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1.
An expert consensus to standardise definitions, diagnosis and treatment targets for anti-fibrotic stricture therapies in Crohn's disease.
Rieder, F, Bettenworth, D, Ma, C, Parker, CE, Williamson, LA, Nelson, SA, van Assche, G, Di Sabatino, A, Bouhnik, Y, Stidham, RW, et al
Alimentary pharmacology & therapeutics. 2018;(3):347-357
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Abstract
BACKGROUND Fibrotic stricture is a common complication of Crohn's disease (CD) affecting approximately half of all patients. No specific anti-fibrotic therapies are available; however, several therapies are currently under evaluation. Drug development for the indication of stricturing CD is hampered by a lack of standardised definitions, diagnostic modalities, clinical trial eligibility criteria, endpoints and treatment targets in stricturing CD. AIM: To standardise definitions, diagnosis and treatment targets for anti-fibrotic stricture therapies in Chron's disease. METHODS An interdisciplinary expert panel consisting of 15 gastroenterologists and radiologists was assembled. Using modified RAND/University of California Los Angeles appropriateness methodology, 109 candidate items derived from systematic review and expert opinion focusing on small intestinal strictures were anonymously rated as inappropriate, uncertain or appropriate. Survey results were discussed as a group before a second and third round of voting. RESULTS Fibrotic strictures are defined by the combination of luminal narrowing, wall thickening and pre-stenotic dilation. Definitions of anastomotic (at site of prior intestinal resection with anastomosis) and naïve small bowel strictures were similar; however, there was uncertainty regarding wall thickness in anastomotic strictures. Magnetic resonance imaging is considered the optimal technique to define fibrotic strictures and assess response to therapy. Symptomatic strictures are defined by abdominal distension, cramping, dietary restrictions, nausea, vomiting, abdominal pain and post-prandial abdominal pain. Need for intervention (endoscopic balloon dilation or surgery) within 24-48 weeks is considered the appropriate endpoint in pharmacological trials. CONCLUSIONS Consensus criteria for diagnosis and response to therapy in stricturing Crohn's disease should inform both clinical practice and trial design.
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Familial hypercholesterolemia treatments: Guidelines and new therapies.
Raal, FJ, Hovingh, GK, Catapano, AL
Atherosclerosis. 2018;:483-492
Abstract
Familial hypercholesterolemia (FH) is a genetic disorder resulting from mutations in genes encoding proteins involved in the metabolism of low density lipoproteins (LDL) and characterized by premature cardiovascular disease due to the exposure to high levels of LDL-cholesterol (LDL-C) from birth. Thus, the early identification of FH subjects, followed by appropriate treatment is essential to prevent or at least delay the onset of cardiovascular events. However, FH is largely underdiagnosed; in addition, FH patients are frequently not adequately treated, despite the availability of several pharmacological therapies to significantly reduce LDL-C levels. Current guidelines recommend LDL-C targets for FH (either heterozygotes [HeFH] or homozygotes [HoFH]) <100 mg/dL (<2.6 mmol/L) for adults or <70 mg/dL (<1.8 mmol/L) for adults with CHD or diabetes, and <135 mg/dL (<3.5 mmol/L) for children. With the pharmacological options now available, which include statins as a first approach, ezetimibe, and the recently approved monoclonal antibodies targeting PCSK9, the guideline recommended LDL-C target levels can be achieved in the majority of heterozygous FH subjects, while for the most severe forms of homozygous FH, the addition of therapies such as lomitapide either with or without apheresis may be required.
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Reflections on treatment of IBD in children and adolescents.
Veereman, G, Hauser, B, De Greef, E, Devreker, T, Huysentruyt, K, Lemmens, R, Vandenplas, Y
Immunopharmacology and immunotoxicology. 2018;(6):461-464
Abstract
Major pharmaceutical advancements in the field of inflammatory bowel diseases benefit to children and adolescents affected with this progressive chronic condition. Scientific organisations such as ESPGHAN and ECCO actively publish guidelines related to the many aspects of care from these patients. Clinical studies and long-term prospective registries in the appropriate age groups are crucial to support an evidence based strategy.
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Magnetic resonance imaging T1- and T2-mapping to assess renal structure and function: a systematic review and statement paper.
Wolf, M, de Boer, A, Sharma, K, Boor, P, Leiner, T, Sunder-Plassmann, G, Moser, E, Caroli, A, Jerome, NP
Nephrology, dialysis, transplantation : official publication of the European Dialysis and Transplant Association - European Renal Association. 2018;(suppl_2):ii41-ii50
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Abstract
This systematic review, initiated by the European Cooperation in Science and Technology Action Magnetic Resonance Imaging Biomarkers for Chronic Kidney Disease (PARENCHIMA), focuses on potential clinical applications of magnetic resonance imaging in renal non-tumour disease using magnetic resonance relaxometry (MRR), specifically, the measurement of the independent quantitative magnetic resonance relaxation times T1 and T2 at 1.5 and 3Tesla (T), respectively. Healthy subjects show a distinguishable cortico-medullary differentiation (CMD) in T1 and a slight CMD in T2. Increased cortical T1 values, that is, reduced T1 CMD, were reported in acute allograft rejection (AAR) and diminished T1 CMD in chronic allograft rejection. However, ambiguous findings were reported and AAR could not be sufficiently differentiated from acute tubular necrosis and cyclosporine nephrotoxicity. Despite this, one recent quantitative study showed in renal transplants a direct correlation between fibrosis and T1 CMD. Additionally, various renal diseases, including renal transplants, showed a moderate to strong correlation between T1 CMD and renal function. Recent T2 studies observed increased values in renal transplants compared with healthy subjects and in early-stage autosomal dominant polycystic kidney disease (ADPKD), which could improve diagnosis and progression assessment compared with total kidney volume alone in early-stage ADPKD. Renal MRR is suggested to be sensitive to renal perfusion, ischaemia/oxygenation, oedema, fibrosis, hydration and comorbidities, which reduce specificity. Due to the lack of standardization in patient preparation, acquisition protocols and adequate patient selection, no widely accepted reference values are currently available. Therefore this review encourages efforts to optimize and standardize (multi-parametric) protocols to increase specificity and to tap the full potential of renal MRR in future research.
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Systematic Review for the 2017 ACC/AHA/AAPA/ABC/ACPM/AGS/APhA/ASH/ASPC/NMA/PCNA Guideline for the Prevention, Detection, Evaluation, and Management of High Blood Pressure in Adults: A Report of the American College of Cardiology/American Heart Association Task Force on Clinical Practice Guidelines.
Reboussin, DM, Allen, NB, Griswold, ME, Guallar, E, Hong, Y, Lackland, DT, Miller, EPR, Polonsky, T, Thompson-Paul, AM, Vupputuri, S
Circulation. 2018;(17):e595-e616
Abstract
Objective To review the literature systematically and perform meta-analyses to address these questions: 1) Is there evidence that self-measured blood pressure (BP) without other augmentation is superior to office-based measurement of BP for achieving better BP control or for preventing adverse clinical outcomes that are related to elevated BP? 2) What is the optimal target for BP lowering during antihypertensive therapy in adults? 3) In adults with hypertension, how do various antihypertensive drug classes differ in their benefits and harms compared with each other as first-line therapy? Methods Electronic literature searches were performed by Doctor Evidence, a global medical evidence software and services company, across PubMed and EMBASE from 1966 to 2015 using key words and relevant subject headings for randomized controlled trials that met eligibility criteria defined for each question. We performed analyses using traditional frequentist statistical and Bayesian approaches, including random-effects Bayesian network meta-analyses. Results Our results suggest that: 1) There is a modest but significant improvement in systolic BP in randomized controlled trials of self-measured BP versus usual care at 6 but not 12 months, and for selected patients and their providers self-measured BP may be a helpful adjunct to routine office care. 2) systolic BP lowering to a target of <130 mm Hg may reduce the risk of several important outcomes including risk of myocardial infarction, stroke, heart failure, and major cardiovascular events. No class of medications (ie, angiotensin-converting enzyme inhibitors, angiotensin-receptor blockers, calcium channel blockers, or beta blockers) was significantly better than thiazides and thiazide-like diuretics as a first-line therapy for any outcome.
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Rethinking Management Strategies for Proliferative Diabetic Retinopathy.
Tang, PH, Hariprasad, SM, Do, DV
Ophthalmic surgery, lasers & imaging retina. 2018;(4):224-227
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Recommendations from the international evidence-based guideline for the assessment and management of polycystic ovary syndrome.
Teede, HJ, Misso, ML, Costello, MF, Dokras, A, Laven, J, Moran, L, Piltonen, T, Norman, RJ, ,
Fertility and sterility. 2018;(3):364-379
Abstract
STUDY QUESTION What is the recommended assessment and management of women with polycystic ovary syndrome (PCOS), based on the best available evidence, clinical expertise, and consumer preference? SUMMARY ANSWER International evidence-based guidelines including 166 recommendations and practice points, addressed prioritized questions to promote consistent, evidence-based care and improve the experience and health outcomes of women with PCOS. WHAT IS KNOWN ALREADY Previous guidelines either lacked rigorous evidence-based processes, did not engage consumer and international multidisciplinary perspectives, or were outdated. Diagnosis of PCOS remains controversial and assessment and management are inconsistent. The needs of women with PCOS are not being adequately met and evidence practice gaps persist. STUDY DESIGN, SIZE, DURATION International evidence-based guideline development engaged professional societies and consumer organizations with multidisciplinary experts and women with PCOS directly involved at all stages. Appraisal of Guidelines for Research and Evaluation (AGREE) II-compliant processes were followed, with extensive evidence synthesis. The Grading of Recommendations, Assessment, Development, and Evaluation (GRADE) framework was applied across evidence quality, feasibility, acceptability, cost, implementation and ultimately recommendation strength. PARTICIPANTS/MATERIALS, SETTING, METHODS Governance included a six continent international advisory and a project board, five guideline development groups, and consumer and translation committees. Extensive health professional and consumer engagement informed guideline scope and priorities. Engaged international society-nominated panels included pediatrics, endocrinology, gynecology, primary care, reproductive endocrinology, obstetrics, psychiatry, psychology, dietetics, exercise physiology, public health and other experts, alongside consumers, project management, evidence synthesis, and translation experts. Thirty-seven societies and organizations covering 71 countries engaged in the process. Twenty face-to-face meetings over 15 months addressed 60 prioritized clinical questions involving 40 systematic and 20 narrative reviews. Evidence-based recommendations were developed and approved via consensus voting within the five guideline panels, modified based on international feedback and peer review, with final recommendations approved across all panels. MAIN RESULTS AND THE ROLE OF CHANCE The evidence in the assessment and management of PCOS is generally of low to moderate quality. The guideline provides 31 evidence based recommendations, 59 clinical consensus recommendations and 76 clinical practice points all related to assessment and management of PCOS. Key changes in this guideline include: i) considerable refinement of individual diagnostic criteria with a focus on improving accuracy of diagnosis; ii) reducing unnecessary testing; iii) increasing focus on education, lifestyle modification, emotional wellbeing and quality of life; and iv) emphasizing evidence based medical therapy and cheaper and safer fertility management. LIMITATIONS, REASONS FOR CAUTION Overall evidence is generally low to moderate quality, requiring significantly greater research in this neglected, yet common condition, especially around refining specific diagnostic features in PCOS. Regional health system variation is acknowledged and a process for guideline and translation resource adaptation is provided. WIDER IMPLICATIONS OF THE FINDINGS The international guideline for the assessment and management of PCOS provides clinicians with clear advice on best practice based on the best available evidence, expert multidisciplinary input and consumer preferences. Research recommendations have been generated and a comprehensive multifaceted dissemination and translation program supports the guideline with an integrated evaluation program. STUDY FUNDING/COMPETING INTEREST(S): The guideline was primarily funded by the Australian National Health and Medical Research Council of Australia (NHMRC) supported by a partnership with ESHRE and the American Society for Reproductive Medicine. Guideline development group members did not receive payment. Travel expenses were covered by the sponsoring organizations. Disclosures of conflicts of interest were declared at the outset and updated throughout the guideline process, aligned with NHMRC guideline processes. Full details of conflicts declared across the guideline development groups are available at https://www.monash.edu/medicine/sphpm/mchri/pcos/guideline in the Register of disclosures of interest. Of named authors, Dr Costello has declared shares in Virtus Health and past sponsorship from Merck Serono for conference presentations. Prof. Laven declared grants from Ferring, Euroscreen and personal fees from Ferring, Euroscreen, Danone and Titus Healthcare. Prof. Norman has declared a minor shareholder interest in an IVF unit. The remaining authors have no conflicts of interest to declare. The guideline was peer reviewed by special interest groups across our partner and collaborating societies and consumer organizations, was independently assessed against AGREEII criteria and underwent methodological review. This guideline was approved by all members of the guideline development groups and was submitted for final approval by the NHMRC.
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Arterial spin labelling MRI to measure renal perfusion: a systematic review and statement paper.
Odudu, A, Nery, F, Harteveld, AA, Evans, RG, Pendse, D, Buchanan, CE, Francis, ST, Fernández-Seara, MA
Nephrology, dialysis, transplantation : official publication of the European Dialysis and Transplant Association - European Renal Association. 2018;(suppl_2):ii15-ii21
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Abstract
Renal perfusion provides the driving pressure for glomerular filtration and delivers the oxygen and nutrients to fuel solute reabsorption. Renal ischaemia is a major mechanism in acute kidney injury and may promote the progression of chronic kidney disease. Thus, quantifying renal tissue perfusion is critically important for both clinicians and physiologists. Current reference techniques for assessing renal tissue perfusion have significant limitations. Arterial spin labelling (ASL) is a magnetic resonance imaging (MRI) technique that uses magnetic labelling of water in arterial blood as an endogenous tracer to generate maps of absolute regional perfusion without requiring exogenous contrast. The technique holds enormous potential for clinical use but remains restricted to research settings. This statement paper from the PARENCHIMA network briefly outlines the ASL technique and reviews renal perfusion data in 53 studies published in English through January 2018. Renal perfusion by ASL has been validated against reference methods and has good reproducibility. Renal perfusion by ASL reduces with age and excretory function. Technical advancements mean that a renal ASL study can acquire a whole kidney perfusion measurement in less than 5-10 min. The short acquisition time permits combination with other MRI techniques that might inform drug mechanisms and renal physiology. The flexibility of renal ASL has yielded several variants of the technique, but there are limited data comparing these approaches. We make recommendations for acquiring and reporting renal ASL data and outline the knowledge gaps that future research should address.
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Quality assessment of cancer cachexia clinical practice guidelines.
Shen, WQ, Yao, L, Wang, XQ, Hu, Y, Bian, ZX
Cancer treatment reviews. 2018;:9-15
Abstract
OBJECTIVES The aim of this study was to investigate the quality of clinical practice guidelines of cancer cachexia and identify gaps limiting knowledge. METHODS A systematic search of relevant guideline websites and literature databases (including PubMed, NCCN, NGC, SIGN, NICE, and google) was undertaken from inception to March 2017 to identify and select clinical guidelines related to cancer cachexia. Four independent reviewers assessed the eligible guidelines using the Appraisal of Guidelines for Research and Evaluation (AGREE II) instrument. Agreement among reviewers of the guidelines was measured by using intra-class correlation coefficient (ICC). The number of recommendations, strength of recommendation, and levels of evidence were determined. RESULTS Nine cancer cachexia guidelines published from 2006 to 2017 were identified. An overall high degree of agreement among reviewers to each domain was observed (ICC ranged from 0.75 to 0.91). The median scores and range for each AGREE II domain were as follows: (i) scope and purpose (median = 61.1%, range: 13.9% to 80.7%); (ii) stakeholder involvement (median = 26.4%, range: 8.3% to 81.9%); (iii) rigour of development (median = 35.9%, range: 3.6% to 84.4%); (iv) clarity and presentation (median = 56.9%, range: 30.6% to 76.4%); (v) applicability (median = 19.8%, range: 0% to 77.1%) and (vi) editorial independence (median = 27.1%, range: 0% to 85.4%). Two cancer cachexia guidelines (ESPEN, 2017 and University of Queensland, 2013) scored higher on all domains and were classified as recommended for clinical practice, among which, one was developed by European Society for Parenteral and Enteral Nutrition and European Partnership for Action Against Cancer, and the other was developed by University of Queensland. In addition, more than a half recommendations were based on nonrandomized studies (Level C, 50.0%) and expert opinion (Level D, 8.2%). CONCLUSIONS The quality of cancer cachexia guidelines was highly heterogeneous among different domains even within the same guideline. There is significant room for improvement to develop high quality cancer cachexia guidelines, which urgently warrants first-class research to minimize the vital gaps in the evidence for formulation of cancer cachexia guidelines.
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A Review of ACE Inhibitors and ARBs in Black Patients With Hypertension.
Helmer, A, Slater, N, Smithgall, S
The Annals of pharmacotherapy. 2018;(11):1143-1151
Abstract
OBJECTIVE To review current guidelines and recent data evaluating the efficacy and safety of angiotensin-converting enzyme (ACE) inhibitors and angiotensin receptor blockers (ARBs) in black hypertensive patients. DATA SOURCES Articles evaluating race-specific outcomes in hypertension were gathered using a MEDLINE search with keywords black, African American, ACE inhibitor, angiotensin receptor blocker, angiotensin system, and hypertension. Studies published from 2000 through April 2018 were reviewed. STUDY SELECTION AND DATA EXTRACTION Six guidelines, 8 monotherapy publications, and 5 combination therapy publications included race-specific results and were included in the review. The authors individually compared and contrasted the results from each publication. DATA SYNTHESIS Numerous monotherapy trials indicate that black patients may have a reduced blood pressure (BP) response with ACE inhibitors or ARBs compared with white patients. Conversely, additional studies propose that race may not be the primary predictor of BP response. Reduced efficacy is not observed in trials involving combination therapy. Some studies suggest increased cardiovascular and cerebrovascular morbidity and mortality with ACE inhibitor or ARB monotherapy in black patients; however, data are conflicting. Relevance to Patient Care and Clinical Practice: This article clarifies vague guideline statements and informs clinicians on the appropriate use of ACE inhibitors or ARBs for hypertension treatment in black patients through an in-depth look into the evidence. CONCLUSIONS Potentially reduced efficacy and limited outcomes data indicate that ACE inhibitors or ARBs should not routinely be initiated as monotherapy in black hypertensive patients. Use in combination with a calcium channel blocker or thiazide diuretic is efficacious in black patients, and there are no data showing that this increases or decreases cardiovascular or cerebrovascular outcomes.