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randomised controlled trial

Junko Watanabe, Mariko Watanabe, Kazue Yamaoka, Misa Adachi, Asuka Nemoto, Toshiro Tango
In this study, we aimed to assess the effectiveness of a school-based home-collaborative lifestyle education program for adolescents (PADOK) in reducing poor subjective psychosomatic symptoms (SPS). The study was designed as a two-armed parallel cluster randomised controlled trial and the study population comprised adolescent students (aged 12-14 years, n = 1,565) who were recruited from 19 middle schools in Japan. The PADOK intervention or usual school programme was provided in schools to all eligible participants...
2016: PloS One
Joanne Elizabeth Hegarty, Jane Elizabeth Harding, Gregory David Gamble, Caroline Anne Crowther, Richard Edlin, Jane Marie Alsweiler
BACKGROUND: Neonatal hypoglycaemia is common, affecting up to 15% of newborns, and can cause brain damage. Currently, there are no strategies, beyond early feeding, to prevent neonatal hypoglycaemia. Our aim was to determine a dose of 40% oral dextrose gel that will prevent neonatal hypoglycaemia in newborn babies at risk. METHODS AND FINDINGS: We conducted a randomised, double-blind, placebo-controlled dose-finding trial of buccal dextrose gel to prevent neonatal hypoglycaemia at two hospitals in New Zealand...
October 2016: PLoS Medicine
Barbara Farquharson, Marie Johnston, Karen Smith, Brian Williams, Shaun Treweek, Stephan U Dombrowski, Nadine Dougall, Purva Abhyankar
AIMS: To evaluate the efficacy of a behaviour change technique-based intervention and compare two possible modes of delivery (text+visual and text-only) with usual care. BACKGROUND: Patient delay prevents many people from achieving optimal benefit of time-dependent treatments for Acute Coronary Syndrome. Reducing delay would reduce mortality and morbidity, but interventions to change behaviour have had mixed results. Systematic inclusion of behaviour change techniques or a visual mode of delivery might improve the efficacy of interventions...
October 25, 2016: Journal of Advanced Nursing
Carine Meslot, Aurélie Gauchet, Martin S Hagger, Nikos Chatzisarantis, Audrey Lehmann, Benoît Allenet
BACKGROUND: Low levels of adherence to medication prescribed to treat and manage chronic disease may lead to maladaptive health outcomes. Theory-based, easy-to-administer interventions that promote patients' effective self-regulation of their medication-taking behaviour are needed if adherence is to be maximised. We tested the effectiveness of an intervention adopting planning techniques to promote medication adherence. METHODS: Outpatients with cardiovascular disease (N = 71) were allocated to either an experimental condition, in which participants were asked to form implementation intentions and coping plans related to their treatment, or to a no-planning control condition, in which participants received no treatment...
October 25, 2016: Applied Psychology. Health and Well-being
Declan T Millett, Anne-Marie Glenny, Rye Cr Mattick, Joy Hickman, Nicky A Mandall
BACKGROUND: Orthodontic treatment involves using fixed or removable appliances (dental braces) to correct the positions of teeth. It has been shown that the quality of treatment result obtained with fixed appliances is much better than with removable appliances. Fixed appliances are, therefore, favoured by most orthodontists for treatment. The success of a fixed orthodontic appliance depends on the metal attachments (brackets and bands) being attached securely to the teeth so that they do not become loose during treatment...
October 25, 2016: Cochrane Database of Systematic Reviews
Fang Hua, Huixu Xie, Helen V Worthington, Susan Furness, Qi Zhang, Chunjie Li
BACKGROUND: Ventilator-associated pneumonia (VAP) is defined as pneumonia developing in people who have received mechanical ventilation for at least 48 hours. VAP is a potentially serious complication in these patients who are already critically ill. Oral hygiene care (OHC), using either a mouthrinse, gel, toothbrush, or combination, together with aspiration of secretions, may reduce the risk of VAP in these patients. OBJECTIVES: To assess the effects of oral hygiene care on incidence of ventilator-associated pneumonia in critically ill patients receiving mechanical ventilation in hospital intensive care units (ICUs)...
October 25, 2016: Cochrane Database of Systematic Reviews
Anthony J Hatswell, Nick Freemantle, Gianluca Baio
BACKGROUND: Pharmaceuticals are usually granted a marketing authorisation on the basis of randomised controlled trials (RCTs). Occasionally the efficacy of a treatment is assessed without a randomised comparator group (either active or placebo). OBJECTIVE: To identify and develop a taxonomic account of economic modelling approaches for pharmaceuticals licensed without RCT data. METHODS: We searched PubMed, the websites of UK health technology assessment bodies and the International Society for Pharmacoeconomics and Outcomes Research Scientific Presentations Database for assessments of treatments granted a marketing authorisation by the US Food and Drug Administration or European Medicines Agency from January 1999 to May 2014 without RCT data (74 indications)...
October 24, 2016: PharmacoEconomics
Alberto Arezzo, Roberto Passera, Alberto Bullano, Yoav Mintz, Asaf Kedar, Luigi Boni, Elisa Cassinotti, Riccardo Rosati, Uberto Fumagalli Romario, Mario Sorrentino, Marco Brizzolari, Nicola Di Lorenzo, Achille Lucio Gaspari, Dario Andreone, Elena De Stefani, Giuseppe Navarra, Salvatore Lazzara, Maurizio Degiuli, Kirill Shishin, Igor Khatkov, Ivan Kazakov, Rudolf Schrittwieser, Thomas Carus, Alessio Corradi, Guenther Sitzman, Antonio Lacy, Selman Uranues, Amir Szold, Mario Morino
BACKGROUND: Single-port laparoscopic surgery as an alternative to conventional laparoscopic cholecystectomy for benign disease has not yet been accepted as a standard procedure. The aim of the multi-port versus single-port cholecystectomy trial was to compare morbidity rates after single-access (SPC) and standard laparoscopy (MPC). METHODS: This non-inferiority phase 3 trial was conducted at 20 hospital surgical departments in six countries. At each centre, patients were randomly assigned to undergo either SPC or MPC...
October 24, 2016: Surgical Endoscopy
Michalis Koullouros, Nadir Khan, Emad H Aly
BACKGROUND: Surgical site infection (SSI) continues to be a challenge in colorectal surgery. Over the years, various modalities have been used in an attempt to reduce SSI risk in elective colorectal surgery, which include mechanical bowel preparation before surgery, oral antibiotics and intravenous antibiotic prophylaxis at induction of surgery. Even though IV antibiotics have become standard practice, there has been a debate on the exact role of oral antibiotics. AIM: The primary aim was to identify the role of oral antibiotics in reduction of SSI in elective colorectal surgery...
October 24, 2016: International Journal of Colorectal Disease
Bernhard Rauch, Constantinos H Davos, Patrick Doherty, Daniel Saure, Maria-Inti Metzendorf, Annett Salzwedel, Heinz Völler, Katrin Jensen, Jean-Paul Schmid
BACKGROUND: The prognostic effect of multi-component cardiac rehabilitation (CR) in the modern era of statins and acute revascularisation remains controversial. Focusing on actual clinical practice, the aim was to evaluate the effect of CR on total mortality and other clinical endpoints after an acute coronary event. DESIGN: Structured review and meta-analysis. METHODS: Randomised controlled trials (RCTs), retrospective controlled cohort studies (rCCSs) and prospective controlled cohort studies (pCCSs) evaluating patients after acute coronary syndrome (ACS), coronary artery bypass grafting (CABG) or mixed populations with coronary artery disease (CAD) were included, provided the index event was in 1995 or later...
October 24, 2016: European Journal of Preventive Cardiology
Julian Savulescu, Karolina Wartolowska, Andy Carr
Use of a placebo control in surgical trials is a divisive issue. We argue that, in principle, placebo controls for surgery are necessary in the same way as for medicine. However, there are important differences between these types of trial, which both increase justification and limit application of surgical studies. We propose that surgical randomised placebo-controlled trials are ethical if certain conditions are fulfilled: (1) the presence of equipoise, defined as a lack of unbiased evidence for efficacy of an intervention; (2) clinically important research question; (3) the risk to patients is minimised and reasonable; (4) there is uncertainty about treatment allocation rather than deception; (5) there is preliminary evidence for efficacy, which justifies a placebo-controlled design; and (6) ideally, the placebo procedure should have some direct benefit to the patient, for example, as a diagnostic tool...
October 24, 2016: Journal of Medical Ethics
Mark M Smits, Lennart Tonneijck, Marcel H A Muskiet, Trynke Hoekstra, Mhh Kramer, Michaela Diamant, Daniël H van Raalte
OBJECTIVE: To examine mechanisms underlying resting heart rate (RHR) increments of GLP-1 receptor agonists in type 2 diabetes patients. DESIGN: Acute and 12-week randomised placebo-controlled, double-blind, single-centre parallel-group trial. METHODS: 57 type 2 diabetes patients (mean±SD age 62.8±6.9 years; BMI 31.8±4.1 kg/m2; HbA1c 7.3±0.6%), treated with metformin and/or sulfonylureas, were included between July 2013 and August 2015...
October 24, 2016: European Journal of Endocrinology
Marc Dewey, Matthias Rief, Peter Martus, Benjamin Kendziora, Sarah Feger, Henryk Dreger, Sascha Priem, Fabian Knebel, Marko Böhm, Peter Schlattmann, Bernd Hamm, Eva Schönenberger, Michael Laule, Elke Zimmermann
OBJECTIVE:  To evaluate whether invasive coronary angiography or computed tomography (CT) should be performed in patients clinically referred for coronary angiography with an intermediate probability of coronary artery disease. DESIGN:  Prospective randomised single centre trial. SETTING:  University hospital in Germany. PARTICIPANTS:  340 patients with suspected coronary artery disease and a clinical indication for coronary angiography on the basis of atypical angina or chest pain...
October 24, 2016: BMJ: British Medical Journal
Christopher Coyle, Fay H Cafferty, Samuel Rowley, Mairead MacKenzie, Lindy Berkman, Sudeep Gupta, C S Pramesh, Duncan Gilbert, Howard Kynaston, David Cameron, Richard H Wilson, Alistair Ring, Ruth E Langley
BACKGROUND: There is a considerable body of pre-clinical, epidemiological and randomised data to support the hypothesis that aspirin has the potential to be an effective adjuvant cancer therapy. METHODS: Add-Aspirin is a phase III, multi-centre, double-blind, placebo-controlled randomised trial with four parallel cohorts. Patients who have undergone potentially curative treatment for breast (n=3100), colorectal (n=2600), gastro-oesophageal (n=2100) or prostate cancer (n=2120) are registered into four tumour specific cohorts...
October 21, 2016: Contemporary Clinical Trials
C Parkinson, P Constantin, C Goyal, C Hall
OBJECTIVES: This study aimed to investigate whether addition of an octadecene/maleic anhydride copolymer (O/MA) to a potassium nitrate (KNO3) dentifrice could facilitate delivery of potassium to dentine and enhance its efficacy in dentine hypersensitivity relief. METHODS: This was a randomised, examiner-blind, controlled, parallel group study in 139 healthy subjects with at ≥2 sensitive teeth. Assessment of dentine hypersensitivity to tactile (Yeaple probe) and evaporative (air) stimuli (Schiff Sensitivity Scale, visual analogue scale [VAS]) was carried out at baseline and after 1, 2, 4 and 8 weeks twice daily treatment with an experimental 5% KNO3/3% O/MA dentifrice, a comparator 5% KNO3 dentifrice (active comparator), a 0% KNO3/3% O/MA dentifrice (placebo) and a regular fluoride dentifrice (negative control)...
October 21, 2016: Journal of Dentistry
Subethini Roopan, Erik Roj Larsen
OBJECTIVE: Depression may be difficult to treat and with comorbid diabetes mellitus (DM) it is an even bigger challenge. This article aims to evaluate antidepressants most suitable for patients with depression and comorbid DM. Design and methods Initially we searched for randomised, controlled double-blind trials of treatment with antidepressants in depressed with DM but there were only a few studies and many of them were small trials. Thus, we decided to include studies that were not only randomised-controlled trials...
October 25, 2016: Acta Neuropsychiatrica
Barbara N Arch, Joanne Blair, Andrew McKay, John W Gregory, Paul Newland, Carrol Gamble
BACKGROUND: Glycated haemoglobin (HbA1c) is an important outcome measure in diabetes clinical trials. For multicentre designs, HbA1c can be measured locally at participating centres or by sending blood samples to a central laboratory. This study analyses the agreement between local and central measurements, using 1-year follow-up data collected in a multicentre randomised controlled trial (RCT) of newly diagnosed children with type I diabetes. METHODS: HbA1c measurements were routinely analysed both locally and centrally at baseline and then at 3, 6, 9 and 12 months and the data reported in mmol/mol...
October 24, 2016: Trials
Natalia Sanchez-Aguadero, Luis Garcia-Ortiz, Maria C Patino-Alonso, Sara Mora-Simon, Manuel A Gomez-Marcos, Rosario Alonso-Dominguez, Benigna Sanchez-Salgado, Jose I Recio-Rodriguez
BACKGROUND: Postprandial glycaemic response affects cognitive and vascular function. The acute effect of breakfast glycaemic index on vascular parameters is not sufficiently known. Also, the influence of breakfasts with different glycaemic index on cognitive performance has been mostly studied in children and adolescents with varying results. Therefore, the purpose of this study is to analyse the postprandial effect of high and low glycaemic index breakfasts on vascular function and cognitive performance and their relationship with postprandial glycaemic response in healthy young adults...
October 24, 2016: Trials
Xing Lin Ho, Jonathan Jia He Liu, Wai Mun Loke
A randomized, double blind, placebo-controlled and crossover study was conducted to simultaneously measure the effects, after 3-hour and 4-week daily exposure to plant sterols-enriched food product, on inflammation, oxidative status, 5-lipoxygenase, 12-lipoxygenase and myeloperoxidase activities in healthy adults. Eighteen healthy participants (67% female, 35.3 (mean)±9.5 (SD) years, mean body mass index 22.8 kg m(-2)) received 2 soy milk (20g) treatments daily: placebo and one containing 2.0g free plant sterols equivalent of their palmitates (β-sitosterol, 55%; campesterol, 29% and stigmasterol, 23%)...
October 24, 2016: Free Radical Research
Richard Ac Hughes, Ruth Brassington, Angela A Gunn, Pieter A van Doorn
BACKGROUND: Guillain-Barré syndrome (GBS) is an acute paralysing disease caused by inflammation of the peripheral nerves, which corticosteroids would be expected to benefit. OBJECTIVES: To examine the ability of corticosteroids to hasten recovery and reduce the long-term morbidity from GBS. SEARCH METHODS: On 12 January 2016, we searched the Cochrane Neuromuscular Specialised Register, the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, and Embase...
October 24, 2016: Cochrane Database of Systematic Reviews
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