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Fraser J.G.,Boston Medical Center | Fraser J.G.,Rti International | Murphy R.,Center for Child and Family Health | Coker-Schwimmer E.,Evidence based Practice Center | Viswanathan M.,Rti International
Journal of Developmental and Behavioral Pediatrics | Year: 2013

Objective: To systematically review the comparative effectiveness evidence for interventions to ameliorate the negative sequelae of maltreatment exposure in children ages birth to 14 years. Methods: We assessed the research on pharmacological and psychosocial interventions (parent-mediated approaches or trauma-focused treatments) reporting mental and behavioral health, caregiver-child relationship, and developmental and/or school functioning outcomes. We conducted focused searches of MEDLINE (through PubMed), Social Sciences Citation Index, PsycINFO, and the Cochrane Library (1990-2012). Reviewer pairs independently evaluated the studies for eligibility using predetermined inclusion/exclusion criteria, evaluated studies for risk of bias, extracted data, and graded the strength of evidence (SOE) for each comparison and each outcome based on predetermined criteria. Results: Based on our review of 6282 unduplicated citations, we found 17 trials eligible for inclusion. Although several interventions show promising comparative benefit for child well-being outcomes, the SOE for all but one of these interventions was low. The results highlight numerous substantive and methodological gaps to address in the future research. CONCLUSIONS:: It is too early to make strong treatment recommendations, as comparative research remains relatively nascent in the child maltreatment arena. These gaps reflect, in large part, the Herculean demands on researchers involved in conducting high-quality clinical studies with this highly vulnerable population. The National Child Traumatic Stress Network and the Developmental-Behavioral Pediatrics Research Network (DBPNet) are two potentially powerful platforms to conduct large rigorous trials needed to move the field forward. More broadly, a paradigm shift among researchers and funders alike is needed to galvanize the commitment and resources necessary for conducting collaborative clinical trials with this highly vulnerable population. © 2013 Lippincott Williams & Wilkins. Source


Guise J.-M.,Scientific Resource Center for the Effective Health Care Program | Chang C.,Agency for Healthcare Research and Quality | Viswanathan M.,Evidence based Practice Center | Glick S.,Blue Cross Blue Shield Evidence based Practice Center | And 9 more authors.
Journal of Clinical Epidemiology | Year: 2014

Objectives The purpose of this Agency for Healthcare Research and Quality Evidence-based Practice Center methods white paper was to outline approaches to conducting systematic reviews of complex multicomponent health care interventions.Study Design and Setting We performed a literature scan and conducted semistructured interviews with international experts who conduct research or systematic reviews of complex multicomponent interventions (CMCIs) or organizational leaders who implement CMCIs in health care.Results Challenges identified include lack of consistent terminology for such interventions (eg, complex, multicomponent, multidimensional, multifactorial); a wide range of approaches used to frame the review, from grouping interventions by common features to using more theoretical approaches; decisions regarding whether and how to quantitatively analyze the interventions, from holistic to individual component analytic approaches; and incomplete and inconsistent reporting of elements critical to understanding the success and impact of multicomponent interventions, such as methods used for implementation the context in which interventions are implemented.Conclusion We provide a framework for the spectrum of conceptual and analytic approaches to synthesizing studies of multicomponent interventions and an initial list of critical reporting elements for such studies. This information is intended to help systematic reviewers understand the options and tradeoffs available for such reviews. © 2014 Elsevier Inc. Source


Coleman C.I.,University of Connecticut | Coleman C.I.,Evidence based Practice Center | Limone B.L.,University of Connecticut | Limone B.L.,Evidence based Practice Center
American Journal of Cardiology | Year: 2013

Assays monitoring P2Y12 platelet reactivity can accurately predict which patients will have a poor response to clopidogrel. We sought to determine the cost-effectiveness of using platelet reactivity assays (PRAs) to select a dual-antiplatelet regimen for patients with acute coronary syndrome. A hybrid decision tree Markov model was developed to determine the cost-effectiveness of universal clopidogrel, ticagrelor, or prasugrel (given to all patients) or PRA-driven ticagrelor or prasugrel (given to patients with high platelet reactivity, defined as >230 on the VerifyNow P2Y12 assay; the others received generic clopidogrel). We assumed a cohort of 65-year-old patients with acute coronary syndrome and an incidence of high platelet reactivity of 32% and 13% at ∼24 to 48 hours after revascularization and 1 month, respectively. The 5-year costs, quality-adjusted life-years, and incremental cost-effectiveness ratios were calculated for PRA-driven ticagrelor and prasugrel compared with universal clopidogrel, ticagrelor, or prasugrel. PRA-driven ticagrelor and prasugrel were cost-effective compared with universal clopidogrel (incremental cost-effectiveness ratio $40,100 and $49,143/quality-adjusted life-year, respectively); however, universal ticagrelor and prasugrel were not (incremental cost-effectiveness ratio $61,651 and $96,261/quality- adjusted life-year, respectively). Monte Carlo simulation suggested PRA-driven ticagrelor, PRA-driven prasugrel, universal ticagrelor, and universal prasugrel would have an incremental cost-effectiveness ratio <$50,000/quality- adjusted life-year in 52%, 40%, 23%, and 2% of the iterations compared with universal clopidogrel, respectively. Universal ticagrelor and prasugrel were not cost-effective compared with their respective PRA-driven regimens (incremental cost-effectiveness ratio $68,182; $116,875/quality-adjusted life-year, respectively). Monte Carlo simulation suggested universal ticagrelor and prasugrel would have an incremental cost-effectiveness ratio <$50,000/quality-adjusted life-year in 26% and 4% of iterations compared with their respective PRA-driven regimens. The results were most sensitive to differences in agent costs and drug-specific relative risks of death. In conclusion, even with generic clopidogrel, PRA-driven selection of antiplatelet therapy appeared to be a cost-effective strategy with the potential to decrease the overall acute coronary syndrome-associated healthcare costs. © 2013 Elsevier Inc. All rights reserved. Source


Limone B.L.,University of Connecticut | Limone B.L.,Evidence based Practice Center | Hernandez A.V.,Cleveland Clinic | Hernandez A.V.,Instituto Nacional Of Salud | And 4 more authors.
Thrombosis Research | Year: 2013

Introduction Studies suggest a decreasing risk of recurrent venous thromboembolism (rVTE) in relation to time since the index event. We sought to conduct a meta-analysis examining the time course of rVTE over the first 3-months of anticoagulation. Materials and Methods A literature search of MEDLINE, EMBASE and CENTRAL (through 4/2013) was conducted to identify randomized trials of acute pharmacologic treatment and prevention of rVTE, enrolling ≥ 200 subjects/treatment arm, requiring anticoagulation for ≥ 3-months and reporting time-to-objectively-confirmed rVTE. Trials assessing extended-duration treatment, randomizing only cancer patients or not in English were excluded. Treatment arms were divided into monthly and weekly time periods for comparison (months 1-3 and weeks 1-12 after the index event). Treatment arm rVTE rates (per person-year) were pooled using a random-effects approach. Results Fifteen trials (31 treatment arms; n = 27,237) were included. Higher rVTE rates were observed during the first month after the index event (0.19, 95%CI = 0.16-0.23) compared to the second (0.05, 95%CI 0.04-0.06; p < 0.001 vs. first month) and third months (0.02, 95%CI = 0.02-0.03; p < 0.001 vs. first month). While the highest rate of rVTE was in week 1 (0.29, 95%CI = 0.21-0.37; p < 0.01 vs. week 2), rates remained high through the fourth week (between 0.15 and 0.10 events/person-year) before decreasing and stabilizing at week 5 (≤ 0.05 events/person-year; p < 0.01 vs. week 4). Conclusions Our findings demonstrate a significant interaction between rVTE rates and time after the index event. High rVTE rates during the 3-4 weeks following the index event emphasize the importance of frequent surveillance during this time and the early optimization of pharmacologic therapy. © 2013 Elsevier Ltd. Source


Mainou M.,Evidence based Practice Center | Alahdab F.,Evidence based Practice Center | Tobian A.A.R.,Johns Hopkins University | Asi N.,Evidence based Practice Center | And 3 more authors.
Transfusion | Year: 2016

BACKGROUND Leukoreduced (LR) or cytomegalovirus (CMV)-seronegative cellular blood components are commonly used to reduce the risk of transfusion-transmitted CMV infection in high-risk patients. STUDY DESIGN AND METHODS We performed a systematic review and meta-analysis to evaluate the evidence for the use of LR cellular blood components with or without concurrent CMV testing of donor units in patients undergoing chemotherapy or solid organ and hematopoietic stem cell transplantation, in pregnant women, in very-low-birthweight infants, and in patients with primary immunodeficiency. We searched MEDLINE, EMBASE, Cochrane Central Register of Controlled Trials, Cochrane Database of Systematic Reviews, and Scopus from 1980 through February 2015. Studies were included if they had a comparison group. Two independent reviewers selected and appraised studies. Meta-analysis was performed when appropriate. RESULTS Of 457 studies screened, 11 were eligible. One study was excluded from the meta-analysis because the comparison performed differed significantly from the others. Meta-analysis of five studies that compared leukoreduction to transfusing CMV-untested blood components showed no significant difference in clinical CMV infection (relative risk [RR], 0.26; 95% confidence interval [CI], 0.04-1.57) or laboratory CMV infection (RR, 0.33; 95% CI, 0.08-1.37). Meta-analysis of three studies that compared leukoreduction to transfusing CMV-seronegative cellular components showed no significant difference in laboratory CMV infection (RR, 2.18; 95% CI, 0.96-4.98). Meta-analysis of two studies that compared adding CMV testing to leukoreduction (vs. leukoreduction alone) showed no significant difference in clinical or laboratory CMV infection. The certainty in estimates was low for all comparisons. CONCLUSION At present, the scientific evidence does not favor a single strategy for reducing the risk of transfusion-related CMV infection in high-risk patients. © 2016 AABB. Source

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