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Trial methodology

Damien Lesenfants, Dina Habbal, Camille Chatelle, Caroline Schnakers, Steven Laureys, Quentin Noirhomme
OBJECTIVE: To propose a new methodology based on single-trial analysis for detecting residual response to command with EMG in patients with disorders of consciousness (DOC), overcoming the issue of trial dependency and decreasing the influence of a patient's fluctuation of vigilance or arousal over time on diagnostic accuracy. METHODS: Forty-five patients with DOC (18 with vegetative/unresponsive wakefulness syndrome [VS/UWS], 22 in a minimally conscious state [MCS], 3 who emerged from MCS [EMCS], and 2 with locked-in syndrome [LIS]) and 20 healthy controls were included in the study...
October 21, 2016: Neurology
Ari Shechter, Kyle Kovtun, Marie-Pierre St-Onge
Obesity is among the leading risk factors for obstructive sleep apnea (OSA). A reciprocal relationship between obesity and OSA has been proposed, which may be due to excessive food intake. We conducted a pilot study to test the effects of continuous positive airway pressure (CPAP) on energy intake (EI) in OSA patients using a sham-controlled crossover design. In-laboratory total daily EI was assessed after 2mo of active and sham CPAP. Four men were enrolled (age±SEM: 51.8±2.1y; body mass index: 31.5±1.5kg/m(2))...
October 18, 2016: Physiology & Behavior
Zainab Khan, Jordan Milko, Munir Iqbal, Moness Masri, David R P Almeida
OBJECTIVE: To investigate the power of unpaired t tests in prospective, randomized controlled trials when these tests failed to detect a statistically significant difference and to determine the frequency of type II errors. DESIGN: Systematic review and meta-analysis. METHODS: We examined all prospective, randomized controlled trials published between 2010 and 2012 in 4 major ophthalmology journals (Archives of Ophthalmology, British Journal of Ophthalmology, Ophthalmology, and American Journal of Ophthalmology)...
October 2016: Canadian Journal of Ophthalmology. Journal Canadien D'ophtalmologie
Chantal Arditi, Bernard Burnand, Isabelle Peytremann-Bridevaux
BACKGROUND: To reduce the burden of asthma, chronic disease management (CDM) programmes have been widely implemented and evaluated. Reviews including randomised controlled trials (RCTs) suggest that CDM programmes for asthma are effective. Other study designs are however often used for pragmatic reasons, but excluded from these reviews because of their design. We aimed to examine what complementary information could be retrieved from the addition of non-randomised studies to the studies included in a published Cochrane review on asthma CDM programmes, for healthcare stakeholders involved in the development, implementation, conduct or long-term sustainability of such programmes...
October 21, 2016: BMC Health Services Research
David Feifel, Katherine Pappas
Repetitive transcranial magnetic stimulation (rTMS) is an emerging non-pharmacological approach to treating many brain-based disorders. rTMS uses electromagnetic coils to stimulate areas of the brain non-invasively. Deep transcranial magnetic stimulation (dTMS) with the Brainsway H1-coil system specifically is a type of rTMS indicated for treating patients with major depressive disorder (MDD) who are resistant to medication. The unique H1-coil design of this device is able to stimulate neuronal pathways that lie deeper in the targeted brain areas than those reached by conventional rTMS coils...
October 4, 2016: Journal of Visualized Experiments: JoVE
Yin J Wong
Data sourcesThe Cochrane Database of Systematic Reviews on the Cochrane Library.Study selectionAll Cochrane reviews of RCTs between 1999 to 2015, conducted in adults examining the adverse events associated with single dose oral analgesics used for acute post-operative pain were considered.Data extraction and synthesisStudies were searched, reviewed and assessed independently by two reviewers and standard data items extracted. Methodological quality was assessed using criteria adapted from AMSTAR (Assessing the Methodological Quality of Systematic Reviews)...
September 2016: Evidence-based Dentistry
Lakshmi Rasaratnam
Data sourcesPubMed, the Cochrane Library, Embase, and the Web of Knowledge.Study selectionRandomised controlled trials (RCTs) or retrospective non-randomised trials (RNTs) of direct pulp capping in patients comparing mineral trioxide aggregate (MTA) with calcium hydroxide (CH) were considered.Data extraction and synthesisTwo reviewers independently abstracted data. Risk of bias for the RCTs was assessed using the Cochrane risk of bias tool and RNTs were assessed according to the methodological index for non-randomised studies...
September 2016: Evidence-based Dentistry
M Bryant Howren, Jeffrey S Gonzalez
The current issue is devoted broadly to research on treatment adherence and chronic illness self-management behavior. As the prevalence of chronic illness increases, the pervasive problem of treatment nonadherence is increasingly viewed as having a major impact on treatment outcomes, public health and healthcare costs, making this issue particularly timely. Sixteen articles spanning an array of topics are presented; articles include empirical studies, statistical simulations, systematic reviews, and theoretical commentaries...
October 20, 2016: Journal of Behavioral Medicine
S Mickenautsch
OBJECTIVES: To provide a brief overview of the current evidence-base for direct posterior tooth restorations in permanent teeth placed using high-viscosity glass-ionomer cement (HVGIC). METHODS: The evidence sources: laboratory trials, uncontrolled clinical trials, controlled clinical trials with HVGIC restorations placed after conventional cavity preparation by drill and controlled clinical trials with HVGIC restorations placed following the atraumatic restorative treatment (ART) approach, were assessed based on systematic reviews and meta-analyses, as well as methodological studies...
October 17, 2016: Journal of Dentistry
Domenico Intiso, Andrea Santamato, Filomena Di Rienzo
OBJECTIVE: To investigate whether electrical stimulation (ES) as an adjunct to BTX-A boosts botulinum activity and whether the combined therapeutic procedure is more effective than BTX-A alone in reducing spasticity in adult subjects. DATA SOURCES: A search was conducted in PubMed, EMBASE, Cochrane Central Register, and CINAHL from January 1966 to January 2016. STUDY SELECTION: Only randomized controlled studies (RCT) involving the combination of BTX-A and ES were considered...
October 21, 2016: Disability and Rehabilitation
Steffen T Simon, Irene J Higginson, Sara Booth, Richard Harding, Vera Weingärtner, Claudia Bausewein
BACKGROUND: This is an updated version of the original Cochrane review published in Issue 1, 2010, on 'Benzodiazepines for the relief of breathlessness in advanced malignant and non-malignant diseases in adults'. Breathlessness is one of the most common symptoms experienced in the advanced stages of malignant and non-malignant disease. Benzodiazepines are widely used for the relief of breathlessness in advanced diseases and are regularly recommended in the literature. At the time of the previously published Cochrane review, there was no evidence for a beneficial effect of benzodiazepines for the relief of breathlessness in people with advanced cancer and chronic obstructive pulmonary disease (COPD)...
October 20, 2016: Cochrane Database of Systematic Reviews
Marius N Stan, Mario Salvi
Rituximab (RTX) use in open label series has been associated with very encouraging responses in patients with active and moderate-to-severe Graves' Orbitopathy (GO). Recently randomized controlled trials of RTX have been performed in such patients in order to answer the question of clinical efficacy and the safety profile of this agent. That data, reported separately, focused on Clinical Activity Score (CAS) and indicated in one trial a strong benefit of RTX in comparison with IV glucocorticoids while the other trial noted the absence of a benefit by comparison with placebo...
October 19, 2016: European Journal of Endocrinology
Daniel W Birch, Jerry T Dang, Noah J Switzer, Namdar Manouchehri, Xinzhe Shi, Ghassan Hadi, Shahzeer Karmali
BACKGROUND: Intraoperative hypothermia during both open and laparoscopic abdominal surgery may be associated with adverse events. For laparoscopic abdominal surgery, the use of heated insufflation systems for establishing pneumoperitoneum has been described to prevent hypothermia. Humidification of the insufflated gas is also possible. Past studies on heated insufflation have shown inconclusive results with regards to maintenance of core temperature and reduction of postoperative pain and recovery times...
October 19, 2016: Cochrane Database of Systematic Reviews
Mariana Carvalho de Menezes, Lydiane Bragunci Bedeschi, Luana Caroline Dos Santos, Aline Cristine Souza Lopes
INTRODUCTION: The multi-behavioral Transtheoretical Model (TTM) addresses multiple behaviors and it is a promising strategy to control multifactorial morbidities, such as chronic diseases. The results obtained using the TTM are positive, but are not consistently methodical. OBJECTIVES: The aim of this study was to systematically review the effectiveness of the Transtheoretical Model in multi-behavioral interventions for changing eating habits and levels of physical activity...
September 20, 2016: Nutrición Hospitalaria: Organo Oficial de la Sociedad Española de Nutrición Parenteral y Enteral
Zhao Chenhui, Wei Yi
BACKGROUND: Despite great advances in treatment of Aneurysmal subarachnoid hemorrhage (aSAH), yet, a consensus as to the most optimal timing of surgery has not been reached. MATERIALS AND METHODS: PubMed and the Cochrane Library were searched for English-language studies published up to May 2015. Before conducting the meta-analysis, the studies were evaluated for publication bias and heterogeneity. Fixed and random effect models were used to estimate relative risks (RR) and the corresponding 95% confidence intervals (CIs)...
December 7, 2015: Turkish Neurosurgery
Adam Simning, Kelsey V Simons
BACKGROUND: Depression in nursing facilities is widespread and has been historically under-recognized and inadequately treated. Many interventions have targeted depression among residents with dementia in these settings. Less is known about depression treatment in residents without dementia who may be more likely to return to community living. Our study aimed to systematically evaluate randomized control trials (RCTs) in nursing facilities that targeted depression within samples largely comprised of residents without dementia...
October 19, 2016: International Psychogeriatrics
Koko Asakura, Toshimitsu Hamasaki, Scott R Evans
We discuss group-sequential designs in superiority clinical trials with multiple co-primary endpoints, that is, when trials are designed to evaluate if the test intervention is superior to the control on all primary endpoints. We consider several decision-making frameworks for evaluating efficacy or futility, based on boundaries using group-sequential methodology. We incorporate the correlations among the endpoints into the calculations for futility boundaries and sample sizes as a function of other design parameters, including mean differences, the number of analyses, and efficacy boundaries...
October 19, 2016: Biometrical Journal. Biometrische Zeitschrift
L Jefferson, C Fairhurst, E Cooper, C Hewitt, T Torgerson, L Cook, P Tharmanathan, S Cockayne, D Torgerson
OBJECTIVE: Time-lag from study completion to publication is a potential source of publication bias in randomised controlled trials. This study sought to update the evidence base by identifying the effect of the statistical significance of research findings on time to publication of trial results. DESIGN: Literature searches were carried out in four general medical journals from June 2013 to June 2014 inclusive (BMJ, JAMA, the Lancet and the New England Journal of Medicine)...
October 2016: JRSM Open
Frederic Denis, Isabelle Millot, Nicolas Abello, Maud Carpentier, Audrey Peteuil, Agnès Soudry-Faure
BACKGROUND: Schizophrenia is a severe mental disorder that affects 1 % of the world's population, including 600,000 people in France. Persons with schizophrenia (PWS) have excess mortality (their life expectancy is reduced by 20 %) and excess morbidity. In addition, such persons may have a large number of missing or decayed teeth. Dental caries and periodontal measurement indexes are often twice as high as the level found in the general population. Poor oral health can also affect quality of life and oral health is inseparable from general health...
2016: International Journal of Mental Health Systems
Angelo Alonzo, Scott Aaronson, Marom Bikson, Mustafa Husain, Sarah Lisanby, Donel Martin, Shawn M McClintock, William M McDonald, John O'Reardon, Zeinab Esmailpoor, Colleen Loo
Transcranial Direct Current Stimulation (tDCS) is a new, non-invasive neuromodulation approach for treating depression that has shown promising efficacy. The aim of this trial was to conduct the first international, multicentre randomised controlled trial of tDCS as a treatment for unipolar and bipolar depression. The study recruited 120 participants across 6 sites in the USA and Australia. Participants received active or sham tDCS (2.5mA, 20 sessions of 30min duration over 4weeks), followed by a 4-week open label active treatment phase and a 4-week taper phase...
October 15, 2016: Contemporary Clinical Trials
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