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https://www.readbyqxmd.com/read/28340625/habit-training-versus-habit-training-with-direct-visual-biofeedback-in-adults-with-chronic-constipation-study-protocol-for-a-randomised-controlled-trial
#1
Christine Norton, Anton Emmanuel, Natasha Stevens, S Mark Scott, Ugo Grossi, Sybil Bannister, Sandra Eldridge, James M Mason, Charles H Knowles
BACKGROUND: Constipation affects up to 20% of adults. Chronic constipation (CC) affects 1-2% of adults. Patient dissatisfaction is high; nearly 80% feel that laxative therapy is unsatisfactory and symptoms have significant impact on quality of life. There is uncertainty about the value of specialist investigations and whether equipment-intensive therapies using biofeedback confer additional benefit when compared with specialist conservative advice. METHODS/DESIGN: A three-arm, parallel-group, multicentre randomised controlled trial...
March 24, 2017: Trials
https://www.readbyqxmd.com/read/28335809/poor-uptake-of-an-online-intervention-in-a-cluster-randomised-controlled-trial-of-online-diabetes-education-for-rural-general-practitioners
#2
Christine L Paul, Leon Piterman, Jonathan E Shaw, Catherine Kirby, Kristy L Forshaw, Jennifer Robinson, Isaraporn Thepwongsa, Robert W Sanson-Fisher
BACKGROUND: In Australia, rural and remote communities have high rates of diabetes-related death and hospitalisation. General practitioners (GPs) play a major role in diabetes detection and management. Education of GPs could optimise diabetes management and improve patient outcomes at a population level. The study aimed to describe the uptake of a continuing medical education intervention for rural GPs and its impact on the viability of a cluster randomised controlled trial of the effects of continuing medical education on whole-town diabetes monitoring and control...
March 23, 2017: Trials
https://www.readbyqxmd.com/read/28335805/erratum-to-cognitive-rehabiliation-for-parkinson-s-disease-dementia-a-study-protocol-for-a-pilot-randomised-controlled-trial
#3
John V Hindle, Tamlyn J Watermeyer, Julie Roberts, Anthony Martyr, Huw Lloyd-Williams, Andrew Brand, Petra Gutting, Zoe Hoare, Rhiannon Tudor Edwards, Linda Clare
No abstract text is available yet for this article.
March 23, 2017: Trials
https://www.readbyqxmd.com/read/28330497/atopic-dermatitis-anti-ige-paediatric-trial-adapt-the-role-of-anti-ige-in-severe-paediatric-eczema-study-protocol-for-a-randomised-controlled-trial
#4
Susan Chan, Victoria Cornelius, Tao Chen, Suzana Radulovic, Mandy Wan, Rahi Jahan, Gideon Lack
BACKGROUND: The evidence for systemic treatments for severe childhood eczema is limited and largely based on extrapolation of data from adult studies. Current therapies are often immunosuppressant and may be associated with both short- and long-term side effects. There is increasing in vitro and murine-model evidence for the role of IgE in the immunopathogenesis of atopic eczema. The aim of the study is to assess whether anti-IgE treatment (omalizumab) improves eczema, compared to placebo...
March 22, 2017: Trials
https://www.readbyqxmd.com/read/28327195/does-rating-the-operation-videos-with-a-checklist-score-improve-the-effect-of-e-learning-for-bariatric-surgical-training-study-protocol-for-a-randomized-controlled-trial
#5
Javier Rodrigo De La Garza, Karl-Friedrich Kowalewski, Mirco Friedrich, Mona Wanda Schmidt, Thomas Bruckner, Hannes Götz Kenngott, Lars Fischer, Beat-Peter Müller-Stich, Felix Nickel
BACKGROUND: Laparoscopic training has become an important part of surgical education. Laparoscopic Roux-en-Y gastric bypass (RYGB) is the most common bariatric procedure performed. Surgeons must be well trained prior to operating on a patient. Multimodality training is vital for bariatric surgery. E-learning with videos is a standard approach for training. The present study investigates whether scoring the operation videos with performance checklists improves learning effects and transfer to a simulated operation...
March 21, 2017: Trials
https://www.readbyqxmd.com/read/28327182/the-possibility-of-critical-realist-randomised-controlled-trials
#6
LETTER
Sam Porter, Tracey McConnell, Joanne Reid
BACKGROUND: Some realists have criticised randomised controlled trials for their inability to explain the causal relations that they identify; to take into account the influence of the social context of the interventions they evaluate; and to account for individual difference. However, among realists, there is controversy over whether it is possible to improve trials by making them realist, or whether realism and the philosophical assumptions underlying trials are incompatible. This paper contributes to the debate in Trials on this issue...
March 21, 2017: Trials
https://www.readbyqxmd.com/read/28327172/effect-of-guizhifulingwan-keishibukuryogan-on-climacteric-syndrome-study-protocol-for-a-randomized-controlled-pilot-trial
#7
Jung-Eun Kim, Junghyo Cho, Ojin Kwon, Ae-Ran Kim, Hyo-Ju Park, So-Young Jung, Joo-Hee Kim, Mikyung Kim, Hye-Yoon Lee, Jun-Hwan Lee
BACKGROUND: The aim of this study is to explore the efficacy of Guizhifulingwan (GFW) in the treatment of climacteric syndrome in women. METHODS/DESIGN: This is a single-center, randomized, placebo-controlled, parallel-group design pilot trial. Fifty participants with climacteric syndrome will be randomly allocated to the GFW or placebo group in a 1:1 ratio. The participants will be administered GFW or placebo granules three times a day for 4 weeks and will be followed up for a further 4 weeks...
March 21, 2017: Trials
https://www.readbyqxmd.com/read/28320484/nutritional-intervention-preconception-and-during-pregnancy-to-maintain-healthy-glucose-metabolism-and-offspring-health-nipper-study-protocol-for-a-randomised-controlled-trial
#8
Keith M Godfrey, Wayne Cutfield, Shiao-Yng Chan, Philip N Baker, Yap-Seng Chong
BACKGROUND: Improved maternal nutrition and glycaemic control before and during pregnancy are thought to benefit the health of the mother, with consequent benefits for infant body composition and later obesity risk. Maternal insulin resistance and glycaemia around conception and in early pregnancy may be key determinants of maternal physiology and placental function, affecting fetal nutrient supply and maternal-feto-placental communications throughout gestation, with implications for later postnatal health...
March 20, 2017: Trials
https://www.readbyqxmd.com/read/28320482/pressure-relieving-support-surfaces-a-randomised-evaluation-2-pressure-2-photographic-validation-sub-study-study-protocol-for-a-randomised-controlled-trial
#9
Elizabeth McGinnis, Sarah Brown, Howard Collier, Phil Faulks, Rachael Gilberts, Clare Greenwood, Valerie Henderson, Delia Muir, Andrea Nelson, Jane Nixon, Isabelle Smith, Nikki Stubbs, Kay Walker, Lyn Wilson, Susanne Coleman
BACKGROUND: PRESSURE 2 is a randomised evaluation of the clinical and cost effectiveness of two types of pressure relieving mattress for the prevention of pressure ulcers. The primary endpoint is the time to development of a Category ≥2 pressure ulcer. The current 'gold standard' for the identification of a Category ≥2 pressure ulcer is expert clinical assessment. Due to the appearance of the bed, it is not possible to achieve blinding of the endpoint. This therefore poses a risk to the internal validity of the study...
March 20, 2017: Trials
https://www.readbyqxmd.com/read/28302178/laser-peripheral-iridotomy-versus-laser-peripheral-iridotomy-plus-laser-peripheral-iridoplasty-in-the-treatment-of-multi-mechanism-angle-closure-study-protocol-for-a-randomized-controlled-trial
#10
Shida Chen, Jianhua Lv, Sujie Fan, Hong Zhang, Lin Xie, Ling Xu, Bing Jiang, Huipin Yuan, Yuanbo Liang, Shuning Li, Pingyan Chen, Xiulan Zhang, Ningli Wang
BACKGROUND: China has the largest burden of primary angle-closure glaucoma (PACG) worldwide. The mechanism of the angle closure is complex and includes pupillary block and non-pupillary block. Currently, opinion is that laser peripheral iridotomy (LPI) alone is not sufficient to prevent disease progression. Laser peripheral iridoplasty (LPIP) is an alternative and effective way of widening the angle recess in eyes that are affected by primary angle closure (PAC). However, it is not known if greater benefit would be achieved using LPI plus LPIP for PAC with multiple mechanisms (MAC)...
March 17, 2017: Trials
https://www.readbyqxmd.com/read/28302179/balanced-crystalloids-versus-saline-in-the-intensive-care-unit-study-protocol-for-a-cluster-randomized-multiple-crossover-trial
#11
Matthew W Semler, Wesley H Self, Li Wang, Daniel W Byrne, Jonathan P Wanderer, Jesse M Ehrenfeld, Joanna L Stollings, Avinash B Kumar, Antonio Hernandez, Oscar D Guillamondegui, Addison K May, Edward D Siew, Andrew D Shaw, Gordon R Bernard, Todd W Rice
BACKGROUND: Saline, the intravenous fluid most commonly administered to critically ill adults, contains a high chloride content, which may be associated with acute kidney injury and death. Whether using balanced crystalloids rather than saline decreases the risk of acute kidney injury and death among critically ill adults remains unknown. METHODS: The Isotonic Solutions and Major Adverse Renal Events Trial (SMART) is a pragmatic, cluster-level allocation, cluster-level crossover trial being conducted between 1 June 2015 and 30 April 2017 in five intensive care units at Vanderbilt University Medical Center in Nashville, TN, USA...
March 16, 2017: Trials
https://www.readbyqxmd.com/read/28302155/a-prospective-randomised-placebo-controlled-double-masked-three-armed-multicentre-phase-ii-iii-trial-for-the-study-of-a-topical-treatment-of-ischaemic-central-retinal-vein-occlusion-to-prevent-neovascular-glaucoma-the-strong-study-study-protocol-for-a-randomised
#12
Katrin Lorenz, Yvonne Scheller, Katharina Bell, Franz Grus, Katharina A Ponto, Felix Bock, Claus Cursiefen, Jens Flach, Marta Gehring, Tunde Peto, Rufino Silva, Yossi Tal, Norbert Pfeiffer
BACKGROUND: Neovascular glaucoma (NVG) is rare, comprising only 3.9% of all glaucoma cases. The most common cause of NVG is ischaemic central retinal vein occlusion (iCRVO). NVG frequently results in blindness and painful end-stage glaucomatous damage leading to the need for enucleation. Currently, there is no preventive therapy for NVG following iCRVO. Rescue treatments have severe drawbacks. Accordingly, there is a great need for preventing the often visually devastating outcomes of NVG...
March 16, 2017: Trials
https://www.readbyqxmd.com/read/28298244/frailty-related-to-anesthesia-guided-by-the-index-bispectral-frail-study-study-protocol-for-a-randomized-controlled-trial
#13
Morgan Le Guen, Marie Herr, Antoine Bizard, Caroline Bichon, Nathalie Boichut, Thierry Chazot, Ngai Liu, Joel Ankri, Marc Fischler
BACKGROUND: Currently, patients older than 60 years of age represent 25% of the population and are at an increased risk during surgery. Therefore, reducing postoperative morbidity and mortality is a major concern in medical research and practice. Dependence on caregivers and cognitive impairment represent two major risk factors in the elderly, especially in frail patients after surgery under general anesthesia. In this context, continuous monitoring of the depth of anesthesia using a bispectral index (BIS) sensor may reduce the occurrence of impairments by gaining better control of the anesthetic depth...
March 16, 2017: Trials
https://www.readbyqxmd.com/read/28292331/the-ghent-psychotherapy-study-gps-on-the-differential-efficacy-of-supportive-expressive-and-cognitive-behavioral-interventions-in-dependent-and-self-critical-depressive-patients-study-protocol-for-a-randomized-controlled-trial
#14
Reitske Meganck, Mattias Desmet, Claudi Bockting, Ruth Inslegers, Femke Truijens, Melissa De Smet, Rosa De Geest, Kimberly Van Nieuwenhove, Vicky Hennissen, Goedele Hermans, Tom Loeys, Ufuoma Angelica Norman, Chris Baeken, Stijn Vanheule
BACKGROUND: Major depressive disorder is a leading cause of disease burden worldwide, indicating the importance of effective therapies. Outcome studies have shown overall efficacy of different types of psychotherapy across groups, yet large variability within groups. Although patient characteristics are considered crucial in understanding outcome, they have received limited research attention. This trial aims at investigating the interaction between therapeutic approach (pre-structured versus explorative) and the personality style of patients (dependent versus self-critical), which is considered a core underlying dimension of depressive pathology...
March 14, 2017: Trials
https://www.readbyqxmd.com/read/28292320/addition-of-propranolol-in-resistant-arterial-hypertension-treatment-apropriate-study-study-protocol-for-a-randomized-double-blind-placebo-controlled-trial
#15
G R Constantine, P Ranasinghe, P Weeratunga, C Weeraratne, P Galappatthy, S Rajapakse, U Senarath, P Katulanda
BACKGROUND: Resistant hypertension is defined as an uncontrolled blood pressure despite treatment at best-tolerated doses with at least three antihypertensive agents including a diuretic. It is an emerging public health problem. At present clinical trial data on management of resistant hypertension is limited. Management is largely based on observational studies and expert opinions. Propranolol is a nonselective beta blocker. Several studies have confirmed that propranolol has a significant hypotensive action, both when used alone and as an adjuvant therapy...
March 14, 2017: Trials
https://www.readbyqxmd.com/read/28292319/quality-of-transurethral-resection-of-bladder-tumor-procedure-influenced-a-phase-iii-trial-comparing-the-effect-of-klh-and-mitomycin-c
#16
LETTER
Narasimha N G Prasad, Shammana N Muddukrishna
BACKGROUND: Retrospective analysis of Center effect of the multi-center trial conducted to compare Immucothel (KLH Immunotherapy drug product) with Mytomycin-C (MM) concluded that efficacy evaluation of the drug product may be impacted by physician's subjective performance of Transurethral resection of bladder tumor (TURBT). METHODS: A randomized trial was performed in 18 hospitals (clinical centers) and a total of 553 recruited, 283 patients under KLH arm and 270 patients under MM...
March 14, 2017: Trials
https://www.readbyqxmd.com/read/28292317/the-association-of-funding-source-on-effect-size-in-randomized-controlled-trials-2013-2015-a-cross-sectional-survey-and-meta-analysis
#17
Alberto Falk Delgado, Anna Falk Delgado
BACKGROUND: Trials financed by for-profit organizations have been associated with favorable outcomes of new treatments, although the effect size of funding source impact on outcome is unknown. The aim of this study was to estimate the effect size for a favorable outcome in randomized controlled trials (RCTs), stratified by funding source, that have been published in general medical journals. METHODS: Parallel-group RCTs published in The Lancet, New England Journal of Medicine, and JAMA between 2013 and 2015 were identified...
March 14, 2017: Trials
https://www.readbyqxmd.com/read/28288676/why-clinical-trial-outcomes-fail-to-translate-into-benefits-for-patients
#18
LETTER
Carl Heneghan, Ben Goldacre, Kamal R Mahtani
Clinical research should ultimately improve patient care. For this to be possible, trials must evaluate outcomes that genuinely reflect real-world settings and concerns. However, many trials continue to measure and report outcomes that fall short of this clear requirement. We highlight problems with trial outcomes that make evidence difficult or impossible to interpret and that undermine the translation of research into practice and policy. These complex issues include the use of surrogate, composite and subjective endpoints; a failure to take account of patients' perspectives when designing research outcomes; publication and other outcome reporting biases, including the under-reporting of adverse events; the reporting of relative measures at the expense of more informative absolute outcomes; misleading reporting; multiplicity of outcomes; and a lack of core outcome sets...
March 14, 2017: Trials
https://www.readbyqxmd.com/read/28283026/preventing-recurrence-of-endometriosis-by-means-of-long-acting-progestogen-therapy-pre-empt-report-of-an-internal-pilot-multi-arm-randomised-controlled-trial-incorporating-flexible-entry-design-and-adaption-of-design-based-on-feasibility-of-recruitment
#19
Lee J Middleton, Jane P Daniels, Annalise Weckesser, Siladitya Bhattacharya
BACKGROUND: Endometriosis is associated with the growth of endometrium in ectopic sites mainly within the pelvis. This results in inflammation and scarring, causing pain and impaired quality of life. Endometriotic lesions can be excised or ablated surgically, but the risk of recurrence is high. A Heath Technology Assessment commissioning call in 2011 sought applications for trials aimed at evaluating long-term effectiveness of postoperative, long-acting, reversible contraceptives (LARCs) in preventing recurrence of endometriosis...
March 11, 2017: Trials
https://www.readbyqxmd.com/read/28279222/minimum-number-of-clusters-and-comparison-of-analysis-methods-for-cross-sectional-stepped-wedge-cluster-randomised-trials-with-binary-outcomes-a-simulation-study
#20
Daniel Barker, Catherine D'Este, Michael J Campbell, Patrick McElduff
BACKGROUND: Stepped wedge cluster randomised trials frequently involve a relatively small number of clusters. The most common frameworks used to analyse data from these types of trials are generalised estimating equations and generalised linear mixed models. A topic of much research into these methods has been their application to cluster randomised trial data and, in particular, the number of clusters required to make reasonable inferences about the intervention effect. However, for stepped wedge trials, which have been claimed by many researchers to have a statistical power advantage over the parallel cluster randomised trial, the minimum number of clusters required has not been investigated...
March 9, 2017: Trials
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