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Randomized Control Study

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https://www.readbyqxmd.com/read/28110508/on-an-enhanced-rank-preserving-structural-failure-time-model-to-handle-treatment-switch-crossover-and-dropout
#1
Lingling Li, Shijie Tang, Liewen Jiang
It is very challenging to estimate the comparative treatment effect between a treatment therapy and a control therapy on overall survival in the presence of treatment crossover, switch to an alternative non-study therapy, and non-random patient dropout. Existing methods (e.g., intent-to-treat and per-protocol) are known to be biased. We proposed two new estimators to address these analytical challenges and evaluated their performance via a comprehensive simulation study. The new estimators were constructed by combining an enhanced rank-preserving structural failure time model and the inverse probability censoring weighting approach...
January 22, 2017: Statistics in Medicine
https://www.readbyqxmd.com/read/28110443/aerobic-endurance-training-does-not-protect-bone-against-poorly-controlled-type-1-diabetes-in-young-adult-rats
#2
Tom J Hazell, T Dylan Olver, Hana Kowalchuk, Matthew W McDonald, Adwitia Dey, Kenneth N Grisé, Earl G Noble, C W James Melling, Paula Lavery, Hope A Weiler
Streptozotocin (STZ)-induced type 1 diabetes mellitus (T1DM) decreases trabecular bone volume and bone strength in rodents. The current study investigated the potential protective effects of aerobic endurance training (AET) on bone in STZ-induced T1DM young adult rats. Sixty-four 8-week-old male Sprague-Dawley rats were randomly divided into 4 groups of 16: control non-T1DM sedentary (CS) and exercised (CX), T1DM sedentary (DS) and exercised (DX). Blood glucose was maintained at 9-15 mmol/L using subcutaneously implanted insulin pellets (Linplant, Linshin Canada, Inc...
January 21, 2017: Calcified Tissue International
https://www.readbyqxmd.com/read/28110355/venous-gas-emboli-are-involved-in-post-dive-macro-but-not-microvascular-dysfunction
#3
Kate Lambrechts, Costantino Balestra, Michaël Theron, Anne Henckes, Hubert Galinat, Fanny Mignant, Marc Belhomme, Jean-Michel Pontier, François Guerrero
PURPOSE: Previous studies have shown vascular dysfunction of main conductance arteries and microvessels after diving. We aim to evaluate the impact of bubble formation on vascular function and haemostasis. To achieve this, we used a vibration preconditioning to influence bubble levels without changing any other parameters linked to the dive. METHODS: Twentty-six divers were randomly assigned to one of three groups: (1) the "vibrations-dive" group (VD; n = 9) was exposed to a whole-body vibration session 30 min prior the dive; (2) the "diving" group (D; n = 9) served as a control for the effect of the diving protocol; (3) The "vibration" protocol (V; n = 8) allowed us to assess the effect of vibrations without diving...
January 21, 2017: European Journal of Applied Physiology
https://www.readbyqxmd.com/read/28110322/classification-of-facial-wrinkles-among-chinese-women
#4
Zhang Jiechen, Hou Wei, Feng Suying, Chen Xiangsheng, Wang Hongwei
It is generally recognized that Caucasians and Asians have different skin aging features. The aim of this study was to develop a facial wrinkle grading scale for Chinese women. Standard photographs were taken of 242 Chinese women. Six sets of 0 to 9 wrinkle scales with reference photographs and descriptions were selected, including grading scales for resting and hyperkinetic crow's feet, frontalis lines, glabellar frown lines, and nasolabial folds. To identify the scale by objective quantitative measurement, skin surface measurements from the Visioscan(®) VC98 were used...
October 17, 2016: Journal of Biomedical Research
https://www.readbyqxmd.com/read/28110297/the-technical-report-on-sodium-intake-and-cardiovascular-disease-in-low-and-middle-income-countries-by-the-joint-working-group-of-the-world-heart-federation-the-european-society-of-hypertension-and-the-european-public-health-association
#5
REVIEW
Giuseppe Mancia, Suzanne Oparil, Paul K Whelton, Martin McKee, Anna Dominiczak, Friedrich C Luft, Khalid AlHabib, Fernando Lanas, Albertino Damasceno, Dorairaj Prabhakaran, Giuseppe La Torre, Michael Weber, Martin O'Donnell, Sidney C Smith, Jagat Narula
Ingestion of sodium is essential to health, but excess sodium intake is a risk factor for hypertension and cardiovascular disease. Defining an optimal range of sodium intake in populations has been challenging and controversial. Clinical trials evaluating the effect of sodium reduction on blood pressure have shown blood pressure lowering effects down to sodium intake of less than 1.5 g/day. Findings from these blood pressure trials form the basis for current guideline recommendations to reduce sodium intake to less than 2...
January 21, 2017: European Heart Journal
https://www.readbyqxmd.com/read/28110285/validation-of-a-clinical-screening-instrument-for-tumour-predisposition-syndromes-in-patients-with-childhood-cancer-tups-protocol-for-a-prospective-observational-multicentre-study
#6
Floor A M Postema, Saskia M J Hopman, Corianne A J M de Borgie, Peter Hammond, Raoul C Hennekam, Johannes H M Merks, Cora M Aalfs, Jakob K Anninga, Lieke Pv Berger, Fonnet E Bleeker, Eveline Sjm de Bont, Corianne Ajm de Borgie, Charlotte J Dommering, Natasha Ka van Eijkelenburg, Peter Hammond, Raoul C Hennekam, Marry M van den Heuvel-Eibrink, Saskia Mj Hopman, Marjolijn Cj Jongmans, Wijnanda A Kors, Tom Gw Letteboer, Jan Lcm Loeffen, Johannes Hm Merks, Maran Jw Olderode-Berends, Floor Am Postema, Anja Wagner
INTRODUCTION: Recognising a tumour predisposition syndrome (TPS) in patients with childhood cancer is of significant clinical relevance, as it affects treatment, prognosis and facilitates genetic counselling. Previous studies revealed that only half of the known TPSs are recognised during standard paediatric cancer care. In current medical practice it is impossible to refer every patient with childhood cancer to a clinical geneticist, due to limited capacity for routine genetic consultation...
January 20, 2017: BMJ Open
https://www.readbyqxmd.com/read/28110270/assessment-of-neonatal-pain-during-heel-prick-lancet-vs-needle-a-randomized-controlled-study
#7
Carl Britto, Suman P N Rao
BACKGROUND: Heel prick is a frequent painful procedure in newborns. A lancet or a 26-gauge needle is used for a heel prick in India. OBJECTIVE: To compare the pain caused by heel prick with a lancet or a 26-gauge needle in newborns admitted in the neonatal intensive care unit (NICU) using the preterm infant pain profile (PIPP). METHODS: This randomized controlled trial was conducted over 2 months in a Level III NICU with a sample size of 40 subjects (20 in each group), which was required for the study to have a power of 80% with an alpha error of 0...
January 21, 2017: Journal of Tropical Pediatrics
https://www.readbyqxmd.com/read/28110265/comparative-effectiveness-of-two-disparate-policies-on-child-health-experimental-evidence-from-the-philippines
#8
John W Peabody, Stella Quimbo, Jhiedon Florentino, Riti Shimkhada, Xylee Javier, David Paculdo, Dean Jamison, Orville Solon
BACKGROUND  : Should health systems invest more in access to care by expanding insurance coverage or in health care services including improving the quality of care? Comparing these options experimentally would shed light on the impact and cost-effectiveness of these strategies. METHODS  : The Quality Improvement Demonstration Study (QIDS) was a randomized policy experiment conducted across 30 districts in the Philippines. The study had a control group and two policy intervention groups intended to improve the health of young children...
January 20, 2017: Health Policy and Planning
https://www.readbyqxmd.com/read/28110255/the-impact-of-using-standardized-patients-in-psychiatric-cases-on-the-levels-of-motivation-and-perceived-learning-of-the-nursing-students
#9
Gamze Sarikoc, Celale Tangul Ozcan, Melih Elcin
BACKGROUND: The use of standardized patients is not very common in psychiatric nursing education and there has been no study conducted in Turkey. AIM: This study evaluated the impact of using standardized patients in psychiatric cases on the levels of motivation and perceived learning of the nursing students. DESIGN: This manuscript addressed the quantitative aspect of a doctoral thesis study in which both quantitative and qualitative methods were used...
January 8, 2017: Nurse Education Today
https://www.readbyqxmd.com/read/28110207/the-effect-of-physical-activity-on-depressive-symptoms-and-quality-of-life-among-elderly-nursing-home-residents-randomized-controlled-trial
#10
Neslihan Lok, Sefa Lok, Muammer Canbaz
OBJECTIVES: Physical activity may have positive effects on decreasing anxiety, stress and depression, maintaining mental health and ensuring psychological vitality.This study aimed to determine how a "Physical Activity Program" for elderly people in nursing homes affected their depressive symptoms and quality of life. METHODS: We included 80 individuals aged >65years (40 in the intervention group, 40 controls) in this experimental, randomized, controlled pretest-posttest study...
January 16, 2017: Archives of Gerontology and Geriatrics
https://www.readbyqxmd.com/read/28110205/a-systematic-review-of-randomized-controlled-trials-of-interventions-designed-to-decrease-child-abuse-in-high-risk-families
#11
Elizabeth J Levey, Bizu Gelaye, Paul Bain, Marta B Rondon, Christina P C Borba, David C Henderson, Michelle A Williams
Child abuse is a global problem, and parents with histories of childhood abuse are at increased risk of abusing their offspring. The objective of this systematic review is to provide a clear overview of the existing literature of randomized controlled trials evaluating the effectiveness of interventions to prevent child abuse. PubMed, PsychINFO, Web of Science, Sociological Abstracts, and CINAHL were systematically searched and expanded by hand search. This review includes all randomized controlled trials (RCTs) of interventions designed to prevent abuse among mothers identified as high-risk...
January 19, 2017: Child Abuse & Neglect
https://www.readbyqxmd.com/read/28110155/first-in-man-study-with-a-novel-pegylated-recombinant-human-insulin-like-growth-factor-i
#12
H Kletzl, A Guenther, A Höflich, C Höflich, J Frystyk, R F Staack, E Schick, C Wandel, N Bleich, F Metzger
OBJECTIVE: This study is a first time assessment of safety and tolerability, pharmacokinetics, and pharmacodynamics of RO5046013 in human, in comparison with unmodified rhIGF-I. DESIGN: The study was conducted as a single-center, randomized, double-blinded, placebo-controlled, single ascending dose, parallel group study in a clinical research unit in France. A total of 62 healthy volunteers participated in this clinical trial. RO5046013 was given as single subcutaneous injection, or as intravenous infusion over 48h, at ascending dose levels...
January 10, 2017: Growth Hormone & IGF Research
https://www.readbyqxmd.com/read/28110112/verbal-memory-functioning-moderates-psychotherapy-treatment-response-for-ptsd-related-nightmares
#13
J Cobb Scott, Gerlinde Harb, Janeese A Brownlow, Jennifer Greene, Ruben C Gur, Richard J Ross
Posttraumatic stress disorder (PTSD) is associated with cognitive deficits in attention, executive control, and memory, although few studies have investigated the relevance of cognitive difficulties for treatment outcomes. We examined whether cognitive functioning and history of traumatic brain injury (TBI) were associated with response to cognitive-behavioral therapy (CBT) for PTSD-related sleep problems. In a randomized controlled trial of Imagery Rehearsal (IR) added to components of CBT for Insomnia (IR + cCBT-I) compared to cCBT-I alone for PTSD-related recurrent nightmares, 94 U...
January 13, 2017: Behaviour Research and Therapy
https://www.readbyqxmd.com/read/28110111/applying-a-novel-statistical-method-to-advance-the-personalized-treatment-of-anxiety-disorders-a-composite-moderator-of-comparative-drop-out-from-cbt-and-act
#14
Andrea N Niles, Kate B Wolitzky-Taylor, Joanna J Arch, Michelle G Craske
BACKGROUND: No prior studies have examined moderators of dropout between distinct treatments for anxiety disorders. This study applied a novel statistical approach for examining moderators of dropout from traditional cognitive behavioral therapy (CBT) and acceptance and commitment therapy (ACT). METHOD: We combined data from two randomized controlled trials (N = 208) comparing CBT and ACT for patients with DSM-IV anxiety disorders. Adapting Kraemer's method for constructing and evaluating composite moderators (2013), 26 variables were examined for individual effect sizes...
January 4, 2017: Behaviour Research and Therapy
https://www.readbyqxmd.com/read/28110031/interspinous-process-devices-ipd-alone-versus-decompression-surgery-for-lumbar-spinal-stenosis-lss-a-systematic-review-and-meta-analysis-of-randomized-controlled-trials
#15
REVIEW
Xing-Wen Zhao, Jian-Xiong Ma, Xin-Long Ma, Fei Li, Wei-Wei He, Xuan Jiang, Yin Wang, Biao Han, Bin Lu
BACKGROUND: and purpose: Interspinous process devices (IPD) were widely used for the treatment of lumbar spinal stenosis (LSS). However, whether IPD was superior to bony decompression was still debated. We aimed to compare the clinical outcomes of IPD to bony decompression for LSS. METHODS: PubMed, Cochrane library, Cochrane Central Register of Controlled Trials (CCTR), Ovid Medline, China national knowledge internet database, Wan Fang database were searched in August...
January 18, 2017: International Journal of Surgery
https://www.readbyqxmd.com/read/28110000/drones-may-be-used-to-save-lives-in-out-of-hospital-cardiac-arrest-due-to-drowning
#16
A Claesson, L Svensson, P Nordberg, M Ringh, M Rosenqvist, T Djarv, J Samuelsson, O Hernborg, P Dahlbom, A Jansson, J Hollenberg
BACKGROUND: Drowning leading to out-of-hospital cardiac arrest (OHCA) and death is a major public health concern. Submersion with duration of less than 10minutes is associated with favourable neurological outcome and nearby bystanders play a considerable role in rescue and resuscitation. Drones can provide a visual overview of an accident scene, their potential as lifesaving tools in drowning has not been evaluated. AIM: The aim of this simulation study was to evaluate the efficiency of a drone for providing earlier location of a submerged possible drowning victim in comparison with standard procedure...
January 18, 2017: Resuscitation
https://www.readbyqxmd.com/read/28109939/peripheral-venous-catheter-insertion-simulation-training-a-randomized-controlled-trial-comparing-performance-after-instructor-led-teaching-versus-peer-assisted-learning
#17
Sophie Pelloux, Arnaud Grégoire, Patrice Kirmizigul, Sandrine Maillot, Bernard Bui-Xuan, Guy Llorca, Sylvain Boet, Jean-Jacques Lehot, Thomas Rimmelé
INTRODUCTION: Peripheral venous catheter insertion is a procedural skill that every medical student should master. Training is often limited to a small number of students and is poorly evaluated. The objective of this study was to evaluate the performance of peer-assisted learning in comparison to instructor-led teaching for peripheral venous catheter insertion training. METHODS: Students were randomized to the control group attending a traditional instructor-led training session (slideshow and demonstration by an anaesthetist instructor, followed by training on a procedural simulator) or to the test group attending a peer-assisted training session (slideshow and demonstration video-recorded by the same instructor, followed by training on a procedural simulator...
January 18, 2017: Anaesthesia, Critical Care & Pain Medicine
https://www.readbyqxmd.com/read/28109872/5-year-safety-and-efficacy-of-resolute%C3%A2-zotarolimus-eluting-stent-the-resolute-global-clinical-trial-program
#18
Robert W Yeh, Sigmund Silber, Lianglong Chen, Shaoliang Chen, Shirish Hiremath, Franz-Josef Neumann, Shubin Qiao, Shigeru Saito, Bo Xu, Yuejin Yang, Laura Mauri
OBJECTIVES: The authors evaluated the 5-year cumulative incidence of cardiovascular events following Resolute zotarolimus-eluting stent (R-ZES) implantation. BACKGROUND: Individual trials are often underpowered to show differences for low-frequency adverse events. The R-ZES was studied in 10 prospective clinical trials, designed with identical adverse event definitions, ascertainment, and adjudication. METHODS: The RESOLUTE Global Clinical Trial Program includes 7,618 patients treated with R-ZES: RESOLUTE first-in-human study (N = 139), RESOLUTE All Comers (N = 1,140), RESOLUTE International (N = 2,349), RESOLUTE US (N = 1,402), RESOLUTE US 38 mm (N = 114), RESOLUTE Japan (N = 100), RESOLUTE Japan Small Vessel Study (N = 65), RESOLUTE Asia (N = 311), RESOLUTE China Randomized Controlled Trial (N = 198), and RESOLUTE China Registry (N = 1,800)...
January 11, 2017: JACC. Cardiovascular Interventions
https://www.readbyqxmd.com/read/28109628/preoperative-bathing-of-the-surgical-site-with-chlorhexidine-for-infection-prevention-systematic-review-with-meta-analysis
#19
Lúcia Maciel de Castro Franco, Gláucia Fernandes Cota, Tatiana Saraiva Pinto, Flávia Falci Ercole
BACKGROUND: Preoperative bathing with 4% chlorhexidine is recommended as a measure to prevent surgical site infection (SSI) despite uncertainty regarding the effectiveness of the intervention. This review aimed to assess the effect of bathing with 4% chlorhexidine on the prevention of SSIs in clean surgeries compared with bathing with placebo solution or soap. METHODS: Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines for systematic reviews and the Cochrane manual were followed...
January 18, 2017: American Journal of Infection Control
https://www.readbyqxmd.com/read/28109620/effect-of-pre-operative-octenidine-nasal-ointment-and%C3%A2-showering-on-surgical-site-infections-in-patients-undergoing-cardiac-surgery
#20
M Reiser, A Scherag, C Forstner, F M Brunkhorst, S Harbarth, T Doenst, M W Pletz, S Hagel
OBJECTIVE: To evaluate the effect of pre-operative octenidine (OCT) decolonization on surgical site infection (SSI) rates. DESIGN: Before-and-after cohort study. PATIENTS: Patients undergoing an elective isolated coronary artery bypass graft (CABG) procedure: control group (1(st) January to 31(st) December 2013), N=475; intervention group (1(st) January to 31(st) December 2014), N=428. INTERVENTIONS: The intervention consisted of nasal application of OCT ointment three times daily, beginning on the day before surgery, and showering the night before and on the day of surgery with OCT soap...
November 18, 2016: Journal of Hospital Infection
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