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https://www.readbyqxmd.com/read/28742713/does-prolonged-enteral-feeding-with-supplemental-omega-3-fatty-acids-impact-on-recovery-post-esophagectomy-results-of-a-randomized-double-blind-trial
#1
Laura A Healy, Aoife Ryan, Suzanne L Doyle, Éadaoin Bríd Ní Bhuachalla, Samantha Cushen, Ricardo Segurado, Thomas Murphy, Narayanasamy Ravi, Claire L Donohoe, John V Reynolds
OBJECTIVE: This randomized controlled trial (RCT) hypothesized that prolonged enteral nutrition (EN) with supplemental eicosapentanoic acid (EPA), an omega-3 fatty acid with immune and anabolic properties, may impact on clinical and nutritional outcomes. BACKGROUND: Esophagectomy is associated with significant weight loss and catabolism, and negatively impacts quality of life (QL). Strategies to counter sustained catabolism have therapeutic rationale. METHODS: This multicenter, double-blind, placebo-controlled RCT was powered on a 5% difference in lean body mass (LBM) at 1 month...
July 24, 2017: Annals of Surgery
https://www.readbyqxmd.com/read/28741729/influence-of-timing-of-delayed-hard-palate-closure-on-articulation-skills-in-3-year-old-danish-children-with-unilateral-cleft-lip-and-palate
#2
Elisabeth Willadsen, Maria Boers, Antje Schöps, Mia Kisling-Møller, Joan Bogh Nielsen, Line Dahl Jørgensen, Mikael Andersen, Stig Bolund, Helene Søgaard Andersen
BACKGROUND: Differing results regarding articulation skills in young children with cleft palate (CP) have been reported and often interpreted as a consequence of different surgical protocols. AIMS: To assess the influence of different timing of hard palate closure in a two-stage procedure on articulation skills in 3-year-olds born with unilateral cleft lip and palate (UCLP). Secondary aims were to compare results with peers without CP, and to investigate if there are gender differences in articulation skills...
July 25, 2017: International Journal of Language & Communication Disorders
https://www.readbyqxmd.com/read/28739561/smartphone-based-monitoring-of-objective-and-subjective-data-in-affective-disorders-where-are-we-and-where-are-we-going-systematic-review
#3
Ezgi Dogan, Christian Sander, Xenija Wagner, Ulrich Hegerl, Elisabeth Kohls
BACKGROUND: Electronic mental health interventions for mood disorders have increased rapidly over the past decade, most recently in the form of various systems and apps that are delivered via smartphones. OBJECTIVE: We aim to provide an overview of studies on smartphone-based systems that combine subjective ratings with objectively measured data for longitudinal monitoring of patients with affective disorders. Specifically, we aim to examine current knowledge on: (1) the feasibility of, and adherence to, such systems; (2) the association of monitored data with mood status; and (3) the effects of monitoring on clinical outcomes...
July 24, 2017: Journal of Medical Internet Research
https://www.readbyqxmd.com/read/28738794/escaschool-study-trial-protocol-of-an-adaptive-treatment-approach-for-school-age-children-with-adhd-including-two-randomised-trials
#4
Manfred Döpfner, Christopher Hautmann, Christina Dose, Tobias Banaschewski, Katja Becker, Daniel Brandeis, Martin Holtmann, Thomas Jans, Carolin Jenkner, Sabina Millenet, Tobias Renner, Marcel Romanos, Elena von Wirth
BACKGROUND: The ESCAschool study addresses the treatment of school-age children with attention-deficit/hyperactivity disorder (ADHD) in a large multicentre trial. It aims to investigate three interrelated topics: (i) Clinical guidelines often recommend a stepped care approach, including different treatment strategies for children with mild to moderate and severe ADHD symptoms, respectively. However, this approach has not yet been empirically validated. (ii) Behavioural interventions and neurofeedback have been shown to be effective, but the superiority of combined treatment approaches such as medication plus behaviour therapy or medication plus neurofeedback compared to medication alone remains questionable...
July 24, 2017: BMC Psychiatry
https://www.readbyqxmd.com/read/28732525/effectiveness-and-cost-effectiveness-of-embedded-simulation-in-occupational-therapy-clinical-practice-education-study-protocol-for-a-randomised-controlled-trial
#5
Christine Imms, Eli Mang Yee Chu, Stephen Guinea, Loretta Sheppard, Elspeth Froude, Rob Carter, Susan Darzins, Samantha Ashby, Susan Gilbert-Hunt, Nigel Gribble, Kelli Nicola-Richmond, Merrolee Penman, Elena Gospodarevskaya, Erin Mathieu, Mark Symmons
BACKGROUND: Clinical placements are a critical component of the training for health professionals such as occupational therapists. However, with growing student enrolments in professional education courses and workload pressures on practitioners, it is increasingly difficult to find sufficient, suitable placements that satisfy program accreditation requirements. The professional accrediting body for occupational therapy in Australia allows up to 200 of the mandatory 1000 clinical placement hours to be completed via simulation activities, but evidence of effectiveness and efficiency for student learning outcomes is lacking...
July 21, 2017: Trials
https://www.readbyqxmd.com/read/28729329/fluids-in-sepsis-and-septic-shock-fissh-protocol-for-a-pilot-randomised-controlled-trial
#6
Bram Rochwerg, Tina Millen, Peggy Austin, Michelle Zeller, Frédérick D'Aragon, Roman Jaeschke, Marie-Hélène Masse, Sangeeta Mehta, Francois Lamontagne, Maureen Meade, Gordon Guyatt, Deborah J Cook
INTRODUCTION: Observational evidence suggests physiological benefits and lower mortality with lower chloride solutions; however, 0.9% saline remains the most widely used fluid worldwide. Given uncertainty regarding the association of lower chloride on mortality, it is unlikely that practice will change without direct randomised clinical trial (RCT) evidence. This pilot RCT will investigate the feasibility of a large-scale trial directly comparing low chloride with high chloride fluids in patients with septic shock...
July 20, 2017: BMJ Open
https://www.readbyqxmd.com/read/28724513/development-of-a-tailored-hiv-prevention-intervention-for-single-young-men-who-have-sex-with-men-who-meet-partners-online-protocol-for-the-mydex-project
#7
Jose Arturo Bauermeister, Ryan C Tingler, Michele Demers, Gary W Harper
BACKGROUND: New cases of human immunodeficiency virus (HIV) among young men who have sex with men (YMSM), aged 18 to 24, underscore the importance of developmentally-informed HIV programs for YMSM. We developed an online intervention focused on risk reduction strategies across different sexual partner types. Intervention activities focus on assisting YMSM reflect on their partner-seeking behaviors, develop sexual decision-making rules to reduce their HIV risks, and consider the adoption of HIV prevention behaviors...
July 19, 2017: JMIR Research Protocols
https://www.readbyqxmd.com/read/28724423/effectiveness-and-cost-effectiveness-of-telephone-based-cognitive-behavioural-therapy-in-primary-care-study-protocol-of-tide-telephone-intervention-for-depression
#8
Birgit Watzke, Elisa Haller, Maya Steinmann, Daniela Heddaeus, Martin Härter, Hans-Helmut König, Karl Wegscheider, Thomas Rosemann
BACKGROUND: Despite the availability of evidence-based treatments for depression, a large proportion of patients remains untreated or adequate treatment is initiated with delay. This situation is particularly critical in primary care, where not only most individuals first seek help for their mental health problems, but also depressive disorders - particularly mild to moderate levels of severity - are highly prevalent given the high comorbidity of chronic somatic conditions and depression...
July 19, 2017: BMC Psychiatry
https://www.readbyqxmd.com/read/28724351/impact-of-a-lay-led-home-based-intervention-programme-on-quality-of-life-in-community-dwelling-pre-frail-and-frail-older-adults-a-randomized-controlled-trial
#9
A Kapan, E Winzer, S Haider, S Titze, K Schindler, C Lackinger, T E Dorner
BACKGROUND: Due to the demographic ageing process and the increasing number of pre-frail and frail individuals, new lifestyle interventions to enhance the quality of life (QoL) in community-dwelling older adults are necessary. Therefore, we performed a randomised controlled trial (RCT) to compare effects of a lay-led home-based physical and nutritional intervention programme with social support alone on different QoL domains in community-dwelling pre-frail and frail older adults. METHODS: In this analysis within a RCT (12 weeks), lay volunteers visited one-on-one pre-frail or frail older adults at home twice a week...
July 19, 2017: BMC Geriatrics
https://www.readbyqxmd.com/read/28724178/could-myo-inositol-soft-gel-capsules-outperform-clomiphene-in-inducing-ovulation-results-of-a-pilot-study
#10
A-L Rolland, M Peigné, P Plouvier, A Dumont, S Catteau-Jonard, D Dewailly
OBJECTIVE: Insulin resistance is known to worsen polycystic ovarian syndrome (PCOS). The management of insulin resistance is crucial in the treatment of PCOS and insulin-sensitizing molecule as myo-inositol (MYO) seems to have promising effects. The aim of our pilot study was to study whether supplementation with MYO can improve patients' sensitivity to clomiphene citrate (CC) in terms of ovulation and pregnancy rates. PATIENTS AND METHODS: This study included 26 patients with PCOS, eligible to ovulation induction with CC...
June 2017: European Review for Medical and Pharmacological Sciences
https://www.readbyqxmd.com/read/28720557/comparing-mobile-health-strategies-to-improve-medication-adherence-for-veterans-with-coronary-heart-disease-mobile4meds-protocol-for-a-mixed-methods-study
#11
Linda G Park, Eileen G Collins, Janet K Shim, Mary A Whooley
BACKGROUND: Adherence to antiplatelet medications is critical to prevent life threatening complications (ie, stent thrombosis) after percutaneous coronary interventions (PCIs), yet rates of nonadherence range from 21-57% by 12 months. Mobile interventions delivered via text messaging or mobile apps represent a practical and inexpensive strategy to promote behavior change and enhance medication adherence. OBJECTIVE: The Mobile4Meds study seeks to determine whether text messaging or a mobile app, compared with an educational website control provided to all Veterans, can improve adherence to antiplatelet therapy among patients following acute coronary syndrome (ACS) or PCI...
July 18, 2017: JMIR Research Protocols
https://www.readbyqxmd.com/read/28718012/implant-decontamination-with-phosphoric-acid-during-surgical-peri-implantitis-treatment-a-rct
#12
Diederik F M Hentenaar, Yvonne C M De Waal, Hans Strooker, Henny J A Meijer, Arie-Jan Van Winkelhoff, Gerry M Raghoebar
BACKGROUND: Peri-implantitis is known as an infectious disease that affects the peri-implant soft and hard tissue. Today, scientific literature provides very little evidence for an effective intervention protocol for treatment of peri-implantitis. The aim of the present randomized controlled trial is to evaluate the microbiological and clinical effectiveness of phosphoric acid as a decontaminating agent of the implant surface during surgical peri-implantitis treatment. METHODS: Peri-implantitis lesions were treated with resective surgical treatment aimed at peri-implant granulation tissue removal, bone recontouring, and pocket elimination...
December 2017: International Journal of Implant Dentistry
https://www.readbyqxmd.com/read/28710229/pirate-project-point-of-care-informatics-based-randomised-controlled-trial-for-decreasing-overuse-of-antibiotic-therapy-in-gram-negative-bacteraemia
#13
Angela Huttner, Werner C Albrich, Pierre-Yves Bochud, Angèle Gayet-Ageron, Anne Rossel, Elodie von Dach, Stephan Harbarth, Laurent Kaiser
INTRODUCTION: Antibiotic overuse drives antibiotic resistance. The optimal duration of antibiotic therapy for Gram-negative bacteraemia (GNB), a common community and hospital-associated infection, remains unknown and unstudied via randomised controlled trials (RCTs). METHODS AND ANALYSIS: This investigator-initiated, multicentre, non-inferiority, informatics-based point-of-care RCT will randomly assign adult hospitalised patients receiving microbiologically efficacious antibiotic(s) for GNB to (1) 14 days of antibiotic therapy, (2) 7 days of therapy or (3) an individualised duration determined by clinical response and 75% reduction in peak C reactive protein (CRP) values...
July 13, 2017: BMJ Open
https://www.readbyqxmd.com/read/28709470/the-effects-of-cognitive-bias-modification-training-and-oxytocin-administration-on-trust-in-maternal-support-study-protocol-for-a-randomized-controlled-trial
#14
Martine W F T Verhees, Eva Ceulemans, Marian J Bakermans-Kranenburg, Marinus H van IJzendoorn, Simon de Winter, Guy Bosmans
BACKGROUND: Lack of trust in parental support is a transdiagnostic risk factor for the development of psychological problems throughout the lifespan. Research suggests that children's cognitive attachment representations and related information processing biases could be an important target for interventions aiming to build trust in the parent-child relationship. A paradigm that can alter these biases and increase trust is that of Cognitive Bias Modification (CBM), during which a target processing bias is systematically trained...
July 14, 2017: Trials
https://www.readbyqxmd.com/read/28704247/comparison-of-registered-and-reported-outcomes-in-randomized-clinical-trials-published-in-anesthesiology-journals
#15
Philip M Jones, Jeffrey T Y Chow, Miguel F Arango, Jason A Fridfinnson, Nan Gai, Kevin Lam, Timothy P Turkstra
BACKGROUND: Randomized clinical trials (RCTs) provide high-quality evidence for clinical decision-making. Trial registration is one of the many tools used to improve the reporting of RCTs by reducing publication bias and selective outcome reporting bias. The purpose of our study is to examine whether RCTs published in the top 6 general anesthesiology journals were adequately registered and whether the reported primary and secondary outcomes corresponded to the originally registered outcomes...
July 10, 2017: Anesthesia and Analgesia
https://www.readbyqxmd.com/read/28701412/the-effect-of-blinding-on-estimates-of-mortality-in-randomised-clinical-trials-of-intensive-care-interventions-protocol-for-a-systematic-review-and-meta-analysis
#16
Carl Thomas Anthon, Anders Granholm, Anders Perner, Jon Henrik Laake, Morten Hylander Møller
INTRODUCTION: Evidence exists that unblinded randomised clinical trials (RCTs) overestimate intervention effects compared with blinded RCTs. It has been suggested that this is less pronounced for objective (ie, not subject to interpretation) outcome measures, including mortality. This may not apply in the intensive care unit (ICU), as most deaths are preceded by decisions to withhold or withdraw treatments. Lack of blinding of physicians in RCTs of ICU interventions may potentially influence the decision towards a higher threshold for discontinuing treatment in patients who receive the investigational treatment and/or a lower threshold for discontinuing treatment in patients who receive the comparator (control)...
July 11, 2017: BMJ Open
https://www.readbyqxmd.com/read/28701360/multicentre-randomised-clinical-trial-of-paediatric-concussion-assessment-of-rest-and-exertion-pedcare-a-study-to-determine-when-to-resume-physical-activities-following-concussion-in-children
#17
Andrée-Anne Ledoux, Nicholas J Barrowman, Kathy Boutis, Adrienne Davis, Sarah Reid, Gurinder Sangha, Ken J Farion, Kevin Belanger, Mark S Tremblay, Keith Owen Yeates, Carol DeMatteo, Nick Reed, Roger Zemek
INTRODUCTION: Rest until symptom-free, followed by a progressive stepwise return to activities, is often prescribed in the management of paediatric concussions. Recent evidence suggests prolonged rest may hinder recovery, and early resumption of physical activity may be associated with more rapid recovery postconcussion. The primary objective is to determine whether the early reintroduction of non-contact physical activity beginning 72 hours postinjury reduces postconcussive symptoms at 2 weeks in children following an acute concussion as compared with a rest until asymptomatic protocol...
July 12, 2017: British Journal of Sports Medicine
https://www.readbyqxmd.com/read/28699556/community-led-trials-intervention-co-design-in-a-cluster-randomised-controlled-trial
#18
Neil Andersson
In conventional randomised controlled trials (RCTs), researchers design the interventions. In the Camino Verde trial, each intervention community designed its own programmes to prevent dengue. Instead of fixed actions or menus of activities to choose from, the trial randomised clusters to a participatory research protocol that began with sharing and discussing evidence from a local survey, going on to local authorship of the action plan for vector control.Adding equitable stakeholder engagement to RCT infrastructure anchors the research culturally, making it more meaningful to stakeholders...
May 30, 2017: BMC Public Health
https://www.readbyqxmd.com/read/28698320/a-self-management-programme-of-activity-coping-and-education-space-for-copd-c-in-primary-care-the-protocol-for-a-pragmatic-trial
#19
Claire LA Bourne, Pratiksha Kanabar, Katy Mitchell, Sally Schreder, Linzy Houchen-Wolloff, M John G Bankart, Lindsay Apps, Stacey Hewitt, Theresa Harvey-Dunstan, Sally J Singh
INTRODUCTION: National guidance for chronic obstructive pulmonary disease (COPD) suggests that self-management support be provided for patients. Our institution has developed a standardised, manual-based, supported self-management programme: Self-Management Programme of Activity Coping and Education (SPACE for COPD(C)). SPACE was previously piloted on a 1-2-1 basis, delivered by researchers, to individuals with COPD. Discussions with stakeholders highlighted considerable interest in delivering the SPACE for COPD(C) intervention as a group-based self-management programme facilitated by healthcare professionals (HCPs) in primary care settings...
July 10, 2017: BMJ Open
https://www.readbyqxmd.com/read/28698319/the-supporting-patient-activation-in-transition-to-home-spath-intervention-a-study-protocol-of-a-randomised-controlled-trial-using-motivational-interviewing-to-decrease-re-hospitalisation-for-patients-with-copd-or-heart-failure
#20
Maria Flink, Marléne Lindblad, Oscar Frykholm, Åsa Kneck, Per Nilsen, Kristofer Årestedt, Mirjam Ekstedt
INTRODUCTION: Deficient hospital discharging and patients struggling to handle postdischarge self-management have been identified as potential causes of re-hospitalisation rates. Despite an increased interest in interventions aiming to reduce re-hospitalisation rates, there is yet no best evidence on how to support patients in being active participants in their self-management postdischarge. The aim of this paper is to describe the study protocol for an upcoming randomised controlled trial (RCT) of the Supporting Patient in Activation to Home (sPATH) intervention...
July 10, 2017: BMJ Open
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