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https://www.readbyqxmd.com/read/28737661/toward-establishing-core-outcome-domains-for-trials-in-kidney-transplantation-report-of-the-standardized-outcomes-in-nephrology-kidney-transplantation-consensus-workshops
#1
Allison Tong, John Gill, Klemens Budde, Lorna Marson, Peter P Reese, David Rosenbloom, Lionel Rostaing, Germaine Wong, Michelle A Josephson, Timothy L Pruett, Anthony N Warrens, Jonathan C Craig, Benedicte Sautenet, Nicole Evangelidis, Angelique F Ralph, Camilla S Hanson, Jenny I Shen, Kirsten Howard, Klemens Meyer, Ronald D Perrone, Daniel E Weiner, Samuel Fung, Maggie K M Ma, Caren Rose, Jessica Ryan, Ling-Xin Chen, Martin Howell, Nicholas Larkins, Siah Kim, Sobhana Thangaraju, Angela Ju, Jeremy R Chapman
BACKGROUND: Treatment decisions in kidney transplantation requires patients and clinicians to weigh the benefits and harms of a broad range of medical and surgical interventions, but the heterogeneity and lack of patient-relevant outcomes across trials in transplantation makes these trade-offs uncertain, thus, the need for a core outcome set that reflects stakeholder priorities. METHODS: We convened 2 international Standardized Outcomes in Nephrology-Kidney Transplantation stakeholder consensus workshops in Boston (17 patients/caregivers; 52 health professionals) and Hong Kong (10 patients/caregivers; 45 health professionals)...
August 2017: Transplantation
https://www.readbyqxmd.com/read/28736045/comparative-effectiveness-of-high-dose-versus-standard-dose-influenza-vaccination-on-numbers-of-us-nursing-home-residents-admitted-to-hospital-a-cluster-randomised-trial
#2
Stefan Gravenstein, H Edward Davidson, Monica Taljaard, Jessica Ogarek, Pedro Gozalo, Lisa Han, Vincent Mor
BACKGROUND: Immune responses to influenza vaccines decline with age, reducing clinical effectiveness. We compared the effect of the more immunogenic high-dose trivalent influenza vaccine with a standard-dose vaccine to identify the effect on reducing hospital admissions of nursing home residents in the USA. METHODS: We did a single-blind, pragmatic, comparative effectiveness, cluster-randomised trial with a 2 × 2 factorial design. Medicare-certified nursing homes in the USA located within 50 miles of a Centers for Disease Control and Prevention influenza reporting city were recruited, so long as the facilities were not located in a hospital, had more than 50 long-stay residents, had less than 20% of the population aged under 65 years, and were not already planning to administer the high-dose influenza vaccine to residents...
July 20, 2017: Lancet Respiratory Medicine
https://www.readbyqxmd.com/read/28735337/thresholds-of-toxicological-concern-setting-a-threshold-for-testing-below-which-there-is-little-concern
#3
Thomas Hartung
Low dose, low risk; very low dose, no real risk. Setting a pragmatic threshold below which concerns become negligible is the purpose of thresholds of toxicological concern (TTC). The idea is that such threshold values do not need to be established for each and every chemical based on experimental data, but that by analyzing the distribution of lowest or no-effect doses of many chemicals, a TTC can be defined - typically using the 5th percentile of this distribution and lowering it by an uncertainty factor of, e...
2017: ALTEX
https://www.readbyqxmd.com/read/28735109/design-and-rationale-for-a-real-world-observational-cohort-of-patients-with-nonalcoholic-fatty-liver-disease-the-target-nash-study
#4
A Sidney Barritt, Norman Gitlin, Samuel Klein, Anna S Lok, Rohit Loomba, Laura Malahias, Margaret Powell, Miriam B Vos, L Michael Weiss, Kenneth Cusi, Brent A Neuschwander-Tetri, Arun Sanyal
Nonalcoholic fatty liver disease (NAFLD) is highly prevalent and can lead to cirrhosis, hepatocellular carcinoma, and end-stage liver disease. NAFLD comprises the spectrum from simple steatosis (nonalcoholic fatty liver, NAFL), to steatosis with inflammation (nonalcoholic steatohepatitis, NASH). Current primary therapy recommended for NAFLD is weight loss induced by lifestyle modification. The difficulty in achieving this has led to robust pharmacological therapy development. While new drugs may show efficacy in selected phase II/III clinical trial populations, their real-world effectiveness is unknown...
July 19, 2017: Contemporary Clinical Trials
https://www.readbyqxmd.com/read/28735036/proactive-tobacco-treatment-for-individuals-with-and-without-a-mental-health-diagnosis-secondary-analysis-of-a-pragmatic-randomized-controlled-trial
#5
Sandra J Japuntich, Scott E Sherman, Anne M Joseph, Barbara Clothier, Siamak Noorbaloochi, Elisheva Danan, Diana Burgess, Erin Rogers, Steven S Fu
INTRODUCTION: Individuals with (vs. without) mental illness use tobacco at higher rates and have more difficulty quitting. Treatment models for smokers with mental illness are needed. METHODS: This secondary analysis of the Victory Over Tobacco study [a pragmatic randomized clinical trial (N=5123) conducted in 2009-2011 of Proactive Care (proactive outreach plus connection to smoking cessation services) vs. Usual Care] tests the effectiveness of treatment assignment in participants with and without a mental health diagnosis on population-level, 6month prolonged abstinence at one year follow-up...
July 15, 2017: Addictive Behaviors
https://www.readbyqxmd.com/read/28733698/expert-agreed-standards-for-the-selection-and-development-of-cancer-support-group-leaders-an-online-reactive-delphi-study
#6
Amanda Pomery, Penelope Schofield, Miranda Xhilaga, Karla Gough
PURPOSE: The aim of this study was to develop pragmatic, consensus-based minimum standards for the role of a cancer support group leader. Secondly, to produce a structured interview designed to assess the knowledge, skills and attributes of the individuals who seek to undertake the role. METHODS: An expert panel of 73 academics, health professionals, cancer agency workers and cancer support group leaders were invited to participate in a reactive online Delphi study involving three online questionnaire rounds...
July 21, 2017: Supportive Care in Cancer: Official Journal of the Multinational Association of Supportive Care in Cancer
https://www.readbyqxmd.com/read/28733461/should-heart-failure-be-regarded-as-a-terminal-illness-requiring-palliative-care-a-study-of-heart-failure-patients-carers-and-clinicians-understanding-of-heart-failure-prognosis-and-its-management
#7
Rachel Stocker, Helen Close, Helen Hancock, A Pali S Hungin
OBJECTIVES: Communication and planning for heart failure (HF) care near the end of life is known to be complex. Little is known about how the patient experience of palliative assessment and communication needs change over time, and how this might inform management. Our aim was to explore experiences of giving or receiving a prognosis and advanced palliative care planning (ACP) for those with HF. METHODS: We carried out a longitudinal grounded theory study, employing in-depth interviews with 14 clinicians (primary and secondary care) and observations of clinic and home appointments, followed by a series of interviews with 13 patients with HF and 9 carers...
July 21, 2017: BMJ Supportive & Palliative Care
https://www.readbyqxmd.com/read/28732525/effectiveness-and-cost-effectiveness-of-embedded-simulation-in-occupational-therapy-clinical-practice-education-study-protocol-for-a-randomised-controlled-trial
#8
Christine Imms, Eli Mang Yee Chu, Stephen Guinea, Loretta Sheppard, Elspeth Froude, Rob Carter, Susan Darzins, Samantha Ashby, Susan Gilbert-Hunt, Nigel Gribble, Kelli Nicola-Richmond, Merrolee Penman, Elena Gospodarevskaya, Erin Mathieu, Mark Symmons
BACKGROUND: Clinical placements are a critical component of the training for health professionals such as occupational therapists. However, with growing student enrolments in professional education courses and workload pressures on practitioners, it is increasingly difficult to find sufficient, suitable placements that satisfy program accreditation requirements. The professional accrediting body for occupational therapy in Australia allows up to 200 of the mandatory 1000 clinical placement hours to be completed via simulation activities, but evidence of effectiveness and efficiency for student learning outcomes is lacking...
July 21, 2017: Trials
https://www.readbyqxmd.com/read/28732519/effectiveness-and-cost-effectiveness-of-daily-all-over-body-application-of-emollient-during-the-first-year-of-life-for-preventing-atopic-eczema-in-high-risk-children-the-beep-trial-protocol-for-a-randomised-controlled-trial
#9
Joanne R Chalmers, Rachel H Haines, Eleanor J Mitchell, Kim S Thomas, Sara J Brown, Matthew Ridd, Sandra Lawton, Eric L Simpson, Michael J Cork, Tracey H Sach, Lucy E Bradshaw, Alan A Montgomery, Robert J Boyle, Hywel C Williams
BACKGROUND: Atopic eczema (AE) is a common skin problem that impairs quality of life and is associated with the development of other atopic diseases including asthma, food allergy and allergic rhinitis. AE treatment is a significant cost burden for health care providers. The purpose of the trial is to investigate whether daily application of emollients for the first year of life can prevent AE developing in high-risk infants (first-degree relative with asthma, AE or allergic rhinitis)...
July 21, 2017: Trials
https://www.readbyqxmd.com/read/28730950/statistical-analysis-plan-for-the-head-position-in-stroke-trial-headpost-an-international-cluster-cross-over-randomized-trial
#10
Laurent Billot, Mark Woodward, Hisatomi Arima, Maree L Hackett, Paula Muñoz Venturelli, Pablo M Lavados, Alejandro Brunser, Bin Peng, Liying Cui, Lily Song, Stephane Heritier, Stephen Jan, Sandy Middleton, Verónica V Olavarría, Joyce Lim, Thompson Robinson, Octavio Pontes-Neto, Caroline Watkins, Craig S Anderson
Background There is evidence to indicate that the lying flat head position increases cerebral blood flow and oxygenation in patients with acute ischemic stroke, but how these physiological effects translate into clinical outcomes is uncertain. The Head Position in Stroke Trial aims to determine the comparative effectiveness of lying flat (0°) compared to sitting up (≥30°) head positioning, initiated within 24 h of hospital admission for patients with acute stroke. Design An international, pragmatic, cluster-randomized, crossover, open, blinded outcome assessed clinical trial...
August 2017: International Journal of Stroke: Official Journal of the International Stroke Society
https://www.readbyqxmd.com/read/28730944/integrating-bioassays-and-analytical-chemistry-as-an-improved-approach-to-support-safety-assessment-of-food-contact-materials
#11
Julien Veyrand, Maricel Marin-Kuan, Claudine Bezencon, Nancy Frank, Violaine Guérin, Sander Koster, Hélia Latado, Julie Mollergues, Amaury Patin, Dominique Piguet, Patrick Serrant, Jesus Varela, Benoît Schilter
Food contact materials (FCM) contain chemicals which can migrate into food and result in human exposure. Although it is mandatory to ensure that migration does not endanger human health, there is still no consensus on how to pragmatically assess the safety of FCM since traditional approaches would require extensive toxicological and analytical testing which are expensive and time consuming. Recently, the combination of bioassays, analytical chemistry and risk assessment has been promoted as a new paradigm to identify toxicologically relevant molecules and address safety issues...
July 21, 2017: Food Additives & Contaminants. Part A, Chemistry, Analysis, Control, Exposure & Risk Assessment
https://www.readbyqxmd.com/read/28730671/many-faces-of-rationality-implications-of-the-great-rationality-debate-for-clinical-decision-making
#12
Benjamin Djulbegovic, Shira Elqayam
Given that more than 30% of healthcare costs are wasted on inappropriate care, suboptimal care is increasingly connected to the quality of medical decisions. It has been argued that personal decisions are the leading cause of death, and 80% of healthcare expenditures result from physicians' decisions. Therefore, improving healthcare necessitates improving medical decisions, ie, making decisions (more) rational. Drawing on writings from The Great Rationality Debate from the fields of philosophy, economics, and psychology, we identify core ingredients of rationality commonly encountered across various theoretical models...
July 20, 2017: Journal of Evaluation in Clinical Practice
https://www.readbyqxmd.com/read/28729753/gesture-and-intonation-are-sister-systems-of-infant-communication-evidence-from-regression-patterns-of-language-development
#13
David P Snow
This study investigates infants' transition from nonverbal to verbal communication using evidence from regression patterns. As an example of regressions, prelinguistic infants learning American Sign Language (ASL) use pointing gestures to communicate. At the onset of single signs, however, these gestures disappear. Petitto (1987) attributed the regression to the children's discovery that pointing has two functions, namely, deixis and linguistic pronouns. The 1:2 relation (1 form, 2 functions) violates the simple 1:1 pattern that infants are believed to expect...
January 2017: Language Sciences
https://www.readbyqxmd.com/read/28729568/nhs-dental-service-utilisation-and-social-deprivation-in-older-adults-in-north-west-england
#14
K W McKenzie, M Goodwin, I Pretty
Objective To explore NHS dental service utilisation (attendance and treatment activity) of older adults.Design Retrospective analysis of dental treatment claim forms (FP17s) over a 15 month period.Population A total of 690,433 older adults in North West England.Results NHS dental care attendance decreased with increasing age; 49% in 65-74 years, 39% in 75-84 years and 23% in the over 85 years age group. Across all older age stratifications, the more deprived patients had a higher rate of examinations, extractions, dentures and preventative advice compared to the least deprived patients...
July 21, 2017: British Dental Journal
https://www.readbyqxmd.com/read/28728602/robot-assisted-training-for-the-upper-limb-after-stroke-ratuls-study-protocol-for-a-randomised-controlled-trial
#15
Helen Rodgers, Lisa Shaw, Helen Bosomworth, Lydia Aird, Natasha Alvarado, Sreeman Andole, David L Cohen, Jesse Dawson, Janet Eyre, Tracy Finch, Gary A Ford, Jennifer Hislop, Steven Hogg, Denise Howel, Niall Hughes, Hermano Igo Krebs, Christopher Price, Lynn Rochester, Elaine Stamp, Laura Ternent, Duncan Turner, Luke Vale, Elizabeth Warburton, Frederike van Wijck, Scott Wilkes
BACKGROUND: Loss of arm function is a common and distressing consequence of stroke. We describe the protocol for a pragmatic, multicentre randomised controlled trial to determine whether robot-assisted training improves upper limb function following stroke. METHODS/DESIGN: Study design: a pragmatic, three-arm, multicentre randomised controlled trial, economic analysis and process evaluation. SETTING: NHS stroke services. PARTICIPANTS: adults with acute or chronic first-ever stroke (1 week to 5 years post stroke) causing moderate to severe upper limb functional limitation...
July 20, 2017: Trials
https://www.readbyqxmd.com/read/28728080/neural-correlates-underlying-the-comprehension-of-deceitful-and-ironic-communicative-intentions
#16
Francesca M Bosco, Alberto Parola, Maria C Valentini, Rosalba Morese
Neuroimaging studies have shown that a left fronto-temporo-parietal cerebral network is recruited in the comprehension of both deceitful and ironic speech acts. However, no studies to date have directly compared neural activation during the comprehension of these pragmatic phenomena. We used fMRI to investigate the existence of common and specific neural circuits underlying the comprehension of the same speech act, uttered with different communicative intentions, i.e., of being sincere, deceitful or ironic...
June 27, 2017: Cortex; a Journal Devoted to the Study of the Nervous System and Behavior
https://www.readbyqxmd.com/read/28727924/does-early-change-predict-long-term-6-months-improvements-in-subjects-who-receive-manual-therapy-for-low-back-pain
#17
Chad Cook, Shannon Petersen, Megan Donaldson, Mark Wilhelm, Ken Learman
Early change is commonly assessed for manual therapy interventions and has been used to determine treatment appropriateness. However, current studies have only explored the relationship of between or within-session changes and short-/medium-term outcomes. The goal of this study was to determine whether pain changes after two weeks of pragmatic manual therapy could predict those participants with chronic low back pain who demonstrate continued improvements at 6-month follow-up. This study was a retrospective observational design...
July 20, 2017: Physiotherapy Theory and Practice
https://www.readbyqxmd.com/read/28727796/effects-of-health-risk-assessment-and-counselling-on-physical-activity-in-older-people-a-pragmatic-randomised-trial
#18
Anna Marie Herghelegiu, André Moser, Gabriel Ioan Prada, Stephan Born, Matthias Wilhelm, Andreas E Stuck
BACKGROUND: Interventions to increase physical activity (PA) among older community-dwelling adults may be enhanced by using multidimensional health risk assessment (HRA) as a basis for PA counselling. METHODS: The study was conducted among nondisabled but mostly frail persons 65 years of age and older at an ambulatory geriatric clinic in Bucharest, Romania. From May to July 2014, 200 participants were randomly allocated to intervention and control groups. Intervention group participants completed an initial HRA questionnaire and then had monthly counselling sessions with a geriatrician over a period of six months that were aimed at increasing low or maintaining higher PA...
2017: PloS One
https://www.readbyqxmd.com/read/28727629/an-automated-inpatient-split-dose-bowel-preparation-system-improves-colonoscopy-quality-and-reduces-repeat-procedures
#19
Rena Yadlapati, Elyse R Johnston, Adam B Gluskin, Dyanna L Gregory, Rachel Cyrus, Lindsay Werth, Jody D Ciolino, David P Grande, Rajesh N Keswani
BACKGROUND/GOALS: Inpatient colonoscopy preparations are often inadequate, compromising patient safety and procedure quality, while resulting in greater hospital costs. The aims of this study were to: (1) design and implement an electronic inpatient split-dose bowel preparation order set; (2) assess the intervention's impact upon preparation adequacy, repeated colonoscopies, hospital days, and costs. STUDY: We conducted a single center prospective pragmatic quasiexperimental study of hospitalized adults undergoing colonoscopy...
July 19, 2017: Journal of Clinical Gastroenterology
https://www.readbyqxmd.com/read/28725451/feasibility-of-the-trial-procedures-for-a-randomized-controlled-trial-of-a-community-based-peer-led-wheelchair-training-program-for-older-adults
#20
Krista L Best, William C Miller, François Routhier, Janice J Eng
BACKGROUND: A novel peer-led manual wheelchair (MWC) training program may support the training needs of older adults, but establishing program feasibility is a pragmatic first step. The purpose of this study was to evaluate the feasibility of a peer-led Wheelchair training Self-Efficacy Enhanced for Use (WheelSeeU) program. METHODS: Forty MWC users (mean age 65 years) were randomly assigned to the experimental (WheelSeeU) or control group. Feasibility indicators of process, resources, management, and safety were collected throughout the study...
2018: Pilot and Feasibility Studies
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