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https://www.readbyqxmd.com/read/28812979/truth-in-research-labelling
#1
John H Noble
This report describes the background and context of a currently circulating petition to the US Congress that seeks amendment of Section 801 of the Public Health Services Act (42 U.S.C. 282) to close a loophole in existing law which makes possible post hoc adjustment of randomised controlled trial (RCT) results reported to the Food and Drug Administration that differ from those reported to ClinicalTrials.gov and to medical journals. The report describes the petition's rationale, underlying assumptions, and support for its proposed remedy in deontological, consequentialist, and casuist philosophical ethics theories...
July 2017: Indian Journal of Medical Ethics
https://www.readbyqxmd.com/read/28812541/systematic-review-of-interventions-for-treating-or-preventing-antipsychotic-induced-tardive-dyskinesia
#2
Hanna Bergman, Dawn-Marie Walker, Adriani Nikolakopoulou, Karla Soares-Weiser, Clive E Adams
BACKGROUND: Antipsychotic medication can cause tardive dyskinesia (TD) - late-onset, involuntary, repetitive movements, often involving the face and tongue. TD occurs in > 20% of adults taking antipsychotic medication (first-generation antipsychotics for > 3 months), with this proportion increasing by 5% per year among those who continue to use these drugs. The incidence of TD among those taking newer antipsychotics is not different from the rate in people who have used older-generation drugs in moderate doses...
August 2017: Health Technology Assessment: HTA
https://www.readbyqxmd.com/read/28812160/robotic-versus-open-pancreatoduodenectomy-a-propensity-score-matched-analysis-based-on-factors-predictive-of-postoperative-pancreatic-fistula
#3
Niccolò Napoli, Emanuele F Kauffmann, Francesca Menonna, Francesca Costa, Sara Iacopi, Gabriella Amorese, Serena Giorgi, Angelo Baggiani, Ugo Boggi
BACKGROUND: Improvement in morbidity of pancreatoduodenectomy (PD) largely depends on the reduction in the incidence of clinically relevant (CR) postoperative pancreatic fistula (POPF). METHODS: After internal validation of the clinical risk score (CRS) of POPF, and identification of other predictive factors for POPF, robotic (RPD), and open (OPD) PDs were stratified into risk categories and matched by propensity scores. The primary endpoint of this study was incidence of CR-POPF...
August 15, 2017: Surgical Endoscopy
https://www.readbyqxmd.com/read/28812044/monte-carlo-simulations-of-randomized-clinical-trials-in-epilepsy
#4
Daniel M Goldenholz, Joseph Tharayil, Robert Moss, Evan Myers, William H Theodore
BACKGROUND: The placebo response in epilepsy randomized clinical trials (RCTs) has recently been shown to largely reflect underlying natural variability in seizure frequency. Based on this observation, we sought to explore the parameter space of RCT design to optimize trial efficiency and cost. METHODS: We used one of the world's largest patient reported seizure diary databases, SeizureTracker.com to derive virtual patients for simulated RCTs. We ran 1000 randomly generated simulated trials using bootstrapping (sampling with replacement) for each unique combination of trial parameters, sweeping a large set of parameters in durations of the baseline and test periods, number of patients, eligibility criteria, drug effect size, and patient dropout...
August 2017: Annals of Clinical and Translational Neurology
https://www.readbyqxmd.com/read/28811798/an-experience-with-mesh-versus-darn-repair-in-inguinal-hernias
#5
Gulshan Ali Memon, Syed Kashif Ali Shah, Habib-Ur-Rehman
BACKGROUND & OBJECTIVE: The inguinal hernia accounts for 50 percent in old age males. A Lichtenstein type of operation has now become the method of choice in most developed countries but in the developing world traditional simple suture repair is still in common practice in resource limited hospitals due to the scarcity and expensive nature of the commercial prosthetic mesh. Our objective was to compare the rates of complications in Lichtenstein repair to tension free Darn repair. METHODS: Ninety two male patients from 20-60 years of age reported for direct or indirect inguinal hernia with open Mesh/Lichtenstein or darn repair in emergency or electively from January 2014 to December 2015 were enrolled in this prospective randomized control trial (RCT)...
May 2017: Pakistan Journal of Medical Sciences Quarterly
https://www.readbyqxmd.com/read/28811738/predictors-of-retention-among-african-americans-in-a-randomized-controlled-trial-to-test-the-healthy-eating-and-active-living-in-the-spirit-heals-intervention
#6
Oluwole A Babatunde, Swann Arp Adams, Michael D Wirth, Jan M Eberth, Jameson Sofge, Seul Ki Choi, Brook E Harmon, Lisa Davis, Ruby Drayton, Thomas G Hurley, Heather M Brandt, Cheryl A Armstead, James R Hébert
INTRODUCTION: Retention of racial/ethnic minority groups into research trials is necessary to fully understand and address health disparities. This study was conducted to identify participants' characteristics associated with retention of African Americans (AAs) in a randomized controlled trial (RCT) of a behavioral intervention. METHODS: Using data from an RCT conducted from 2009 to 2012 among AAs, participant-level factors were examined for associations with retention between three measurement points (ie, baseline, 3-month, and 12-month)...
2017: Ethnicity & Disease
https://www.readbyqxmd.com/read/28811351/content-and-construct-validity-reliability-and-responsiveness-of-the-rheumatoid-arthritis-flare-questionnaire-omeract-2016-workshop-report
#7
Susan J Bartlett, Skye P Barbic, Vivian P Bykerk, Ernest H Choy, Rieke Alten, Robin Christensen, Alfons den Broeder, Bruno Fautrel, Daniel E Furst, Francis Guillemin, Sarah Hewlett, Amye L Leong, Anne Lyddiatt, Lyn March, Pamela Montie, Christoph Pohl, Marieke Scholte Voshaar, Thasia G Woodworth, Clifton O Bingham
OBJECTIVE: The Outcome Measures in Rheumatology (OMERACT) Rheumatoid Arthritis (RA) Flare Group was established to develop a reliable way to identify and measure RA flares in randomized controlled trials (RCT). Here, we summarized the development and field testing of the RA Flare Questionnaire (RA-FQ), and the voting results at OMERACT 2016. METHODS: Classic and modern psychometric methods were used to assess reliability, validity, sensitivity, factor structure, scoring, and thresholds...
August 15, 2017: Journal of Rheumatology
https://www.readbyqxmd.com/read/28810909/a-multi-center-randomized-controlled-open-label-trial-evaluating-the-effects-of-eosinophil-guided-corticosteroid-sparing-therapy-in-hospitalised-patients-with-copd-exacerbations-the-cortico-steroid-reduction-in-copd-cortico-cop-study-protocol
#8
Pradeesh Sivapalan, Mia Moberg, Josefin Eklöf, Julie Janner, Jørgen Vestbo, Rasmus Rude Laub, Andrea Browatzki, Karin Armbruster, Jon Torgny Wilcke, Niels Seersholm, Ulla Møller Weinreich, Ingrid Louise Titlestad, Helle Frost Andreassen, Charlotte Suppli Ulrik, Uffe Bødtger, Thyge Lynghøj Nielsen, Ejvind Frausing Hansen, Jens Ulrik Stæhr Jensen
BACKGROUND: The most commonly applied treatment for acute exacerbations of chronic obstructive pulmonary disease (AECOPD) is a 5-day course of high-dose systemic corticosteroids. However, this treatment has not been shown to reduce mortality and can potentially have serious side effects. Recent research has shown that, presumably, only a subgroup of COPD patients identifieable by blood eosinophil count benefit from a rescue course of prednisolone. By applying a biomarker-guided strategy, the aim of this study is to determine whether it is possible to reduce the use of systemic corticosteroids in AECOPD without influencing the outcome...
August 15, 2017: BMC Pulmonary Medicine
https://www.readbyqxmd.com/read/28810841/effectiveness-of-online-and-mobile-telephone-applications-apps-for-the-self-management-of-suicidal-ideation-and-self-harm-a-systematic-review-and-meta-analysis
#9
Katrina Witt, Matthew J Spittal, Gregory Carter, Jane Pirkis, Sarah Hetrick, Dianne Currier, Jo Robinson, Allison Milner
BACKGROUND: Online and mobile telephone applications ('apps') have the potential to improve the scalability of effective interventions for suicidal ideation and self-harm. The aim of this review was therefore to investigate the effectiveness of digital interventions for the self-management of suicidal ideation or self-harm. METHODS: Seven databases (Applied Science & Technology; CENTRAL; CRESP; Embase; Global Health; PsycARTICLES; PsycINFO; Medline) were searched to 31 March, 2017...
August 15, 2017: BMC Psychiatry
https://www.readbyqxmd.com/read/28810136/dysfunctional-posttraumatic-cognitions-as-a-mediator-of-symptom-reduction-in-trauma-focused-cognitive-behavioral-therapy-with-children-and-adolescents-results-of-a-randomized-controlled-trial
#10
Elisa Pfeiffer, Cedric Sachser, Anke de Haan, Dunja Tutus, Lutz Goldbeck
OBJECTIVE: To investigate whether the change in dysfunctional posttraumatic cognitions (PTC) during Trauma-Focused Cognitive Behavioral Therapy (TF-CBT) is a mediator of posttraumatic stress symptom (PTSS) reduction in a sample of children and adolescents. METHOD: A bootstrap mediation analysis was performed to investigate the indirect effect of dysfunctional PTC on treatment outcome in a recently completed RCT study with children and adolescents (n = 123; 7-17 years old) that investigated the effectiveness of TF-CBT...
August 4, 2017: Behaviour Research and Therapy
https://www.readbyqxmd.com/read/28809637/-comparison-of-short-therm-results-of-conservative-versus-operative-treatment-of-distal-ulna-fractures-associated-with-distal-radius-fracture-treated-by-plate-osteosynthesis
#11
P Meluzinová, L Kopp, P Dráč, K Edelmann, P Obruba
PURPOSE OF THE STUDY The study aims to evaluate and compare the results of conservative and operative treatment of individual types of distal ulna fractures associated with distal radius fracture treated by plate osteosynthesis and to verify the conclusions of the other authors regarding the recommended therapeutic procedures in these fractures. MATERIAL AND METHODS In the period from 08/2013 to 09/2015, a total of 81 patients participated in the prospective randomised study, with the mean follow-up period of 24 months (6-36)...
2017: Acta Chirurgiae Orthopaedicae et Traumatologiae Cechoslovaca
https://www.readbyqxmd.com/read/28807033/sponsorship-bias-and-quality-of-randomised-controlled-trials-in-veterinary-medicine
#12
K J Wareham, R M Hyde, D Grindlay, M L Brennan, R S Dean
BACKGROUND: Randomised controlled trials (RCTs) are considered the gold standard form of evidence for assessing treatment efficacy, but many factors can influence their reliability including methodological quality, reporting quality and funding source. The aim of this study was to examine the relationship between funding source and positive outcome reporting in veterinary RCTs published in 2011 and to assess the risk of bias in the RCTs identified. METHODS: A structured search of PubMed was used to identify feline, canine, equine, bovine and ovine clinical trials examining the efficacy of pharmaceutical interventions published in 2011...
August 14, 2017: BMC Veterinary Research
https://www.readbyqxmd.com/read/28806994/patterns-of-locoregional-failure-following-post-operative-intensity-modulated-radiotherapy-to-oral-cavity-cancer-quantitative-spatial-and-dosimetric-analysis-using-a-deformable-image-registration-workflow
#13
Abdallah S R Mohamed, Andrew J Wong, Clifton D Fuller, Mona Kamal, Gary B Gunn, Jack Phan, William H Morrison, Beth M Beadle, Heath Skinner, Stephen Y Lai, Sean R Quinlan-Davidson, Abdelaziz M Belal, Ahmed G El-Gowily, Steven J Frank, David I Rosenthal, Adam S Garden
BACKGROUND: We sought to identify spatial/dosimetric patterns of failure for oral cavity cancer patients receiving post-operative IMRT (PO-IMRT). METHODS: Two hundred eighty-nine OCC patients receiving PO-IMRT were retrospectively reviewed from 2000 to 2012. Diagnostic CT documenting recurrence (rCT) was co-registered with planning CT (pCT) using a validated deformable image registration software. Manually segmented recurrent gross disease (rGTV) was deformed to co-registered pCTs...
August 15, 2017: Radiation Oncology
https://www.readbyqxmd.com/read/28806480/aerosolized-prostacyclins-for-acute-respiratory-distress-syndrome-ards
#14
REVIEW
Arash Afshari, Anders Bastholm Bille, Mikkel Allingstrup
BACKGROUND: Acute respiratory distress syndrome (ARDS) is a critical condition that is associated with high mortality and morbidity. Aerosolized prostacyclin has been used to improve oxygenation despite the limited evidence available so far.This review was originally published in 2010 and updated in 2017. OBJECTIVES: To assess the benefits and harms of aerosolized prostacyclin in adults and children with ARDS. SEARCH METHODS: In this update, we searched CENTRAL (2017, Issue 4); MEDLINE (OvidSP), Embase (OvidSP), ISI BIOSIS Previews, ISI Web of Science, LILACS, CINAHL (EBSCOhost), and three trials registers...
July 24, 2017: Cochrane Database of Systematic Reviews
https://www.readbyqxmd.com/read/28805717/the-fragility-index-in-a-cohort-of-pediatric-randomized-controlled-trials
#15
Travis J Matics, Nadia Khan, Priti Jani, Jason M Kane
Data suggest inadequacy of common statistical techniques for reporting outcomes in clinical trials. The Fragility Index can measure how many events the statistical significance hinges on, and may facilitate better interpretation of trial results. This study aimed to assess the Fragility Index in pediatric randomized controlled trials (RCTs) with statistically significant findings published in high-quality medical journals. A Fragility Index was calculated on included trials with dichotomous positive outcomes...
August 14, 2017: Journal of Clinical Medicine
https://www.readbyqxmd.com/read/28805255/mandibular-complete-denture-versus-single-implant-overdenture-a-systematic-review-of-patient-reported-outcomes
#16
REVIEW
Túlio Eduardo Nogueira, Danilo Rocha Dias, Cláudio Rodrigues Leles
The single-implant mandibular overdenture (SIMO) has been proposed as an alternative for edentulous patients who are poorly adapted to their dentures due to low retention and stability of the conventional mandibular complete denture (CD). However, there is a lack of evidence regarding the effectiveness of SIMO, which can be measured by examining patient perception of treatment effects. The aim of this systematic review was to assess the comparative results of CD and SIMO treatments by using patient-reported outcome measures...
August 14, 2017: Journal of Oral Rehabilitation
https://www.readbyqxmd.com/read/28803834/transcutaneous-auricular-vagal-nerve-stimulation-tavns-might-be-a-mechanism-behind-the-analgesic-effects-of-auricular-acupuncture
#17
Taras Usichenko, Henriette Hacker, Martin Lotze
BACKGROUND: Randomized clinical trials (RCT) demonstrated that auricular acupuncture (AA) is effective in treatment of acute and chronic pain, although the mechanisms behind AA are not elucidated. METHODS: The data concerning the localization of AA points, which are commonly used to treat pain, were extracted from the meta-analysis of 17 RCTs and evaluated using the anatomical map of auricular afferent nerve supply. RESULTS: Fifteen out of 20 specific AA points, used in the treatment of pain, are situated in areas innervated mostly by the auricular branch of the vagal nerve (ABVN), whereas sham stimulation was applied at the helix of the auricle, innervated by cervical nerves...
August 2, 2017: Brain Stimulation
https://www.readbyqxmd.com/read/28803752/optimal-dose-timing-and-ratio-of-blood-products-in-massive-transfusion-results-from-a-systematic-review
#18
REVIEW
Zoe K McQuilten, Gemma Crighton, Susan Brunskill, Jessica K Morison, Tania H Richter, Neil Waters, Michael F Murphy, Erica M Wood
Optimal dose, timing and ratio to red blood cells (RBC) of blood component therapy (fresh frozen plasma [FFP], platelets, cryoprecipitate or fibrinogen concentrate) to reduce morbidity and mortality in critically bleeding patients requiring massive transfusion is unknown. We performed a systematic review for randomized controlled trials (RCT) in MEDLINE, The Cochrane Library, Embase, CINAHL, PubMed the Transfusion Evidence Library and using multiple clinical trials registries to 21 February 2017. Sixteen RCTs were identified: six completed (five in adult trauma patients, one pediatric burn patients) and ten ongoing trials...
July 6, 2017: Transfusion Medicine Reviews
https://www.readbyqxmd.com/read/28801475/understanding-the-gap-between-efficacy-in-randomized-controlled-trials-and-effectiveness-in-real-world-use-of-glp-1ra-and-dpp4-therapies-in-patients-with-type-2-diabetes
#19
Ginger S Carls, Edward Tuttle, Ruo-Ding Tan, Johnny Huynh, John Yee, Steven V Edelman, William H Polonsky
OBJECTIVE: This objective of this study was to estimate and explain the gap between clinical efficacy and real-world (RW) effectiveness of type 2 diabetes medications. RESEARCH DESIGN AND METHODS: This mixed-methods quasi-experimental study used retrospective claims (Optum/Humedica) to compare the change in HbA1c of RW patients with type 2 diabetes 12 months after starting a glucagon-like peptide-1 receptor agonist (GLP-1RA) or dipeptidyl peptidase-4 inhibitor (DPP4) with published findings from randomized controlled trials (RCTs) evaluating these drugs...
August 11, 2017: Diabetes Care
https://www.readbyqxmd.com/read/28801473/type-2-diabetes-in-the-real-world-the-elusive-nature-of-glycemic-control
#20
Steven V Edelman, William H Polonsky
Despite U.S. Food and Drug Administration (FDA) approval of over 40 new treatment options for type 2 diabetes since 2005, the latest data from the National Health and Nutrition Examination Survey show that the proportion of patients achieving glycated hemoglobin (HbA1c) <7.0% (<53 mmol/mol) remains around 50%, with a negligible decline between the periods 2003-2006 and 2011-2014. The Healthcare Effectiveness Data and Information Set reports even more alarming rates, with only about 40% and 30% of patients achieving HbA1c <7...
August 11, 2017: Diabetes Care
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