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Risk management in clinical trials

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https://www.readbyqxmd.com/read/28449205/impact-of-pharmacist-involved-collaborative-care-on-the-clinical-humanistic-and-cost-outcomes-of-high-risk-patients-with-type-2-diabetes-impact-a-randomized-controlled-trial
#1
M Y L Siaw, Y Ko, D C Malone, K Y K Tsou, Y-J Lew, D Foo, E Tan, S C Chan, A Chia, S S Sinaram, K C Goh, J Y-C Lee
WHAT IS KNOWN AND OBJECTIVE: With the increasing prevalence of diabetes, the physician-centred model is challenged to deliver holistic care in Asia. Diabetes may be managed effectively within a multidisciplinary collaborative care model; however, evidence on its effectiveness in Asian patients is lacking. Therefore, the primary objective was to evaluate the clinical outcomes of multidisciplinary collaborative care vs physician-centred care in diabetes. The secondary objectives were to evaluate humanistic and economic outcomes among the two types of care...
April 27, 2017: Journal of Clinical Pharmacy and Therapeutics
https://www.readbyqxmd.com/read/28448856/impact-of-a-risk-based-follow-up-in-patients-affected-by-gastrointestinal-stromal-tumour
#2
Lorenzo D'Ambrosio, Erica Palesandro, Paola Boccone, Francesco Tolomeo, Sara Miano, Danilo Galizia, Antonio Manca, Gabriele Chiara, Ilaria Bertotto, Filippo Russo, Delia Campanella, Tiziana Venesio, Dario Sangiolo, Ymera Pignochino, Dimitrios Siatis, Michele De Simone, Alessandro Ferrero, Alberto Pisacane, Angelo Paolo Dei Tos, Sandra Aliberti, Massimo Aglietta, Giovanni Grignani
BACKGROUND: Follow-up aims to precociously identify recurrences, metastases or treatment-related adverse events so as to undertake the appropriate therapy. Guidelines admit lack of knowledge on optimal surveillance schedule, but suggest follow-up based on experts' opinion and risk stratification. To identify the impact, if any, of regular follow-up, we interrogated our prospectively collected database whether early detection of recurrences affected both clinical management and, likely, the outcome...
April 24, 2017: European Journal of Cancer
https://www.readbyqxmd.com/read/28447767/biopsy-versus-resection-for-the-management-of-low-grade-gliomas
#3
REVIEW
Bowen Jiang, Kaisorn Chaichana, Anand Veeravagu, Steven D Chang, Keith L Black, Chirag G Patil
BACKGROUND: This is an updated version of the original Cochrane review published in 2013, Issue 4.Low-grade gliomas (LGG) constitute a class of slow-growing primary brain neoplasms. Patients with clinically and radiographically suspected LGG have two initial surgical options, biopsy or resection. Biopsy can provide a histological diagnosis with minimal risk but does not offer a direct treatment. Resection may have additional benefits such as increasing survival and delaying recurrence, but is associated with a higher risk for surgical morbidity...
April 27, 2017: Cochrane Database of Systematic Reviews
https://www.readbyqxmd.com/read/28447766/supervised-dosing-with-a-long-acting-opioid-medication-in-the-management-of-opioid-dependence
#4
REVIEW
Rosella Saulle, Simona Vecchi, Linda Gowing
BACKGROUND: Opioid dependence (OD) is an increasing clinical and public health problem worldwide. International guidelines recommend opioid substitution treatment (OST), such as methadone and buprenorphine, as first-line medication treatment for OD. A negative aspect of OST is that the medication used can be diverted both through sale on the black market, and the unsanctioned use of medications. Daily supervised administration of medications used in OST has the advantage of reducing the risk of diversion, and may promote therapeutic engagement, potentially enhancing the psychosocial aspect of OST, but costs more and is more restrictive on the client than dispensing for off-site consumption...
April 27, 2017: Cochrane Database of Systematic Reviews
https://www.readbyqxmd.com/read/28447016/deriving-meaningful-insights-from-clinical-trial-and-postmarketing-safety-data-perspectives-from-india
#5
REVIEW
Anand Harugeri, Vineet Shastri, Chanakya Patel
Today, drug safety data collection in India is both manual and electronic with reporting of potential overlapping and duplicate data, which is likely incomplete for further review and analysis. Furthermore, standardized data collection and timelines are not aligned with international standards. Complete coverage of safety data from all sources throughout the life of the drug cannot be ensured. There is no requirement to submit periodic safety data in clinical trials to regulatory authority. There is clearly a lack of emphasis on deriving meaningful safety data insights for ensuring patient safety...
April 2017: Perspectives in Clinical Research
https://www.readbyqxmd.com/read/28446943/the-updated-nice-guidelines-cardiac-ct-as-the-first-line-test-for-coronary-artery-disease
#6
REVIEW
Alastair J Moss, Michelle C Williams, David E Newby, Edward D Nicol
PURPOSE OF REVIEW: Cost-effective care pathways are integral to delivering sustainable healthcare programmes. Due to the overestimation of coronary artery disease using traditional risk tables, non-invasive testing has been utilised to improve risk stratification and initiate appropriate management to reduce the dependence on invasive investigations. In line with recent technological improvements, cardiac CT is a modality that offers a detailed anatomical assessment of coronary artery disease comparable to invasive coronary angiography...
2017: Current Cardiovascular Imaging Reports
https://www.readbyqxmd.com/read/28446599/acute-respiratory-distress-syndrome
#7
REVIEW
Marco Confalonieri, Francesco Salton, Francesco Fabiano
Since its first description, the acute respiratory distress syndrome (ARDS) has been acknowledged to be a major clinical problem in respiratory medicine. From July 2015 to July 2016 almost 300 indexed articles were published on ARDS. This review summarises only eight of them as an arbitrary overview of clinical relevance: definition and epidemiology, risk factors, prevention and treatment. A strict application of definition criteria is crucial, but the diverse resource-setting scenarios foster geographic variability and contrasting outcome data...
June 30, 2017: European Respiratory Review: An Official Journal of the European Respiratory Society
https://www.readbyqxmd.com/read/28444704/how-does-lower-urinary-tract-dysfunction-lutd-affect-sexual-function-in-men-and-women-ici-rs-2015-part-2
#8
REVIEW
Apostolos Apostolidis, Angie Rantell, Ralf Anding, Ruth Kirschner-Hermanns, Linda Cardozo
AIM: To discuss available data on the links between LUTD and sexual dysfunction, what is still unknown about the causative effect of disease processes on sexual function (SF), and to suggest proposals for further research. METHODS: At the 2015 International Consultation on Incontinence-Research Society (ICI-RS), a multi-disciplinary group presented a literature search of what is known about the effect of LUTD on SF in men and women. Wider discussions regarding knowledge gaps, and ideal research methodology ensued and are presented...
April 2017: Neurourology and Urodynamics
https://www.readbyqxmd.com/read/28444116/effectiveness-of-in-hospital-geriatric-co-management-a-systematic-review-and-meta-analysis
#9
Bastiaan Van Grootven, Johan Flamaing, Bernadette Dierckx de Casterlé, Christophe Dubois, Katleen Fagard, Marie-Christine Herregods, Miek Hornikx, Annouschka Laenen, Bart Meuris, Steffen Rex, Jos Tournoy, Koen Milisen, Mieke Deschodt
Background: geriatric consultation teams have failed to impact clinical outcomes prompting geriatric co-management programmes to emerge as a promising strategy to manage frail patients on non-geriatric wards. Objective: to conduct a systematic review of the effectiveness of in-hospital geriatric co-management. Data sources: MEDLINE, EMBASE, CINAHL and CENTRAL were searched from inception to 6 May 2016. Reference lists, trial registers and PubMed Central Citations were additionally searched...
April 24, 2017: Age and Ageing
https://www.readbyqxmd.com/read/28443360/overview-of-procalcitonin-assays-and-procalcitonin-guided-protocols-for-the-management-of-patients-with-infections-and-sepsis
#10
Philipp Schuetz, Celine Bretscher, Luca Bernasconi, Beat Mueller
Procalcitonin is a surrogate infection blood marker whose levels help estimate the likelihood of bacterial infections and correlate with their resolution. Recent trials have revealed the benefits of inclusion of procalcitonin in antibiotic stewardship protocols for initiation and discontinuation of antimicrobial therapy. Areas covered: Procalcitonin-guided antibiotic stewardship protocols have shown appreciable reductions in antibiotic use and duration of therapy in respiratory infections, sepsis, and other infections, with positive effects on clinical outcomes...
April 26, 2017: Expert Review of Molecular Diagnostics
https://www.readbyqxmd.com/read/28443024/low-dose-of-bergamot-derived-polyphenolic-fraction-bpf-did-not-improve-metabolic-parameters-in-second-generation-antipsychotics-treated-patients-results-from-a-60-days-open-label-study
#11
Antonio Bruno, Gianluca Pandolfo, Manuela Crucitti, Massimo Cacciola, Vincenza Santoro, Edoardo Spina, Rocco A Zoccali, Maria R A Muscatello
Objectives: The nutraceutical approach to the management of metabolic syndrome (MetS) might be a promising strategy in the prevention of cardio-metabolic risk. Low-dose bergamot-derived polyphenolic fraction (BPF) has been proven effective in patients with MetS, as demonstrated by a concomitant improvement in lipemic and glycemic profiles. The present study was aimed to further explore, in a sample of subjects receiving second generation antipsychotics (SGAs), the effects on body weight and metabolic parameters of a low dose of BPF (500 mg/day) administered for 60 days...
2017: Frontiers in Pharmacology
https://www.readbyqxmd.com/read/28442959/evaluation-of-different-doses-of-dexmedetomidine-alone-versus-the-combination-of-dexmedetomidine-and-fentanyl-in-sedation-during-awake-fiberoptic-intubation-in-oral-cancer-surgery-patients-a-prospective-randomized-double-blind-clinical-trial
#12
Mohamed Elsayed Hassan, Essam Mahran
BACKGROUND: Awake fiberoptic intubation (AFOI) is one of the principal techniques in the management of difficult airway in oral cancer surgery. We hypothesized that the addition of a small dose of fentanyl could improve the sedative criteria of dexmedetomidine during AFOI technique, without the need to increase the dose of dexmedetomidine which may be associated with airway compromise. PATIENTS AND METHODS: One hundred and fifty American Society of Anesthesiologists physical status 1 and 2 patients planned for AFOI for oral cancer surgery patients were allocated into three groups (fifty patients each)...
April 2017: Saudi Journal of Anaesthesia
https://www.readbyqxmd.com/read/28441936/rationale-and-design-of-bistro-a-randomized-controlled-trial-to-determine-whether-bioimpedance-spectroscopy-guided-fluid-management-maintains-residual-kidney-function-in-incident-haemodialysis-patients
#13
Simon J Davies, Fergus J Caskey, David Coyle, Elizabeth Lindley, Jamie Macdonald, Sandip Mitra, Martin Wilkie, Andrew Davenport, Ken Farrington, Indranil Dasgupta, Paula Ormandy, Lazaros Andronis, Ivonne Solis-Trapala, Julius Sim
BACKGROUND: Preserved residual kidney function (RKF) and normal fluid status are associated with better patient outcomes in incident haemodialysis patients. The objective of this trial is to determine whether using bioimpedance technology in prescribing the optimal post-dialysis weight can reduce the rate of decline of RKF and potentially improve patient outcomes. METHODS/DESIGN: 516 pateints commencing haemodialysis, aged >18 with RKF of > 3 ml/min/1...
April 26, 2017: BMC Nephrology
https://www.readbyqxmd.com/read/28440892/the-effect-of-adult-early-warning-systems-education-on-nurses-knowledge-confidence-and-clinical-performance-a-systematic-review
#14
REVIEW
Mohamad M Saab, Bridie McCarthy, Tom Andrews, Eileen Savage, Frances J Drummond, Nuala Walshe, Mary Forde, Dorothy Breen, Patrick Henn, Jonathan Drennan, Josephine Hegarty
AIMS: This review aims to determine the effect of adult Early Warning Systems education on nurses' knowledge, confidence and clinical performance. BACKGROUND: Early Warning Systems support timely identification of clinical deterioration and prevention of avoidable deaths. Several educational programmes have been designed to help nurses recognise and manage deteriorating patients. Little is known as to the effectiveness of these programmes. DESIGN: SYSTEMATIC REVIEW: DATA SOURCES: Academic Search Complete, CINAHL, MEDLINE, PsycINFO, PsycARTICLES, Psychology and Behavioral Science Collection, SocINDEX and the UK & Ireland Reference Centre, EMBASE, the Turning Research Into Practice database, the Cochrane Central Register of Controlled Trials (CENTRAL) and Grey Literature sources were searched between October - November 2015...
April 25, 2017: Journal of Advanced Nursing
https://www.readbyqxmd.com/read/28440858/treatment-with-disease-modifying-drugs-for-people-with-a-first-clinical-attack-suggestive-of-multiple-sclerosis
#15
REVIEW
Graziella Filippini, Cinzia Del Giovane, Marinella Clerico, Omid Beiki, Miriam Mattoscio, Federico Piazza, Sten Fredrikson, Irene Tramacere, Antonio Scalfari, Georgia Salanti
BACKGROUND: The treatment of multiple sclerosis has changed over the last 20 years. The advent of disease-modifying drugs in the mid-1990s heralded a period of rapid progress in the understanding and management of multiple sclerosis. With the support of magnetic resonance imaging early diagnosis is possible, enabling treatment initiation at the time of the first clinical attack. As most of the disease-modifying drugs are associated with adverse events, patients and clinicians need to weigh the benefit and safety of the various early treatment options before taking informed decisions...
April 25, 2017: Cochrane Database of Systematic Reviews
https://www.readbyqxmd.com/read/28440126/transcranial-doppler-screening-for-stroke-risk-in-children-with-sickle-cell-disease-a-systematic-review
#16
Sara Mazzucco, Marina Diomedi, Amrana Qureshi, Laura Sainati, Soundrie T Padayachee
Background Sickle cell disease (SCD) is one of the most common causes of stroke in children worldwide. Based on the results of the Stroke Prevention Trial in Sickle Cell Anemia (STOP), annual transcranial Doppler ultrasound (TCD) screening for affected children is standard practice. However, the need for TCD surveillance programs could override the accuracy of the screening, affecting the correct stratification of stroke risk and subsequent clinical management of the target population. Aims To shed light on this issue, a systematic review of the literature on TCD screening for children and adolescents with SCD was carried out (CRD42016050549), according to a list of clinically relevant questions, with a particular focus on screening practices in European countries...
January 1, 2017: International Journal of Stroke: Official Journal of the International Stroke Society
https://www.readbyqxmd.com/read/28439881/effect-of-cocoa-on-blood-pressure
#17
REVIEW
Karin Ried, Peter Fakler, Nigel P Stocks
BACKGROUND: High blood pressure is an important risk factor for cardiovascular disease, contributing to about 50% of cardiovascular events worldwide and 37% of cardiovascular-related deaths in Western populations. Epidemiological studies suggest that cocoa-rich products reduce the risk of cardiovascular disease. Flavanols found in cocoa have been shown to increase the formation of endothelial nitric oxide which promotes vasodilation and therefore blood pressure reduction. Here we update previous meta-analyses on the effect of cocoa on blood pressure...
April 25, 2017: Cochrane Database of Systematic Reviews
https://www.readbyqxmd.com/read/28438398/triglycerides-a-reappraisal
#18
REVIEW
Philipp Wiesner, Karol E Watson
Elevated cholesterol levels are clearly independently associated with adverse cardiovascular events. Another class of lipid particles, triglycerides, is also abundant in the human body and has been found in atherosclerotic plaques. Recent observational studies have demonstrated an association between elevated triglyceride levels and increased risk for future cardiovascular events. With this knowledge and the discovery of effective agents to lower triglyceride levels, the management of triglycerides is currently undergoing a renaissance...
March 21, 2017: Trends in Cardiovascular Medicine
https://www.readbyqxmd.com/read/28437620/american-association-of-clinical-endocrinologists-and-american-college-of-endocrinology-guidelines-for-management-of-dyslipidemia-and-prevention-of-cardiovascular-disease
#19
Paul S Jellinger, Yehuda Handelsman, Paul D Rosenblit, Zachary T Bloomgarden, Vivian A Fonseca, Alan J Garber, George Grunberger, Chris K Guerin, David S H Bell, Jeffrey I Mechanick, Rachel Pessah-Pollack, Kathleen Wyne, Donald Smith, Eliot A Brinton, Sergio Fazio, Michael Davidson
OBJECTIVE: The development of these guidelines is mandated by the American Association of Clinical Endocrinologists (AACE) Board of Directors and American College of Endocrinology (ACE) Board of Trustees and adheres with published AACE protocols for the standardized production of clinical practice guidelines (CPGs). METHODS: Recommendations are based on diligent reviews of the clinical evidence with transparent incorporation of subjective factors, according to established AACE/ACE guidelines for guidelines protocols...
April 2017: Endocrine Practice
https://www.readbyqxmd.com/read/28434650/global-kidney-health-2017-and-beyond-a-roadmap-for-closing-gaps-in-care-research-and-policy
#20
REVIEW
Adeera Levin, Marcello Tonelli, Joseph Bonventre, Josef Coresh, Jo-Ann Donner, Agnes B Fogo, Caroline S Fox, Ron T Gansevoort, Hiddo J L Heerspink, Meg Jardine, Bertram Kasiske, Anna Köttgen, Matthias Kretzler, Andrew S Levey, Valerie A Luyckx, Ravindra Mehta, Orson Moe, Gregorio Obrador, Neesh Pannu, Chirag R Parikh, Vlado Perkovic, Carol Pollock, Peter Stenvinkel, Katherine R Tuttle, David C Wheeler, Kai-Uwe Eckardt
The global nephrology community recognises the need for a cohesive plan to address the problem of chronic kidney disease (CKD). In July, 2016, the International Society of Nephrology hosted a CKD summit of more than 85 people with diverse expertise and professional backgrounds from around the globe. The purpose was to identify and prioritise key activities for the next 5-10 years in the domains of clinical care, research, and advocacy and to create an action plan and performance framework based on ten themes: strengthen CKD surveillance; tackle major risk factors for CKD; reduce acute kidney injury-a special risk factor for CKD; enhance understanding of the genetic causes of CKD; establish better diagnostic methods in CKD; improve understanding of the natural course of CKD; assess and implement established treatment options in patients with CKD; improve management of symptoms and complications of CKD; develop novel therapeutic interventions to slow CKD progression and reduce CKD complications; and increase the quantity and quality of clinical trials in CKD...
April 20, 2017: Lancet
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