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https://www.readbyqxmd.com/read/28336478/an-extended-protocol-for-usability-validation-of-medical-devices-research-design-and-reference-model
#1
Martin Schmettow, Raphaela Schnittker, Jan Maarten Schraagen
This paper proposes and demonstrates an extended protocol for usability validation testing of medical devices. A review of currently used methods for the usability evaluation of medical devices revealed two main shortcomings. Firstly, the lack of methods to closely trace the interaction sequences and derive performance measures. Secondly, a prevailing focus on cross-sectional validation studies, ignoring the issues of learnability and training. The U.S. Federal Drug and Food Administration's recent proposal for a validation testing protocol for medical devices is then extended to address these shortcomings: (1) a novel process measure 'normative path deviations' is introduced that is useful for both quantitative and qualitative usability studies and (2) a longitudinal, completely within-subject study design is presented that assesses learnability, training effects and allows analysis of diversity of users...
March 21, 2017: Journal of Biomedical Informatics
https://www.readbyqxmd.com/read/28324962/design-of-a-dual-hormone-model-predictive-control-for-artificial-pancreas-with-exercise-model
#2
Navid Resalat, Joseph El Youssef, Ravi Reddy, Peter G Jacobs
The Artificial Pancreas (AP) is a new technology for helping people with type 1 diabetes to better control their glucose levels through automated delivery of insulin and optionally glucagon in response to sensed glucose levels. In a dual hormone AP, insulin and glucagon are delivered automatically to the body based on glucose sensor measurements using a control algorithm that calculates the amount of hormones to be infused. A dual-hormone MPC may deliver insulin continuously; however, it must avoid continuous delivery of glucagon because nausea can occur from too much glucagon...
August 2016: Conference Proceedings: Annual International Conference of the IEEE Engineering in Medicine and Biology Society
https://www.readbyqxmd.com/read/28298760/the-effectiveness-of-intravenous-dexmedetomidine-on-perioperative-hemodynamics-analgesic-requirement-and-side-effects-profile-in-patients-undergoing-laparoscopic-surgery-under-general-anesthesia
#3
Vinayak Panchgar, Akshaya N Shetti, H B Sunitha, Vithal K Dhulkhed, A V Nadkarni
BACKGROUND: There is an upward surge in the use of laparoscopic surgeries due to various advantages when compared to open surgeries. Major advantages are, due to small incisions which are cosmetically acceptable and most of them are now daycare procedures. Problem of economic burden and hospital bed occupancy has been overcome with laparoscopic surgeries. All these advantages are not free from disadvantages, as hemodynamic changes such as hypertension; tachycardia and other surgical-related complications are commonly observed intraoperatively...
January 2017: Anesthesia, Essays and Researches
https://www.readbyqxmd.com/read/28270721/the-hospital-at-home-program-no-place-like-home
#4
M Lippert, S Semmens, L Tacey, T Rent, K Defoe, M Bucsis, T Shykula, J Crysdale, V Lewis, D Strother, L Lafay-Cousin
BACKGROUND: The treatment of children with cancer is associated with significant burden for the entire family. Frequent clinic visits and extended hospital stays can negatively affect quality of life for children and their families. METHODS: Here, we describe the development of a Hospital at Home program (H@H) that delivers therapy to pediatric hematology, oncology, and blood and marrow transplant (bmt) patients in their homes. The services provided include short infusions of chemotherapy, supportive-care interventions, antibiotics, post-chemotherapy hydration, and teaching...
February 2017: Current Oncology
https://www.readbyqxmd.com/read/28268105/prolonged-striatal-disinhibition-as-a-chronic-animal-model-of-tic-disorders
#5
Esther Vinner, Michal Israelashvili, Izhar Bar-Gad
BACKGROUND: Experimental findings and theoretical models have associated Tourette syndrome with abnormal striatal inhibition. The expression of tics, the hallmark symptom of this disorder, has been transiently induced in non-human primates and rodents by the injection of GABAA antagonists into the striatum, leading to temporary disinhibition. NEW METHOD: The novel chronic model of tic expression utilizes mini-osmotic pumps implanted subcutaneously in the rat back for prolonged infusion of bicuculline into the dorsolateral striatum...
March 4, 2017: Journal of Neuroscience Methods
https://www.readbyqxmd.com/read/28264846/substantial-impact-of-altered-pharmacokinetics-in-critically-ill-patients-on-the-antibacterial-effects-of-meropenem-evaluated-via-the-dynamic-hollow-fiber-infection-model
#6
Phillip J Bergen, Jürgen B Bulitta, Carl M J Kirkpatrick, Kate E Rogers, Megan J McGregor, Steven C Wallis, David L Paterson, Roger L Nation, Jeffrey Lipman, Jason A Roberts, Cornelia B Landersdorfer
Critically ill patients frequently have substantially altered pharmacokinetics compared to non-critically ill patients. We investigated the impact of pharmacokinetic alterations on bacterial killing and resistance for commonly used meropenem dosing regimens. A Pseudomonas aeruginosa isolate (MICmeropenem 0.25 mg/L) was studied in the hollow-fiber infection model (inoculum ∼10(7.5) CFU/mL; 10 days). Pharmacokinetic profiles representing critically ill patients with augmented renal clearance (ARC), normal, or impaired renal function (creatinine clearances of 285, 120 or ∼10 mL/min, respectively) were generated for three meropenem regimens (2g, 1g and 0...
March 6, 2017: Antimicrobial Agents and Chemotherapy
https://www.readbyqxmd.com/read/28250601/early-administration-of-selenium-in-patients-with-acute-traumatic-brain-injury-a-randomized-double-blinded-controlled-trial
#7
Omid Moradi Moghaddam, Mohammad Niakan Lahiji, Valiollah Hassani, Shakiba Mozari
AIM: The present study was carried out to examine this hypothesis that administration of selenium can prevent the development of injuries by brain trauma and thus can modulate patients' functional recovery and also improve posttraumatic outcome. MATERIALS AND METHODS: This double-blinded controlled trial was carried out on 113 patients who were hospitalized following traumatic brain injury (TBI) with Glasgow Coma Scale score of 4-12 that were randomly assigned to receive selenium within 8 h after injury plus standard treatment group or routine standard treatment alone as the control...
February 2017: Indian Journal of Critical Care Medicine
https://www.readbyqxmd.com/read/28237801/inactivation-of-the-medial-mammillary-nucleus-attenuates-theta-rhythm-activity-in-the-hippocampus-in-urethane-anesthetized-rats
#8
Witold Żakowski, Łukasz Braszka, Piotr Zawistowski, Jolanta Orzeł-Gryglewska, Edyta Jurkowlaniec
Although the importance of the mammillary body for memory and learning processes is well known, its exact role has remained vague. The fact, that many neurons in one nucleus of the mammillary body in rats, i.e. the medial mammillary nucleus (MM), fires according with hippocampal theta rhythm, makes this structure crucial for a theta rhythm signaling in so-called extended hippocampal system. These neurons are driven by descending projections from the hippocampal formation, but it is still unknown whether the mammillary body only conveys theta rhythm or may also modulate it...
February 22, 2017: Neuroscience Letters
https://www.readbyqxmd.com/read/28229812/successful-extension-of-tocilizumab-infusion-intervals-from-4-weeks-to-6-or-5-weeks-in-90-of-ra-patients-with-good-response-to-4-week-intervals
#9
Osamu Saiki, Hiroshi Uda
OBJECTIVES: A period of 4 weeks (w) has been recommended as the interval between tocilizumab (TCZ) infusions for rheumatoid arthritis (RA). However, treating the patients with TCZ (8 mg/kg), we experienced that longer intervals were also effective. We conducted the study to investigate whether the intervals of TCZ infusions could extend from 4w to 5 or 6w. METHODS: This was a retrospective observational study. RA patients who had shown good response to TCZ infusions at 4w intervals were enrolled, and the intervals of TCZ infusions were extended to 5w...
February 20, 2017: Clinical and Experimental Rheumatology
https://www.readbyqxmd.com/read/28228578/proof-of-concept-randomized-trial-of-the-monoclonal-antibody-gsk249320-versus-placebo-in-stroke-patients
#10
Steven C Cramer, Lori A Enney, Colleen K Russell, Monica Simeoni, Thomas R Thompson
BACKGROUND AND PURPOSE: One class of poststroke restorative therapy focuses on promoting axon outgrowth by blocking myelin-based inhibitory proteins such as myelin-associated glycoprotein. The purpose of the current study was to extend preclinical and clinical findings of GSK249320, a humanized monoclonal antibody to myelin-associated glycoprotein with disabled Fc region, to explore effects on motor outcomes poststroke. METHODS: In this phase IIb double-blind, randomized, placebo-controlled study, patients at 30 centers with ischemic stroke 24 to 72 hours prior and gait deficits were randomized to 2 IV infusions of GSK249320 or placebo...
March 2017: Stroke; a Journal of Cerebral Circulation
https://www.readbyqxmd.com/read/28228418/folic-acid-supplementation-increases-cutaneous-vasodilator-sensitivity-to-sympathetic-nerve-activity-in-older-adults
#11
Anna E Stanhewicz, Jody L Greaney, Lacy M Alexander, W Larry Kenney
During heat stress, blunted increases in skin sympathetic nervous system activity (SSNA) and reductions in end-organ vascular responsiveness contribute to the age-related reduction in reflex cutaneous vasodilation. In older adults, folic acid supplementation improves the cutaneous vascular conductance (CVC) response to passive heating; however, the influence of folic acid supplementation on SSNA:CVC transduction is unknown. Fourteen older adults (66±1yrs, 8M/6F) ingested folic acid (5mg·day(-1)) or placebo for 6 weeks in a randomized, double-blind, crossover design...
February 22, 2017: American Journal of Physiology. Regulatory, Integrative and Comparative Physiology
https://www.readbyqxmd.com/read/28226972/design-of-a-dual-hormone-model-predictive-control-for-artificial-pancreas-with-exercise-model
#12
Navid Resalat, Joseph El Youssef, Ravi Reddy, Peter G Jacobs, Navid Resalat, Joseph El Youssef, Ravi Reddy, Peter G Jacobs, Navid Resalat, Joseph El Youssef, Peter G Jacobs, Ravi Reddy
The Artificial Pancreas (AP) is a new technology for helping people with type 1 diabetes to better control their glucose levels through automated delivery of insulin and optionally glucagon in response to sensed glucose levels. In a dual hormone AP, insulin and glucagon are delivered automatically to the body based on glucose sensor measurements using a control algorithm that calculates the amount of hormones to be infused. A dual-hormone MPC may deliver insulin continuously; however, it must avoid continuous delivery of glucagon because nausea can occur from too much glucagon...
August 2016: Conference Proceedings: Annual International Conference of the IEEE Engineering in Medicine and Biology Society
https://www.readbyqxmd.com/read/28213939/protective-antibodies-against-clostridium-difficile-are-present-in-intravenous-immunoglobulin-and-are-retained-in-humans-following-its-administration
#13
Ola H Negm, Brendon MacKenzie, Mohamed R Hamed, Omar Aj Ahmad, Clifford C Shone, David P Humphreys, K Ravi Acharya, Christine E Loscher, Izabela Marszalowska, Mark Lynch, Mark H Wilcox, Tanya M Monaghan
The prevalence of serum antibodies against C. difficile (CD) toxins A and B in healthy populations have prompted interest in evaluating the therapeutic activity of intravenous immunoglobulin (IVIg) in individuals experiencing severe or recurrent C. difficile infection (CDI). Despite some promising case reports, a definitive clinical role for IVIg in CDI remains unclear. Contradictory results may be attributed to a lack of consensus regarding optimal dose, timing of administration and patient selection as well as variability in specific antibody content between commercial preparations...
February 18, 2017: Clinical and Experimental Immunology
https://www.readbyqxmd.com/read/28199785/assessment-of-tocilizumab-anti-il-6-receptor-monoclonal-as-a-potential-treatment-for-chronic-antibody-mediated-rejection-and-transplant-glomerulopathy-in-hla-sensitized-renal-allograft-recipients
#14
Jua Choi, Olivier Aubert, Ashley Vo, Alexandre Loupy, Mark Haas, Dechu Puliyanda, Irene Kim, Sabrina Louie, Alexis Kang, Alice Peng, Joe Kahwaji, Nancy Reinsmoen, Mieko Toyoda, Stanley C Jordan
Extending the functional integrity of renal allografts is the primary goal of transplant medicine. Development of donor-specific antibodies (DSAs) post-transplant leads to chronic active antibody-mediated rejection (cABMR) and transplant glomerulopathy (TG), resulting in the majority of graft losses in the U.S. This reduces the quality & length of life for patients and increases cost. There are no approved treatments for cABMR. Evidence suggests the pro-inflammatory cytokine interleukin 6 (IL-6) may play an important role in DSA generation and cABMR...
February 15, 2017: American Journal of Transplantation
https://www.readbyqxmd.com/read/28193052/characterization-of-chain-pairing-variants-of-bispecific-igg-expressed-in-a-single-host-cell-by-high-resolution-native-and-denaturing-mass-spectrometry
#15
Luis Schachner, Guanghui Han, Michael Dillon, Jianhui Zhou, Luke McCarty, Diego Ellerman, Yiyuan Yin, Christoph Spiess, Jennie R Lill, Paul J Carter, Wendy Sandoval
Bispecific antibodies, including bispecific IgG, show some promise in clinical trials as a means to extend the therapeutic potential of antibodies. Bispecific IgG can be made by separate expression and purification of each parent half antibody followed by in vitro reconstitution. Generating bispecific IgG by coexpression of two different light and heavy chains in a single host cell is potentially more efficient because it obviates the need for two separate cell lines and purification processes. However, this workflow may produce unwanted mispaired IgG species in addition to the desired bispecific IgG...
December 20, 2016: Analytical Chemistry
https://www.readbyqxmd.com/read/28185779/corrigendum-to-comparison-of-the-clinical-efficacy-between-tigecycline-plus-extended-infusion-imipenem-and-sulbactam-plus-imipenem-against-ventilator-associated-pneumonia-with-pneumonic-extensively-drug-resistant-acinetobacter-baumannii-bacteremia-and-correlation
#16
https://www.readbyqxmd.com/read/28156494/embedding-palliative-care-pc-in-a-community-based-cancer-center-benefits-and-barriers
#17
John Weems, Robert D Siegel, Teresa N Bowen, Leigh Stinnett, Jennifer Ashley
153 Background: The importance of involving PC early in the disease process of oncology patients is well documented. Decreased symptom burden, increased quality of life, and extended survival are proven outcomes; however, the provision of PC has largely been limited to the acute care setting in most institutions. Bon Secours St. Francis Health System, a community based healthcare system in Greenville, South Carolina, opened a comprehensive cancer center in late 2014. Our established inpatient PC team began seeing outpatients at the cancer center shortly after its opening...
October 9, 2016: Journal of Clinical Oncology: Official Journal of the American Society of Clinical Oncology
https://www.readbyqxmd.com/read/28151818/the-effect-of-fixation-technique-on-continuous-interscalene-nerve-block-catheter-success-a-randomized-double-blind-trial
#18
David B Auyong, David Asher Cantor, Cynthia Green, Neil A Hanson
BACKGROUND: Continuous peripheral nerve blocks offer advantages over single-injection blocks, including extended analgesia and reduction in opioid consumption. These benefits require that the perineural catheter remain intact for the duration of the planned local anesthetic infusion. Mechanical displacement of catheters, leaking, and consequent failure are known complications. The aim of this study was to evaluate continuous perineural catheter tip-to-nerve apposition in vivo over 48 hours comparing 2 different simple fixation strategies...
March 2017: Anesthesia and Analgesia
https://www.readbyqxmd.com/read/28143397/retrospective-case-control-non-inferiority-analysis-of-intravenous-lidocaine-in-a-colorectal-surgery-enhanced-recovery-program
#19
Bhiken I Naik, Siny Tsang, Anne Knisely, Sandeep Yerra, Marcel E Durieux
BACKGROUND: Enhanced recovery after surgery (ERAS) programs typically utilizes multi-modal analgesia to reduce perioperative opioid consumption. Systemic lidocaine is used in several of these ERAS algorithms and has been shown to reduce opioid use after colorectal surgery. However it is unclear how much the other components of an ERAS protocol contribute to the final outcome. Using a noninferiority analysis we sought to assess the role of perioperative lidocaine in an ERAS program for colorectal surgery, using pain and opioid consumption as outcomes...
January 31, 2017: BMC Anesthesiology
https://www.readbyqxmd.com/read/28133121/-a-case-of-advanced-hepatocellular-carcinoma-its-disease-progression-could-be-controlled-by-multimodal-treatment
#20
Takahiro Yoshikawa, Takeo Nomi, Daisuke Hokuto, Ichirou Yamato, Satoshi Yasuda, Shinsaku Obara, Chihiro Kawaguchi, Shoichi Kinoshita, Satoshi Nishiwada, Minako Nagai, Takahiro Akahori, Takatsugu Yamada, Masayuki Sho, Hiromichi Kanehiro, Yoshiyuki Nakajima
The patient was a 73-year-old man, diagnosed with advanced huge hepatocellular carcinoma with a tumor thrombus extending into the inferior vena cava and extrahepatic metastases. Radiation therapy(50 Gy)was applied for the bone metastases, primary tumor, and tumor thrombus, and the patient received a cisplatin transcatheter arterial infusion(100mg/ body, 5 courses). Sorafenib was administered orally once the local lesion was under control. The tumor showed a partial response according to the RECIST criteria, but the tumor thrombus in the inferior vena cava almost disappeared...
November 2016: Gan to Kagaku Ryoho. Cancer & Chemotherapy
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