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https://www.readbyqxmd.com/read/29149915/quality-of-intervention-delivery-in-a-cluster-randomised-controlled-trial-a-qualitative-observational-study-with-lessons-for-fidelity
#1
Karen James, Alan Quirk, Sue Patterson, Geoff Brennan, Duncan Stewart
BACKGROUND: Understanding intervention fidelity is an essential part of the evaluation of complex interventions because fidelity not only affects the validity of trial findings, but also because studies of fidelity can be used to identify barriers and facilitators to successful implementation, and so provide important information about factors likely to impact the uptake of the intervention into clinical practice. Participant observation methods have been identified as being particularly valuable in studies of fidelity, yet are rarely used...
November 17, 2017: Trials
https://www.readbyqxmd.com/read/29149912/trial-to-incentivise-adherence-for-diabetes-triad-study-protocol-for-a-randomised-controlled-trial
#2
Marcel Bilger, Mitesh Shah, Ngiap Chuan Tan, Kaye Louise Howard, Hui Yan Xu, Ecosse Luc Lamoureux, Eric Andrew Finkelstein
BACKGROUND: Many people with diabetes have suboptimal glycaemic control due to not being adherent to their treatment regimen. Behavioural economic theory suggests that the lack of adherence results from the disconnect between the timing of when costs and benefits accrue. One strategy to address this discontinuity is to offer patients a near-term benefit, such as a financial reward. Whereas there is evidence that rewards can improve treatment adherence and sometimes health outcomes, further research is needed to determine whether rewards are more effective when targeting processes or intermediary health outcomes...
November 17, 2017: Trials
https://www.readbyqxmd.com/read/29149905/the-kusamala-program-for-primary-caregivers-of-children-6-59-months-of-age-hospitalized-with-severe-acute-malnutrition-in-malawi-study-protocol-for-a-cluster-randomized-controlled-trial
#3
Allison I Daniel, Meta van den Heuvel, Wieger P Voskuijl, Melissa Gladstone, Mike Bwanali, Isabel Potani, Celine Bourdon, Jenala Njirammadzi, Robert H J Bandsma
BACKGROUND: Severe acute malnutrition (SAM) is associated with high mortality rates and impairments in growth and development in children that do survive. There are complex nutritional, health, and behavioural risk factors involving severely malnourished children and their primary caregivers, requiring integrated intervention approaches. METHODS: A cluster-randomized controlled trial at the Queen Elizabeth Central Hospital in Blantyre, Malawi will be conducted to evaluate the effectiveness of a 4-day hospital-based intervention programme directed at primary caregivers...
November 17, 2017: Trials
https://www.readbyqxmd.com/read/29149904/concomitant-sequential-and-7-day-triple-therapy-in-first-line-treatment-of-helicobacter-pylori-infection-in-korea-study-protocol-for-a-randomized-controlled-trial
#4
Hyuk Lee, Beom Jin Kim, Sang Gyun Kim, Jin Il Kim, Il Ju Choi, Yong Chan Lee, Jae G Kim, Jae J Kim
BACKGROUND: Most international guidelines recommend triple-therapy regimens consisting of a proton pump inhibitor, clarithromycin, and amoxicillin/metronidazole for at least 7 days for the eradication of Helicobacter pylori. However, the efficacy of 7-day clarithromycin-based standard triple therapy for H. pylori infection is currently unacceptable in Korea. In this study, we will compare the efficacy and safety of 7-day standard triple therapy, 10-day sequential therapy, and 10-day concomitant therapy for the first-line treatment of H...
November 17, 2017: Trials
https://www.readbyqxmd.com/read/29145894/inositol-in-the-management-of-abdominal-aortic-aneurysm-imagen-study-protocol-for-a-randomised-controlled-trial
#5
Sophie E Rowbotham, Jenna L Pinchbeck, Georgina Anderson, Bernie Bourke, Michael Bourke, T Christian Gasser, Rene Jaeggi, Jason S Jenkins, Corey S Moran, Susan K Morton, Christopher M Reid, Ramesh Velu, Lisan Yip, Joseph V Moxon, Jonathan Golledge
BACKGROUND: An abdominal aortic aneurysm (AAA) is a focal dilation of the abdominal aorta and is associated with a risk of fatal rupture. Experimental studies suggest that myo-inositol may exert beneficial effects on AAAs through favourable changes to biological pathways implicated in AAA pathology. The aim of the Inositol in the MAnaGemENt of abdominal aortic aneurysm (IMAGEN) trial is to assess if myo-inositol will reduce AAA growth. METHODS/DESIGN: IMAGEN is a multi-centre, prospective, parallel-group, randomised, double-blind, placebo-controlled trial...
November 16, 2017: Trials
https://www.readbyqxmd.com/read/29145879/allogeneic-mesenchymal-stem-cell-as-induction-therapy-to-prevent-both-delayed-graft-function-and-acute-rejection-in-deceased-donor-renal-transplantation-study-protocol-for-a-randomized-controlled-trial
#6
Qipeng Sun, Liangqing Hong, Zhengyu Huang, Ning Na, Xuefeng Hua, Yanwen Peng, Ming Zhao, Ronghua Cao, Qiquan Sun
BACKGROUND: Using kidneys from deceased donors is an available strategy to meet the growing need of grafts. However, higher incidences of delayed graft function (DGF) and acute rejection exert adverse effects on graft outcomes. Since ischemia-reperfusion injury (IRI) and ongoing process of immune response to grafts are the major causes of DGF and acute rejection, the optimal induction intervention should possess capacities of both repairing renal structure injury and suppressing immune response simultaneously...
November 16, 2017: Trials
https://www.readbyqxmd.com/read/29145878/improving-readiness-for-recruitment-through-simulated-trial-activation-the-adjuvant-steroids-in-adults-with-pandemic-influenza-asap-trial
#7
Wei Shen Lim, Garry Meakin, Clare Brittain, Thomas Bewick, Lelia Duley
BACKGROUND: Research in public health emergencies requires trials to be set up in readiness for activation at short notice and in anticipation of limited timelines for patient recruitment. We conducted a simulated activation of a hibernating pandemic influenza clinical trial in order to test trial processes and to determine the value of such simulation in maintaining trial readiness. METHODS: The simulation involved the Nottingham Clinical Trials Unit, one participating hospital, one manufacturing unit and the Investigational Medicinal Product (IMP) supplier...
November 16, 2017: Trials
https://www.readbyqxmd.com/read/29145873/group-physiotherapy-compared-to-individual-physiotherapy-to-treat-urinary-incontinence-in-aging-women-study-protocol-for-a-randomized-controlled-trial
#8
Chantale Dumoulin, Mélanie Morin, Marie-Hélène Mayrand, Michel Tousignant, Michal Abrahamowicz
BACKGROUND: Urinary incontinence (UI), one of the most prevalent health concerns confronting women aged over 60 years, affects up to 55% of older community-dwelling women-20-25% with severe symptoms. Clinical practice guidelines recommend individualized pelvic floor muscle training (PFMT) as a first-line treatment for stress or mixed UI in women, although lack of human and financial resources limits delivery of this first-line treatment. Preliminary data suggest that group-based treatments may provide the answer...
November 16, 2017: Trials
https://www.readbyqxmd.com/read/29141694/the-icu-diary-study-prospective-multicenter-comparative-study-of-the-impact-of-an-icu-diary-on-the-wellbeing-of-patients-and-families-in-french-icus
#9
Maïté Garrouste-Orgeas, Cécile Flahault, Léonor Fasse, Stéphane Ruckly, Nora Amdjar-Badidi, Laurent Argaud, Julio Badie, Amélie Bazire, Naike Bige, Eric Boulet, Lila Bouadma, Cédric Bretonnière, Bernard Floccard, Alain Gaffinel, Xavier de Forceville, Hubert Grand, Rebecca Halidfar, Olfa Hamzaoui, Mercé Jourdain, Paul-Henri Jost, Eric Kipnis, Audrey Large, Alexandre Lautrette, Olivier Lesieur, Virginie Maxime, Emmanuelle Mercier, Jean Paul Mira, Yannick Monseau, Erika Parmentier-Decrucq, Jean-Philippe Rigaud, Antoine Rouget, François Santoli, Georges Simon, Fabienne Tamion, Nathalie Thieulot-Rolin, Marina Thirion, Sandrine Valade, Isabelle Vinatier, Christel Vioulac, Sebastien Bailly, Jean-François Timsit
BACKGROUND: Post-intensive care syndrome includes the multiple consequences of an intensive care unit (ICU) stay for patients and families. It has become a new challenge for intensivists. Prevention programs have been disappointing, except for ICU diaries, which report the patient's story in the ICU. However, the effectiveness of ICU diaries for patients and families is still controversial, as the interpretation of the results of previous studies was open to criticism hampering an expanded use of the diary...
November 15, 2017: Trials
https://www.readbyqxmd.com/read/29141692/the-marketing-plan-and-outcome-indicators-for-recruiting-and-retaining-parents-in-the-homestyles-randomized-controlled-trial
#10
Carol Byrd-Bredbenner, Colleen Delaney, Jennifer Martin-Biggers, Mallory Koenings, Virginia Quick
BACKGROUND: Despite the critical importance of successful recruitment and retention to study integrity, reporting of recruitment and retention strategies along with factors associated with successful recruitment and retention of participants in health-related interventions remain rare, especially for health and obesity prevention programs. Thus, the purpose of this article is to retrospectively examine the recruitment and retention marketing plan used in the online HomeStyles randomized controlled trial (RCT) and discuss outcomes associated with completion of the intervention...
November 15, 2017: Trials
https://www.readbyqxmd.com/read/29141679/intramuscular-oxytocin-versus-intravenous-oxytocin-to-prevent-postpartum-haemorrhage-at-vaginal-delivery-labor-trial-study-protocol-for-a-randomised-controlled-trial
#11
Nita Adnan, Fiona Boland, Deirdre J Murphy
BACKGROUND: Primary postpartum haemorrhage (PPH) is one of the leading causes of maternal morbidity and mortality worldwide. The most common cause of primary PPH is uterine atony. Atonic PPH rates are increasing in developed countries despite routine active management of the third stage of labour. In less-developed countries, primary PPH remains the leading cause of maternal death. Although the value of routine oxytocics in the third stage of labour has been well established, there is inconsistent practice in the choice of agent and route of administration...
November 15, 2017: Trials
https://www.readbyqxmd.com/read/29141661/preventing-enduring-behavioural-problems-in-young-children-through-early-psychological-intervention-healthy-start-happy-start-study-protocol-for-a-randomized-controlled-trial
#12
Paul G Ramchandani, Christine O'Farrelly, Daphne Babalis, Marian J Bakermans-Kranenburg, Sarah Byford, Ellen S R Grimas, Jane E Iles, Marinus H van IJzendoorn, Julia McGinley, Charlotte M Phillips, Alan Stein, Jane Warwick, Hillary C Watt, Stephen Scott
BACKGROUND: Behavioural problems are common in early childhood, and can result in enduring costs to the individual and society, including an increased risk of mental and physical illness, criminality, educational failure and drug and alcohol misuse. Most previous research has examined the impact of interventions targeting older children when difficulties are more established and harder to change, and have rarely included fathers. We are conducting a trial of a psychological intervention delivered to families with very young children, engaging both parents where possible...
November 15, 2017: Trials
https://www.readbyqxmd.com/read/29137679/trial-of-acute-femoral-fracture-fixation-traffix-study-protocol-for-a-randomised-controlled-feasibility-trial
#13
Xavier L Griffin, Matthew L Costa, Juul Achten, Melina Dritsaki, Janis Baird, Nicholas Parsons
BACKGROUND: Distal femoral fractures are a source of considerable morbidity and best treatment is currently uncertain. The Trial of Acute Femoral Fracture Fixation (TrAFFix) is a randomised, parallel-group feasibility study designed to inform the design of a later, definitive clinical trial comparing intramedullary nails and locking plates for the treatment of distal femoral fractures. METHODS/DESIGN: Patients aged 50 years and older with a femoral fracture within the distal two Müller squares are potentially eligible for inclusion...
November 14, 2017: Trials
https://www.readbyqxmd.com/read/29137655/can-integrating-the-memory-support-intervention-into-cognitive-therapy-improve-depression-outcome-study-protocol-for-a-randomized-controlled-trial
#14
Allison G Harvey, Lu Dong, Jason Y Lee, Nicole B Gumport, Steven D Hollon, Sophia Rabe-Hesketh, Kerrie Hein, Kirsten Haman, Mary E McNamara, Claire Weaver, Armando Martinez, Haruka Notsu, Garret Zieve, Courtney C Armstrong
BACKGROUND: The Memory Support Intervention was developed in response to evidence showing that: (1) patient memory for treatment is poor, (2) poor memory for treatment is associated with poorer adherence and poorer outcome, (3) the impact of memory impairment can be minimized by the use of memory support strategies and (4) improved memory for treatment improves outcome. The aim of this study protocol is to conduct a confirmatory efficacy trial to test whether the Memory Support Intervention improves illness course and functional outcomes...
November 14, 2017: Trials
https://www.readbyqxmd.com/read/29132441/early-screening-for-chlamydia-trachomatis-in-young-women-for-primary-prevention-of-pelvic-inflammatory-disease-i-predict-study-protocol-for-a-randomised-controlled-trial
#15
Jeanne Tamarelle, Anne C M Thiébaut, Bénédicte Sabin, Cécile Bébéar, Philippe Judlin, Arnaud Fauconnier, Delphine Rahib, Layidé Méaude-Roufai, Jacques Ravel, Servaas A Morré, Bertille de Barbeyrac, Elisabeth Delarocque-Astagneau
BACKGROUND: Genital infection with Chlamydia trachomatis (Ct) is the most common bacterial sexually transmitted infection, especially among young women. Mostly asymptomatic, it can lead, if untreated, to pelvic inflammatory disease (PID), tubal factor infertility and ectopic pregnancy. Recent data suggest that Ct infections are not controlled in France and in Europe. The effectiveness of a systematic strategy for Ct screening in under-25 women remains controversial. The main objective of the i-Predict trial (Prevention of Diseases Induced by Chlamydia trachomatis) is to determine whether early screening and treatment of 18- to-24-year-old women for genital Ct infection reduces the incidence of PID over 24 months...
November 13, 2017: Trials
https://www.readbyqxmd.com/read/29132440/influence-of-successful-periodontal-intervention-in-renal-disease-inspired-study-protocol-for-a-randomised-controlled-pilot-clinical-trial
#16
Praveen Sharma, Paul Cockwell, Thomas Dietrich, Charles Ferro, Natalie Ives, Iain L C Chapple
BACKGROUND: Patients with chronic kidney disease (CKD) exhibit increased morbidity and mortality which is associated with an increased systemic inflammatory burden. Identifying and managing comorbid diseases that contribute to this load may inform novel care pathways that could have a beneficial impact on the morbidity/mortality associated with CKD. Periodontitis, a highly prevalent, chronic inflammatory disease affecting the supporting structures of teeth, is associated with an increased systemic inflammatory and oxidative stress burden and the successful treatment of periodontitis has been shown to reduce both...
November 13, 2017: Trials
https://www.readbyqxmd.com/read/29132415/acupuncture-for-postprandial-distress-syndrome-apds-study-protocol-for-a-randomized-controlled-trial
#17
Jing-Wen Yang, Li-Wen Zhang, Guang-Xia Shi, Yi Du, Jun Wang, Jing-Jie Zhao, Yan Cao, Jian-Feng Tu, Shuai Zhang, Cheng Tan, San-San Chen, Cun-Zhi Liu
BACKGROUND: Postprandial distress syndrome (PDS) is referred to as meal-related functional dyspepsia (FD) and causes a reduced quality of life (QoL) for patients. Several randomized controlled trials (RCTs) have suggested that acupuncture is an effective treatment for FD, but few studies were particularly for PDS. This pilot study was designed to determine the feasibility and efficacy of acupuncture in patients with PDS characterized by postprandial fullness and early satiation according to the Rome III criteria...
November 13, 2017: Trials
https://www.readbyqxmd.com/read/29132404/comparison-of-the-efficacy-and-safety-of-fp-1201-lyo-intravenously-administered-recombinant-human-interferon-beta-1a-and-placebo-in-the-treatment-of-patients-with-moderate-or-severe-acute-respiratory-distress-syndrome-study-protocol-for-a-randomized-controlled
#18
Geoff Bellingan, David Brealey, Jordi Mancebo, Alain Mercat, Nicolò Patroniti, Ville Pettilä, Michael Quintel, Jean-Louis Vincent, Mikael Maksimow, Markku Jalkanen, Ilse Piippo, V Marco Ranieri
BACKGROUND: Acute respiratory distress syndrome (ARDS) results in vascular leakage, inflammation and respiratory failure. There are currently no approved pharmacological treatments for ARDS and standard of care involves treatment of the underlying cause, and supportive care. The vascular leakage may be related to reduced concentrations of local adenosine, which is involved in maintaining endothelial barrier function. Interferon (IFN) beta-1a up-regulates the cell surface ecto-5'-nucleotidase cluster of differentiation 73 (CD73), which increases adenosine levels, and IFN beta-1 may, therefore, be a potential treatment for ARDS...
November 13, 2017: Trials
https://www.readbyqxmd.com/read/29126461/impact-of-a-deferred-recruitment-model-in-a-randomised-controlled-trial-in-primary-care-cream-study
#19
Victoria Shepherd, Emma Thomas-Jones, Matthew J Ridd, Kerenza Hood, Katy Addison, Nick A Francis
BACKGROUND: Recruitment of participants is particularly challenging in primary care, with less than a third of randomised controlled trials (RCT) achieving their target within the original time frame. Participant identification, consent, randomisation and data collection can all be time-consuming. Trials recruiting an incident, as opposed to a prevalent, population may be particularly affected. This paper describes the impact of a deferred recruitment model in a RCT of antibiotics for children with infected eczema in primary care, which required the recruitment of cases presenting acutely...
November 10, 2017: Trials
https://www.readbyqxmd.com/read/29126449/advancing-real-world-trials-that-take-account-of-social-context-and-human-volition
#20
LETTER
Anders Blædel Gottlieb Hansen, Allan Jones
BACKGROUND: The recent paper in Trials by Porter and colleagues highlights the utility of applying a critical realism approach in randomised trials, an approach central to the Medical Research Council's (MRC) Framework for the Development and Evaluation of Complex Healthcare Interventions. The MRC framework offers a pragmatic step towards a more open systems approach that bridges randomised evaluation with social context and human agency in an effort to improve the generalisability of trial outcomes...
November 10, 2017: Trials
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