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https://www.readbyqxmd.com/read/29691998/a-novel-method-to-combine-assessment-of-benefit-and-harm-omeract-3x3-methodology-applied-to-two-active-comparator-trials
#1
Maarten Boers, Jasvinder A Singh, Stacey S Cofield, S Louis Bridges, Larry W Moreland, James R O'Dell, Hongsheng Wu, Sarah Leatherman, Jeffrey R Curtis
INTRODUCTION: The Outcome Measures in Rheumatology (OMERACT) '3x3' method analyzes the occurrence of benefit and harm simultaneously at the individual patient level. We applied this method to two recent rheumatoid arthritis (RA) trial datasets. METHODS: Treatment of Early Aggressive RA (TEAR) and the RA Comparison of Active Therapies (RACAT) randomized trial outcomes for safety were defined according to OMERACT as no events, non-serious events, and serious events...
April 25, 2018: Arthritis Care & Research
https://www.readbyqxmd.com/read/29691297/validation-of-a-plasma-based-comprehensive-cancer-genotyping-assay-utilizing-orthogonal-tissue-and-plasma-based-methodologies
#2
Justin I Odegaard, John J Vincent, Stefanie Mortimer, James V Vowles, Bryan C Ulrich, Kimberly C Banks, Stephen R Fairclough, Oliver A Zill, Marcin Sikora, Reza Mokhtari, Diana Abdueva, Rebecca J Nagy, Christine E Lee, Lesli A Kiedrowski, Cloud P Paweletz, Helmy Eltoukhy, Richard B Lanman, Darya I Chudova, AmirAli Talasaz
PURPOSE: Liquid biopsies are powerful tools that enable non-invasive genotyping of advanced solid tumors; however, comprehensive, structured validation studies employing validated orthogonal comparator methods are lacking. EXPERIMENTAL DESIGN: Analytical validation was conducted according to established principles and guidelines. Blood-to-blood clinical validation comprised blinded external comparison to clinical digital droplet PCR across 222 consecutive biomarker-positive clinical samples...
April 24, 2018: Clinical Cancer Research: An Official Journal of the American Association for Cancer Research
https://www.readbyqxmd.com/read/29691101/influenza-vaccination-in-the-elderly-is-a-trial-on-mortality-ethically-acceptable
#3
Ruud Andreas Fritz Verhees, Wybo Dondorp, Carel Thijs, Geert Jan Dinant, Johannes Andreas Knottnerus
The effectiveness of influenza vaccination in the elderly has long been a topic of debate, fueled by the absence of direct evidence from randomized trials on its effect on mortality and the methodological limitations of observational studies pointing this direction. It is argued that new placebo-controlled trials should be undertaken to resolve this uncertainty. However, such trials may be ethically questionable. To bring this discussion forward, we provide a comprehensive overview of the ethical challenges of an influenza vaccine efficacy trial designed to evaluate mortality in the elderly...
April 21, 2018: Vaccine
https://www.readbyqxmd.com/read/29688573/antidepressants-for-the-treatment-of-people-with-co-occurring-depression-and-alcohol-dependence
#4
REVIEW
Roberta Agabio, Emanuela Trogu, Pier Paolo Pani
BACKGROUND: Alcohol dependence is a major public health problem characterized by recidivism, and medical and psychosocial complications. The co-occurrence of major depression in people entering treatment for alcohol dependence is common, and represents a risk factor for morbidity and mortality, which negatively influences treatment outcomes. OBJECTIVES: To assess the benefits and risks of antidepressants for the treatment of people with co-occurring depression and alcohol dependence...
April 24, 2018: Cochrane Database of Systematic Reviews
https://www.readbyqxmd.com/read/29688301/right-minithoracotomy-versus-median-sternotomy-for-reoperative-mitral-valve-surgery-a-systematic-review-and-meta-analysis-of-observational-studies
#5
Jean H T Daemen, Samuel Heuts, Jules R Olsthoorn, Jos G Maessen, Peyman Sardari Nia
Reoperative mitral valve surgery (MVS) through a median sternotomy (ST-MVS) can be particularly challenging due to dense adhesions and is known to carry a substantial risk of injuries to vascular structures. These injuries occur in 7-9% of cases and are associated with increased mortality rates. A valid alternative that could avoid the risks associated with redo ST-MVS is the right anterolateral minithoracotomy (MT-MVS) approach. The aim of this study was to quantify the effects of MT-MVS compared with those of ST-MVS on morbidity and mortality among patients who underwent prior cardiac surgery through a sternotomy...
April 23, 2018: European Journal of Cardio-thoracic Surgery
https://www.readbyqxmd.com/read/29688176/impact-of-bleeding-assessment-and-adjudication-methodology-on-event-rates-and-clinical-trial-outcomes-insights-from-the-horizons-ami-trial
#6
Ioanna Kosmidou, Gary S Mintz, Tannas Jatene, Monica Embacher, Björn Redfors, S Chiu Wong, Ovidiu Dressler, Roxana Mehran, Ori Ben-Yehuda, Paul L Jenkins, Gregg W Stone
AIMS: Bleeding is a major safety outcome in cardiovascular trials. The present study assessed the impact of the adjudication process of bleeding events on 3-year outcomes in the Harmonizing Outcomes with Revascularization and Stents in Acute Myocardial Infarction (HORIZONS-AMI) trial. METHODS AND RESULTS: HORIZONS-AMI enrolled 3,602 patients with ST-segment elevation myocardial infarction undergoing primary percutaneous coronary intervention. An independent CEC reviewed 445 potential bleeding events identified from 3 sources: 339 site-reported (SR), 35 CEC-identified, and 71 database (DB)-triggered events based on programmatic identification of a decline in hemoglobin of ≥3 g/dL or in hematocrit by ≥9%; of those, 383/445 (86...
April 24, 2018: EuroIntervention
https://www.readbyqxmd.com/read/29687024/improved-stratification-of-als-clinical-trials-using-predicted-survival
#7
James D Berry, Albert A Taylor, Danielle Beaulieu, Lisa Meng, Amy Bian, Jinsy Andrews, Mike Keymer, David L Ennist, Bernard Ravina
Introduction: In small trials, randomization can fail, leading to differences in patient characteristics across treatment arms, a risk that can be reduced by stratifying using key confounders. In ALS trials, riluzole use (RU) and bulbar onset (BO) have been used for stratification. We hypothesized that randomization could be improved by using a multifactorial prognostic score of predicted survival as a single stratifier. Methods: We defined a randomization failure as a significant difference between treatment arms on a characteristic...
April 2018: Annals of Clinical and Translational Neurology
https://www.readbyqxmd.com/read/29686975/laparoscopic-versus-open-surgery-for-hepatocellular-carcinoma-a-meta-analysis-of-high-quality-case-matched-studies
#8
REVIEW
Ke Chen, Yu Pan, Bin Zhang, Xiao-Long Liu, Hendi Maher, Xue-Yong Zheng
Objective: To present a meta-analysis of high-quality case-matched studies comparing laparoscopic (LH) and open hepatectomy (OH) for hepatocellular carcinoma (HCC). Methods: Studies published up to September 2017 comparing LH and OH for HCC were identified. Selection of high-quality, nonrandomized comparative studies (NRCTs) with case-matched design was based on a validated tool (Methodological Index for Nonrandomized Studies) since no randomized controlled trials (RCTs) were published...
2018: Canadian Journal of Gastroenterology & Hepatology
https://www.readbyqxmd.com/read/29685678/prophylactic-mesh-reinforcement-versus-sutured-closure-to-prevent-incisional-hernias-after-open-abdominal-aortic-aneurysm-repair-via-midline-laparotomy-a-systematic-review-and-meta-analysis
#9
REVIEW
Reza Indrakusuma, Hamid Jalalzadeh, Jessica E van der Meij, Ron Balm, Mark J W Koelemay
OBJECTIVE/BACKGROUND: Incisional hernia is a frequent late complication after open abdominal aortic aneurysm (AAA) repair. We aimed to determine whether prophylactic mesh reinforcement of the abdominal wall at open AAA repair via midline laparotomy reduces the rate of incisional hernia compared to standard sutured closure. METHODS: A systematic review and meta-analysis was carried out in accordance with the PRISMA statement (PROSPERO registration CRD42017072508)...
April 20, 2018: European Journal of Vascular and Endovascular Surgery
https://www.readbyqxmd.com/read/29685058/the-effect-of-open-vs-closed-kinetic-chain-exercises-on-anterior-tibial-laxity-strength-and-function-following-anterior-cruciate-ligament-reconstruction-a-systematic-review-and-meta-analysis
#10
Alyssa Perriman, Edmund Leahy, Adam Ivan Semciw
Study Design Systematic review with meta-analysis. Background There is controversy surrounding the early use of Open Kinetic Chain (OKC) quadriceps strengthening exercises post anterior cruciate ligament reconstruction (ACLR) due to the belief that increased strain in the graft could cause damage. Objectives To determine if OKC quadriceps exercises result in differences in anterior tibial laxity, strength, function, quality of life or adverse events in the ACLR population, when compared to closed kinetic chain (CKC) quadriceps exercises...
April 23, 2018: Journal of Orthopaedic and Sports Physical Therapy
https://www.readbyqxmd.com/read/29684391/a-randomized-control-trial-of-preoperative-prophylactic-antibiotics-prior-to-percutaneous-nephrolithotomy-in-low-infectious-risk-population-a-report-from-the-edge-consortium
#11
Ben H Chew, Nicole L Miller, Joel E Abbott, Dirk Lange, Mitchell R Humphreys, Vernon M Pais, Manoj Monga, Amy E Krambeck, Roger L Sur
INTRODUCTION: Single institution studies suggest a benefit of a week of preoperative antibiotics prior to percutaneous nephrolithotomy (PCNL). These studies are limited by lower quality methodology such as the inclusion of heterogeneous populations or the use of non-standard definitions of sepsis. The American Urological Association (AUA) Best Practice Statement recommends <24 hours of IV antibiotics, but no other data exist about the duration/benefit of preoperative antibiotics. We sought to perform a rigorous (using CONSORT guidelines), multi-institutional trial to assess preoperative antibiotics in PCNL patients at low risk of developing infections...
April 20, 2018: Journal of Urology
https://www.readbyqxmd.com/read/29684249/standard-head-down-tilt-versus-modified-without-head-down-tilt-postural-drainage-in-infants-and-young-children-with-cystic-fibrosis
#12
REVIEW
Diana A Freitas, Gabriela Ss Chaves, Thayla A Santino, Cibele Td Ribeiro, Fernando Al Dias, Ricardo O Guerra, Karla Mpp Mendonça
BACKGROUND: Postural drainage is used primarily in infants with cystic fibrosis from diagnosis up to the moment when they are mature enough to actively participate in self-administered treatments. However, there is a risk of gastroesophageal reflux associated with this technique.This is an update of a review published in 2015. OBJECTIVES: To compare the effects of standard postural drainage (15º to 45º head-down tilt) with modified postural drainage (15º to 30º head-up tilt) with regard to gastroesophageal reflux in infants and young children up to six years old with cystic fibrosis in terms of safety and efficacy...
March 9, 2018: Cochrane Database of Systematic Reviews
https://www.readbyqxmd.com/read/29683474/antidepressants-for-the-treatment-of-depression-in-people-with-cancer
#13
REVIEW
Giovanni Ostuzzi, Faith Matcham, Sarah Dauchy, Corrado Barbui, Matthew Hotopf
BACKGROUND: Major depression and other depressive conditions are common in people with cancer. These conditions are not easily detectable in clinical practice, due to the overlap between medical and psychiatric symptoms, as described by diagnostic manuals such as the Diagnostic and Statistical Manual of Mental Disorders (DSM) and International Classification of Diseases (ICD). Moreover, it is particularly challenging to distinguish between pathological and normal reactions to such a severe illness...
April 23, 2018: Cochrane Database of Systematic Reviews
https://www.readbyqxmd.com/read/29682533/bilateral-hip-arthroplasty-when-is-it-safe-to-operate-the-second-hip-a-systematic-review
#14
REVIEW
Meilyn Muskus, Jorge Rojas, Camilo Gutiérrez, Juan Guio, Guillermo Bonilla, Adolfo Llinás
Introduction: Patients with degenerative hip disease frequently present with bilateral involvement that requires surgical management. The main goal when treating these patients is to achieve the maximum efficiency without increasing risk of perioperative complications; therefore, the decision regarding the best moment to operate the second hip becomes relevant. Although studies have addressed this topic, whether a simultaneous or staged surgery should be performed remains controversial...
2018: BioMed Research International
https://www.readbyqxmd.com/read/29682277/the-allergic-rhinitis-clinical-investigator-collaborative-ar-cic-verification-of-nasal-allergen-challenge-procedures-in-a-study-utilizing-an-investigational-immunotherapy-for-cat-allergy
#15
Helen Neighbour, Mena Soliman, Lisa M Steacy, Pascal Hickey, Beth Forbes, Mark Larché, Anne K Ellis
Background: The Allergic Rhinitis Clinical Investigator Collaborative (AR-CIC) is a network of experienced Allergic Rhinitis (AR) researchers developing better research tools based on the nasal allergen challenge (NAC). A key objective of such is the ability to detect efficacy in a small population. AR-CIC sought to test its NAC protocol as a secondary objective in two small mechanistic research trials of a novel form of immunotherapy [Cat Peptide Antigen Desensitisation (Cat-PAD)] for which efficacy had previously been demonstrated...
2018: Clinical and Translational Allergy
https://www.readbyqxmd.com/read/29682147/acupuncture-or-acupressure-on-yintang-ex-hn-3-for-anxiety-a-preliminary-review
#16
REVIEW
Chan-Young Kwon, Boram Lee
Background: Anxiety is a very common psychiatric symptom and can also occur in many physical conditions. Due to the limitations of conventional pharmacotherapy, the discovery of nonpharmacologic treatments that alleviate anxiety effectively is clinically important. Yintang (EX-HN 3), an acupoint located between the eyebrows, is known to have a mentally stabilizing effect in Traditional Chinese Medicine. Objectives: This preliminary review was conducted to investigate the current state of studies using acupressure or acupuncture on EX-HN 3 alone for anxiety, and to explore ways to apply this in clinical settings and future research, including systematic reviews and clinical trials...
April 1, 2018: Medical Acupuncture
https://www.readbyqxmd.com/read/29681213/therapeutic-whole-body-hypothermia-reduces-mortality-in-severe-traumatic-brain-injury-if-the-cooling-index-is-sufficiently-high-meta-analyses-of-the-effect-of-single-cooling-parameters-and-their-integrated-measure
#17
Emoke Olah, Laszlo Poto, Peter Hegyi, Imre Szabo, Petra Hartmann, Margit Solymar, Erika Petervari, Marta Balasko, Tamas Habon, Zoltan Rumbus, Judit Tenk, Ildiko Rostas, Jordan Weinberg, Andrej A Romanovsky, Andras Garami
Therapeutic hypothermia was investigated repeatedly as a tool to improve the outcome of severe traumatic brain injury (TBI), but previous clinical trials and meta-analyses found contradictory results. We aimed to determine the effectiveness of therapeutic whole-body hypothermia on the mortality of adult patients with severe TBI by using a novel approach of meta-analysis. We searched the PubMed, EMBASE, and Cochrane Library databases from inception to February 2017. The identified human studies were evaluated regarding statistical, clinical, and methodological designs to ensure inter-study homogeneity...
April 21, 2018: Journal of Neurotrauma
https://www.readbyqxmd.com/read/29680895/patent-foramen-ovale-and-stroke
#18
Bruno Miranda, Ana Catarina Fonseca, José M Ferro
A patent foramen ovale (PFO) is a highly prevalent finding in cryptogenic ischaemic stroke, particularly in young adults. A common challenge in clinical practice is to distinguish between incidental and pathogenic PFO. Some clinical features and tools such as the Risk of Paradoxical Embolism score may help determining the probability of a stroke-related PFO. Nonetheless, the best therapeutic option to reduce stroke recurrence after a cryptogenic stroke with PFO has been a matter of debate for a long time. We review the mechanisms of stroke-related PFO, together with its clinical features and diagnostic criteria...
April 21, 2018: Journal of Neurology
https://www.readbyqxmd.com/read/29680840/is-arthrocentesis-of-temporomandibular-joint-with-corticosteroids-beneficial-a-systematic-review
#19
A Davoudi, H Khaki, I Mohammadi, M Daneshmand, A Tamizifar, M Bigdelou, F Ansaripoor
BACKGROUND: Temporomandibular disorders (TMDs) are musculoskeletal conditions that can inhibit the normal function of temporomandibular joints (TMJs) and affect the patient's quality of life, negatively. Arthrocentesis (AC) is a minimally invasive surgical procedure used for treating TMDs. The aim of present paper is to evaluate the advantages of administrating corticosteroid (CS) during AC by reviewing high quality released articles. MATERIAL AND METHODS: Searching on Cochrane Library, Web of Science, Google Scholar, PubMed, ProQuest, and Scopus databases were performed with focusing on proper key words...
April 22, 2018: Medicina Oral, Patología Oral y Cirugía Bucal
https://www.readbyqxmd.com/read/29680814/spect-v-q-for-the-diagnosis-of-pulmonary-embolism-protocol-for-a-systematic-review-and-meta-analysis-of-diagnostic-accuracy-and-clinical-outcome
#20
Pierre-Yves Le Roux, Philippe Robin, Cécile Tromeur, Alexandra Davis, Helia Robert-Ebadi, Marc Carrier, Francis Couturaud, Grégoire Le Gal, Pierre-Yves Salaun
INTRODUCTION: Single photon emission computed tomography ventilation/perfusion (SPECT V/Q) imaging has many proponents within the nuclear medicine community and has already largely replaced planar V/Q scintigraphy in daily practice for the diagnosis of pulmonary embolism (PE). However, the test is still described in clinical guidelines as an experimental test because of insufficient evidence. METHODS AND ANALYSIS: We will conduct a systematic review and a meta-analysis of diagnostic accuracy and management outcome studies involving patients evaluated with V/Q SPECT for suspected acute PE...
April 21, 2018: BMJ Open
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