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Trial methodology

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https://www.readbyqxmd.com/read/28110382/economic-evaluations-alongside-efficient-study-designs-using-large-observational-datasets-the-pleasant-trial-case-study
#1
Matthew Franklin, Sarah Davis, Michelle Horspool, Wei Sun Kua, Steven Julious
BACKGROUND: Large observational datasets such as Clinical Practice Research Datalink (CPRD) provide opportunities to conduct clinical studies and economic evaluations with efficient designs. OBJECTIVES: Our objectives were to report the economic evaluation methodology for a cluster randomised controlled trial (RCT) of a UK NHS-delivered public health intervention for children with asthma that was evaluated using CPRD and describe the impact of this methodology on results...
January 21, 2017: PharmacoEconomics
https://www.readbyqxmd.com/read/28109722/sleep-insomnia-and-hypertension-current-findings-and-future-directions
#2
REVIEW
S Justin Thomas, David Calhoun
Blood pressure (BP) varies over 24 hours. During normal sleep, BP typically decreases by 10% or more. Research suggests that disordered sleep, particularly sleep deprivation and obstructive sleep apnea, is associated with increased BP and risk of hypertension. Less is known about the relationship between insomnia and hypertension. Population-based studies have reported an association between insomnia symptoms and both prevalent and incident hypertension, particularly in the context of short sleep duration...
December 29, 2016: Journal of the American Society of Hypertension: JASH
https://www.readbyqxmd.com/read/28109628/preoperative-bathing-of-the-surgical-site-with-chlorhexidine-for-infection-prevention-systematic-review-with-meta-analysis
#3
Lúcia Maciel de Castro Franco, Gláucia Fernandes Cota, Tatiana Saraiva Pinto, Flávia Falci Ercole
BACKGROUND: Preoperative bathing with 4% chlorhexidine is recommended as a measure to prevent surgical site infection (SSI) despite uncertainty regarding the effectiveness of the intervention. This review aimed to assess the effect of bathing with 4% chlorhexidine on the prevention of SSIs in clean surgeries compared with bathing with placebo solution or soap. METHODS: Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines for systematic reviews and the Cochrane manual were followed...
January 18, 2017: American Journal of Infection Control
https://www.readbyqxmd.com/read/28109405/challenges-and-methodology-in-the-incorporation-of-biomarkers-in-cancer-clinical-trials
#4
REVIEW
Charlotte S Wilhelm-Benartzi, Shahrul Mt-Isa, Francesca Fiorentino, Robert Brown, Deborah Ashby
Biomarkers can be used to establish more homogeneous groups using the genetic makeup of the tumour to inform the selection of treatment for each individual patient. However, proper preclinical work and stringent validation are needed before taking forward biomarkers into confirmatory studies. Despite the challenges, incorporation of biomarkers into clinical trials could better target appropriate patients, and potentially be lifesaving. The authors conducted a systematic review to describe marker-based and adaptive design methodology for their integration in clinical trials, and to further describe the associated practical challenges...
February 2017: Critical Reviews in Oncology/hematology
https://www.readbyqxmd.com/read/28109160/antibiotics-for-infection-prevention-after-excision-of-the-cervical-transformation-zone
#5
REVIEW
Chumnan Kietpeerakool, Bandit Chumworathayi, Jadsada Thinkhamrop, Butsakorn Ussahgij, Pisake Lumbiganon
BACKGROUND: Excision of the transformation zone of the cervix is the most commonly used approach to treat cervical precancerous lesions (cervical intraepithelial neoplasia (CIN)) to reduce the risk of developing cervical cancer. As the excision of the transformation zone leaves a raw area on the cervix, there is a risk of infection following the procedure. The incidence of infection after cold knife conization (CKC) is 36%, whereas the incidence for large loop excision of the transformation zone (LLETZ, also known as loop electrical excision procedure (LEEP)) is much lower (0...
January 21, 2017: Cochrane Database of Systematic Reviews
https://www.readbyqxmd.com/read/28108686/use-of-mechanical-insufflation-exsufflation-devices-for-airway-clearance-in-subjects-with-neuromuscular-disease
#6
REVIEW
Catherine Auger, Vanessa Hernando, Hubert Galmiche
The aim of this systematic review is to examine the benefit/risk ratio of the use of mechanical insufflation-exsufflation (MI-E) devices for airway clearance in patients with neuromuscular diseases. A search was conducted for relevant studies in MEDLINE, the Cochrane Library, and the Health Technology Assessment Database using the main key words: cough, airway clearance, in-exsufflation. The search limits were studies published in English and French between 1970 and 2014 (literature watch until December 2015)...
February 2017: Respiratory Care
https://www.readbyqxmd.com/read/28108321/virtual-reality-conditioned-place-preference-using-monetary-reward
#7
Emma Childs, Robert S Astur, Harriet de Wit
Computerized tasks based on conditioned place preference (CPP) methodology offer the opportunity to study learning mechanisms involved in conditioned reward in humans. In this study, we examined acquisition and extinction of a CPP for virtual environments associated with monetary reward ($). Healthy men and women (N=57) completed a computerized CPP task in which they controlled an avatar within a virtual environment. On day 1, subjects completed 6 conditioning trials in which one room was paired with high $ and another with low $...
January 17, 2017: Behavioural Brain Research
https://www.readbyqxmd.com/read/28108179/symptomatic-treatment-of-cough-among-adult-patients-with-lung-cancer-chest-guidelines-and-expert-panel-report
#8
Alex Molassiotis, Jaclyn A Smith, Peter Mazzone, Fiona Blackhall, Richard S Irwin
BACKGROUND: Cough among patients with lung cancer is a common but often undertreated symptom. We have used a recent Cochrane systematic review, among other sources of evidence, to update the recommendations and suggestions of the CHEST 2006 guideline on this topic. METHODS: The American College of Chest Physicians (CHEST) methodologic guidelines and the Grading of Recommendations, Assessment, Development, and Evaluation framework were used. The Expert Cough Panel based their recommendations on data from the Cochrane systematic review on the topic, uncontrolled studies, case studies, and the clinical context...
January 17, 2017: Chest
https://www.readbyqxmd.com/read/28107664/safety-and-efficacy-of-cardiopoietic-stem-cells-in-the-treatment-of-post-infarction-left-ventricular-dysfunction-from-cardioprotection-to-functional-repair-in-a-translational-pig-infarction-model
#9
Maximilian Y Emmert, Petra Wolint, Andras Jakab, Sean P Sheehy, Francesco S Pasqualini, Thi Dan Linh Nguyen, Monika Hilbe, Burkhardt Seifert, Benedikt Weber, Chad E Brokopp, Dominika Macejovska, Etem Caliskan, Arnold von Eckardstein, Ruth Schwartlander, Viola Vogel, Volkmar Falk, Kevin Kit Parker, Mariann Gyöngyösi, Simon P Hoerstrup
To date, clinical success of cardiac cell-therapies remains limited. To enhance the cardioreparative properties of stem cells, the concept of lineage-specification through cardiopoietic-guidance has been recently suggested. However, so far, only results from murine studies and from a clinical pilot-trial in chronic heart-failure (CHF) are available, while systematic evidence of its therapeutic-efficacy is still lacking. Importantly, also no data from large animals or for other indications are available. Therefore, we here investigate the therapeutic-efficacy of human cardiopoietic stem cells in the treatment of post-infarction LV-dysfunction using a translational pig-model...
November 23, 2016: Biomaterials
https://www.readbyqxmd.com/read/28106822/red-fruits-extraction-of-antioxidants-phenolic-content-and-radical-scavenging-determination-a-review
#10
REVIEW
Gádor-Indra Hidalgo, María Pilar Almajano
Red fruits, as rich antioxidant foods, have gained over recent years capital importance for consumers and manufacturers. The industrial extraction of the phenolic molecules from this source has been taking place with the conventional solvent extraction method. New non-conventional extraction methods have been devised as environmentally friendly alternatives to the former method, such as ultrasound, microwave, and pressure assisted extractions. The aim of this review is to compile the results of recent studies using different extraction methodologies, identify the red fruits with higher antioxidant activity, and give a global overview of the research trends regarding this topic...
January 19, 2017: Antioxidants (Basel, Switzerland)
https://www.readbyqxmd.com/read/28106272/health-claims-and-methodological-controversy-in-nutrition-science
#11
Oliver Todt, José Luis Luján
This article analyzes the debate about data acquisition and assessment in health claims regulation by identifying the underlying controversies on methodological choice. Regulation in the European Union imposes the need for a scientific substantiation of all health claims (claims about a relationship between consumption of certain food ingredients and positive health effects). Randomized controlled trials (RCTs) are the method that generally is considered to provide the highest quality data for decision making in claims regulation because they allow for establishing cause-effect relationships...
January 20, 2017: Risk Analysis: An Official Publication of the Society for Risk Analysis
https://www.readbyqxmd.com/read/28106094/sham-electroacupuncture-methods-in-randomized-controlled-trials
#12
Zi-Xian Chen, Yan Li, Xiao-Guang Zhang, Shuang Chen, Wen-Ting Yang, Xia-Wei Zheng, Guo-Qing Zheng
Sham electroacupuncture (EA) control is commonly used to evaluate the specific effects of EA in randomized-controlled trials (RCTs). However, establishing an inert and concealable sham EA control remains methodologically challenging. Here, we aimed to systematically investigate the sham EA methods. Eight electronic databases were searched from their inception to April 2015. Ten out of the 17 sham EA methods were identified from 94 RCTs involving 6134 participants according to three aspects: needle location, depth of needle insertion and electrical stimulation...
January 20, 2017: Scientific Reports
https://www.readbyqxmd.com/read/28103918/the-effects-of-asking-a-fertility-intention-question-in-primary-care-settings-a-systematic-review-protocol
#13
Paul A Henning, Carolyne K Burgess, Heidi E Jones, Wendy V Norman
BACKGROUND: Planning for pregnancy has been associated with reduced unwanted pregnancies and improved pregnancy outcomes. Despite the benefits of planned pregnancy, there are no guideline recommendations on routine counseling regarding pregnancy intention in primary care settings. The objective of the systematic review is to determine the effectiveness of incorporating questions of pregnancy intention into primary care. METHODS: A systematic search of the literature will be conducted for any studies comparing questions of pregnancy intention in primary care settings with no intervention or a control intervention...
January 19, 2017: Systematic Reviews
https://www.readbyqxmd.com/read/28103853/effectiveness-of-aquatic-therapy-vs-land-based-therapy-for-balance-and-pain-in-women-with-fibromyalgia-a-study-protocol-for-a-randomised-controlled-trial
#14
Sabela Rivas Neira, Amélia Pasqual Marques, Irene Pegito Pérez, Ramón Fernández Cervantes, Jamile Vivas Costa
BACKGROUND: Fibromyalgia is a disease with an increasing incidence. It impairs the quality of life of patients and decreases their functional capacity. Aquatic therapy has already been used for managing the symptoms of this syndrome. However, aquatic therapy has only recently been introduced as a treatment modality for improving proprioception in fibromyalgia. The main objective of this study is to determine the effectiveness of two physiotherapy protocols, one in and one out of water, for improving balance and decreasing pain in women with fibromyalgia...
January 19, 2017: BMC Musculoskeletal Disorders
https://www.readbyqxmd.com/read/28102100/a-systematic-review-the-influence-of-real-time-feedback-on-wheelchair-propulsion-biomechanics
#15
Andrew Symonds, Giulia Barbareschi, Stephen Taylor, Catherine Holloway
BACKGROUND: Clinical guidelines recommend that, in order to minimize upper limb injury risk, wheelchair users adopt a semi-circular pattern with a slow cadence and a large push arc. OBJECTIVES: To examine whether real time feedback can be used to influence manual wheelchair propulsion biomechanics. REVIEW METHODS: Clinical trials and case series comparing the use of real time feedback against no feedback were included. A general review was performed and methodological quality assessed by two independent practitioners using the Downs and Black checklist...
January 19, 2017: Disability and Rehabilitation. Assistive Technology
https://www.readbyqxmd.com/read/28101720/enhanced-recovery-after-surgery-programs-for-liver-resection-a-meta-analysis
#16
Cheng Wang, Guoqun Zheng, Wenlong Zhang, Fabiao Zhang, Shangdong Lv, Aidong Wang, Zheping Fang
BACKGROUND AND AIMS: Due to the limited number of high-quality randomized controlled trials on enhanced recovery after surgery for hepatectomy, previous reviews have not been sufficiently comprehensive. Our objectives were to evaluate and compare the safety and efficacy of enhanced recovery after surgery programs and traditional care in patients undergoing open or laparoscopic surgery and to assess the optimized items for hepatectomy. METHODS: We searched the PubMed, Embase, and the Cochrane Library databases for all the relevant studies regardless of study design...
January 18, 2017: Journal of Gastrointestinal Surgery: Official Journal of the Society for Surgery of the Alimentary Tract
https://www.readbyqxmd.com/read/28100441/assessing-the-efficacy-of-an-app-based-method-of-family-planning-the-dot-study-protocol
#17
Rebecca G Simmons, Dominick C Shattuck, Victoria H Jennings
BACKGROUND: Some 222 million women worldwide have unmet needs for contraception; they want to avoid pregnancy, but are not using a contraceptive method, primarily because of concerns about side effects associated with most available methods. Expanding contraceptive options-particularly fertility awareness options that provide women with information about which days during their menstrual cycles they are likely to become pregnant if they have unprotected intercourse-has the potential to reduce unmet need...
January 18, 2017: JMIR Research Protocols
https://www.readbyqxmd.com/read/28100276/realising-stratified-psychiatry-using-multidimensional-signatures-and-trajectories
#18
Dan W Joyce, Angie A Kehagia, Derek K Tracy, Jessica Proctor, Sukhwinder S Shergill
BACKGROUND: Stratified or personalised medicine targets treatments for groups of individuals with a disorder based on individual heterogeneity and shared factors that influence the likelihood of response. Psychiatry has traditionally defined diagnoses by constellations of co-occurring signs and symptoms that are assigned a categorical label (e.g. schizophrenia). Trial methodology in psychiatry has evaluated interventions targeted at these categorical entities, with diagnoses being equated to disorders...
January 18, 2017: Journal of Translational Medicine
https://www.readbyqxmd.com/read/28100160/determining-the-potential-benefits-of-yoga-in-chronic-stroke-care-a-systematic-review-and-meta-analysis
#19
Tharshanah Thayabaranathan, Nadine E Andrew, Maarten A Immink, Susan Hillier, Philip Stevens, Rene Stolwyk, Monique Kilkenny, Dominique A Cadilhac
BACKGROUND: Survivors of stroke have long-term physical and psychological consequences that impact their quality of life. Few interventions are available in the community to address these problems. Yoga, a type of mindfulness-based intervention, is shown to be effective in people with other chronic illnesses and may have the potential to address many of the problems reported by survivors of stroke. OBJECTIVES: To date only narrative reviews have been published. We sought to perform, the first systematic review with meta-analyses of randomized controlled trials (RCTs) that investigated yoga for its potential benefit for chronic survivors of stroke...
January 19, 2017: Topics in Stroke Rehabilitation
https://www.readbyqxmd.com/read/28099689/effectiveness-and-safety-of-procalcitonin-evaluation-for-reducing-mortality-in-adults-with-sepsis-severe-sepsis-or-septic-shock
#20
REVIEW
Brenda Ng Andriolo, Regis B Andriolo, Reinaldo Salomão, Álvaro N Atallah
BACKGROUND: Serum procalcitonin (PCT) evaluation has been proposed for early diagnosis and accurate staging and to guide decisions regarding patients with sepsis, severe sepsis and septic shock, with possible reduction in mortality. OBJECTIVES: To assess the effectiveness and safety of serum PCT evaluation for reducing mortality and duration of antimicrobial therapy in adults with sepsis, severe sepsis or septic shock. SEARCH METHODS: We searched the Central Register of Controlled Trials (CENTRAL; 2015, Issue 7); MEDLINE (1950 to July 2015); Embase (Ovid SP, 1980 to July 2015); Latin American Caribbean Health Sciences Literature (LILACS via BIREME, 1982 to July 2015); and the Cumulative Index to Nursing and Allied Health Literature (CINAHL; EBSCO host, 1982 to July 2015), and trial registers (ISRCTN registry, ClinicalTrials...
January 18, 2017: Cochrane Database of Systematic Reviews
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