated medical treatment (392 patients), and 12 were comparative studies. In patients with angiodysplasias, the combination of estrogen and progesterone did not significantly reduce bleeding episodes, compared with placebo (0.7/y vs 0.9/y, respectively), and increased mortality, compared with conservative therapy (33% vs 21%). A higher percentage of patients receiving octreotide were free of rebleeding at 1 and 2 years vs placebo (77% vs 55% and 68% vs 36%, respectively; P= .03). Thalidomide reduced the number of bleeding episodes (-8.96/y), compared with iron therapy (-1.38/y, P < .01), but neither treatment reduced mortality. More patients with GAVE treated by endoscopic band ligation were free from rebleeding (92%) than those treated with argon plasma coagulation (32%, P= .01). Conclusions: In a systematic review, we found a low quality of evidence to support treatment of angiodysplasias with thalidomide or the combination of estrogen and progesterone and insufficient evidence to support treatment with octreotide. There is also insufficient evidence for endoscopic therapy of angiodysplasia or GAVE. Well-designed randomized controlled trials are needed to study the efficacy and complications of medical and endoscopic treatments for patients with angiodysplasias or GAVE. © 2014 AGA Institute.

Shamliyan T.,University of Minnesota | Shamliyan T.,Minnesota Evidence based Practice Center | Wang S.,University of Minnesota | Virnig B.A.,University of Minnesota | And 3 more authors.
Journal of the National Cancer Institute - Monographs | Year: 2010

We synthesized the evidence of the association between patient and tumor characteristics with clinical outcomes in women with ductal carcinoma in situ of the breast. We identified five randomized controlled clinical trials and 64 observational studies that were published in English from January 1970 to January 2009. Younger women with clinically presented ductal carcinoma in situ had higher risk of ipsilateral recurrent cancer. African Americans had higher mortality and greater rates of advanced recurrent cancer. Women with larger tumor size, comedo necrosis, worse pathological grading, positive surgical margins, and at a higher risk category, using a composite prognostic index, had worse outcomes. Inconsistent evidence suggested that positive HER2 receptor and negative estrogen receptor status were associated with worse outcomes. Synthesis of evidence was hampered by low statistical power to detect significant differences in predictor categories and inconsistent adjustment practices across the studies. Future research should address composite prediction indices among race groups for all outcomes. © The Author 2010. Published by Oxford University Press. All rights reserved.

Shamliyan T.A.,University of Minnesota | Shamliyan T.A.,Minnesota Evidence based Practice Center | Shamliyan T.A.,Elsevier | Kane R.L.,University of Minnesota | Kane R.L.,Minnesota Evidence based Practice Center
Journal of Epidemiology and Global Health | Year: 2014

Objectives: Trial registration has a great potential to increase research transparency and public access to research results. This study examined the availability of results either in journal publications or in the trial registry from all studies registered at ClinicalTrials.gov. Methods: All 137,612 records from ClinicalTrials.gov in December 2012 were merged with all 19,158 PubMed records containing registration numbers in the indexing field or in the abstracts. A multivariate analysis was conducted to examine the association between the availability of the results with study and participant characteristics available in registration records. Results: Fewer than 10% of the registered studies and 15% of the registered and completed studies had published results. The highest publication rate of 22.4% was for randomized trials completed between 2005 (starting year for structured indexing in PubMed of study registration) and 2010. For 86% of overall and 78% of completed registered studies, no results were available in ClinicalTrials.gov or in journal publications. Studies funded by industry vs. other funding sources and drug studies vs. all studies of other interventions were published less often after adjustment for study type, subject characteristics, or posting of results in ClinicalTrials.gov. Conclusion: Existing policy does not ensure availability of results from clinical research. International policy revisions should charge principal investigators with ensuring that the approved protocols and posted data elements are aligned and that results are available from all conducted studies. © 2013 Ministry of Health, Saudi Arabia.

Wang S.-Y.,University of Minnesota | Chu H.,University of Minnesota | Shamliyan T.,University of Minnesota | Shamliyan T.,Minnesota Evidence based Practice Center | And 5 more authors.
Journal of the National Cancer Institute | Year: 2012

Background Negative margins are associated with reduced risk of ipsilateral breast tumor recurrence (IBTR) for women with ductal carcinoma in situ (DCIS) treated with breast-conserving surgery (BCS). However, there is no consensus about the best minimum margin width. Methods We searched the PubMed database for studies of DCIS published in English between January 1970 and July 2010 and examined the relationship between IBTR and margin status after BCS for DCIS. Women with DCIS were stratified into two groups, BCS with or without radiotherapy. We used frequentist and Bayesian approaches to estimate the odds ratios (OR) of IBTR for groups with negative margins and positive margins. We further examined specific margin thresholds using mixed treatment comparisons and meta-regression techniques. All statistical tests were two-sided.Results We identified 21 studies published in 24 articles. A total of 1066 IBTR events occurred in 7564 patients, including BCS alone (565 IBTR events in 3098 patients) and BCS with radiotherapy (501 IBTR events in 4466 patients). Compared with positive margins, negative margins were associated with reduced risk of IBTR in patients with radiotherapy (OR = 0.46, 95% credible interval [CrI] = 0.35 to 0.59), and in patients without radiotherapy (OR = 0.34, 95% CrI = 0.24 to 0.47). Compared with patients with positive margins, the risk of IBTR for patients with negative margins was smaller (negative margin >0 mm, OR = 0.45, 95% CrI = 0.38 to 0.53; >2 mm, OR = 0.38, 95% CrI = 0.28 to 0.51; >5 mm, OR = 0.55, 95% CrI = 0.15 to 1.30; and >10 mm, OR = 0.17, 95% CrI = 0.12 to 0.24). Compared with a negative margin greater than 2 mm, a negative margin of at least 10 mm was associated with a lower risk of IBTR (OR = 0.46, 95% CrI = 0.29 to 0.69). We found a probability of. 96 that a negative margin threshold greater than 10 mm is the best option compared with other margin thresholds. Conclusion s Negative surgical margins should be obtained for DCIS patients after BCS regardless of radiotherapy. Within cosmetic constraint, surgeons should attempt to achieve negative margins as wide as possible in their first attempt. More studies are needed to understand whether margin thresholds greater than 10 mm are warranted. © 2012 The Author.

Kulasingam S.L.,Minnesota Evidence Based Practice Center | Kulasingam S.L.,University of Minnesota | Kulasingam S.L.,Duke Evidence Based Practice Center | Kulasingam S.L.,Duke University | And 5 more authors.
Journal of Lower Genital Tract Disease | Year: 2013

OBJECTIVE: This study addresses the following 3 questions posed by the US Preventive Services Task Force: (1) at what age should screening for cervical cancer begin; (2) at what age should screening for cervical cancer end; and (3) how do the benefits and potential harms of screening strategies that use human papillomavirus DNA testing in conjunction with cytology (cotesting) compare with those strategies that use cytology only? MATERIALS AND METHODS: A Markov model was updated and used to quantify clinical outcomes (i.e., colposcopies, cancers, and life expectancy) associated with different screening strategies. RESULTS: Screening in the teenaged years is associated with a high number of colposcopies (harms), small differences in cancers detected and, as a result, small gains in life expectancy (benefits). Screening women beginning in the early 20s provides a reasonable balance of the harms and benefits of screening. Among women who have been screened according to the current recommendations for cervical cancer (beginning at age 21 years and conducted every 3 years with cytology), screening beyond 65 years is associated with small additional gains in life expectancy but large increases in colposcopies. For cotesting, a strategy of cytology only conducted every 3 years, followed by cotesting conducted every 5 years (for women ≥30 years), is associated with fewer colposcopies and greater gains in life expectancy compared with screening with cytology only conducted every 3 years. CONCLUSIONS: The results of this modeling study support current US Preventive Services Task Force recommendations for cervical cancer screening. © 2013, American Society for Colposcopy and Cervical Pathology.

Wang S.-Y.,University of Minnesota | Shamliyan T.,University of Minnesota | Shamliyan T.,Minnesota Evidence based Practice Center | Virnig B.A.,University of Minnesota | And 2 more authors.
Breast Cancer Research and Treatment | Year: 2011

While ductal carcinoma in situ (DCIS) is seldom life threatening, the management of DCIS remains a dilemma for patients and their physicians. Aggressive treatment reduces the risk of ipsilateral breast tumor recurrence (IBTR), but has never been proven to improve survival. There is interest in identifying the prognostic factors for determining low-risk DCIS patients, but a comprehensive review of high-quality evidence on tumor characteristics in predicting local recurrence has never been carried out. We examined the following tumor characteristics: biomarkers, comedonecrosis, focality, surgical margin, method of detection, tumor grade, and tumor size. For this systematic review we restricted the analyses to the results of subgroup analyses from randomized controlled trials (RCTs) and multivariate analyses from RCTs and observational studies. We identified 44 eligible articles. The pooled random-effects risk estimates for IBTR are comedonecrosis 1.71(95% CI, 1.36-2.16), focality 1.95(95% CI, 1.59-2.40), margin 2.25(95% CI, 1.77-2.86), method of detection 1.35(95% CI, 1.12-1.62), tumor grade 1.81(95% CI, 1.53-2.13), and tumor size 1.63(95% CI, 1.30-2.06). Limited evidence indicated that women whose DCIS is ER-negative, PR-negative, or HER2/neu receptor positive have an IBTR higher than those whose DCIS is ER-positive, PR-positive, and HER2/neu receptor negative. A variety of tumor characteristics are significant predictors for IBTR. These results are important for both clinicians and patients to interpret the risk of local recurrence and to decide on a course of treatment. © 2011 Springer Science+Business Media, LLC.

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