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Determining the research priorities for patients with chronic kidney disease not on dialysis.
Hemmelgarn, BR, Pannu, N, Ahmed, SB, Elliott, MJ, Tam-Tham, H, Lillie, E, Straus, SE, Donald, M, Barnieh, L, Chong, GC, et al
Nephrology, dialysis, transplantation : official publication of the European Dialysis and Transplant Association - European Renal Association. 2017;(5):847-854
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Abstract
BACKGROUND The importance of engaging key stakeholders, and patients in particular, in determining research priorities has been recognized. We sought to identify the top 10 research priorities for patients with non-dialysis chronic kidney disease (CKD), their caregivers, and the clinicians and policy-makers involved in their care. METHODS We used the four-step James Lind Alliance process to establish the top 10 research priorities. A national survey of patients with non-dialysis CKD (estimated glomerular filtration rate <45 mL/min/1.73 m 2 ), their caregivers, and the clinicians and policy-makers involved in their care was conducted to identify research uncertainties. A Steering Group of patients, caregivers, clinicians and researchers combined and reduced these uncertainties to 30 through a series of iterations. Finally, a workshop with participants from across Canada (12 patients, 6 caregivers, 3 physicians, 2 nurses, 1 pharmacist and 1 policy-maker) was held to determine the top 10 research priorities, using a nominal group technique. RESULTS Overall, 439 individuals responded to the survey and identified 1811 uncertainties, from which the steering group determined the top 30 uncertainties to be considered at the workshop. The top 10 research uncertainties prioritized at the workshop included questions about treatments to prevent progression of kidney disease (including diet) and to treat symptoms of CKD, provider- and patient-targeted strategies for managing CKD, the impact of lifestyle on disease progression, harmful effects of medications on disease progression, optimal strategies for treatment of cardiovascular disease in CKD and for early identification of kidney disease, and strategies for equitable access to care for patients with CKD. CONCLUSIONS We identified the top 10 research priorities for patients with CKD that can be used to guide researchers, as well as inform funders of health-care research.
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Effects of acute memantine administration on MATRICS Consensus Cognitive Battery performance in psychosis: Testing an experimental medicine strategy.
Bhakta, SG, Chou, HH, Rana, B, Talledo, JA, Balvaneda, B, Gaddis, L, Light, GA, Swerdlow, NR
Psychopharmacology. 2016;(12):2399-410
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Abstract
RATIONALE Pro-cognitive agents for chronic psychotic disorders (CPDs) might be detected via experimental medicine models, in which neural targets engaged by the drug predict sensitivity to the drug's pro-cognitive effects. OBJECTIVE This study aims to use an experimental medicine model to test the hypothesis that "target engagement" predicts pro-cognitive effects of the NMDA antagonist, memantine (MEM), in CPDs. METHODS MATRICS Consensus Cognitive Battery (MCCB) performance was assessed in CPD (n = 41) and healthy subjects (HS; n = 41) in a double-blind, randomized cross-over design of acute (single dose) MEM (placebo vs. 10 or 20 mg p.o.). Measures of prepulse inhibition (PPI) and mismatch negativity previously reported from this cohort substantiated target engagement. Biomarkers predicting MEM neurocognitive sensitivity were assessed. RESULTS Testing confirmed MCCB deficits associated with CPD diagnosis, age, and anticholinergic exposure. MEM (20 mg p.o.) reduced MCCB performance in HS. To control for significant test order effects, an "order-corrected MEM effect" (OCME) was calculated. In CPD subjects, greater age, positive MEM effects on PPI, and SNP rs1337697 (within the ionotropic NMDA receptor gene, GRIN3A) predicted greater positive OCME with 20 mg MEM. CONCLUSIONS An experimental medicine model to assess acute pro-cognitive drug effects in CPD subjects is feasible but not without challenges. A single MEM 20 mg dose had a negative impact on neurocognition among HS. In CPD patients, age, MEM effects on PPI, and rs1337697 predicted sensitivity to the neurocognitive effects of MEM. Any potential clinical utility of these predictive markers for pro-cognitive effects of MEM in subgroups of CPD patients cannot be inferred without a validating clinical trial.
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Innovation to reduce cardiovascular complications of diabetes at the intersection of discovery, prevention and knowledge exchange.
Noble, E, Melling, J, Shoemaker, K, Tikkanen, H, Peltonen, J, Stuckey, M, Petrella, RJ
Canadian journal of diabetes. 2013;(5):282-93
Abstract
This article describes selected primary outcomes from a series of linked, collaborative projects among multidisciplinary investigators from Canada and Finland dedicated to quantifying the benefits and detriments of prescriptive exercise in the prevention and control of the cardiovascular complications (CVCs) of diabetes along the continuum of disease risk.
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Use of electronic data capture in a clinical trial on infant feeding.
Pawellek, I, Richardsen, T, Oberle, D, Grote, V, Koletzko, B
European journal of clinical nutrition. 2012;(12):1342-3
Abstract
BACKGROUND/OBJECTIVE The European Childhood Obesity Project is a multi-centre double-blind randomised clinical trial in five countries testing whether protein intake in early life is related to later obesity risk. We use electronic data capture (EDC) in this trial and report here on our experience with the method. SUBJECTS/METHODS Data capture for the first two study years was done with 10 notebooks, which were installed with the RDE (Remote Data Entry) programme Clindoc. RESULTS We here exemplary report our experiences in 1 of the 11 study centres. A total of 205 of 760 visits (27.0%) were documented with interim paper-based case report forms, whereas 555 (73.0%) visits were recorded with electronic case report forms (eCRF). The need for after-trial plausibility checks of anthropometric data is significantly reduced in visits done by eCRF in comparison with visits done by paper-based CRFs (14.05% versus 35.61%). CONCLUSION EDC reduces significantly the need for after-trial data checks but the planning and implementation process before starting the trial is more time-consuming.