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1.
Paediatric migraine: evidence-based management and future directions.
Orr, SL, Kabbouche, MA, O'Brien, HL, Kacperski, J, Powers, SW, Hershey, AD
Nature reviews. Neurology. 2018;(9):515-527
Abstract
Migraine is prevalent in children and adolescents and constitutes an important cause of disability in this population. Early, effective treatment of paediatric migraine is likely to result in improved outcomes. Findings from the past few years suggest that a biopsychosocial approach that uses interdisciplinary multimodal care is most effective for treatment of migraine in the paediatric population. Key elements of this management include effective and timely acute pharmacological interventions (such as NSAIDs and/or triptans), education of patients regarding self-management techniques, and psychological interventions such as biofeedback, relaxation and cognitive-behavioural therapy. The efficacy of current pharmacological or nutraceutical interventions for migraine prevention in children and adolescents is unclear, although reported placebo response patterns suggest that the effect of pill-taking behaviour is positive. As such, clinicians can consider adding a preventive intervention that involves a daily pill-taking behaviour to evidence-based non-pharmacological first-line preventive interventions (such as cognitive-behavioural therapy). More rigorous research is needed to delineate the role of pharmacological and nutraceutical interventions, the mechanisms of the clinically relevant placebo response, and interventions that enhance this response for migraine prevention in this population. Given the prevalence of migraine, cost-effective and efficacious strategies are needed for the large-scale delivery of interdisciplinary multimodal paediatric migraine care.
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2.
Fitting the right non-vitamin K antagonist oral anticoagulant to the right patient with non-valvular atrial fibrillation: an evidence-based choice.
Li, YG, Pastori, D, Lip, GYH
Annals of medicine. 2018;(4):288-302
Abstract
Atrial fibrillation (AF) is the most prevalent arrhythmia and is associated with an increased risk of ischemic stroke (IS) and systemic embolism (SE). Stroke prevention is a key element for the overall management of AF patients. The non-vitamin K antagonist oral anticoagulants (NOACs), such as dabigatran, rivaroxaban, apixaban and edoxaban, are at least as effective as warfarin in reducing IS/SE with a lower rate of major bleeding. Various analyses from the large Phase III randomized trials demonstrated different efficacy and safety of NOACs in specific subgroups of patients. The randomized trials are supplemented by effectiveness and safety data from real-world observational cohorts following the availability of these drugs for use in everyday clinical practice. Given the clinical heterogeneity of AF patients, the available data from trials and real-world studies allow us to fit the right NOAC to the particular patient's characteristics, with the aim of optimizing outcomes for the individual patient. This review article aims to provide a summary of the evidence on the performance of NOACs in AF patients with specific clinical characteristics. Evidence-based suggestions are presented to provide a simple and viable strategy for clinicians for the choice of a particular NOAC. KEY MESSAGE Given the different performance of the new-oral anticoagulants in patients with the different clinical situation, evidence-based choice of fitting the right new-oral anticoagulants to the patients is provided in this review article.
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The IMPROVE-GAP Trial aiming to improve evidence-based management of community-acquired pneumonia: study protocol for a stepped-wedge randomised controlled trial.
Skinner, EH, Lloyd, M, Janus, E, Ong, ML, Karahalios, A, Haines, TP, Kelly, AM, Shackell, M, Karunajeewa, H
Trials. 2018;(1):88
Abstract
BACKGROUND Community-acquired pneumonia is a leading worldwide cause of hospital admissions and healthcare resource consumption. The largest proportion of hospitalisations now occurs in older patients, with high rates of multimorbidity and complex care needs. In Australia, this population is usually managed by hospital inpatient general internal medicine units. Adherence to consensus best-practice guidelines is poor. Ensuring evidence-based care and reducing length of stay may improve patient outcomes and reduce organisational costs. This study aims to evaluate an alternative model of care designed to improve adherence to four Level 1 or 2 evidence-supported interventions (routine corticosteroids, early switch to oral antibiotics, early mobilisation and routine malnutrition screening). METHODS/DESIGN The IMPROVing Evidence-based treatment Gaps and outcomes in community-Acquired Pneumonia (IMPROVE-GAP) trial is a pragmatic, investigator-initiated, stepped-wedge randomised trial. Patients hospitalised under a general internal medicine unit who meet a standard case definition for community-acquired pneumonia will be included. Eight general internal medicine units at two Australian hospitals in a single health service will be randomised using concealed allocation to: (i) usual medical, nursing and allied health care delivered according to existing organisational practice or (ii) care supported by a dedicated "community-acquired pneumonia service": a multidisciplinary team deploying algorithm-based implementation of a bundle of the four evidence-based interventions. The primary outcome measure will be length of hospital stay. Secondary outcome measures include inpatient mortality, 30 and 90 day readmission rates and mortality and health-service utilisation costs. Protocol adherence will be measured and reported, and serious adverse events (rates of hyperglycaemia requiring new insulin; falls during mobilisation) will be collected and reported. DISCUSSION IMPROVE-GAP represents an important and unique precedent for testing a new service-delivery model for improving compliance with a number of evidence-based interventions. Its stepped-wedge randomised controlled trial design provides a means to address some significant ethical, organisational and other methodological challenges to evaluating the effectiveness of health-service interventions in complex hospital populations. The new service-delivery model will effectively be fully implemented by trial completion, facilitating rapid, seamless translation into practice should care outcomes be superior. This trial is currently recruiting. TRIAL REGISTRATION ClinicalTrials.gov, NCT02835040. Prospectively registered on 22 May 2016.
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Challenges in comparing the non-vitamin K antagonist oral anticoagulants for atrial fibrillation-related stroke prevention.
Camm, AJ, Fox, KAA, Peterson, E
Europace : European pacing, arrhythmias, and cardiac electrophysiology : journal of the working groups on cardiac pacing, arrhythmias, and cardiac cellular electrophysiology of the European Society of Cardiology. 2018;(1):1-11
Abstract
The aim of this review is to provide context for meta-analyses interpreting data from phase III stroke prevention studies of non-vitamin K antagonist oral anticoagulants (NOACs) in patients with non-valvular atrial fibrillation (NVAF). Differences between the four phase III NOAC stroke prevention studies in patients with NVAF (ROCKET AF, ARISTOTLE, RE-LY, and ENGAGE AF), their potential impact on outcomes, and inter-study differences were evaluated, as well as the potential role of real-world evidence in evaluating NOACs in this setting. Study design differences included blinding strategy, dose-reduction options, and transition from blinded treatment to standard of care. There were small but relevant variations in the definition of AF used (RE-LY used the least precise definition); patient risk profiles (ROCKET AF patients had the highest risk); the primary safety outcome (a composite of major bleeding and clinically relevant non-major bleeding events in ROCKET AF vs. major bleeding in the others); and the definitions of stroke, major bleeding, and clinically relevant non-major bleeding events. In real-world studies, methodological variations and biases are amplified, making cross-study comparisons and meta-analyses problematic. Because of these methodological differences, meta-analyses of phase III studies need to be robust, and if outcomes of the reference (warfarin-treated) arms differ significantly, the basis of the meta-analysis is not strong. These key issues need to be taken into consideration for direct comparisons across studies, and for the interpretation of meta-analytic data.
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Lipid-Lowering Therapies: Risks in Women and Evidence-Based Options.
Shah, T, Virani, SS
Texas Heart Institute journal. 2018;(4):238-239
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Statin Trials, Cardiovascular Events, and Coronary Artery Calcification: Implications for a Trial-Based Approach to Statin Therapy in MESA.
Mortensen, MB, Falk, E, Li, D, Nasir, K, Blaha, MJ, Sandfort, V, Rodriguez, CJ, Ouyang, P, Budoff, M
JACC. Cardiovascular imaging. 2018;(2 Pt 1):221-230
Abstract
OBJECTIVES This study sought to determine whether coronary artery calcium (CAC) could be used to optimize statin allocation among individuals for whom trial-based evidence supports efficacy of statin therapy. BACKGROUND Recently, allocation of statins was proposed for primary prevention of atherosclerotic cardiovascular disease (ASCVD) based on proven efficacy from randomized controlled trials (RCTs) of statin therapy, a so-called trial-based approach. METHODS The study used data from MESA (Multi-Ethnic Study of Atherosclerosis) with 5,600 men and women, 45 to 84 years of age, and free of clinical ASCVD, lipid-lowering therapy, or missing information for risk factors at baseline examination. RESULTS During 10 years' follow-up, 354 ASCVD and 219 hard coronary heart disease (CHD) events occurred. Based on enrollment criteria for 7 RCTs of statin therapy in primary prevention, 73% of MESA participants (91% of those >55 years of age) were eligible for statin therapy according to a trial-based approach. Among those individuals, CAC = 0 was common (44%) and was associated with low rates of ASCVD and CHD (3.9 and 1.7, respectively, per 1,000 person-years). There was a graded increase in event rates with increasing CAC score, and in individuals with CAC >100 (27% of participants) the rates of ASCVD and CHD were 18.9 and 12.7, respectively. Consequently, the estimated number needed to treat (NNT) in 10 years to prevent 1 event varied greatly according to CAC score. For ASCVD events, the NNT was 87 for CAC = 0 and 19 for CAC >100. For CHD events, the NNT was 197 for CAC = 0 and 28 for CAC >100. CONCLUSIONS Most MESA participants qualified for trial-based primary prevention with statins. Among the individuals for whom trial-based evidence supports efficacy of statin therapy, CAC = 0 and CAC >100 were common and associated with low and high cardiovascular risks, respectively. This information may guide shared decision making aimed at targeting evidence-based statins to those who are likely to benefit the most.
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7.
Diabetic macular oedema: evidence-based treatment recommendations for Asian countries.
Cheung, GC, Yoon, YH, Chen, LJ, Chen, SJ, George, TM, Lai, TY, Park, KH, Tahija, SG, Uy, HS, Wong, TY
Clinical & experimental ophthalmology. 2018;(1):75-86
Abstract
Diabetic macular oedema is the most common cause of diabetic retinopathy-induced vision loss. Efficacy of anti-vascular endothelial growth factor therapy in diabetic macular oedema has been demonstrated in randomized controlled trials. An Asian-specific guideline for diabetic macular oedema treatment is needed as patients in Asia tend to present with far more advanced disease than seen elsewhere in the world. Previous reviews of diabetic macular oedema management lacked a broader assessment of anti-vascular endothelial growth factor treatment choices and newer trials. Recent clinical trial data allow head-to-head comparisons between the different anti-vascular endothelial growth factor agents and treatment regimens. This review aims to summarize the clinical evidence related to various treatment regimens for clinicians, with a focus on anti-vascular endothelial growth factor therapies, and to provide guidance on the treatment of diabetic macular oedema in Asian patients.
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8.
Evidence-based guidelines for fall prevention in Korea.
Kim, KI, Jung, HK, Kim, CO, Kim, SK, Cho, HH, Kim, DY, Ha, YC, Hwang, SH, Won, CW, Lim, JY, et al
The Korean journal of internal medicine. 2017;(1):199-210
Abstract
Falls and fall-related injuries are common in older populations and have negative effects on quality of life and independence. Falling is also associated with increased morbidity, mortality, nursing home admission, and medical costs. Korea has experienced an extreme demographic shift with its population aging at the fastest pace among developed countries, so it is important to assess fall risks and develop interventions for high-risk populations. Guidelines for the prevention of falls were first developed by the Korean Association of Internal Medicine and the Korean Geriatrics Society. These guidelines were developed through an adaptation process as an evidence-based method; four guidelines were retrieved via systematic review and the Appraisal of Guidelines for Research and Evaluation II process, and seven recommendations were developed based on the Grades of Recommendation, Assessment, Development, and Evaluation framework. Because falls are the result of various factors, the guidelines include a multidimensional assessment and multimodal strategy. The guidelines were developed for primary physicians as well as patients and the general population. They provide detailed recommendations and concrete measures to assess risk and prevent falls among older people.
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9.
Information exchange networks of health care providers and evidence-based cardiovascular risk management: an observational study.
Heijmans, N, van Lieshout, J, Wensing, M
Implementation science : IS. 2017;(1):7
Abstract
BACKGROUND Although a wide range of preventive and clinical interventions has targeted cardiovascular risk management (CVRM), outcomes remain suboptimal. Therefore, the question is what additional determinants of CVRM and outcomes can be identified and addressed to optimize CVRM. In this study, we aimed to identify new perspectives for improving healthcare delivery and explored associations between information exchange networks of health care providers and evidence-based CVRM. METHODS This observational study was performed parallel to a randomized clinical trial which aimed to improve professional performance of practice nurses in the Netherlands. Information exchange on medical policy for CVRM ("general information networks") and CVRM for individual patients ("specific information networks") of 180 health professionals in 31 general practices was measured with personalized questionnaires. Medical record audit was performed concerning 1620 patients in these practices to document quality of care delivery and two risk factors (systolic blood pressure (SBP) and LDL cholesterol level). Hypothesized effects of five network characteristics (density, frequency of contact, centrality of CVRM-coordinators, homophily on positive attitudes for treatment target achievement, and presence of an opinion leader for CVRM) constructed on both general and specific information exchange networks were tested and controlled for practice and patient factors using logistic multilevel analyses. RESULTS Odds for adequate performance were enhanced in practices with an opinion leader for CVRM (OR 2.75, p < .05). Odds for achievement of SBP targets were reduced in practices who had networks with low homophily on positive attitudes for SBP and LDL targets (homophily for SBP targets OR 0.57, p < .05 and OR 0.60, p < .05, homophily for LDL targets OR 0.59, p < .05 and OR 0.61, p < .05 in general and specific information networks, respectively). No effects of network characteristics on cholesterol were found. CONCLUSIONS Delivery of evidence-based CVRM is associated with homophily of clinical attitudes and presence of opinion leaders in primary care teams. These results signal the potential of social networks to be taken into account in further attempts to improve the implementation of evidence-based care for CVRM. Future research is needed to identify and formulate optimal strategies for using opinion leaders to improve CVRM. Future interventions may be more effective if they target a common vision on CVRM within practices.
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10.
The PREDIMED trial, Mediterranean diet and health outcomes: How strong is the evidence?
Guasch-Ferré, M, Salas-Salvadó, J, Ros, E, Estruch, R, Corella, D, Fitó, M, Martínez-González, MA, ,
Nutrition, metabolism, and cardiovascular diseases : NMCD. 2017;(7):624-632
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Abstract
AIMS: To address potential controversies on the health benefits of the Mediterranean diet (MedDiet) after PREDIMED, a randomized trial of MedDiet for primary cardiovascular prevention. We have focused on: a) the PREDIMED study design, b) analysis of PREDIMED data and c) interpretation of its results. DATA SYNTHESIS Regarding the design of the trial, its early termination and between-group differences in the intensity of the intervention are potential causes of concern. The planned duration was 6 years but the trial was prematurely stopped when an interim analysis at 4.8-year provided sufficient evidence of benefit for the two MedDiets. In the MedDiet groups supplemented with extra-virgin olive oil or mixed-nuts, the primary composite endpoint (myocardial infarction, stroke, or cardiovascular death) was reduced by 30% and 28% respectively, as compared with the control group. Final results did not change after taking into account the different intensity of educational efforts during the trial. Other potential doubts related to data analysis (e.g., intention to treat versus a per-protocol approach, and consequences of dropouts) should not be causes of concern. Finally, we addressed alternative interpretations of the effect on all-cause mortality. The protocol-defined primary endpoint was a composite cardiovascular endpoint, not all-cause mortality. To analyze total mortality, we would have needed a much larger sample size and longer follow-up. Therefore, the PREDIMED results cannot be used to draw firm conclusions on MedDiets and all-cause mortality. CONCLUSIONS The PREDIMED study was designed to overcome three major problems of previous nutritional research: a) residual confounding, addressed by using a randomized design; b) single-nutrient approaches, by randomizing an overall dietary pattern; and c) the limitations of assessing only intermediate risk markers, by using hard clinical end-points.